A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis

J Clin Pharmacol. 2001 Feb;41(2):127-38. doi: 10.1177/00912700122009935.


As the trend for Americans to self-medicate continues to increase, it becomes important to review the safety of over-the-counter (OTC) medications. This article will review the safety of an OTC analgesic, Aleve (naproxen sodium). The objective of this meta-analysis is to evaluate the frequency of occurrence of all adverse events in subjects taking various doses of OTC naproxen sodium as compared to placebo. These varying doses and dosage regimens were studied individually and consisted of 220 to 880 mg administered in single, multiple, and PRN (as needed) doses of naproxen sodium. This meta-analysis confirmed the favorable safety profile of naproxen sodium at OTC doses and established that the overall occurrence of adverse events with naproxen sodium was comparable and in some cases significantly lower than placebo. These results indicate that treatment with naproxen sodium may be highly beneficial from a clinical and economical perspective and safe when adhering to labeled directions.

Publication types

  • Meta-Analysis

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Dizziness / chemically induced
  • Headache / chemically induced
  • Humans
  • Naproxen / adverse effects*
  • Nausea / chemically induced
  • Nonprescription Drugs / adverse effects*
  • Randomized Controlled Trials as Topic


  • Anti-Inflammatory Agents, Non-Steroidal
  • Nonprescription Drugs
  • Naproxen