Dosing & Uses
Dosage Forms & Strengths
ibuprofen/famotidine
tablet
- 800mg/26.6mg
Rheumatoid Arthritis
Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers
1 tablet PO q8hr
Osteoarthritis
Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers
1 tablet PO q8hr
Safety and efficacy not established
Rheumatoid Arthritis
Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers
1 tablet PO q8hr
Osteoarthritis
Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers
1 tablet PO q8hr
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (20)
- atazanavir
ibuprofen/famotidine will decrease the level or effect of atazanavir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Atazanavir solubility decreases as pH increases. Substantially reduced plasma concentrations of atazanavir are expected if H2-receptor antagonists (H2RA) are coadministered. For treatment-naïve patients, take atazanavir simultaneously with the H2RA or at least 10 h afterwards. See dosage adjustment recommendations if coadministered in treatment-experienced patients.
- bosutinib
ibuprofen/famotidine will decrease the level or effect of bosutinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- dapsone
ibuprofen/famotidine will decrease the level or effect of dapsone by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- dasatinib
ibuprofen/famotidine will decrease the level or effect of dasatinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- digoxin
ibuprofen/famotidine will increase the level or effect of digoxin by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- indinavir
ibuprofen/famotidine will decrease the level or effect of indinavir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- itraconazole
ibuprofen/famotidine will decrease the level or effect of itraconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Administer acid neutralizing medicines at least 2 hours before or 2 hours after the intake of itraconazole.
- ketoconazole
ibuprofen/famotidine will decrease the level or effect of ketoconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- levoketoconazole
ibuprofen/famotidine will decrease the level or effect of levoketoconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- mefloquine
mefloquine increases toxicity of ibuprofen/famotidine by QTc interval. Avoid or Use Alternate Drug. Mefloquine may enhance the QTc prolonging effect of high risk QTc prolonging agents.
- neratinib
ibuprofen/famotidine will decrease the level or effect of neratinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- nimodipine
ibuprofen/famotidine will increase the level or effect of nimodipine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- nisoldipine
ibuprofen/famotidine will increase the level or effect of nisoldipine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- nitrendipine
ibuprofen/famotidine will increase the level or effect of nitrendipine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- pazopanib
ibuprofen/famotidine will decrease the level or effect of pazopanib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Avoid coadministration of pazopanib with drugs that raise gastric pH; consider short-acting antacids in place of PPIs and H2 antagonists; separate antacid and pazopanib dosing by several hours
- pimozide
ibuprofen/famotidine, pimozide. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug.
pimozide, ibuprofen/famotidine. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. - ponatinib
ibuprofen/famotidine decreases levels of ponatinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- risedronate
ibuprofen/famotidine will increase the level or effect of risedronate by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to delayed release formulation; accelerates pH-sensitive dissolution of delayed release risedronate
- secretin
ibuprofen/famotidine, secretin. Other (see comment). Avoid or Use Alternate Drug. Comment: Concomitant use of H2-receptor antagonists may cause a hyperresponse in gastrin secretion in response to stimulation testing with secretin, falsely suggesting gastrinoma. Discontinue H2-receptor antagonists at least 2 days before administering secretin to aid in the diagnosis of gastrinoma.
- vandetanib
ibuprofen/famotidine, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug.
vandetanib, ibuprofen/famotidine. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug.
Monitor Closely (59)
- aliskiren
ibuprofen/famotidine will decrease the level or effect of aliskiren by Other (see comment). Use Caution/Monitor. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs with drugs that affect RAAS may increase the risk of renal impairment (including acute renal failure) and cause loss of antihypertensive effect. Monitor renal function periodically.
- ampicillin
ibuprofen/famotidine will decrease the level or effect of ampicillin by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- bimatoprost
bimatoprost, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).
- budesonide
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.
- carbamazepine
ibuprofen/famotidine will increase the level or effect of carbamazepine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor plasma levels when used concomitantly
- carbonyl iron
ibuprofen/famotidine will decrease the level or effect of carbonyl iron by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- cefdinir
ibuprofen/famotidine will decrease the level or effect of cefdinir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- cefditoren
ibuprofen/famotidine will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- cefpodoxime
ibuprofen/famotidine will decrease the level or effect of cefpodoxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- cefuroxime
ibuprofen/famotidine will decrease the level or effect of cefuroxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- crizotinib
ibuprofen/famotidine decreases levels of crizotinib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Drugs that elevate the gastric pH may decrease the solubility of crizotinib and subsequently reduce its bioavailability. However, no formal studies have been conducted. .
