Skip to main content
Start triage

Start triage first, then route to emergency care.

Start symptom intake Emergency vets near you

Need urgent help? Start triage first, then route to emergency care.

Start symptom intake Emergency vets near you

Roxee Medication Guide

Acepromazine Maleate

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Liquid (Solution) Multiple FDA sponsors Official label facts Owner quick guide first
Start Symptom Intake Talk to a Vet / Find a Vet Near You

Veterinary professional?

Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Jun 22, 2026, 10:42 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Image coming soon
Acepromazine Maleate

Acepromazine Maleate

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Liquid (Solution) Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Acepromazine Maleate

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. Species commonly shown: Both, Dog, Horse.

Generic name
Acepromazine Maleate
Brand names
Acepromazine Maleate Injection, Acepromazine Maleate Tablets
Manufacturer
Multiple FDA sponsors
Species
Both, Dog, Horse, Cat
Dosage forms
Liquid (Solution), Tablet
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
Acepromazine Maleate Injection Acepromazine Maleate Tablets
Dosage forms
Liquid (Solution) Tablet

Indications / Uses

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.

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.

  • 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

Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Death by euthanasia, Diarrhoea, Lack of efficacy - NOS.

FAQ

Both, Dog, Horse, Cat

Yes. Roxee shows this as prescription-only.

Liquid (Solution), Tablet

Source Transparency

Add to My Pet's Medications

Choose a pet, confirm current or past, and optionally add reminder notes.

Sign in to save this medication to your pet profile.

Sign in to continue

Videos

Video education and manufacturer materials for Acepromazine Maleate.

Educational Videos

Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

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...

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Loss of appetite (1 reports)
  • Lateral recumbency (1 reports)
  • Lack of efficacy - NOS (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or 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?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Acepromazine Maleate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-070682
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 29 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-070682
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-070682
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Loss of appetite (1 reports), Lateral recumbency (1 reports), Lack of efficacy - NOS (1 reports), Laboured breathing (1 reports), Injection site lump (1 reports)

Body systems represented Signal grouping

Digestive (2), Neurologic (1), Behavior (1), Effectiveness (1)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (16 reports), Cat (16 reports)

Breed metadata in reports Metadata only

Greyhound (1), ['Retriever - Golden', 'Poodle - Standard'] (1), Crossbred Canine/dog (1), Bulldog - French (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Acepromazine Maleate fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Loss of appetite, Lateral recumbency, Lack of efficacy - NOS

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Acepromazine Maleate brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-070682 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 15, 2026, 10:04 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Loss of appetite
  • Lateral recumbency
  • Lack of efficacy - NOS

Most reported reactions:

  • Loss of appetite (1 reports)
  • Lateral recumbency (1 reports)
  • Lack of efficacy - NOS (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Cat, Dog, Horse
Indication / use
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, treatm…
Form / route / dose
Form: Liquid (Solution), Tablet
Route: Intramuscular, Intravenous, Oral, Subcutaneous
Confirm product label and patient-specific plan.
Warnings
  • High: Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veter…
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA sponsors
Form: Liquid (Solution), Tablet
Identifiers:
ANADA: 200319 ANADA: 200361 ANADA: 200757 NADA: 135299 NADA: 15030 NADA: 32702 NDC Package: 0010-3827-01 NDC Package: 0010-6703-01 NDC Package: 0010-6703-02 NDC Package: 0010-6704-01 NDC Package: 0010-6704-02 NDC Package: 10695-181-10 NDC Package: 11695-0093-1 NDC Package: 11695-0093-5 NDC Package: 11695-0094-1 NDC Package: 11695-0094-5 NDC Package: 11695-0095-5 NDC Package: 11695-7033-1 NDC Package: 11695-7033-2 NDC Package: 11695-7034-1
Source metadata:

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.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
8
Matching reports
3
Active filters
2
Selected filters
Reaction: Unrelated death Clear Body system: Effectiveness Clear
Reset
Drill into common report signals
Lack of efficacy - NOS (4) Unrelated death (3) Abnormal cytology (1) Abnormal radiograph finding (1) Other (7) Effectiveness (4) Behavior (1) Digestive (1)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-075461

Received 2025-12-29 · MSK · MSK

Serious
Species
Dog
Breed
Greyhound
Size / weight
50-99 lb (27.3 Kilogram)
Age
8+ years (9 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy - NOSUnrelated death
Body systems
EffectivenessOther
Outcomes
Euthanized

USA-USFDACVM-2025-US-075440

Received 2025-12-29 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Golden', 'Poodle - Standard']
Size / weight
50-99 lb (25.5 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSUnrelated death
Body systems
EffectivenessOther
Outcomes
Euthanized

USA-USFDACVM-2025-US-075367

Received 2025-12-29 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (17.7 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSUnrelated death
Body systems
EffectivenessOther
Outcomes
Euthanized

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
29
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Diarrhea Neurologic (1) · Hind limb ataxia Behavior (1) · Behavioral disorder (unspecified) Effectiveness (1) · Lack of efficacy - NOS Other (27) · Lateral recumbency, Laboured breathing, Injection site lump
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Other 1 Dog 1
Effectiveness 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1

Species coverage: Dog (16) Cat (16)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Serious - 1
Other Dog Serious - 1
Effectiveness Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Neurologic Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Digestive Cat Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Behavior Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Acepromazine Maleate Tablets SPL · SPL Acepromazine Maleate Injection SPL · SPL Acepromazine Maleate Injection SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

3

FOI

3

Acepromazine Maleate Tablets

SPL · SPL

Open original
FDA Structured Product Label

Acepromazine Maleate Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
ZYVET AH, Inc.
ANADA
200-757
Status
RX
Form
Tablet
Route
Oral
Species
Dog
Composition / specifications
10 mg and 25 mg tablet sizes

Dogs

Indication

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.

Dosage

0.25 – 1.0 mg/lb of body weight. Dosage may be repeated as required.

Acepromazine Maleate Injection

SPL · SPL

Open original
FDA Structured Product Label

Acepromazine Maleate Injection

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Boehringer Ingelheim Animal Health USA Inc.
ANADA
200-361
Status
RX
Form
Liquid (Solution)
Route
Intramuscular, Intravenous, Subcutaneous
Species
Dog • Horse • Cat
Composition / specifications
Each milliliter of sterile aqueous solution contains 10 milligrams of acepromazine maleate.

Cats

Indication
It is used as a tranquilizer.
Dosage
0.5 to 1.0 milligram per pound of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dogs

Indication
It is used as a tranquilizer.
Dosage
0.25 to 0.5 milligram per pound of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Horses

Indication
It is used as a tranquilizer.
Dosage
2.0 to 4.0 milligrams per 100 pounds of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Acepromazine Maleate Injection

SPL · SPL

Open original
FDA Structured Product Label

Acepromazine Maleate Injection

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
ANADA
200-319
Status
RX
Form
Liquid (Solution)
Route
Subcutaneous, Intravenous, Intramuscular
Species
Dog • Horse • Cat
Composition / specifications
Each milliliter of sterile aqueous solution contains 10 milligrams of acepromazine maleate.

Dogs

Indication
It is used as a tranquilizer.
Dosage
0.25 to 0.5 milligram per pound of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication
It is used as a tranquilizer.
Dosage
0.5 to 1.0 milligram per pound of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Horses

Indication
It is used as a tranquilizer.
Dosage
2.0 to 4.0 milligrams per 100 pounds of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FOI Summary oA 200-757 Approved August 31, 2023.pdf

FOI · FOI

Open original

ucm059294.pdf

FOI · FOI

Open original

ucm061778.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

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.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 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.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog, Horse
Rx/OTC: RX
Form/route: Liquid (Solution), Tablet • Intramuscular, Intravenous, Oral, Subcutaneous
Applications: ANADA 200-757 • ANADA 200-361 • ANADA 200-319
Documents: 3 (FOI: 3) • SPL: 3 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 9 • Cat 17 • View
Case summaries: 8 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Diagnosis Codes

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.

