FDA — authorised 20 March 1968
- Application: NDA016324
- Marketing authorisation holder: LEGACY PHARMA
- Status: supplemented
🇺🇸 Imuran in United States
FDA authorised Imuran on 20 March 1968 · 20,548 US adverse-event reports
Marketing authorisations
FDA — authorised 19 July 1974
- Application: NDA017391
- Marketing authorisation holder: CASPER PHARMA LLC
- Local brand name: IMURAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 June 1999
- Application: ANDA075252
- Marketing authorisation holder: AAIPHARMA LLC
- Local brand name: AZASAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 1999
- Application: ANDA075568
- Marketing authorisation holder: RISING
- Local brand name: AZATHIOPRINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 March 2007
- Application: ANDA077621
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: AZATHIOPRINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2020
- Application: ANDA208687
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: AZATHIOPRINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071056
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: AZATHIOPRINE
- Indication: Injectable — Injection
- Status: approved
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 20,548
Most-reported reactions
- Off Label Use — 3,526 reports (17.16%)
- Drug Ineffective — 3,443 reports (16.76%)
- Arthralgia — 1,929 reports (9.39%)
- Condition Aggravated — 1,906 reports (9.28%)
- Diarrhoea — 1,864 reports (9.07%)
- Nausea — 1,818 reports (8.85%)
- Fatigue — 1,780 reports (8.66%)
- Crohn^S Disease — 1,452 reports (7.07%)
- Pain — 1,443 reports (7.02%)
- Abdominal Pain — 1,387 reports (6.75%)
Imuran 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 Imuran approved in United States?
Yes. FDA authorised it on 20 March 1968; FDA authorised it on 19 July 1974; FDA authorised it on 7 June 1999.
Who is the marketing authorisation holder for Imuran in United States?
LEGACY PHARMA holds the US marketing authorisation.