Mometavet® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Mometavet®

Active ingredient

Clotrimazole Gentamicin Sulfate Mometasone furoate

Application type

ANADA

Sponsor

Dechra Veterinary Products LLC

Applications on record

1

First published

May 14, 2026

Adverse event reports

Source: openFDA VeDDRA

1,289

Reports mentioning this ingredient

August 19, 2005 – December 11, 2014

0

Classified serious

per reporter assessment

50

Lack of expected efficacy

resistance signal

55

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 “CLOTRIMAZOLE, GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE”. 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
Deafness	666
Partial deafness	138
Missing Cap	86
Accidental exposure	55
Vomiting	49
Depression	41
Lack of efficacy - NOS	39
Pinnal erythema	31
Anorexia	26
Polyuria	21
Diarrhoea	20
Pruritus	20
Polydipsia	20
Application site erythema	20
Ataxia	19
Head tilt - ear disorder	18
Death by euthanasia	17
Underfilling, Tubes	17
Underfilling, Vials	16
Skin hyperaemia	16

Species affected

Source: openFDA VeDDRA

Dog 1,061 Cat 35 Human 7 Camel 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