Gastrointestinal safety and tolerance of ibuprofen at maximum over-the-counter dose
Article first published online: 24 DEC 2001
Alimentary Pharmacology & Therapeutics
Volume 13, Issue 7, pages 897–906, July 1999
How to Cite
Doyle, Furey, Berlin, Cooper, Jayawardena, Ashraf and Baird (1999), Gastrointestinal safety and tolerance of ibuprofen at maximum over-the-counter dose. Alimentary Pharmacology & Therapeutics, 13: 897–906. doi: 10.1046/j.1365-2036.1999.00539.x
- Issue published online: 24 DEC 2001
- Article first published online: 24 DEC 2001
: Delineation of non-steroidal anti-inflammatory drug (NSAID) gastrointestinal toxicity has largely depended on retrospective epidemiologic studies which demonstrate that lower doses of NSAIDs pose a lower risk of gastrointestinal toxicity. Ibuprofen, a propionic acid NSAID, has, in most such studies, exhibited a favourable profile in terms of gastrointestinal bleeding. Since 1984, ibuprofen has been available as a non-prescription analgesic/antipyretic with a limit of 1200 mg/day for 10 days of continuous use. Trials and spontaneously reported adverse experiences suggest that gastrointestinal symptoms and bleeding are rare.
: This study prospectively evaluated the gastrointestinal tolerability, as compared to placebo, of the maximum non-prescription dose and duration of ibuprofen use in healthy subjects representative of a non-prescription analgesic user population.
: Gastrointestinal adverse experiences were similar in the placebo and 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 proportion discontinuing due to a gastrointestinal event. Gastrointestinal adverse experiences reported by ≥ 1% of subjects were: dyspepsia, abdominal pain, nausea, diarrhoea, flatulence, and constipation. Seventeen (1.4%) subjects had positive occult blood tests: their frequency was comparable between treatments.
: When used as directed to treat episodic pain, non-prescription ibuprofen at the maximum dose of 1200 mg/day for 10 days, is well-tolerated.