- cyclosporine
ibuprofen/famotidine, cyclosporine. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor. NSAIDs decrease prostaglandin synthesis, increasing the risk of nephrotoxicity.
- dabrafenib
ibuprofen/famotidine will decrease the level or effect of dabrafenib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Drugs that alter upper GI tract pH (eg, PPIs, H2-blockers, antacids) may decrease dabrafenib solubility and reduce its bioavailability
- dexmethylphenidate
ibuprofen/famotidine will increase the level or effect of dexmethylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies only to extended release formulation
- erlotinib
ibuprofen/famotidine decreases levels of erlotinib by Other (see comment). Use Caution/Monitor. Comment: Avoid combination when possible. If concurrent use is required erlotinib should be taken 10 hours after a H2-antagonist and at least 2 hours before the next dose of H2-antagonist.
- ferric carboxymaltose
ibuprofen/famotidine will decrease the level or effect of ferric carboxymaltose by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ferric gluconate
ibuprofen/famotidine will decrease the level or effect of ferric gluconate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ferric maltol
ibuprofen/famotidine will decrease the level or effect of ferric maltol by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ferrous fumarate
ibuprofen/famotidine will decrease the level or effect of ferrous fumarate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ferrous gluconate
ibuprofen/famotidine will decrease the level or effect of ferrous gluconate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- ferrous sulfate
ibuprofen/famotidine will decrease the level or effect of ferrous sulfate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- fish oil triglycerides
fish oil triglycerides will increase the level or effect of ibuprofen/famotidine by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.
- fosamprenavir
ibuprofen/famotidine will decrease the level or effect of fosamprenavir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- gefitinib
ibuprofen/famotidine decreases levels of gefitinib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Separate gefitinib and H2-antagonist doses by at least 6 hr.
- glipizide
ibuprofen/famotidine will increase the level or effect of glipizide by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- glyburide
ibuprofen/famotidine will increase the level or effect of glyburide by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- icosapent
icosapent, ibuprofen/famotidine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time. Periodically monitor if coadministered with other drugs that affect bleeding.
- iron dextran complex
ibuprofen/famotidine will decrease the level or effect of iron dextran complex by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- iron sucrose
ibuprofen/famotidine will decrease the level or effect of iron sucrose by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- latanoprost
latanoprost, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).
- latanoprostene bunod ophthalmic
latanoprostene bunod ophthalmic, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).
- ledipasvir/sofosbuvir
ibuprofen/famotidine decreases levels of ledipasvir/sofosbuvir by Other (see comment). Use Caution/Monitor. Comment: Ledipasvir solubility decreases as pH increases; drugs that increase gastric pH are expected to decrease levels of ledipasvir; H2-receptor antagonists may be administered simultaneously with or 12 hr apart from ledipasvir/sofosbuvir at a dose that does not exceed doses comparable to famotidine 40 mg BID.
- mesalamine
ibuprofen/famotidine will decrease the level or effect of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely.
- methylphenidate
ibuprofen/famotidine will increase the level or effect of methylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies only to extended release formulation
- mifepristone
ibuprofen/famotidine, mifepristone. Either increases toxicity of the other by QTc interval. Use Caution/Monitor.
mifepristone, ibuprofen/famotidine. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. - mycophenolate
ibuprofen/famotidine will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- nelfinavir
ibuprofen/famotidine will decrease the level or effect of nelfinavir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- nilotinib
ibuprofen/famotidine decreases levels of nilotinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Avoid this interaction by administering H2 antagonists 10 hr after or 2 hr before nilotinib.
- polysaccharide iron
ibuprofen/famotidine will decrease the level or effect of polysaccharide iron by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- posaconazole
ibuprofen/famotidine will decrease the level or effect of posaconazole by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- potassium iodide
potassium iodide and ibuprofen/famotidine both increase serum potassium. Use Caution/Monitor.
- prasugrel
ibuprofen/famotidine, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.
