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Roxee Medication Guide

Capromorelin

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

Both Reference complete FDA data linked Rx required Oral Solution Elanco US Inc. Official label facts Owner quick guide first
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Data freshness

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

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

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

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

Safety reports
Safety data refreshed
Aug 6, 2026, 7:49 p.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Illustration placeholder
Capromorelin

Capromorelin

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Oral Solution Rx required 100% reference complete

Species: Both

Manufacturer: Elanco US Inc.

Medication Snapshot

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

Capromorelin

For appetite stimulation in dogs. For management of weight loss in cats with chronic kidney disease. Species commonly shown: Both, Dog, Cat.

Generic name
Capromorelin
Brand names
ENTYCE™, Elura™
Manufacturer
Elanco US Inc.
Species
Both, Dog, Cat
Dosage forms
Oral Solution
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
ENTYCE™ Elura™
Dosage forms
Oral Solution

Indications / Uses

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

Warnings / Contraindications

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

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

Side Effects

Top reported reactions (openFDA): Vomiting, Death by euthanasia, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NOS, Not eating, Diarrhoea.

FAQ

Both, Dog, Cat

Yes. Roxee shows this as prescription-only.

Oral Solution

Related Conditions

Chronic Kidney Disease (CKD) Weight loss

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 appetite stimulation 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:

  • The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches
  • Loss of appetite (1 reports)
  • Death by euthanasia (1 reports)
  • Death (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 Capromorelin; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-070810
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 24 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-070810
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-070810
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

Loss of appetite (1 reports), Death by euthanasia (1 reports), Death (1 reports), Cyst NOS (1 reports), Crackles on auscultation (1 reports)

Body systems represented Signal grouping

Digestive (2), Behavior (2), Other (28)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (16 reports), Dog (16 reports)

Breed metadata in reports Metadata only

Domestic Shorthair (2), ['Pit Bull', 'Dog (unknown)'] (1), Retriever - Labrador (1), Rottweiler (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 Capromorelin 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

The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bit, Loss of appetite, Death by euthanasia, Death

Call sooner if Escalation

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

Bottom line: Use this Capromorelin 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-070810 · 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: April 15, 2026, 10:04 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches
  • Loss of appetite
  • Death by euthanasia
  • Death

Most reported reactions:

  • Loss of appetite (1 reports)
  • Death by euthanasia (1 reports)
  • Death (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
Cat, Dog
Indication / use
For appetite stimulation in dogs.
Form / route / dose
Form: Oral Solution
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches.
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: Both
Manufacturer: Elanco US Inc.
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.

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
41
Matching reports
41
Active filters
0
Reset
Drill into common report signals
Lethargy (see also Central nervous system depression in Neurological) (13) Not eating (10) Death (9) Diarrhoea (7) Other (35) Digestive (22) Neurologic (16) Effectiveness (7)
Showing up to 50 matching reports.

USA-USFDACVM-2026-US-013847

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
['Pit Bull', 'Dog (unknown)']
Size / weight
25-49 lb (18.869 Kilogram)
Age
4-7 years (4.5 Year)
Sex
Female Neutered
Region
USA
Reactions
Decreased appetiteEar infection NOSOther abnormal test result NOSLoose stoolFallingVomitingWeaknessDeathElevated creatinineElevated renal parametersUNPALATABLE
Body systems
DigestiveOther
Outcomes
Died

USA-USFDACVM-2026-US-013503

Received 2026-03-23 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (35.017 Kilogram)
Age
8+ years (15 Year)
Sex
Male Neutered
Region
USA
Reactions
Unable to standMusculoskeletal disorder NOSWeaknessNot eatingLethargy (see also Central nervous system depression in Neurological)Proprioception deficitWeight lossTarry or black stool (see also haemorrhagic diarrhoea)
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-013169

