The labeling for ALEVE is consistent with over-the-counter (OTC) nonsteroidal anti-inflammatory drug (NSAID) labeling and a “Stomach Bleeding Warning” designed to inform consumers that the product contains an NSAID, which "may cause severe stomach bleeding."1
The warning informs consumers that the risk of stomach bleeding is higher if: they are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using the product or take more or for a longer time than directed.1
Consumers are advised to ask a doctor before use if: the stomach bleeding warning applies to them, or if they have a history of stomach problems such as heartburn.1
Consumers are advised to stop use and ask a doctor if: they experience any of the following signs of stomach bleeding including feeling faint, vomiting blood, bloody or black stools, or stomach pain that does not get better.1
The risk of GI bleeding with NSAID use is dose dependent and impacted by the duration of use.2 The minimum effective dose for the shortest duration of NSAID use is generally recommended to minimize undesirable effects including GI side effects.
A meta-analysis of 46 randomized, controlled studies demonstrated that the incidence of patient- reported GI adverse events (nausea and `dyspepsia, and were the most commonly reported) with OTC naproxen sodium was comparable with placebo.3
In patients taking naproxen sodium, the reporting rate of GI bleeding from clinical trial data was rare (0.01% to <0.1%).4 A review of 101 short-term studies (30 days or less) with naproxen at OTC doses (up to 600 mg a day) found that the incidence of new-onset upper GI bleeding ranged from 0% to 0.036%.4 In 1 long-term studies (1 year in length) with naproxen at OTC doses (up to or equal to 440 mg a day), there was no significant difference between naproxen sodium and placebo in the incidence of new onset GI bleeding.5
For more information on the GI safety of naproxen/naproxen sodium, see the following selected references. These are not intended to be a comprehensive review of the literature:
Aisen PS, et al. Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. 2003.
Bansal V, et al. A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis. J Clin Pharmacol. 2001.
Biskupiak JE, et al. Gastrointestinal complications of over-the-counter nonsteroidal antiinflammatory drugs. J Pain Palliat Care Pharmacother. 2006.
Bombardier C, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000.
Castellsague J, et al. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf. 2012.
DeArmond B, et al. Safety profile of over-the-counter naproxen sodium. Clin Ther. 1995.
Dikman A, et al. A randomized, placebo-controlled study of the effects of naproxen, aspirin, celecoxib or clopidogrel on gastroduodenal mucosal healing. Aliment Pharmacol Ther. 2009.
Lewis JD, et al. Risk of serious upper gastrointestinal toxicity with over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs. Gastroenterology. 2005.
Massó González EL, et al. Variability among nonsteroidal antiinflammatory drugs in risk of upper gastrointestinal bleeding. Arthritis Rheum. 2010.
Mellemkjaer L, et al. Upper gastrointestinal bleeding among users of NSAIDs: a population-based cohort study in Denmark. Br J Clin Pharmacol. 2002.
Niculescu L, et al. Pooled analysis of GI tolerability of 21 randomized controlled trials of celecoxib and nonselective NSAIDs. Curr Med Res Opin. 2009.
Rahme E, et al. Hospitalization for gastrointestinal adverse events attributable to the use of low-dose aspirin among patients 50 years or older also using non-steroidal anti-inflammatory drugs: a retrospective cohort study. Aliment Pharmacol Ther. 2007.
Schnitzer TJ, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet. 2004.
Zhang W, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008.
1. ALEVE label.
2. Tarone RE, Blot WJ, McLaughlin JK. Nonselective nonaspirin nonsteroidal anti-inflammatory drugs and gastrointestinal bleeding: relative and absolute risk estimates from recent epidemiologic studies. Am J Ther. 2004;11(1):17-25.
3. Bansal V, Dex T, Proskin H, et al. A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis. J Clin Pharmacol. 2001;41:127-138.
4. Data on file. Bayer HealthCare LLC.
5. Aisen PS, Schafer KA, Grundman M, et al. Effects of rofecoxib or naproxen vs placebo on alzheimer disease progression: a randomized controlled trial. JAMA. 2003;289:2819-2826.
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