Deucravacitinib: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 27, 2026🚩 Report this page

Deucravacitinib

Janus-Associated Kinase (Jak) Inhibitors

Sold as Sotyktu

EU EMAGB MHRACA Health Canada

Drug class: Janus-Associated Kinase (Jak) Inhibitors
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 3

L04AFJanus-Associated Kinase (Jak) Inhibitors

Overview

Deucravacitinib is an active pharmaceutical ingredient in the Janus-Associated Kinase (Jak) Inhibitors group (L04AF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	May 12, 2026
GB United Kingdom	MHRA	1	November 7, 2025
CA Canada	Health Canada	1	May 27, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 12, 2026[1]

Plaque psoriasis SOTYKTU is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 1).

How to take

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised November 7, 2025[2]

SOTYKTU is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

How to take

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

SOTYKTUBRISTOL-MYERS SQUIBB CANADA

Sources & citations

[1]European Medicines Agency · EMEA/H/C/005755 · revised May 12, 2026
[2]MHRA (UK) · PLGB151050179 · revised November 7, 2025
[3]Health Canada (DPD) · 02533030 · revised May 27, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised May 12, 2026[1]

1% in psoriatic arthritis studies). Overall, the safety profile observed in psoriatic arthritis patients treated with deucravacitinib was consistent with the safety profile observed in patients with plaque psoriasis. The longer-term safety profile of deucravacitinib was similar and consistent with previous experience.
Tabulated list of adverse reactions Adverse reactions for deucravacitinib from clinical studies are listed (see Table 1) by MedDRA System Organ Class and are based on the following conventions: very common (≥ 1/10); 6 common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000) and not known (cannot be estimated from the available data).
Table 1:
List of adverse reactions System Organ Class Frequency Adverse reaction Infections and infestations Very common Upper respiratory infectionsa Common Herpes simplex infectionsb Uncommon Pneumonia Herpes zoster Bronchitis Gastrointestinal disorders Common Oral ulcersc Skin and subcutaneous tissue disorders Common Acneiform rashd Folliculitis Investigations Common Blood creatine phosphokinase increased a Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, sinusitis, acute sinusitis, rhinitis, tonsillitis, peritonsillar abscess, laryngitis, tracheitis, pharyngotonsillitis, and rhinotracheitis.
b Herpes simplex infections include oral herpes, herpes simplex, genital herpes, herpes ophthalmic, and herpes viral infection. c Oral ulcers include aphthous ulcer, mouth ulceration, tongue ulceration, and stomatitis. d Acneiform rash includes acne, dermatitis acneiform, rash, rosacea, pustule, rash pustular, rash papular, and papule.
7 events per 100 person-years) during the first 16 weeks. The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of deucravacitinib. 6 events per 100 person-years). 4 events per 100 person-years).
7 events per 100 person-years). Overall, the rate of infections including serious infections observed in psoriatic arthritis patients treated with deucravacitinib was consistent with that observed in patients with plaque psoriasis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised May 12, 2026[1]

8). 3). Caution should be exercised when considering the use of deucravacitinib in patients with a chronic infection or a history of recurrent infection. Patients treated with deucravacitinib should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
If a patient develops a clinically important infection or is not responding to standard therapy, the patient should be monitored carefully and deucravacitinib should not be given until the infection resolves. Pre-treatment evaluation for tuberculosis Prior to initiating treatment with deucravacitinib, patients should be evaluated for tuberculosis (TB) infection.
3). Treatment of latent TB should be initiated prior to administering deucravacitinib. Anti-TB therapy should be considered prior to initiation of deucravacitinib in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Patients receiving deucravacitinib should be monitored for signs and symptoms of active TB. 4 Malignancies Malignancies, including lymphomas and non-melanoma skin cancer (NMSC), were observed in clinical studies with deucravacitinib.
It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the adverse reactions of Janus Kinase (JAK) inhibition. In a large randomised active controlled study of a JAK inhibitor in rheumatoid arthritis (RA) patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and NMSC, was observed with a JAK inhibitor compared to tumour necrosis factor (TNF) inhibitors.
Limited clinical data are available to assess the potential relationship of exposure to deucravacitinib and the development of malignancies. Long-term safety evaluations are ongoing. The risks and benefits of deucravacitinib treatment should be considered prior to initiating patients.
Major adverse cardiovascular events (MACE), deep venous thrombosis (DVT) and pulmonary embolism (PE) It is not known whether TYK2 inhibition may be associated with the adverse reactions of JAK inhibition. In a large randomised active-controlled study of a JAK inhibitor in RA patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of MACE, defined as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, and a dose dependent higher rate of venous thromboembolism including DVT and PE were observed with a JAK inhibitor compared to TNF inhibitors.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised November 7, 2025[2]

