🇺🇸 Ketalar in United States

FDA authorised Ketalar on 19 February 1970 · 695 US adverse-event reports

Marketing authorisations

FDA — authorised 19 February 1970

  • Application: NDA016812
  • Marketing authorisation holder: PH HEALTH
  • 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 Abuse — 183 reports (26.33%)
  2. Off Label Use — 107 reports (15.4%)
  3. Hydronephrosis — 101 reports (14.53%)
  4. Cystitis — 59 reports (8.49%)
  5. Biliary Tract Disorder — 43 reports (6.19%)
  6. Bladder Disorder — 43 reports (6.19%)
  7. Hepatotoxicity — 41 reports (5.9%)
  8. Liver Function Test Abnormal — 41 reports (5.9%)
  9. Haematuria — 39 reports (5.61%)
  10. Dilatation Intrahepatic Duct Acquired — 38 reports (5.47%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Ketalar approved in United States?

Yes. FDA authorised it on 19 February 1970; FDA has authorised it.

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

PH HEALTH holds the US marketing authorisation.