Adequan® Injectable — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Adequan® Injectable

Active ingredient

Polysulfated Glycosaminoglycan

Application type

NADA

Sponsor

American Regent, Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

5,761

Reports mentioning this ingredient

January 23, 2006 – March 18, 2026

1,873

Classified serious

per reporter assessment

750

Lack of expected efficacy

resistance signal

14

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 “POLYSULFATED GLYCOSAMINOGLYCAN”. 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	891
Product Defect, General	626
Diarrhoea	620
Lack of efficacy - NOS	469
Lethargy (see also Central nervous system depression in 'Neurological')	414
Not eating	327
Color, Abnormal	266
Death by euthanasia	211
Lethargy (see also Central nervous system depression in Neurological)	198
Anorexia	161
Elevated alanine aminotransferase (ALT)	159
Other abnormal test result NOS	143
Weight loss	135
Bloody diarrhoea	132
Decreased appetite	126
Uncoded sign	122
Behavioural disorder NOS	116
Elevated serum alkaline phosphatase (SAP)	115
Injection site swelling	114
Incorrect route of drug administration	112

Species affected

Source: openFDA VeDDRA

Dog 3,955 Horse 415 Cat 312 Human 27 Other Birds 7 Other 6 Rabbit 4 Goat 2 Duck 1 Starling 1 Camel 1 Goose 1

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

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