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Roxee Medication Guide

Ilunocitinib

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 Tablet 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • 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
Ilunocitinib

Ilunocitinib

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

Both Tablet 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.

Ilunocitinib

For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Species commonly shown: Both.

Generic name
Ilunocitinib
Brand names
Zenrelia™, Zenrelia
Manufacturer
Elanco US Inc.
Species
Both
Dosage forms
Tablet
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Zenrelia™ Zenrelia
Dosage forms
Tablet

Indications / Uses

For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Lethargy (see also Central nervous system depression in Neurological), Diarrhoea, Vomiting, Leucopenia NOS, Neutropenia.

FAQ

Both

Yes. Roxee shows this as prescription-only.

Tablet

Related Conditions

Atopic Dermatitis (Canine Atopy) Pruritus (itching, undifferentiated)

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 control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

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:

  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (1 reports)
  • Cyanotic mucous membranes (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 Ilunocitinib; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-072174
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 11 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-072174
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-072174
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

Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Cyanotic mucous membranes (1 reports), Cough (1 reports), Breathing difficulty (1 reports)

Body systems represented Signal grouping

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

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (31 reports), Cat (1 reports)

Breed metadata in reports Metadata only

Mastiff (unspecified) (1), Chinese Crested Dog (unspecified) (1), Dog (unknown) (1), Shiba Inu (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 Ilunocitinib 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

wobbly/unsteady walking, Loss of appetite, Cyanotic mucous membranes

Call sooner if Escalation

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

Bottom line: Use this Ilunocitinib 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-072174 · adverse_reaction · adverse reactions
  2. FDA application profile · official_label · quick facts
  3. Medication usage source · fda_animal_drugs · quick facts
  4. FOI · document · documents
  5. FOI · document · documents
  6. SPL · document · documents
  7. Structured Product Label · document · documents
  8. Structured Product Label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:
Safety & side effects

Side effects to monitor:

  • wobbly/unsteady walking
  • Loss of appetite
  • Cyanotic mucous membranes

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
  • Cyanotic mucous membranes (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
Not linked yet
Indication / use
For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Form / route / dose
Form: Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
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: Tablet
Identifiers:
NADA: 141585 NDC Package: 58198-5536-1 NDC Package: 58198-5536-2 NDC Package: 58198-5536-3 NDC Package: 58198-5537-1 NDC Package: 58198-5537-2 NDC Package: 58198-5537-3 NDC Package: 58198-5538-1 NDC Package: 58198-5538-2 NDC Package: 58198-5538-3 NDC Package: 58198-5539-1 NDC Package: 58198-5539-2 NDC Package: 58198-5539-3 NDC Product: 58198
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
63
Matching reports
63
Active filters
0
Reset
Drill into common report signals
Lethargy (see also Central nervous system depression in Neurological) (10) Neutropenia (10) Anaemia NOS (9) Death (7) Other (51) Neurologic (17) Digestive (14) Skin & allergy (8)
Showing up to 50 matching reports. Narrow filters to inspect the remaining reports.

USA-USFDACVM-2026-US-014510

Received 2026-03-26 · MSK · MSK

Non-serious
Species
Dog
Breed
Mastiff (unspecified)
Size / weight
100+ lb (74.38 Kilogram)
Age
4-7 years (5.5 Year)
Sex
Male Neutered
Region
USA
Reactions
Hair coat discolouration
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-014507

Received 2026-03-26 · MSK · MSK

Non-serious
Species
Dog
Breed
Chinese Crested Dog (unspecified)
Size / weight
25-49 lb (11.34 Kilogram)
Age
8+ years (12.83 Year)
Sex
Male Unknown
Region
USA
Reactions
AtaxiaUrinary incontinenceFalling
Body systems
NeurologicOther
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014491

Received 2026-03-26 · MSK · MSK

Non-serious
Species
Dog
Breed
Dog (unknown)
Sex
Unknown Unknown
Region
USA
Reactions
Biting -aggression (see also Skin and appendages disorders)Anxiety
Body systems
Behavior
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-014490

