Afoxolaner

52,656 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.

52,656

Total Reports

1,653

Deaths Reported

310.0%

Death Rate

Active Ingredients

Afoxolaner

Administration Routes

OralUnknownOtherTopicalParenteralSubcutaneousOphthalmicTransplacentalTransdermalAuricular (Otic)

Species Affected

Dog 49,011

Unknown 3,492

Human 81

Cat 64

Other Canids 3

Other 2

Wolf 1

Spider 1

Goat 1

Most Affected Breeds

Retriever - Labrador 5,367

Dog (unknown) 4,871

Unknown 3,625

Retriever - Golden 3,303

Crossbred Canine/dog 2,283

Shepherd Dog - German 2,006

Chihuahua 1,854

Shih Tzu 1,570

Terrier - Yorkshire 1,547

Shepherd Dog - Australian 1,295

Most Reported Reactions

Vomiting 12,941

Lethargy (see also Central nervous system depression in 'Neurological') 5,200

Diarrhoea 4,727

Lack of efficacy (ectoparasite) - tick NOS 4,524

Lack of efficacy (ectoparasite) - flea 4,016

Seizure NOS 3,781

Lack of efficacy (bacteria) - Borrelia 2,910

Lack of efficacy (bacteria) - NOS 2,607

Lack of efficacy (tick) 2,200

Pruritus 1,920

Tablets, Abnormal 1,742

Itching 1,722

Outcome Breakdown

Outcome Unknown

28,240 (57.5%)

Recovered/Normal

15,020 (30.6%)

Ongoing

4,090 (8.3%)

Died

971 (2.0%)

Euthanized

683 (1.4%)

Recovered with Sequela

111 (0.2%)

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