Meds A-Z
Oclacitinib
Detailed information about Oclacitinib
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
What it does:
Used for allergic and atopic dermatitis itch control in dogs.
When it's needed:
Not for use in dogs with serious infections; avoid use in very young dogs.
Call your vet sooner if you notice:
- Not for use in dogs with serious infections; avoid use in very young dogs.
Commonly reported reactions:
- (1 reports)
- (1 reports)
- (1 reports)
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?
Oclacitinib
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Dog
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141555 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141345 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
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.
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
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.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 |
Species coverage: Dog (28) Cat (4)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-053873
Storage & Handling
Store at room temperature.
Documents
Official label facts are separated from secondary summaries.
Official documents: 4 • Secondary summaries: 0
- N-141555-Q-0004-OT-AA_foi.pdf · FOI
- apoquel® chewable · SPL
- UCM363901.pdf · FOI
- apoquel® · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/14146 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/14400/apoquel%C2%AE%20chewable · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/902 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1653/apoquel%C2%AE · document · SPL
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 7:40 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 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 Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:02 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:19 AM UTC
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- Not for use in dogs with serious infections; avoid use in very young dogs. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| 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 & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- 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)
- 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
|
Zoetis Inc. | NADA 141-555 | Approved | Oct 17, 2024 |
|
apoquel®
RX
Oclacitinib
Tablet
• Oral
|
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.
Composition / specifications
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
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.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
- apoquel® chewable (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM363901.pdf
Summary
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
- apoquel® (ZIP)
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)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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
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
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
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
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
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
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
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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