Torbutrol® Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Torbutrol® Tablets

Active ingredient

Butorphanol Tartrate

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

3,281

Reports mentioning this ingredient

May 26, 1987 – March 24, 2026

975

Classified serious

per reporter assessment

371

Lack of expected efficacy

resistance signal

13

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 “BUTORPHANOL TARTRATE”. 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
Death	321
Tablets, Abnormal	158
Vomiting	155
Cardiac arrest	141
Anorexia	120
Fever	109
Ataxia	106
Depression	104
Bradycardia	96
Death by euthanasia	94
Apnoea	92
Lack of efficacy - NOS	88
INEFFECTIVE, SEDATION	87
Recovery prolonged	87
Diarrhoea	81
Convulsion	76
Sedation prolonged	76
Tachycardia	69
Elevated alanine aminotransferase (ALT)	65
Vocalisation	61

Species affected

Source: openFDA VeDDRA

Dog 1,689 Cat 849 Horse 172 Other 24 Human 11 Rabbit 5 Cattle 4 Guinea Pig 4 Alpaca 3 Donkey 3 Sheep 2 Chicken 2

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