- rilpivirine
ibuprofen/famotidine, rilpivirine. increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Combination of rilpivirine and H2-receptor antagonists should be used with caution as coadministration may cause significant decreases in rilpivirine plasma concentrations (increase in gastric pH). Administer famotidine at least 12 hours before or at least 4 hours after rilpivirine.
- rose hips
ibuprofen/famotidine will decrease the level or effect of rose hips by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- saquinavir
ibuprofen/famotidine will increase the level or effect of saquinavir by unspecified interaction mechanism. Use Caution/Monitor.
- serdexmethylphenidate/dexmethylphenidate
ibuprofen/famotidine will increase the level or effect of serdexmethylphenidate/dexmethylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies only to extended release formulation
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of ibuprofen/famotidine by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of ibuprofen/famotidine by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sofosbuvir/velpatasvir
ibuprofen/famotidine will decrease the level or effect of sofosbuvir/velpatasvir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Velpatasvir solubility decreases as gastric pH increases (practically insoluble at pH >5). H2 receptor antagonists may be administered simultaneously with or 12 hr apart from sofosbuvir/velpatasvir at a dose that does not exceed doses comparable to famotidine 40 mg BID.
- sparsentan
ibuprofen/famotidine and sparsentan both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Coadministration of NSAIDS, including selective COX-2 inhibitors, may result in deterioration of kidney function (eg, possible kidney failure). Monitor for signs of worsening renal function with concomitant use with NSAIDs.
- tafluprost
tafluprost, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).
- tolbutamide
ibuprofen/famotidine will increase the level or effect of tolbutamide by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- travoprost ophthalmic
travoprost ophthalmic, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).
- triamcinolone acetonide injectable suspension
ibuprofen/famotidine, triamcinolone acetonide injectable suspension. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Concomitant use of NSAIDS and corticosteroids increases the risk of gastrointestinal side effects. .
- vandetanib
vandetanib increases levels of ibuprofen/famotidine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Vandetanib inhibits the uptake of substrates of organic cation transporter type 2 (OCT2).
- varenicline
ibuprofen/famotidine will increase the level or effect of varenicline by decreasing renal clearance. Use Caution/Monitor.
- vismodegib
ibuprofen/famotidine will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown
- voclosporin
voclosporin, ibuprofen/famotidine. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
- zanubrutinib
ibuprofen/famotidine, zanubrutinib. Either increases effects of the other by anticoagulation. Modify Therapy/Monitor Closely. Zanubrutinib-induced cytopenias increases risk of hemorrhage. Coadministration of zanubritinib with antiplatelets or anticoagulants may further increase this risk.
Minor (10)
- alendronate
ibuprofen/famotidine increases levels of alendronate by unspecified interaction mechanism. Minor/Significance Unknown. Monitor for increase in alendronate side effects.
- aripiprazole
ibuprofen/famotidine decreases levels of aripiprazole by unspecified interaction mechanism. Minor/Significance Unknown.
- axitinib
ibuprofen/famotidine will decrease the level or effect of axitinib by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.
- blessed thistle
blessed thistle decreases effects of ibuprofen/famotidine by pharmacodynamic antagonism. Minor/Significance Unknown. Theoretical interaction.
- ceftibuten
ibuprofen/famotidine will decrease the level or effect of ceftibuten by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.
- cyanocobalamin
ibuprofen/famotidine decreases levels of cyanocobalamin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- devil's claw
devil's claw decreases effects of ibuprofen/famotidine by pharmacodynamic antagonism. Minor/Significance Unknown.
- melphalan
ibuprofen/famotidine decreases levels of melphalan by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- metformin
ibuprofen/famotidine increases levels of metformin by decreasing renal clearance. Minor/Significance Unknown.
