Sotyktu Side Effects

Generic name: deucravacitinib

Medically reviewed by Drugs.com. Last updated on Jul 22, 2023.

Note: This document provides detailed information about Sotyktu.

Applies to deucravacitinib: oral tablet Side Effects associated with deucravacitinib. Some dosage forms listed on this page may not apply specifically to the brand name Sotyktu.

Applies to deucravacitinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.

Your body's ability to fight infections may be reduced while you are using deucravacitinib (the active ingredient contained in Sotyktu) It is very important that you call your doctor at the first sign of an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Check with your doctor right away if you have burning or stinging of the skin or painful cold sores or blisters on the lips, nose, eyes, or genitals. These may be symptoms of herpes simplex infection or shingles.

This medicine may cause serious allergic reaction, including angioedema, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.

This medicine may increase your risk of cancer, including lymphoma. Check with your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, or yellow skin and eyes.

This medicine may cause rhabdomyolysis (severe muscle problem). Check with your doctor right away if you have dark-colored urine, fever, muscle cramps, spasms, pain, or stiffness, or unusual tiredness or weakness.

This medicine may increase your risk of developing blood clots (eg, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area, or trouble breathing.

Do not have any live vaccines (immunizations) while you are being treated with deucravacitinib. Check with your doctor before having any vaccines.

Serious side effects of Sotyktu

Along with its needed effects, deucravacitinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking deucravacitinib:

Other side effects of Sotyktu

Some side effects of deucravacitinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to deucravacitinib: oral tablet.

General adverse events

The most common adverse reactions occurring in 1% of patients or greater included upper respiratory infections, increased blood creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension^[Ref]

Dermatologic

• Common (1% to 10%): Psoriasis, folliculitis, acne, acneiform rash^[Ref]

"Acne" included acne, acne cystic, and dermatitis acneiform.

"Acneiform rash" included acne, dermatitis acneiform, rash, rosacea, pustule, rash pustular, and papule.^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, diarrhea, mouth ulcers^[Ref]

"Mouth ulcers" included aphthous ulcer, tongue ulceration, and stomatitis.^[Ref]

Hepatic

• Frequency not reported: Increased liver enzymes (AST, ALT)^[Ref]

Hypersensitivity

• Frequency not reported: Angioedema^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, back pain, increased creatine phosphokinase
• Frequency not reported: Rhabdomyolysis^[Ref]

Nervous system

• Common (1% to 10%): Headache^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Malignancies (excluding nonmelanoma skin cancer)^[Ref]

Other

• Very common (10% or more): General infections (up to 29%)
• Common (1% to 10%): Herpes simplex infections
• Uncommon (0.1% to 1%): Herpes zoster, serious infections (including coronavirus disease 2019 [COVID-19], pneumonia)
• Frequency not reported: Increased triglycerides, multidermatomal herpes zoster^[Ref]

"Herpes simplex infections" included oral herpes, herpes simplex, genital herpes, and herpes viral infection.^[Ref]

Renal

• Frequency not reported: Decreased glomerular filtration rate, worsening proteinuria^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory infections (up to 19.2%)^[Ref]

"Upper respiratory infections" includes viral upper respiratory tract infection, pharyngitis, sinusitis, acute sinusitis, rhinitis, tonsillitis, peritonsillar abscess, laryngitis, tracheitis, and rhinotracheitis.^[Ref]

See also:

Frequently asked questions

• Sotyktu vs Otezla: How do they compare?
• How long does it take for Sotyktu to work?
• How long can I take Sotyktu for?
• How is Sotyktu given / administered?

Further information

Sotyktu side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer