Moxidectin + Pyrantel + Sarolaner

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79 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.
79
Total Reports
10
Deaths Reported
1270.0%
Death Rate

Active Ingredients

MoxidectinPyrantelSarolaner

Administration Routes

OralUnknown

Species Affected

Dog 60
Unknown 19

Most Affected Breeds

Unknown 19
Dog (unknown) 6
Retriever - Labrador 4
Maltese 4
Shiba Inu 3
Shepherd Dog - German 3
Poodle (unspecified) 3
Mixed (Dog) 3
Terrier - Yorkshire 2
Crossbred Canine/dog 2

Most Reported Reactions

Seizure NOS 21
Vomiting 11
Vocalisation 7
Diarrhoea 7
Ataxia 6
Lethargy (see also Central nervous system depression in 'Neurological') 6
Suspect counterfeit product 6
Death by euthanasia 6
Shaking 5
Polydipsia 4
Anorexia 4
Product label issues 4

Outcome Breakdown

Recovered/Normal
18 (30.0%)
Outcome Unknown
12 (20.0%)
Ongoing
11 (18.3%)
Recovered with Sequela
9 (15.0%)
Euthanized
6 (10.0%)
Died
4 (6.7%)

Data Summary

Metric Value
Total adverse event reports 79
Reports involving death 10
Case-fatality rate (reported events) 1270.0%
Distinct species in reports 2
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.

Moxidectin + Pyrantel + Sarolaner Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 79 adverse event reports referencing Moxidectin + Pyrantel + Sarolaner, including 10 reports in which the animal died — a 1270.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Moxidectin, Pyrantel, Sarolaner. 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 Moxidectin + Pyrantel + Sarolaner reports are Dog (60 reports), Unknown (19 reports), with Dog accounting for the largest share. Within those species, Unknown (19), Dog (unknown) (6), Retriever - Labrador (4) 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 Moxidectin + Pyrantel + Sarolaner are Seizure NOS (21), Vomiting (11), Vocalisation (7), Diarrhoea (7). Of the 60 reports with a coded outcome, Recovered/Normal is the leading category at 30.0%. 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 Moxidectin + Pyrantel + Sarolaner.

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