Azathioprine
According to the FDA label: INDICATIONS AND USAGE Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation.
64,425 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Azathioprine in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Off Label Use 10,042 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Ineffective 9,977 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Condition Aggravated 4,994 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Arthralgia 4,158 reports
Diarrhoea 3,756 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 3,604 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 3,500 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Headache 3,184 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Drug Intolerance 3,161 reports
A report that the person could not tolerate a medication, often due to uncomfortable effects.
Full definition in the glossary →Pyrexia 3,007 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 2,975 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Pain 2,972 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Crohn's Disease 2,904 reports
A long-term condition that causes inflammation of the digestive tract. It often appears in reports as a condition being treated.
Full definition in the glossary →Rheumatoid Arthritis 2,842 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Dyspnoea 2,757 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 33,368 |
| Male | 21,283 |
| Unknown | 220 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 4,295 |
| 18-34 | 9,455 |
| 35-49 | 10,554 |
| 50-64 | 11,364 |
| 65-74 | 5,871 |
| 75+ | 2,270 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Azathioprine. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 44,288 |
| Hospitalization | 22,394 |
| Death | 7,144 |
| Non-Serious | 6,672 |
| Life-Threatening | 4,094 |
| Disability | 2,338 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Azathioprine. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 6 |
| 2004 | 691 |
| 2005 | 540 |
| 2006 | 593 |
| 2007 | 686 |
| 2008 | 1,148 |
| 2009 | 1,196 |
| 2010 | 1,142 |
| 2011 | 1,480 |
| 2012 | 1,627 |
| 2013 | 1,773 |
| 2014 | 2,237 |
| 2015 | 2,467 |
| 2016 | 2,821 |
| 2017 | 3,060 |
| 2018 | 4,367 |
| 2019 | 5,041 |
| 2020 | 6,250 |
| 2021 | 5,191 |
| 2022 | 5,414 |
| 2023 | 4,977 |
| 2024 | 5,528 |
| 2025 | 5,211 |
| 2026 (partial) | 975 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Azathioprine
In FDA adverse event reports that mention Azathioprine, these medications appeared most often in the same report.
- Prednisone (19,361 reports)
- Adalimumab (14,115 reports)
- Infliximab (13,955 reports)
- Methotrexate (11,837 reports)
- Prednisolone (10,504 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026