Meds A-Z
Acepromazine Maleate
Detailed information about Acepromazine Maleate
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
As an aid in tranquilization and as a preanesthetic agent in dogs. Acepromazine Maleate Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical p...
What it does:
PromAce Injectable can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antieme...
When it's needed:
Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Call your vet sooner if you notice:
- Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Commonly reported reactions:
- (2 reports)
- (2 reports)
- (2 reports)
What to ask your vet today:
- Is this medicine the right fit for my pet’s current symptoms?
- Which warning signs mean I should call back right away?
- How should I handle missed doses or refusal to take the medicine?
Acepromazine Maleate
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200757 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200361 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- High: Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
Adverse Reactions
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Tap or hover a reaction to see what it means in plain language.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 2 | Cat, Dog | 2 | |
| 2 | Cat, Dog | 2 | |
| 2 | Cat, Dog | 2 | |
| 2 | Cat, Dog | 1 | |
| 2 | Cat, Dog | 0 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 |
Species coverage: Dog (20) Cat (12)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-044760
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 9 • Secondary summaries: 0
- FOI Summary oA 200-757 Approved August 31, 2023.pdf · FOI
- Acepromazine Maleate Tablets · SPL
- ucm059294.pdf · FOI
- Acepromazine Maleate Injection · SPL
- PromAce® Tablets · SPL
- ucm061778.pdf · FOI
- Acepromazine Maleate Injection · SPL
- Acepromazine Maleate Tablets · SPL
- PromAce® Injectable · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/14444 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/14716/Acepromazine%20Maleate%20Tablets · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1115 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/133/Acepromazine%20Maleate%20Injection · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1181/PromAce%C2%AE%20Tablets · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1069 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/161/Acepromazine%20Maleate%20Injection · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2129/Acepromazine%20Maleate%20Tablets · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1696/PromAce%C2%AE%20Injectable · document · SPL
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
At a Glance
Quick facts and links to official labeling and safety signals.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:04 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Diagnosis-code mappings are not available for this medication yet.
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 0010-3827-01 | 0010 | - | |
| 0010-6703-01 | 0010 | - | |
| 0010-6703-02 | 0010 | - | |
| 0010-6704-01 | 0010 | - | |
| 0010-6704-02 | 0010 | - | |
| 10695-181-10 | 10695 | - | |
| 11695-0093-1 | 11695 | - | |
| 11695-0093-5 | 11695 | - | |
| 11695-0094-1 | 11695 | - | |
| 11695-0094-5 | 11695 | - | |
| 11695-0095-5 | 11695 | - | |
| 11695-7033-1 | 11695 | - | |
| 11695-7033-2 | 11695 | - | |
| 11695-7034-1 | 11695 | - | |
| 11695-7034-2 | 11695 | - | |
| 13985-582-25 | 13985 | - | |
| 13985-582-50 | 13985 | - | |
| 13985-583-10 | 13985 | - | |
| 13985-583-50 | 13985 | - | |
| 13985-587-50 | 13985 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
FOI Summary oA 200-757 Approved August 31, 2023.pdf
• FOI summary • Official
• Sept. 1, 2023
FDA FOI summary for application 200757
-
ucm059294.pdf
• FOI summary • Official
• May 3, 2023
FDA FOI summary for application 200361
-
ucm061778.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 200319
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Death by euthanasia, Diarrhoea, Lac… (Official, 2026-02-12)
- usage: PromAce Injectable can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to al… (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
FDA Products & Applications (Animal Drugs @ FDA)
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
Acepromazine Maleate Tablets
RX
Acepromazine Maleate
Tablet
• Oral
|
ZYVET AH, Inc. | ANADA 200-757 | Approved | Sep 1, 2023 |
|
Acepromazine Maleate Injection
RX
Acepromazine Maleate
Liquid (Solution)
• Intramuscular, Intravenous, Subcutaneous
|
Boehringer lngelheim Animal Health USA Inc. | ANADA 200-361 | W | May 3, 2023 |
|
PromAce® Tablets
RX
Acepromazine Maleate
Tablet
• Oral
|
Boehringer lngelheim Animal Health USA Inc. | NADA 32702 | W | May 3, 2023 |
|
Acepromazine Maleate Injection
RX
Acepromazine Maleate
Liquid (Solution)
• Subcutaneous, Intravenous, Intramuscular
|
Elanco US Inc. | ANADA 200-319 | Approved | Jun 1, 2016 |
|
Acepromazine Maleate Tablets
RX
Acepromazine Maleate
|
Bolar Pharmaceutical Co., Inc. | NADA 135-299 | W | Jun 1, 2016 |
|
PromAce® Injectable
RX
Acepromazine Maleate
Liquid (Solution)
• Intravenous, Intramuscular, Subcutaneous
|
Boehringer lngelheim Animal Health USA, Inc. | NADA 15030 | Approved | Jun 1, 2016 |
Data source: FDA Animal Drugs @ FDA (public search export).
