Atipamezole

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859 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.
859
Total Reports
140
Deaths Reported
1630.0%
Death Rate

Active Ingredients

Atipamezole

Administration Routes

IntramuscularUnknownParenteralIntravenousSubcutaneousOther

Species Affected

Dog 550
Cat 277
Unknown 24
Turtle 3
Monkey 1
Rabbit 1
Human 1
Other 1
Camel 1

Most Affected Breeds

Domestic Shorthair 115
Retriever - Labrador 67
Domestic (unspecified) 59
Dog (unknown) 50
Cat (unknown) 38
Crossbred Canine/dog 37
Unknown 32
Pit Bull 31
Retriever - Golden 27
Boxer (German Boxer) 21

Most Reported Reactions

Lack of efficacy - NOS 116
Death 91
Injection site swelling 86
Vomiting 76
Diarrhoea 62
INEFFECTIVE, REVERSAL 62
Hypersalivation 52
Behavioural disorder NOS 52
Not eating 51
Lethargy (see also Central nervous system depression in Neurological) 48
Anorexia 47
Weight loss 39

Outcome Breakdown

Outcome Unknown
215 (34.6%)
Recovered/Normal
170 (27.3%)
Died
115 (18.5%)
Ongoing
94 (15.1%)
Euthanized
25 (4.0%)
Recovered with Sequela
3 (0.5%)

Data Summary

Metric Value
Total adverse event reports 859
Reports involving death 140
Case-fatality rate (reported events) 1630.0%
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.

Atipamezole Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 859 adverse event reports referencing Atipamezole, including 140 reports in which the animal died — a 1630.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Atipamezole. Reported administration routes include Intramuscular, Unknown, Parenteral, Intravenous. 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 Atipamezole reports are Dog (550 reports), Cat (277 reports), Unknown (24 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (115), Retriever - Labrador (67), Domestic (unspecified) (59) 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 Atipamezole are Lack of efficacy - NOS (116), Death (91), Injection site swelling (86), Vomiting (76). Of the 622 reports with a coded outcome, Outcome Unknown is the leading category at 34.6%. 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 Atipamezole.

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