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Roxee Medication Guide

Oclacitinib

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Dog Reference complete FDA data linked Rx required Tablet Zoetis Inc. Official label facts Owner quick guide first
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Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:40 a.m.

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

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:40 a.m.

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

Safety reports
Safety data refreshed
Jun 21, 2026, 5:14 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, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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.
  • 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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Oclacitinib

Oclacitinib

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Dog Tablet Rx required 100% reference complete

Species: Dog

Manufacturer: Zoetis Inc.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Oclacitinib

Used for allergic and atopic dermatitis itch control in dogs. Species commonly shown: Dog.

Generic name
Oclacitinib
Brand names
apoquel®, apoquel® chewable
Manufacturer
Zoetis Inc.
Species
Dog
Dosage forms
Tablet, Chewable Tablets
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
apoquel® apoquel® chewable
Dosage forms
Tablet Chewable Tablets

Indications / Uses

Used for allergic and atopic dermatitis itch control in dogs.

Administration / How To Give

Oral

Storage

Store at room temperature.

Warnings / Contraindications

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

  • 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.

FAQ

Dog

Yes. Roxee shows this as prescription-only.

Tablet, Chewable Tablets

Store at room temperature.

Related Medications

Cyclosporine Same category: Allergies / Itching Diphenhydramine Same category: Allergies / Itching Lokivetmab Same category: Allergies / Itching Oclacitinib Maleate Same category: Allergies / Itching Prednisone Same category: Allergies / Itching Famotidine Same category: GI

Related Conditions

Atopic Dermatitis (Canine Atopy) Demodicosis 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:

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:

  • Not for use in dogs with serious infections
  • avoid use in very young dogs
  • wobbly/unsteady walking (1 reports)
  • Dilated pupils (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 Oclacitinib; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-074324
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 26 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-074324
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-074324
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), Dilated pupils (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 (2), 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

Bulldog - English (2), Terrier (unspecified) (1), Chihuahua (1), Terrier - Boston (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 Oclacitinib 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

Not for use in dogs with serious infections, avoid use in very young dogs, wobbly/unsteady walking, Dilated pupils, 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 Oclacitinib 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-074324 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 15, 2026, 10:04 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Not for use in dogs with serious infections
  • avoid use in very young dogs
  • wobbly/unsteady walking
  • Dilated pupils
  • Diabetes mellitus

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Dilated pupils (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
Dog
Indication / use
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Form / route / dose
Form: Chewable Tablets, Tablet
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Not for use in dogs with serious infections; avoid use in very young dogs.
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: Dog
Manufacturer: Zoetis Inc.
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.

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
0
Active filters
2
Selected filters
Reaction: Overdose Clear Body system: Neurologic Clear
Reset
Drill into common report signals
Lack of efficacy - NOS (8) Overdose (6) Lethargy (see also Central nervous system depression in Neurological) (5) Vomiting (5) Other (24) Effectiveness (10) Digestive (8) Neurologic (6)
No stored openFDA reports match the selected 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.

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

Tracked signals
32
Reported cases
32
Serious reports
26
Species represented
2
Grouped by Body System
Digestive (3) · Diarrhea, Decreased appetite, Blood in vomit Skin & allergy (2) · Hair loss, Application site hair loss Neurologic (2) · Unsteady walking (ataxia), Convulsion Behavior (2) · Behavioral disorder (unspecified), Aggression Other (23) · Dilated pupils, Difficulty going up/down stairs, Diabetes mellitus
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Digestive 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (31) Cat (1)

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

Storage & Handling

Store at room temperature.

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.

apoquel® chewable SPL · SPL apoquel® SPL · SPL N-141555-Q-0004-OT-AA_foi.pdf FOI · FOI

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

2

FOI

2

apoquel® chewable

SPL · SPL

Open original
FDA Structured Product Label

apoquel® chewable

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
141-555
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Dog
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.

apoquel®

SPL · SPL

Open original
FDA Structured Product Label

apoquel®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Zoetis Inc.
NADA
141-345
Status
RX
Form
Tablet
Route
Oral
Species
Dog
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.

