🇺🇸 celebrex in United States

FDA authorised celebrex on 31 December 1998 · 77,446 US adverse-event reports

Marketing authorisations

FDA — authorised 31 December 1998

  • Application: NDA020998
  • Marketing authorisation holder: UPJOHN
  • Status: supplemented

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. Drug Ineffective — 13,750 reports (17.75%)
  2. Pain — 10,099 reports (13.04%)
  3. Arthralgia — 8,827 reports (11.4%)
  4. Fatigue — 7,579 reports (9.79%)
  5. Nausea — 7,137 reports (9.22%)
  6. Myocardial Infarction — 6,811 reports (8.79%)
  7. Drug Hypersensitivity — 6,479 reports (8.37%)
  8. Rheumatoid Arthritis — 5,814 reports (7.51%)
  9. Headache — 5,555 reports (7.17%)
  10. Off Label Use — 5,395 reports (6.97%)

Source database →

Other Immunology approved in United States

Frequently asked questions

Is celebrex approved in United States?

Yes. FDA authorised it on 31 December 1998; FDA has authorised it.

Who is the marketing authorisation holder for celebrex in United States?

UPJOHN holds the US marketing authorisation.