Drug Safety Information for AZATHIOPRINE (Azathioprine sodium)

Adverse Drug Reactions for AZATHIOPRINE* (Azathioprine sodium)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with AZATHIOPRINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia1330
2Crohn's disease1137
3Drug ineffective1104
4Diarrhoea1096
5Nausea*1029
6Fatigue*896
7Injection site pain875
8Vomiting*867
9Arthralgia*843
10Abdominal pain832
11Dyspnoea796
12Headache*788
13Pain*709
14Pneumonia628
15Weight decreased573
16Asthenia572
17Malaise555
18Anaemia529
19Infusion related reaction477
20Sepsis473

* This side effect also appears in "Top 10 Side Effects of AZATHIOPRINE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking AZATHIOPRINE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Crohn's disease*15917
2Product used for unknown indication13025
3Colitis ulcerative*4167
4Renal transplant*3265
5Immunosuppression2770
6Rheumatoid arthritis*2505
7Systemic lupus erythematosus1722
8Lung transplant1101
9Immunosuppressant drug therapy1003
10Heart transplant1003

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for AZATHIOPRINE

Total Reports Filed with FDA: 99526


Number of FDA Adverse Event Reports by Patient Age for AZATHIOPRINE

Total Reports Filed with FDA: 99526*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Azathioprine sodium (Immunoprin, Aza, Imurel, Azothioprine, Azatioprina, Azathioprine sodium, Azasan, Imuran, Azathioprine)

Charts are based on 99526 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and AZATHIOPRINE Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.