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Capromorelin

Detailed information about Capromorelin

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

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

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

For appetite stimulation in dogs.

What to watch for:

  • The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches
  • Hyperphosphataemia (1 reports)
  • Haematochezia (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.

Bloodwork changes are grouped in Vet View.

What to 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?
Safety & side effects

What to watch:

  • The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches
  • Hyperphosphataemia
  • Haematochezia

Most reported reactions:

  • Hyperphosphataemia (1 reports)
  • Haematochezia (1 reports)
  • Elevated creatinine (1 reports)

When to call your vet:

  • 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

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:04 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Image coming soon
Capromorelin

Capromorelin

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

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both
Manufacturer: Not available
Form: Oral Solution
Identifiers:
NADA: 141457 NADA: 141536 NDC Package: 58198-5535-1 NDC Package: 58198-5535-2 NDC Package: 58198-5535-3 NDC Package: 58198-5545-1 NDC Product: 58198
Source metadata:

Warnings / Contraindications

The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches.

  • High: The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches.
Source metadata:

Adverse Reactions

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

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

Tracked signals
32
Reported cases
32
Serious reports
9
Species represented
2
Grouped by Body System
Digestive (5) · Loss of appetite, Increased appetite, Drooling Neurologic (1) · Tiredness (lethargy) Behavior (2) · Circling - behavioural disorder, Behavioral disorder (unspecified) Effectiveness (1) · Lack of efficacy - NOS Other (23) · Pancreas disorder, Nystagmus, Not himself/herself
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Digestive 1 Cat 1
Digestive 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Cat (20) Dog (12)

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

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (0)
  • No official label or package insert links yet.
SPL (2)
  • ENTYCE™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2569/ENTYCE%E2%84%A2
  • Elura™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/9970/Elura%E2%84%A2
FOI (2)
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
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: ENTYCE™ Elura™
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog
Rx/OTC: RX
Form/route: Oral Solution • Oral
Applications: NADA 141-457 • NADA 141-536
Documents: 2 (FOI: 2) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 20 • Cat 20 • View
Case summaries: 10 (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
ICD10_CM: N18.9
Chronic kidney disease, unspecified

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
  • The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches. (Contraindication, High)
Top reaction signals
Hyperphosphataemia (1) Haematochezia (1) Elevated creatinine (1) Elevated blood urea nitrogen (1) Diarrhea (1) Decreased appetite (1) Death by euthanasia (1) Death (1)

Identifiers & Packages

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

Identifiers
NADA: 141457 NADA: 141536 NDC Package: 58198-5535-1 NDC Package: 58198-5535-2 NDC Package: 58198-5535-3 NDC Package: 58198-5545-1 NDC Product: 58198
Package NDC Product NDC Form / Route Status
58198-5535-1 58198 -
58198-5535-2 58198 -
58198-5535-3 58198 -
58198-5545-1 58198 -

Enriched Documents

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

Data Sources & Change Log

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

Official 5 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches. (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death by euthanasia, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NO… (Official, 2026-02-12)
  • usage: For appetite stimulation in dogs. For management of weight loss in cats with chronic kidney disease. (Official, 2026-02-12)
Recent Revisions
  • 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
ENTYCE™
RX
Capromorelin
Oral Solution • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-457 Approved Nov 19, 2020
Elura™
RX
Capromorelin
Oral Solution • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-536 Approved Oct 16, 2020

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, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of solution contains 30 milligrams (mg) capromorelin.
Dogs
Indication
For appetite stimulation in dogs.
Dosage
Administer 3 mg/kg once daily by mouth.
Limitations
The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches.

FDA page: Open in Animal Drugs @ FDA

Species: Cat, No Use Class Stated Or Implied
Composition / specifications
20 mg/mL flavored oral solution
Cats
Indication

For management of weight loss in cats with chronic kidney disease.

Dosage

2 mg/kg once daily

Limitations

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

For appetite stimulation in dogs. For management of weight loss in cats with chronic kidney disease.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches.

Top Reported Reactions (openFDA)

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

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

Showing top 5 for Digestive.

Neurologic
Tiredness (1) • Cat

Showing top 5 for Neurologic.

Behavior
Circling - behavioural disorder (1) • Dog Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Effectiveness
Lack of efficacy - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other
Pancreas disorder (1) • Cat Nystagmus (1) • Dog Not himself/herself (1) • Dog Not eating (1) • Cat Neuromuscular disorder NOS (1) • Dog
Show more (18)
Malaise (1) • Dog Intestinal stasis (1) • Cat Increased respiratory rate (1) • Cat Hypotension (1) • Cat Hyperthermia (1) • Cat Hyperphosphataemia (1) • Dog Hiding (1) • Cat Haematochezia (1) • Cat Gall bladder & bile duct disorder NOS (1) • Cat Fever (1) • Cat Elevated creatinine (1) • Dog Elevated blood urea nitrogen (1) • Dog Death by euthanasia (1) • Cat Death (1) • Cat Corneal ulcer (1) • Dog Bradycardia (1) • Cat Administration error NOS (1) • Cat Adipsia (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, Alaskan Malamute, Male, 9.5 year, 45.35 kilogram • Drug: MSK, Solution, Oral, Dose: 2.20 mL per animal, Frequency: 1 per day • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055798
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 9.50 Year
  • Weight: 45.350 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 2.20 mL per animal
  • Frequency: 1 per day
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Shar Pei, Female, 5 year, 16.23 kilogram • Drug: MSK, Solution, Oral, Dose: 1.70 mL per animal • Reactions: Neuromuscular disorder NOS, Unsteady gait, Nystagmus, Circling - behavioural disorder, Not himself/herself • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055976
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 16.230 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1.70 mL per animal
Reactions Reported:
Neuromuscular disorder NOS Unsteady gait Nystagmus Circling - behavioural disorder Not himself/herself
Outcomes: Recovered/Normal

Dog, Chihuahua, Female, 16 year, 3.12 kilogram • Drug: MSK, Solution, Oral • Reactions: Reduced responses, Elevated creatinine, Corneal ulcer, Sleepiness - systemic disorder, Elevated blood urea nitrogen… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055817
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 16.00 Year
  • Weight: 3.120 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
Reactions Reported:
Reduced responses Elevated creatinine Corneal ulcer Sleepiness - systemic disorder Elevated blood urea nitrogen Lack of efficacy - NOS Hyperphosphataemia
Outcomes: Ongoing

Dog, Dog (unknown), Male • Drug: MSK, Solution, Oral • Reactions: Increased appetite • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055935
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
Reactions Reported:
Increased appetite
Outcomes: Outcome Unknown

Dog, Dachshund (unspecified), Male, 14 year, 9.25 kilogram • Drug: MSK, Solution, Oral, Dose: 1 mL per animal • Reactions: Unwell, Loss of appetite, Malaise, Whining, Drooling… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055407
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 9.250 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 1 mL per animal
Reactions Reported:
Unwell Loss of appetite Malaise Whining Drooling Lack of efficacy - NOS
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 4.5 year, 4.39 kilogram • Drug: MSK, Solution, Oral • Reactions: Tiredness (lethargy), Not eating • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-054125
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.50 Year
  • Weight: 4.390 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
Reactions Reported:
Tiredness (lethargy) Not eating
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 8 year, 5.7 kilogram • Drug: MSK, Solution, Oral • Reactions: Tiredness (lethargy), Not eating, Gall bladder & bile duct disorder NOS, Pancreas disorder, Not himself/herself… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-053793
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 5.700 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
Reactions Reported:
Tiredness (lethargy) Not eating Gall bladder & bile duct disorder NOS Pancreas disorder Not himself/herself Weight gain
Outcomes: Ongoing

Cat, Cat (other), Unknown, 2.39 kilogram • Drug: MSK, Solution, Oral, Dose: 2.70 mL per animal • Reactions: Bradycardia, Increased respiratory rate, Hypotension, Vocalisation • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-054818
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Unknown
  • Weight: 2.390 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 2.70 mL per animal
Reactions Reported:
Bradycardia Increased respiratory rate Hypotension Vocalisation
Outcomes: Ongoing

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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