Drug profile

The FDA adverse-event record for Tiletamine Hcl, Zolazepam Hcl

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

263
adverse-event reports
45.2%
death-coded share
Dog
most-reported species
126
Lack of efficacy - NOS - 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.
263
Total Reports
119
Deaths Reported
45.2%
Death Rate

Active Ingredients

Tiletamine Hcl, Zolazepam Hcl

Administration Routes

IntramuscularUnknownIntravenousSubcutaneousOtherParenteralOralOphthalmic

Species Affected

Dog 127
Cat 105
Unknown 21
Pig 4
Human 3
Rabbit 1
Guinea Pig 1
Other Birds 1

Most Affected Breeds

Dog (unknown) 51
Cat (unknown) 45
Domestic Shorthair 44
Unknown 25
Retriever - Labrador 12
Shepherd Dog - German 10
Domestic Longhair 9
Chihuahua 4
Rottweiler 4
Pig (unknown) 4

Most Reported Reactions

Lack of efficacy - NOS 126
Unrelated death 67
Death 44
Death by euthanasia 39
Cardiac arrest 18
Respiratory arrest 15
Recovery prolonged 14
Apnoea 12
Cyanosis 12
Hyperthermia 11
Aggression 7
Appearance, Abnormal 7

Outcome Breakdown

Recovered/Normal
112 (45.0%)
Euthanized
71 (28.5%)
Died
48 (19.3%)
Outcome Unknown
15 (6.0%)
Ongoing
2 (0.8%)
Recovered with Sequela
1 (0.4%)

Tiletamine Hcl, Zolazepam Hcl Adverse Event Insights

263 reports name Tiletamine Hcl, Zolazepam Hcl; 119 recorded a death outcome (45.2% of reported events, not a population-level mortality rate). Active ingredient: Tiletamine Hcl, Zolazepam Hcl. Administration routes: Intramuscular, Unknown, Intravenous, Subcutaneous.

By species: Dog (127 reports), Cat (105 reports), Unknown (21 reports). By breed: Dog (unknown) (51), Cat (unknown) (45), Domestic Shorthair (44).

Leading clinical signs: Lack of efficacy - NOS (126), Unrelated death (67), Death (44), Death by euthanasia (39). Outcome, 249 coded reports: Recovered/Normal leads at 45.0%.

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.