Diclazuril Oral Pellets

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128 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.
128
Total Reports
5
Deaths Reported
390.0%
Death Rate

Active Ingredients

Diclazuril Oral Pellets

Administration Routes

OralUnknown

Species Affected

Horse 65
Unknown 60
Other Equids 1
Other Mammals 1
Dog 1

Most Affected Breeds

Unknown 62
Quarter Horse 14
Horse (unknown) 9
Warmblood (unspecified) 9
Thoroughbred 7
Crossbred Equine/horse 3
Irish Hunter 2
Appaloosa 2
Warmblood - Dutch 2
Hanovarian 2

Most Reported Reactions

Lack of efficacy (protozoa) - NOS 29
Containers, Damaged 17
Closure, Abnormal 14
Underfilling, Container 13
Defect Unknown/Not Specified 10
Underfilling, Buckets/Pails 8
Containers, Abnormal 8
Uncoded sign 6
Drug administration duration too long 6
Death by euthanasia 5
Weight loss 5
Diarrhoea 4

Outcome Breakdown

Ongoing
54 (79.4%)
Recovered/Normal
7 (10.3%)
Euthanized
5 (7.4%)
Outcome Unknown
2 (2.9%)

Data Summary

Metric Value
Total adverse event reports 128
Reports involving death 5
Case-fatality rate (reported events) 390.0%
Distinct species in reports 5
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.

Diclazuril Oral Pellets Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 128 adverse event reports referencing Diclazuril Oral Pellets, including 5 reports in which the animal died — a 390.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Diclazuril Oral Pellets. 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 Diclazuril Oral Pellets reports are Horse (65 reports), Unknown (60 reports), Other Equids (1 reports), with Horse accounting for the largest share. Within those species, Unknown (62), Quarter Horse (14), Horse (unknown) (9) 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 Oral Pellets are Lack of efficacy (protozoa) - NOS (29), Containers, Damaged (17), Closure, Abnormal (14), Underfilling, Container (13). Of the 68 reports with a coded outcome, Ongoing is the leading category at 79.4%. 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 Oral Pellets.

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