Amprolium Ion

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80 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.
80
Total Reports
16
Deaths Reported
2000.0%
Death Rate

Active Ingredients

Amprolium Ion

Administration Routes

OralUnknownOphthalmicTopicalRespiratory (Inhalation)

Species Affected

Cattle 24
Unknown 24
Human 15
Chicken 8
Goat 3
Duck 1
Llama 1
Other Deer 1
Sheep 1
Dog 1

Most Affected Breeds

Unknown 41
Holstein-Friesian also known as Holstein 11
Cattle (unknown) 5
Crossbred Bovine/Cattle 4
Chicken (unknown) 3
Bantam 3
Aberdeen Angus 2
Goat (unknown) 2
Duck (unknown) 1
Guernsey 1

Most Reported Reactions

Lack of efficacy (protozoa) - Coccidia 22
Death 16
Appearance, Abnormal 13
Accidental exposure 12
Lethargy (see also Central nervous system depression in 'Neurological') 8
Diarrhoea 6
Anorexia 6
Contamination, Particulate Matter 6
Potency, Low 5
NT - Abnormal necropsy finding NOS 5
No sign 5
Underdose 5

Outcome Breakdown

Outcome Unknown
31 (53.4%)
Died
16 (27.6%)
Recovered/Normal
8 (13.8%)
Recovered with Sequela
2 (3.4%)
Ongoing
1 (1.7%)

Data Summary

Metric Value
Total adverse event reports 80
Reports involving death 16
Case-fatality rate (reported events) 2000.0%
Distinct species in reports 10
Distinct breeds in reports 17
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.

Amprolium Ion Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 80 adverse event reports referencing Amprolium Ion, including 16 reports in which the animal died — a 2000.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Amprolium Ion. Reported administration routes include Oral, Unknown, Ophthalmic, Topical. 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 Amprolium Ion reports are Cattle (24 reports), Unknown (24 reports), Human (15 reports), with Cattle accounting for the largest share. Within those species, Unknown (41), Holstein-Friesian also known as Holstein (11), Cattle (unknown) (5) 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 Amprolium Ion are Lack of efficacy (protozoa) - Coccidia (22), Death (16), Appearance, Abnormal (13), Accidental exposure (12). Of the 58 reports with a coded outcome, Outcome Unknown is the leading category at 53.4%. 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 Amprolium Ion.

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