The labeling for ALEVE is consistent with over-the-counter (OTC) nonsteroidal anti-inflammatory drug (NSAID) labeling and contains a warning for patients with liver cirrhosis to consult with their doctors before use.1
Little data exist for naproxen sodium at OTC doses, but serious or life-threatening hepatic (ie, liver) adverse events are very rare when naproxen sodium is taken as directed. Severe hepatic reactions, including jaundice, hepatitis, and biliary adverse events, have been reported with the use of NSAIDs, including naproxen sodium, but such cases are very rare (less than 0.01% combined reporting rate from clinical trial data). In patients with severe hepatic impairment, dose reduction may be necessary.2
For more information on the hepatic safety of naproxen/naproxen sodium, see the following selected references. These are not intended to be a comprehensive review of the literature:
Lapeyre-Mestre M, et al. Non-steroidal anti-inflammatory drug-related hepatic damage in France and Spain: analysis from national spontaneous reporting systems. Fundam Clin Pharmacol. 2006.
Rostom A, et al. Nonsteroidal anti-inflammatory drugs and hepatic toxicity: a systematic review of randomized controlled trials in arthritis patients. Clin Gastroenterol Hepatol. 2005.
Soni P, et al. The hepatic safety and tolerability of the cyclooxygenase-2 selective NSAID celecoxib: pooled analysis of 41 randomized controlled trials. Curr Med Res Opin. 2009.
1. ALEVE label.
2. Data on file. Bayer HealthCare LLC
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