Fluralaner Spot-On Solution

13,829 adverse event reports submitted to the FDA

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

270.0%

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%)

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.