Ivermectin + Pyrantel

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8,038 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.
8,038
Total Reports
134
Deaths Reported
170.0%
Death Rate

Active Ingredients

IvermectinIvermectin + PyrantelPyrantel

Administration Routes

OralUnknownIntrathoracicUnassigned

Species Affected

Dog 7,638
Unknown 391
Cat 8
Human 1

Most Affected Breeds

Crossbred Canine/dog 1,308
Retriever - Labrador 866
Unknown 838
Shepherd Dog - German 391
Dog (unknown) 310
Pit Bull 262
Chihuahua 254
Retriever - Golden 253
Beagle 186
Boxer (German Boxer) 169

Most Reported Reactions

Lack of efficacy (endoparasite) - heartworm 2,155
Vomiting 1,217
INEFFECTIVE, HEARTWORM LARVAE 954
Lack of efficacy (endoparasite) - hookworm 604
Diarrhoea 504
UNPALATABLE 492
Lethargy (see also Central nervous system depression in 'Neurological') 420
Emesis (multiple) 330
INEFFECTIVE, HOOKS 310
Lack of efficacy (endoparasite) - roundworm NOS 228
Product Defect, General 219
Product problem 184

Outcome Breakdown

Ongoing
3,886 (50.8%)
Recovered/Normal
2,084 (27.3%)
Outcome Unknown
1,443 (18.9%)
Recovered with Sequela
98 (1.3%)
Euthanized
68 (0.9%)
Died
66 (0.9%)

Data Summary

Metric Value
Total adverse event reports 8,038
Reports involving death 134
Case-fatality rate (reported events) 170.0%
Distinct species in reports 4
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 3

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Ivermectin + Pyrantel Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 8,038 adverse event reports referencing Ivermectin + Pyrantel, including 134 reports in which the animal died — a 170.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Ivermectin, Ivermectin + Pyrantel, Pyrantel. Reported administration routes include Oral, Unknown, Intrathoracic, Unassigned. 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 Ivermectin + Pyrantel reports are Dog (7,638 reports), Unknown (391 reports), Cat (8 reports), with Dog accounting for the largest share. Within those species, Crossbred Canine/dog (1,308), Retriever - Labrador (866), Unknown (838) 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 Ivermectin + Pyrantel are Lack of efficacy (endoparasite) - heartworm (2,155), Vomiting (1,217), INEFFECTIVE, HEARTWORM LARVAE (954), Lack of efficacy (endoparasite) - hookworm (604). Of the 7,645 reports with a coded outcome, Ongoing 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 Ivermectin + Pyrantel.

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