Phenobarbitol

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58 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
58
Total Reports
14
Deaths Reported
2410.0%
Death Rate

Active Ingredients

Phenobarbitol

Administration Routes

OralUnknownIntravenousTopicalOphthalmic

Species Affected

Dog 57
Cat 1

Most Affected Breeds

Crossbred Canine/dog 8
Retriever - Labrador 5
Chihuahua 4
Dachshund (unspecified) 4
Retriever - Golden 4
Terrier - Yorkshire 3
Shih Tzu 3
Bulldog - French 2
Bichon Frise 2
Mixed (Dog) 1

Most Reported Reactions

Seizure NOS 24
Death by euthanasia 9
Ataxia 5
Lethargy (see also Central nervous system depression in 'Neurological') 5
Death 5
Unable to stand 4
Behavioural disorder NOS 4
Restlessness 3
Weakness 3
Diarrhoea 3
Elevated gamma-glutamyl transferase (GGT) 3
Paddling 3

Outcome Breakdown

Outcome Unknown
19 (32.8%)
Recovered/Normal
17 (29.3%)
Euthanized
9 (15.5%)
Ongoing
7 (12.1%)
Died
5 (8.6%)
Recovered with Sequela
1 (1.7%)

Data Summary

Metric Value
Total adverse event reports 58
Reports involving death 14
Case-fatality rate (reported events) 2410.0%
Distinct species in reports 2
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Phenobarbitol Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 58 adverse event reports referencing Phenobarbitol, including 14 reports in which the animal died — a 2410.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Phenobarbitol. Reported administration routes include Oral, Unknown, Intravenous, Topical. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Phenobarbitol reports are Dog (57 reports), Cat (1 reports), with Dog accounting for the largest share. Within those species, Crossbred Canine/dog (8), Retriever - Labrador (5), Chihuahua (4) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Phenobarbitol are Seizure NOS (24), Death by euthanasia (9), Ataxia (5), Lethargy (see also Central nervous system depression in 'Neurological') (5). Of the 58 reports with a coded outcome, Outcome Unknown is the leading category at 32.8%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Phenobarbitol.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial