Drug profile

The FDA adverse-event record for Acepromazine Maleate

1,034 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Acepromazine Maleate. See the species affected, top reactions, and outcomes below.

1,034
adverse-event reports
21.2%
death-coded share
Dog
most-reported species
137
Vomiting - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
1,034
Total Reports
219
Deaths Reported
21.2%
Death Rate

Active Ingredients

Acepromazine Maleate

Administration Routes

UnknownIntramuscularOralSubcutaneousIntravenousIntraperitonealOphthalmicTransdermalOtherParenteral

Species Affected

Dog 732
Cat 193
Unknown 62
Horse 30
Human 5
Cattle 5
Mouse 3
Rabbit 2
Pig 1
Other Rodents 1

Most Affected Breeds

Domestic Shorthair 107
Retriever - Labrador 100
Dog (unknown) 73
Unknown 67
Chihuahua 39
Crossbred Canine/dog 28
Shepherd Dog - German 27
Terrier - Bull - American Pit 22
Retriever - Golden 21
Cat (other) 19

Most Reported Reactions

Vomiting 137
Lethargy (see also Central nervous system depression in 'Neurological') 117
Death 109
Death by euthanasia 80
Anorexia 75
Diarrhoea 56
Other abnormal test result NOS 55
Lack of efficacy - NOS 53
Seizure NOS 51
Bradycardia 50
Elevated alanine aminotransferase (ALT) 49
Cardiac arrest 47

Outcome Breakdown

Recovered/Normal
327 (35.0%)
Ongoing
276 (29.6%)
Died
124 (13.3%)
Outcome Unknown
109 (11.7%)
Euthanized
96 (10.3%)
Recovered with Sequela
2 (0.2%)

Acepromazine Maleate Adverse Event Insights

1,034 reports name Acepromazine Maleate; 219 recorded a death outcome (21.2% of reported events, not a population-level mortality rate). Active ingredient: Acepromazine Maleate. Administration routes: Unknown, Intramuscular, Oral, Subcutaneous.

By species: Dog (732 reports), Cat (193 reports), Unknown (62 reports). By breed: Domestic Shorthair (107), Retriever - Labrador (100), Dog (unknown) (73).

Leading clinical signs: Vomiting (137), Lethargy (see also Central nervous system depression in 'Neurological') (117), Death (109), Death by euthanasia (80). Outcome, 934 coded reports: Recovered/Normal leads at 35.0%.

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.