Owner-facing counseling points
  • 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)
Top reaction signals
Loss of appetite (1) Lateral recumbency (1) Lack of efficacy - NOS (1) Laboured breathing (1) Injection site lump (1) Increased respiratory rate (1) Increased heart rate (1) Hypothermia (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200319 ANADA: 200361 ANADA: 200757 NADA: 135299 NADA: 15030 NADA: 32702 NDC Package: 0010-3827-01 NDC Package: 0010-6703-01 NDC Package: 0010-6703-02 NDC Package: 0010-6704-01 NDC Package: 0010-6704-02 NDC Package: 10695-181-10 NDC Package: 11695-0093-1 NDC Package: 11695-0093-5 NDC Package: 11695-0094-1 NDC Package: 11695-0094-5 NDC Package: 11695-0095-5 NDC Package: 11695-7033-1 NDC Package: 11695-7033-2 NDC Package: 11695-7034-1 NDC Package: 11695-7034-2 NDC Package: 13985-582-25 NDC Package: 13985-582-50 NDC Package: 13985-583-10
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.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 13 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • 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. (Clinical, 2026-04-16)
  • 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. (Clinical, 2026-04-15)
  • 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. (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Death by euthanasia, Diarrhoea, Lac… (Clinical, 2026-04-11)
  • 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… (Clinical, 2026-04-16)
  • 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… (Clinical, 2026-04-15)
  • 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… (Clinical, 2026-04-11)
  • 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, 2026-04-22)
  • 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, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Death by euthanasia, Diarrhoea, Lac… (Official, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death, Death by euthanasia, Diarrhoea, Lac… (Official, 2026-04-15)
  • 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, 2026-04-22)
  • usage: Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. (Official, 2026-04-16)
  • usage: Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. (Official, 2026-04-16)
  • 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)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 13:28 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 13:28 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 13:28 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 13:28 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 13:28 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 13:28 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-16 10:08 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 10:08 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 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
Label highlights
Official documents
ZYVET AH, Inc. ANADA 200-757 Approved Sep 1, 2023
Acepromazine Maleate Injection
RX
Acepromazine Maleate
Liquid (Solution) • Intramuscular, Intravenous, Subcutaneous
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA Inc. ANADA 200-361 W May 3, 2023
Acepromazine Maleate Injection
RX
Acepromazine Maleate
Liquid (Solution) • Subcutaneous, Intravenous, Intramuscular
Label highlights
Official documents
Elanco US Inc. ANADA 200-319 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.

Species: Dog
Composition / specifications
10 mg and 25 mg tablet sizes
Dogs
Indication

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.

Dosage

0.25 – 1.0 mg/lb of body weight. Dosage may be repeated as required.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Horse • Cat
Composition / specifications
Each milliliter of sterile aqueous solution contains 10 milligrams of acepromazine maleate.
Cats
Indication
It is used as a tranquilizer.
Dosage
0.5 to 1.0 milligram per pound of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dogs
Indication
It is used as a tranquilizer.
Dosage
0.25 to 0.5 milligram per pound of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Horses
Indication
It is used as a tranquilizer.
Dosage
2.0 to 4.0 milligrams per 100 pounds of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog • Horse • Cat
Composition / specifications
Each milliliter of sterile aqueous solution contains 10 milligrams of acepromazine maleate.
Dogs
Indication
It is used as a tranquilizer.
Dosage
0.25 to 0.5 milligram per pound of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cats
Indication
It is used as a tranquilizer.
Dosage
0.5 to 1.0 milligram per pound of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Horses
Indication
It is used as a tranquilizer.
Dosage
2.0 to 4.0 milligrams per 100 pounds of body weight. The drug is administered intravenously, intramuscularly or subcutaneously with the dosage individualized depending upon the degree of tranquilization required.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Dog Diarrhea (1) • Cat

Showing top 5 for Digestive.