9%), most frequently nasopharyngitis. The longer-term safety profile of deucravacitinib was similar and consistent with previous experience. Tabulated list of adverse reactions The following list of adverse reactions for deucravacitinib is from clinical trials in plaque psoriasis (Table 1).
These reactions are presented by MedDRA System Organ Class and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Table 1:
List of adverse reactions System Organ Class Frequency Adverse reaction Very common Upper respiratory infectionsa Common Herpes simplex infectionsb Infections and infestations Uncommon Herpes zoster Gastrointestinal disorders Common Oral ulcersc Skin and subcutaneous tissue disorders Common Acneiform rashd Folliculitis Investigations Common Blood creatine phosphokinase increased a Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, sinusitis, acute sinusitis, rhinitis, tonsillitis, peritonsillar abscess, laryngitis, tracheitis, and rhinotracheitis.
b Herpes simplex infections include oral herpes, herpes simplex, genital herpes, and herpes viral infection. c Oral ulcers include aphthous ulcer, mouth ulceration, tongue ulceration, and stomatitis. d Acneiform rash includes acne, dermatitis acneiform, rash, rosacea, pustule, rash pustular, and papule.
7 events per 100 person- years) during the first 16 weeks. The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of deucravacitinib. 6 events per 100 person- years). 4 events per 100 person-years).
7 events per 100 person- years). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised November 7, 2025[2]

8). 3). Caution should be exercised when considering the use of deucravacitinib in patients with a chronic infection or a history of recurrent infection. Patients treated with deucravacitinib should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
If a patient develops a clinically important infection or is not responding to standard therapy, the patient should be monitored carefully and deucravacitinib should not be given until the infection resolves. Pre-treatment evaluation for tuberculosis Prior to initiating treatment with deucravacitinib, patients should be evaluated for tuberculosis (TB) infection.
3). Treatment of latent TB should be initiated prior to administering deucravacitinib. Anti-TB therapy should be considered prior to initiation of deucravacitinib in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Patients receiving deucravacitinib should be monitored for signs and symptoms of active TB. Malignancies Malignancies, including lymphomas and non-melanoma skin cancer (NMSC), were observed in clinical studies with deucravacitinib. It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the adverse reactions of Janus Kinase (JAK) inhibition.
In a large randomised active controlled study of a JAK inhibitor in rheumatoid arthritis (RA) patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and NMSC, was observed with a JAK inhibitor compared to tumour necrosis factor (TNF) inhibitors.
Limited clinical data are available to assess the potential relationship of exposure to deucravacitinib and the development of malignancies. Long-term safety evaluations are ongoing. The risks and benefits of deucravacitinib treatment should be considered prior to initiating patients.
Major adverse cardiovascular events (MACE), deep venous thrombosis (DVT) and pulmonary embolism (PE) It is not known whether TYK2 inhibition may be associated with the adverse reactions of JAK inhibition. In a large randomised active-controlled study of a JAK inhibitor in RA patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of MACE, defined as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, and a dose dependent higher rate of venous thromboembolism including DVT and PE were observed with a JAK inhibitor compared to TNF inhibitors.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

GBUnited Kingdom· MHRA

CACanada· Health Canada

Drugs in the same class

Sources & citations