85/100 · Critical
Manufactured by Sebela Pharmaceuticals Inc.
High Serious Adverse Events with AZATHIOPRINE
237,317 FDA adverse event reports analyzed
Last updated: 2026-05-12
AZATHIOPRINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sebela Pharmaceuticals Inc.. Based on analysis of 237,317 FDA adverse event reports, AZATHIOPRINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for AZATHIOPRINE include OFF LABEL USE, DRUG INEFFECTIVE, CONDITION AGGRAVATED, ARTHRALGIA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AZATHIOPRINE.
Azathioprine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 237,317 adverse event reports for this medication, which is primarily manufactured by Sebela Pharmaceuticals Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Condition Aggravated. Of classified reports, 86.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. AZATHIOPRINE reports include a high percentage of serious adverse events, particularly infections and gastrointestinal issues.
The drug is associated with a wide range of reactions, indicating potential for diverse side effects. Reports show a significant number of fatalities and severe conditions like pneumonia and sepsis.
Patients taking Azathioprine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. AZATHIOPRINE can cause serious drug interactions, and patients should be monitored for signs of infection and gastrointestinal issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Azathioprine received a safety concern score of 85/100 (high concern). This is based on a 86.5% serious event ratio across 84,838 classified reports. The score accounts for 237,317 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 45,460, Male: 27,717, Unknown: 258. The most frequently reported age groups are age 40 (1,327 reports), age 60 (1,188 reports), age 65 (1,141 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 84,838 classified reports for AZATHIOPRINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
AZATHIOPRINE can cause serious drug interactions, and patients should be monitored for signs of infection and gastrointestinal issues.
If you are taking Azathioprine, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, condition aggravated, arthralgia, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow prescribed dosages and schedules to minimize the risk of adverse reactions. Report any signs of infection or gastrointestinal issues to your healthcare provider immediately. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
AZATHIOPRINE is subject to strict FDA oversight due to its potential for severe adverse reactions, particularly in older adults and those with pre-existing conditions.
The FDA has received approximately 237,317 adverse event reports associated with Azathioprine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Azathioprine include Off Label Use, Drug Ineffective, Condition Aggravated, Arthralgia, Diarrhoea. By volume, the top reported reactions are: Off Label Use (12,776 reports), Drug Ineffective (12,642 reports), Condition Aggravated (6,364 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Azathioprine.
Out of 84,838 classified reports, 73,414 (86.5%) were classified as serious and 11,424 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Azathioprine break down by patient sex as follows: Female: 45,460, Male: 27,717, Unknown: 258. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Azathioprine adverse events are: age 40: 1,327 reports, age 60: 1,188 reports, age 65: 1,141 reports, age 43: 1,134 reports, age 34: 1,124 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Azathioprine adverse event reports is Sebela Pharmaceuticals Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Azathioprine include: Nausea, Fatigue, Headache, Crohn^S Disease, Pain. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Azathioprine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Azathioprine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. AZATHIOPRINE reports include a high percentage of serious adverse events, particularly infections and gastrointestinal issues.
Key safety signals identified in Azathioprine's adverse event data include: High percentage of serious adverse events (86.5%). Frequent reports of infections, including pneumonia and sepsis. Multiple reports of gastrointestinal issues like diarrhea and abdominal pain. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
AZATHIOPRINE can cause serious drug interactions, and patients should be monitored for signs of infection and gastrointestinal issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Azathioprine.
Always follow prescribed dosages and schedules to minimize the risk of adverse reactions. Report any signs of infection or gastrointestinal issues to your healthcare provider immediately.
Azathioprine has 237,317 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating potential for diverse side effects. The volume of reports for Azathioprine reflects both the drug's usage level and the vigilance of the reporting community.
AZATHIOPRINE is subject to strict FDA oversight due to its potential for severe adverse reactions, particularly in older adults and those with pre-existing conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with AZATHIOPRINE:
Drugs related to AZATHIOPRINE based on therapeutic use, drug class, or shared indications: