Diazepam

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922 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.
922
Total Reports
248
Deaths Reported
2690.0%
Death Rate

Active Ingredients

Diazepam

Administration Routes

UnknownIntravenousOralParenteralRectalIntramuscularOtherSubcutaneous

Species Affected

Dog 656
Cat 241
Horse 14
Human 6
Rabbit 1
Ferret 1
Unknown 1
Other Mammals 1
Donkey 1

Most Affected Breeds

Domestic Shorthair 165
Retriever - Labrador 66
Chihuahua 40
Shih Tzu 29
Terrier - Yorkshire 28
Crossbred Canine/dog 27
Dog (unknown) 25
Terrier - Bull - American Pit 24
Retriever - Golden 24
Shepherd Dog - German 19

Most Reported Reactions

Seizure NOS 240
Lethargy (see also Central nervous system depression in 'Neurological') 131
Vomiting 123
Death by euthanasia 123
Death 121
Other abnormal test result NOS 110
Ataxia 86
Anorexia 83
Behavioural disorder NOS 74
Vocalisation 68
Elevated alanine aminotransferase (ALT) 61
Lack of efficacy - NOS 57

Outcome Breakdown

Recovered/Normal
280 (30.2%)
Ongoing
247 (26.6%)
Outcome Unknown
137 (14.8%)
Died
126 (13.6%)
Euthanized
122 (13.2%)
Recovered with Sequela
15 (1.6%)

Data Summary

Metric Value
Total adverse event reports 922
Reports involving death 248
Case-fatality rate (reported events) 2690.0%
Distinct species in reports 9
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.

Diazepam Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 922 adverse event reports referencing Diazepam, including 248 reports in which the animal died — a 2690.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Diazepam. Reported administration routes include Unknown, Intravenous, Oral, Parenteral. 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 Diazepam reports are Dog (656 reports), Cat (241 reports), Horse (14 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (165), Retriever - Labrador (66), Chihuahua (40) 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 Diazepam are Seizure NOS (240), Lethargy (see also Central nervous system depression in 'Neurological') (131), Vomiting (123), Death by euthanasia (123). Of the 927 reports with a coded outcome, Recovered/Normal is the leading category at 30.2%. 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 Diazepam.

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