Ustekinumab Side Effects

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

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

• Do I qualify for the Stelara copay card, how much can I save?
• 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?
• 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

Ustekinumab 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