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Roxee Medication Guide

Pimobendan

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

Dog Reference complete FDA data linked Rx required Solution Multiple FDA labelers Official label facts Owner quick guide first
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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, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • 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
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Pimobendan

Pimobendan

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

Dog Solution Rx required 100% reference complete

Species: Dog

Manufacturer: Multiple FDA labelers

Medication Snapshot

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

Pimobendan

Inodilator used for certain forms of canine heart failure (e.g., myxomatous mitral valve disease, dilated cardiomyopathy). Species commonly shown: Dog.

Generic name
Pimobendan
Brand names
Vetmedin®, Vetmedin® Solution, Pimobendan Chewable Tablets, Pimobendan
Manufacturer
Multiple FDA labelers
Species
Dog
Dosage forms
Solution, Tablet (Chewable), Chewable Tablets
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Vetmedin® Vetmedin® Solution Pimobendan Chewable Tablets Pimobendan AX Pharmaceutical Corp Vetmedin SolutitionKits Pimobendan CaniBendan Vetmedin Solution
Dosage forms
Solution Tablet (Chewable) Chewable Tablets

Indications / Uses

Inodilator used for certain forms of canine heart failure (e.g., myxomatous mitral valve disease, dilated cardiomyopathy).

Administration / How To Give

Oral

Storage

Store at room temperature.

Warnings / Contraindications

Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance).

  • Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance).

Side Effects

GI upset, increased heart rate, lethargy.

FAQ

Dog

Yes. Roxee shows this as prescription-only.

Solution, Tablet (Chewable), Chewable Tablets

Store at room temperature.

Related Medications

Furosemide Same category: Heart Ivermectin Same category: Heart Phenobarbital Same category: Deworming Cephalexin Same category: Heart Imidacloprid Same category: Heart Ivermectin, Pyrantel Same category: Heart

Related Conditions

Congestive heart failure Dilated cardiomyopathy (dogs)

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:

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:

  • Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance)
  • General illness (1 reports)
  • Found dead (1 reports)
  • Focal seizure (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.

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

Source: openFDA case USA-USFDACVM-2025-US-072512
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 26 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-072512
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-072512
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

General illness (1 reports), Found dead (1 reports), Focal seizure (1 reports), Elevated temperature (1 reports), Elevated renal parameters (1 reports)

Body systems represented Signal grouping

Digestive (4), Skin & allergy (1), Neurologic (3), Behavior (2)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (17 reports), Cat (15 reports)

Breed metadata in reports Metadata only

Crossbred Canine/dog (3), Chihuahua (1), ['Beagle', 'Schnauzer (unspecified)'] (1), Cat (other) (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 Pimobendan 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

Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guid, General illness, Found dead, Focal seizure

Call sooner if Escalation

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

Bottom line: Use this Pimobendan 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-072512 · 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: February 12, 2026, 7:40 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance)
  • General illness
  • Found dead
  • Focal seizure

Most reported reactions:

  • General illness (1 reports)
  • Found dead (1 reports)
  • Focal seizure (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
Dog
Indication / use
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…
Form / route / dose
Form: Chewable Tablets, Solution, Tablet (Chewable)
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance).
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: Dog
Manufacturer: Multiple FDA labelers
Form: Chewable Tablets, Solution, Tablet (Chewable)
Identifiers:
ANADA: 200728 NADA: 141273 NADA: 141575 NDC Package: 0010-4131-01 NDC Package: 0010-4479-01 NDC Package: 0010-4480-01 NDC Package: 0010-4481-01 NDC Package: 0010-4482-01 NDC Package: 0010-4610-01 NDC Package: 0010-4612-01 NDC Package: 11695-7058-1 NDC Package: 11695-7059-1 NDC Package: 11695-7060-1 NDC Package: 11695-7061-1 NDC Package: 13612-0034-0 NDC Package: 13612-0034-1 NDC Package: 46066-252-31 NDC Package: 46066-253-31 NDC Package: 46066-254-31 NDC Package: 46066-255-31
Source metadata:

Warnings / Contraindications

Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance).

  • High: Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance).
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
0
Active filters
2
Selected filters
Reaction: Circling - neurological disorder (see also Behavioural disorders) Clear Body system: Behavior Clear
Reset
Drill into common report signals
Vomiting (5) Lethargy (see also Central nervous system depression in Neurological) (4) Death (3) Circling - neurological disorder (see also Behavioural disorders) (2) Other (16) Neurologic (11) Digestive (8) Behavior (1)
No stored openFDA reports match the selected 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.

