Acepromazine Maleate (PromAce): adverse event reports that FDA received

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 2,597 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. Death12.1%314 reports
2. Vomiting12.1%314 reports
3. Lethargy[unusually tired or inactive]11.1%288 reports
4. Anorexia[not eating]6.5%168 reports
5. Death by euthanasia[the animal was euthanized]6.2%161 reports
6. Lack of efficacy - NOS[the product did not have the expected effect]6%156 reports
7. Diarrhoea[diarrhea]4.9%127 reports
8. Behavioural disorder NOS[behaviour change, type not specified]4.7%123 reports
9. Other abnormal test result NOS[abnormal laboratory result, type not specified]4.5%118 reports
10. Ataxia[unsteady, uncoordinated movement]4.4%114 reports
11. Cardiac arrest4.3%111 reports
12. Seizure NOS[seizure, type not specified]4.2%110 reports
13. Bradycardia[slow heart rate]4.1%107 reports
14. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]4%103 reports

The list shows 30 of 1,264 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

• Dog69.2%1,797
• Cat23.1%601
• Horse2.7%71
• Human exposure0.3%8
• Other0.3%7
• Cattle0.2%6

The share is of all 2,597 reports that name acepromazine maleate. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

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

2026 has the reports that FDA received through Jun 2026. Download the years (CSV)

What the reports record

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

Next in the A to Z list

• (S) - methoprene
• Acetaminophen
• Acetylsalicylic Acid
• Afoxolaner
• Afoxolaner + Moxidectin + Pyrantel Pamoate

All drugs by active ingredient. Brand names A to Z

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 015-030The FDA record of the application for PromAce Injectable.
• Green Book record of NADA 117-532The FDA record of the application for PromAce.
• Green Book record of ANADA 200-319The FDA record of the application for Acepromazine Maleate Injection.
• Green Book record of ANADA 200-757The FDA record of the application for Acepromazine Maleate Tablets.
• Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Pet Drug Reports. Acepromazine Maleate: adverse event reports that FDA received. https://petdrugreports.com/drug/acepromazine-maleate/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

Where the data come from

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 140 reports in the 12 months to June 2026. It received 171 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 2,597 reports received from April 1987 to June 2026, 85.3% are about a safety issue only. 10.4% are about a lack of expected effectiveness, alone or with a safety issue. 4.3% are about a defect of the product or its package.