Afoxolaner 75Mg / Moxidectin 360Mcg / Pyrantel 150Mg Chewable Tablet

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2,159 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.
2,159
Total Reports
31
Deaths Reported
140.0%
Death Rate

Active Ingredients

Afoxolaner 75Mg / Moxidectin 360Mcg / Pyrantel 150Mg Chewable Tablet

Administration Routes

OralUnknownTopicalSubcutaneous

Species Affected

Dog 1,960
Unknown 198
Human 1

Most Affected Breeds

Retriever - Labrador 324
Unknown 199
Retriever - Golden 183
Crossbred Canine/dog 160
Pit Bull 119
Shepherd Dog - Australian 116
Shepherd Dog - German 100
Dog (unknown) 73
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 63
Collie - Border 53

Most Reported Reactions

Vomiting 303
Lack of efficacy (endoparasite) - heartworm 293
Lack of efficacy (endoparasite) - hookworm 245
Lack of efficacy (bacteria) - Borrelia 191
Tablets, Abnormal 181
Diarrhoea 167
Lack of efficacy (endoparasite) - roundworm NOS 147
Lethargy (see also Central nervous system depression in Neurological) 133
Lack of efficacy (endoparasite) - tapeworm 103
Seizure NOS 93
Lack of efficacy (ectoparasite) - flea 82
Lack of efficacy (ectoparasite) - tick NOS 67

Outcome Breakdown

Outcome Unknown
1,067 (54.4%)
Recovered/Normal
484 (24.7%)
Ongoing
379 (19.3%)
Died
17 (0.9%)
Euthanized
14 (0.7%)

Data Summary

Metric Value
Total adverse event reports 2,159
Reports involving death 31
Case-fatality rate (reported events) 140.0%
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 75Mg / Moxidectin 360Mcg / Pyrantel 150Mg Chewable Tablet Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 2,159 adverse event reports referencing Afoxolaner 75Mg / Moxidectin 360Mcg / Pyrantel 150Mg Chewable Tablet, including 31 reports in which the animal died — a 140.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Afoxolaner 75Mg / Moxidectin 360Mcg / Pyrantel 150Mg Chewable Tablet. Reported administration routes include Oral, Unknown, Topical, Subcutaneous. 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 75Mg / Moxidectin 360Mcg / Pyrantel 150Mg Chewable Tablet reports are Dog (1,960 reports), Unknown (198 reports), Human (1 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (324), Unknown (199), Retriever - Golden (183) 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 75Mg / Moxidectin 360Mcg / Pyrantel 150Mg Chewable Tablet are Vomiting (303), Lack of efficacy (endoparasite) - heartworm (293), Lack of efficacy (endoparasite) - hookworm (245), Lack of efficacy (bacteria) - Borrelia (191). Of the 1,961 reports with a coded outcome, Outcome Unknown is the leading category at 54.4%. 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 75Mg / Moxidectin 360Mcg / Pyrantel 150Mg Chewable Tablet.

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