Pet Drug Reports

Cloprostenol Sodium (Estrumate, Heifex)adverse event reports that FDA received

Active ingredient

Also sold as: Estrumate, Heifex, EstroPLAN.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Read this first. FDA says this about the data:

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarianHow to report to FDA

From January 1994 to August 2025, FDA received 223 adverse event reports that name a drug with cloprostenol sodium as its active ingredient. Of the 223 reports, 131 (58.7%) are about cattle. 19 reports are about people who were exposed to the drug (8.5%).

In January to March 2026, FDA received no reports that name this drug. The signs that appear in the largest number of the 223 reports are "Ineffective, estrus synchroniz", "Lack of efficacy - NOS" and "Death". A report is not proof that a drug caused a sign.

Fewer than 20 reports named this drug in the 12 months before June 2026, so this page gives no change. Reports about cattle are 58.7% of the reports that name this drug, and 2.3% of all reports.

Search engines list a drug page with 500 reports or more in all years. The page also needs 30 reports or more in the 12 months to June 2026. This page is under one of these numbers. The site keeps the page and keeps it out of search engines.

Since the last update of the FDA data

The latest update of the FDA data, recorded on , changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 0 reports that name cloprostenol sodium: 0 dog, 0 cat, 0 horse, 0 other or not given.

All updatesFeed of updates (RSS)

Signs that the reports list

A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 223 reports that list the sign. One report can list more than one sign.

The sign that is in the largest number of the reports comes first.

  1. Ineffective, estrus synchroniz[legacy FDA term: the product did not have the expected effect (estrus synchroniz)]25.1%56 reports
  2. Lack of efficacy - NOS[the product did not have the expected effect]14.3%32 reports
  3. Death11.7%26 reports
  4. Stopper, abnormal7.6%17 reports
  5. Accidental exposure[exposure that was not intended]7.2%16 reports
  6. Unclassifiable adverse event[event that fits no dictionary term]6.7%15 reports
  7. Ineffective, abortion[legacy FDA term: the product did not have the expected effect (abortion)]3.6%8 reports
  8. Abdominal pain2.7%6 reports
  9. Emphysema NOS[NOS: not otherwise specified]2.7%6 reports
  10. Anaphylaxis[sudden severe allergic-type reaction]2.2%5 reports
  11. Hyperhidrosis2.2%5 reports
  12. Product Defect, General[a product quality report, not a sign in an animal]2.2%5 reports
  13. Solution, Abnormal[a product quality report, not a sign in an animal]2.2%5 reports
  14. Vials, Leaking[a product quality report, not a sign in an animal]2.2%5 reports
Show the next 16 signs
  1. Caps, Abnormal[a product quality report, not a sign in an animal]1.8%4 reports
  2. Containers, Damaged[a product quality report, not a sign in an animal]1.8%4 reports
  3. Contamination, Particulate Matter1.8%4 reports
  4. Ineffective, estrus induction[legacy FDA term: the product did not have the expected effect (estrus induction)]1.8%4 reports
  5. Oedema NOS[NOS: not otherwise specified]1.8%4 reports
  6. Suspected infectious agent transmission1.8%4 reports
  7. Underfilling, Vials[a product quality report, not a sign in an animal]1.8%4 reports
  8. Abortion1.3%3 reports
  9. Hyperextension1.3%3 reports
  10. No sign[no clinical sign was reported]1.3%3 reports
  11. Oedema of the extremities[swollen legs or paws]1.3%3 reports
  12. Recumbency[lying down and unable or unwilling to rise]1.3%3 reports
  13. Respiratory tract disorder NOS[NOS: not otherwise specified]1.3%3 reports
  14. Seal, Abnormal[a product quality report, not a sign in an animal]1.3%3 reports
  15. Tachycardia[fast heart rate]1.3%3 reports
  16. Vials, Damaged[a product quality report, not a sign in an animal]1.3%3 reports

The list shows 30 of 122 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

The share is of all 223 reports that name cloprostenol sodium. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog0 reports

No chart: no month has 5 or more reports.

Cat0 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given11 reports

No chart: no month has 5 or more reports.

The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

Reports by year

  • Dog
  • Cat
  • Horse
  • Other or not given
Reports that name cloprostenol sodium, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
202500044
202400022
202300022
202200011
20210001313
202000077
201900066
201800022
201700011
201600033
201500022
20140001111
20130011516
2012002911
20110001818
2010100910
20090001212
20080042327
200700178
20060011112
200510067
200400156
200300088
200200022
200100235
200000099
199900022
199800167
199700011
199600011
199500033
199400044

2025 has the reports that FDA received through Aug 2025. Download the years (CSV)

What the reports record

Outcome at the time of the report

  • Recovered/Normal0%0
  • Recovered with Sequela[recovered, with a lasting effect]0%0
  • Ongoing0.9%2
  • Died13%29
  • Euthanized0%0
  • Outcome Unknown8.1%18

An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 223 reports that name cloprostenol sodium.

A report about more than one animal can have more than one outcome.

Kind of report

  • Safety issue67.3%150
  • Lack of expected effectiveness5.4%12
  • Both safety and lack of expected effectiveness2.2%5
  • Manufacturing or product defect25.1%56
  • Other0%0

16 reports say if the event was serious. 37.5% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed and route

Age of the animal

  • Under 1 year1.3%3
  • 1 to 3 years17%38
  • 4 to 7 years4%9
  • 8 to 11 years0.9%2
  • 12 years and over5.4%12
  • Age not given71.3%159

Weight of the animal

  • Under 5 kg (11 lb)0%0
  • 5 to 9.9 kg (11 to 22 lb)0%0
  • 10 to 24.9 kg (22 to 55 lb)0%0
  • 25 to 44.9 kg (55 to 99 lb)0.4%1
  • 45 kg and over (99 lb and over)26%58
  • Weight not given73.5%164

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Intramuscular42.6%95
  • Topical3.6%8
  • Subcutaneous3.1%7
  • Intravenous0.4%1
  • Oral0.4%1
  • Other0.4%1

Each bar is on a scale of 0 to 100%.

Approved animal drugs with this active ingredient (FDA Green Book)

This section is reference data. It has no report count.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Brand names

  • Estrumate
  • Heifex
  • EstroPLAN

What the Green Book records give

Applications with an approval in force
2
Approved species
Cattle
Dose forms
Injectable Solution
Routes
Intramuscular
Sale
RX (prescription)

The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
Estrumate; HeifexCloprostenol SodiumIntervet, Inc.CattleNADA 113-645
EstroPLANCloprostenol SodiumParnell Technologies Pty. Ltd.CattleANADA 200-310

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

The site checked these addresses on . The links open in a new tab.

Cite this page

Pet Drug Reports. Cloprostenol Sodium: adverse event reports that FDA received. https://petdrugreports.com/drug/cloprostenol-sodium/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site does not use the application number that a record has.

The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.

Questions about these reports

Which brand are these reports about?

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists the brand names with this active ingredient.

Do the reports show that the drug caused the signs?

No. FDA states this about the data.

When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.

The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices

How many reports did FDA receive in the latest 12 months?

FDA received 2 reports in the 12 months to June 2026. It received 3 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

What kinds of report are in the count?

Of the 223 reports received from January 1994 to August 2025, 67.3% are about a safety issue only. 7.6% are about a lack of expected effectiveness, alone or with a safety issue. 25.1% are about a defect of the product or its package.