Ketamine Hydrochloride Injection, USP — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Ketamine Hydrochloride Injection, USP

Active ingredient

Ketamine Hydrochloride

Application type

ANADA

Sponsor

Elanco US Inc.

Applications on record

2

First published

May 19, 2017

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200042	ANADA	Approved	—
200073	ANADA	Approved	—

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

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

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