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Oclacitinib

Detailed information about Oclacitinib

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

Reviewed: Not available

Updated: February 12, 2026, 7:40 PM UTC

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

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

What to watch for:

  • Not for use in dogs with serious infections
  • avoid use in very young dogs
  • Shivering (1 reports)
  • Premature ventricular contractions (1 reports)
  • Pitting oedema (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:

  • Not for use in dogs with serious infections
  • avoid use in very young dogs
  • Shivering
  • Premature ventricular contractions
  • Pitting oedema

Most reported reactions:

  • Shivering (1 reports)
  • Premature ventricular contractions (1 reports)
  • Pitting oedema (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, 10:01 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 7:40 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 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 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 17, 2026, 10:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:19 AM UTC
Image coming soon
Oclacitinib

Oclacitinib

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

Species: Dog

Manufacturer: Not available (source)

Quick Facts

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

Species: Dog
Manufacturer: Not available
Form: Chewable Tablets, Tablet
Identifiers:
NADA: 141345 NADA: 141555 NDC Package: 54771-4322-1 NDC Package: 54771-4322-2 NDC Package: 54771-4322-3 NDC Package: 54771-4322-4 NDC Package: 54771-4323-1 NDC Package: 54771-4323-2 NDC Package: 54771-4323-3 NDC Package: 54771-4323-4 NDC Package: 54771-4324-1 NDC Package: 54771-4324-2 NDC Package: 54771-4324-3 NDC Package: 54771-4324-4 NDC Package: 54771-8721-1 NDC Package: 54771-8721-2 NDC Package: 54771-8721-3 NDC Package: 54771-8722-1 NDC Package: 54771-8722-2 NDC Package: 54771-8722-3
Source metadata:

Warnings / Contraindications

Not for use in dogs with serious infections; avoid use in very young dogs.

  • High: Not for use in dogs with serious infections; avoid use in very young dogs.
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
31
Species represented
2
Grouped by Body System
Skin & allergy (1) · Application site hair loss Neurologic (2) · Neurological signs NOS, Convulsion Other (29) · Suspect counterfeit product, Shivering, Premature ventricular contractions
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (28) Cat (4)

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

Storage & Handling

Store at room temperature.

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 (2)
  • apoquel® chewable · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/14400/apoquel%C2%AE%20chewable
  • apoquel® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1653/apoquel%C2%AE
FOI (2)
  • N-141555-Q-0004-OT-AA_foi.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/14146
  • UCM363901.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/902
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, 7:40 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 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 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 17, 2026, 10:02 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:19 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: apoquel® apoquel® chewable
Case-reported brands (openFDA): MSK
Catalog species: Dog • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Chewable Tablets, Tablet • Oral
Applications: NADA 141-555 • NADA 141-345
Documents: 2 (FOI: 2) • SPL: 2 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 19 • Cat 6 • View
Case summaries: 7 (showing 7) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), 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.

Owner-facing counseling points
  • Not for use in dogs with serious infections; avoid use in very young dogs. (Contraindication, High)
Top reaction signals
Shivering (1) Premature ventricular contractions (1) Pitting oedema (1) Panting (1) Pain NOS (1) Pacing (1) Not eating (1) Not drinking (1)

Identifiers & Packages

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

Identifiers
NADA: 141345 NADA: 141555 NDC Package: 54771-4322-1 NDC Package: 54771-4322-2 NDC Package: 54771-4322-3 NDC Package: 54771-4322-4 NDC Package: 54771-4323-1 NDC Package: 54771-4323-2 NDC Package: 54771-4323-3 NDC Package: 54771-4323-4 NDC Package: 54771-4324-1 NDC Package: 54771-4324-2 NDC Package: 54771-4324-3 NDC Package: 54771-4324-4 NDC Package: 54771-8721-1 NDC Package: 54771-8721-2 NDC Package: 54771-8721-3 NDC Package: 54771-8722-1 NDC Package: 54771-8722-2 NDC Package: 54771-8722-3 NDC Package: 54771-8723-1 NDC Package: 54771-8723-2 NDC Package: 54771-8723-3 NDC Package: 82712-2004-1
Package NDC Product NDC Form / Route Status
54771-4322-1 54771 -
54771-4322-2 54771 -
54771-4322-3 54771 -
54771-4322-4 54771 -
54771-4323-1 54771 -
54771-4323-2 54771 -
54771-4323-3 54771 -
54771-4323-4 54771 -
54771-4324-1 54771 -
54771-4324-2 54771 -
54771-4324-3 54771 -
54771-4324-4 54771 -
54771-8721-1 54771 -
54771-8721-2 54771 -
54771-8721-3 54771 -
54771-8722-1 54771 -
54771-8722-2 54771 -
54771-8722-3 54771 -
54771-8723-1 54771 -
54771-8723-2 54771 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • N-141555-Q-0004-OT-AA_foi.pdf • FOI summary • Official • Oct. 17, 2024
    FDA FOI summary for application 141555
  • UCM363901.pdf • FOI summary • Official • Aug. 17, 2023
    FDA FOI summary for application 141345

