Apoquel 5.4mg Film-coated Tablet for Dogs
Active ingredient: Oclacitinib
Form
Tablet
Species
Manufacturer
Zoetis Belgium
VMD MA No.
EU/2/13/154/003-004,008,013-015,022-024
What it's used for
Treatment of pruritus associated with allergic dermatitis in dogs. Treatment of clinical manifestations of atopic dermatitis in dogs.
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Apoquel 5.4mg Film-coated Tablet for Dogs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Treatment of clinical manifestations of atopic dermatitis in dogs.
excipients.
Do not use in dogs less than 12 months of age or less than 3 kg bodyweight.
Do not use in dogs with evidence of immune suppression, such as hyperadrenocorticism, or
with evidence of progressive malignant neoplasia as the active substance has not been
evaluated in these cases.
Very common
(>1 animal / 10 animals treated):
pyoderma, skin lump, papillomaCommon
(1 to 10 animals / 100 animals treated):
lethargy, lipoma, polydipsia, increased
appetite
nausea, vomiting, diarrhoea, anorexia
histiocytoma, fungal skin infection,
pododermatitis
otitis
lymphadenopathy
cystitis
aggression
Revised: December 2025
AN: 03096/2025
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
anaemia, lymphoma, convulsion
Treatment-related clinical pathology changes were restricted to an increase in mean serum
cholesterol and a decrease in mean leukocyte count, however, all mean values remained
within the laboratory reference range. The decrease in mean leukocyte count observed in
oclacitinib-treated dogs was not progressive, and affected all white blood cell counts
(neutrophil, eosinophil and monocyte counts) except lymphocyte counts. Neither of these
clinical pathology changes appeared clinically significant.
Regarding susceptibility to infection and neoplastic conditions, see section 4.5 “Special
precautions for use”.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary
medicinal product. Reports should be sent, preferably via a veterinarian, to either the
marketing authorisation holder or the national competent authority via the national reporting
system. See the package leaflet for respective contact details.
Revised: December 2025
AN: 03096/2025
i) Special precautions for use in animals
Oclacitinib modulates the immune system and may increase susceptibility to infection and
exacerbate neoplastic conditions. Dogs receiving the veterinary medicinal product should
therefore be monitored for the development of infections and neoplasia.
When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and
treat any underlying causes (e.g. flea allergic dermatitis, contact dermatitis, food
hypersensitivity). Furthermore, in cases of allergic dermatitis and atopic dermatitis, it is
recommended to investigate and treat complicating factors, such as bacterial, fungal or
parasitic infections/infestations (e.g. flea and mange).
Given the potential for effects on certain clinicopathological parameters (see section
administered concomitantly with veterinary medicinal products such as endo- and
ectoparasiticides, antimicrobials and anti-inflammatories.
The impact of oclacitinib administration on vaccination with modified live vaccines, canine
parvovirus (CPV), canine distemper virus (CDV) and canine parainfluenza (CPI) and
inactivated rabies vaccine (RV), on 16 week old vaccine naive puppies has been studied.
An adequate immune response (serology) to CDV and CPV vaccination was achieved when
puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days.
However, the findings of this study indicated a reduction in serological response to
vaccination with CPI and RV in puppies being treated with oclacitinib compared to untreated
controls. The clinical relevance of these observed effects for animals vaccinated while being
administered oclacitinib (in accordance with the recommended dosing regimen) is unclear.
Remaining tablet parts should be stored in the blister and be given at the next
administration.
Apoquel 16 mg
tablets
3.0–4.4½4.5–5.9½
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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Related Conditions
Other Products Containing Oclacitinib
These products share the same active ingredient and may be suitable alternatives. Always consult your vet.
Apoquel 16 mg Chewable Tablets for Dogs
POM-VZoetis Belgium
Apoquel 16 mg Chewable Tablets for Dogs
POM-VZoetis UK Limited
Apoquel 16mg Film-coated Tablet for Dogs
POM-VZoetis UK Limited
Apoquel 16mg Film-coated Tablet for Dogs
POM-VZoetis Belgium
Apoquel 3.6 mg Chewable Tablets for Dogs
POM-VZoetis Belgium
Apoquel 3.6 mg Chewable Tablets for Dogs
POM-VZoetis UK Limited
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