Drug profile

The FDA adverse-event record for Primidone

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

25
adverse-event reports
8.0%
death-coded share
Dog
most-reported species
6
Elevated serum alkaline phosphatase (SAP) - 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.
25
Total Reports
2
Deaths Reported
8.0%
Death Rate

Active Ingredients

Primidone

Administration Routes

OralUnknown

Species Affected

Dog 24
Human 1

Most Affected Breeds

Crossbred Canine/dog 6
Retriever - Labrador 3
Spaniel - Cocker American 2
Retriever - Golden 2
Shepherd Dog - Australian 2
Schnauzer (unspecified) 1
Pekingese 1
Weimaraner 1
Terrier - Bull - Staffordshire 1
Pug 1

Most Reported Reactions

Elevated serum alkaline phosphatase (SAP) 6
Ataxia 4
Elevated alanine aminotransferase (ALT) 4
Pacing 3
Polydipsia 3
Apprehension 3
Elevated bile acids 3
Hyperactivity 3
Seizure NOS 3
Death by euthanasia 2
Polypnoea 2
Lameness 2

Outcome Breakdown

Outcome Unknown
2 (40.0%)
Died
1 (20.0%)
Euthanized
1 (20.0%)
Recovered/Normal
1 (20.0%)

Primidone Adverse Event Insights

25 reports name Primidone; 2 recorded a death outcome (8.0% of reported events, not a population-level mortality rate). Active ingredient: Primidone. Administration routes: Oral, Unknown.

By species: Dog (24 reports), Human (1 reports). By breed: Crossbred Canine/dog (6), Retriever - Labrador (3), Spaniel - Cocker American (2).

Leading clinical signs: Elevated serum alkaline phosphatase (SAP) (6), Ataxia (4), Elevated alanine aminotransferase (ALT) (4), Pacing (3). Outcome, 5 coded reports: Outcome Unknown leads at 40.0%.

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.