Drug profile

The FDA adverse-event record for Lotilaner

11,447 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Lotilaner. See the species affected, top reactions, and outcomes below.

11,447
adverse-event reports
2.6%
death-coded share
Dog
most-reported species
2,850
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.
11,447
Total Reports
295
Deaths Reported
2.6%
Death Rate

Active Ingredients

Lotilaner

Administration Routes

OralUnknownTopicalOtherSubcutaneousOphthalmicCutaneousAuricular (Otic)IntrauterineIntraocular

Species Affected

Dog 9,880
Unknown 778
Cat 762
Human 24
Pig 1
Cattle 1
Goat 1

Most Affected Breeds

Retriever - Labrador 1,192
Unknown 810
Retriever - Golden 729
Dog (unknown) 638
Crossbred Canine/dog 437
Domestic Shorthair 384
Shepherd Dog - Australian 383
Shepherd Dog - German 360
Chihuahua 339
Shih Tzu 296

Most Reported Reactions

Vomiting 2,850
Diarrhoea 1,184
Lack of efficacy (ectoparasite) - tick NOS 811
Other abnormal test result NOS 763
Lethargy (see also Central nervous system depression in 'Neurological') 702
Lack of efficacy (bacteria) - Borrelia 698
UNPALATABLE 681
Seizure NOS 661
Lack of efficacy (ectoparasite) - flea 540
Lack of efficacy (endoparasite) - heartworm 516
Behavioural disorder NOS 492
Not eating 416

Outcome Breakdown

Outcome Unknown
4,784 (44.8%)
Recovered/Normal
3,501 (32.8%)
Ongoing
2,084 (19.5%)
Died
180 (1.7%)
Euthanized
116 (1.1%)
Recovered with Sequela
8 (0.1%)

Lotilaner Adverse Event Insights

11,447 reports name Lotilaner; 295 recorded a death outcome (2.6% of reported events, not a population-level mortality rate). Active ingredient: Lotilaner. Administration routes: Oral, Unknown, Topical, Other.

By species: Dog (9,880 reports), Unknown (778 reports), Cat (762 reports). By breed: Retriever - Labrador (1,192), Unknown (810), Retriever - Golden (729).

Leading clinical signs: Vomiting (2,850), Diarrhoea (1,184), Lack of efficacy (ectoparasite) - tick NOS (811), Other abnormal test result NOS (763). Outcome, 10,673 coded reports: Outcome Unknown leads at 44.8%.

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.