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Roxee Medication Guide

Enalapril

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 Tablet AX Pharmaceutical Corp Official label facts Owner quick guide first

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

Data freshness

Reference facts
Reference refreshed
Aug 6, 2026, 7:47 p.m.

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

FDA applications
FDA application data refreshed
Aug 6, 2026, 7:47 p.m.

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

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.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 Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM 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 Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Enalapril

Enalapril

Drug type: Generic ingredient • Branded profile FDA branded products available

Both Tablet Rx required 100% reference complete

Species: Both

Manufacturer: AX Pharmaceutical Corp

Medication Snapshot

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

Enalapril

Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs. Species commonly shown: Both, Dog.

Generic name
Enalapril
Brand names
Enacard® Tablets For Dogs, Enalapril Maleate
Manufacturer
AX Pharmaceutical Corp
Species
Both, Dog
Dosage forms
Tablet
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Enacard® Tablets For Dogs Enalapril Maleate
Dosage forms
Tablet

Indications / Uses

Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.

Warnings / Contraindications

Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

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

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Tablet

Related Conditions

Source Transparency

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Pet Owner Quick Guide

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

Used for:

Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.

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:

  • Use 0.5 milligram per kilogram once daily
  • In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram)
  • Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease
  • The safety of enalapril for use in breeding dogs has not been established
  • Use in pregnant bitches is not recommended
  • wobbly/unsteady walking (1 reports)
  • trouble breathing (1 reports)
  • Elevated renal parameters (1 reports)

When to call the vet:

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

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 Enalapril; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-045457
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 27 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-045457
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-045457
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

Unsteady walking (ataxia) (1 reports), Trouble breathing (dyspnea) (1 reports), Elevated renal parameters (1 reports), Elevated globulins (1 reports), Elevated creatinine (1 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (1), Neurologic (1), Behavior (2)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (17 reports), Dog (15 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (3), Spaniel (unspecified) (1), Terrier - Rat (1), Crossbred Canine/dog (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 Enalapril 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

Use 0.5 milligram per kilogram once daily, In the absence of adequate clinical response within a 2-week period, use may be increased to twice d, Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatmen, The safety of enalapril for use in breeding dogs has not been established, Use in pregnant bitches is not recommended

Call sooner if Escalation

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

Bottom line: Use this Enalapril 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-045457 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. Medication usage source · fda_animal_drugs · quick facts
  5. SPL · document · documents
  6. Structured Product Label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Use 0.5 milligram per kilogram once daily
  • In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram)
  • Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease
  • The safety of enalapril for use in breeding dogs has not been established
  • Use in pregnant bitches is not recommended

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Trouble breathing (dyspnea) (1 reports)
  • Elevated renal parameters (1 reports)
Explore reported case details

Emergency warning signs:

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

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.
Form / route / dose
Form: Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may…
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.

Quick Facts

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

Species: Both
Manufacturer: AX Pharmaceutical Corp
Form: Tablet
Identifiers:
NADA: 141015 NDC Package: 73377-124-02 NDC Package: 73377-124-03 NDC Product: 73377
Source metadata:

Warnings / Contraindications

Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. 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
21
Matching reports
21
Active filters
0
Reset
Showing up to 50 matching reports.

USA-USFDACVM-2026-US-011644

Received 2026-03-10 · MSK · MSK

Non-serious
Species
Dog
Breed
Spaniel (unspecified)
Size / weight
25-49 lb (11.476 Kilogram)
Age
8+ years (12 Year)
Sex
Male Neutered
Region
USA
Reactions
TremblingAtaxia
Body systems
OtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2026-US-010351

Received 2026-03-03 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Rat
Size / weight
10-24 lb (6.441 Kilogram)
Age
8+ years (16 Year)
Sex
Female Unknown
Region
USA
Reactions
Low platelet count
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-011033

Received 2026-03-02 · MSK · MSK

Serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
10-24 lb (9.34 Kilogram)
Age
8+ years (11.2 Year)
Sex
Male Neutered
Region
USA
Reactions
CataractEnlarged lymph node (localised)Mass NOSLipaemiaLow sodium-potassium ratio (Na:K ratio)Electrolyte disorder
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-008729

Received 2026-02-20 · MSK · MSK

Serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (6.532 Kilogram)
Age
8+ years (12 Year)
Sex
Female Unknown
Region
USA
Reactions
Vomiting
Body systems
Digestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-007113

Received 2026-02-18 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Yorkshire
Size / weight
10-24 lb (4.59 Kilogram)
Age
8+ years (14 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy (bacteria) - BorreliaProteinuriaAcidic urine
Body systems
EffectivenessOther
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-007943

Received 2026-02-02 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.221 Kilogram)
Age
8+ years (13 Year)
Sex
Male Neutered
Region
USA
Reactions
Pemphigus foliaceus
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-003559

Received 2026-01-22 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.99 Kilogram)
Age
8+ years (15 Year)
Sex
Female Neutered
Region
USA
Reactions
HypertensionConstipation
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-003666

Received 2026-01-14 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.59 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Pulmonary neoplasmIncreased lung soundsTachypnoeaLaboured breathingWeak pulseCrackles on auscultationDeath by euthanasiaAbnormal ultrasound findingHaemorrhage NOS
Body systems
Other
Outcomes
Euthanized

USA-USFDACVM-2026-US-004182

Received 2026-01-12 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.1 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
VomitingWeight gain
Body systems
DigestiveOther
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-072177

Received 2025-12-08 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Yorkshire
Size / weight
Under 10 lb (2.8 Kilogram)
Age
8+ years (13.5 Year)
Sex
Female Neutered
Region
USA
Reactions
Pale mucous membraneLaboured breathingIncreased respiratory rateCrackles on auscultationProlonged capillary refill timeOther abnormal test result NOS
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-071646

Received 2025-12-04 · MSK · MSK

Serious
Species
Dog
Breed
['Collie - Border', 'Dog (unknown)']
Size / weight
25-49 lb (20.321 Kilogram)
Age
8+ years (14 Year)
Sex
Female Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)GrowlingBiting -aggression (see also Skin and appendages disorders)Not himself/herselfPacingCoughEmesis (multiple)RegurgitationWeaknessAtaxiaNot eatingElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)Elevated renal parametersHyperphosphataemiaUnable to walk
Body systems
NeurologicOtherBehaviorDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-074767

Received 2025-12-02 · MSK · MSK

Non-serious
Species
Dog
Breed
Shepherd Dog - Australian
Size / weight
25-49 lb (11.79 Kilogram)
Age
8+ years (12.92 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)InappetenceElevated blood urea nitrogen (BUN)Vomiting
Body systems
NeurologicOtherDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-075069

Received 2025-12-01 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Boston
Size / weight
10-24 lb (9.163 Kilogram)
Age
8+ years (12 Year)
Sex
Female Neutered
Region
USA
Reactions
Head tremor
Body systems
Neurologic
Outcomes
Ongoing

USA-USFDACVM-2025-US-073558

Received 2025-11-27 · MSK · MSK

Non-serious
Species
Dog
Breed
Chihuahua
Size / weight
10-24 lb (4.99 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
Limb weaknessProprioception abnormality
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-072103

Received 2025-11-26 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (7.66 Kilogram)
Age
8+ years (13.1 Year)
Sex
Male Neutered
Region
USA
Reactions
Dry coatDull reflexesElevated blood urea nitrogen (BUN)Elevated creatinineHyperphosphataemiaHypokalaemiaHypertrophic concentric cardiomyopathyDecreased haematocritSyncopeHypertension
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-073427

Received 2025-11-25 · MSK · MSK

Serious
Species
Dog
Breed
Dachshund - Miniature
Size / weight
10-24 lb (7.167 Kilogram)
Age
8+ years (15 Year)
Sex
Male Intact
Region
USA
Reactions
Elevated globulinsLeucocytosis NOSNeutrophiliaMonocytosisSeizure NOS
Body systems
OtherNeurologic
Outcomes
Ongoing

USA-USFDACVM-2025-US-069860

Received 2025-11-12 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.1 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
Loose stool
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-071041