- phytoestrogens
ibuprofen/famotidine decreases levels of phytoestrogens by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
Adverse Effects
1-10%
Nausea (6%)
Dyspepsia (5%)
Diarrhea (5%)
Constipation (4%)
Headache (3%)
Hypertension (3%)
Upper abdominal pain (3%)
Gastroesophageal reflux (2%)
Vomiting (2%)
Stomach discomfort (2%)
Anemia (2%)
Peripheral edema (2%)
Warnings
Black Box Warnings
Cardiovascular risk
- Contains ibuprofen; may increase the risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal; risk may increase with duration of use
- Patients with CV disease or risk factors may be at greater risk
- Contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery
Gastrointestinal risk
- NSAIDs, including ibuprofen, increase the risk of serious GI adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal
- Reactions can occur at any time without warning symptoms
- Elderly patients are at greater risk
Contraindications
Hypersensitivity
Pre-existing asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs
Use during the perioperative period in the setting of CABG surgery
Starting at 30 weeks gestation, NSAIDs should not be used by pregnant women as premature closure of the ductus arteriosus in the fetus may occur
Cautions
Therapy can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to increased incidence of CV events; patients taking angiotensin-converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs; monitor blood pressure (BP) during initiation of NSAID treatment and throughout course of therapy
Fluid retention and edema can occur with NSAID treatment; use with caution in patients with fluid retention or heart failure; ibuprofen may blunt CV effects of several therapeutic agents used to treat medical conditions associated with fluid retention and edema (eg, diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]); avoid use in patients with severe heart failure unless benefits expected to outweigh risk of worsening heart failure; if drug is used in patients with severe heart failure, monitor patients for signs and symptoms of worsening heart failure
Antiplatelet effect; active and clinically significant bleeding from any source can occur; discontinue if active bleeding occurs; patients with initial hemoglobin values of 10 g or less who are to receive long-term therapy should have hemoglobin values determined periodically
Long-term NSAID administration can result in renal papillary necrosis and other renal injury; caution in patients at risk (eg elderly, existing renal impairment, heart failure, liver impairment, coadministration with diuretics or ACE inhibitors)
Anaphylaxis may occur; especially in asthmatic patients experiencing rhinitis and bronchospasm; discontinue immediately if an anaphylactoid reaction occurs
A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs; because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, this drug is contraindicated in patients with this form of aspirin sensitivity; when used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma
Serious/fatal skin reactions may occur and include exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis; discontinue if rash or other signs of local skin reaction occur; inform patients about signs and symptoms of serious skin reactions and to discontinue use at first appearance of skin rash or any other sign of hypersensitivity; this drug is contraindicated in patients with previous serious skin reactions to NSAIDs
Central nervous system (CNS) adverse effects including seizures, delirium, and coma reported with famotidine in patients with moderate (creatinine clearance <50 mL/min) and severe renal insufficiency (creatinine clearance <10mL/min); dosage of famotidine component this drug combination is fixed; therefore, this drug is not recommended in patients with creatinine clearance <50 mL/min
The pharmacological activity of this drug in reducing inflammation, and possibly fever, may diminish utility of diagnostic signs in detecting infections
Aseptic meningitis with fever and coma reported on rare occasions in patients on ibuprofen, which is a component of this drug combination; although it is probably more likely to occur in patients with systemic lupus erythematosus (SLE) and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease; if signs or symptoms of meningitis develop in a patient on therapy, the possibility of it being related to ibuprofen should be considered
Blurred and/or diminished vision, scotomata, and/or changes in color vision reported; if a patient develops such complaints while receiving therapy, the drug should be discontinued, and the patient have an ophthalmologic examination which includes central visual fields and color vision testing
Hematologic toxicity
- Anemia reported in NSAID-treated patients; this may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis; if a patient treated with this drug has any signs or symptoms of anemia,monitor hemoglobin or hematocrit; therapy may increase risk of bleeding events
- Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, and other anticoagulants, antiplatelet agents (eg, aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) may increase risk; monitor these patients for signs of bleeding
Renal toxicity and hyperkalemia
- Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; renal toxicity seen in patients in whom renal prostaglandins have compensatory role in maintenance of renal perfusion; in these patients, administration of NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation; patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors or ARBs, and elderly; discontinuation of NSAID therapy was usually followed by recovery to pretreatment state
- Therapy may hasten progression of renal dysfunction in patients with pre-existing renal disease
- Correct volume status in dehydrated or hypovolemic patients prior to initiating therapy; monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during therapy
