Revolution® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Revolution®

Active ingredient

Selamectin

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

May 17, 2021

Adverse event reports

Source: openFDA VeDDRA

62,138

Reports mentioning this ingredient

May 22, 1999 – March 27, 2026

4,209

Classified serious

per reporter assessment

14,978

Lack of expected efficacy

resistance signal

2,222

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 “SELAMECTIN”. 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
INEFFECTIVE, HEARTWORM LARVAE	8,080
Application site alopecia	5,719
Lack of efficacy (ectoparasite) - flea	5,551
Vomiting	4,874
Underfilling, Tubes	4,105
Depression	3,563
Anorexia	3,302
Diarrhoea	2,627
Pruritus	2,437
Unclassifiable adverse event	2,431
Application site hair loss	2,225
Accidental exposure	2,189
Lethargy (see also Central nervous system depression in 'Neurological')	2,079
Lack of efficacy (endoparasite) - hookworm	1,929
Tubes, Leaking	1,898
Application site lesion	1,455
Lack of efficacy (ectoparasite) - ear mite	1,343
Application site erythema	1,343
Ataxia	1,313
Death	1,289

Species affected

Source: openFDA VeDDRA

Dog 29,364 Cat 21,950 Human 2,218 Other 293 Rabbit 99 Ferret 36 Guinea Pig 24 Rat 9 Other Rodents 5 Mouse 4 Hamster 3 Other Birds 2

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