Received 2025-11-11 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.99 Kilogram)
Age
8+ years (15 Year)
Sex
Female Neutered
Region
USA
Reactions
VocalisationRestlessnessPacing
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-068187

Received 2025-11-03 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.1 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
Hypersalivation
Body systems
Digestive
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-066492

Received 2025-10-27 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (7 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
Biting - pruritus (see also Behavioural disorders)ItchingHot spot (pyotraumatic dermatitis)
Body systems
Skin & allergyOther
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-065173

Received 2025-10-27 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.175 Kilogram)
Age
8+ years (13 Year)
Sex
Male Neutered
Region
USA
Reactions
Anaemia NOSWeight loss
Body systems
Other
Outcomes
Outcome Unknown

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

Tracked signals
32
Reported cases
32
Serious reports
27
Species represented
2
Grouped by Body System
Digestive (3) · Diarrhea, Decreased appetite, Appetite disorder NOS Skin & allergy (1) · Biting - pruritus Neurologic (1) · Unsteady walking (ataxia) Behavior (2) · Biting -aggression, Behavioral disorder (unspecified) Other (25) · Trouble breathing (dyspnea), Elevated renal parameters, Elevated globulins
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Cat (17) Dog (15)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Digestive Dog Serious - 1
Other Cat Serious - 1
Digestive Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Behavior Dog Serious - 1
Skin & allergy Cat Non-serious - 1
Behavior Dog Serious - 1
Digestive Dog Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Non-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.

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

2

FOI

0
No FOI links yet.

Enacard® Tablets For Dogs

SPL · SPL

FDA Structured Product Label

Enacard® Tablets For Dogs

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.
NADA
141-015
Status
RX
Form
Tablet
Route
Oral
Species
Dog
Composition / specifications
Each tablet contains either 1.0, 2.5, 5.0, 10.0, or 20.0 milligrams of enalapril maleate.

Dogs

Indication
Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.
Dosage
0.5 to 1.0 milligram of enalapril maleate per kilogram of body weight per day.
Limitations
Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Enalapril Maleate SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enalapril Maleate. Use the source link for the full official labeling record.
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 Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM 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 Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Enalapril Maleate
Manufacturer mapping: AX Pharmaceutical Corp
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Tablet Oral
Applications: NADA 141-015
NDC: Packages 73377-124-02 73377-124-03 Products 73377
Documents: • SPL: 1 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 44 Cat 33 View
Case summaries: 21 (showing 8) View
openFDA reports are unverified and do not prove causation.

Explore
Related conditions: Dilated cardiomyopathy (dogs)
Linked using: Fda_Label (0.95)

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
  • Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Trouble breathing (dyspnea) (1) Elevated renal parameters (1) Elevated globulins (1) Elevated creatinine (1) Elevated alanine aminotransferase (1) Electrolyte disorder (1) Dull reflexes (1)

Identifiers & Packages

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

Identifiers
NADA: 141015 NDC Package: 73377-124-02 NDC Package: 73377-124-03 NDC Product: 73377
Package NDC Product NDC Form / Route Status
73377-124-02 73377 -
73377-124-03 73377 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • Enalapril Maleate SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.

Data Sources & Change Log

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

Official 113 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Diarrhoea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death by euthanasia, Seizure NO… (Clinical, 2026-04-11)
  • contraindications: Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of… (Official, 2026-04-12)
  • contraindications: Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of… (Official, 2026-04-11)
  • contraindications: Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of… (Official, 2026-02-12)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-08-06)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-08-05)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-08-04)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-08-03)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-08-02)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-08-01)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-31)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-30)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-29)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-28)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-27)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-26)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-25)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-25)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-22)
  • manufacturer_name: AX Pharmaceutical Corp (Official, 2026-07-22)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • 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
Enacard® Tablets For Dogs
RX
Enalapril Maleate
Tablet Oral
Boehringer Ingelheim Animal Health USA Inc. NADA 141-015 W May 15, 2024

