Pet Drug Reports

Misoprostoladverse event reports that FDA received

Active ingredient

The Green Book lists no brand name for exactly this active ingredient.

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 April 2012 to June 2026, FDA received 171 adverse event reports that name a drug with misoprostol as its active ingredient. Of the 171 reports, 106 (62%) are about horses. 62 reports are about dogs (36.3%).

In January to March 2026, FDA received 5 reports that name this drug. The signs that appear in the largest number of the 171 reports are "Lack of efficacy - NOS", "Ineffective, gastric ulcer(s)" and "Vomiting". A report is not proof that a drug caused a sign.

Reports that name this drug rose by 28.1% 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 horses are 62% of the reports that name this drug, and 1.4% 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 5 reports that name misoprostol: 0 dog, 0 cat, 5 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 171 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. Lack of efficacy - NOS[the product did not have the expected effect]47.4%81 reports
  2. Ineffective, gastric ulcer(s)[legacy FDA term: the product did not have the expected effect (gastric ulcer(s))]15.8%27 reports
  3. Vomiting14%24 reports
  4. Lethargy[unusually tired or inactive]13.5%23 reports
  5. Death by euthanasia[the animal was euthanized]11.7%20 reports
  6. Anorexia[not eating]9.9%17 reports
  7. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]9.9%17 reports
  8. Diarrhoea[diarrhea]9.4%16 reports
  9. Elevated serum alkaline phosphatase (SAP)[a liver and bone enzyme above the normal range]9.4%16 reports
  10. Anaemia NOS[low red blood cell count]8.8%15 reports
  11. Other abnormal test result NOS[abnormal laboratory result, type not specified]8.2%14 reports
  12. Hypoproteinaemia[low blood protein]7%12 reports
  13. Partial lack of efficacy[the product worked less well than expected]7%12 reports
  14. Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]6.4%11 reports
Show the next 16 signs
  1. Hypoalbuminaemia[low blood albumin]6.4%11 reports
  2. Elevated creatinine[a kidney value above the normal range]5.8%10 reports
  3. Leucocytosis NOS[high white blood cell count]5.8%10 reports
  4. Thrombocytopenia[low platelet count]5.8%10 reports
  5. Abnormal ultrasound finding5.3%9 reports
  6. Decreased packed cell volume (PCV)[lower share of red cells in the blood]5.3%9 reports
  7. Melaena[dark, tarry stool containing digested blood]5.3%9 reports
  8. Overdose[more than the labelled amount was given]5.3%9 reports
  9. Loose stool4.7%8 reports
  10. Neutrophilia[high neutrophil count]4.7%8 reports
  11. Elevated liver enzymes[liver enzymes above the normal range]4.1%7 reports
  12. Elevated total bilirubin[bilirubin above the normal range]4.1%7 reports
  13. Decreased appetite3.5%6 reports
  14. Elevated gamma-glutamyl transferase (GGT)[a liver enzyme above the normal range]3.5%6 reports
  15. Inappetence[reduced appetite]3.5%6 reports
  16. Decreased haematocrit2.9%5 reports

The list shows 30 of 266 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 171 reports that name misoprostol. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog8 reports

No chart: no month has 5 or more reports.

Cat0 reports

No chart: no month has 5 or more reports.

Horse106 reports. Largest count in one month: 7 (May 2026)
Other or not given1 report

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 misoprostol, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20260018018
20256034040
20242026028
20230019120
202200707
202100202
202010001
201910001
201830003
20171000010
201680008
201580008
201470007
201381009
201281009

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/Normal12.3%21
  • Recovered with Sequela[recovered, with a lasting effect]0.6%1
  • Ongoing31%53
  • Died2.3%4
  • Euthanized11.7%20
  • Outcome Unknown42.1%72

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 171 reports that name misoprostol.

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

Kind of report

  • Safety issue38.6%66
  • Lack of expected effectiveness58.5%100
  • Both safety and lack of expected effectiveness2.3%4
  • Manufacturing or product defect0.6%1
  • Other0%0

170 reports say if the event was serious. 21.8% 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 year2.3%4
  • 1 to 3 years11.1%19
  • 4 to 7 years26.3%45
  • 8 to 11 years24.6%42
  • 12 years and over25.1%43
  • Age not given10.5%18

Weight of the animal

  • Under 5 kg (11 lb)1.8%3
  • 5 to 9.9 kg (11 to 22 lb)5.3%9
  • 10 to 24.9 kg (22 to 55 lb)9.9%17
  • 25 to 44.9 kg (55 to 99 lb)16.4%28
  • 45 kg and over (99 lb and over)36.8%63
  • Weight not given29.8%51

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Oral15.2%26
  • Topical0.6%1
  • Transplacental0.6%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.

The Green Book lists no approved animal drug with this active ingredient. FDA also receives reports for human drugs and compounded drugs that veterinarians prescribe.

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. Misoprostol: adverse event reports that FDA received. https://petdrugreports.com/drug/misoprostol/ 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 lists no brand name for exactly 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 41 reports in the 12 months to June 2026. It received 32 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 171 reports received from April 2012 to June 2026, 38.6% are about a safety issue only. 60.8% are about a lack of expected effectiveness, alone or with a safety issue. 0.6% are about a defect of the product or its package.