- Avoid use of drug in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal failure; if drug is used in patients with advanced renal disease, monitor patients for signs of worsening renal function
- Increases in serum potassium concentration, including hyperkalemia, reported with use of NSAIDs, even in some patients without renal impairment; in patients with normal renal function, these effects have been attributed to ahyporeninemic-hypoaldosteronism state
Cardiovascular thromboembolic events
- Unclear that the risk for CV thrombotic events is similar for all NSAIDS; relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease
- Increased risk of serious CV thrombotic events began as early as first weeks of treatment; increase in CV thrombotic risk observed most consistently at higher doses
- To minimize potential risk for an adverse CV event in NSAID-treated patients, use lowest effective dose for shortest duration possible; physicians and patients should remain alert for development of such events, throughout entire treatment course, even in absence of previous CV symptoms; patients should be informed about symptoms of serious CV events and steps to take if they occur
- There is no consistent evidence that concurrent use of aspirin mitigates increased risk of serious CV thrombotic events associated with NSAID use; concurrent use of aspirin and an NSAID, such as ibuprofen, increases risk of serious gastrointestinal GI events
- Patients treated with NSAIDs in post-MI period may be at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in firstweek of treatment; although absolute rate of death have been shown to decline somewhat after first-year post-MI, increased relative risk of death in NSAID users have persisted over at least next four years of follow-up
- Avoid the use of the drug in patients with a recent MI unless benefits are expected to outweigh risk of recurrent CV thrombotic events; if drug is used in patients with a recent MI, monitor patients for signs of cardiac ischemia
GI bleeding ulceration, and perforation
- Patients with prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs shown to have >10-fold increased risk for developing a GI bleed compared to patients without these risk factors
- Other factors that increase risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status
- Most postmarketing reports of fatal GI events reported in elderly or debilitated patients; patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding; NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated
Minimizing GI risks
- Use the lowest effective dosage for shortest possible duration.
- Avoid administration of more than one NSAID at a time.
- Avoid use in patients at higher risk unless benefits expected to outweigh increased risk of bleeding; for such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs
- Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy
- If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue drug until serious GI adverse event ruled out
- In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding
Hepatic injury
- Elevations to liver failure can occur; elevations of ALT or AST (three or more times upper limit of normal [ULN]) reported in approximately 1% of NSAID-treated patients in clinical trials; rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure reported
- Inform patients of warning signs and symptoms of hepatotoxicity (eg, nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and flu-like symptoms); if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash, etc.), discontinue drug immediately, and perform clinical evaluation of the patient
Drug reaction with eosinophilia and systemic symptoms
- Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
- Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
- Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
- Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately
Pregnancy & Lactation
Pregnancy
Use of NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy
Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus
Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment
There are no available data with use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; however, there are published studies with each individual component of the drug combination
Ibuprofen
- Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
- In animal reproduction studies, there were no clear developmental effects at doses up to 0.4-times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation
- In contrast, an increase in membranous ventricular septal defects was reported in rats treated on gestation days 9 & 10 with 0.8-times the MRHD
- Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre-and post-implantation loss
- Prostaglandins also have been shown to have an important role in fetal kidney development; in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses
Famotidine
- Limited published data do not report an increased risk of congenital malformations or other adverse pregnancy effects with use of H2-receptor antagonists during pregnancy; however, these data are insufficient to adequately determine a drug-associated risk
- Reproductive studies with famotidine have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day (approximately 243 and 122 times the recommended human dose, respectively, based on body surface area) and in both species at intravenous (IV) doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine
- Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, can cause premature closure of fetal ductus arteriosus
- If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to lowest effective dose and shortest duration possible
- If treatment is needed for a pregnant woman, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue therapy and follow up according to clinical practice
Labor or Delivery
- There are no studies on the effects of drug combination during labor or delivery; in animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.
