Drug profile

The FDA adverse-event record for Alfaxalone

907 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Alfaxalone. See the species affected, top reactions, and outcomes below.

907
adverse-event reports
20.2%
death-coded share
Dog
most-reported species
134
Death - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
907
Total Reports
183
Deaths Reported
20.2%
Death Rate

Active Ingredients

Alfaxalone

Administration Routes

IntravenousUnknownIntramuscularSubcutaneousParenteralOralTopicalIntraperitonealIntrauterineOphthalmic

Species Affected

Dog 442
Cat 407
Rabbit 22
Unknown 11
Guinea Pig 4
Human 4
Other Reptiles 2
Mouse 2
Lizard 2
Ferret 2

Most Affected Breeds

Domestic Shorthair 205
Unknown 81
Retriever - Labrador 39
Domestic Longhair 39
Chihuahua 34
Dog (unknown) 22
Domestic Mediumhair 21
Cat (other) 20
Cat (unknown) 19
Crossbred Canine/dog 18

Most Reported Reactions

Death 134
Cardiac arrest 74
Bradycardia 71
Lack of efficacy - NOS 59
Vomiting 57
Not eating 57
Hypotension 50
Diarrhoea 49
Tachycardia 48
Apnoea 46
Vocalisation 46
Cyanosis 44

Outcome Breakdown

Recovered/Normal
430 (47.4%)
Ongoing
179 (19.7%)
Died
145 (16.0%)
Outcome Unknown
107 (11.8%)
Euthanized
38 (4.2%)
Recovered with Sequela
9 (1.0%)

Alfaxalone Adverse Event Insights

907 reports name Alfaxalone; 183 recorded a death outcome (20.2% of reported events, not a population-level mortality rate). Active ingredient: Alfaxalone. Administration routes: Intravenous, Unknown, Intramuscular, Subcutaneous.

By species: Dog (442 reports), Cat (407 reports), Rabbit (22 reports). By breed: Domestic Shorthair (205), Unknown (81), Retriever - Labrador (39).

Leading clinical signs: Death (134), Cardiac arrest (74), Bradycardia (71), Lack of efficacy - NOS (59). Outcome, 908 coded reports: Recovered/Normal leads at 47.4%.

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.