CARPROFEN Soft Chewable Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

CARPROFEN Soft Chewable Tablets

Active ingredient

Carprofen

Application type

ANADA

Sponsor

Felix Pharmaceuticals Pvt. Ltd.

Applications on record

1

First published

October 1, 2024

Adverse event reports

Source: openFDA VeDDRA

51,388

Reports mentioning this ingredient

February 21, 1997 – March 26, 2026

8,526

Classified serious

per reporter assessment

1,756

Lack of expected efficacy

resistance signal

6,093

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 “CARPROFEN”. 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	11,398
Anorexia	9,242
Elevated alanine aminotransferase (ALT)	8,118
Elevated serum alkaline phosphatase (SAP)	7,276
Depression	6,137
Accidental exposure	6,074
Diarrhoea	4,340
Elevated total bilirubin	4,206
Death	3,858
Death by euthanasia	3,566
No sign	3,371
Elevated blood urea nitrogen (BUN)	3,306
Elevated creatinine	2,936
Icterus	2,675
Anaemia NOS	2,516
Leucocytosis NOS	2,327
Elevated liver enzymes	2,318
Weight loss	2,283
Polydipsia	2,031
Elevated aspartate aminotransferase (AST)	1,993

Species affected

Source: openFDA VeDDRA

Dog 46,231 Cat 1,708 Human 844 Other 46 Rabbit 9 Pig 9 Mouse 7 Other Birds 5 Guinea Pig 4 Rat 4 Panda 2 Goat 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