🇺🇸 Azathioprine (AZA) in United States

FDA authorised Azathioprine (AZA) on 19 July 1974 · 10 US adverse-event reports

Marketing authorisation

FDA — authorised 19 July 1974

  • Application: NDA017391
  • Marketing authorisation holder: CASPER PHARMA LLC
  • Local brand name: IMURAN
  • Indication: INJECTABLE — INJECTION
  • 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. Abscess — 1 report (10%)
  2. Asthenia — 1 report (10%)
  3. Bradyphrenia — 1 report (10%)
  4. Child-Pugh-Turcotte Score Increased — 1 report (10%)
  5. Dehydration — 1 report (10%)
  6. Diarrhoea — 1 report (10%)
  7. Disease Progression — 1 report (10%)
  8. Disorientation — 1 report (10%)
  9. Hepatic Failure — 1 report (10%)
  10. Intestinal Obstruction — 1 report (10%)

Source database →

Other Immunology approved in United States

Frequently asked questions

Is Azathioprine (AZA) approved in United States?

Yes. FDA authorised it on 19 July 1974.

Who is the marketing authorisation holder for Azathioprine (AZA) in United States?

CASPER PHARMA LLC holds the US marketing authorisation.