Tiletamine Hcl, Zolazepam Hcl

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263 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.
263
Total Reports
119
Deaths Reported
4520.0%
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%)

Data Summary

Metric Value
Total adverse event reports 263
Reports involving death 119
Case-fatality rate (reported events) 4520.0%
Distinct species in reports 8
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.

Tiletamine Hcl, Zolazepam Hcl Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 263 adverse event reports referencing Tiletamine Hcl, Zolazepam Hcl, including 119 reports in which the animal died — a 4520.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Tiletamine Hcl, Zolazepam Hcl. Reported administration routes include Intramuscular, Unknown, Intravenous, Subcutaneous. 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 Tiletamine Hcl, Zolazepam Hcl reports are Dog (127 reports), Cat (105 reports), Unknown (21 reports), with Dog accounting for the largest share. Within those species, Dog (unknown) (51), Cat (unknown) (45), Domestic Shorthair (44) 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 Tiletamine Hcl, Zolazepam Hcl are Lack of efficacy - NOS (126), Unrelated death (67), Death (44), Death by euthanasia (39). Of the 249 reports with a coded outcome, Recovered/Normal is the leading category at 45.0%. 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 Tiletamine Hcl, Zolazepam Hcl.

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