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adverse reactions
ADVERSE REACTIONS The most frequent type of adverse reaction occurring withIbuprofen tablets is gastrointestinal. In controlled clinical trials thepercentage of patients reporting one or more gastrointestinal complaintsranged from 4% to 16%. In controlled studies when Ibuprofen tablets were compared toaspirin and indomethacin in equally effective doses, the overall incidenceof gastrointestinal complaints was about half that seen in eitherthe aspirin- or indomethacin-treated patients. Adverse reactions observed during controlled clinical trials at anincidence greater than 1% are listed in the table. Those reactions listedin Column one encompass observations in approximately 3,000patients. More than 500 of these patients were treated for periods ofat least 54 weeks. Still other reactions occurring less frequently than 1 in 100 werereported in controlled clinical trials and from marketing experience.These reactions have been divided into two categories: Column twoof the table lists reactions with therapy with Ibuprofen tablets wherethe probability of a causal relationship exists: for the reactions inColumn three, a causal relationship with Ibuprofen tablets has notbeen established. Reported side effects were higher at doses of 3,200 mg/day thanat doses of 2,400 mg or less per day in clinical trials of patients withrheumatoid arthritis. The increases in incidence were slight and stillwithin 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** GASTROINTESTINAL Nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating or flatulence). Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, jaundice, abnormal liver function tests; pancreatitis CENTRAL NERVOUS SYSTEM Dizziness*, headache, nervousness Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS ) Paresthesias, hallucinations, dream abnormalities, pseudotumor cerebri DERMATOLOGIC Rash*, (including maculopapular type), pruritus Vesiculobullous eruptions, urticaria, erythema ...
adverse reactions 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**GASTROINTESTINALNausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating or flatulence).Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, jaundice, abnormal liver function tests; pancreatitisCENTRAL NERVOUS SYSTEMDizziness*, headache, nervousnessDepression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS)Paresthesias, hallucinations, dream abnormalities, pseudotumor cerebriDERMATOLOGICRash*, (including maculopapular type), pruritusVesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopeciaToxic epidermal necrolysis, photoallergic skin reactionsSPECIAL SENSESTinnitusHearing loss, amblyopia (blurred and/or diminished vision, sco-tomata and/or changes in color vision) (see PRECAUTIONS)Conjunctivitis, diplopia, optic neuritis, cataractsHEMATOLOGICNeutropenia, 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)METABOLIC/ENDOCRINEDecreased appetiteGynecomastia, hypoglycemic reaction, acidosisCARDIOVASCULAREdema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS)Congestive heart failure in patients with marginal cardiac function, elevate blood pressure, palpitationsArrhythmias (sinus tachycardia, sinus bradycardia)ALLERGICSyndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS)Serum sickness, lupus erythematosus syndrome. Henoch- Schonlein vasculitis, angiodemaRENALAcute renal failure (see PRECAUTIONS), decreased creatinine clearance, poliuria, azotemia, cystitis, HematuriaRenal papillary necrosisMISCELLANEOUSDry eyes and mouth, gingival ulcer, rhinitis