Frequently Asked Questions


The labeling for ALEVE is consistent with over-the-counter (OTC) nonsteroidal anti-inflammatory drug (NSAID) labeling with regards to the "Allergy Alert" and states that naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.1

How common are allergic reactions to naproxen/naproxen sodium?

Immune system reactions such as anaphylaxis have been observed very rarely in patients taking naproxen/naproxen sodium. The combined reported rate in clinical trials is less than 0.01%.1

Which patients are at an increased risk for experiencing allergic reactions to naproxen/naproxen sodium?

Hypersensitivity reactions may occur both in individuals with and without a history of hypersensitivity on exposure to aspirin, other pain relievers/fever reducers, or naproxen-containing products. Patients with known hypersensitivity to naproxen or any other ingredient in the product, or who have a history of asthma, rash, or allergic-type reactions after taking aspirin or other pain relievers/fever reducers, should not use naproxen-containing products, including ALEVE.2  

1. ALEVE label.
2. Data on file. Bayer HealthCare LLC
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