Received 2026-03-26 · MSK · MSK

Non-serious
Species
Dog
Breed
Shiba Inu
Size / weight
25-49 lb (11.43 Kilogram)
Age
8+ years (13 Year)
Sex
Male Neutered
Region
USA
Reactions
Elevated serum alkaline phosphatase (ALP)
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-014485

Received 2026-03-25 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
25-49 lb (22.044 Kilogram)
Age
4-7 years (6.75 Year)
Sex
Female Neutered
Region
USA
Reactions
Not himself/herselfAnorexiaLethargy (see also Central nervous system depression in Neurological)Anaemia NOSThrombocytopeniaVomitingDecreased haematocritUncomfortable
Body systems
OtherDigestiveNeurologic
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014194

Received 2026-03-25 · MSK · MSK

Non-serious
Species
Dog
Breed
['Maltese', 'Dog (unknown)']
Size / weight
10-24 lb (11 Kilogram)
Age
8+ years (12 Year)
Sex
Female Neutered
Region
USA
Reactions
Mass NOSAbnormal histology NOS
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-014104

Received 2026-03-25 · MSK · MSK

Serious
Species
Dog
Breed
Retriever - Golden
Size / weight
50-99 lb (37.194 Kilogram)
Age
8+ years (12 Year)
Sex
Female Neutered
Region
USA
Reactions
Plasmacytoma
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-014098

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
Bulldog - American
Size / weight
50-99 lb (43.1 Kilogram)
Age
1-3 years (3 Year)
Sex
Male Neutered
Region
USA
Reactions
Elevated serum alkaline phosphatase (ALP)Not eatingAtaxiaHepatopathyRollingElevated alanine aminotransferase (ALT)Jaundice
Body systems
OtherNeurologic
Outcomes
Ongoing

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-013823

Received 2026-03-24 · MSK · MSK

Serious
Species
Dog
Breed
['Shepherd Dog - Australian', 'Dog (unknown)']
Size / weight
50-99 lb (41.05 Kilogram)
Age
8+ years (10.4 Year)
Sex
Male Neutered
Region
USA
Reactions
Lack of efficacy - NOSLow thyroxine (T4)
Body systems
EffectivenessOther
Outcomes
Ongoing

USA-USFDACVM-2026-US-013873

Received 2026-03-23 · MSK · MSK

Serious
Species
Dog
Breed
Setter (unspecified)
Size / weight
50-99 lb (27.2 Kilogram)
Age
8+ years (14 Year)
Sex
Male Neutered
Region
USA
Reactions
DeathBreathing difficultyWeight loss
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-013334

Received 2026-03-20 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (42.8 Kilogram)
Age
8+ years (8 Year)
Sex
Female Neutered
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-014100

Received 2026-03-18 · MSK · MSK

Non-serious
Species
Dog
Breed
['Retriever - Labrador', 'Poodle (unspecified)']
Size / weight
25-49 lb (11.7 Kilogram)
Age
8+ years (8.08 Year)
Sex
Female Neutered
Region
USA
Reactions
HypoalbuminaemiaNeutropenia
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013535

Received 2026-03-18 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Sex
Female Neutered
Region
USA
Reactions
Anaemia NOSLeukopenia NOSNeutropeniaLethargy (see also Central nervous system depression in Neurological)AnorexiaDiarrhoeaLymphadenopathyEnteritisAbnormal radiograph findingOther abnormal test result NOSUrinary tract infectionIncreased band neutrophiliaPain NOSWobblinessTiredness
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2026-US-012607

Received 2026-03-18 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (28.53 Kilogram)
Age
8+ years (8 Year)
Sex
Female Intact
Region
USA
Reactions
Lack of efficacy - NOS
Body systems
Effectiveness
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-014633

Received 2026-03-17 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Bull
Size / weight
50-99 lb (24.9 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
Soft stoolDecreased appetiteHypoalbuminaemiaReduced globulinsAscites
Body systems
OtherDigestive
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-012291

