Dinoprost Tromethamine (Lutalyse, ProstaMate): adverse event reports that FDA received
Active ingredient
Also sold as: Lutalyse, ProstaMate, Prostin F2 Alpha.
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 FDAFrom January 1987 to June 2026, FDA received 1,299 adverse event reports that name a drug with dinoprost tromethamine as its active ingredient. Of the 1,299 reports, 910 (70.1%) are about cattle. 177 reports are about people who were exposed to the drug (13.6%).
In January to March 2026, FDA received 4 reports that name this drug. The signs that appear in the largest number of the 1,299 reports are "Ineffective, estrus synchroniz", "Lack of efficacy - NOS" and "Death". A report is not proof that a drug caused a sign.
Reports that name this drug fell by 56.8% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about cattle are 70.1% 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 4 reports that name dinoprost tromethamine: 0 dog, 0 cat, 0 horse, 4 other or not given.
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 1,299 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.
- Ineffective, estrus synchroniz[legacy FDA term: the product did not have the expected effect (estrus synchroniz)]22.9%298 reports
- Lack of efficacy - NOS[the product did not have the expected effect]19.6%255 reports
- Death18.9%245 reports
- Injection site swelling[swelling where the injection was given]14.5%188 reports
- Unclassifiable adverse event[event that fits no dictionary term]8.5%110 reports
- Accidental exposure[exposure that was not intended]8%104 reports
- Ineffective, abortion[legacy FDA term: the product did not have the expected effect (abortion)]4.8%63 reports
- Myositis4.7%61 reports
- Injection site infection[infection where the injection was given]3.7%48 reports
- Recumbency[lying down and unable or unwilling to rise]3.2%42 reports
- Death by euthanasia[the animal was euthanized]3.2%41 reports
- Lameness3.1%40 reports
- No sign[no clinical sign was reported]3%39 reports
- Injection site gaseous gangrene[gaseous gangrene where the injection was given]2.9%38 reports
Show the next 16 signs
- Injection site pain[pain where the injection was given]2.8%36 reports
- Injection site abscess[abscess where the injection was given]2.5%33 reports
- Abdominal pain2.1%27 reports
- Fever1.8%24 reports
- Injection site inflammation[inflammation where the injection was given]1.8%23 reports
- Anorexia[not eating]1.5%20 reports
- Oedema of the extremities[swollen legs or paws]1.5%20 reports
- PR-muscle(s), lesion(s)[legacy FDA term: lesions found in the muscles]1.4%18 reports
- Injection site reaction NOS[reaction nos where the injection was given]1.3%17 reports
- Milk production decrease1.3%17 reports
- Anaphylaxis[sudden severe allergic-type reaction]1.2%16 reports
- Vomiting1.2%16 reports
- Hyperhidrosis1.2%15 reports
- Nausea1.2%15 reports
- Color, Abnormal[a product quality report, not a sign in an animal]1%13 reports
- Containers, Damaged[a product quality report, not a sign in an animal]1%13 reports
The list shows 30 of 406 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 1,299 reports that name dinoprost tromethamine. The other reports give a different species or no species.
Reports for each month, Jul 2021 to Jun 2026
No chart: no month has 5 or more reports.
No chart: no month has 5 or more 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
| Year | Dog | Cat | Horse | Other or not given | All species |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 9 | 9 |
| 2025 | 0 | 0 | 0 | 33 | 33 |
| 2024 | 1 | 0 | 2 | 42 | 45 |
| 2023 | 1 | 0 | 1 | 31 | 33 |
| 2022 | 0 | 0 | 1 | 40 | 41 |
| 2021 | 0 | 0 | 2 | 39 | 41 |
| 2020 | 0 | 0 | 4 | 50 | 54 |
| 2019 | 0 | 0 | 0 | 37 | 37 |
| 2018 | 0 | 1 | 2 | 53 | 56 |
| 2017 | 1 | 0 | 4 | 60 | 65 |
| 2016 | 0 | 1 | 1 | 50 | 52 |
| 2015 | 0 | 0 | 1 | 29 | 30 |
| 2014 | 0 | 0 | 1 | 46 | 47 |
| 2013 | 1 | 0 | 2 | 38 | 41 |
| 2012 | 0 | 0 | 1 | 41 | 42 |
| 2011 | 1 | 0 | 1 | 33 | 35 |
| 2010 | 2 | 0 | 4 | 44 | 50 |
| 2009 | 4 | 0 | 2 | 59 | 65 |
| 2008 | 1 | 0 | 5 | 48 | 54 |
| 2007 | 1 | 0 | 1 | 48 | 50 |
| 2006 | 1 | 0 | 2 | 61 | 64 |