N-141555-Q-0004-OT-AA_foi.pdf

FOI · FOI

Open original

UCM363901.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, 10:40 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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.
  • 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 • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
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 106 • Cat 0 • 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), 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
Unsteady walking (ataxia) (1) Dilated pupils (1) Diabetes mellitus (1) Dermal thickening (1) Decreased red blood cell count (1) Decreased appetite (1) Death by euthanasia (1) Death (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 12 Clinical 14 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Not for use in dogs with serious infections; avoid use in very young dogs. (Clinical, 2026-04-15)
  • contraindications: Not for use in dogs with serious infections; avoid use in very young dogs. (Clinical, 2026-04-15)
  • contraindications: Not for use in dogs with serious infections; avoid use in very young dogs. (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • side_effects: GI upset, lethargy; immune modulation may increase infection risk. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature. (Clinical, 2026-04-22)
  • storage_handling: Store at room temperature. (Clinical, 2026-04-15)
  • storage_handling: Store at room temperature. (Clinical, 2026-04-15)
  • storage_handling: Store at room temperature. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature. (Clinical, 2026-02-12)
  • usage: Used for allergic and atopic dermatitis itch control in dogs. (Clinical, 2026-04-15)
  • usage: Used for allergic and atopic dermatitis itch control in dogs. (Clinical, 2026-04-15)
  • usage: Used for allergic and atopic dermatitis itch control in dogs. (Clinical, 2026-04-11)
  • contraindications: Not for use in dogs with serious infections; avoid use in very young dogs. (Official, 2026-04-22)
  • 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, 2026-04-22)
  • side_effects: GI upset, lethargy; immune modulation may increase infection risk. (Official, 2026-04-15)
  • side_effects: GI upset, lethargy; immune modulation may increase infection risk. (Official, 2026-04-15)
  • side_effects: GI upset, lethargy; immune modulation may increase infection risk. (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 13:27 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 13:27 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 13:27 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 13:27 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 13:27 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 13:27 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:06 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:06 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:06 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-15 10:06 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-15 10:06 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-15 10:06 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-15 10:06 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-15 10:06 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-15 10:06 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 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
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
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

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).

Digestive
Diarrhea (1) • Dog Decreased appetite (1) • Dog Blood in vomit (1) • Dog

Showing top 5 for Digestive.

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

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Convulsion (1) • Dog

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog Aggression (1) • Dog

Showing top 5 for Behavior.

Other
Dilated pupils (1) • Dog Difficulty going up/down stairs (1) • Dog Diabetes mellitus (1) • Dog Dermal thickening (1) • Dog Decreased urine concentration (1) • Dog
Show more (18)
Decreased red blood cell count (1) • Dog Death by euthanasia (1) • Dog Death (1) • Dog Deafness (1) • Dog Cyanotic mucous membranes (1) • Dog Coma (1) • Dog Claw / hoof / nail disorder NOS (1) • Dog Cellulitis (1) • Dog Cartilage degeneration (1) • Dog Cardiorespiratory arrest (1) • Dog Bone and joint disorder NOS (1) • Dog Bloody stool (1) • Dog Asystole (1) • Dog Application site discharge NOS (1) • Dog Agitation (1) • Dog Active urine sediment (1) • Dog Abnormal ultrasound finding (1) • Dog Abnormal red blood cell (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 (unspecified), Male, 6.9 year, 3.36 kilogram • Drug: MSK, Tablet, Oral • Reactions: Lack of efficacy - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075257
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 6.90 Year
  • Weight: 3.360 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Ongoing

Dog, Chihuahua, Female, 1.5 year, 3.583 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 21 tablet per animal • Reactions: Leucocytosis NOS, Elevated bile acids, Overdose • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075415
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.50 Year
  • Weight: 3.583 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 21 tablet per animal
Reactions Reported:
Leucocytosis NOS Elevated bile acids Overdose
Outcomes: Ongoing

Dog, Terrier - Boston, Female, 2 year, 8.16 kilogram • Drug: MSK, Unknown • Reactions: Rash, Hair loss • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075064
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 2.00 Year
  • Weight: 8.160 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Rash Hair loss
Outcomes: Ongoing

Dog, Bulldog - English, Female, 11.2 year, 29.94 kilogram • Drug: MSK, Tablet, Oral • Reactions: Urinary incontinence • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075305
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 11.20 Year
  • Weight: 29.940 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Urinary incontinence
Outcomes: Ongoing

Dog, Shepherd Dog - German, Female, 10.9 year, 44.45 kilogram • Drug: MSK, Tablet, Oral • Reactions: Lack of efficacy - NOS, Seizure NOS, Other abnormal test result NOS, Unsteady walking (ataxia), Musculoskeletal disorder NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075291
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 10.90 Year
  • Weight: 44.450 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Lack of efficacy - NOS Seizure NOS Other abnormal test result NOS Unsteady walking (ataxia) Musculoskeletal disorder NOS Elevated serum alkaline phosphatase
Outcomes: Ongoing

Dog, Bulldog - English, Male, 8.58 year, 44.906 kilogram • Drug: MSK, Unknown • Reactions: Lack of efficacy (protozoa) - Giardia, Lack of efficacy (endoparasite) - hookworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074714
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 8.58 Year
  • Weight: 44.906 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Lack of efficacy (protozoa) - Giardia Lack of efficacy (endoparasite) - hookworm
Outcomes: Outcome Unknown

Dog, ['Pointer (unspecified)', 'Dog (unknown)'], Male, 15 year, 35.698 kilogram • Drug: MSK, Tablet, Oral, Dose: 8 Milligram per animal • Reactions: Lack of efficacy - NOS, Death, Local erythema, Underdose, Tiredness (lethargy)… • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-075270
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 15.00 Year
  • Weight: 35.698 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 8 Milligram per animal
Reactions Reported:
Lack of efficacy - NOS Death Local erythema Underdose Tiredness (lethargy) Blood in vomit
Outcomes: Died

Dog, Terrier - West Highland White, Female, 8 year, 6.53 kilogram • Drug: MSK, Tablet, Oral • Reactions: Partial lack of efficacy • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074452
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 6.530 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Partial lack of efficacy
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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