Flunixin Meglumine Solution — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Flunixin Meglumine Solution

Active ingredient

Flunixin Meglumine

Application type

ANADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

July 28, 2017

Adverse event reports

Source: openFDA VeDDRA

1,085

Reports mentioning this ingredient

February 25, 1987 – February 18, 2026

191

Classified serious

per reporter assessment

40

Lack of expected efficacy

resistance signal

65

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 “FLUNIXIN MEGLUMINE”. 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
Death	172
Injection site swelling	82
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	80
Accidental exposure	63
Anaphylaxis	56
Unclassifiable adverse event	53
Convulsion	52
Solution, Abnormal	52
Color, Abnormal	51
Ataxia	43
Fever	42
Urticaria	37
Depression	36
Injection site abscess	34
Death by euthanasia	30
Recumbency	28
Anorexia	28
Tachypnoea	25
Hyperhidrosis	25
Injection site pain	24

Species affected

Source: openFDA VeDDRA

Horse 492 Cattle 188 Dog 70 Human 48 Cat 14 Pig 10 Goat 9 Sheep 7 Donkey 3 Mule 2 Alpaca 2 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