Valbazen® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Valbazen®

Active ingredient

Albendazole

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

3

First published

December 7, 2017

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
110048	NADA	Approved	—
128070	NADA	Approved	—
140934	NADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

768

Reports mentioning this ingredient

September 20, 1989 – October 15, 2025

177

Classified serious

per reporter assessment

200

Lack of expected efficacy

resistance signal

34

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 “ALBENDAZOLE”. 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	208
Anorexia	70
Diarrhoea	56
Depression	54
No sign	54
Leucopenia NOS	46
Vomiting	44
Fever	40
INEFFECTIVE, WORMS NOS	34
Unclassifiable adverse event	34
Accidental exposure	34
Lack of efficacy (endoparasite) - tapeworm	29
Lack of efficacy (endoparasite) - trematode	25
Dyspnoea	22
Vials, Leaking	21
Anaemia NOS	20
Recumbency	19
Abortion	18
Death by euthanasia	17
Hypersalivation	17

Species affected

Source: openFDA VeDDRA

Cattle 271 Sheep 143 Dog 138 Goat 70 Human 26 Other Deer 8 Alpaca 8 Other 7 Rabbit 4 Chicken 4 Cat 2 Llama 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