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]