On this page

Ketaset®

Ketamine Hydrochloride

Veterinary NADA Approved 4,578 adverse event reports

Overview

Source: Animal Drugs @ FDA
Proprietary name
Ketaset®
Active ingredient
Ketamine Hydrochloride
Application type
NADA
Sponsor
Zoetis Inc.
Applications on record
1
First published
May 14, 2026

Adverse event reports

Source: openFDA VeDDRA
4,578
Reports mentioning this ingredient
January 8, 1987 – March 16, 2026
619
Classified serious
per reporter assessment
405
Lack of expected efficacy
resistance signal
8
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 “KETAMINE HYDROCHLORIDE”. 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
INEFFECTIVE, ANESTHESIA 1,270
Death 953
Apnoea 324
Cardiac arrest 315
Recovery prolonged 282
INEFFECTIVE, SEDATION 258
Convulsion 217
Fever 186
Lack of efficacy - NOS 179
Ataxia 159
Hyperexcitation 155
Anorexia 95
Cyanosis 91
Depression 85
Death by euthanasia 84
Blindness 81
Vials, Leaking 80
Vomiting 76
Potency, Low 71
Bradycardia 70

Species affected

Source: openFDA VeDDRA
Cat 2,169 Dog 1,019 Horse 561 Other 170 Rat 59 Mouse 39 Rabbit 36 Monkey 21 Human 15 Pig 13 Primate 13 Other Rodents 8

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