Ivermectin 68Mcg, Pyrantel Pamoate 57Mg

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135 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.
135
Total Reports
2
Deaths Reported
150.0%
Death Rate

Active Ingredients

Ivermectin 68Mcg, Pyrantel Pamoate 57Mg

Administration Routes

OralUnknown

Species Affected

Dog 127
Unknown 6
Human 2

Most Affected Breeds

Terrier - Yorkshire 17
Chihuahua 12
Spitz - German Pomeranian 10
Dog (unknown) 9
Maltese 9
Unknown 8
Shih Tzu 7
Shepherd Dog - German 5
Retriever - Labrador 5
Pug 4

Most Reported Reactions

Vomiting 55
INEFFECTIVE, HEARTWORM LARVAE 37
Diarrhoea 16
Lethargy (see also Central nervous system depression in 'Neurological') 16
Lack of efficacy - NOS 12
Lack of efficacy (endoparasite) - hookworm 5
Seizure NOS 4
Panting 4
Inappetence 4
Ataxia 4
Drug dose omission 4
Abnormal radiograph finding 4

Outcome Breakdown

Recovered/Normal
62 (48.1%)
Outcome Unknown
61 (47.3%)
Ongoing
3 (2.3%)
Recovered with Sequela
1 (0.8%)
Euthanized
1 (0.8%)
Died
1 (0.8%)

Data Summary

Metric Value
Total adverse event reports 135
Reports involving death 2
Case-fatality rate (reported events) 150.0%
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.

Ivermectin 68Mcg, Pyrantel Pamoate 57Mg Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 135 adverse event reports referencing Ivermectin 68Mcg, Pyrantel Pamoate 57Mg, including 2 reports in which the animal died — a 150.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Ivermectin 68Mcg, Pyrantel Pamoate 57Mg. Reported administration routes include Oral, Unknown. 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 68Mcg, Pyrantel Pamoate 57Mg reports are Dog (127 reports), Unknown (6 reports), Human (2 reports), with Dog accounting for the largest share. Within those species, Terrier - Yorkshire (17), Chihuahua (12), Spitz - German Pomeranian (10) 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 68Mcg, Pyrantel Pamoate 57Mg are Vomiting (55), INEFFECTIVE, HEARTWORM LARVAE (37), Diarrhoea (16), Lethargy (see also Central nervous system depression in 'Neurological') (16). Of the 129 reports with a coded outcome, Recovered/Normal is the leading category at 48.1%. 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 68Mcg, Pyrantel Pamoate 57Mg.

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