🇺🇸 Amicar in United States

1,383 US adverse-event reports

Marketing authorisation

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. Pain — 175 reports (12.65%)
  2. Anxiety — 158 reports (11.42%)
  3. Injury — 153 reports (11.06%)
  4. Renal Failure — 153 reports (11.06%)
  5. Unevaluable Event — 145 reports (10.48%)
  6. Death — 128 reports (9.26%)
  7. Fear — 128 reports (9.26%)
  8. Renal Injury — 123 reports (8.89%)
  9. Emotional Distress — 118 reports (8.53%)
  10. Anhedonia — 102 reports (7.38%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Amicar approved in United States?

Yes. FDA has authorised it.

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

Duke University is the originator. The local marketing authorisation holder may differ — check the official source linked above.