Drug profile

The FDA adverse-event record for Fluralaner 13.64% Chew Tablets

873 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Fluralaner 13.64% Chew Tablets. See the species affected, top reactions, and outcomes below.

873
adverse-event reports
0.8%
death-coded share
Dog
most-reported species
311
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.
873
Total Reports
7
Deaths Reported
0.8%
Death Rate

Active Ingredients

Fluralaner 13.64% Chew Tablets

Administration Routes

OralUnknown

Species Affected

Dog 861
Unknown 10
Cat 2

Most Affected Breeds

Crossbred Canine/dog 227
Retriever - Labrador 74
Chihuahua 31
Retriever - Golden 29
Shepherd Dog - German 28
Pit Bull 28
Shih Tzu 27
Terrier - Yorkshire 23
Shepherd Dog - Australian 23
Terrier (unspecified) 20

Most Reported Reactions

Vomiting 311
Lack of efficacy (ectoparasite) - flea 141
Lack of efficacy (ectoparasite) - tick NOS 138
Emesis (multiple) 83
Lethargy (see also Central nervous system depression in 'Neurological') 76
Diarrhoea 51
Drug administration error 45
Product Defect, General 37
Product problem 33
UNPALATABLE 33
Lack of efficacy (bacteria) - NOS 27
Seizure NOS 27

Outcome Breakdown

Ongoing
432 (50.0%)
Recovered/Normal
408 (47.2%)
Outcome Unknown
15 (1.7%)
Euthanized
4 (0.5%)
Died
3 (0.3%)
Recovered with Sequela
2 (0.2%)

Fluralaner 13.64% Chew Tablets Adverse Event Insights

873 reports name Fluralaner 13.64% Chew Tablets; 7 recorded a death outcome (0.8% of reported events, not a population-level mortality rate). Active ingredient: Fluralaner 13.64% Chew Tablets. Administration routes: Oral, Unknown.

By species: Dog (861 reports), Unknown (10 reports), Cat (2 reports). By breed: Crossbred Canine/dog (227), Retriever - Labrador (74), Chihuahua (31).

Leading clinical signs: Vomiting (311), Lack of efficacy (ectoparasite) - flea (141), Lack of efficacy (ectoparasite) - tick NOS (138), Emesis (multiple) (83). Outcome, 864 coded reports: Ongoing leads at 50.0%.

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.