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Ilunocitinib

Detailed information about Ilunocitinib

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

Reviewed: Not available

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

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

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

What to watch for:

  • Swollen limb (1 reports)
  • Paralysis NOS (1 reports)
  • Panting (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 ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
Safety & side effects

What to watch:

  • Swollen limb
  • Paralysis NOS
  • Panting

Most reported reactions:

  • Swollen limb (1 reports)
  • Paralysis NOS (1 reports)
  • Panting (1 reports)

When to call your vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Data freshness: source data appears current.

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

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 24, 2026, 11:07 AM UTC
Image coming soon
Ilunocitinib

Ilunocitinib

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

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both
Manufacturer: Not available
Form: 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
24
Reported cases
16
Serious reports
5
Species represented
1
Grouped by Body System
Digestive (2) · Vomiting, Diarrhea Skin & allergy (2) · Hives, Alopecia local Neurologic (2) · Tiredness (lethargy), Unsteady walking (ataxia) Other (18) · Unable to jump, Swollen limb, Polyuria
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Digestive 1 Dog 0
Other 1 Dog 0
Neurologic 1 Dog 0

Species coverage: Dog (24)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Dog Non-serious - 1
Other Dog Non-serious - 1
Neurologic 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 Serious - 1
Other Dog Non-serious - 1
Skin & allergy Dog Non-serious - 1
Other Dog Serious - 1
Digestive Dog Non-serious - 1
Other Dog Non-serious - 1
Neurologic Dog Unknown - -
Other Dog Unknown - -
Other Dog Unknown - -
Other Dog Unknown - -
Skin & allergy Dog Unknown - -
Other Dog Unknown - -
Other Dog Unknown - -
Other Dog Unknown - -
Source metadata:

Documents

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

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (0)
  • No official label or package insert links yet.
SPL (1)
  • Zenrelia™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/16205/Zenrelia%E2%84%A2
FOI (2)
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 24, 2026, 11:07 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Zenrelia™
Case-reported brands (openFDA): MSK
Catalog species: Both
Rx/OTC: RX
Form/route: Tablet • Oral
Applications: NADA 141-585
Documents: 2 (FOI: 2) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 28 • Cat 0 • View
Case summaries: 9 (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
Swollen limb (1) Paralysis NOS (1) Panting (1) Localised pain NOS (1) Fever (1) Vomiting (1) Unable to jump (1) Tiredness (lethargy) (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 4 Clinical 0 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… (Official, 2026-02-12)
  • usage: For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (Official, 2026-02-12)
Recent Revisions
  • 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

Official Documents (FDA)

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

Documents
SPL Packages

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
Vomiting (1) • Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hives (1) • Dog Alopecia local • Dog

Showing top 5 for Skin & allergy.

Neurologic
Tiredness (1) • Dog Unsteady walking • Dog

Showing top 5 for Neurologic.

Other
Unable to jump (1) • Dog Swollen limb (1) • Dog Polyuria (1) • Dog Paralysis NOS (1) • Dog Panting (1) • Dog
Show more (13)
Oral mass (1) • Dog Not eating (1) • Dog Muscle weakness NOS (1) • Dog Localised pain NOS (1) • Dog Inappropriate urination (1) • Dog Fever (1) • Dog Cough, hacking (1) • Dog Decreased haemoglobin • Dog Decreased haematocrit • Dog Death by euthanasia • Dog Abnormal radiograph finding • Dog Abnormal movement NOS • Dog Abnormal cytology • 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, Lhasa Apso, Female, 10.92 year, 11.16 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Diarrhea, Oral mass • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-056010
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 10.92 Year
  • Weight: 11.160 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Diarrhea Oral mass
Outcomes: Ongoing

Dog, Pit Bull, Male, 8 year, 24.86 kilogram • Drug: MSK, Tablet, Oral, Dose: 2 tablet per animal, Frequency: 1 per day • Reactions: Unable to jump, Muscle weakness NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055968
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 24.860 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 2 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Unable to jump Muscle weakness NOS
Outcomes: Outcome Unknown

Dog, Sheepdog - Shetland, Female, 4.5 year, 9 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Inappropriate urination, Polyuria • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055980
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.50 Year
  • Weight: 9.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Inappropriate urination Polyuria
Outcomes: Outcome Unknown

Dog, Bulldog - French, Unknown, 12.06 kilogram • Drug: MSK, Tablet, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Hives • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055627
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Weight: 12.060 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Hives
Outcomes: Ongoing

Dog, Dog (unknown), Unknown • Drug: MSK, Tablet, Oral • Reactions: Diarrhea • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055782
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Diarrhea
Outcomes: Recovered/Normal

Dog, Pit Bull, Female, 3 year, 26.3 kilogram • Drug: MSK, Tablet, Oral, Dose: 2 tablet per animal, Frequency: 1 per day • Reactions: Tiredness (lethargy), Vomiting, Diarrhea • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055512
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 3.00 Year
  • Weight: 26.300 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) Vomiting Diarrhea
Outcomes: Recovered/Normal

Dog, ['Dachshund - Standard Long-haired', 'Dog (unknown)'], Male, 12 year, 8.936 kilogram • Drug: MSK, Tablet, Oral • Reactions: Fever, Panting, Swollen limb, Localised pain NOS, Paralysis NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055637
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 8.936 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Fever Panting Swollen limb Localised pain NOS Paralysis NOS
Outcomes: Ongoing

Dog, Retriever - Labrador, Male, 8 year, 24.94 kilogram • Drug: MSK, Tablet, Oral, Frequency: 1 per day • Reactions: Diarrhea • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055970
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 24.940 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Frequency: 1 per day
Reactions Reported:
Diarrhea
Outcomes: Recovered/Normal

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

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

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