Received 2026-03-19 · MSK · MSK

Serious
Species
Dog
Breed
Rottweiler
Size / weight
50-99 lb (43.001 Kilogram)
Age
8+ years (1 Year)
Sex
Male Neutered
Region
USA
Reactions
Musculoskeletal disorder NOSCollapse NOS (see also Cardio-vascular and Neurological disorders)Lethargy (see also Central nervous system depression in Neurological)Unable to walkNot eatingWeaknessDeath
Body systems
OtherNeurologic
Outcomes
Died

USA-USFDACVM-2026-US-014358

Received 2026-03-16 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.37 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
VomitingLethargy (see also Central nervous system depression in Neurological)High pancreatic-specific lipaseDehydrationNeutrophiliaPancreatitis NOSNot eatingLeukocytosis NOSDepressionElevated gamma-glutamyl transferase (GGT)AzotaemiaAnaemia NOSHypoalbuminaemiaAbdominal effusionHyperglycaemiaElevated symmetrical dimethylarginine (SDMA)Elevated blood urea nitrogen (BUN)Elevated creatinineHyponatremiaHypochloraemiaLow serum alkaline phosphatase (ALP)Decreased red blood cell countDecreased haemoglobinProteinuria
Body systems
DigestiveNeurologicOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-013265

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Corso Dog
Size / weight
50-99 lb (42.184 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Not eatingFeverInjection site lumpApplication site serous discharge
Body systems
NeurologicOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-012478

Received 2026-03-16 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Terrier - Bull - American Pit']
Size / weight
50-99 lb (31.298 Kilogram)
Age
8+ years (14 Year)
Sex
Female Neutered
Region
USA
Reactions
Limb weaknessDecreased appetiteDeath by euthanasiaLethargy (see also Central nervous system depression in Neurological)Panting
Body systems
OtherDigestiveNeurologic
Outcomes
Euthanized

USA-USFDACVM-2026-US-012464

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Dog
Breed
['Chihuahua', 'Dog (unknown)']
Size / weight
Under 10 lb (4.354 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
ShakingHair shedding
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-012224

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3 Kilogram)
Age
8+ years (12.5 Year)
Sex
Female Neutered
Region
USA
Reactions
Tongue disorder NOSTongue ulcerationDroolingUnwellTracheal and laryngeal disorder NOSCrustDecreased appetiteLaryngeal oedemaCoughHead tilt - neurological disorder (see also Head tilt - ear disorder)Swallowing disorder NOSLocal swelling (not application site)Lethargy (see also Central nervous system depression in Neurological)Nasal dischargeMalaiseDehydrationOcular discharge
Body systems
OtherDigestiveNeurologicSkin & allergy
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-012003

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Cat
Breed
Persian
Size / weight
Under 10 lb (3.36 Kilogram)
Age
8+ years (11 Year)
Sex
Female Neutered
Region
USA
Reactions
Hypersalivation
Body systems
Digestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-010813

Received 2026-03-09 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.7 Kilogram)
Age
8+ years (12 Year)
Sex
Female Neutered
Region
USA
Reactions
DullBradycardiaLow blood pressure
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-010089

Received 2026-03-07 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.4 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
HypotensionBradycardiaHypernatraemiaLying downLethargy (see also Central nervous system depression in Neurological)Reduced responses
Body systems
OtherNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-008761

Received 2026-02-27 · MSK · MSK

Non-serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (3.5 Kilogram)
Age
8+ years (17 Year)
Sex
Female Neutered
Region
USA
Reactions
Decreased mean corpuscular volume (MCV)Decreased haematocritDecreased mean corpuscular haemoglobin concentration (MCHC)Lack of efficacy - NOSIron deficiency anaemia
Body systems
OtherEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2026-US-008188

Received 2026-02-24 · MSK · MSK

Non-serious
Species
Dog
Breed
Portuguese Water Dog
Size / weight
25-49 lb (18.23 Kilogram)
Age
8+ years (13.58 Year)
Sex
Female Neutered
Region
USA
Reactions
PolydipsiaPacingLethargy (see also Central nervous system depression in Neurological)DisorientationGaggingDiarrhoeaDifficulty standingRetching
Body systems
OtherNeurologicDigestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-011611

