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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: Dog
Manufacturer: Multiple FDA labelers
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Inodilator used for certain forms of canine heart failure (e.g., myxomatous mitral valve disease, dilated cardiomyopathy). Species commonly shown: Dog.
Inodilator used for certain forms of canine heart failure (e.g., myxomatous mitral valve disease, dilated cardiomyopathy).
Oral
Store at room temperature.
Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance).
GI upset, increased heart rate, lethargy.
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Used for:
For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for co...
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:
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 Pimobendan; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 22 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.
Loss of appetite (1 reports), Electrolyte disorder (1 reports), Ear twitching (1 reports), Dull reflexes (1 reports), Dry coat (1 reports)
Digestive (3), Skin & allergy (1), Neurologic (2), Behavior (2)
Dog (23 reports), Cat (9 reports)
Retriever - Labrador (2), Spaniel - King Charles Cavalier (1), Schnauzer (unspecified) (1), Setter (unspecified) (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Pimobendan 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.
Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guid, Loss of appetite, Electrolyte disorder, Ear twitching
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, 7:40 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.
Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance).
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 2026-03-24 · MSK · MSK
Received 2026-03-13 · MSK · MSK
Received 2026-01-17 · MSK · MSK
Received 2026-01-16 · MSK · MSK
Received 2025-12-18 · MSK · MSK
Received 2025-12-17 · MSK · MSK
Received 2025-12-09 · MSK · MSK
Received 2025-12-03 · MSK · MSK
Received 2025-12-02 · MSK · MSK
Received 2025-11-25 · MSK · MSK
Received 2025-11-24 · MSK · MSK
Received 2025-11-03 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Skin & allergy | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Digestive | 1 | Cat | 1 |
Species coverage: Dog (23) Cat (9)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Neurologic | Dog | Non-serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Skin & allergy | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Neurologic | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Behavior | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 |
Store at room temperature.
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.
For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
Administer orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into 2 portions that are not necessarily equal, and the portions should be administered approximately 12 hours apart (i.e., morning and evening).
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.
Vetmedin® is indicated for the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease. Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly.
For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
Administer orally at a total daily dose of 0.23 mg/lb. (0.5 mg/kg) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into 2 portions that are not necessarily equal, and the portions should be administered approximately 12 hours apart (i.e., morning and evening). The tablets are scored, and the calculated dosage should be provided to the nearest half tablet increment.
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.
For the delay of onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). Stage B2 preclinical MMVD refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly.
For the management of the signs of mild, moderate, or severe CHF in dogs due to clinical MMVD or dilated cardiomyopathy (DCM). For use with concurrent therapy for CHF (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
Administer orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight. The total daily dose should be divided into 2 equal portions administered approximately 12 hours apart (i.e., morning and evening).
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
SPL · Structured Product Label
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
FOI · FOI
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 |
|---|---|---|---|
| 0010-4131-01 | 0010 | - | |
| 0010-4479-01 | 0010 | - | |
| 0010-4480-01 | 0010 | - | |
| 0010-4481-01 | 0010 | - | |
| 0010-4482-01 | 0010 | - | |
| 0010-4610-01 | 0010 | - | |
| 0010-4612-01 | 0010 | - | |
| 11695-7058-1 | 11695 | - | |
| 11695-7059-1 | 11695 | - | |
| 11695-7060-1 | 11695 | - | |
| 11695-7061-1 | 11695 | - | |
| 13612-0034-0 | 13612 | - | |
| 13612-0034-1 | 13612 | - | |
| 46066-252-31 | 46066 | - | |
| 46066-253-31 | 46066 | - | |
| 46066-254-31 | 46066 | - | |
| 46066-255-31 | 46066 | - | |
| 46144-606-01 | 46144 | - | |
| 49452-5072-1 | 49452 | - | |
| 49452-5072-2 | 49452 | - |
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 |
|---|---|---|---|---|
|
Pimobendan Chewable Tablets
RX
Pimobendan
Chewable Tablets
• Oral
|
Cronus Pharma Specialities India Private Ltd. | ANADA 200-728 | Approved | May 12, 2026 |
|
Vetmedin®
RX
Pimobendan
Tablet (Chewable)
• Oral
|
Boehringer Ingelheim Animal Health USA, Inc. | NADA 141-273 | Approved | Mar 10, 2026 |
|
Vetmedin® Solution
RX
Pimobendan
Solution
• Oral
|
Boehringer Ingelheim Animal Health USA, Inc. | NADA 141-575 | Approved | Feb 2, 2026 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
Administer orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into 2 portions that are not necessarily equal, and the portions should be administered approximately 12 hours apart (i.e., morning and evening).
