budesonide (Rx)

Brand and Other Names:Entocort EC, Uceris, more...Ortikos, Tarpeyo

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule, delayed-release

  • 3mg (Entocort EC)
  • 4mg (Tarpeyo)
  • 6mg (Ortikos)
  • 9mg (Ortikos)

tablet, extended-release

  • 9mg (Uceris)

Ulcerative Colitis

Uceris only

Indicated for the induction of remission of active, mild-to-moderate ulcerative colitis

9 mg PO qAM for up to 8 weeks

Crohn Disease

Entocort EC or Ortikos

Indicated for treatment of mild-to-moderate active Crohn disease involving the ileum and/or ascending colon

Induction

  • 9 mg PO qAM for up to 8 weeks; for recurring episodes of active disease, 8-week courses may be repeated
  • Once symptoms are controlled, may be tapered to 6 mg PO qAM for maintenance

Maintenance

  • 6 mg PO qAM for up to 3 months
  • If symptom control is maintained at 3 months, tapering to complete cessation may be attempted (recommended)

Primary Immunoglobulin A Nephropathy

Tarpeyo only

Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g

16 mg PO qDay

Therapy duration: 9 Months

When discontinuing, reduce to 8 mg PO qDay for the last 2 weeks of therapy

Safety and efficacy of treatment with subsequent courses have not been established

Dosage Modifications

Hepatic impairment

  • Mild: No dosage modification recommended
  • Moderate-to-severe: Consider discontinuing budesonide

Renal impairment

  • Not studied; intact budesonide is not renally excreted, but metabolites are renally excreted to a large extent; metabolites have negligible corticosteroid activity compared with budesonide

Immunoglobulin A Nephropathy (Orphan)

Orphan designation to slow progression of immunoglobulin A nephropathy, and therefore, delaying of onset of kidney failure in patients affected by this disease

Orphan sponsor

  • Pharmalink AB; Engelbrekts kyrkogata 7b; Stockholm, Sweden

Cholangitis (Orphan)

Orphan designation for treatment of primary biliary cholangitis

Orphan sponsor

  • Calliditas Therapeutics AB; 26B Wallingatan; Norrmalm,Sweden

Eosinophilic Esophagitis (Orphan)

Orphan designation for treatment of eosinophilic esophagitis

Orphan sponsor

  • Salix Pharmaceuticals, Inc., division of Valeant Pharmaceuticals North America; 400 Somerset Corporate Boulevard; Bridgewater, NJ 08807

Dosage Forms & Strengths

capsule, extended-release

  • 3mg (Entocort EC)
  • 6mg (Ortikos)
  • 9mg (Ortikos)

Crohn Disease

Entocort EC or Ortikos

Indicated for mild-to-moderate active Crohn disease involving the ileum and/or the ascending colon in patients aged ≥8 years

<8 years: Safety and efficacy not established

≥8 years and weight >25 kg: 9 mg PO qAm for up to 8 weeks, followed by 6 mg qAM for 2 weeks

Ulcerative Colitis (Orphan)

Orphan designation (budesonide [Uceris]) for treatment ulcerative colitis in pediatric patients aged 0 through 16 years

Orphan sponsor

  • Santarus, Inc.; 3611 Valley Centre Drive, Suite 400; San Diego, CA 92130
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Interactions

Interaction Checker

and budesonide

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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             activity indicator 

            Contraindicated (3)

            • lopinavir

              lopinavir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • mifepristone

              mifepristone, budesonide. Mechanism: unknown. Contraindicated. Mfr. states that mifepristone is contraindicated in pts. on long term corticosteroid Tx.

            • ribociclib

              ribociclib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            Serious - Use Alternative (77)

            • abametapir

              abametapir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • aldesleukin

              budesonide decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

            • anthrax vaccine

              budesonide decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • apalutamide

              apalutamide will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • BCG vaccine live

              budesonide decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • carbamazepine

              carbamazepine will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ceritinib

              ceritinib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • cimetidine

              cimetidine will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • clarithromycin

              clarithromycin will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • dihydroergotamine

              budesonide will decrease the level or effect of dihydroergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • dihydroergotamine intranasal

              budesonide will decrease the level or effect of dihydroergotamine intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • diltiazem

              diltiazem will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of CYP3A4 inhibitors and oral budesonide. If coadministration is necessary, closely monitor for signs and symptoms of corticosteroid excess.

            • diphtheria & tetanus toxoids

              budesonide decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • diphtheria & tetanus toxoids/ acellular pertussis vaccine

              budesonide decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine

              budesonide decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • dronedarone

              budesonide will decrease the level or effect of dronedarone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ergotamine

              budesonide will decrease the level or effect of ergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin base

              erythromycin base will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              budesonide will decrease the level or effect of erythromycin base by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              budesonide will decrease the level or effect of erythromycin ethylsuccinate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              budesonide will decrease the level or effect of erythromycin lactobionate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              budesonide will decrease the level or effect of erythromycin stearate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • everolimus

              budesonide will decrease the level or effect of everolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • hepatitis A vaccine inactivated

              budesonide decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • hepatitis a/b vaccine

              budesonide decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • hepatitis a/typhoid vaccine

              budesonide decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • hepatitis b vaccine

              budesonide decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • human papillomavirus vaccine, nonavalent

              budesonide decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

            • human papillomavirus vaccine, quadrivalent

              budesonide decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

            • influenza virus vaccine quadrivalent

              budesonide decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine quadrivalent, cell-cultured

              budesonide decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine quadrivalent, intranasal

              budesonide decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine trivalent

              budesonide decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • itraconazole

              itraconazole will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration is necessary, closely monitor for signs and symptoms of corticosteroid excess.