Received 2026-02-14 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.3 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
DeathDullNot himself/herselfHead pressingHypotensionUnresponsive to stimuli
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-005800

Received 2026-02-02 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (6.3 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
DeathDullNot himself/herselfHead pressingHypotensionUnresponsive to stimuli
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-004302

Received 2026-01-27 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
10-24 lb (4.62 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
EmesisNot eatingHidingHyperglycaemiaFeverTachycardiaTachypnoeaBloody stoolWeight lossGall bladder & bile duct disorder NOSGastric distensionIntestinal thickeningDiarrhoea
Body systems
DigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-003268

Received 2026-01-14 · MSK · MSK

Serious
Species
Dog
Breed
Dachshund (unspecified)
Size / weight
10-24 lb (5.8 Kilogram)
Age
8+ years (15 Year)
Sex
Male Neutered
Region
USA
Reactions
VomitingLethargy (see also Central nervous system depression in Neurological)RetchingDental diseaseDry mucous membraneDehydrationAnorexiaBloody diarrhoeaIncreased heart rateIncreased respiratory ratePale mucous membraneJaundiceHeart murmurTense abdomenLeukocytosis NOSNeutrophiliaLymphocytosisMonocytosisLow platelet countAzotaemiaElevated blood urea nitrogen (BUN)HyperphosphataemiaElevated alanine aminotransferase (ALT)Elevated serum alkaline phosphatase (ALP)Elevated total bilirubinElevated cholesterol (total)Blood in urineProteinuriaLiver disorder NOSPancreas disorderIntestinal thickeningUrinary tract disorder NOSNon-regenerative anaemiaHypokalaemiaNot eatingDecreased red blood cell countDecreased haematocritPolyuriaPolydipsiaAbdominal discomfortIncreased percentage reticulocytesPlatelet disorder NOSLack of efficacy - NOSGut sounds decreasedOther blood disorder NOSBilirubinuriaAbnormal ultrasound findingElevated gamma-glutamyl transferase (GGT)ThrombocytosisIleus
Body systems
DigestiveNeurologicOtherEffectiveness
Outcomes
Ongoing

USA-USFDACVM-2026-US-000241

Received 2026-01-07 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Longhair
Size / weight
10-24 lb (5 Kilogram)
Age
1-3 years (3 Year)
Sex
Male Neutered
Region
USA
Reactions
Unresponsive to stimuliHeart block NOSBradycardia
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-000138

Received 2026-01-06 · MSK · MSK

Non-serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
10-24 lb (6.986 Kilogram)
Age
8+ years (16 Year)
Sex
Female Neutered
Region
USA
Reactions
Increased drinkingUrinary incontinence
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-075006

Received 2025-12-24 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.85 Kilogram)
Age
8+ years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
Heart murmurHigh ionized calcium (Ca; Hypercalcemia, ionized)Cyst NOSAortic mineralisationNot eatingThird eyelid protrusionPawingMental impairment NOSHypotensionDecreased packed cell volume (PCV)
Body systems
Other
Outcomes
Ongoing

CAN-USFDACVM-2025-CA-000113

Received 2025-12-19 · MSK · MSK

Non-serious
Species
Dog
Breed
['Siberian Husky', 'Dog (unknown)']
Size / weight
25-49 lb (22 Kilogram)
Age
1-3 years (2 Year)
Sex
Male Intact
Region
USA
Reactions
Diarrhoea
Body systems
Digestive
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-074788

Received 2025-12-16 · MSK · MSK

Non-serious
Species
Cat
Breed
Cat (unknown)
Sex
Unknown Unknown
Region
USA
Reactions
DroolingNausea
Body systems
Digestive
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-074897

