Firocoxib Chewable Tablets for Dogs — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Firocoxib Chewable Tablets for Dogs

Active ingredient

Firocoxib

Application type

ANADA

Sponsor

Pegasus Laboratories, Inc.

Applications on record

1

First published

March 4, 2024

Adverse event reports

Source: openFDA VeDDRA

7,725

Reports mentioning this ingredient

January 20, 2005 – March 16, 2026

1,018

Classified serious

per reporter assessment

186

Lack of expected efficacy

resistance signal

160

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 “FIROCOXIB”. 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	1,969
Anorexia	1,159
Elevated blood urea nitrogen (BUN)	838
Diarrhoea	757
Depression	682
Death	639
Elevated serum alkaline phosphatase (SAP)	634
Elevated creatinine	624
Elevated alanine aminotransferase (ALT)	559
Death by euthanasia	547
Anaemia NOS	346
Ataxia	291
INEFFECTIVE, ANALGESIA	282
Polydipsia	276
Intestinal perforation	258
Lethargy (see also Central nervous system depression in 'Neurological')	249
Labelled drug-drug interaction medication error	247
Bloody diarrhoea	246
Melaena	244
Leucocytosis NOS	241

Species affected

Source: openFDA VeDDRA

Dog 6,630 Horse 402 Cat 39 Human 27 Mule 3 Other 2 Donkey 2

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