Drug profile

The FDA adverse-event record for Sarolaner

17,001 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Sarolaner. See the species affected, top reactions, and outcomes below.

17,001
adverse-event reports
3.0%
death-coded share
Dog
most-reported species
3,807
Vomiting - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
17,001
Total Reports
515
Deaths Reported
3.0%
Death Rate

Active Ingredients

Sarolaner

Administration Routes

OralUnknownTopicalSubcutaneousOphthalmicOtherIntradermalEndotrachealRectalRespiratory (Inhalation)

Species Affected

Dog 16,093
Unknown 637
Cat 244
Human 27

Most Affected Breeds

Retriever - Labrador 1,665
Dog (unknown) 1,308
Retriever - Golden 903
Chihuahua 765
Terrier - Yorkshire 729
Unknown 670
Shih Tzu 580
Shepherd Dog - German 540
Terrier - Bull - American Pit 460
Crossbred Canine/dog 415

Most Reported Reactions

Vomiting 3,807
Seizure NOS 2,814
Lethargy (see also Central nervous system depression in 'Neurological') 1,592
Tremor 1,373
Diarrhoea 1,328
Lack of efficacy (ectoparasite) - tick NOS 1,183
Lack of efficacy (ectoparasite) - flea 1,032
Ataxia 1,015
Lack of efficacy (tick) 850
Lack of efficacy (bacteria) - Borrelia 716
Anorexia 560
Twitching 548

Outcome Breakdown

Ongoing
6,842 (41.7%)
Outcome Unknown
5,031 (30.7%)
Recovered/Normal
3,987 (24.3%)
Died
281 (1.7%)
Euthanized
234 (1.4%)
Recovered with Sequela
14 (0.1%)

Sarolaner Adverse Event Insights

17,001 reports name Sarolaner; 515 recorded a death outcome (3.0% of reported events, not a population-level mortality rate). Active ingredient: Sarolaner. Administration routes: Oral, Unknown, Topical, Subcutaneous.

By species: Dog (16,093 reports), Unknown (637 reports), Cat (244 reports). By breed: Retriever - Labrador (1,665), Dog (unknown) (1,308), Retriever - Golden (903).

Leading clinical signs: Vomiting (3,807), Seizure NOS (2,814), Lethargy (see also Central nervous system depression in 'Neurological') (1,592), Tremor (1,373). Outcome, 16,389 coded reports: Ongoing leads at 41.7%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.