🇺🇸 Naproxen Sodium (Aleve) in United States

22 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 23 April 2025 – 23 April 2026
• Total reports: 22

Most-reported reactions

1. Asthenia — 3 reports (13.64%)
2. Diarrhoea — 3 reports (13.64%)
3. Anaemia — 2 reports (9.09%)
4. Arthralgia — 2 reports (9.09%)
5. Blood Glucose Increased — 2 reports (9.09%)
6. Blood Lactic Acid Increased — 2 reports (9.09%)
7. Chest Pain — 2 reports (9.09%)
8. Diffuse Large B-Cell Lymphoma Recurrent — 2 reports (9.09%)
9. Dizziness — 2 reports (9.09%)
10. Drug Ineffective — 2 reports (9.09%)

Source database →

Frequently asked questions

Is Naproxen Sodium (Aleve) approved in United States?

Naproxen Sodium (Aleve) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Naproxen Sodium (Aleve) in United States?

Seattle Institute for Biomedical and Clinical Research is the originator. The local marketing authorisation holder may differ — check the official source linked above.