            • ivosidenib

              ivosidenib will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • Japanese encephalitis virus vaccine

              budesonide decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • ketoconazole

              ketoconazole will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lasmiditan

              lasmiditan increases levels of budesonide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • levoketoconazole

              levoketoconazole will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lonafarnib

              lonafarnib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

            • macimorelin

              budesonide, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH growth hormone release before administering prior to administration of macimorelin. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin.

            • measles (rubeola) vaccine

              budesonide decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • measles mumps and rubella vaccine, live

              budesonide decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • measles, mumps, rubella and varicella vaccine, live

              budesonide decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • meningococcal A C Y and W-135 polysaccharide vaccine combined

              budesonide decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • mifepristone

              mifepristone will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • nefazodone

              nefazodone will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • pneumococcal vaccine 13-valent

              budesonide decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • pneumococcal vaccine heptavalent

              budesonide decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • pneumococcal vaccine polyvalent

              budesonide decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • quinidine

              quinidine will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • rabies vaccine

              budesonide decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids may interfere with development of active immunity.

            • rabies vaccine chick embryo cell derived

              budesonide decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • ranolazine

              budesonide will decrease the level or effect of ranolazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifabutin

              rifabutin will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifampin

              rifampin will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rotavirus oral vaccine, live

              budesonide decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • rubella vaccine

              budesonide decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • saquinavir

              saquinavir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • silodosin

              budesonide will decrease the level or effect of silodosin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • sirolimus

              budesonide will decrease the level or effect of sirolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • smallpox (vaccinia) vaccine, live

              budesonide decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • sotorasib

              sotorasib will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

            • squill

              budesonide increases toxicity of squill by unspecified interaction mechanism. Avoid or Use Alternate Drug.

            • St John's Wort

              St John's Wort will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • tepotinib

              tepotinib will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

            • tetanus toxoid adsorbed or fluid

              budesonide decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • tick-borne encephalitis vaccine

              budesonide decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • tolvaptan

              budesonide will decrease the level or effect of tolvaptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • travelers diarrhea and cholera vaccine inactivated

              budesonide decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • tucatinib

              tucatinib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • typhoid polysaccharide vaccine

              budesonide decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • typhoid vaccine live

              budesonide decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • varicella virus vaccine live

              budesonide decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • voxelotor

              voxelotor will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            • yellow fever vaccine

              budesonide decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • zoster vaccine live

              budesonide decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            Monitor Closely (228)

            • aceclofenac

              aceclofenac, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • acemetacin

              acemetacin, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • almotriptan

              budesonide will decrease the level or effect of almotriptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • alprazolam

              budesonide will decrease the level or effect of alprazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • aluminum hydroxide

              aluminum hydroxide decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • aluminum hydroxide/magnesium carbonate

              aluminum hydroxide/magnesium carbonate decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • aluminum hydroxide/magnesium trisilicate

              aluminum hydroxide/magnesium trisilicate decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • amiodarone

              budesonide will decrease the level or effect of amiodarone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              amiodarone will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • amobarbital

              amobarbital will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • antithrombin alfa

              budesonide, antithrombin alfa. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • antithrombin III

              budesonide, antithrombin III. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • aprepitant

              aprepitant will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of aprepitant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • argatroban

              budesonide, argatroban. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • aripiprazole

              budesonide will decrease the level or effect of aripiprazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • armodafinil

              armodafinil will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • artemether/lumefantrine

              artemether/lumefantrine will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of artemether/lumefantrine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • aspirin rectal

              aspirin rectal, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • aspirin/citric acid/sodium bicarbonate

              aspirin/citric acid/sodium bicarbonate decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • atazanavir

              atazanavir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • atorvastatin

              atorvastatin will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • bazedoxifene/conjugated estrogens

              budesonide will decrease the level or effect of bazedoxifene/conjugated estrogens by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • belzutifan

              belzutifan will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

            • bemiparin

              budesonide, bemiparin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • berotralstat

              berotralstat will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

            • bivalirudin

              budesonide, bivalirudin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • bosentan

              bosentan will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • buspirone

              budesonide will decrease the level or effect of buspirone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • butabarbital

              butabarbital will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • butalbital

              butalbital will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • calcium carbonate

              calcium carbonate decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • carbamazepine

              budesonide will decrease the level or effect of carbamazepine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • celecoxib

              celecoxib, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • cenobamate

              cenobamate will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • cholestyramine

              cholestyramine decreases levels of budesonide by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • choline magnesium trisalicylate

              choline magnesium trisalicylate, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • cilostazol

              budesonide will decrease the level or effect of cilostazol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • cimetidine

              cimetidine decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • cinacalcet

              budesonide will decrease the level or effect of cinacalcet by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • citric acid/sodium bicarbonate

              citric acid/sodium bicarbonate decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • clarithromycin

              clarithromycin will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • clopidogrel

              budesonide will increase the level or effect of clopidogrel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. CYP3A4 inducers may increase the metabolism of clopidogrel to its active metabolite. Monitor patients for potential increase in antiplatelet effects when CYP3A4 inducers are used in combination with clopidogrel

