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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Generic profile • No FDA branded products linked
Species: Dog
Manufacturer: Zoetis Inc.
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
Used for allergic and atopic dermatitis itch control in dogs. Species commonly shown: Dog.
Used for allergic and atopic dermatitis itch control in dogs.
Oral
Store at room temperature.
Not for use in dogs with serious infections; avoid use in very young dogs.
GI upset, lethargy; immune modulation may increase infection risk.
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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:
When to call the vet:
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Oclacitinib; use the official documents and your veterinarian's instructions for product-specific decisions.
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.
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.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
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.
Unsteady walking (ataxia) (1 reports), Dilated pupils (1 reports), Diabetes mellitus (1 reports), Dermal thickening (1 reports), Decreased red blood cell count (1 reports)
Digestive (3), Skin & allergy (2), Neurologic (2), Behavior (2)
Dog (31 reports), Cat (1 reports)
Bulldog - English (2), Terrier (unspecified) (1), Chihuahua (1), Terrier - Boston (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Oclacitinib fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
Not for use in dogs with serious infections, avoid use in very young dogs, wobbly/unsteady walking, Dilated pupils, Diabetes mellitus
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: April 15, 2026, 10:04 AM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Not for use in dogs with serious infections; avoid use in very young dogs.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2025-12-03 · MSK · MSK
Received 2025-12-01 · MSK · MSK
Received 2025-11-18 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| 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)
| 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 |
Store at room temperature.
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.
Full source previews and metadata remain in the veterinary/professional layer.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
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.
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
FOI · FOI
FOI · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
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 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
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).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
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
FDA page: Open in Animal Drugs @ FDA
Used for allergic and atopic dermatitis itch control in dogs.
Source: FDA Animal Drugs @ FDA • Reference
Not for use in dogs with serious infections; avoid use in very young dogs.
GI upset, lethargy; immune modulation may increase infection risk.
Source: FDA openFDA • Reference
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Behavior.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
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
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
Dog, Terrier - Boston, Female, 2 year, 8.16 kilogram • Drug: MSK, Unknown • Reactions: Rash, Hair loss • Outcome: Ongoing
Dog, Bulldog - English, Female, 11.2 year, 29.94 kilogram • Drug: MSK, Tablet, Oral • Reactions: Urinary incontinence • Outcome: 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
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
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
Dog, Terrier - West Highland White, Female, 8 year, 6.53 kilogram • Drug: MSK, Tablet, Oral • Reactions: Partial lack of efficacy • Outcome: Ongoing
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
Store at room temperature.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.