Phenylbutazone 20% Injection — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Phenylbutazone 20% Injection

Active ingredient

Phenylbutazone

Application type

ANADA

Sponsor

Elanco US Inc.

Applications on record

2

First published

June 1, 2016

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200126	ANADA	Approved	—
200371	ANADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

211

Reports mentioning this ingredient

April 14, 1988 – January 13, 2026

65

Classified serious

per reporter assessment

6

Lack of expected efficacy

resistance signal

10

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 “PHENYLBUTAZONE”. 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	22
Diarrhoea	12
Abdominal pain	12
Anorexia	11
Death by euthanasia	10
Accidental exposure	10
Depression	8
Tubes, Leaking	8
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	7
Fever	6
Tubes, Abnormal	6
Convulsion	5
Colitis	5
No sign	5
Product syringe issue	5
Oral ulceration	5
Anaemia NOS	4
Vomiting	4
Oedema NOS (see other SOCs for specific oedemas)	4
Gel/Paste, Abnormal	4

Species affected

Source: openFDA VeDDRA

Horse 143 Dog 19 Cat 2 Other 1 Other Equids 1 Donkey 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