What It's For (FDA Label Highlights)
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
Composition / specifications
As an aid in tranquilization and as a preanesthetic agent in dogs. Acepromazine Maleate Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures.
0.25 – 1.0 mg/lb of body weight. Dosage may be repeated as required.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
As an aid in tranquilization and as a preanesthetic agent in dogs. Acepromazine Maleate Tablets can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures.
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm059294.pdf
Summary
Dogs and Cats: Acepromazine Maleate Injection can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. Acepromazine Maleate Injection is particularly useful as a preanesthetic agent (1) to enhance and prolong the effects of barbiturates, thus reducing the requirements for general anesthesia; (2) as an adjunct to surgery under local anesthesia. Horses: Acepromazine Maleate Injection can be used as an aid in controlling fractious animals during examination, treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts.
FDA page: Open in Animal Drugs @ FDA
- PromAce® Tablets (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm061778.pdf
Summary
Dogs and Cats: Acepromazine Maleate Injection can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. Acepromazine Maleate Injection is particularly useful as a preanesthetic agent (1) to enhance and prolong the effects of barbiturates, thus reducing the requirements for general anesthesia; (2) as an adjunct to surgery under local anesthesia. Horses: Acepromazine Maleate Injection can be used as an aid in controlling fractious animals during examination, treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts.
FDA page: Open in Animal Drugs @ FDA
FDA page: Open in Animal Drugs @ FDA
- PromAce® Injectable (ZIP)
FDA page: Open in Animal Drugs @ FDA
Usage
PromAce Injectable can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. PromAce Injectable can be used as an aid in controlling fractious animals during examination,treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts. Used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray, and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antlemetic to control comiting associated with motion sickness.
Source: FDA Animal Drugs @ FDA • Reference
Contraindications
Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 26 and Cat 8 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Adverse Event Case Summaries (openFDA)
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, Retriever - Labrador, Male, 25 kilogram • Drug: MSK, Unknown, Dose: 0.25 mL per animal • Reactions: Death, Haematochezia, Diarrhea • Outcome: Euthanized
- Report ID: GBR-USFDACVM-2025-GB-000061
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Weight: 25.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Dose: 0.25 mL per animal
Dog, Shepherd Dog (unspecified), Female, 2 year, 29.846 kilogram • Drug: MSK, Solution, Unknown • Reactions: Arrhythmia, Sedation prolonged, Obtunded, Lateral recumbency, Tachycardia… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-044760
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 2.00 Year
- Weight: 29.846 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Solution
Cat, Domestic Shorthair, Male, 5 month, 3.493 kilogram • Drug: MSK, Intramuscular, Dose: 0.30 mL per animal • Reactions: Head bobbing, Hind limb ataxia, Laboured breathing, Tremors, Death by euthanasia • Outcome: Euthanized
- Report ID: USA-USFDACVM-2025-US-030289
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 5.00 Month
- Weight: 3.493 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Intramuscular
- Dose: 0.30 mL per animal
Dog, Pit Bull, Female, 7 year • Drug: MSK, Tablet • Reactions: Lack of efficacy - NOS • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-035578
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 7.00 Year
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Form: Tablet
Cat, Cat (unknown), Female • Drug: MSK, Solution, Unknown • Reactions: Death, Cardiac arrest • Outcome: Died
- Report ID: USA-USFDACVM-2025-US-030343
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Solution
Cat, Cat (unknown), Unknown • Drug: MSK, Solution, Unknown • Reactions: Cardiac arrest • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-027319
- Serious AE: Yes
- Treated For AE: No
- Sex: Unknown
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Solution
Dog, Dog (unknown), Unknown • Drug: MSK, Solution, Unknown • Reactions: Cardiac arrest • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-027317
- Serious AE: Yes
- Treated For AE: No
- Sex: Unknown
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Solution
Dog, Crossbred Canine/dog, Male, 12.5 year, 15.15 kilogram • Drug: MSK, Unknown • Reactions: Behavioral disorder (unspecified), Loss of appetite, Polydipsia, Falling, Unable to rise… • Outcome: Euthanized
- Report ID: USA-USFDACVM-2025-US-014361
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 12.50 Year
- Weight: 15.150 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
Storage & Handling
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
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Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.