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 5 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • storage_handling: Store at room temperature. (Clinical, 2026-02-12)
  • contraindications: Not for use in dogs with serious infections; avoid use in very young dogs. (Official, 2026-02-12)
  • side_effects: GI upset, lethargy; immune modulation may increase infection risk. (Official, 2026-02-12)
  • usage: Used for allergic and atopic dermatitis itch control in dogs. (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 19:40 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
apoquel® chewable
RX
Oclacitinib
Chewable Tablets • Oral
Label highlights
Official documents
Zoetis Inc. NADA 141-555 Approved Oct 17, 2024
apoquel®
RX
Oclacitinib
Tablet • Oral
Label highlights
Official documents
Zoetis Inc. NADA 141-345 Approved Aug 17, 2023

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
3.6, 5.4, or 16 mg of oclacitinib as oclacitinib maleate per tablet
Dogs
Indication

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

Dosage

The dose is 0.18 to 0.27 mg oclacitinib/lb (0.4 to 0.6 mg oclacitinib/kg) body weight, administered orally, twice daily for up to 14 days, and then administered once daily for maintenance therapy.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
3.6, 5.4, or 16 mg of oclacitinib as oclacitinib maleate per tablet
Dogs
Indication
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Dosage
Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.
Limitations
APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

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

Documents
  • Summary

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

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

Used for allergic and atopic dermatitis itch control in dogs.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Not for use in dogs with serious infections; avoid use in very young dogs.

Side Effects

GI upset, lethargy; immune modulation may increase infection risk.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Skin & allergy
Application site hair loss (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Neurological signs NOS (1) • Dog Convulsion (1) • Dog

Showing top 5 for Neurologic.

Other
Suspect counterfeit product (1) • Dog Shivering (1) • Cat Premature ventricular contractions (1) • Dog Pitting oedema (1) • Dog Panting (1) • Dog
Show more (24)
Pain NOS (1) • Dog Pacing (1) • Cat Not eating (1) • Dog Not drinking (1) • Dog Local skin slough (1) • Dog Injection site skin discolouration (1) • Dog Injection site serosanguinous discharge (1) • Dog Injection site reaction NOS (1) • Dog Injection site discharge NOS (1) • Dog Increased respiratory rate (1) • Dog Increased heart rate (1) • Dog Fixed pupil (1) • Dog Elevated temperature (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Drug administered at inappropriate site (1) • Cat Dilated pupils (1) • Dog Death (1) • Dog Deafness (1) • Dog Cyanotic mucous membranes (1) • Dog Coma (1) • Dog Cellulitis (1) • Dog Cardiorespiratory arrest (1) • Dog Asystole (1) • Dog Application site discharge NOS (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, Boxer (German Boxer), Female, 2.3 year, 28.7 kilogram • Drug: MSK, Tablet, Oral, Dose: 16 Milligram per dose, Frequency: 1 per day • Reactions: Death, Injection site discharge NOS, Swollen limb, Pain NOS, Not eating… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-055852
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 2.30 Year
  • Weight: 28.700 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 16 Milligram per dose
  • Frequency: 1 per day
Reactions Reported:
Death Injection site discharge NOS Swollen limb Pain NOS Not eating Not drinking Uncomfortable Elevated temperature Increased heart rate Increased respiratory rate Pitting oedema Injection site skin discolouration Injection site serosanguinous discharge Injection site reaction NOS Wound Cellulitis Local skin slough Convulsion Cardiorespiratory arrest Panting Fixed pupil Dilated pupils Cyanotic mucous membranes Coma Neurological signs NOS Premature ventricular contractions Ventricular fibrillation Asystole
Outcomes: Died

Dog, Mixed (Dog), Male, 10 year, 39 kilogram • Drug: MSK, Oral • Reactions: Elevated serum alkaline phosphatase, Panting, Underdose • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-056107
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 39.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
Reactions Reported:
Elevated serum alkaline phosphatase Panting Underdose
Outcomes: Outcome Unknown

Dog, Terrier - Fox Wire, Male, 10.8 year, 9.68 kilogram • Drug: MSK, Oral, Dose: 5.40 Milligram per unknown, Frequency: 24 per hour • Reactions: Deafness, Tympanic rupture, Application site discharge NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-053873
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 10.80 Year
  • Weight: 9.680 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Dose: 5.40 Milligram per unknown
  • Frequency: 24 per hour
Reactions Reported:
Deafness Tympanic rupture Application site discharge NOS
Outcomes: Outcome Unknown

Dog, Dog (unknown), Unknown • Drug: MSK, Tablet, chewable, Oral, Dose: 16 Milligram per animal • Reactions: Systemic disorder NOS, Suspect counterfeit product • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-066567
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 16 Milligram per animal
Reactions Reported:
Systemic disorder NOS Suspect counterfeit product
Outcomes: Recovered/Normal

Dog, American Pit Bull Terrier, Male, 12 year, 30 kilogram • Drug: MSK, Tablet, Oral • Reactions: Deafness • Outcome: Recovered with Sequela

  • Report ID: USA-USFDACVM-2025-US-048607
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 30.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Deafness
Outcomes: Recovered with Sequela

Cat, Male, 12 year, 8.618 kilogram • Drug: MSK, Tablet, Unknown, Dose: 4 Milligram per dose • Reactions: Shivering, Pacing, Uncomfortable, Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2023-US-005653
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 8.618 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet
  • Dose: 4 Milligram per dose
Reactions Reported:
Shivering Pacing Uncomfortable Vomiting
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Female, 11 year, 4.536 kilogram • Drug: MSK, Oral • Reactions: Application site hair loss, Drug administered at inappropriate site • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2019-US-018159
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
Reactions Reported:
Application site hair loss Drug administered at inappropriate site
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

Store at room temperature.

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