Pimobendan Chewable Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Pimobendan Chewable Tablets

Active ingredient

Pimobendan

Application type

ANADA

Sponsor

Cronus Pharma Specialities India Private Ltd.

Applications on record

1

First published

May 12, 2026

Adverse event reports

Source: openFDA VeDDRA

6,325

Reports mentioning this ingredient

March 4, 2003 – March 26, 2026

1,851

Classified serious

per reporter assessment

358

Lack of expected efficacy

resistance signal

225

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 “PIMOBENDAN”. 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
Diarrhoea	636
Vomiting	636
Tablets, Abnormal	397
Death	325
Cough	313
Lethargy (see also Central nervous system depression in 'Neurological')	303
Anorexia	300
Death by euthanasia	257
Accidental exposure	212
Tachycardia	160
Lack of efficacy - NOS	143
Product Defect, General	140
Elevated blood urea nitrogen (BUN)	133
Seizure NOS	130
Lethargy (see also Central nervous system depression in Neurological)	127
Depression	124
Overdose	119
Decreased appetite	116
Ataxia	114
Elevated alanine aminotransferase (ALT)	112

Species affected

Source: openFDA VeDDRA

Dog 5,258 Cat 144 Human 39 Other Birds 2 Rabbit 2 Macaw 1 Chinchilla 1

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

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