Stelara Side Effects

Generic name: ustekinumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 22, 2022.

Note: This document contains side effect information about ustekinumab. Some dosage forms listed on this page may not apply to the brand name Stelara.

Summary

More frequent side effects include: headache. Continue reading for a comprehensive list of adverse effects.

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

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 causes Plaque Psoriasis?
• What food should I avoid while on Stelara?
• Stelara and the Covid Vaccine: What should I know?
• Does Stelara cause hair loss?
• Does Stelara treat ulcerative colitis?
• Is Stelara an immunosuppressant?
• Is Stelara a biologic?
• What are the new drugs for the treatment of plaque psoriasis?
• How quickly or how long before Stelara starts to work?
• How long can you keep Stelara in or out of the fridge?
• Can you get a flu shot or take antibiotics while on Stelara?
• How is Stelara injected or administered?
• What blood tests are needed for Stelara?

Further information

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