Drug profile

The FDA adverse-event record for Fluralaner

3,442 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Fluralaner. See the species affected, top reactions, and outcomes below.

3,442
adverse-event reports
6.0%
death-coded share
Dog
most-reported species
880
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.
3,442
Total Reports
205
Deaths Reported
6.0%
Death Rate

Active Ingredients

Fluralaner

Administration Routes

OralUnknownTopicalOtherDentalIntragastricTransdermalSubcutaneous

Species Affected

Dog 3,283
Cat 154
Unknown 3
Other Canids 1
Goat 1

Most Affected Breeds

Retriever - Labrador 453
Retriever - Golden 187
Crossbred Canine/dog 164
Shepherd Dog - German 134
Shepherd Dog - Australian 114
Chihuahua 110
Shih Tzu 106
Dog (unknown) 104
Domestic Shorthair 98
Pit Bull 96

Most Reported Reactions

Vomiting 880
Lack of efficacy (endoparasite) - heartworm 432
Lethargy (see also Central nervous system depression in 'Neurological') 361
Diarrhoea 296
Other abnormal test result NOS 206
Seizure NOS 179
Weight loss 138
Not eating 135
Anorexia 122
Behavioural disorder NOS 110
INEFFECTIVE, HOOKS 110
Death 101

Outcome Breakdown

Outcome Unknown
1,430 (41.7%)
Recovered/Normal
906 (26.4%)
Ongoing
861 (25.1%)
Died
110 (3.2%)
Euthanized
95 (2.8%)
Recovered with Sequela
29 (0.8%)

Fluralaner Adverse Event Insights

3,442 reports name Fluralaner; 205 recorded a death outcome (6.0% of reported events, not a population-level mortality rate). Active ingredient: Fluralaner. Administration routes: Oral, Unknown, Topical, Other.

By species: Dog (3,283 reports), Cat (154 reports), Unknown (3 reports). By breed: Retriever - Labrador (453), Retriever - Golden (187), Crossbred Canine/dog (164).

Leading clinical signs: Vomiting (880), Lack of efficacy (endoparasite) - heartworm (432), Lethargy (see also Central nervous system depression in 'Neurological') (361), Diarrhoea (296). Outcome, 3,431 coded reports: Outcome Unknown 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.