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Clin Ther. 2000 May;22(5):500-48.

Over-the-counter analgesics and antipyretics: a critical assessment.

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  • 1Division of Pharmacology and Therapeutics, School of Dental Medicine, University of Pennsylvania, Philadelphia 19104-6003, USA.



It is just 100 years since the introduction of aspirin to medicine. Since then, aspirin and its derivatives have been joined by acetaminophen, and the nonsteroidal anti-inflammatory drugs--ibuprofen, naproxen sodium, and ketoprofen--as the only over-the-counter (OTC) agents approved by the US Food and Drug Administration for the short-term treatment of pain, headache, dysmenorrhea, and fever. Recently the prescription use of aspirin has expanded to include a number of antiplatelet indications.


The purpose of this paper is to review critically the history, mechanisms of action, efficacy, and tolerability of OTC analgesic and antipyretic products. Relatively new and potential future indications for these drugs are also discussed.


Although all of the OTC analgesic/antipyretic agents seem to share a common mechanism of prostaglandin inhibition, there are important differences in their pharmacology, efficacy, and side-effect profiles. Considering their often-unsupervised use, the risk-benefit ratio of this class of drugs has been extremely favorable. However, when used inappropriately, even these drugs pose significant risks to certain patient populations.

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