            • clotrimazole

              clotrimazole will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • clozapine

              budesonide will decrease the level or effect of clozapine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • cobicistat

              cobicistat will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • colchicine

              budesonide will decrease the level or effect of colchicine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • conivaptan

              conivaptan will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of conivaptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • conjugated estrogens

              budesonide will decrease the level or effect of conjugated estrogens by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • conjugated estrogens, vaginal

              budesonide will decrease the level or effect of conjugated estrogens, vaginal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • cortisone

              budesonide will decrease the level or effect of cortisone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • crizotinib

              crizotinib increases levels of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

            • crofelemer

              crofelemer increases levels of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

            • cyclosporine

              cyclosporine will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              cyclosporine will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • dabrafenib

              dabrafenib will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • dalteparin

              budesonide, dalteparin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • darifenacin

              darifenacin will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • darunavir

              darunavir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of darunavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dasatinib

              dasatinib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of dasatinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • deferasirox

              deferasirox will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including corticosteroids.

            • denosumab

              budesonide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • dexamethasone

              budesonide will decrease the level or effect of dexamethasone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dexlansoprazole

              dexlansoprazole decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • DHEA, herbal

              DHEA, herbal will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dichlorphenamide

              dichlorphenamide and budesonide both decrease serum potassium. Use Caution/Monitor.

            • diclofenac

              diclofenac, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • diflunisal

              diflunisal, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • dronedarone

              dronedarone will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              dronedarone will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • duvelisib

              duvelisib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. will increase the level or effect of

            • elagolix

              elagolix will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              elagolix will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • eletriptan

              budesonide will decrease the level or effect of eletriptan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • eliglustat

              eliglustat increases levels of budesonide by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

            • encorafenib

              encorafenib, budesonide. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • enoxaparin

              budesonide, enoxaparin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • erlotinib

              budesonide will decrease the level or effect of erlotinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • erythromycin base

              erythromycin base will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • esomeprazole

              esomeprazole decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • estradiol

              budesonide will decrease the level or effect of estradiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • estrogens conjugated synthetic

              budesonide will decrease the level or effect of estrogens conjugated synthetic by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • estropipate

              budesonide will decrease the level or effect of estropipate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • etodolac

              etodolac, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • etravirine

              budesonide will decrease the level or effect of etravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              etravirine will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • famotidine

              famotidine decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • fedratinib

              fedratinib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • felodipine

              budesonide will decrease the level or effect of felodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              felodipine will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • fenoprofen

              fenoprofen, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • fesoterodine

              budesonide will decrease the level or effect of fesoterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fingolimod

              budesonide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • fluconazole

              fluconazole will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fludrocortisone

              budesonide will decrease the level or effect of fludrocortisone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • flurbiprofen

              flurbiprofen, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • fluvoxamine

              fluvoxamine will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fondaparinux

              budesonide, fondaparinux. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • fosamprenavir

              fosamprenavir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of fosamprenavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fosaprepitant

              fosaprepitant will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of fosaprepitant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              fosphenytoin will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • glecaprevir/pibrentasvir

              glecaprevir/pibrentasvir will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • grapefruit

              grapefruit will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • griseofulvin

              griseofulvin will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • haemophilus influenzae type b vaccine

              budesonide decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored.

            • heparin

              budesonide, heparin. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • hydrocortisone

              budesonide will decrease the level or effect of hydrocortisone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • hydroxyprogesterone caproate (DSC)

              budesonide will decrease the level or effect of hydroxyprogesterone caproate (DSC) by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ibuprofen

              ibuprofen, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • ibuprofen IV

              ibuprofen IV, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • ibuprofen/famotidine

              ibuprofen/famotidine decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • idelalisib

              idelalisib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Corticosteroids may be needed to treat severe diarrhea or colitis associated with idelalisib therapy. Strong CYP3A4 inhibitors are known to increase systemic exposure to oral budesonide. Monitor closely for increased systemic corticosteroid effects.

            • iloperidone

              budesonide will decrease the level or effect of iloperidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              iloperidone increases levels of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

            • indinavir

              indinavir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              indinavir will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • indomethacin

              indomethacin, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • influenza virus vaccine quadrivalent, recombinant

              budesonide decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • influenza virus vaccine trivalent, recombinant

              budesonide decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • isoniazid

              isoniazid will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              istradefylline will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

            • ivacaftor

              ivacaftor increases levels of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.

            • ketoconazole

              ketoconazole will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              ketoconazole increases effects of budesonide by decreasing metabolism. Use Caution/Monitor.

            • ketoprofen

              ketoprofen, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • ketorolac

              ketorolac, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • ketorolac intranasal

              ketorolac intranasal, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • lansoprazole

              lansoprazole decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • lapatinib

              lapatinib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of lapatinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • letermovir

              letermovir increases levels of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • levoketoconazole

              levoketoconazole will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              levoketoconazole increases effects of budesonide by decreasing metabolism. Use Caution/Monitor.

