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The most frequent type of adverse reaction occurring with MOTRIN (ibuprofen) tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%.
In controlled studies when MOTRIN (ibuprofen) tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin- or indomethacin-treated patients.
Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the table. Those reactions listed in Column one encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.
Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column two of the table lists reactions with therapy with MOTRIN (ibuprofen) tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with MOTRIN (ibuprofen) tablets has not been established.
Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis. The increases in incidence were slight and still within the ranges reported in the table.
|Incidence Greater than 1% (but less than 3%) Probable Causal Relationship||Precise Incidence Unknown (but less than 1%) Probable Causal Relationship*||Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown*|
|Nausea†, epigastric pain†, heartburn†, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating and flatulence)||Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis|
|CENTRAL NERVOUS SYSTEM|
|Dizzinesst, headache, nervousness||Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS)||Paresthesias, hallucinations, dream abnormalities, pseudo-tumor cerebri|
|Rasht (including maculopapular type), pruritus||Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia||Toxic epidermal necrolysis, photoallergic skin reactions|
|Tinnitus||Hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision) (see PRECAUTIONS)||Conjunctivitis, diplopia, optic neuritis, cataracts|
|Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit (see PRECAUTIONS)||Bleeding episodes (eg epistaxis, menorrhagia)|
|Decreased appetite||Gynecomastia, hypoglycemic reaction, acidosis|
|Edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS)||Congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations||Arrhythmias (sinus tachycardia, sinus bradycardia)|
|Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS)||Serum sickness, lupuserythematosus syndrome. Henoch-Schonlein vasculitis, angioedema|
|RENAL||Acute renal failure (see PRECAUTIONS), decreased creatinine clearance, polyuria, azotemia, cystitis, Hematuria||Renal papillary necrosis|
|Dry eyes and mouth, gingival ulcer, rhinitis|
| *Reactions are classified under "Probable
Causal Relationship (PCR)" if there has been one positive rechallenge
or if three or more cases occur which might be causally related. Reactions
are classified under "Causal Relationship Unknown" if seven
or more events have been reported but the criteria for PCR have not been
†Reactions occurring in 3% to 9% of patients treated with MOTRIN (ibuprofen) . (Those reactions occurring in less than 3% of the patients are unmarked).
Read the Motrin (ibuprofen) Side Effects Center for a complete guide to possible side effects
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
When MOTRIN (ibuprofen) tablets are administered with aspirin, its protein binding is reduced, although the clearance of free MOTRIN (ibuprofen) tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects.
Clinical studies, as well as post marketing observations, have shown that MORTIN tablets can reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as to assure diuretic efficacy.
Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Several short-term controlled studies failed to show that MOTRIN (ibuprofen) tablets significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when MOTRIN (ibuprofen) tablets and other NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering MOTRIN (ibuprofen) tablets to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.
Read the Motrin Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/18/2007
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