Levetiracetam

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614 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.
614
Total Reports
93
Deaths Reported
1510.0%
Death Rate

Active Ingredients

Levetiracetam

Administration Routes

OralUnknownIntravenousRectalSubcutaneousTopicalParenteral

Species Affected

Dog 583
Cat 29
Unknown 1
Human 1

Most Affected Breeds

Retriever - Labrador 61
Retriever - Golden 33
Chihuahua 26
Shepherd Dog - German 23
Crossbred Canine/dog 22
Boxer (German Boxer) 21
Terrier - Yorkshire 20
Domestic Shorthair 20
Dog (unknown) 19
Terrier (unspecified) 18

Most Reported Reactions

Seizure NOS 290
Vomiting 71
Death by euthanasia 66
Lethargy (see also Central nervous system depression in 'Neurological') 59
Ataxia 52
Tremor 35
Diarrhoea 33
Elevated alanine aminotransferase (ALT) 33
Behavioural disorder NOS 31
Lack of efficacy - NOS 30
Other abnormal test result NOS 27
Death 27

Outcome Breakdown

Ongoing
225 (36.6%)
Recovered/Normal
149 (24.3%)
Outcome Unknown
138 (22.5%)
Euthanized
65 (10.6%)
Died
28 (4.6%)
Recovered with Sequela
9 (1.5%)

Data Summary

Metric Value
Total adverse event reports 614
Reports involving death 93
Case-fatality rate (reported events) 1510.0%
Distinct species in reports 4
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.

Levetiracetam Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 614 adverse event reports referencing Levetiracetam, including 93 reports in which the animal died — a 1510.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Levetiracetam. Reported administration routes include Oral, Unknown, Intravenous, Rectal. 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 Levetiracetam reports are Dog (583 reports), Cat (29 reports), Unknown (1 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (61), Retriever - Golden (33), Chihuahua (26) 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 Levetiracetam are Seizure NOS (290), Vomiting (71), Death by euthanasia (66), Lethargy (see also Central nervous system depression in 'Neurological') (59). Of the 614 reports with a coded outcome, Ongoing is the leading category at 36.6%. 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 Levetiracetam.

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