Ponazuril

Verify with FDA CVM →

312 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.
312
Total Reports
53
Deaths Reported
1700.0%
Death Rate

Active Ingredients

Ponazuril

Administration Routes

OralUnknownTopicalSubcutaneousIntramuscularIntragastricOtherIntraocular

Species Affected

Horse 117
Unknown 96
Dog 58
Cat 32
Human 3
Ferret 2
Pig 2
Macaw 1
Cattle 1

Most Affected Breeds

Unknown 104
Quarter Horse 24
Horse (unknown) 22
Domestic Shorthair 19
Thoroughbred 14
Paint 12
Warmblood (unspecified) 11
Tennessee Walking Horse 8
Retriever - Labrador 8
Crossbred Canine/dog 7

Most Reported Reactions

Uncoded sign 32
Death by euthanasia 28
Death 27
Ataxia 26
Diarrhoea 22
Other abnormal test result NOS 21
Anorexia 20
Lack of efficacy (protozoa) - NOS 20
Vomiting 19
Lethargy (see also Central nervous system depression in 'Neurological') 18
Lack of efficacy - NOS 14
Dispenser, Abnormal 14

Outcome Breakdown

Outcome Unknown
82 (38.1%)
Recovered/Normal
49 (22.8%)
Ongoing
29 (13.5%)
Died
28 (13.0%)
Euthanized
27 (12.6%)

Data Summary

Metric Value
Total adverse event reports 312
Reports involving death 53
Case-fatality rate (reported events) 1700.0%
Distinct species in reports 9
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.

Ponazuril Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 312 adverse event reports referencing Ponazuril, including 53 reports in which the animal died — a 1700.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Ponazuril. Reported administration routes include Oral, Unknown, Topical, Subcutaneous. 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 Ponazuril reports are Horse (117 reports), Unknown (96 reports), Dog (58 reports), with Horse accounting for the largest share. Within those species, Unknown (104), Quarter Horse (24), Horse (unknown) (22) 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 Ponazuril are Uncoded sign (32), Death by euthanasia (28), Death (27), Ataxia (26). Of the 215 reports with a coded outcome, Outcome Unknown is the leading category at 38.1%. 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 Ponazuril.

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