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 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: