Drug profile

The FDA adverse-event record for Masitinib

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

35
adverse-event reports
34.3%
death-coded share
Dog
most-reported species
11
Elevated alanine aminotransferase (ALT) - 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.
35
Total Reports
12
Deaths Reported
34.3%
Death Rate

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
Pinscher - Miniature 1
Siberian Husky 1
Terrier - Bull 1
Ridgeback - Rhodesian 1
Bulldog - American 1
Beagle 1

Most Reported Reactions

Elevated alanine aminotransferase (ALT) 11
Anaemia NOS 10
Vomiting 10
Anorexia 8
Elevated serum alkaline phosphatase (SAP) 7
Decreased haemoglobin 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 Adverse Event Insights

35 reports name Masitinib; 12 recorded a death outcome (34.3% of reported events, not a population-level mortality rate). Active ingredient: Masitinib. Administration route: Oral.

By species: Dog (32 reports), Cat (3 reports). By breed: Dog (unknown) (10), Terrier - Bull - Staffordshire (3), Boxer (German Boxer) (2).

Leading clinical signs: Elevated alanine aminotransferase (ALT) (11), Anaemia NOS (10), Vomiting (10), Anorexia (8). Outcome, 34 coded reports: Recovered with Sequela leads at 35.3%.

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.