Gastrointestinal safety and tolerance of ibuprofen at maximum over-the-counter dose

Background: Delineation of non-steroidal anti-inflammatory drug (NSAID) gas trointestinal toxicity has largely depended on retrospective epidemiologic studies which demonstrate that lower doses of NSAIDs pose a lower risk of g astrointestinal toxicity. Ibuprofen, a propionic acid NSAID, has, in most s uch studies, exhibited a favourable profile in terms of gastrointestinal bl eeding, Since 1984, ibuprofen has been available as a non-prescription anal gesic/antipyretic with a limit of 1200 mg/day for 10 days of continuous use . Trials and spontaneously reported adverse experiences suggest that gastro intestinal symptoms and bleeding are rare. Methods: This study prospectively evaluated the gastrointestinal tolerabili ty, as compared to placebo, of the maximum non-prescription dose and durati on of ibuprofen use in healthy subjects representative of a nonprescription analgesic user population. Results: Gastrointestinal adverse experiences were similar in the placebo a nd ibuprofen groups (67 out of 413, 16% with placebo vs. 161 out of 833, 19 % with ibuprofen). There was no difference between the two groups in the pr oportion discontinuing due to a gastrointestinal event. Gastrointestinal ad verse experiences reported by greater than or equal to 1% of subjects were: dyspepsia, abdominal pain, nausea, diarrhoea, flatulence, and constipation . Seventeen (1.4%) subjects had positive occult blood tests: their frequenc y was comparable between treatments. Conclusions: When used as directed to treat episodic pain, non-prescription ibuprofen at the maximum dose of 1200 mg/day for 10 days, is well-tolerate d.