Drug profile

The FDA adverse-event record for Masitinib

35 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Masitinib. Species, reactions, and outcomes follow.

#1337 of 2,679
by report volume (all drugs)
35
adverse-event reports
34.3%
death-coded share
Dog
most-reported species
Verify with FDA CVM →

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Masitinib ranks #1331 of 2679 by total reports (35). Death-coded-share rank requires at least 50 reports. 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)
#1331
This drug, reports of 2679

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. Masitinib has 35 reports now versus 35 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
Death-coded share
+0.0 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 Masitinib changes

Signature read: Masitinib's 34.3% 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.
35
Total Reports
12
Deaths Reported
34.3%
Death-coded share of reports

Active Ingredients

Masitinib

Administration Routes

Oral

Species Affected

Dog 32
Cat 3

Most Affected Breeds

Dog (unknown) 10
Terrier - Bull - Staffordshire 3
Boxer (German Boxer) 2
Australian Kelpie 1
Siberian Husky 1
Pinscher - Miniature 1
Terrier - Bull 1
Ridgeback - Rhodesian 1
Bulldog - American 1
Cat (unknown) 1

Most Reported Reactions

Elevated alanine aminotransferase (ALT) 11
Anaemia NOS 10
Vomiting 10
Anorexia 8
Decreased haemoglobin 7
Elevated serum alkaline phosphatase (SAP) 7
Death by euthanasia 7
Leucopenia NOS 6
Diarrhoea 6
Neutropenia 6
Lymphopenia 4
Proteinuria 4

Outcome Breakdown

Recovered with Sequela
12 (35.3%)
Recovered/Normal
7 (20.6%)
Euthanized
7 (20.6%)
Died
5 (14.7%)
Outcome Unknown
2 (5.9%)
Ongoing
1 (2.9%)

Masitinib: 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.

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 Masitinib (#1337 of 2,679 by report volume); death-coded 34.3%. PlainBreed drug row · death-coded share stamp 34.3% · 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 →