Drug profile

The FDA adverse-event record for Clemastine Fumarate

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

25
adverse-event reports
16.0%
death-coded share
Dog
most-reported species
5
Emesis - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
25
Total Reports
4
Deaths Reported
16.0%
Death Rate

Active Ingredients

Clemastine Fumarate

Administration Routes

OralUnknown

Species Affected

Dog 25

Most Affected Breeds

Bulldog 3
Bulldog - French 2
Shih Tzu 1
Poodle (unspecified) 1
Sheepdog - Shetland 1
Crossbred Canine/dog 1
Spaniel - Clumber 1
Retriever - Labrador 1
Cattle Dog (unspecified) 1
Pointing Dog - Hungarian Short-haired (Vizsla) 1

Most Reported Reactions

Emesis 5
Lethargy (see also Central nervous system depression in 'Neurological') 5
Lack of efficacy - NOS 5
Death 3
Diarrhoea 2
Seizure NOS 2
Anorexia 2
Vomiting 2
Ataxia 2
INEFFECTIVE, LOSS OF EFFECT 2
INEFFECTIVE, ATOPY CONTROL 2
Halitosis 1

Outcome Breakdown

Recovered/Normal
8 (32.0%)
Ongoing
5 (20.0%)
Recovered with Sequela
4 (16.0%)
Outcome Unknown
4 (16.0%)
Died
3 (12.0%)
Euthanized
1 (4.0%)

Clemastine Fumarate Adverse Event Insights

25 reports name Clemastine Fumarate; 4 recorded a death outcome (16.0% of reported events, not a population-level mortality rate). Active ingredient: Clemastine Fumarate. Administration routes: Oral, Unknown.

By species: Dog (25 reports). By breed: Bulldog (3), Bulldog - French (2), Shih Tzu (1).

Leading clinical signs: Emesis (5), Lethargy (see also Central nervous system depression in 'Neurological') (5), Lack of efficacy - NOS (5), Death (3). Outcome, 25 coded reports: Recovered/Normal leads at 32.0%.

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.