Nonprescription Ibuprofen: Side Effect Profile

Abstract

Single doses of nonprescription analgesics are commonly used to treat self-diagnosed conditions. To evaluate the safety of single doses of nonprescription-strength ibuprofen, we examined reported side effects from 15 double-blind, randomized, controlled trials we conducted of the drug to treat various common painful conditions (e.g., headache, sore throat). All studies included placebo and another nonprescription analgesic, acetaminophen. A total of 878 subjects received ibuprofen 200 or 400 mg, 849 acetaminophen 650 or 1000 mg, and 852 placebo. The overall frequency of side effects was comparable: ibuprofen 2.4%, acetaminophen 3.2%, and placebo 2.1%. The frequency of central nervous system symptoms was 0.8%, 2.1%, and 0.9%, respectively. Upper gastro-intestinal upset ranged from 0.8-0.9% of subjects in all groups. We conclude that single doses of nonprescription ibuprofen are well tolerated and demonstrate a side effect profile indistinguishable from that of acetaminophen and placebo.