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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
Jun 22, 2026, 10:41 a.m.

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

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

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

Safety reports
Safety data refreshed
Jun 22, 2026, 10:42 a.m.

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

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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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)
  • Diabetes mellitus (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; 14 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), Diabetes mellitus (1 reports), Dermal thickening (1 reports), Decreased red blood cell count (1 reports)

Body systems represented Signal grouping

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

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

Terrier - Jack Russell (1), ['Retriever - Labrador', 'Dog (unknown)'] (1), Bulldog - English (1), Dog (unknown) (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, Diabetes mellitus

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
  • Diabetes mellitus

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (1 reports)
  • Diabetes mellitus (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
32
Matching reports
5
Active filters
2
Selected filters
Reaction: Lethargy (see also Central nervous system depression in Neurological) Clear Body system: Other Clear
Reset
Drill into common report signals
Lethargy (see also Central nervous system depression in Neurological) (7) Leucopenia NOS (7) Neutropenia (6) Anaemia NOS (4) Other (25) Neurologic (10) Digestive (7) Skin & allergy (6)
Showing up to 50 matching reports.

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-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-074320

Received 2025-11-24 · MSK · MSK

Serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
25-49 lb (18.14 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Behavioural disorder NOSEpidermal collaretteHepatic toxicosisDermal thickeningPyodermaJoint swellingLocal swelling (not application site)Skin ulcerLethargy (see also Central nervous system depression in Neurological)ItchingHair loss NOSDeathInappetence
Body systems
BehaviorOtherSkin & allergyNeurologic
Outcomes
Died

USA-USFDACVM-2025-US-068424

Received 2025-11-17 · MSK · MSK

Serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
25-49 lb (18.14 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Behavioural disorder NOSEpidermal collaretteHepatic toxicosisDermal thickeningPyodermaJoint swellingLocal swelling (not application site)Skin ulcerLethargy (see also Central nervous system depression in Neurological)ItchingHair loss NOSDeathInappetence
Body systems
BehaviorOtherSkin & allergyNeurologic
Outcomes
Died

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

Tracked signals
32
Reported cases
32
Serious reports
14
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Diarrhea, Decreased appetite Skin & allergy (2) · Hair loss, Application site hair loss Neurologic (1) · Unsteady walking (ataxia) Behavior (2) · Behavioral disorder (unspecified), Aggression Other (24) · Disorder of red blood cell NOS, Diabetes mellitus, Dermal thickening
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
Digestive 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 Non-serious - 1
Digestive Dog Non-serious - 1
Other Dog 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
Digestive Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Behavior Dog Non-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
Skin & allergy Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Behavior Dog Non-serious - 1
Other Dog Serious - 1
Other Cat 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 Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: 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 118 • Cat 5 • View
Case summaries: 32 (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) Diabetes mellitus (1) Dermal thickening (1) Decreased red blood cell count (1) Decreased haemoglobin (1) Decreased haematocrit (1) Decreased appetite (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, 2026-06-22)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-22)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-21)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-20)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-13)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-12)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-12)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-11)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-11)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-10)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-09)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-08)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-07)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-06)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-05)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-04)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-03)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-02)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-06-01)
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 Oct 1, 2025

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 Diarrhea (1) • Dog Decreased 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
Behavioral disorder (1) • Dog Aggression (1) • Dog

Showing top 5 for Behavior.

Other
Disorder of red blood cell NOS (1) • Dog Diabetes mellitus (1) • Dog Dermal thickening (1) • Dog Dermal nodule (1) • Dog Decreased urine concentration (1) • Dog
Show more (19)
Decreased red blood cell count (1) • Dog Decreased packed cell volume (1) • Dog Decreased haemoglobin (1) • Dog Decreased haematocrit (1) • Dog Death (1) • Dog Crust (1) • Dog Cough, hacking (1) • Dog Breathing difficulty (1) • Dog Blood in urine (1) • Dog Basophilia (1) • Dog Bacterial skin infection NOS (1) • Dog Application site reddening (1) • Dog Application site reaction NOS (1) • Dog Application site irritation (1) • Dog Application site hair change (1) • Dog Anaemia NOS (1) • Dog Adipsia (1) • Dog Accidental exposure (1) • Cat 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, Terrier - Jack Russell, Male, 6 year, 9.2 kilogram • Drug: MSK, Tablet, Unknown • Reactions: Seizure NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075234
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 6.00 Year
  • Weight: 9.200 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet
Reactions Reported:
Seizure NOS
Outcomes: Outcome Unknown

Dog, ['Retriever - Labrador', 'Dog (unknown)'], Male, 6.08 year, 31.75 kilogram • Drug: MSK, Tablet, Oral, Dose: 1.50 tablet per animal, Frequency: 1 per day • Reactions: Loose stool, Diarrhea • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075008
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 6.08 Year
  • Weight: 31.750 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:
Loose stool Diarrhea
Outcomes: Ongoing

Dog, Bulldog - English, Male, 9.17 year, 28.21 kilogram • Drug: MSK, Tablet, Oral, Dose: 1.50 tablet per animal, Frequency: 1 per day • Reactions: Loose stool, Diarrhea • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074996
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 9.17 Year
  • Weight: 28.210 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:
Loose stool Diarrhea
Outcomes: Ongoing

Dog, Dog (unknown), Female • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal • Reactions: Excessive appetite • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075048
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
Reactions Reported:
Excessive appetite
Outcomes: Ongoing

Dog, Terrier - West Highland White, Male, 11 year, 11.5 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Crust, Vomiting, Hair change, Dermal nodule, Hyperpigmentation • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075047
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 11.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Crust Vomiting Hair change Dermal nodule Hyperpigmentation
Outcomes: Ongoing

Dog, Retriever - Labrador, Female, 4 year, 32.21 kilogram • Drug: MSK, Tablet, Oral, Dose: 1.50 tablet per animal, Frequency: 1 per day • Reactions: Itching, Neutropenia, Lymphopenia, Leucopenia NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074814
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 32.210 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:
Itching Neutropenia Lymphopenia Leucopenia NOS
Outcomes: Outcome Unknown

Dog, ['Pit Bull', 'Dog (unknown)'], Female, 5 year, 36.29 kilogram • Drug: MSK, Tablet, Oral, Dose: 1.50 tablet per animal, Frequency: 1 per day • Reactions: Tiredness (lethargy), Diarrhea, Haematuria, Vomiting, Basophilia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074795
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 36.290 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:
Tiredness (lethargy) Diarrhea Haematuria Vomiting Basophilia Loss of appetite Adipsia Wheezing Unable to walk Unsteady walking (ataxia) Increased respiratory rate Dry mucous membrane Leucopenia NOS Fever Lameness Breathing difficulty Reluctant to move
Outcomes: Ongoing

Dog, Bloodhound, Female, 5 year, 41.28 kilogram • Drug: MSK, Tablet, Oral, Dose: 2 tablet per animal, Frequency: 1 per day • Reactions: Tiredness (lethargy), Stiffness NOS, Walking difficulty, Generalised weakness, Neutropenia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074895
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 41.280 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 2 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Tiredness (lethargy) Stiffness NOS Walking difficulty Generalised weakness Neutropenia Low platelet count Pain NOS Decreased appetite Vomiting Elevated liver enzymes NOS Fluid in abdomen NOS Liver disorder NOS Other immune system disorder NOS Fever Leucopenia NOS Distension of abdomen Hypoglycaemia Anaemia NOS Indigestion
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

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