Received 2026-03-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Lhasa Apso
Size / weight
10-24 lb (4.853 Kilogram)
Age
8+ years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
Injection site mass NOSInjection site inflammationAbnormal cytology
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-011925

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Dog
Breed
Shar Pei
Size / weight
25-49 lb (14.97 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
TremblingSwollen jointFeverShaking
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-011917

Received 2026-03-13 · MSK · MSK

Non-serious
Species
Dog
Breed
Spaniel - Cocker American
Size / weight
25-49 lb (11.79 Kilogram)
Age
8+ years (12.5 Year)
Sex
Male Neutered
Region
USA
Reactions
LimpingLickingPain NOSHyperkeratosisBumps on skinLocal swelling (not application site)
Body systems
OtherSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2026-US-012599

Received 2026-03-12 · MSK · MSK

Serious
Species
Dog
Breed
Bulldog - English
Size / weight
50-99 lb (22.68 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
Head tremorFly biting behaviourLack of efficacy - NOSPolydipsiaPruritusPolyuriaPyodermaElevated blood urea nitrogen (BUN)Urinary tract infectionProteinuriaHaematuria
Body systems
NeurologicBehaviorEffectivenessOtherSkin & allergy
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-012303

Received 2026-03-11 · MSK · MSK

Non-serious
Species
Dog
Breed
Spaniel - Cocker American
Size / weight
10-24 lb (10.4 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
Neutropenia
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-011047

Received 2026-03-09 · MSK · MSK

Non-serious
Species
Dog
Breed
['Pit Bull', 'Dog (unknown)']
Size / weight
50-99 lb (38.555 Kilogram)
Age
1-3 years (2.33 Year)
Sex
Female Neutered
Region
USA
Reactions
Leukopenia NOSNeutropenia
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-013719

Received 2026-02-25 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (33.75 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
Vomiting bile
Body systems
Digestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-007171

Received 2026-02-18 · MSK · MSK

Serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (5.4 Kilogram)
Age
8+ years (14.91 Year)
Sex
Male Neutered
Region
USA
Reactions
CoughDeathPneumonia
Body systems
Other
Outcomes
Died

USA-USFDACVM-2026-US-006095

Received 2026-02-11 · MSK · MSK

Serious
Species
Dog
Breed
['American Pit Bull Terrier', 'Dog (unknown)']
Size / weight
50-99 lb (41.73 Kilogram)
Age
1-3 years (3 Year)
Sex
Female Neutered
Region
USA
Reactions
HypersalivationDeathSeizure NOSDiarrhoeaPericardial effusionDigestive tract disorder NOSHepatopathyNephropathyFemale reproductive tract disorder NOSPulmonary haemorrhageGastric dilationLateral recumbencySkin disorders NOSPetechiae NOSNecropsy performedAsystoleCyanotic mucous membranes
Body systems
DigestiveOtherNeurologic
Outcomes
Died

USA-USFDACVM-2026-US-005907

Received 2026-02-11 · MSK · MSK

Non-serious
Species
Dog
Breed
['Maltese', 'Poodle (unspecified)']
Size / weight
Under 10 lb (4.5 Kilogram)
Age
8+ years (1 Year)
Sex
Female Neutered
Region
USA
Reactions
DiarrhoeaVomiting
Body systems
Digestive
Outcomes
Recovered/Normal

USA-USFDACVM-2026-US-005375

Received 2026-02-05 · MSK · MSK

Non-serious
Species
Dog
Breed
['Hound (unspecified)', 'Dog (unknown)']
Size / weight
50-99 lb (34.69 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
Allergic dermatitisEar infection NOSAbnormal cytologyOther ear disorder NOSApplication site painApplication site reddeningApplication site inflammation
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-005573

Received 2026-01-30 · MSK · MSK

Non-serious
Species
Dog
Breed
['Retriever - Labrador', 'Chow Chow']
Size / weight
50-99 lb (24.95 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Localised oedema (not application site)WoundSwollen limbLickingLocalised pain NOS (see other SOCs for specific pain)Tooth disorder
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2026-US-007782

Received 2026-01-28 · MSK · MSK

Serious
Species
Dog
Breed
Rottweiler
Size / weight
100+ lb (47.62 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Urinary bladder disorder NOSAnaemia NOSSepticaemiaUnresponsive to stimuliDeath by euthanasiaEmphysema NOS (see Respiratory for pulmonary emphysema)
Body systems
Other
Outcomes
Euthanized

USA-USFDACVM-2026-US-003824

Received 2026-01-26 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (37 Kilogram)
Age
8+ years (9 Year)
Sex
Male Intact
Region
USA
Reactions
Elevated serum alkaline phosphatase (ALP)Lethargy (see also Central nervous system depression in Neurological)Anaemia NOS
Body systems
OtherNeurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2026-US-003069

Received 2026-01-22 · MSK · MSK

Serious
Species
Dog
Breed
Rottweiler
Size / weight
100+ lb (47.62 Kilogram)
Age
4-7 years (4 Year)
Sex
Male Neutered
Region
USA
Reactions
Urinary bladder disorder NOSAnaemia NOSSepticaemiaUnresponsive to stimuliDeath by euthanasiaEmphysema NOS (see Respiratory for pulmonary emphysema)
Body systems
Other
Outcomes
Euthanized

USA-USFDACVM-2025-US-075234

Received 2025-12-24 · MSK · MSK

Serious
Species
Dog
Breed
Terrier - Jack Russell
Size / weight
10-24 lb (9.2 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
Seizure NOS
Body systems
Neurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-075008

Received 2025-12-24 · MSK · MSK

Non-serious
Species
Dog
Breed
['Retriever - Labrador', 'Dog (unknown)']
Size / weight
50-99 lb (31.75 Kilogram)
Age
4-7 years (6.08 Year)
Sex
Male Neutered
Region
USA
Reactions
Loose stoolDiarrhoea
Body systems
OtherDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-074996

Received 2025-12-24 · MSK · MSK

Non-serious
Species
Dog
Breed
Bulldog - English
Size / weight
50-99 lb (28.21 Kilogram)
Age
8+ years (9.17 Year)
Sex
Male Intact
Region
USA
Reactions
Loose stoolDiarrhoea
Body systems
OtherDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-075048

Received 2025-12-23 · MSK · MSK

Non-serious
Species
Dog
Breed
Dog (unknown)
Sex
Female Unknown
Region
USA
Reactions
Excessive appetite
Body systems
Digestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-075047

Received 2025-12-23 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - West Highland White
Size / weight
25-49 lb (11.5 Kilogram)
Age
8+ years (11 Year)
Sex
Male Neutered
Region
USA
Reactions
CrustVomitingHair changeDermal noduleHyperpigmentation
Body systems
OtherDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-074814

Received 2025-12-23 · MSK · MSK

Non-serious
Species
Dog
Breed
Retriever - Labrador
Size / weight
50-99 lb (32.21 Kilogram)
Age
4-7 years (4 Year)
Sex
Female Neutered
Region
USA
Reactions
PruritusNeutropeniaLymphopeniaLeucopenia NOS
Body systems
Skin & allergyOther
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-074795

Received 2025-12-20 · MSK · MSK

Serious
Species
Dog
Breed
['Pit Bull', 'Dog (unknown)']
Size / weight
50-99 lb (36.29 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)DiarrhoeaHaematuriaVomitingBasophiliaAnorexiaAdipsiaWheezingUnable to walkAtaxiaIncreased respiratory rateDry mucous membraneLeucopenia NOSPyrexiaLamenessBreathing difficultyReluctant to move
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-074895

Received 2025-12-19 · MSK · MSK

Serious
Species
Dog
Breed
Bloodhound
Size / weight
50-99 lb (41.28 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Stiffness NOSWalking difficultyGeneralised weaknessNeutropeniaLow platelet countPain NOSDecreased appetiteVomitingElevated liver enzymes NOSFluid in abdomen NOSLiver disorder NOSOther immune system disorder NOSFeverLeucopenia NOSDistension of abdomenHypoglycaemiaAnaemia NOSIndigestion
Body systems
NeurologicOtherDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-074827

