Afoxolaner 2.27% Chewable Tablet (68 Mg)

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272 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.
272
Total Reports
8
Deaths Reported
290.0%
Death Rate

Active Ingredients

Afoxolaner 2.27% Chewable Tablet (68 Mg)

Administration Routes

OralUnknown

Species Affected

Dog 272

Most Affected Breeds

Crossbred Canine/dog 35
Dog (unknown) 23
Collie - Border 17
Spaniel - Cocker American 15
Retriever - Golden 12
Retriever - Labrador 11
Shepherd Dog - German 8
Bulldog - French 8
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 6
Spaniel - Cocker English 6

Most Reported Reactions

Vomiting 71
Skin disorders NOS 45
Pruritus 43
Diarrhoea 30
Lack of efficacy (ectoparasite) - tick NOS 27
Lack of efficacy (ectoparasite) - flea 24
Lethargy (see also Central nervous system depression in 'Neurological') 19
Erythema (for urticaria see Immune SOC) 15
Anorexia 14
Panting 11
Seizure NOS 11
Scratching 11

Outcome Breakdown

Recovered/Normal
136 (50.0%)
Outcome Unknown
109 (40.1%)
Ongoing
19 (7.0%)
Died
5 (1.8%)
Euthanized
3 (1.1%)

Data Summary

Metric Value
Total adverse event reports 272
Reports involving death 8
Case-fatality rate (reported events) 290.0%
Distinct species in reports 1
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Afoxolaner 2.27% Chewable Tablet (68 Mg) Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 272 adverse event reports referencing Afoxolaner 2.27% Chewable Tablet (68 Mg), including 8 reports in which the animal died — a 290.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Afoxolaner 2.27% Chewable Tablet (68 Mg). Reported administration routes include Oral, Unknown. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Afoxolaner 2.27% Chewable Tablet (68 Mg) reports are Dog (272 reports), with Dog accounting for the largest share. Within those species, Crossbred Canine/dog (35), Dog (unknown) (23), Collie - Border (17) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Afoxolaner 2.27% Chewable Tablet (68 Mg) are Vomiting (71), Skin disorders NOS (45), Pruritus (43), Diarrhoea (30). Of the 272 reports with a coded outcome, Recovered/Normal is the leading category at 50.0%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Afoxolaner 2.27% Chewable Tablet (68 Mg).

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

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Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial