Regulatory product record
APOQUEL
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- APOQUEL
- DIN
- 02530686
- DPD drug code
- 101984
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- TABLET (CHEWABLE)
- Ingredients
- OCLACITINIB (OCLACITINIB MALEATE) (16 MG)
- Species (DPD record)
- DOGS
- Company
- ZOETIS CANADA INC (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 101984
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications2
Pruritus from allergic dermatitis; control of atopic dermatitis
DogOn-label (ON_LABEL)1 source record · View provenance
- Dog · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Pruritus from allergic dermatitis; control of atopic dermatitis — Authorized (FDA)
- Dog · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Allergic dermatitis, possibly feline asthma (very limited data)
CatExtra-label (EXTRA_LABEL)1 source record · View provenance
- Cat · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Allergic dermatitis, possibly feline asthma (very limited data) — Extra-label, not established
- Cat · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens3
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Select a species above to calculate a dose.
Adverse effects204
Vomiting (~9%), diarrhea (~6%) — Most common, similar to placebo rates in field trials
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
↓ Leukocytes, ↓ serum globulin — Documented on treatment vs. placebo
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Mild dose-dependent ↓ hemoglobin/hematocrit/reticulocytes (twice-daily >14 days) — With prolonged BID dosing
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Demodicosis, pyoderma, pneumonia, neoplasia (isolated cases) — Causality not established but flagged in field trials
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Lack of efficacy - NOS3,664 reports
- Vomiting3,333 reports
- INEFFECTIVE, ATOPY CONTROL2,679 reports
- Diarrhoea2,263 reports
- Lethargy (see also Central nervous system depression in 'Neurological')2,145 reports
- INEFFECTIVE, LOSS OF EFFECT1,799 reports
- Other abnormal test result NOS1,399 reports
- Elevated alanine aminotransferase (ALT)1,133 reports
- Seizure NOS1,121 reports
- Elevated serum alkaline phosphatase (SAP)1,052 reports
- Anorexia952 reports
- Leucopenia NOS858 reports
Cat
- Accidental exposure107 reports
- Vomiting72 reports
- Lack of efficacy - NOS63 reports
- Lethargy (see also Central nervous system depression in Neurological)58 reports
- Overdose57 reports
- Intentional misuse47 reports
- Medication error NOS43 reports
- Elevated alanine aminotransferase (ALT)40 reports
- Death by euthanasia38 reports
- Diarrhoea29 reports
- Not eating29 reports
- Weight loss29 reports
Monitoring1
CBC periodically if continued on twice-daily dosing beyond manufacturer recommendation
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications1
Dogs <12 months of age; serious/active infections
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Precautions4
May increase susceptibility to infection (incl. demodicosis) and could exacerbate neoplastic conditions — avoid high/prolonged twice-daily dosing
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Reduce from twice-daily to once-daily after the 14-day induction period — this step-down is a core part of the label, not optional; prolonged BID dosing has a documented immunosuppressive signal (bone marrow, leukocyte effects).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Notably fast onset (within hours) compared to cyclosporine's multi-week lag — useful as a bridge or fast-acting option, including alongside cyclosporine during its induction period.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Feline dosing is not established — treat any use in cats as investigational/extra-label with correspondingly cautious counseling.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions1
Minimal CYP450 inhibition at therapeutic concentrations — Used clinically alongside corticosteroids, cyclosporine, and other systemic agents by dermatologists, though the manufacturer states formal safety data for these combinations is lacking
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics3
Bioavailability — 89% (dog)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — 3–5h (dog)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Predominantly hepatic
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Safety not evaluated in breeding, pregnant, or lactating dogs.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 574–576; (Not present in Plumb's Veterinary Drug Handbook, 7th ed. — drug post-dates that edition) — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references16
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Transcriptomic Effects of Oclacitinib and Prednisolone in an Acute IgE-Mediated Experimental Model of Canine Atopic Dermatitis.
Study summary not available in the imported record. Open the original citation to review the study.
- Oral Administration of Aster yomena Butanol Fraction Attenuates DNCB-Induced Atopic Dermatitis-like Skin Inflammation in Mice: Implications as a Dietary Supplement Candidate for Companion Animals.
Study summary not available in the imported record. Open the original citation to review the study.
- Oclacitinib for Controlling Pruritus and Associated Skin Lesions in 16 Horses With Allergic Dermatitis.
Study summary not available in the imported record. Open the original citation to review the study.
- A Retrospective Case Series Reporting the Clinical Efficacy and Adverse Events of Oclacitinib Administration for Skin Disease in 238 Cats.
Study summary not available in the imported record. Open the original citation to review the study.
- Treatment of Canine Pemphigus Foliaceus, Pemphigus Vulgaris and Mucous Membrane Pemphigoid With Oclacitinib: A Retrospective Analysis of 21 Cases.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.