Domitor® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Domitor®

Active ingredient

Medetomidine

Application type

NADA

Sponsor

Orion Corp.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

2,623

Reports mentioning this ingredient

October 11, 1996 – January 5, 2026

71

Classified serious

per reporter assessment

38

Lack of expected efficacy

resistance signal

33

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 “MEDETOMIDINE”. 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	685
Death	464
Sedation prolonged	215
Vomiting	187
Cardiac arrest	174
Bradycardia	167
Apnoea	154
Depression	145
Convulsion	141
Anorexia	124
Labelled drug-drug interaction medication error	122
Hypersalivation	89
Lung oedema	86
Fever	85
Cyanosis	83
Dyspnoea	79
Elevated alanine aminotransferase (ALT)	76
Death by euthanasia	68
Elevated serum alkaline phosphatase (SAP)	67
Ataxia	66

Species affected

Source: openFDA VeDDRA

Dog 2,090 Cat 463 Human 19 Other 10 Rabbit 4 Monkey 4 Rat 3 Horse 2 Pig 2 Other Deer 2 Deer 2 Tiger 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