Tiletamine Hcl;Zolazapam Hcl

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300 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.
300
Total Reports
72
Deaths Reported
2400.0%
Death Rate

Active Ingredients

Tiletamine Hcl;Zolazapam Hcl

Administration Routes

IntramuscularUnknownIntravenousSubcutaneousOphthalmicOralOther

Species Affected

Dog 146
Cat 105
Unknown 35
Human 6
Monkey 2
Horse 2
Other 1
Tiger 1
Pig 1
Bear 1

Most Affected Breeds

Domestic Shorthair 59
Unknown 46
Dog (unknown) 39
Cat (other) 33
Retriever - Labrador 12
Terrier - Bull - American Pit 10
Shepherd Dog - German 6
Domestic Mediumhair 6
Terrier - Yorkshire 5
Terrier (unspecified) 5

Most Reported Reactions

Lack of efficacy - NOS 72
Death 41
Unrelated death 19
Cardiac arrest 18
Ataxia 17
Lethargy (see also Central nervous system depression in 'Neurological') 16
Recovery prolonged 16
Vomiting 15
Color, Abnormal 13
Bradycardia 13
Cyanosis 13
Tachycardia 12

Outcome Breakdown

Recovered/Normal
96 (35.8%)
Ongoing
77 (28.7%)
Died
44 (16.4%)
Euthanized
28 (10.4%)
Outcome Unknown
23 (8.6%)

Data Summary

Metric Value
Total adverse event reports 300
Reports involving death 72
Case-fatality rate (reported events) 2400.0%
Distinct species in reports 10
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;Zolazapam Hcl Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 300 adverse event reports referencing Tiletamine Hcl;Zolazapam Hcl, including 72 reports in which the animal died — a 2400.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Tiletamine Hcl;Zolazapam 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;Zolazapam Hcl reports are Dog (146 reports), Cat (105 reports), Unknown (35 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (59), Unknown (46), Dog (unknown) (39) 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;Zolazapam Hcl are Lack of efficacy - NOS (72), Death (41), Unrelated death (19), Cardiac arrest (18). Of the 268 reports with a coded outcome, Recovered/Normal is the leading category at 35.8%. 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;Zolazapam 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