Progesterone;Estradiol Benzoate

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102 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.
102
Total Reports
29
Deaths Reported
2840.0%
Death Rate

Active Ingredients

Progesterone;Estradiol Benzoate

Administration Routes

UnknownSubcutaneous

Species Affected

Cattle 74
Unknown 24
Human 3
Horse 1

Most Affected Breeds

Mixed (Cattle) 54
Unknown 27
Holstein-Friesian also known as Holstein 7
Aberdeen Angus 5
Crossbred Bovine/Cattle 2
Horse (unknown) 1
Gelbvieh 1
Charolais 1
Cattle (unknown) 1
Beefmaster 1

Most Reported Reactions

Death 22
INEFFECTIVE, WEIGHT INC 16
Implant, Abnormal 8
Underfilling, Container 8
Device Defective NOS 7
Tablets, Abnormal 7
Anaphylactic-type reaction 6
Increased sexual interest 6
Lack of efficacy - NOS 6
Containers, Abnormal 5
Anaphylaxis 4
Found dead 3

Outcome Breakdown

Outcome Unknown
51 (56.0%)
Died
28 (30.8%)
Recovered/Normal
8 (8.8%)
Ongoing
3 (3.3%)
Euthanized
1 (1.1%)

Data Summary

Metric Value
Total adverse event reports 102
Reports involving death 29
Case-fatality rate (reported events) 2840.0%
Distinct species in reports 4
Distinct breeds in reports 12
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.

Progesterone;Estradiol Benzoate Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 102 adverse event reports referencing Progesterone;Estradiol Benzoate, including 29 reports in which the animal died — a 2840.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Progesterone;Estradiol Benzoate. Reported administration routes include Unknown, Subcutaneous. 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 Progesterone;Estradiol Benzoate reports are Cattle (74 reports), Unknown (24 reports), Human (3 reports), with Cattle accounting for the largest share. Within those species, Mixed (Cattle) (54), Unknown (27), Holstein-Friesian also known as Holstein (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 Progesterone;Estradiol Benzoate are Death (22), INEFFECTIVE, WEIGHT INC (16), Implant, Abnormal (8), Underfilling, Container (8). Of the 91 reports with a coded outcome, Outcome Unknown is the leading category at 56.0%. 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 Progesterone;Estradiol Benzoate.

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