Drug profile

The FDA adverse-event record for Cloprostenol Sodium

107 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Cloprostenol Sodium. See the species affected, top reactions, and outcomes below.

107
adverse-event reports
9.3%
death-coded share
Cattle
most-reported species
22
Lack of efficacy - NOS - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
107
Total Reports
10
Deaths Reported
9.3%
Death Rate

Active Ingredients

Cloprostenol Sodium

Administration Routes

UnknownIntramuscularSubcutaneousRespiratory (Inhalation)IntravenousParenteral

Species Affected

Cattle 56
Unknown 43
Human 4
Horse 3
Dog 1

Most Affected Breeds

Unknown 48
Cattle (unknown) 27
Holstein-Friesian also known as Holstein 8
Aberdeen Angus 6
Mixed (Cattle) 6
Cattle (unspecified) 4
Crossbred Bovine/Cattle 3
Arab 2
Mixed (Dog) 1
Quarter Horse 1

Most Reported Reactions

Lack of efficacy - NOS 22
INEFFECTIVE, ESTRUS SYNCHRONIZ 18
Stopper, abnormal 17
Death 8
Product Defect, General 5
Accidental exposure 5
Contamination, Particulate Matter 4
Containers, Damaged 4
INEFFECTIVE, ESTRUS INDUCTION 4
Caps, Abnormal 3
Anaphylaxis 3
Hyperextension 3

Outcome Breakdown

Outcome Unknown
16 (57.1%)
Died
10 (35.7%)
Ongoing
2 (7.1%)

Cloprostenol Sodium Adverse Event Insights

107 reports name Cloprostenol Sodium; 10 recorded a death outcome (9.3% of reported events, not a population-level mortality rate). Active ingredient: Cloprostenol Sodium. Administration routes: Unknown, Intramuscular, Subcutaneous, Respiratory (Inhalation).

By species: Cattle (56 reports), Unknown (43 reports), Human (4 reports). By breed: Unknown (48), Cattle (unknown) (27), Holstein-Friesian also known as Holstein (8).

Leading clinical signs: Lack of efficacy - NOS (22), INEFFECTIVE, ESTRUS SYNCHRONIZ (18), Stopper, abnormal (17), Death (8). Outcome, 28 coded reports: Outcome Unknown leads at 57.1%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.