| 2005 | 0 | 0 | 1 | 33 | 34 |
| 2004 | 0 | 0 | 4 | 50 | 54 |
| 2003 | 0 | 1 | 3 | 24 | 28 |
| 2002 | 1 | 0 | 2 | 12 | 15 |
| 2001 | 0 | 0 | 1 | 18 | 19 |
| 2000 | 0 | 0 | 2 | 12 | 14 |
| 1999 | 0 | 0 | 3 | 24 | 27 |
| 1998 | 0 | 0 | 3 | 37 | 40 |
| 1997 | 1 | 0 | 0 | 35 | 36 |
| 1996 | 0 | 0 | 1 | 2 | 3 |
| 1995 | 0 | 0 | 1 | 26 | 27 |
| 1994 | 0 | 0 | 0 | 9 | 9 |
| 1993 | 0 | 0 | 2 | 8 | 10 |
| 1992 | 0 | 0 | 0 | 14 | 14 |
| 1991 | 0 | 0 | 0 | 7 | 7 |
| 1990 | 0 | 0 | 1 | 3 | 4 |
| 1989 | 0 | 0 | 0 | 5 | 5 |
| 1988 | 0 | 0 | 0 | 3 | 3 |
| 1987 | 1 | 0 | 0 | 5 | 6 |
2026 has the reports that FDA received through Jun 2026. Download the years (CSV)
What the reports record
Outcome at the time of the report
- Recovered/Normal5.5%71
- Recovered with Sequela[recovered, with a lasting effect]0.4%5
- Ongoing4.2%54
- Died22.9%297
- Euthanized2.3%30
- Outcome Unknown28.7%373
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 1,299 reports that name dinoprost tromethamine.
A report about more than one animal can have more than one outcome.
Kind of report
- Safety issue70.2%912
- Lack of expected effectiveness19.2%249
- Both safety and lack of expected effectiveness2.4%31
- Manufacturing or product defect8.2%107
- Other0%0
567 reports say if the event was serious. 45.5% 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 year2.1%27
- 1 to 3 years32%416
- 4 to 7 years5.7%74
- 8 to 11 years0.5%7
- 12 years and over8.6%112
- Age not given51%663
Weight of the animal
- Under 5 kg (11 lb)0.2%2
- 5 to 9.9 kg (11 to 22 lb)0.2%2
- 10 to 24.9 kg (22 to 55 lb)0.1%1
- 25 to 44.9 kg (55 to 99 lb)0.6%8
- 45 kg and over (99 lb and over)29.9%389
- Weight not given69.1%897
Breed, where the report gives one breed
- Holstein-Friesian19.2%249
- Aberdeen Angus8.6%112
- Jersey1.8%24
- Quarter Horse1.5%19
- Cattle1.1%14
- Hereford cattle1.1%14
- Simmental0.9%12
- Thoroughbred0.7%9
A breed with many animals has many reports.
Route in the report
- Intramuscular68.7%892
- Subcutaneous5.7%74
- Topical5.7%74
- Oral0.9%12
- Intravenous0.6%8
- Other0.2%3
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
- Lutalyse
- ProstaMate
- Prostin F2 Alpha
What the Green Book records give
- Applications with an approval in force
- 4
- Approved species
- Cattle, Horses, Swine, Equids
- Dose forms
- Injectable Solution, Liquid (Solution)
- Routes
- Intramuscular, Subcutaneous
- Sale
- RX (prescription)
- Earliest approval date in the records
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.
| Brand name | Active ingredients | Sponsor | Approved species | Application |
|---|---|---|---|---|
| Prostin F2 Alpha Sterile Solution | Dinoprost Tromethamine | Zoetis Inc. | Horses | NADA 100-202 |
| Lutalyse Injection | Dinoprost Tromethamine | Zoetis Inc. | Horses, Cattle, Swine | NADA 108-901 |
| Lutalyse HighCon Injection | Dinoprost Tromethamine | Zoetis Inc. | Cattle | NADA 141-442 |
| ProstaMate | Dinoprost Tromethamine | Bimeda Animal Health Ltd. | Horses, Cattle, Swine | ANADA 200-253 |
Next in the A to Z list
FDA pages for this drug
- How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
- Green Book record of NADA 108-901The FDA record of the application for Lutalyse Injection.
- Green Book record of NADA 141-442The FDA record of the application for Lutalyse HighCon Injection.
- Green Book record of ANADA 200-253The FDA record of the application for ProstaMate.
- Green Book record of NADA 100-202The FDA record of the application for Prostin F2 Alpha Sterile Solution.
- Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.
The site checked these addresses on . The links open in a new tab.
Cite this page
Pet Drug Reports. Dinoprost Tromethamine: adverse event reports that FDA received. https://petdrugreports.com/drug/dinoprost-tromethamine/ 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 19 reports in the 12 months to June 2026. It received 44 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 1,299 reports received from January 1987 to June 2026, 70.2% are about a safety issue only. 21.6% are about a lack of expected effectiveness, alone or with a safety issue. 8.2% are about a defect of the product or its package.