Generic name
Azathioprine: adverse event reports filed with FDA
33,639 reports list it as a suspect or interacting product, 2004–2026. Class: Purine antimetabolite. Also reported as Azathioprine Tablets Usp, Azathioprine 50mg, Azathioprine /00001502/.
- 33,639
- reports as suspect product
- 0.2% of all reports · about 1,495 a year
- 2,890
- reports, 12 months to June 2026
- 3,182 in the 12 months before
- 94.7%
- marked serious by the reporter
- 90.3% across the class
- 15.1%
- record death among outcomes, as reported
- 5,089 reports · not verified by FDA
Between January 2004 and June 2026, 33,639 adverse event reports received by FDA list azathioprine, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (32,393) are left out of every figure here.
In the 12 months to June 2026, 2,890 reports listed it, close to the 3,182 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 1,495 reports a year and 0.2% of the 20,646,523 reports in the database, and 67.7% of the reports for the purine antimetabolite class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (20.3%), off label use (14.8%) and drug intolerance (8.2%). A report can list several reactions, so shares add to more than 100%; 3,541 different terms appear across these reports. Drug ineffective is recorded in 20.3% of these reports, about the same share as in the median purine antimetabolite drug (20.3%).
94.7% of the reports are marked serious by the reporter (90.3% across the class); 15.1% record death among the outcomes and 32.8% record hospitalisation, as reported. 54.6% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (26.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Azathioprine reports recording the termmedian drug in purine antimetabolite
- Drug ineffectivethe medicine did not work as expected20.3%6,814
- Off label useused for a purpose or in a way not on the label14.8%4,978
- Drug intolerancethe medicine was not tolerated8.2%2,765
- Condition aggravatedthe condition being treated got worse7.6%2,554
- Treatment failurethe treatment did not work6.7%2,252
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease6.4%2,165
- Arthralgiajoint pain6%2,008
- Drug hypersensitivityan allergic-type reaction to a medicine5.8%1,961
- Pneumonialung infection5.8%1,945
- Product use in unapproved indicationused for a purpose not on the label5.7%1,901
- Nauseafeeling sick5.6%1,886
- Diarrhoealoose or frequent stools5.4%1,833
- Rashskin rash5.1%1,728
- Maternal exposure during pregnancythe mother took the medicine during pregnancy4.9%1,662
- Pyrexiafever4.9%1,652
- Fatiguetiredness4.8%1,606
- Painpain, site not specified4.5%1,525
- Headachehead pain4.5%1,517
- Joint swellinga swollen joint4.4%1,465
- Dyspnoeashortness of breath4.3%1,458
- Vomitingbeing sick4.1%1,384
- Hypertensionhigh blood pressure4%1,357
- Hypersensitivityan allergic-type reaction4%1,348
- Pain in extremitypain in an arm or leg3.9%1,323
- Therapeutic product effect decreased3.9%1,321
- Synovitis3.8%1,292
- Malaisegeneral feeling of being unwell3.8%1,263
- Contraindicated product administered3.7%1,257
- Hepatic enzyme increasedraised liver enzymes3.7%1,243
Top 30 of 3,541 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the purine antimetabolite class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 49,725 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 18.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Immunosuppressant drug therapy | 2,448 | 7.3% |
| Crohn's disease | 2,412 | 7.2% |
| Colitis ulcerative | 1,884 | 5.6% |
| Immunosuppression | 1,626 | 4.8% |
| Rheumatoid arthritis | 1,617 | 4.8% |
| Systemic lupus erythematosus | 1,239 | 3.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 33,639 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Azathioprine reports |
|---|---|---|
| Prednisone | 10,627 | 31.6% |
| Methotrexate | 8,061 | 24% |
| Prednisolone | 7,254 | 21.6% |
| Rituximab | 5,861 | 17.4% |
| Mycophenolate mofetil | 5,728 | 17% |
| Infliximab | 4,794 | 14.3% |
| Hydroxychloroquine | 4,599 | 13.7% |
| Humira | 4,537 | 13.5% |
| Tacrolimus | 4,503 | 13.4% |
| Sulfasalazine | 3,887 | 11.6% |
Other products listed in reports where Azathioprine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Azathioprine | Purine antimetabolite | All reports |
|---|---|---|---|
| Reports as suspect product | 33,639 | 49,725 | 20,646,523 |
| Share of that pool | — | 67.7% | 0.2% |
| Reports, latest 12 months | 2,890 | — | 1,332,454 |
| Marked serious | 94.7% | 90.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 151 | 142 | 91 |
| Hospitalisation recorded, per 1,000 reports | 328 | 319 | 213 |
| Consumer-filed share | 9.2% | 18.3% | 45.8% |
| Top term, share of reports | Drug ineffective 20.3% | median 20.3% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the purine antimetabolite class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Mavenclad | brand | 6,763 | 1,128 | 67.2% |
| Imuran | brand | 5,749 | 407 | 87.3% |
| Cladribine | generic | 2,083 | 200 | 96.2% |
| Azathioprine sodium | generic | 1,491 | 166 | 99.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Azathioprine reports
How many adverse event reports has FDA received for Azathioprine?
33,639 reports list Azathioprine as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 2,890 of them arrived in the latest 12 months. Another 32,393 list it only as a concomitant medication.
What reactions are recorded in Azathioprine reports?
drug ineffective (20.3%), off label use (14.8%), drug intolerance (8.2%), condition aggravated (7.6%) and treatment failure (6.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Azathioprine was responsible.
How serious are the reports?
94.7% are marked serious by the reporter. Among the outcomes recorded, 15.1% of reports include death and 32.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (54.6%), physician (30.9%) and consumer or non-health professional (9.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Azathioprine rising?
2,890 reports in the 12 months to June 2026, close to the 3,182 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Azathioprine was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Azathioprine?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Azathioprine as a suspect or interacting product; reports listing it only as a concomitant medication (32,393) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.