Isoflupredone Acetate

Verify with FDA CVM →

36 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.
36
Total Reports
17
Deaths Reported
4720.0%
Death Rate

Active Ingredients

Isoflupredone Acetate

Administration Routes

IntramuscularUnknownIntra-ArticularIntravenous

Species Affected

Cattle 19
Unknown 5
Horse 5
Pig 5
Cat 1
Dog 1

Most Affected Breeds

Holstein-Friesian also known as Holstein 9
Cattle (other) 9
Unknown 5
Pig (unknown) 3
Thoroughbred 2
Warmblood (unspecified) 2
Crossbred Porcine/Pig 2
Domestic Shorthair 1
Retriever - Labrador 1
Mixed (Cattle) 1

Most Reported Reactions

Death 7
Death by euthanasia 4
Recumbency 4
Anaphylaxis 3
Color, Abnormal 3
Joint effusion 3
Anaphylactic-type reaction 3
Dyspnoea 3
Abortion 3
Increased mortality rate 3
Sudden death 2
Sternoabdominal recumbency 2

Outcome Breakdown

Died
14 (35.0%)
Recovered/Normal
11 (27.5%)
Outcome Unknown
9 (22.5%)
Euthanized
4 (10.0%)
Ongoing
2 (5.0%)

Data Summary

Metric Value
Total adverse event reports 36
Reports involving death 17
Case-fatality rate (reported events) 4720.0%
Distinct species in reports 6
Distinct breeds in reports 11
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.

Isoflupredone Acetate Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 36 adverse event reports referencing Isoflupredone Acetate, including 17 reports in which the animal died — a 4720.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Isoflupredone Acetate. Reported administration routes include Intramuscular, Unknown, Intra-Articular, 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 Isoflupredone Acetate reports are Cattle (19 reports), Unknown (5 reports), Horse (5 reports), with Cattle accounting for the largest share. Within those species, Holstein-Friesian also known as Holstein (9), Cattle (other) (9), 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 Isoflupredone Acetate are Death (7), Death by euthanasia (4), Recumbency (4), Anaphylaxis (3). Of the 40 reports with a coded outcome, Died is the leading category at 35.0%. 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 Isoflupredone Acetate.

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