🇺🇸 Celecoxib capsules in United States

FDA authorised Celecoxib capsules on 23 December 1999 · 124 US adverse-event reports

Marketing authorisation

FDA — authorised 23 December 1999

  • Application: NDA021156
  • Marketing authorisation holder: GD SEARLE LLC
  • Local brand name: CELEBREX
  • Indication: CAPSULE — ORAL
  • Status: approved

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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 — 60 reports (48.39%)
  2. Pain — 14 reports (11.29%)
  3. Product Substitution Issue — 12 reports (9.68%)
  4. Nausea — 8 reports (6.45%)
  5. Diarrhoea — 6 reports (4.84%)
  6. Headache — 6 reports (4.84%)
  7. Rash — 6 reports (4.84%)
  8. Arthralgia — 4 reports (3.23%)
  9. Chest Pain — 4 reports (3.23%)
  10. Hypoaesthesia — 4 reports (3.23%)

Source database →

Other Rheumatology / Pain Management approved in United States

Frequently asked questions

Is Celecoxib capsules approved in United States?

Yes. FDA authorised it on 23 December 1999.

Who is the marketing authorisation holder for Celecoxib capsules in United States?

GD SEARLE LLC holds the US marketing authorisation.