Drug profile

The FDA adverse-event record for Tiletamine + Zolazepam

247 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Tiletamine + Zolazepam. See the species affected, top reactions, and outcomes below.

247
adverse-event reports
26.3%
death-coded share
Cat
most-reported species
76
Lack of efficacy - NOS - 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.
247
Total Reports
65
Deaths Reported
26.3%
Death Rate

Active Ingredients

TiletamineTiletamine + ZolazepamZolazepam

Administration Routes

UnknownIntramuscularIntravenousParenteralSubcutaneousVaginalOralOther

Species Affected

Cat 115
Dog 96
Unknown 33
White tailed deer 2
Buffalo 1

Most Affected Breeds

Unknown 90
Domestic Shorthair 44
Cat (unknown) 28
Retriever - Labrador 8
Domestic Mediumhair 8
Dog (unknown) 7
Domestic Longhair 4
Mixed (Dog) 3
Poodle (unspecified) 3
Shepherd Dog - German 3

Most Reported Reactions

Lack of efficacy - NOS 76
Death 28
Behavioural disorder NOS 12
Hyperactivity 12
Vomiting 11
Recovery prolonged 10
Vocalisation 10
Hyperthermia 10
Dilated pupils 10
Cardiac arrest 9
Appearance, Abnormal 9
Cyanosis 8

Outcome Breakdown

Recovered/Normal
107 (49.1%)
Euthanized
35 (16.1%)
Died
30 (13.8%)
Outcome Unknown
23 (10.6%)
Ongoing
22 (10.1%)
Recovered with Sequela
1 (0.5%)

Tiletamine + Zolazepam Adverse Event Insights

247 reports name Tiletamine + Zolazepam; 65 recorded a death outcome (26.3% of reported events, not a population-level mortality rate). Active ingredients: Tiletamine, Tiletamine + Zolazepam, Zolazepam. Administration routes: Unknown, Intramuscular, Intravenous, Parenteral.

By species: Cat (115 reports), Dog (96 reports), Unknown (33 reports). By breed: Unknown (90), Domestic Shorthair (44), Cat (unknown) (28).

Leading clinical signs: Lack of efficacy - NOS (76), Death (28), Behavioural disorder NOS (12), Hyperactivity (12). Outcome, 218 coded reports: Recovered/Normal leads at 49.1%.

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.