Mirataz® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Mirataz®

Active ingredient

Mirtazapine

Application type

NADA

Sponsor

Dechra Veterinary Products LLC

Applications on record

1

First published

July 14, 2026

Adverse event reports

Source: openFDA VeDDRA

2,793

Reports mentioning this ingredient

July 29, 2008 – March 25, 2026

994

Classified serious

per reporter assessment

348

Lack of expected efficacy

resistance signal

25

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 “MIRTAZAPINE”. 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
Appearance, Abnormal	267
Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle')	249
Tubes, Leaking	235
Lack of efficacy - NOS	168
Application site reddening	146
Application site crust	100
Death by euthanasia	93
Underfilling, Container	88
Application site irritation	81
Containers, Abnormal	79
Vocalisation	68
Vomiting	68
Application site erythema	66
Underfilling, Tubes	63
Application site skin scaling	62
Underfilling, Package	61
Death	58
Tubes, Abnormal	49
Containers, Damaged	47
Application site inflammation	45

Species affected

Source: openFDA VeDDRA

Cat 1,749 Dog 274 Human 54 Tiger 1 Other 1 Fallow 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