SIMPARICA® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

SIMPARICA®

Active ingredient

Sarolaner

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

December 2, 2024

Adverse event reports

Source: openFDA VeDDRA

17,347

Reports mentioning this ingredient

March 24, 2016 – March 25, 2026

5,841

Classified serious

per reporter assessment

4,621

Lack of expected efficacy

resistance signal

304

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 “SAROLANER”. 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
Vomiting	3,423
Seizure NOS	2,659
Lethargy (see also Central nervous system depression in 'Neurological')	1,466
Tremor	1,326
Lack of efficacy (ectoparasite) - tick NOS	1,176
Diarrhoea	1,171
Lack of efficacy (ectoparasite) - flea	1,023
Ataxia	957
Lack of efficacy (tick)	834
Lack of efficacy (bacteria) - Borrelia	685
Twitching	526
Anorexia	521
Behavioural disorder NOS	456
Shaking	431
Underfilling, Container	428
Overdose	309
Decreased appetite	295
Not eating	293
Accidental exposure	288
Panting	277

Species affected

Source: openFDA VeDDRA

Dog 16,431 Cat 251 Human 28

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