Afoxolaner 2.27% Chewable Tablet (136 Mg)

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237 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.
237
Total Reports
7
Deaths Reported
300.0%
Death Rate

Active Ingredients

Afoxolaner 2.27% Chewable Tablet (136 Mg)

Administration Routes

OralUnknown

Species Affected

Dog 235
Unknown 1
Horse 1

Most Affected Breeds

Retriever - Labrador 57
Retriever - Golden 26
Shepherd Dog - German 23
Crossbred Canine/dog 21
Rottweiler 12
Pit Bull 10
Dog (unknown) 8
Unknown 7
Boxer (German Boxer) 6
Collie - Border 4

Most Reported Reactions

Vomiting 56
Skin disorders NOS 37
Pruritus 34
Diarrhoea 25
Lethargy (see also Central nervous system depression in 'Neurological') 24
Lack of efficacy (ectoparasite) - flea 21
Lack of efficacy (ectoparasite) - tick NOS 18
Scratching 16
Erythema (for urticaria see Immune SOC) 16
Restlessness 13
Anorexia 12
Itching 12

Outcome Breakdown

Outcome Unknown
112 (47.5%)
Recovered/Normal
99 (41.9%)
Ongoing
11 (4.7%)
Died
7 (3.0%)
Recovered with Sequela
7 (3.0%)

Data Summary

Metric Value
Total adverse event reports 237
Reports involving death 7
Case-fatality rate (reported events) 300.0%
Distinct species in reports 3
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 (136 Mg) Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 237 adverse event reports referencing Afoxolaner 2.27% Chewable Tablet (136 Mg), including 7 reports in which the animal died — a 300.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Afoxolaner 2.27% Chewable Tablet (136 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 (136 Mg) reports are Dog (235 reports), Unknown (1 reports), Horse (1 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (57), Retriever - Golden (26), Shepherd Dog - German (23) 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 (136 Mg) are Vomiting (56), Skin disorders NOS (37), Pruritus (34), Diarrhoea (25). Of the 236 reports with a coded outcome, Outcome Unknown is the leading category at 47.5%. 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 (136 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

Related

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