Dexmedetomidine Hydrochloride — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Dexmedetomidine Hydrochloride

Active ingredient

Dexmedetomidine hydrochloride

Application type

ANADA

Sponsor

ZyVet Animal Health, Inc.

Applications on record

2

First published

February 1, 2023

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200735	ANADA	Approved	—
200824	ANADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

5,606

Reports mentioning this ingredient

September 7, 2007 – March 25, 2026

1,784

Classified serious

per reporter assessment

1,243

Lack of expected efficacy

resistance signal

104

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 “DEXMEDETOMIDINE 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, SEDATION	876
Lack of efficacy - NOS	435
Bradycardia	403
Death	377
Cardiac arrest	276
Vomiting	209
Apnoea	169
Sedation	168
Sedation prolonged	165
Hypersalivation	130
Underdose	126
Pale mucous membrane	105
Overdose	102
Lethargy (see also Central nervous system depression in 'Neurological')	99
Depression	98
Tachycardia	96
Accidental exposure	94
Anorexia	90
Cyanosis	89
Convulsion	87

Species affected

Source: openFDA VeDDRA

Dog 3,862 Cat 1,412 Human 52 Rabbit 15 Other Mammals 12 Rat 7 Other 6 Horse 6 Guinea Pig 4 Monkey 3 Mouse 3 Turtle 3

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