Drug profile

The FDA adverse-event record for Ondansetron

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

#250 of 2,679
by report volume (all drugs)
657
adverse-event reports
28.3%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Ondansetron ranks #250 of 2679 by total reports (657) and #134 of 1130 by death-coded share (28.3%). 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)
#250
This drug, reports of 2679
#134
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. Ondansetron has 657 reports now versus 586 in that prior snapshot: 71 more (12.1%).

Report change
+71
Death-coded reports
+11
Death-coded share
−1.6 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 Ondansetron changes

Signature read: death-coded report count at 186 is the most distinctive stamp on Ondansetron's FDA AER row.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
657
Total Reports
186
Deaths Reported
28.3%
Death-coded share of reports

Active Ingredients

Ondansetron

Administration Routes

UnknownOralIntravenousParenteralSubcutaneousIntramuscularOtherTransdermal

Species Affected

Dog 472
Cat 181
Human 3
Lynx 1

Most Affected Breeds

Domestic Shorthair 105
Retriever - Labrador 74
Retriever - Golden 29
Crossbred Canine/dog 24
Domestic Longhair 18
Domestic Mediumhair 17
Bulldog - French 16
Pit Bull 14
Shepherd Dog - German 14
Boxer (German Boxer) 13

Most Reported Reactions

Vomiting 176
Lethargy (see also Central nervous system depression in Neurological) 168
Death by euthanasia 129
Diarrhoea 127
Not eating 125
Elevated alanine aminotransferase (ALT) 90
Decreased appetite 84
Weight loss 81
Other abnormal test result NOS 81
Abnormal ultrasound finding 80
Elevated total bilirubin 80
Anorexia 73

Outcome Breakdown

Ongoing
218 (33.2%)
Euthanized
129 (19.6%)
Recovered/Normal
127 (19.3%)
Outcome Unknown
125 (19.0%)
Died
57 (8.7%)
Recovered with Sequela
1 (0.2%)

Ondansetron: 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 Ondansetron, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other drugs by FDA report count (657 here).

Similar death-coded share

Nearest other drugs by death-coded share (28.3% here), distinct from the volume row.

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 Ondansetron (#250 of 2,679 by report volume); death-coded 28.3%. PlainBreed drug row · death-coded report count stamp 186 · 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 →