The safety profile of nonprescription ibuprofen in multiple-dose use: a meta-analysis.

A meta-analysis was performed to compare the incidence of adverse experiences (AEs) during the multiple-dose use of nonprescription ibuprofen to a placebo. Eight studies, with doses ranging from 800 to 1200 mg/day and durations of 1 to 10 days, met the criteria for inclusion. AEs were classified according to COSTART, except that "abdominal pain" was conservatively reassigned to the digestive system. In each study, the overall AE frequency among ibuprofen-treated subjects (n = 1094) was numerically less than or equal to the placebo (n = 1093). Pooled across all studies, placebo subjects reported AEs significantly (p = 0.018) more often (31.7%) than ibuprofen subjects (27.4%). The frequency of digestive system AEs was comparable (p = 0.420) for the placebo (11.0%) and ibuprofen (12.1%); there was no significant difference for any specific digestive system AE. AE frequency in the "body-as-a-whole" category was significantly higher (p < 0.001) in the placebo (20.4%) than in ibuprofen (14.8%). The number of severe AEs in all of these categories was lower for ibuprofen than for the placebo. These data indicate that nonprescription ibuprofen has an excellent side effect profile in multiple-dose use, with a frequency of gastrointestinal AEs comparable to a placebo.