Neurologic
Hind limb ataxia (1) • Cat

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Effectiveness
Lack of efficacy - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other
Lateral recumbency (1) • Dog Laboured breathing (1) • Cat Injection site lump (1) • Cat Increased respiratory rate (1) • Cat Increased heart rate (1) • Cat
Show more (22)
Inappropriate urination (1) • Cat Inappropriate defecation (1) • Cat Hypothermia (1) • Dog Hissing (1) • Cat Head bobbing (1) • Cat Haematochezia (1) • Dog Gingivitis (1) • Cat Fibrosarcoma (1) • Cat Falling (1) • Dog Decreased activity (1) • Cat Death by euthanasia (1) • Dog Death (1) • Dog Cyanosis (1) • Dog Cardiac arrest (1) • Dog Bradycardia (1) • Dog Arrhythmia (1) • Dog Apnoea (1) • Dog Angioedema (1) • Dog Anaphylaxis (1) • Dog Anaemia NOS (1) • Dog Abnormal radiograph finding (1) • Cat Abnormal cytology (1) • Cat

Showing top 5 for Other.

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, Greyhound, Female, 9 year, 27.3 kilogram • Drug: MSK, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-075461
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 9.00 Year
  • Weight: 27.300 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
Reactions Reported:
Lack of efficacy - NOS Unrelated death
Outcomes: Euthanized

Dog, ['Retriever - Golden', 'Poodle - Standard'], Male, 5 year, 25.5 kilogram • Drug: MSK, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-075440
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 25.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
Reactions Reported:
Lack of efficacy - NOS Unrelated death
Outcomes: Euthanized

Dog, Crossbred Canine/dog, Male, 14 year, 17.7 kilogram • Drug: MSK, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-075367
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 17.700 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
Reactions Reported:
Lack of efficacy - NOS Unrelated death
Outcomes: Euthanized

Dog, Bulldog - French, Female, 8 year, 12.927 kilogram • Drug: MSK, Injection, solution, Intramuscular, Dose: 0.03 mL per animal • Reactions: Tachycardia, Apnoea, Cyanosis, Cardiac arrest, Death… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-073109
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 12.927 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Form: Injection, solution
  • Dose: 0.03 mL per animal
Reactions Reported:
Tachycardia Apnoea Cyanosis Cardiac arrest Death Angioedema
Outcomes: Died

Cat, Domestic Shorthair, Male, 2 year, 4.536 kilogram • Drug: MSK, Injection, solution, Unknown • Reactions: Seizure NOS, Death by euthanasia • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-072459
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection, solution
Reactions Reported:
Seizure NOS Death by euthanasia
Outcomes: Euthanized

Dog, Spitz - German Pomeranian, Male, 10 year, 3.221 kilogram • Drug: MSK, Unknown • Reactions: Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-070754
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 3.221 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Vomiting
Outcomes: Recovered/Normal

Cat, Domestic Mediumhair, Female, 6.08 year, 4.82 kilogram • Drug: MSK, Intramuscular, Dose: 1 Milligram per ml • Reactions: Fibrosarcoma, Decreased activity, Hissing, Injection site lump, Behavioral disorder (unspecified)… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-070682
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.08 Year
  • Weight: 4.820 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Dose: 1 Milligram per ml
Reactions Reported:
Fibrosarcoma Decreased activity Hissing Injection site lump Behavioral disorder (unspecified) Tooth disorder Gingivitis Neoplasia NOS Leucocytosis NOS Skin inflammation NOS Abnormal radiograph finding Abnormal cytology
Outcomes: Outcome Unknown

Cat, Cat (unknown), Mixed, 4 month, 1.09 kilogram • Drug: MSK, Intramuscular, Dose: 0.05 Milligram per kilogram • Reactions: Increased heart rate, Increased respiratory rate, Lack of efficacy - NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-070955
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Mixed
  • Age: 4.00 Month
  • Weight: 1.090 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intramuscular
  • Dose: 0.05 Milligram per kilogram
Reactions Reported:
Increased heart rate Increased respiratory rate Lack of efficacy - NOS
Outcomes: Recovered/Normal

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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.