Anipryl® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Anipryl®

Active ingredient

Selegiline Hydrochloride

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

December 13, 2017

Adverse event reports

Source: openFDA VeDDRA

4,321

Reports mentioning this ingredient

January 5, 1997 – October 21, 2025

32

Classified serious

per reporter assessment

343

Lack of expected efficacy

resistance signal

122

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 “SELEGILINE”. 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
Vomiting	432
INEFFECTIVE, COGNITIVE DYSFUNC	400
INEFFECTIVE, LOSS OF EFFECT	332
Diarrhoea	321
Anorexia	317
Depression	306
Lack of efficacy - NOS	303
Restlessness	242
INEFFECTIVE, CUSHINGS	242
Convulsion	233
Death by euthanasia	231
Elevated serum alkaline phosphatase (SAP)	220
Polypnoea	214
Tablets, Abnormal	192
Polydipsia	187
Hyperactivity	177
Confusion	171
Ataxia	162
Polyuria	153
Elevated alanine aminotransferase (ALT)	152

Species affected

Source: openFDA VeDDRA

Dog 3,942 Human 46 Cat 37 Other 2 Parrot 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