            • lopinavir

              budesonide will decrease the level or effect of lopinavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • loratadine

              budesonide will decrease the level or effect of loratadine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              loratadine will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • lornoxicam

              lornoxicam, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • lumefantrine

              budesonide will decrease the level or effect of lumefantrine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              lumefantrine will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • magnesium oxide

              magnesium oxide decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • maraviroc

              budesonide will decrease the level or effect of maraviroc by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • marijuana

              marijuana will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • meclofenamate

              meclofenamate, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • mefenamic acid

              mefenamic acid, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • meloxicam

              meloxicam, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • mestranol

              budesonide will decrease the level or effect of mestranol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • methadone

              budesonide will decrease the level or effect of methadone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • methylprednisolone

              budesonide will decrease the level or effect of methylprednisolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • metronidazole

              metronidazole will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • miconazole vaginal

              miconazole vaginal will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • midazolam

              budesonide will decrease the level or effect of midazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • mitotane

              mitotane decreases levels of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • nabumetone

              nabumetone, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • nafcillin

              nafcillin will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • naproxen

              naproxen, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • nefazodone

              nefazodone will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nelfinavir

              nelfinavir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nevirapine

              nevirapine will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nicardipine

              budesonide will decrease the level or effect of nicardipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              nicardipine will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nifedipine

              nifedipine will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              nifedipine will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nilotinib

              nilotinib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of nilotinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              nilotinib will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nirmatrelvir

              nirmatrelvir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration may increase certain systemic corticosteroid concentrations. Increased risk for Cushing syndrome and adrenal suppression. Consider alternant corticosteroids, including beclomethasone and prednisolone).

            • nirmatrelvir/ritonavir

              nirmatrelvir/ritonavir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration may increase certain systemic corticosteroid concentrations. Increased risk for Cushing syndrome and adrenal suppression. Consider alternant corticosteroids, including beclomethasone and prednisolone).

            • nisoldipine

              budesonide will decrease the level or effect of nisoldipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nizatidine

              nizatidine decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • ofatumumab SC

              ofatumumab SC, budesonide. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • omeprazole

              omeprazole decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • oxaliplatin

              oxaliplatin and budesonide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.

            • oxaprozin

              oxaprozin, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • oxcarbazepine

              oxcarbazepine will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • pantoprazole

              pantoprazole decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • parecoxib

              parecoxib, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • pazopanib

              budesonide will decrease the level or effect of pazopanib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • pentobarbital

              pentobarbital will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • phenindione

              budesonide, phenindione. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • phenobarbital

              phenobarbital will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              phenobarbital will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • phenytoin

              phenytoin will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              phenytoin will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • piroxicam

              piroxicam, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • poliovirus vaccine inactivated

              budesonide decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .

            • ponatinib

              ponatinib increases levels of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • posaconazole

              posaconazole will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • prednisone

              budesonide will decrease the level or effect of prednisone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • primidone

              primidone will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • protamine

              budesonide, protamine. Other (see comment). Use Caution/Monitor. Comment: Corticosteroids may decrease anticoagulant effects by increasing blood coagulability; conversely, they may impair vascular integrity, thus increasing bleeding risk. Monitor INR closely.

            • quercetin

              quercetin will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • quetiapine

              budesonide will decrease the level or effect of quetiapine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • quinidine

              budesonide will decrease the level or effect of quinidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • quinupristin/dalfopristin

              quinupristin/dalfopristin will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rabeprazole

              rabeprazole decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

            • ranolazine

              ranolazine will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • repaglinide

              budesonide will decrease the level or effect of repaglinide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifampin

              rifampin will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • rifapentine

              rifapentine will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ritonavir

              ritonavir will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of ritonavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              ritonavir will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • rufinamide

              rufinamide will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • salicylates (non-asa)

              salicylates (non-asa), budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • salsalate

              salsalate, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • saquinavir

              budesonide will decrease the level or effect of saquinavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • sarecycline

              sarecycline will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

            • secobarbital

              secobarbital will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • simvastatin

              simvastatin will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • sipuleucel-T

              budesonide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • sirolimus

              sirolimus will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • sodium sulfate/potassium sulfate/magnesium sulfate/polyethylene glycol

              budesonide and sodium sulfate/potassium sulfate/magnesium sulfate/polyethylene glycol both decrease serum potassium. Modify Therapy/Monitor Closely.

            • solifenacin

              budesonide will decrease the level or effect of solifenacin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • somatrem

              budesonide decreases effects of somatrem by pharmacodynamic antagonism. Use Caution/Monitor.

            • sorafenib

              budesonide decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • St John's Wort

              St John's Wort will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • stiripentol

              stiripentol, budesonide. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              stiripentol will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

            • sulfasalazine

              sulfasalazine, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • sulindac

              sulindac, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • sunitinib

              budesonide will decrease the level or effect of sunitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tacrolimus

              budesonide will decrease the level or effect of tacrolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              tacrolimus will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • tadalafil

              budesonide will decrease the level or effect of tadalafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tazemetostat

              tazemetostat will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • temsirolimus

              budesonide will decrease the level or effect of temsirolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • theophylline

              budesonide will decrease the level or effect of theophylline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tipranavir

              budesonide will decrease the level or effect of tipranavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tolfenamic acid

              tolfenamic acid, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • tolmetin

              tolmetin, budesonide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of GI ulceration.

