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FirodylTM

Firocoxib

Veterinary ANADA Approved 7,725 adverse event reports

Overview

Source: Animal Drugs @ FDA
Proprietary name
FirodylTM
Active ingredient
Firocoxib
Application type
ANADA
Sponsor
ZyVet Animal Health, Inc.
Applications on record
1
First published
July 20, 2026

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