Drug profile

The FDA adverse-event record for Afoxolaner 68 Mg Chewable Tablets

1,663 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Afoxolaner 68 Mg Chewable Tablets. See the species affected, top reactions, and outcomes below.

1,663
adverse-event reports
2.3%
death-coded share
Dog
most-reported species
341
Vomiting - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
1,663
Total Reports
39
Deaths Reported
2.3%
Death Rate

Active Ingredients

Afoxolaner 68 Mg Chewable Tablets

Administration Routes

OralUnknownOther

Species Affected

Dog 1,548
Unknown 113
Human 2

Most Affected Breeds

Crossbred Canine/dog 322
Unknown 127
Dog (unknown) 126
Collie - Border 86
Mixed (Dog) 79
Retriever - Labrador 77
Spaniel - Cocker American 52
Retriever - Golden 42
Shepherd Dog - German 41
Terrier - Bull - Staffordshire 38

Most Reported Reactions

Vomiting 341
Skin disorders NOS 313
Lack of efficacy (tick) 288
Lack of efficacy (flea) 215
Diarrhoea 174
Lethargy (see also Central nervous system depression in 'Neurological') 143
Pruritus 100
Emesis 68
Scratching 66
Anorexia 51
Lack of efficacy (ectoparasite) - NOS 48
Inappetence 46

Outcome Breakdown

Outcome Unknown
889 (57.2%)
Recovered/Normal
536 (34.5%)
Ongoing
86 (5.5%)
Died
22 (1.4%)
Euthanized
18 (1.2%)
Recovered with Sequela
3 (0.2%)

Afoxolaner 68 Mg Chewable Tablets Adverse Event Insights

1,663 reports name Afoxolaner 68 Mg Chewable Tablets; 39 recorded a death outcome (2.3% of reported events, not a population-level mortality rate). Active ingredient: Afoxolaner 68 Mg Chewable Tablets. Administration routes: Oral, Unknown, Other.

By species: Dog (1,548 reports), Unknown (113 reports), Human (2 reports). By breed: Crossbred Canine/dog (322), Unknown (127), Dog (unknown) (126).

Leading clinical signs: Vomiting (341), Skin disorders NOS (313), Lack of efficacy (tick) (288), Lack of efficacy (flea) (215). Outcome, 1,554 coded reports: Outcome Unknown leads at 57.2%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.