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

Tracked signals
32
Reported cases
32
Serious reports
26
Species represented
2
Grouped by Body System
Digestive (4) · Vomiting, Loss of appetite, Drooling Skin & allergy (1) · Ear twitching Neurologic (3) · Unsteady walking (ataxia), Focal seizure, Circling - neurological disorder Behavior (2) · Behavioral disorder (unspecified), Aggression Other (22) · General illness, Found dead, Elevated temperature
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Dog 1
Neurologic 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Dog (17) Cat (15)

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

Storage & Handling

Store at room temperature.

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.

Pimomedin™ SPL · SPL Vetmedin® SPL · SPL Vetmedin® Solution 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

30

FOI

5

Pimomedin™

SPL · SPL

Open original
FDA Structured Product Label

Pimobendan Chewable 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
Cronus Pharma Specialities India Private Ltd.
ANADA
200-728
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Dog
Composition / specifications
1.25 mg, 2.5 mg, 5 mg, and 10 mg pimobendan per tablet

Dogs

Indication

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.

Dosage

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).

Vetmedin®

SPL · SPL

Open original
FDA Structured Product Label

Vetmedin®

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
141-273
Status
RX
Form
Tablet (Chewable)
Route
Oral
Species
Dog
Composition / specifications
Each chewable tablet contains 1.25, 2.5, 5, or 10 milligrams (mg) pimobendan.

Dogs

Indication

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.

Dosage

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.

Vetmedin® Solution

SPL · SPL

Open original
FDA Structured Product Label

Vetmedin® Solution

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
141-575
Status
RX
Form
Solution
Route
Oral
Species
Dog
Composition / specifications
1.5 mg/mL

Dogs

Indication

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.

Dosage

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).

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

CaniBendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for CaniBendan. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for pimobendan. Use the source link for the full official labeling record.

pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for pimobendan. Use the source link for the full official labeling record.

SolutitionKits Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for SolutitionKits Pimobendan. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

Vetmedin SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Vetmedin. Use the source link for the full official labeling record.

Vetmedin Solution SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Vetmedin Solution. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

PIMOBENDAN SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for PIMOBENDAN. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

CaniBendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for CaniBendan. Use the source link for the full official labeling record.

Pimobendan SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Pimobendan. Use the source link for the full official labeling record.

Vetmedin Solution SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Vetmedin Solution. Use the source link for the full official labeling record.

Vetmedin SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Vetmedin. Use the source link for the full official labeling record.

FOI Summary oA 200-728 Approved April 25, 2024 .pdf

FOI · FOI

Open original

FOI Summary sN 141273 Approved December 19, 2025.pdf

FOI · FOI

Open original

ucm062328.pdf

FOI · FOI

Open original

FOI Summary sN 141-575 Approved January 15, 2026.pdf

FOI · FOI

Open original

FOI Summary oN 141-575 Approved February 13, 2024.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, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • 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 • FDA branded products available
Official FDA brands: AX Pharmaceutical Corp CaniBendan PIMOBENDAN Pimobendan SolutitionKits Pimobendan Vetmedin Vetmedin Solution pimobendan
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Dog • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Chewable Tablets, Solution, Tablet (Chewable) • Oral
Applications: ANADA 200-728 • NADA 141-273 • NADA 141-575
NDC: Packages 0010-4131-01 0010-4479-01 0010-4480-01 0010-4481-01 0010-4482-01 11695-7058-1 • Products 0010 11695 13612 46066 46144 49452
Documents: 5 (FOI: 5) • SPL: 3 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 46 • Cat 18 • View
Case summaries: 21 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), 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
  • Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance). (Contraindication, High)
Top reaction signals
General illness (1) Found dead (1) Focal seizure (1) Elevated temperature (1) Elevated renal parameters (1) Elevated globulins (1) Elevated creatinine (1) Elevated blood urea nitrogen (1)

