KetoMedTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

KetoMedTM

Active ingredient

Ketoprofen

Application type

ANADA

Sponsor

Bimeda Animal Health Ltd.

Applications on record

1

First published

June 1, 2026

Adverse event reports

Source: openFDA VeDDRA

358

Reports mentioning this ingredient

March 13, 1991 – January 28, 2026

78

Classified serious

per reporter assessment

5

Lack of expected efficacy

resistance signal

4

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 “KETOPROFEN”. 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	47
Death	42
Elevated blood urea nitrogen (BUN)	35
Anorexia	34
Depression	34
Elevated creatinine	28
Fever	26
Haemorrhage NOS	25
Leucocytosis NOS	21
Renal failure	17
Polydipsia	17
Death by euthanasia	16
Diarrhoea	16
Coagulopathy	16
Anaemia NOS	14
Blood in vomit	13
Polyuria	13
Haematuria	12
Dehydration	12
Melaena	11

Species affected

Source: openFDA VeDDRA

Dog 216 Cat 85 Horse 24 Cattle 4 Mouse 2 Human 2 Rat 1 Other 1 Goat 1 Other Birds 1 Rabbit 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