Afoxolaner 136 Mg Chewable Tablets

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1,245 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.
1,245
Total Reports
34
Deaths Reported
270.0%
Death Rate

Active Ingredients

Afoxolaner 136 Mg Chewable Tablets

Administration Routes

OralUnknownOther

Species Affected

Dog 1,163
Unknown 80
Cat 2

Most Affected Breeds

Retriever - Labrador 226
Shepherd Dog - German 125
Retriever - Golden 113
Unknown 94
Crossbred Canine/dog 94
Dog (unknown) 65
Rottweiler 48
Pit Bull 39
Boxer (German Boxer) 33
Mixed (Dog) 27

Most Reported Reactions

Vomiting 236
Skin disorders NOS 211
Lack of efficacy (tick) 202
Lack of efficacy (flea) 137
Diarrhoea 122
Pruritus 117
Lethargy (see also Central nervous system depression in 'Neurological') 106
Scratching 57
Panting 51
Anorexia 43
Itching 40
Lack of efficacy (ectoparasite) - NOS 39

Outcome Breakdown

Outcome Unknown
663 (56.9%)
Recovered/Normal
402 (34.5%)
Ongoing
63 (5.4%)
Died
23 (2.0%)
Euthanized
11 (0.9%)
Recovered with Sequela
4 (0.3%)

Data Summary

Metric Value
Total adverse event reports 1,245
Reports involving death 34
Case-fatality rate (reported events) 270.0%
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 136 Mg Chewable Tablets Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 1,245 adverse event reports referencing Afoxolaner 136 Mg Chewable Tablets, including 34 reports in which the animal died — a 270.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Afoxolaner 136 Mg Chewable Tablets. Reported administration routes include Oral, Unknown, Other. 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 136 Mg Chewable Tablets reports are Dog (1,163 reports), Unknown (80 reports), Cat (2 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (226), Shepherd Dog - German (125), Retriever - Golden (113) 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 136 Mg Chewable Tablets are Vomiting (236), Skin disorders NOS (211), Lack of efficacy (tick) (202), Lack of efficacy (flea) (137). Of the 1,166 reports with a coded outcome, Outcome Unknown is the leading category at 56.9%. 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 136 Mg Chewable Tablets.

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