budesonide (Rx)

Brand and Other Names:Entocort EC, Uceris
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Dosing & Uses


Dosage Forms & Strengths

capsule, enteric-coated and delayed-release (Entocort EC)

  • 3mg

tablet, enteric-coated and extended-release (Uceris)

  • 9mg

Ulcerative Colitis

Induction of remission of active mild-to-moderate ulcerative colitis

Uceris: 9 mg PO qAM for up to 8 weeks

Crohn Disease

Treatment of active mild-to-moderate Crohn disease involving ileum or ascending colon; maintenance of clinical remission of mild-to-moderate Crohn disease for up to 3 months

Entocort EC: 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

Crohn disease maintenance

  • Entocort EC: 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)

Immunoglobulin A Nephropathy (Orphan)

Slowing of progression of immunoglobulin A nephropathy; delaying of onset of kidney failure in patients affected by this disease

Orphan indication sponsor

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

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


Interaction Checker

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            Adverse Effects


            Headache (21%)

            Acne (<5-15%)

            Nausea (11%)

            Respiratory infection (11%)


            Back pain (7%)

            Dizziness (7%)

            Abdominal pain (6%)

            Dyspepsia (6%)

            Vomiting (6%)

            Fatigue (5%)

            Frequency Not Defined

            Adrenal suppression


            Anaphylactic reactions

            Benign intracranial hypertension


            Facial edema


            Flu syndrome

            GI irritation


            Increased appetite







            Weight gain

            Postmarketing Reports

            Rectal bleeding

            Peripheral edema

            Muscle cramps/spasms

            Mood swings

            Increased blood pressure




            Documented hypersensitivity


            High-fat meal delays absorption

            Prolonged use may increase risk of secondary infections; mask acute infection, including fungal infections, limit response to killed or inactivated vaccines, and may prolong or exacerbate viral infections

            Use extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities reported

            Rule out amebiasis in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiating corticosteroid therapy

            May increase risk of serious or fatal infection in individuals exposed to viral illnesses such as chickenpox or measles

            Use caution in patients with history of seizure disorders; adrenal crisis may result in seizures

            Use with caution in patients with diabetes mellitus, hypothyroidism, electrolyte abnormalities, sodium and water retention, infections, immunizations, ocular herpes simplex, myasthenia gravis, or renal insufficiency

            Thromboembolic disorders may occur

            Use caution in patients with osteoporosis; increased bone loss and osteoporotic fractures associated with corticosteroid use

            Delayed wound healing is possible

            Patients receiving corticosteroids should avoid chickenpox- or measles-infected persons if unvaccinated

            Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored)

            Some suggestion (not fully substantiated) of slightly increased cleft palate risk if corticosteroids are used in pregnancy

            Use caution in patients with gastrointestinal diseases; therapy may increase risk of perforation in patients with diverticulitis, active or latent peptic ulcer, fresh intestinal anastomoses, ulcerative colitis, abscess or other pyogenic infection

            Prolonged corticosteroid use may result in elevated intraocular pressure, glaucoma, or cataracts and has been associated with development of Karposi sarcoma

            Ocular herpes simplex should not be treated with corticosteroids

            Use caution following acute myocardial infarction; corticosteroid use associated with myocardial rupture

            High-dose corticosteroids may result in acute myopathy, usually in patients with neuromuscular transmission disorders

            Secreted in human milk; no data from controlled trials on potential serious adverse reactions in nursing infants; use with caution

            When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur; glucocorticosteroids can reduce response of hypothalamus-pituitary-adrenal (HPA) axis to stress; in situations where patients are subject to surgery or other stress situations, supplementation with systemic glucocorticosteroid recommended

            Care needed in transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects; symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop; adrenocortical function monitoring may be required in these patients and dose of glucocorticosteroid treatment with high systemic effects should be reduced cautiously

            Use caution when transferring patient from systemic corticosteroid to inhaled products or corticosteroids with lower systemic effect, which may cause adrenal insufficiency or withdrawal from steroids

            Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections

            Use caution in patients with heart failure and/or hypertension; fluid retention resulting from therapy may exacerbate condition

            Replacement of systemic glucocorticosteroids with budesonide tablets may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug

            Reduced liver function affects elimination of glucocorticosteroids; increased systemic availability of oral budesonide has been demonstrated in patients with liver cirrhosis

            Corticosteroid use may cause psychiatric disturbances, including mood swings, insomnia, personality change, euphoria, or psychotic manifestations; preexisting psychiatric conditions may become exacerbated with corticosteroid use

            Anaphylactoid reactions reported in patients receiving corticosteroids


            Pregnancy & Lactation


            Limited published studies report in pregnant women; however, data insufficient to inform a drug-associated risk for major birth defects and miscarriage; there are clinical considerations; in animal reproduction studies with pregnant rats and rabbits, administration of subcutaneous budesonide during organogenesis at doses approximately 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 women of potential risk to a fetus

            Some published epidemiological studies show an association of adverse pregnancy outcomes in women with Crohn’s disease, including preterm birth and low birth weight infants, during periods of increased disease activity (including increased stool frequency and abdominal pain); pregnant women with Crohn’s disease should be counseled regarding importance of controlling disease

            Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy; infants should be carefully observed for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting, and managed accordingly


            Lactation studies conducted with oral budesonide, and no information is available on effects of drug on breastfed infant or effects of drug on milk production; one published study reports that budesonide is present in human milk following maternal inhalation of budesonide; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant or from underlying maternal condition

            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.



            Mechanism of Action

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


            Bioavailability: Capsule, 9-21%

            Peak plasma time: Capsule, 5-10 hr


            Protein bound: 85-90%

            Vd: 2.2-3.9 L/kg


            Extensive 1st-pass metabolism by CYP3A4 in liver

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


            Half-life: 2-3.6 hr

            Excretion: Urine (60%), feces (minimal)





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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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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.