Received 2025-12-12 · MSK · MSK

Serious
Species
Dog
Breed
['Chihuahua', 'Dog (unknown)']
Size / weight
Under 10 lb (2.26 Kilogram)
Age
Under 1 year (2 Week)
Sex
Female Intact
Region
USA
Reactions
IcterusDeathOther abnormal test result NOSElevated liver enzymes NOSSwollen jointLocalised hair lossSkin lesion NOSConjunctival oedemaCorneal oedemaSkin scabSwollen limbLethargy (see also Central nervous system depression in Neurological)AnorexiaEar infection NOSLocal swelling (not application site)
Body systems
OtherSkin & allergyNeurologicDigestive
Outcomes
Died

USA-USFDACVM-2025-US-073622

Received 2025-12-11 · MSK · MSK

Non-serious
Species
Dog
Breed
Collie - Border
Size / weight
25-49 lb (17.23 Kilogram)
Age
8+ years (11 Year)
Sex
Female Neutered
Region
USA
Reactions
GaggingDroolingArthritisUNPALATABLEMedication error NOSINEFFECTIVE, OTHER DRUG(S)
Body systems
OtherDigestive
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-072755

Received 2025-12-10 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
10-24 lb (4.627 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Unknown
Region
USA
Reactions
EmesisNot eatingHidingHyperglycaemiaFeverTachycardiaTachypnoeaBloody stoolWeight lossGall bladder & bile duct disorder NOSGastric distensionIntestinal thickeningDiarrhoea
Body systems
DigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-074690

Received 2025-12-09 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
Under 10 lb (4.2 Kilogram)
Age
1-3 years (2.2 Year)
Sex
Female Neutered
Region
USA
Reactions
Not eatingHidingFeverPyrexiaEmesis (multiple)Low platelet countPlatelet disorder NOSHyperglycaemiaDistressHypothyroidismOther abnormal test result NOSProteinuriaBilirubinuriaTarry or black stool (see also haemorrhagic diarrhoea)Behavioural disorder NOSWarm feeling to the touchReddening of the skinAbnormal radiograph findingDistension of abdomenPancreatitis NOSVomiting
Body systems
OtherDigestiveBehavior
Outcomes
Ongoing

USA-USFDACVM-2025-US-072177

Received 2025-12-08 · MSK · MSK

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

USA-USFDACVM-2025-US-072434

Received 2025-12-05 · MSK · MSK

Non-serious
Species
Dog
Breed
Dog (unknown)
Sex
Unknown Unknown
Region
USA
Reactions
Behavioural disorder NOS
Body systems
Behavior
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-072055

Received 2025-12-05 · MSK · MSK

Non-serious
Species
Dog
Breed
Dog (unknown)
Sex
Unknown Unknown
Region
USA
Reactions
DroolingLack of efficacy - NOSBehavioural disorder NOSUNPALATABLE
Body systems
DigestiveEffectivenessBehaviorOther
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-071528

Received 2025-12-05 · MSK · MSK

Non-serious
Species
Dog
Breed
Dog (unknown)
Sex
Unknown Unknown
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-071565

Received 2025-12-03 · MSK · MSK

Serious
Species
Dog
Breed
Dog (unknown)
Size / weight
25-49 lb (14.969 Kilogram)
Age
8+ years (15 Year)
Sex
Male Neutered
Region
USA
Reactions
Head tilt - neurological disorder (see also Head tilt - ear disorder)Walking difficultyVomitingSkin and tissue infection NOSGeneral illnessDeath
Body systems
NeurologicOtherDigestive
Outcomes
Died

USA-USFDACVM-2025-US-072468

Received 2025-12-01 · MSK · MSK

Serious
Species
Dog
Breed
['Shih Tzu', 'Spitz - German Pomeranian']
Size / weight
Under 10 lb (3.4 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
Seizure NOSDeath
Body systems
NeurologicOther
Outcomes
Died

USA-USFDACVM-2025-US-072451

Received 2025-12-01 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (5.69 Kilogram)
Age
4-7 years (7 Year)
Sex
Male Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)AnorexiaElevated total bilirubinElevated gamma-glutamyl transferase (GGT)Elevated serum alkaline phosphatase (ALP)Elevated alanine aminotransferase (ALT)JaundiceEnlarged liverHidingNausea
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-072073

Received 2025-12-01 · MSK · MSK

Non-serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (4.536 Kilogram)
Age
1-3 years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
Necrotic woundSkin lesion NOSLocal erythemaAnorexiaDiarrhoeaAbdominal discomfortDehydrationBacterial skin infection NOS
Body systems
OtherDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-070810

Received 2025-12-01 · MSK · MSK

Serious
Species
Dog
Breed
['Shih Tzu', 'Spitz - German Pomeranian']
Size / weight
Under 10 lb (3.402 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
Seizure NOSDeathMedication error NOSNot eatingLeucocytosis NOSPain NOSElevated lactateHyperglycaemiaAbdominal discomfortAbnormal radiograph findingNeutrophiliaMonocytosisElevated triglyceride
Body systems
NeurologicOther
Outcomes
Died

USA-USFDACVM-2025-US-072580

Received 2025-11-25 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
Under 10 lb (4.13 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
Reluctant to moveVocalisationLoss of bowel controlNot urinatingEosinopeniaBasophiliaHypernatremiaThrombocytopeniaAbnormal radiograph findingThird eyelid protrusionOther ear disorder NOSNasal dischargeFalling
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-075182

Received 2025-11-24 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Shorthair
Size / weight
10-24 lb (4.76 Kilogram)
Age
8+ years (11 Year)
Sex
Male Neutered
Region
USA
Reactions
Cold feeling to the touchDecreased appetiteLack of efficacy - NOSBehavioural disorder NOSVomitingRenal disorder NOSLethargy (see also Central nervous system depression in Neurological)Elevated renal parametersArthritisReluctant to moveWeight gainWobblinessDental diseaseRespiratory tract infection NOSAnaemia NOSElevated creatinineHypercalcaemiaFeverDehydrationDiarrhoeaDecreased haematocritDecreased red blood cell countDigestive tract disorder NOSSicknessDistressDiabetesDecreased body temperatureDeath by euthanasia
Body systems
OtherDigestiveEffectivenessBehaviorNeurologic
Outcomes
Euthanized

CAN-USFDACVM-2025-CA-000104

Received 2025-11-19 · MSK · MSK

Non-serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (7.6 Kilogram)
Age
8+ years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Outcome Unknown

CAN-USFDACVM-2025-CA-000103

Received 2025-11-19 · MSK · MSK

Serious
Species
Dog
Breed
['Retriever - Labrador', 'Dog (unknown)']
Size / weight
50-99 lb (27.5 Kilogram)
Age
8+ years (13 Year)
Sex
Female Intact
Region
USA
Reactions
Lack of efficacy - NOSDeath by euthanasia
Body systems
EffectivenessOther
Outcomes
Euthanized

USA-USFDACVM-2025-US-068768

Received 2025-11-14 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
Under 10 lb (4.13 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
AnorexiaReluctant to moveVocalisationLoss of bowel controlNot urinatingEosinopeniaBasophiliaHypernatremiaThrombocytopeniaAbnormal radiograph findingThird eyelid protrusionOther ear disorder NOS
Body systems
DigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-068234

Received 2025-11-12 · MSK · MSK

Serious
Species
Cat
Breed
Cat (unknown)
Sex
Mixed Unknown
Region
USA
Reactions
DeathHaematocheziaDecreased appetiteRegurgitationLethargy (see also Central nervous system depression in Neurological)DiarrhoeaDeath by euthanasia
Body systems
OtherDigestiveNeurologic
Outcomes
DiedEuthanizedOutcome Unknown

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

Tracked signals
32
Reported cases
32
Serious reports
24
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Bloody diarrhoea Behavior (2) · Circling - behavioural disorder, Behavioral disorder (unspecified) Other (28) · Death by euthanasia, Death, Cyst NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Cat (16) Dog (16)

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

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

ENTYCE™ SPL · SPL Elura™ SPL · SPL UCM504544.pdf FOI · FOI

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

2

FOI

2

ENTYCE™

SPL · SPL

Open original
FDA Structured Product Label

ENTYCE™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
141-457
Status
RX
Form
Oral Solution
Route
Oral
Species
Dog
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.

