Drug profile

The FDA adverse-event record for Azathioprine

105 FDA reports name Azathioprine, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#762 of 2,679
by report volume (all drugs)
105
adverse-event reports
32.4%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Azathioprine ranks #762 of 2679 by total reports (105) and #110 of 1130 by death-coded share (32.4%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#762
This drug, reports of 2679
#110
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Azathioprine has 105 reports now versus 104 in that prior snapshot: 1 more (1.0%).

Report change
+1
Death-coded reports
+1
Death-coded share
+0.7 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Azathioprine changes

Signature read: Azathioprine's 32.4% death-coded share is among the highest in the openFDA drug corpus.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
105
Total Reports
34
Deaths Reported
32.4%
Death-coded share of reports

Active Ingredients

Azathioprine

Administration Routes

OralUnknown

Species Affected

Dog 105

Most Affected Breeds

Retriever - Labrador 10
Shepherd Dog - German 7
Crossbred Canine/dog 6
Shih Tzu 6
Retriever - Golden 5
Spaniel - Cocker American 4
Shepherd Dog - Australian 4
Boxer (German Boxer) 3
Chihuahua 3
Terrier - Jack Russell 3

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 26
Elevated serum alkaline phosphatase (SAP) 21
Death by euthanasia 20
Anaemia NOS 20
Immune mediated haemolytic anaemia 20
Vomiting 19
Other abnormal test result NOS 18
Diarrhoea 18
Elevated alanine aminotransferase (ALT) 17
Leucocytosis NOS 17
Thrombocytopenia 16
Anorexia 15

Outcome Breakdown

Ongoing
27 (27.6%)
Euthanized
20 (20.4%)
Recovered/Normal
17 (17.3%)
Outcome Unknown
16 (16.3%)
Died
14 (14.3%)
Recovered with Sequela
4 (4.1%)

Azathioprine: high death-coded share in the FDA AER row

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Azathioprine, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Azathioprine (#762 of 2,679 by report volume); death-coded 32.4%. PlainBreed drug row · death-coded share stamp 32.4% · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →