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

A meta-analysis was performed to compare the incidence of adverse experienc es (AEs) during the multiple-dose use of nonprescription ibuprofen, to a pl acebo. Eight studies, with doses ranging from 800 to 1200 mg/day and durati ons of 1 to 10 days, met the criteria for inclusion. AEs were classified ac cording to COSTART: except that "abdominal pain" was conservatively reassig ned 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 report ed 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 dif ference 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 cate gories was lower for ibuprofen than for the placebo. These data indicate th at non-prescription ibuprofen has an excellent side effect profile in multi ple-dose use, with a frequency of gastrointestinal AEs comparable to a plac ebo. (C) 1999 the American College of Clinical Pharmacology.