The most frequently encountered adverse reactions following Ibuprofen administration involve the gastrointestinal tract. Nausea, heartburn, epigastric pain (3 to 9%); vomiting, diarrhea, constipation, abdominal cramps or pain, dyspepsia, bloating or flatulence (1 to 3%); gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, hepatitis, jaundice, abnormal liver function (SGOT, serum bilirubin and alkaline phosphatase) (less than 1%).
Dizziness (3 to 9%); headache, nervousness (1 to 3%); depression, insomnia (less than 1%). Paresthesias, hallucinations and dream abnormalities have been reported in conjunction with Ibuprofen treatment.
Tinnitus (1 to 3%); amblyopia (blurred and/or diminished vision, scotomata and/or change in color vision) (less than 1%). Any patient with eye complaints during Ibuprofen therapy should have an ophthalmological examination (see Precautions).
Conjunctivitis, diplopia and optic neuritis have been reported but causal relationship with Ibuprofen administration has not been established.
Rash (including maculopapular type) (3 to 9%); pruritus (1 to 3%); vesiculobullous eruptions, urticaria, erythema multiforme (less than 1%). Alopecia and Stevens-Johnson syndrome have been reported but causal relationship with Ibuprofen administration has not been established.
Leukopenia and decreases in hemoglobin and hematocrit (less than 1%). Rare cases of hemolytic anemia, thrombocytopenia, granulocytopenia and bleeding episodes (purpura, epistaxis, hematuria, menorrhagia) have been reported in conjunction with Ibuprofen administration.
Edema, fluid retention (1 to 3%). Fluid retention generally responds promptly to drug discontinuation (see Precautions).
Congestive heart failure in patients with marginal cardiac function, elevated blood pressure (less than 1%). Rare cases of arrhythmias (sinus tachycardia, sinus bradycardia, palpitations) have been reported.
Rare cases of decreased creatinine clearance, polyuria and azotemia have been reported in conjunction with Ibuprofen treatment, as well as a case of renal papillary necrosis of uncertain etiology.
Rare cases of gynecomastia and hypoglycemic reactions have been reported in conjunction with Ibuprofen administration.
Anaphylaxis (see Contraindications) (less than 1%). Fever, serum sickness and lupus erythematosus have been rarely reported in connection with Ibuprofen administration.