Simbadol® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Simbadol®

Active ingredient

Buprenorphine

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

February 8, 2023

Adverse event reports

Source: openFDA VeDDRA

6,944

Reports mentioning this ingredient

September 9, 2005 – March 26, 2026

2,710

Classified serious

per reporter assessment

469

Lack of expected efficacy

resistance signal

36

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 “BUPRENORPHINE”. 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
Behavioural disorder NOS	758
Dilated pupils	594
Hyperactivity	480
Not eating	470
Dysphoria	446
Not sleeping	306
Hiding	240
Death	236
Anorexia	231
Hyperthermia	229
Agitation	224
Not drinking	208
Lethargy (see also Central nervous system depression in Neurological)	193
Sedation	192
Fever	186
Restlessness	176
Lethargy (see also Central nervous system depression in 'Neurological')	170
Ataxia	159
Pacing	143
Elevated temperature	142

Species affected

Source: openFDA VeDDRA

Cat 5,308 Dog 1,343 Human 61 Rabbit 30 Mouse 11 Rat 6 Guinea Pig 4 Horse 2 Ferret 2 Hedgehog 1 Chinchilla 1 Wolf 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