USA-USFDACVM-2026-US-008729
Received 2026-02-20 · MSK · MSK
- 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
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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: AX Pharmaceutical Corp
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs. Species commonly shown: Both, Dog.
Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.
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): Diarrhoea, Vomiting, Lethargy (see also Central nervous system depression in 'Neurological'), Death by euthanasia, Seizure NOS, Anorexia.
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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:
When to call the vet:
Regulatory restrictions are shown in Vet View.
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Enalapril; use the official documents and your veterinarian's instructions for product-specific decisions.
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.
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.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
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.
Unsteady walking (ataxia) (1 reports), Trouble breathing (dyspnea) (1 reports), Elevated renal parameters (1 reports), Elevated globulins (1 reports), Elevated creatinine (1 reports)
Digestive (3), Skin & allergy (1), Neurologic (1), Behavior (2)
Cat (17 reports), Dog (15 reports)
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.
Verify whether Enalapril fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
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
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: February 12, 2026, 10:44 PM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
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.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2026-02-20 · MSK · MSK
Received 2026-01-12 · MSK · MSK
Received 2025-12-02 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| 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)
| 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 |
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.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
SPL · Structured Product Label
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Diagnosis-code mappings are not available for this medication yet.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 73377-124-02 | 73377 | - | |
| 73377-124-03 | 73377 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
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).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
FDA page: Open in Animal Drugs @ FDA
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
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.
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
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
Dog, Terrier - Rat, Female, 16 year, 6.441 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Low platelet count • Outcome: 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
Dog, Shih Tzu, Female, 12 year, 6.532 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting • Outcome: 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
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
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
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
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.