Drug profile

The FDA adverse-event record for Afoxolaner 11.3 Mg Chewable Tablets

1,048 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Afoxolaner 11.3 Mg Chewable Tablets. See the species affected, top reactions, and outcomes below.

1,048
adverse-event reports
2.0%
death-coded share
Dog
most-reported species
244
Lack of efficacy (tick) - 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.
1,048
Total Reports
21
Deaths Reported
2.0%
Death Rate

Active Ingredients

Afoxolaner 11.3 Mg Chewable Tablets

Administration Routes

OralUnknownOther

Species Affected

Dog 870
Unknown 174
Human 2
Cat 2

Most Affected Breeds

Terrier - Yorkshire 219
Unknown 182
Dog (unknown) 167
Shih Tzu 99
Poodle - Toy 37
Crossbred Canine/dog 36
Maltese 35
Chihuahua 30
Poodle - Miniature 29
Pinscher - Miniature 28

Most Reported Reactions

Lack of efficacy (tick) 244
Skin disorders NOS 202
Vomiting 185
Lack of efficacy (flea) 152
Diarrhoea 72
Lethargy (see also Central nervous system depression in 'Neurological') 67
Lack of efficacy (ectoparasite) - NOS 57
Underfilling, Container 42
Emesis 40
Scratching 38
Tablets, Abnormal 36
Pruritus 34

Outcome Breakdown

Outcome Unknown
615 (70.3%)
Recovered/Normal
209 (23.9%)
Ongoing
27 (3.1%)
Died
19 (2.2%)
Recovered with Sequela
3 (0.3%)
Euthanized
2 (0.2%)

Afoxolaner 11.3 Mg Chewable Tablets Adverse Event Insights

1,048 reports name Afoxolaner 11.3 Mg Chewable Tablets; 21 recorded a death outcome (2.0% of reported events, not a population-level mortality rate). Active ingredient: Afoxolaner 11.3 Mg Chewable Tablets. Administration routes: Oral, Unknown, Other.

By species: Dog (870 reports), Unknown (174 reports), Human (2 reports). By breed: Terrier - Yorkshire (219), Unknown (182), Dog (unknown) (167).

Leading clinical signs: Lack of efficacy (tick) (244), Skin disorders NOS (202), Vomiting (185), Lack of efficacy (flea) (152). Outcome, 875 coded reports: Outcome Unknown leads at 70.3%.

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.