🇺🇸 Ketolorac in United States

FDA authorised Ketolorac on 20 December 1991 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 20 December 1991

  • Application: NDA019645
  • Marketing authorisation holder: ROCHE PALO
  • Local brand name: TORADOL
  • 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. Anxiety — 1 report (10%)
  2. Arterial Thrombosis Limb — 1 report (10%)
  3. Back Pain — 1 report (10%)
  4. Cellulitis — 1 report (10%)
  5. Cognitive Disorder — 1 report (10%)
  6. Coma — 1 report (10%)
  7. Condition Aggravated — 1 report (10%)
  8. Conversion Disorder — 1 report (10%)
  9. Depression — 1 report (10%)
  10. Endometriosis — 1 report (10%)

Source database →

Ketolorac in other countries

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

Other Other approved in United States

Frequently asked questions

Is Ketolorac approved in United States?

Yes. FDA authorised it on 20 December 1991; FDA has authorised it.

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

ROCHE PALO holds the US marketing authorisation.