Identifiers & Packages

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

Identifiers
ANADA: 200728 NADA: 141273 NADA: 141575 NDC Package: 0010-4131-01 NDC Package: 0010-4479-01 NDC Package: 0010-4480-01 NDC Package: 0010-4481-01 NDC Package: 0010-4482-01 NDC Package: 0010-4610-01 NDC Package: 0010-4612-01 NDC Package: 11695-7058-1 NDC Package: 11695-7059-1 NDC Package: 11695-7060-1 NDC Package: 11695-7061-1 NDC Package: 13612-0034-0 NDC Package: 13612-0034-1 NDC Package: 46066-252-31 NDC Package: 46066-253-31 NDC Package: 46066-254-31 NDC Package: 46066-255-31 NDC Package: 46144-606-01 NDC Package: 49452-5072-1 NDC Package: 49452-5072-2 NDC Package: 49452-5072-3
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 -

Enriched Documents

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

  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • CaniBendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • SolutitionKits Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Vetmedin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Vetmedin Solution SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • PIMOBENDAN SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • CaniBendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Pimobendan SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Vetmedin Solution SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Vetmedin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • FOI Summary oA 200-728 Approved April 25, 2024 .pdf • FOI summary • Official • May 12, 2026
    FDA FOI summary for application 200728
  • ucm062328.pdf • FOI summary • Official • March 10, 2026
    FDA FOI summary for application 141273
  • FOI Summary sN 141273 Approved December 19, 2025.pdf • FOI summary • Official • March 10, 2026
    FDA FOI summary for application 141273
  • FOI Summary oN 141-575 Approved February 13, 2024.pdf • FOI summary • Official • Feb. 2, 2026
    FDA FOI summary for application 141575
  • FOI Summary sN 141-575 Approved January 15, 2026.pdf • FOI summary • Official • Feb. 2, 2026
    FDA FOI summary for application 141575

Data Sources & Change Log

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

Official 145 Clinical 7 Manufacturer 0 Marketing 0
Current Field Facts
  • overdose_info: Overdose may lead to severe tachycardia, hypotension, arrhythmias, or collapse. Supportive and critical care is recommended. (Clinical, 2026-04-12)
  • overdose_info: Overdose may lead to severe tachycardia, hypotension, arrhythmias, or collapse. Supportive and critical care is recommended. (Clinical, 2026-04-11)
  • overdose_info: Overdose may lead to severe tachycardia, hypotension, arrhythmias, or collapse. Supportive and critical care is recommended. (Clinical, 2026-02-12)
  • side_effects: GI upset, increased heart rate, lethargy. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature. (Clinical, 2026-04-12)
  • storage_handling: Store at room temperature. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature. (Clinical, 2026-02-12)
  • contraindications: Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance). (Official, 2026-04-12)
  • contraindications: Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance). (Official, 2026-04-11)
  • contraindications: Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance). (Official, 2026-02-12)
  • dosage_forms: Solution (Official, 2026-06-22)
  • dosage_forms: Solution (Official, 2026-06-22)
  • dosage_forms: Solution (Official, 2026-06-21)
  • dosage_forms: Solution (Official, 2026-06-20)
  • dosage_forms: Solution (Official, 2026-06-13)
  • dosage_forms: Solution (Official, 2026-06-12)
  • dosage_forms: Solution (Official, 2026-06-12)
  • dosage_forms: Solution (Official, 2026-06-11)
  • dosage_forms: Solution (Official, 2026-06-11)
  • dosage_forms: Solution (Official, 2026-06-10)
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 19:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 19:40 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
Pimobendan Chewable Tablets
RX
Pimobendan
Chewable Tablets • Oral
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-728 Approved May 12, 2026
Vetmedin®
RX
Pimobendan
Tablet (Chewable) • Oral
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA, Inc. NADA 141-273 Approved Mar 10, 2026
Vetmedin® Solution
RX
Pimobendan
Solution • Oral
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA, Inc. NADA 141-575 Approved Feb 2, 2026

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
1.25 mg, 2.5 mg, 5 mg, and 10 mg pimobendan per tablet
Dogs
Indication

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.

Dosage

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).

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
Each chewable tablet contains 1.25, 2.5, 5, or 10 milligrams (mg) pimobendan.
Dogs
Indication

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.

Dosage

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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
1.5 mg/mL
Dogs
Indication

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.

Dosage

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).

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

Inodilator used for certain forms of canine heart failure (e.g., myxomatous mitral valve disease, dilated cardiomyopathy).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Not for use in conditions where increased cardiac output is not appropriate (consult cardiology guidance).

Side Effects

GI upset, increased heart rate, lethargy.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

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

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

Showing top 5 for Digestive.

