Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet

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1,348 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.
1,348
Total Reports
21
Deaths Reported
160.0%
Death Rate

Active Ingredients

Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet

Administration Routes

OralUnknownTopicalPeriarticular

Species Affected

Dog 1,227
Unknown 116
Human 3
Cat 2

Most Affected Breeds

Unknown 119
Beagle 93
Retriever - Golden 88
Crossbred Canine/dog 68
Bulldog - French 67
Shepherd Dog - Australian 57
Dog (unknown) 54
Shih Tzu 48
Retriever - Labrador 46
Spaniel - King Charles Cavalier 45

Most Reported Reactions

Vomiting 313
Diarrhoea 150
Lack of efficacy (endoparasite) - hookworm 146
Lethargy (see also Central nervous system depression in Neurological) 126
Tablets, Abnormal 109
Lack of efficacy (endoparasite) - roundworm NOS 105
Lack of efficacy (bacteria) - Borrelia 90
Lack of efficacy (endoparasite) - heartworm 68
Seizure NOS 60
Lack of efficacy (ectoparasite) - flea 56
Itching 43
Lack of efficacy (endoparasite) - tapeworm 39

Outcome Breakdown

Outcome Unknown
626 (50.8%)
Recovered/Normal
416 (33.7%)
Ongoing
170 (13.8%)
Died
12 (1.0%)
Euthanized
9 (0.7%)

Data Summary

Metric Value
Total adverse event reports 1,348
Reports involving death 21
Case-fatality rate (reported events) 160.0%
Distinct species in reports 4
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 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 1,348 adverse event reports referencing Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet, including 21 reports in which the animal died — a 160.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet. Reported administration routes include Oral, Unknown, Topical, Periarticular. 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 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet reports are Dog (1,227 reports), Unknown (116 reports), Human (3 reports), with Dog accounting for the largest share. Within those species, Unknown (119), Beagle (93), Retriever - Golden (88) 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 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet are Vomiting (313), Diarrhoea (150), Lack of efficacy (endoparasite) - hookworm (146), Lethargy (see also Central nervous system depression in Neurological) (126). Of the 1,233 reports with a coded outcome, Outcome Unknown is the leading category at 50.8%. 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 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg 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