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The Safety Profile of Nonprescription Ibuprofen in Multiple‐Dose Use: A Meta‐Analysis
Author(s) -
Kellstein David E.,
Waksman Joel A.,
Furey Sandy A.,
Binstok Giselle,
Cooper Stephen A.
Publication year - 1999
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/009127009903900513
Subject(s) - ibuprofen , placebo , medicine , adverse effect , meta analysis , abdominal pain , incidence (geometry) , anesthesia , pharmacology , physics , alternative medicine , pathology , optics
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.