Itrafungol® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Itrafungol®

Active ingredient

Itraconazole

Application type

NADA

Sponsor

Virbac AH, Inc.

Applications on record

1

First published

October 4, 2022

Adverse event reports

Source: openFDA VeDDRA

570

Reports mentioning this ingredient

October 17, 1998 – March 16, 2026

186

Classified serious

per reporter assessment

147

Lack of expected efficacy

resistance signal

3

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 “ITRACONAZOLE”. 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
Lack of efficacy - NOS	93
Vomiting	80
Not eating	53
Lethargy (see also Central nervous system depression in 'Neurological')	52
Weight loss	51
Elevated alanine aminotransferase (ALT)	48
Decreased appetite	37
Elevated total bilirubin	35
Elevated liver enzymes	34
Diarrhoea	32
Anorexia	27
Lack of efficacy (fungi) - NOS	27
Jaundice	25
Elevated gamma-glutamyl transferase (GGT)	21
Lethargy (see also Central nervous system depression in Neurological)	20
UNPALATABLE	18
Icterus	18
Death by euthanasia	16
Containers, Leaking	16
Difficulty of Use	15

Species affected

Source: openFDA VeDDRA

Cat 427 Dog 45 Other Birds 3 Human 2 Monkey 1 Other Reptiles 1 Goat 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