Stelara Side Effects

Generic name: ustekinumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 23, 2024.

Note: This document provides detailed information about Stelara.

Applies to ustekinumab: parenteral injection, parenteral injection concentrate Side Effects associated with ustekinumab. Some dosage forms listed on this page may not apply specifically to the brand name Stelara.

Applies to ustekinumab: parenteral injection, parenteral injection concentrate.

Side effects include:

Patients with psoriasis (≥3%): Nasopharyngitis, upper respiratory tract infection, headache, fatigue.

Patients with psoriatic arthritis (≥3%): Adverse effects similar to those in patients with psoriasis.

Patients with Crohn disease (≥3%): Vomiting during induction therapy; nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis during maintenance therapy.

Patients with ulcerative colitis (≥3%): Nasopharyngitis during induction therapy; nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, nausea during maintenance therapy.

For healthcare professionals

Applies to ustekinumab: intravenous solution, subcutaneous solution.

Respiratory adverse events

• Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal pain
• Uncommon (0.1% to 1%): Nasal congestion^[Ref]

Nervous system

• Common (1% to 10%): Headache, dizziness
• Uncommon (0.1% to 1%): Facial palsy^[Ref]

Other

• Common (1% to 10%): Fatigue^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, nausea^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, myalgia, arthralgia^[Ref]

Local

• Common (1% to 10%): Injection site erythema, pain, bruising, irritation
• Uncommon (0.1% to 1%): Injection site reactions (including hemorrhage, hematoma, induration, swelling, and pruritus)^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus
• Uncommon (0.1% to 1%): Pustular psoriasis, skin exfoliation
• Rare (less than 0.1%): Exfoliative dermatitis
• Postmarketing reports: Erythrodermic psoriasis^[Ref]

Psychiatric

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

Oncologic

• Common (1% to 10%): Malignancies (1.7%)
• Postmarketing reports: Rapidly appearing, multiple cutaneous squamous cell carcinomas^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reactions (including rash, urticaria)
• Rare (less than 0.1%): Serious hypersensitivity reactions (including anaphylaxis and angioedema)^[Ref]

Immunologic

• Very common (10% or more): Infections (up to 27%)
• Common (1% to 10%): About 6% of patients developed antibodies to this drug, dental infections
• Uncommon (0.1% to 1%): Cellulitis, herpes zoster, viral upper respiratory tract infection^[Ref]

Frequently asked questions

• What are 7 key Stelara side effects to watch out for?
• Does Stelara treat ulcerative colitis?
• Is Stelara an immunosuppressant?
• Is Stelara a biologic?
• Do I qualify for the Stelara copay card, how much can I save?
• Does Stelara cause weight gain?
• What is the mechanism of action of Stelara and how does it work?
• What are the new drugs for plaque psoriasis?
• What biosimilars have been approved in the United States?

Further information

Stelara 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer