Diclazuril

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29 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.
29
Total Reports
5
Deaths Reported
1720.0%
Death Rate

Active Ingredients

Diclazuril

Administration Routes

UnknownOralIntravenous

Species Affected

Unknown 17
Horse 5
Chicken 4
Turkey 3

Most Affected Breeds

Unknown 17
Chicken (unknown) 3
Turkey (unknown) 3
Trakehner 1
Morgan 1
Horse (other) 1
Horse (unknown) 1
Thoroughbred 1
Chicken (other) 1

Most Reported Reactions

Underfilling, Package 10
Lack of efficacy - NOS 3
Increased mortality rate 3
Containers, Damaged 2
Underfilling, Container 2
Loose stool 2
Aggression 1
Abdominal pain 1
Death 1
Containers, Abnormal 1
Ataxia 1
Hind limb ataxia 1

Outcome Breakdown

Died
5 (41.7%)
Recovered/Normal
3 (25.0%)
Outcome Unknown
2 (16.7%)
Ongoing
1 (8.3%)
Euthanized
1 (8.3%)

Data Summary

Metric Value
Total adverse event reports 29
Reports involving death 5
Case-fatality rate (reported events) 1720.0%
Distinct species in reports 4
Distinct breeds in reports 9
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.

Diclazuril Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 29 adverse event reports referencing Diclazuril, including 5 reports in which the animal died — a 1720.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Diclazuril. Reported administration routes include Unknown, Oral, Intravenous. 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 Diclazuril reports are Unknown (17 reports), Horse (5 reports), Chicken (4 reports), with Unknown accounting for the largest share. Within those species, Unknown (17), Chicken (unknown) (3), Turkey (unknown) (3) 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 Diclazuril are Underfilling, Package (10), Lack of efficacy - NOS (3), Increased mortality rate (3), Containers, Damaged (2). Of the 12 reports with a coded outcome, Died is the leading category at 41.7%. 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 Diclazuril.

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