Received 2025-12-19 · MSK · MSK

Non-serious
Species
Cat
Breed
Siamese
Size / weight
10-24 lb (4.93 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
DistressIncreased heart rateIncreased respiratory rateElevated temperatureAccidental exposure
Body systems
Other
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-074810

Received 2025-12-19 · MSK · MSK

Non-serious
Species
Dog
Breed
Crossbred Canine/dog
Size / weight
25-49 lb (17.32 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Weight lossDecreased red blood cell countLeucopenia NOSAnaemia NOSLymphopeniaIncreased percentage reticulocytes
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-074706

Received 2025-12-19 · MSK · MSK

Non-serious
Species
Dog
Breed
Bichon Frise
Size / weight
10-24 lb (7.71 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Leucopenia NOSNeutropenia
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-073859

Received 2025-12-17 · MSK · MSK

Non-serious
Species
Dog
Breed
Shepherd Dog - German
Size / weight
100+ lb (45.81 Kilogram)
Age
8+ years (12 Year)
Sex
Male Neutered
Region
USA
Reactions
Weight gainItchingSkin and tissue infection NOS
Body systems
OtherSkin & allergy
Outcomes
Ongoing

USA-USFDACVM-2025-US-073869

Received 2025-12-16 · MSK · MSK

Non-serious
Species
Dog
Breed
Chihuahua
Size / weight
10-24 lb (7.7 Kilogram)
Age
4-7 years (6 Year)
Sex
Male Neutered
Region
USA
Reactions
Decreased urine concentrationProteinuriaInappropriate urinationWeight loss
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-074712

Received 2025-12-11 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull
Size / weight
50-99 lb (29.9 Kilogram)
Age
4-7 years (6.5 Year)
Sex
Male Neutered
Region
USA
Reactions
Weight gain
Body systems
Other
Outcomes
Ongoing

USA-USFDACVM-2025-US-072512

Received 2025-12-11 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull
Size / weight
50-99 lb (23.9 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Neutered
Region
USA
Reactions
Behavioural disorder NOSAggression
Body systems
Behavior
Outcomes
Ongoing

USA-USFDACVM-2025-US-072277

Received 2025-12-10 · MSK · MSK

Non-serious
Species
Dog
Breed
['Terrier - Yorkshire', 'Maltese']
Size / weight
10-24 lb (7.25 Kilogram)
Age
1-3 years (2 Year)
Sex
Male Neutered
Region
USA
Reactions
Other abnormal test result NOS
Body systems
Other
Outcomes
Recovered/Normal

USA-USFDACVM-2025-US-072427

Received 2025-12-09 · MSK · MSK

Non-serious
Species
Dog
Breed
Dog (unknown)
Sex
Unknown Unknown
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)
Body systems
Neurologic
Outcomes
Outcome Unknown

USA-USFDACVM-2025-US-072729

Received 2025-12-05 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull
Size / weight
25-49 lb (17.6 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Neutered
Region
USA
Reactions
Leucopenia NOSAnaemia NOSHypoalbuminaemiaNeutropeniaPyodermaReduced globulinsHypophosphataemiaNon-regenerative anaemiaLow serum alkaline phosphatase (ALP)Pale mucous membraneElevated alanine aminotransferase (ALT)Decreased packed cell volume (PCV)Lethargy (see also Central nervous system depression in Neurological)HypocalcaemiaElevated aspartate aminotransferase (AST)HypoproteinaemiaProteinuriaElectrolyte disorderDisorder of red blood cell NOSElevated creatine-kinase (CK)Other coagulation investigation abnormalityIncreased band neutrophiliaElevated mean corpuscular volume (MCV)LymphopeniaOther abnormal test result NOSDiarrhoeaPanleucopeniaEosinopeniaDecreased haematocritIncreased percentage reticulocytes
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-072061