            • tolterodine

              budesonide will decrease the level or effect of tolterodine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tolvaptan

              tolvaptan will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • topiramate

              topiramate will decrease the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • trastuzumab

              trastuzumab, budesonide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, budesonide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • trazodone

              budesonide will decrease the level or effect of trazodone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              trazodone will decrease the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • triamcinolone acetonide injectable suspension

              budesonide will decrease the level or effect of triamcinolone acetonide injectable suspension by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • triazolam

              budesonide will decrease the level or effect of triazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tucatinib

              tucatinib will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

            • vardenafil

              budesonide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • verapamil

              verapamil will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              budesonide will decrease the level or effect of verapamil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              verapamil will increase the level or effect of budesonide by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • voriconazole

              voriconazole will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • xipamide

              xipamide, budesonide. pharmacodynamic synergism. Use Caution/Monitor. Risk of hypokalemia.

            • zafirlukast

              zafirlukast will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • zoster vaccine recombinant

              budesonide decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

            Minor (108)

            • acarbose

              budesonide decreases effects of acarbose by pharmacodynamic antagonism. Minor/Significance Unknown.

            • acetazolamide

              acetazolamide will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • alfentanil

              budesonide will decrease the level or effect of alfentanil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • alfuzosin

              budesonide will decrease the level or effect of alfuzosin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • alosetron

              budesonide will decrease the level or effect of alosetron by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • amitriptyline

              budesonide will decrease the level or effect of amitriptyline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • amphotericin B deoxycholate

              amphotericin B deoxycholate, budesonide. Mechanism: unspecified interaction mechanism. Minor/Significance Unknown. Potential for hypokalemia.

            • anastrozole

              anastrozole will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • armodafinil

              budesonide will decrease the level or effect of armodafinil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • aspirin rectal

              budesonide decreases levels of aspirin rectal by increasing renal clearance. Minor/Significance Unknown.

            • atazanavir

              budesonide will decrease the level or effect of atazanavir by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • balsalazide

              budesonide decreases levels of balsalazide by increasing renal clearance. Minor/Significance Unknown.

            • bendroflumethiazide

              budesonide, bendroflumethiazide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • bosentan

              budesonide will decrease the level or effect of bosentan by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • bumetanide

              budesonide, bumetanide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • calcium acetate

              budesonide decreases levels of calcium acetate by increasing elimination. Minor/Significance Unknown.

            • calcium carbonate

              budesonide decreases levels of calcium carbonate by increasing elimination. Minor/Significance Unknown.

            • calcium chloride

              budesonide decreases levels of calcium chloride by increasing elimination. Minor/Significance Unknown.

            • calcium citrate

              budesonide decreases levels of calcium citrate by increasing elimination. Minor/Significance Unknown.

            • calcium gluconate

              budesonide decreases levels of calcium gluconate by increasing elimination. Minor/Significance Unknown.

            • cevimeline

              budesonide will decrease the level or effect of cevimeline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • chlorothiazide

              budesonide, chlorothiazide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • chlorpropamide

              budesonide decreases effects of chlorpropamide by pharmacodynamic antagonism. Minor/Significance Unknown.

            • chlorthalidone

              budesonide, chlorthalidone. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • choline magnesium trisalicylate

              budesonide decreases levels of choline magnesium trisalicylate by increasing renal clearance. Minor/Significance Unknown.

            • chromium

              budesonide decreases levels of chromium by increasing renal clearance. Minor/Significance Unknown.

            • clarithromycin

              budesonide will decrease the level or effect of clarithromycin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • clomipramine

              budesonide will decrease the level or effect of clomipramine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • cyclopenthiazide

              budesonide, cyclopenthiazide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • cyclophosphamide

              cyclophosphamide will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • cyclosporine

              budesonide, cyclosporine. Either increases levels of the other by decreasing metabolism. Minor/Significance Unknown.

            • danazol

              danazol, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • dapsone

              budesonide will decrease the level or effect of dapsone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • diflunisal

              budesonide decreases levels of diflunisal by increasing renal clearance. Minor/Significance Unknown.

            • disopyramide

              budesonide will decrease the level or effect of disopyramide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • donepezil

              budesonide will decrease the level or effect of donepezil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • dutasteride

              budesonide will decrease the level or effect of dutasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • eplerenone

              budesonide will decrease the level or effect of eplerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ethacrynic acid

              budesonide, ethacrynic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • eucalyptus

              budesonide will decrease the level or effect of eucalyptus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • feverfew

              budesonide decreases effects of feverfew by pharmacodynamic antagonism. Minor/Significance Unknown.

            • finasteride

              budesonide will decrease the level or effect of finasteride by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • fluoxymesterone

              fluoxymesterone, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • furosemide

              budesonide, furosemide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • galantamine

              budesonide will decrease the level or effect of galantamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • glimepiride

              budesonide decreases effects of glimepiride by pharmacodynamic antagonism. Minor/Significance Unknown.

            • glipizide

              budesonide decreases effects of glipizide by pharmacodynamic antagonism. Minor/Significance Unknown.

            • glyburide

              budesonide decreases effects of glyburide by pharmacodynamic antagonism. Minor/Significance Unknown.

            • hydrochlorothiazide

              budesonide, hydrochlorothiazide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • imatinib

              budesonide will decrease the level or effect of imatinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • imipramine

              budesonide will decrease the level or effect of imipramine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • indapamide

              budesonide, indapamide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • insulin aspart

              budesonide decreases effects of insulin aspart by pharmacodynamic antagonism. Minor/Significance Unknown.

