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Nonprescription Ibuprofen: Side Effect Profile
Author(s) -
Furey Sandy A.,
Waksman Joel A.,
Dash Barry H.
Publication year - 1992
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1002/j.1875-9114.1992.tb04479.x
Subject(s) - ibuprofen , acetaminophen , placebo , medicine , sore throat , analgesic , anesthesia , side effect (computer science) , pharmacology , alternative medicine , pathology , computer science , programming language
Single doses of nonprescription analgesics are commonly used to treat self‐diagnosed conditions. To evaluate the safety of single doses of nonprescriptionstrength 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 gastrointestinal 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.