Alfaxan® Multidose — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Alfaxan® Multidose

Active ingredient

Alfaxalone

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

April 29, 2026

Adverse event reports

Source: openFDA VeDDRA

993

Reports mentioning this ingredient

July 29, 2013 – March 26, 2026

598

Classified serious

per reporter assessment

94

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 “ALFAXALONE”. 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	90
Cardiac arrest	54
Lack of efficacy - NOS	40
Bradycardia	38
Apnoea	36
Seizure NOS	35
Tachycardia	34
Paddling	32
Recovery prolonged	32
Vocalisation	32
Cyanosis	31
Excitation	31
Twitching	29
Hypotension	24
Intentional misuse	20
Nystagmus	19
Respiratory arrest	18
Vomiting	16
Muscle tremor	15
Death by euthanasia	14

Species affected

Source: openFDA VeDDRA

Dog 476 Cat 457 Rabbit 22 Guinea Pig 4 Human 4 Other Reptiles 2 Mouse 2 Lizard 2 Ferret 2 Snake 2 Chinchilla 1 Other Bovine 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