Drug profile

The FDA adverse-event record for Fluralaner 5.46% 1-Month Chew

1,522 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Fluralaner 5.46% 1-Month Chew. See the species affected, top reactions, and outcomes below.

1,522
adverse-event reports
2.2%
death-coded share
Dog
most-reported species
416
Vomiting - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
1,522
Total Reports
34
Deaths Reported
2.2%
Death Rate

Active Ingredients

Fluralaner 5.46% 1-Month Chew

Administration Routes

OralUnknownOtherTopical

Species Affected

Dog 1,481
Unknown 35
Human 5
Cat 1

Most Affected Breeds

Crossbred Canine/dog 481
Retriever - Labrador 121
Retriever - Golden 75
Shepherd Dog - Australian 53
Shepherd Dog - German 43
Unknown 42
Dog (unknown) 38
Shih Tzu 35
Beagle 31
Bulldog - French 30

Most Reported Reactions

Vomiting 416
Lack of efficacy (ectoparasite) - flea 217
Emesis (multiple) 139
Lack of efficacy (ectoparasite) - tick NOS 126
Lack of efficacy (bacteria) - Borrelia 123
Diarrhoea 100
Seizure NOS 83
Lack of efficacy (bacteria) - Anaplasma 76
Lethargy (see also Central nervous system depression in 'Neurological') 69
Lethargy (see also Central nervous system depression in Neurological) 64
Lack of efficacy (bacteria) - NOS 56
Lack of efficacy (bacteria) - Ehrlichia 56

Outcome Breakdown

Ongoing
826 (55.5%)
Recovered/Normal
567 (38.1%)
Outcome Unknown
49 (3.3%)
Died
18 (1.2%)
Euthanized
16 (1.1%)
Recovered with Sequela
11 (0.7%)

Fluralaner 5.46% 1-Month Chew Adverse Event Insights

1,522 reports name Fluralaner 5.46% 1-Month Chew; 34 recorded a death outcome (2.2% of reported events, not a population-level mortality rate). Active ingredient: Fluralaner 5.46% 1-Month Chew. Administration routes: Oral, Unknown, Other, Topical.

By species: Dog (1,481 reports), Unknown (35 reports), Human (5 reports). By breed: Crossbred Canine/dog (481), Retriever - Labrador (121), Retriever - Golden (75).

Leading clinical signs: Vomiting (416), Lack of efficacy (ectoparasite) - flea (217), Emesis (multiple) (139), Lack of efficacy (ectoparasite) - tick NOS (126). Outcome, 1,487 coded reports: Ongoing leads at 55.5%.

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.