Received 2025-12-05 · MSK · MSK

Non-serious
Species
Dog
Breed
Corso Dog
Size / weight
100+ lb (63.5 Kilogram)
Age
4-7 years (5 Year)
Sex
Male Intact
Region
USA
Reactions
UrinationExcessive thirstInappropriate urination
Body systems
Other
Outcomes
Outcome Unknown

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

Tracked signals
32
Reported cases
32
Serious reports
11
Species represented
2
Grouped by Body System
Digestive (1) · Loss of appetite Skin & allergy (2) · Hair loss, Application site hair loss Neurologic (1) · Unsteady walking (ataxia) Behavior (4) · Biting -aggression, Behavioral disorder (unspecified), Anxiety Other (24) · Cyanotic mucous membranes, Crust, Cough, hacking
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (31) Cat (1)

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

Zenrelia™ SPL · SPL Zenrelia SPL SPL · Structured Product Label Zenrelia SPL SPL · Structured Product Label

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

3

FOI

2

Zenrelia™

SPL · SPL

Open original
FDA Structured Product Label

Zenrelia™

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
141-585
Status
RX
Form
Tablet
Route
Oral
Composition / specifications
4.8, 6.4, 8.5, or 15 mg of ilunocitinib per tablet

Dogs

Indication

For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Dosage

Administer orally 0.27 to 0.36 mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once daily, with or without food.

Zenrelia SPL

SPL · Structured Product Label

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

Zenrelia SPL

SPL · Structured Product Label

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

FOI Summary sN 141-585 Approved September 19, 2025.pdf

FOI · FOI

Open original

FOI Summary oN 141-585 Approved September 19, 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 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Aug 6, 2026, 7:47 PM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • 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 • FDA branded products available
Official FDA brands: Zenrelia
Manufacturer mapping: Elanco US Inc.
Case-reported brands (openFDA): MSK
Catalog species: Both
Rx/OTC: RX
Form/route: Tablet • Oral
Applications: NADA 141-585
NDC: Packages 58198-5536-1 58198-5536-2 58198-5536-3 58198-5537-1 58198-5537-2 58198-5537-3 • Products 58198
Documents: 2 (FOI: 2) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 186 • Cat 5 • View
Case summaries: 63 (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: L20.9
Atopic dermatitis, unspecified

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Top reaction signals
Unsteady walking (ataxia) (1) Loss of appetite (1) Cyanotic mucous membranes (1) Cough (1) Breathing difficulty (1) Blood in urine (1) Basophilia (1) Asystole (1)

Identifiers & Packages

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

Identifiers
NADA: 141585 NDC Package: 58198-5536-1 NDC Package: 58198-5536-2 NDC Package: 58198-5536-3 NDC Package: 58198-5537-1 NDC Package: 58198-5537-2 NDC Package: 58198-5537-3 NDC Package: 58198-5538-1 NDC Package: 58198-5538-2 NDC Package: 58198-5538-3 NDC Package: 58198-5539-1 NDC Package: 58198-5539-2 NDC Package: 58198-5539-3 NDC Product: 58198
Package NDC Product NDC Form / Route Status
58198-5536-1 58198 -
58198-5536-2 58198 -
58198-5536-3 58198 -
58198-5537-1 58198 -
58198-5537-2 58198 -
58198-5537-3 58198 -
58198-5538-1 58198 -
58198-5538-2 58198 -
58198-5538-3 58198 -
58198-5539-1 58198 -
58198-5539-2 58198 -
58198-5539-3 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 123 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Lethargy (see also Central nervous system depression in Neurological), Diarrhoea, Vomiting, Leucopeni… (Clinical, 2026-04-11)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-08-06)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-08-05)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-08-04)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-08-03)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-08-02)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-08-01)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-31)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-30)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-29)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-28)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-27)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-26)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-25)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-25)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-22)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-22)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-22)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-20)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-07-19)
Recent Revisions
  • side_effects 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
  • 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
  • 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
Zenrelia™
RX
Ilunocitinib
Tablet • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-585 Approved Jul 8, 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.