Lactation
No studies conducted with use of drug combination in lactating women; limited data from published literature report famotidine is present in human milk in low amounts
Published literature also reports the presence of ibuprofen in human milk in low amounts; no information is available on effects of famotidine or ibuprofen on milk production or on a breastfed infant
Famotidine is present in milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug combination 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.Pharmacology
Ibuprofen: NSAID; elicits analgesic and antipyretic effects by prostaglandin synthetase inhibition
Famotidine: H2-receptor antagonist; inhibits gastric acid secretion, thereby lowering gastric pH
Pharmacokinetics
Protein Bound: extensive (ibuprofen); 15-20% (famotidine)
Excretion
Half-life: 2 hr (ibuprofen); 4 hr (famotidine)
Renal clearance: 250-450 mL/min (famotidine)
Urine: Ibuprofen metabolite (45-79%); free or conjugated drug (1-14%); famotidine (65-70% with 30% as unchanged)
Absorption
- Peak Plasma Time: 1.9 hr (ibuprofen); 2 hr (famotidine); food delays peak time
- Peak Plasma Concentration: 45 mcg/mL (ibuprofen); 61 ng/mL (famotidine)
- AUC: Food reduces AUC by 11-15%
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| ibuprofen-famotidine oral - | 800-26.6 mg tablet |  | |
| ibuprofen-famotidine oral - | 800-26.6 mg tablet |  | |
| ibuprofen-famotidine oral - | 800-26.6 mg tablet |  | |
| Duexis oral - | 800-26.6 mg tablet | |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ibuprofen-famotidine oral
IBUPROFEN/FAMOTIDINE - ORAL
(EYE-bue-PROE-fen/fam-OH-ti-deen)
COMMON BRAND NAME(S): Duexis
WARNING: Nonsteroidal anti-inflammatory drugs (including ibuprofen) may rarely increase the risk of a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater in older adults or if you have heart disease or an increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG).This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning at any time while taking this drug. Older adults may be at higher risk for this effect.Stop taking this product and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes.Talk to your doctor or pharmacist about the benefits and risks of taking this drug.
USES: This combination medication is used to relieve pain from rheumatoid arthritis and osteoarthritis while decreasing the risk of developing an ulcer from ibuprofen use. It contains ibuprofen and famotidine. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by blocking your body's production of certain natural substances that cause inflammation. This helps to decrease swelling and pain. Famotidine is an H2 blocker that works by reducing the amount of acid in your stomach. This helps prevent ulcers.Ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking ibuprofen/famotidine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually three times a day. Take it with a full glass of water (8 ounces/240 milliliters). Do not lie down for at least 10 minutes after taking this drug. If you have stomach upset while taking this medication, take it with food, milk, or an antacid.Swallow whole. Do not chew, crush, or split the medication. Splitting the medication may not provide enough famotidine to protect against ulcers.The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than prescribed.It may take up to two weeks of taking this drug regularly until you get the full benefit.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: See also Warning section.Upset stomach, nausea, vomiting, headache, diarrhea, constipation, dizziness, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.If your doctor has prescribed this medication, remember that 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.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, hearing changes (such as ringing in the ears), mental/mood changes, unexplained stiff neck, signs of kidney problems (such as change in the amount of urine), vision changes, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine, yellowing eyes/skin.Get medical help right away if you have any very serious side effects, including: fast/slow/irregular heartbeat, severe dizziness, fainting, seizure.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: fever, swollen lymph nodes, 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 ibuprofen/famotidine, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as naproxen, celecoxib); or to other H2 blockers (such as cimetidine, ranitidine) 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stroke, throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers).Kidney problems can sometimes occur with the use of NSAID medications, including ibuprofen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, stroke, mental/mood changes (such as confusion), seizure, or unusual tiredness while using this drug.Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.This medication passes into breast milk, but is unlikely to harm a nursing infant. 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 include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, fezolinetant, lithium, corticosteroids (such as prednisone), "water pills" (diuretics such as furosemide).This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (including aspirin, NSAIDs such as celecoxib, ketorolac, or naproxen). These drugs are similar to ibuprofen and may increase your risk of side effects if taken together. However, 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 the aspirin unless your doctor instructs you otherwise. Daily use of ibuprofen may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you must take ibuprofen, talk to your doctor about taking immediate-release aspirin (not enteric-coated/EC) while taking ibuprofen. Take ibuprofen at least 8 hours before or at least 2 hours after your aspirin dose. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval.Some products need stomach acid so that the body can absorb them properly. Famotidine decreases stomach acid, so it may change how well these products work. Some affected products include atazanavir, dasatinib, certain azole antifungals (such as itraconazole, ketoconazole), levoketoconazole, pazopanib, sparsentan, among others.
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. Symptoms of overdose may include: severe stomach pain, trouble breathing, extreme drowsiness.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood pressure, complete blood counts, liver/kidney function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.Non-drug treatment for arthritis that is approved by your doctor (such as weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.
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.
Information last revised May 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.
Formulary
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