Applies to deucravacitinib: oral tablet.

Serious side effects of Deucravacitinib

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:

More common

• Body aches or pain
• chest tightness
• chills
• cough
• dryness or soreness of the throat
• ear congestion
• fever
• headache
• loss of voice
• muscle aches
• pain or tenderness around eyes and cheekbones
• sneezing
• sore throat
• stuffy or runny nose
• swollen glands
• trouble breathing
• trouble in swallowing
• unusual tiredness or weakness
• voice changes

Less common

• Burning or stinging of skin
• painful cold sores or blisters on the lips, nose, eyes, or genitals

Incidence not known

• Anxiety
• black, tarry stools
• chest pain
• dizziness or lightheadedness
• fainting
• general feeling of illness
• pain, redness, or swelling in the arm or leg
• painful blisters on the trunk of the body
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• weight loss
• yellow skin and eyes

Other side effects of Deucravacitinib

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:

Less common

• Blemishes on the skin
• burning, itching, and pain in the hairy areas, pus at the root of the hair
• irritation or soreness of the mouth
• pimples

For Healthcare Professionals

Applies to deucravacitinib: oral tablet.

General

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, acneiform rash (including acne, acne cystic, dermatitis acneiform, rash, rosacea, pustule, rash pustular, and papule)

Uncommon (0.1% to 1%): Herpes zoster (including multidermatomal)^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, mouth ulcers (including mouth ulceration, aphthous ulcer, tongue ulceration, and stomatitis)^[Ref]

Hepatic

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

Hypersensitivity

Frequency not reported: Angioedema

Metabolic

Common (1% to 10%): Increased creatine phosphokinase^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia

Frequency not reported: Rhabdomyolysis^[Ref]

Nervous system

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

Oncologic

Uncommon (0.1% to 1%): Malignancies, including lymphoma (excluding non-melanoma skin cancer)^[Ref]

Other

Very common (10% or more): General infections (up to 29%)

Common (1% to 10%): Herpes simplex infections (including oral herpes, herpes simplex, genital herpes, and herpes viral infection)

Uncommon (less than 1%): Serious infections^[Ref]

Renal

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

Respiratory

Very common (10% or more): Upper respiratory infections including viral upper respiratory tract infection, pharyngitis, sinusitis, acute sinusitis, rhinitis, tonsillitis, peritonsillar abscess, laryngitis, tracheitis, and

rhinotracheitis (up to 19%)

Frequency not reported: Pneumonia, COVID-19^[Ref]