            • insulin detemir

              budesonide decreases effects of insulin detemir by pharmacodynamic antagonism. Minor/Significance Unknown.

            • insulin glargine

              budesonide decreases effects of insulin glargine by pharmacodynamic antagonism. Minor/Significance Unknown.

            • insulin glulisine

              budesonide decreases effects of insulin glulisine by pharmacodynamic antagonism. Minor/Significance Unknown.

            • insulin lispro

              budesonide decreases effects of insulin lispro by pharmacodynamic antagonism. Minor/Significance Unknown.

            • insulin NPH

              budesonide decreases effects of insulin NPH by pharmacodynamic antagonism. Minor/Significance Unknown.

            • insulin regular human

              budesonide decreases effects of insulin regular human by pharmacodynamic antagonism. Minor/Significance Unknown.

            • isoniazid

              budesonide decreases effects of isoniazid by unknown mechanism. Minor/Significance Unknown.

            • isradipine

              budesonide will decrease the level or effect of isradipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ketoconazole

              budesonide will decrease the level or effect of ketoconazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • larotrectinib

              larotrectinib will increase the level or effect of budesonide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • levoketoconazole

              budesonide will decrease the level or effect of levoketoconazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • mesalamine

              budesonide decreases levels of mesalamine by increasing renal clearance. Minor/Significance Unknown.

            • mesterolone

              mesterolone, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • metformin

              budesonide decreases effects of metformin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • methyclothiazide

              budesonide, methyclothiazide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • metolazone

              budesonide, metolazone. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • metyrapone

              budesonide decreases effects of metyrapone by unspecified interaction mechanism. Minor/Significance Unknown.

            • miglitol

              budesonide decreases effects of miglitol by pharmacodynamic antagonism. Minor/Significance Unknown.

            • montelukast

              budesonide will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • nateglinide

              budesonide decreases effects of nateglinide by pharmacodynamic antagonism. Minor/Significance Unknown.

            • nifedipine

              budesonide will decrease the level or effect of nifedipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • nimodipine

              budesonide will decrease the level or effect of nimodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • nitrendipine

              budesonide will decrease the level or effect of nitrendipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • oxandrolone

              oxandrolone, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • oxybutynin

              budesonide will decrease the level or effect of oxybutynin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • oxymetholone

              oxymetholone, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • paclitaxel

              budesonide will decrease the level or effect of paclitaxel by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • paclitaxel protein bound

              budesonide will decrease the level or effect of paclitaxel protein bound by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • parecoxib

              budesonide will decrease the level or effect of parecoxib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • pimozide

              budesonide will decrease the level or effect of pimozide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • pioglitazone

              budesonide will decrease the level or effect of pioglitazone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              budesonide decreases effects of pioglitazone by pharmacodynamic antagonism. Minor/Significance Unknown.

            • propafenone

              budesonide will decrease the level or effect of propafenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • quinine

              budesonide will decrease the level or effect of quinine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • repaglinide

              budesonide decreases effects of repaglinide by pharmacodynamic antagonism. Minor/Significance Unknown.

            • rosiglitazone

              budesonide decreases effects of rosiglitazone by pharmacodynamic antagonism. Minor/Significance Unknown.

            • salicylates (non-asa)

              budesonide decreases levels of salicylates (non-asa) by increasing renal clearance. Minor/Significance Unknown.

            • salsalate

              budesonide decreases levels of salsalate by increasing renal clearance. Minor/Significance Unknown.

            • sargramostim

              budesonide increases effects of sargramostim by pharmacodynamic synergism. Minor/Significance Unknown.

            • saxagliptin

              budesonide will decrease the level or effect of saxagliptin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              budesonide decreases effects of saxagliptin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • sitagliptin

              budesonide decreases effects of sitagliptin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • somatropin

              budesonide decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • sufentanil

              budesonide will decrease the level or effect of sufentanil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • sulfasalazine

              budesonide decreases levels of sulfasalazine by increasing renal clearance. Minor/Significance Unknown.

            • tacrolimus

              budesonide, tacrolimus. Either increases levels of the other by decreasing metabolism. Minor/Significance Unknown.

            • testosterone

              testosterone, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • testosterone buccal system

              testosterone buccal system, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • testosterone topical

              testosterone topical, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

            • tolazamide

              budesonide decreases effects of tolazamide by pharmacodynamic antagonism. Minor/Significance Unknown.

            • tolbutamide

              budesonide decreases effects of tolbutamide by pharmacodynamic antagonism. Minor/Significance Unknown.

            • torsemide

              budesonide, torsemide. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypokalemia, especially with strong glucocorticoid activity.

            • vildagliptin

              budesonide decreases effects of vildagliptin by pharmacodynamic antagonism. Minor/Significance Unknown.

            • vincristine liposomal

              budesonide will decrease the level or effect of vincristine liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • willow bark

              budesonide decreases levels of willow bark by increasing renal clearance. Minor/Significance Unknown.

