Drug profile

The FDA adverse-event record for Fluralaner Spot-On Solution

13,829 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Fluralaner Spot-On Solution. See the species affected, top reactions, and outcomes below.

13,829
adverse-event reports
2.7%
death-coded share
Cat
most-reported species
2,965
Lack of efficacy (ectoparasite) - flea - 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.
13,829
Total Reports
374
Deaths Reported
2.7%
Death Rate

Active Ingredients

Fluralaner Spot-On Solution

Administration Routes

TopicalUnknownOralOtherSubcutaneousOphthalmicTransdermalRespiratory (Inhalation)IntraocularDental

Species Affected

Cat 9,616
Unknown 2,228
Human 989
Dog 987
Bobcat 2
Rabbit 2
Marsupial 1
Skunk 1
Deer 1
Mouse 1

Most Affected Breeds

Domestic Shorthair 5,905
Unknown 3,254
Domestic Longhair 911
Cat (unknown) 865
Domestic Mediumhair 663
Crossbred Canine/dog 280
Siamese 203
Maine Coon 195
Crossbred Feline/cat 185
Persian 94

Most Reported Reactions

Lack of efficacy (ectoparasite) - flea 2,965
Application site hair loss 1,843
Lethargy (see also Central nervous system depression in 'Neurological') 1,058
Drug administered at inappropriate site 893
Containers, Leaking 835
Underfilling, Container 731
Emesis (multiple) 666
Tubes, Leaking 556
Application site skin change NOS 521
Closure, Abnormal 511
Foaming at the mouth 480
Difficulty of Use 477

Outcome Breakdown

Ongoing
7,990 (68.8%)
Recovered/Normal
2,363 (20.4%)
Outcome Unknown
832 (7.2%)
Died
202 (1.7%)
Euthanized
173 (1.5%)
Recovered with Sequela
50 (0.4%)

Fluralaner Spot-On Solution Adverse Event Insights

13,829 reports name Fluralaner Spot-On Solution; 374 recorded a death outcome (2.7% of reported events, not a population-level mortality rate). Active ingredient: Fluralaner Spot-On Solution. Administration routes: Topical, Unknown, Oral, Other.

By species: Cat (9,616 reports), Unknown (2,228 reports), Human (989 reports). By breed: Domestic Shorthair (5,905), Unknown (3,254), Domestic Longhair (911).

Leading clinical signs: Lack of efficacy (ectoparasite) - flea (2,965), Application site hair loss (1,843), Lethargy (see also Central nervous system depression in 'Neurological') (1,058), Drug administered at inappropriate site (893). Outcome, 11,610 coded reports: Ongoing leads at 68.8%.

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.