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

1999; Wiley; Volume: 13; Issue: 7 Linguagem: Inglês

10.1046/j.1365-2036.1999.00539.x

1365-2036

Doyle, Furey, Berlin, Cooper, Jayawardena, Ashraf Ashraf, Baird,

Nausea and vomiting management

Background : 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. Methods : 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. Results : 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. 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‐tolerated.