            • ziprasidone

              budesonide will decrease the level or effect of ziprasidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • zonisamide

              budesonide will decrease the level or effect of zonisamide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Headache (21%)

            Acne (<5-15%)

            Nausea (11%)

            Respiratory infection (11%)

            IgAN

            • Hypertension (16%)
            • Peripheral edema (14%)
            • Muscle spasms (13%)
            • Acne (11%)

            1-10%

            Back pain (7%)

            Dizziness (7%)

            Abdominal pain (6%)

            Dyspepsia (6%)

            Vomiting (6%)

            Fatigue (5%)

            IgAN

            • Dermatitis (7%)
            • Weight increased (7%)
            • Dyspnea (6%)
            • Face edema (6%)
            • Dyspepsia (5%)
            • Fatigue (5%)
            • Hirsutism (5%)

            Frequency Not Defined

            Adrenal suppression

            Amnesia

            Anaphylactic reactions

            Benign intracranial hypertension

            Diarrhea

            Facial edema

            Fever

            Flu syndrome

            GI irritation

            Hypokalemia

            Increased appetite

            Insomnia

            Migraine

            Nervousness

            Pharyngitis

            Rash

            Xerostomia

            Weight gain

            Postmarketing Reports

            Rectal bleeding

            Peripheral edema

            Muscle cramps/spasms

            Mood swings

            Increased blood pressure

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            Warnings

            Contraindications

            Documented hypersensitivity

            Cautions

            When used chronically, systemic effects (eg, hypercorticism, adrenal suppression) may occur; glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress; if patients are subject to surgery or other stress situations, supplement with a systemic glucocorticosteroid

            Caution in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to those with lower systemic effects (eg, budesonide); monitor for symptoms of steroid withdrawal, including those of acute adrenal suppression or benign intracranial hypertension

            Drugs that suppress the immune system, including budesonide, may increase risk for infection; patients who have not had certain infections (eg, chicken pox, measles) can have more serious infections, including fatalities

            Reduced liver function affects the elimination of glucocorticosteroids; increased systemic availability of oral budesonide demonstrated with liver cirrhosis; consider discontinuing use in patients with moderate-to-severe liver disease

            Caution with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with other conditions where glucocorticosteroids may have unwanted effects

            Drug interaction overview

            • Substrate of CYP3A4
            • CYP3A4 inhibitors or inducers
              • Coadministration with potent CYP3A4 inhibitors may increase systemic exposure; oral ketoconazole (inhibits CYP3A4 in liver and intestine) caused an 8-fold increase of the systemic exposure to oral budesonide
              • If treatment with CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin) is indicated, consider discontinuing budesonide
              • Extensive intake of grapefruit juice (inhibits CYP3A4 activity predominantly in the intestine) increase oral budesonide systemic exposure ~2-fold; avoid coadministration
              • Conversely, CYP3A4 inducers may decrease budesonide systemic exposure
            • Drugs that inhibit gastric acid secretion
              • Uceris: Dissolution of the tablet coating is pH dependent; release properties and uptake of the compound may be altered when used after treatment with gastric acid reducing agents (eg, PPIs, H2-blockers, antacids)
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            Pregnancy & Lactation

            Pregnancy

            Available data from published case series, epidemiological studies and reviews with oral budesonide use in pregnant females have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes

            Animal data

            • SC administration during organogenesis at doses ~0.5 times or ~0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities; maternal toxicity was observed in both rats and rabbits at these dose levels; based on animal data, advise pregnant females of potential risk to a fetus

            Clinical considerations

            • Studies showed an association of adverse pregnancy outcomes in women with Crohn disease, including preterm birth and low birth weight infants, during periods of increased disease activity (including increased stool frequency and abdominal pain)
            • IgA nephropathy in pregnancy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight
            • Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy; carefully observe infants for signs of hypoadrenalism (eg, poor feeding, irritability, weakness, vomiting), and managed accordingly

            Lactation

            Breastfeeding is not expected to result in significant exposure of the infant

            No lactation studies have been conducted; no information is available on effects on infants or effects on milk production

            One published study reports that budesonide is present in human milk following maternal inhalation of budesonide

            Routine monitoring of linear growth in infants is recommended with chronic use of budesonide in nursing mother

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Anti-inflammatory corticosteroid; potent glucocorticoid activity but weak mineralocorticoid activity

            Ulcerative colitis and Crohn disease

            • Controls rate of protein synthesis; decreases inflammation by suppressing migration of polymorphonuclear leukocytes (PMNs) and reducing capillary permeability; stabilizes cell and lysosomal membranes, increases surfactant synthesis, increases serum vitamin A concentration, and inhibits prostaglandin and proinflammatory cytokines; suppresses lymphocyte proliferation through direct cytolysis, inhibits mitosis, and breaks down granulocyte aggregates

            Primary IgA nephropathy

            • Mucosal B-cells present in the ileum, including the Peyer’s patches, express glucocorticoid receptors and are responsible for the production of galactose-deficient IgA1 antibodies causing IgA nephropathy
            • Corticosteroids can modulate B-cell numbers and activity through its anti-inflammatory and immunosuppressive effects

            Absorption

            Peak plasma concentration

            • Tarpeyo: 4.4 ng/mL
            • Ortikos: 4 nmol/L
            • Entocort: 2.23-2.28 ng/mL
            • Uceris: 1.35 ng/mL

            Peak plasma time

            • Tarpeyo: 5.1 hr
            • Uceris: 15.3 hr
            • Ortikos: 2.5-8 hr

            AUC

            • Tarpeyo: 24.1 hr·ng/mL
            • Ortikos: 35 hr·ng/mL
            • Entocort: 15.1-15.93 hr·ng/mL
            • Uceris: 16.43 hr·ng/mL