Skin & allergy
Ear twitching (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Focal seizure (1) • Cat Circling - neurological disorder (1) • Dog

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog Aggression (1) • Dog

Showing top 5 for Behavior.

Other
General illness (1) • Dog Found dead (1) • Dog Elevated temperature (1) • Dog Elevated renal parameters (1) • Cat Elevated globulins (1) • Dog
Show more (17)
Elevated creatinine (1) • Cat Elevated blood urea nitrogen (1) • Cat Dull reflexes (1) • Cat Dry coat (1) • Cat Digestive tract disorder NOS (1) • Dog Dehydration (1) • Dog Decreased haematocrit (1) • Cat Decreased blood urea nitrogen (BUN) or creatinine (1) • Dog Death by euthanasia (1) • Dog Death (1) • Cat Crackles on auscultation (1) • Dog Cough (1) • Dog Corneal ulcer (1) • Dog Conjunctivitis (1) • Cat Collapse NOS (1) • Cat Bradycardia (1) • Dog Agitation (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, Chihuahua, Male, 12 year, 3.084 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Seizure NOS, Lateral recumbency, Unresponsive to stimuli, Bradycardia • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-075262
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 3.084 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Seizure NOS Lateral recumbency Unresponsive to stimuli Bradycardia
Outcomes: Recovered/Normal

Dog, ['Beagle', 'Schnauzer (unspecified)'], Male, 18 year, 9.3 kilogram • Drug: MSK, Solution, Oral, Dose: 0.24 Milligram per kilogram, Frequency: 12 per hour • Reactions: Partial anorexia, Weight loss • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075074
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 18.00 Year
  • Weight: 9.300 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 0.24 Milligram per kilogram
  • Frequency: 12 per hour
Reactions Reported:
Partial anorexia Weight loss
Outcomes: Outcome Unknown

Cat, Cat (other), Mixed, 4.1 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 0.28 Milligram per kilogram, Frequency: 24 per hour • Reactions: Death, Ptyalism, Vomiting • Outcome: Died, Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075090
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Mixed
  • Weight: 4.100 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 0.28 Milligram per kilogram
  • Frequency: 24 per hour
Reactions Reported:
Death Ptyalism Vomiting
Outcomes: Died, Outcome Unknown

Dog, Crossbred Canine/dog, Female, 10 year, 13.608 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 0.28 Milligram per kilogram, Frequency: 12 per hour • Reactions: Tiredness (lethargy) • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074890
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 10.00 Year
  • Weight: 13.608 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 0.28 Milligram per kilogram
  • Frequency: 12 per hour
Reactions Reported:
Tiredness (lethargy)
Outcomes: Outcome Unknown

Dog, Crossbred Canine/dog, Male, 10 year • Drug: MSK, Tablet, chewable, Oral, Dose: 3.75 Milligram per animal, Frequency: 12 per hour • Reactions: Digestive tract disorder NOS, Sudden death • Outcome: Died

  • Report ID: DEU-USFDACVM-2025-DE-000062
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 3.75 Milligram per animal
  • Frequency: 12 per hour
Reactions Reported:
Digestive tract disorder NOS Sudden death
Outcomes: Died

Dog, Terrier - Bull, Male, 5 year, 23.9 kilogram • Drug: MSK, Unknown • Reactions: Behavioral disorder (unspecified), Aggression • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072512
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 23.900 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Behavioral disorder (unspecified) Aggression
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Female, 13 year • Drug: MSK, Tablet, chewable, Oral, Dose: 2.50 Milligram per animal, Frequency: 12 per day • Reactions: Vomiting • Outcome: Outcome Unknown

  • Report ID: PRT-USFDACVM-2025-PT-000010
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 2.50 Milligram per animal
  • Frequency: 12 per day
Reactions Reported:
Vomiting
Outcomes: Outcome Unknown

Dog, Terrier - Yorkshire, Female, 13.5 year, 2.8 kilogram • Drug: MSK, Unknown • Reactions: Pale mucous membrane, Laboured breathing, Increased respiratory rate, Crackles on auscultation, Prolonged capillary refill time… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072177
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.50 Year
  • Weight: 2.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Pale mucous membrane Laboured breathing Increased respiratory rate Crackles on auscultation Prolonged capillary refill time Other abnormal test result NOS
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

Overdose may lead to severe tachycardia, hypotension, arrhythmias, or collapse. Supportive and critical care is recommended.

Storage & Handling

Store at room temperature.

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