Elura™

SPL · SPL

Open original
FDA Structured Product Label

Elura™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
141-536
Status
RX
Form
Oral Solution
Route
Oral
Species
Cat
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

UCM504544.pdf

FOI · FOI

Open original

FOI Summary oN 141-536 Approved October 16, 2020.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 Aug 6, 2026, 7:47 PM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Aug 6, 2026, 7:52 PM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
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 114 • Cat 122 • View
Case summaries: 41 (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
Loss of appetite (1) Death by euthanasia (1) Death (1) Cyst NOS (1) Crackles on auscultation (1) Corneal ulcer (1) Corneal oedema (1) Conjunctival oedema (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 11 Clinical 8 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. (Clinical, 2026-04-16)
  • contraindications: The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches. (Clinical, 2026-04-15)
  • contraindications: The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches. (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death by euthanasia, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NO… (Clinical, 2026-04-11)
  • usage: For appetite stimulation in dogs. For management of weight loss in cats with chronic kidney disease. (Clinical, 2026-04-16)
  • usage: For appetite stimulation in dogs. For management of weight loss in cats with chronic kidney disease. (Clinical, 2026-04-15)
  • usage: For appetite stimulation in dogs. For management of weight loss in cats with chronic kidney disease. (Clinical, 2026-04-11)
  • contraindications: The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches. (Official, 2026-04-22)
  • 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, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death by euthanasia, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NO… (Official, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Vomiting, Death by euthanasia, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy - NO… (Official, 2026-04-15)
  • 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, 2026-04-22)
  • usage: Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. (Official, 2026-04-16)
  • 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 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-16 13:29 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-16 13:29 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-16 13:29 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 13:29 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 13:29 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 13:29 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 13:29 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 13:29 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 13:29 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

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
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
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

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 Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

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

Showing top 5 for Behavior.

Other
Death by euthanasia (1) • Dog Death (1) • Cat Cyst NOS (1) • Cat Crust (1) • Cat Crackles on auscultation (1) • Dog
Show more (23)
Cough (1) • Cat Corneal ulcer (1) • Dog Corneal oedema (1) • Dog Conjunctival oedema (1) • Dog Collapse NOS (1) • Dog Cold feeling to the touch (1) • Cat Bradycardia (1) • Cat Bloody stool (1) • Cat Blood in urine (1) • Dog Bilirubinuria (1) • Cat Basophilia (1) • Cat Bacterial skin infection NOS (1) • Dog Azotaemia (1) • Dog Arthritis (1) • Cat Application site serous discharge (1) • Dog Aortic mineralisation (1) • Cat Anaemia NOS (1) • Cat Administration error NOS (1) • Cat Adipsia (1) • Cat Abnormal ultrasound finding (1) • Dog Abnormal radiograph finding (1) • Dog Abdominal effusion (1) • Cat Abdominal discomfort (1) • Dog

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, ['Pit Bull', 'Dog (unknown)'], Female, 4.5 year, 18.869 kilogram • Drug: MSK, Solution, Oral • Reactions: Decreased appetite, Ear infection NOS, Other abnormal test result NOS, Loose stool, Falling… • Outcome: Died

  • Report ID: USA-USFDACVM-2026-US-013847
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.50 Year
  • Weight: 18.869 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
Reactions Reported:
Decreased appetite Ear infection NOS Other abnormal test result NOS Loose stool Falling Vomiting Weakness Death Elevated creatinine Elevated renal parameters UNPALATABLE
Outcomes: Died

