title: 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.
authors.affiliation: Medical Department, Whitehall Laboratory, New York, NY 10017-4076.
authors.forename: S A
authors.initials: SA
authors.lastname: Furey
authors.forename: J A
authors.initials: JA
authors.lastname: Waksman
authors.forename: B H
authors.initials: BH
authors.lastname: Dash
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012651:Self Medication
chemical_list: D004366:Nonprescription Drugs; D000082:Acetaminophen; D007052:Ibuprofen