Telazol® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Telazol®

Active ingredient

Tiletamine Hydrochloride Zolazepam Hydrochloride

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

December 7, 2017

Adverse event reports

Source: openFDA VeDDRA

2,402

Reports mentioning this ingredient

March 25, 1988 – September 29, 2025

9

Classified serious

per reporter assessment

13

Lack of expected efficacy

resistance signal

15

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “TILETAMINE, ZOLAZEPAM”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Death	657
INEFFECTIVE, ANESTHESIA	315
Recovery prolonged	290
Apnoea	242
Fever	232
Ataxia	214
Cardiac arrest	205
Hyperexcitation	140
Depression	130
Lung oedema	128
Dyspnoea	122
Vocalisation	98
Convulsion	97
Anorexia	94
Vomiting	86
Cyanosis	85
Hypothermia	80
Death by euthanasia	70
Solution, Abnormal	62
Recumbency	58

Species affected

Source: openFDA VeDDRA

Cat 1,250 Dog 889 Other 81 Human 16 Other Deer 8 Pig 7 Primate 5 Monkey 3 Tiger 2 Rabbit 2 Ferret 1 Cattle 1

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient