🇺🇸 Sodium Naproxen in United States

FDA authorised Sodium Naproxen on 11 January 1994 · 33 US adverse-event reports

Marketing authorisations

FDA — authorised 11 January 1994

  • Application: NDA020204
  • Marketing authorisation holder: BAYER
  • Local brand name: ALEVE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Status: approved

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.

Most-reported reactions

  1. Asthenia — 4 reports (12.12%)
  2. Fall — 4 reports (12.12%)
  3. Fatigue — 4 reports (12.12%)
  4. Anaemia — 3 reports (9.09%)
  5. Chest Discomfort — 3 reports (9.09%)
  6. Dehydration — 3 reports (9.09%)
  7. Depression — 3 reports (9.09%)
  8. Dizziness — 3 reports (9.09%)
  9. Gait Disturbance — 3 reports (9.09%)
  10. Headache — 3 reports (9.09%)

Source database →

Sodium Naproxen in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Sodium Naproxen approved in United States?

Yes. FDA authorised it on 11 January 1994; FDA has authorised it.

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

BAYER holds the US marketing authorisation.