XylaMedTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

XylaMedTM

Active ingredient

Xylazine

Application type

ANADA

Sponsor

Bimeda Animal Health Ltd.

Applications on record

1

First published

February 27, 2023

Adverse event reports

Source: openFDA VeDDRA

985

Reports mentioning this ingredient

January 28, 1987 – February 23, 2026

253

Classified serious

per reporter assessment

153

Lack of expected efficacy

resistance signal

12

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 “XYLAZINE”. 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
INEFFECTIVE, SEDATION	223
Death	149
INEFFECTIVE, ANESTHESIA	70
Lack of efficacy - NOS	56
Convulsion	38
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	30
Apnoea	26
Recovery prolonged	25
Hyperactivity	23
Color, Abnormal	23
Cardiac arrest	22
Dyspnoea	21
Sedation prolonged	20
Ataxia	18
Death by euthanasia	18
Recumbency	17
Seizure NOS	17
Hyperexcitation	16
Potency, Low	15
Appearance, Abnormal	13

Species affected

Source: openFDA VeDDRA

Horse 384 Dog 232 Cat 138 Cattle 44 Other 30 Mouse 19 Other Deer 13 Rat 10 Human 10 Pig 8 Sheep 6 Goat 5

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