Ivermectin + Praziquantel + Pyrantel

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22 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.
22
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

IvermectinPraziquantelPyrantel

Administration Routes

OralUnknown

Species Affected

Dog 17
Unknown 5

Most Affected Breeds

Unknown 5
Shih Tzu 3
Retriever - Labrador 2
Crossbred Canine/dog 2
Terrier - Boston 2
Pit Bull 1
Terrier - Jack Russell 1
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 1
Rottweiler 1
Doberman Pinscher 1

Most Reported Reactions

Vomiting 12
Behavioural disorder NOS 3
Diarrhoea 3
Lethargy (see also Central nervous system depression in 'Neurological') 3
INEFFECTIVE, HEARTWORM LARVAE 2
Ataxia 2
Pruritus 2
Lack of efficacy (ectoparasite) - flea 2
Contamination, Foreign Object 2
Tablets, Abnormal 2
Drug dose omission 1
Leucocytosis NOS 1

Outcome Breakdown

Recovered/Normal
12 (70.6%)
Outcome Unknown
2 (11.8%)
Ongoing
2 (11.8%)
Recovered with Sequela
1 (5.9%)

Data Summary

Metric Value
Total adverse event reports 22
Reports involving death 0
Case-fatality rate (reported events) 0.0%
Distinct species in reports 2
Distinct breeds in reports 13
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 + Praziquantel + Pyrantel Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 22 adverse event reports referencing Ivermectin + Praziquantel + Pyrantel, including 0 reports in which the animal died — a 0.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Ivermectin, Praziquantel, Pyrantel. 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 + Praziquantel + Pyrantel reports are Dog (17 reports), Unknown (5 reports), with Dog accounting for the largest share. Within those species, Unknown (5), Shih Tzu (3), Retriever - Labrador (2) 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 + Praziquantel + Pyrantel are Vomiting (12), Behavioural disorder NOS (3), Diarrhoea (3), Lethargy (see also Central nervous system depression in 'Neurological') (3). Of the 17 reports with a coded outcome, Recovered/Normal is the leading category at 70.6%. 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 + Praziquantel + 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