Progesterone

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526 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.
526
Total Reports
22
Deaths Reported
420.0%
Death Rate

Active Ingredients

Progesterone

Administration Routes

VaginalUnknownTopicalOralIntramuscularIntrauterine

Species Affected

Cattle 252
Unknown 209
Sheep 28
Goat 16
Human 11
Dog 4
Horse 4
White tailed deer 2

Most Affected Breeds

Unknown 222
Mixed (Cattle) 97
Aberdeen Angus 66
Cattle (other) 26
Hereford cattle 13
Cattle (unspecified) 12
Cattle (unknown) 10
Sheep (unknown) 10
Holstein-Friesian also known as Holstein 7
Boer 7

Most Reported Reactions

Lack of efficacy - NOS 116
INEFFECTIVE, ESTRUS SYNCHRONIZ 93
Insert, Damaged 60
Containers, Damaged 40
Insert, Abnormal 36
Product Defect, General 29
Rectal prolapse 29
Device Defective NOS 27
Uncoded sign 27
Underfilling, Package 23
Tablets, Abnormal 23
No sign 22

Outcome Breakdown

Outcome Unknown
237 (80.1%)
Recovered/Normal
32 (10.8%)
Died
20 (6.8%)
Ongoing
5 (1.7%)
Euthanized
2 (0.7%)

Data Summary

Metric Value
Total adverse event reports 526
Reports involving death 22
Case-fatality rate (reported events) 420.0%
Distinct species in reports 8
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.

Progesterone Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 526 adverse event reports referencing Progesterone, including 22 reports in which the animal died — a 420.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Progesterone. Reported administration routes include Vaginal, Unknown, Topical, Oral. 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 reports are Cattle (252 reports), Unknown (209 reports), Sheep (28 reports), with Cattle accounting for the largest share. Within those species, Unknown (222), Mixed (Cattle) (97), Aberdeen Angus (66) 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 are Lack of efficacy - NOS (116), INEFFECTIVE, ESTRUS SYNCHRONIZ (93), Insert, Damaged (60), Containers, Damaged (40). Of the 296 reports with a coded outcome, Outcome Unknown is the leading category at 80.1%. 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.

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