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
Each tablet contains either 1.0, 2.5, 5.0, 10.0, or 20.0 milligrams of enalapril maleate.
Dogs
Indication
Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.
Dosage
0.5 to 1.0 milligram of enalapril maleate per kilogram of body weight per day.
Limitations
Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. 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
Diarrhea (1) • Dog Decreased appetite (1) • Cat Appetite disorder NOS (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Biting - pruritus (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Dog Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
Trouble breathing (1) • Cat Elevated renal parameters (1) • Dog Elevated globulins (1) • Dog Elevated creatinine (1) • Cat Elevated blood urea nitrogen (1) • Dog
Show more (20)
Elevated alanine aminotransferase (1) • Dog Electrolyte disorder (1) • Dog Dull reflexes (1) • Cat Dry coat (1) • Cat Disorientation (1) • Cat Decreased haematocrit (1) • Cat Death by euthanasia (1) • Cat Crackles on auscultation (1) • Cat Cough (1) • Dog Constipation (1) • Cat Congestive heart failure (1) • Cat Cognitive disorder NOS (1) • Dog Cataract (1) • Dog Bronchitis (1) • Dog Anaemia NOS (1) • Cat Administration error NOS (1) • Cat Acidic urine (1) • Dog Abnormal ultrasound finding (1) • Cat Abnormal posture NOS (1) • Cat Abnormal echocardiogram (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, Spaniel (unspecified), Male, 12 year, 11.476 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Trembling, Unsteady walking (ataxia) • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-011644
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 11.476 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Trembling Unsteady walking (ataxia)
Outcomes: Ongoing

Dog, Terrier - Rat, Female, 16 year, 6.441 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Low platelet count • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-010351
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 16.00 Year
  • Weight: 6.441 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Low platelet count
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Male, 11.2 year, 9.34 kilogram • Drug: MSK, Unassigned, Oral, Dose: 5 Milligram per animal, Frequency: 12 per hour • Reactions: Cataract, Enlarged lymph node, Mass NOS, Lipaemia, Low sodium-potassium ratio… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-011033
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 11.20 Year
  • Weight: 9.340 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
  • Dose: 5 Milligram per animal
  • Frequency: 12 per hour
Reactions Reported:
Cataract Enlarged lymph node Mass NOS Lipaemia Low sodium-potassium ratio Electrolyte disorder
Outcomes: Ongoing

Dog, Shih Tzu, Female, 12 year, 6.532 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-008729
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 6.532 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Vomiting
Outcomes: Recovered/Normal

Dog, Terrier - Yorkshire, Female, 14 year, 4.59 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (bacteria) - Borrelia, Proteinuria, Acidic urine • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-007113
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 14.00 Year
  • Weight: 4.590 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (bacteria) - Borrelia Proteinuria Acidic urine
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 13 year, 3.221 kilogram • Drug: MSK, Oral, Dose: 1.25 Milligram per animal, Frequency: 1 per day • Reactions: Pemphigus foliaceus • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-007943
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 3.221 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Dose: 1.25 Milligram per animal
  • Frequency: 1 per day
Reactions Reported:
Pemphigus foliaceus
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 15 year, 4.99 kilogram • Drug: MSK, Transdermal, Dose: 2.50 Milligram per dose, Frequency: 12 per hour • Reactions: Hypertension, Constipation • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-003559
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 15.00 Year
  • Weight: 4.990 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Transdermal
  • Dose: 2.50 Milligram per dose
  • Frequency: 12 per hour
Reactions Reported:
Hypertension Constipation
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 9 year, 4.59 kilogram • Drug: MSK, Oral, Dose: 1.25 Milligram per animal, Frequency: 1 per day • Reactions: Pulmonary neoplasm, Increased lung sounds, Tachypnoea, Laboured breathing, Weak pulse… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2026-US-003666
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 4.590 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Dose: 1.25 Milligram per animal
  • Frequency: 1 per day
Reactions Reported:
Pulmonary neoplasm Increased lung sounds Tachypnoea Laboured breathing Weak pulse Crackles on auscultation Death by euthanasia Abnormal ultrasound finding Haemorrhage NOS
Outcomes: Euthanized

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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