FDA page: Open in Animal Drugs @ FDA
Vetmedin® is indicated for the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease. Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly.
For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
Administer orally at a total daily dose of 0.23 mg/lb. (0.5 mg/kg) body weight, using a suitable combination of whole or half tablets. The total daily dose should be divided into 2 portions that are not necessarily equal, and the portions should be administered approximately 12 hours apart (i.e., morning and evening). The tablets are scored, and the calculated dosage should be provided to the nearest half tablet increment.
FDA page: Open in Animal Drugs @ FDA
For the delay of onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD). Stage B2 preclinical MMVD refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly.
For the management of the signs of mild, moderate, or severe CHF in dogs due to clinical MMVD or dilated cardiomyopathy (DCM). For use with concurrent therapy for CHF (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
Administer orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight. The total daily dose should be divided into 2 equal portions administered approximately 12 hours apart (i.e., morning and evening).
FDA page: Open in Animal Drugs @ FDA
Inodilator used for certain forms of canine heart failure (e.g., myxomatous mitral valve disease, dilated cardiomyopathy).
Source: FDA Animal Drugs @ FDA • Reference
Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance).
GI upset, increased heart rate, lethargy.
Source: FDA openFDA • Reference
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 - King Charles Cavalier, Female, 7 year, 9.48 kilogram • Drug: MSK, Unassigned, Oral, Frequency: 12 per hour • Reactions: Cyanosis, Respiratory arrest, Premature ventricular contractions, Death • Outcome: Died
Dog, Schnauzer (unspecified), Male, 13.3 year, 4.45 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Diarrhea, Tense abdomen, Elevated serum alkaline phosphatase, Elevated alanine aminotransferase… • Outcome: Ongoing
Dog, Setter (unspecified), Male, 14 year, 27.2 kilogram • Drug: MSK, Unknown, Frequency: 1 per day • Reactions: Death, Breathing difficulty, Weight loss • Outcome: Died
Dog, Maltese, Female, 16 year, 4.536 kilogram • Drug: MSK, Unknown • Reactions: Seizure NOS • Outcome: Outcome Unknown
Dog, Chihuahua, Female, 12 year, 7.938 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 0.32 Milligram per kilogram, Frequency: 12 per hour • Reactions: Abnormal breathing, Heart pounding, Head tilt - neurological disorder, Other ear disorder NOS, Eye disorder NOS • Outcome: Recovered/Normal
Dog, Retriever - Labrador, Female, 14 year, 22.861 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Lack of efficacy (endoparasite) - hookworm, Urinary tract infection • Outcome: Ongoing
Dog, Retriever - Labrador, Male, 13 year, 23.088 kilogram • Drug: MSK, Unknown • Reactions: Unsteady walking (ataxia), Generalised weakness, Proprioception deficit • Outcome: Ongoing
Dog, Dachshund (unspecified), Female, 12 year, 7.62 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Vomiting, Lack of efficacy - NOS • Outcome: Recovered/Normal
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose may lead to severe tachycardia, hypotension, arrhythmias, or collapse. Supportive and critical care is recommended.
Store at room temperature.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.