Zeranol

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131 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.
131
Total Reports
18
Deaths Reported
1370.0%
Death Rate

Active Ingredients

Zeranol

Administration Routes

UnknownSubcutaneousIntralesionalIntramuscular

Species Affected

Unknown 96
Cattle 30
Human 3
Sheep 1
Horse 1

Most Affected Breeds

Unknown 99
Crossbred Bovine/Cattle 9
Cattle (unknown) 7
Mixed (Cattle) 4
Aberdeen Angus 3
Cattle (other) 3
Holstein-Friesian also known as Holstein 2
Brangus 1
Cattle (unspecified) 1
Crossbred Ovine/sheep 1

Most Reported Reactions

Implant, Abnormal 61
Containers, Abnormal 32
Dispenser, Abnormal 21
Death 16
Anaphylaxis 4
Accidental exposure 4
Underfilling, Package 4
Respiratory tract disorder NOS 4
Dyspnoea 3
Unclassifiable adverse event 3
Injection site pain 3
Collapse (see also 'Cardio-vascular' and 'Systemic disorders') 2

Outcome Breakdown

Died
18 (75.0%)
Outcome Unknown
5 (20.8%)
Recovered/Normal
1 (4.2%)

Data Summary

Metric Value
Total adverse event reports 131
Reports involving death 18
Case-fatality rate (reported events) 1370.0%
Distinct species in reports 5
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.

Zeranol Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 131 adverse event reports referencing Zeranol, including 18 reports in which the animal died — a 1370.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Zeranol. Reported administration routes include Unknown, Subcutaneous, Intralesional, Intramuscular. 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 Zeranol reports are Unknown (96 reports), Cattle (30 reports), Human (3 reports), with Unknown accounting for the largest share. Within those species, Unknown (99), Crossbred Bovine/Cattle (9), Cattle (unknown) (7) 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 Zeranol are Implant, Abnormal (61), Containers, Abnormal (32), Dispenser, Abnormal (21), Death (16). Of the 24 reports with a coded outcome, Died is the leading category at 75.0%. 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 Zeranol.

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