DormosedanTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

DormosedanTM

Active ingredient

Detomidine Hydrochloride

Application type

NADA

Sponsor

Orion Corp.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

701

Reports mentioning this ingredient

July 6, 2011 – March 24, 2026

334

Classified serious

per reporter assessment

185

Lack of expected efficacy

resistance signal

21

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 “DETOMIDINE 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	107
Lack of efficacy - NOS	73
Sedation prolonged	52
Underdose	48
Hives (see also 'Skin')	42
Tachypnoea	33
Colic	28
Urticaria	27
Fever	25
Tachycardia	24
Ataxia	21
Accidental exposure	20
Death by euthanasia	19
Death	19
Lethargy (see also Central nervous system depression in 'Neurological')	18
Seizure NOS	17
Bradycardia	14
Facial oedema	14
Collapse NOS (see also 'Cardio-vascular' and 'Neurological disorders')	13
Pale mucous membrane	12

Species affected

Source: openFDA VeDDRA

Horse 570 Dog 26 Human 25 Donkey 19 Cat 7 Other Equids 7 Pig 3 Mule 2 Goat 2 Ferret 1 Rabbit 1 Other Mustelids 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