Stelara Side Effects

Generic name: ustekinumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 10, 2025.

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?
• What food should I avoid while on Stelara?
• Stelara and the Covid Vaccine: What should I know?
• Does Stelara treat ulcerative colitis?
• Is Stelara an immunosuppressant?
• Does Stelara cause hair loss?
• Is Stelara a biologic?
• Does Stelara cause weight gain?
• Do I qualify for the Stelara copay card, how much can I save?

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.

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