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Roxee Meds Catalog

Ilunocitinib

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Tablet Elanco US Inc. Official label facts Owner quick guide first

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Data freshness

Storefront facts
Catalog refreshed
May 5, 2026, 10:00 a.m.

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

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

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

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

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

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 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 May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

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

Sources:
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Ilunocitinib

Ilunocitinib

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

Both Tablet Rx required 100% storefront ready

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

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?
Major cautions & emergency warning signs

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)

Emergency warning signs:

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

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.

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:

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

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

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

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

Zenrelia SPL

SPL · Structured Product Label

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

FOI Summary oN 141-585 Approved September 19, 2024.pdf

FOI · FOI

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
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 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 May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 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 36 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, 2026-05-05)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-05-03)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-05-02)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-04-29)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-04-28)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-04-27)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-04-26)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-04-25)
  • indications: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-04-22)
  • manufacturer_name: Elanco US Inc. (Official, 2026-05-05)
  • manufacturer_name: Elanco US Inc. (Official, 2026-05-03)
  • manufacturer_name: Elanco US Inc. (Official, 2026-05-02)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-29)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-28)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-27)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-26)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-25)
  • manufacturer_name: Elanco US Inc. (Official, 2026-04-22)
  • prescription_required: Rx required (Official, 2026-05-05)
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
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

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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