Drug profile

The FDA adverse-event record for Masitinib Mesylate

164 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Masitinib Mesylate. See the species affected, top reactions, and outcomes below.

164
adverse-event reports
9.1%
death-coded share
Dog
most-reported species
41
Anaemia NOS - top reaction
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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 Rate

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 Adverse Event Insights

164 reports name Masitinib Mesylate; 15 recorded a death outcome (9.1% of reported events, not a population-level mortality rate). Active ingredient: Masitinib Mesylate. Administration routes: Oral, Unknown.

By species: Dog (156 reports), Cat (7 reports), Human (1 reports). By breed: Dog (unknown) (35), Retriever - Labrador (28), Crossbred Canine/dog (16).

Leading clinical signs: Anaemia NOS (41), Hypoalbuminaemia (33), Anorexia (32), Elevated alanine aminotransferase (ALT) (29). Outcome, 71 coded reports: Recovered with Sequela leads at 32.4%.

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.

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

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.