Dog, Retriever - Labrador, Male, 15 year, 35.017 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Unable to stand, Musculoskeletal disorder NOS, Weakness, Not eating, Tiredness (lethargy)… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013503
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 15.00 Year
  • Weight: 35.017 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Unable to stand Musculoskeletal disorder NOS Weakness Not eating Tiredness (lethargy) Proprioception deficit Weight loss Tarry or black stool
Outcomes: Ongoing

Dog, Rottweiler, Male, 10 year, 43.001 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Musculoskeletal disorder NOS, Collapse NOS, Tiredness (lethargy), Unable to walk, Not eating… • Outcome: Died

  • Report ID: USA-USFDACVM-2026-US-013169
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 43.001 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Musculoskeletal disorder NOS Collapse NOS Tiredness (lethargy) Unable to walk Not eating Weakness Death
Outcomes: Died

Cat, Domestic Shorthair, Female, 2 year, 5.37 kilogram • Drug: MSK, Solution, Oral, Dose: 0.50 mL per animal, Frequency: 1 per day • Reactions: Vomiting, Tiredness (lethargy), High pancreatic-specific lipase, Dehydration, Neutrophilia… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014358
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 5.370 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 0.50 mL per animal
  • Frequency: 1 per day
Reactions Reported:
Vomiting Tiredness (lethargy) High pancreatic-specific lipase Dehydration Neutrophilia Pancreatitis NOS Not eating Leukocytosis NOS Depression Elevated gamma-glutamyl transferase Azotaemia Anaemia NOS Hypoalbuminaemia Abdominal effusion Hyperglycaemia Elevated symmetrical dimethylarginine Elevated blood urea nitrogen Elevated creatinine Hyponatremia Hypochloraemia Low serum alkaline phosphatase Decreased red blood cell count Decreased haemoglobin Proteinuria
Outcomes: Recovered/Normal

Dog, Corso Dog, Female, 1 year, 42.184 kilogram • Drug: MSK, Solution, Unknown • Reactions: Tiredness (lethargy), Not eating, Fever, Injection site lump, Application site serous discharge • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-013265
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.00 Year
  • Weight: 42.184 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Tiredness (lethargy) Not eating Fever Injection site lump Application site serous discharge
Outcomes: Ongoing

Dog, ['Retriever - Labrador', 'Terrier - Bull - American Pit'], Female, 14 year, 31.298 kilogram • Drug: MSK, Solution, Oral • Reactions: Limb weakness, Decreased appetite, Death by euthanasia, Tiredness (lethargy), Panting • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2026-US-012478
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 14.00 Year
  • Weight: 31.298 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
Reactions Reported:
Limb weakness Decreased appetite Death by euthanasia Tiredness (lethargy) Panting
Outcomes: Euthanized

Dog, ['Chihuahua', 'Dog (unknown)'], Male, 14 year, 4.354 kilogram • Drug: MSK, Solution, Unknown • Reactions: Shaking, Hair shedding • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-012464
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 4.354 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Shaking Hair shedding
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 12.5 year, 3 kilogram • Drug: MSK, Solution, Oral, Dose: 0.30 mL per animal, Frequency: 2 per day • Reactions: Tongue disorder NOS, Tongue ulceration, Drooling, Unwell, Tracheal and laryngeal disorder NOS… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-012224
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.50 Year
  • Weight: 3.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Solution
  • Dose: 0.30 mL per animal
  • Frequency: 2 per day
Reactions Reported:
Tongue disorder NOS Tongue ulceration Drooling Unwell Tracheal and laryngeal disorder NOS Crust Decreased appetite Laryngeal oedema Cough Head tilt - neurological disorder Swallowing disorder NOS Local swelling Tiredness (lethargy) Nasal discharge Malaise Dehydration Ocular discharge
Outcomes: Recovered/Normal

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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.