Drug profile

The FDA adverse-event record for Masitinib Mesylate

164 FDA reports name Masitinib Mesylate, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#597 of 2,679
by report volume (all drugs)
164
adverse-event reports
9.1%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Masitinib Mesylate ranks #597 of 2679 by total reports (164) and #588 of 1130 by death-coded share (9.1%). 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)
#597
This drug, reports of 2679
#588
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. Masitinib Mesylate has 164 reports now versus 164 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 Mesylate changes

Signature read: 164 reports place Masitinib Mesylate in the upper third of FDA AER volume (#597 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
164
Total Reports
15
Deaths Reported
9.1%
Death-coded share of reports

Active Ingredients

Masitinib Mesylate

Administration Routes

OralUnknown

Species Affected

Dog 156
Cat 7
Human 1

Most Affected Breeds

Dog (unknown) 35
Retriever - Labrador 28
Crossbred Canine/dog 16
Boxer (German Boxer) 11
Retriever - Golden 7
Spaniel - Cocker American 5
Cat (unknown) 5
Bulldog - French 4
Pug 3
Bulldog 3

Most Reported Reactions

Anaemia NOS 41
Hypoalbuminaemia 33
Anorexia 32
Elevated alanine aminotransferase (ALT) 29
Elevated serum alkaline phosphatase (SAP) 27
Neutropenia 23
Vomiting 21
Depression 18
Proteinuria 16
Elevated creatinine 16
Leucopenia NOS 15
Elevated blood urea nitrogen (BUN) 14

Outcome Breakdown

Recovered with Sequela
23 (32.4%)
Recovered/Normal
23 (32.4%)
Died
14 (19.7%)
Outcome Unknown
10 (14.1%)
Euthanized
1 (1.4%)

Masitinib Mesylate: high report volume 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 Masitinib Mesylate, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar death-coded share

Nearest other drugs by death-coded share (9.1% 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 Masitinib Mesylate (#597 of 2,679 by report volume); death-coded 9.1%. PlainBreed drug row · report volume stamp 164 · 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 →