            Distribution

            Protein bound: 85-90%

            Vd

            • Tarpeyo: 3-4 L/kg
            • Ortikos, Entocort: 2.2-3.9 L/kg

            Metabolism

            Extensive 1st-pass metabolism by CYP3A4 in liver

            Metabolites: 6-Beta-hydroxybudesonide, 16-alpha-hydroxyprednisolone (inactive)

            Elimination

            Clearance: 0.9-1.8 L/min

            Half-life

            • Tarpeyo: 5-6.8 hr
            • IV budesonide: 2-3.6 hr

            Excretion

            • Urine (60% [unchanged])
            • Feces (minimal)
            • Major metabolites (16α-hydroxyprednisolone and 6β-hydroxybudesonide) are mainly renally excreted, intact or in conjugated form
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            Administration

            Oral Administration

            May take with or without food

            Avoid consuming grapefruit juice for duration of treatment

            Missed dose: Take prescribed dose at next scheduled time; do not double the dose

            Uceris

            • Swallow tablet whole with water; do not chew, crush, or break

            Ortikos

            • Take once daily in morning
            • Swallow capsule whole; do not chew or crush

            Entocort EC

            • Swallow capsule whole; do not chew or crush
            • Unable to swallow capsule
              • If unable to swallow intact capsule, open capsule and empty granules onto 1 tablespoonful of applesauce
              • Mix and consume the entire contents within 30 minutes
              • Do not chew or crush
              • Follow with 8 ounces of water

            Tarpeyo

            • Swallow capsule whole in morning, at least 1 hr before a meal; do not open, crush, or chew

            Storage

            Keep container tightly closed

            Uceris

            • Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
            • Protect from light and moisture

            Ortikos, Entocort EC, Tarpeyo

            • Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            budesonide oral
            -
            3 mg capsule
            budesonide oral
            -
            3 mg capsule
            budesonide oral
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            3 mg capsule
            budesonide oral
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            3 mg capsule
            budesonide oral
            -
            9 mg tablet
            budesonide oral
            -
            9 mg tablet
            budesonide oral
            -
            3 mg capsule
            budesonide oral
            -
            3 mg capsule
            budesonide oral
            -
            9 mg tablet
            budesonide oral
            -
            3 mg capsule
            Uceris rectal
            -
            2 mg/actuation foam
            budesonide inhalation
            -
            1 mg/2 mL nebulizer soln
            budesonide inhalation
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            1 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.25 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
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            1 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.25 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.25 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.25 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
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            1 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            1 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            1 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            0.25 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            0.25 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            0.25 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            0.25 mg/2 mL nebulizer soln
            budesonide inhalation
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            1 mg/2 mL nebulizer soln
            budesonide inhalation
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            0.5 mg/2 mL nebulizer soln
            budesonide inhalation
            -
            0.25 mg/2 mL nebulizer soln
            Pulmicort Flexhaler inhalation
            -
            90 mcg/actuation aerosol
            Pulmicort Flexhaler inhalation
            -
            180 mcg/actuation aerosol
            Pulmicort Flexhaler inhalation
            -
            90 mcg/actuation aerosol
            budesonide nasal
            -
            32 mcg/actuation aerosol
            budesonide nasal
            -
            32 mcg/actuation aerosol
            budesonide nasal
            -
            32 mcg/actuation aerosol
            Pulmicort inhalation
            -
            1 mg/2 mL nebulizer soln
            Pulmicort inhalation
            -
            0.25 mg/2 mL nebulizer soln
            Pulmicort inhalation
            -
            0.5 mg/2 mL nebulizer soln
            Uceris oral
            -
            9 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Select a drug:
            Patient Education
            budesonide oral

            BUDESONIDE TABLETS - ORAL

            (bue-DES-oh-nide)

            COMMON BRAND NAME(S): Uceris

            USES: This medication is used to treat a certain bowel condition (ulcerative colitis). While budesonide does not cure this condition, it may decrease symptoms such as pain and diarrhea. Budesonide is an anti-inflammatory drug (corticosteroid hormone). It works by decreasing the body's natural defense response (immune response).

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking budesonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Swallow this medication whole with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.The dosage and length of treatment are based on your medical condition and response to treatment.Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. If you suddenly stop taking the drug, you may also have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may slowly lower the dose of your old medication after you begin taking budesonide. Tell your doctor or pharmacist right away if you have withdrawal. See also Precautions section.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.Tell your doctor if your condition does not get better or if it gets worse.

            SIDE EFFECTS: This medication usually has fewer side effects than other corticosteroids because budesonide works in the gut and only small amounts are absorbed into the body. Nausea, abdominal pain, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough). This medication may sometimes cause oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, puffy face, unusual weight gain, menstrual period changes, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, bone pain, thinning skin, slow wound healing, increased thirst/urination, vision problems, symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking budesonide, tell your doctor if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as cataracts, glaucoma), high blood pressure, liver problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, herpes), bleeding problems, mental/mood problems (such as psychosis, anxiety, depression).Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using budesonide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Older adults may be more sensitive to the side effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used corticosteroids for a long time may develop hormone problems. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn.This medication passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: aldesleukin, mifepristone, drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen).If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.This product may interfere with certain lab tests (such as skin tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.If this medication is used for a long time, lab and/or medical tests (such as blood count, bone density, eye exams, height/weight measurements) may be done while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.This medication may increase the risk of bone loss (osteoporosis) if used for a long time. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.