Genesis® Topical Spray — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Genesis® Topical Spray

Active ingredient

Triamcinolone Acetonide

Application type

NADA

Sponsor

Virbac AH, Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

1,301

Reports mentioning this ingredient

February 13, 1987 – March 13, 2026

223

Classified serious

per reporter assessment

54

Lack of expected efficacy

resistance signal

18

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 “TRIAMCINOLONE ACETONIDE”. 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
Suspension, Abnormal	297
Anaphylaxis	114
Vomiting	113
Depression	57
Pale mucous membrane	46
Urticaria	41
Precipitate, Sediment	40
Fever	37
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	35
Diarrhoea	35
Lameness	32
Product Defect, General	32
Shock	31
Anorexia	31
Polydipsia	30
Death	29
Product problem	29
Polyuria	28
Unclassifiable adverse event	27
Solution, Abnormal	26

Species affected

Source: openFDA VeDDRA

Dog 650 Horse 117 Cat 79 Human 16 Other 2 Alpaca 1 Other Canids 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