Composition / specifications
4.8, 6.4, 8.5, or 15 mg of ilunocitinib per tablet
Dogs
Indication

For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Dosage

Administer orally 0.27 to 0.36 mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once daily, with or without food.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Source: FDA Animal Drugs @ FDA • Reference

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) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog Application site hair loss (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Dog Behavioral disorder (1) • Dog Anxiety (1) • Dog Aggression (1) • Dog

Showing top 5 for Behavior.

Other
Cyanotic mucous membranes (1) • Dog Crust (1) • Dog Cough, hacking (1) • Dog Cough (1) • Dog Bumps on skin (1) • Dog
Show more (19)
Breathing difficulty (1) • Dog Blood in urine (1) • Dog Basophilia (1) • Dog Bacterial skin infection NOS (1) • Dog Asystole (1) • Dog Ascites (1) • Dog Application site reddening (1) • Dog Application site reaction NOS (1) • Dog Application site pain (1) • Dog Application site irritation (1) • Dog Application site inflammation (1) • Dog Application site hair change (1) • Dog Anaemia NOS (1) • Dog Allergic dermatitis (1) • Dog Adipsia (1) • Dog Accidental exposure (1) • Cat Abnormal radiograph finding (1) • Dog Abnormal histology NOS (1) • Dog Abnormal cytology (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, Mastiff (unspecified), Male, 5.5 year, 74.38 kilogram • Drug: MSK, Tablet, Oral, Dose: 3 tablet per animal, Frequency: 1 per day • Reactions: Hair coat discolouration • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014510
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 5.50 Year
  • Weight: 74.380 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 3 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Hair coat discolouration
Outcomes: Ongoing

Dog, Chinese Crested Dog (unspecified), Male, 12.83 year, 11.34 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Unsteady walking (ataxia), Urinary incontinence, Falling • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014507
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 12.83 Year
  • Weight: 11.340 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Unsteady walking (ataxia) Urinary incontinence Falling
Outcomes: Recovered/Normal

Dog, Dog (unknown), Unknown • Drug: MSK, Tablet, Unknown • Reactions: Biting -aggression, Anxiety • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014491
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet
Reactions Reported:
Biting -aggression Anxiety
Outcomes: Outcome Unknown

Dog, Shiba Inu, Male, 13 year, 11.43 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Elevated serum alkaline phosphatase • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014490
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 11.430 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Elevated serum alkaline phosphatase
Outcomes: Ongoing

Dog, Retriever - Labrador, Female, 6.75 year, 22.044 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal • Reactions: Not himself/herself, Loss of appetite, Tiredness (lethargy), Anaemia NOS, Thrombocytopenia… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014485
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.75 Year
  • Weight: 22.044 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
Reactions Reported:
Not himself/herself Loss of appetite Tiredness (lethargy) Anaemia NOS Thrombocytopenia Vomiting Decreased haematocrit Uncomfortable
Outcomes: Recovered/Normal

Dog, ['Maltese', 'Dog (unknown)'], Female, 12 year, 11 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Mass NOS, Abnormal histology NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2026-US-014194
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 11.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Mass NOS Abnormal histology NOS
Outcomes: Recovered/Normal

Dog, Retriever - Golden, Female, 12 year, 37.194 kilogram • Drug: MSK, Tablet, Oral • Reactions: Plasmacytoma • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2026-US-014104
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 12.00 Year
  • Weight: 37.194 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Plasmacytoma
Outcomes: Outcome Unknown

Dog, Bulldog - American, Male, 3 year, 43.1 kilogram • Drug: MSK, Tablet, Oral, Dose: 1.50 tablet per animal, Frequency: 1 per day • Reactions: Elevated serum alkaline phosphatase, Not eating, Unsteady walking (ataxia), Hepatopathy, Rolling… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2026-US-014098
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 43.100 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1.50 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Elevated serum alkaline phosphatase Not eating Unsteady walking (ataxia) Hepatopathy Rolling Elevated alanine aminotransferase Jaundice
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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.