Ustekinumab Side 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
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References
1. Cerner Multum, Inc. UK Summary of Product Characteristics.
2. Cerner Multum, Inc. Australian Product Information.
3. Product Information. Stelara (ustekinumab). Centocor Inc. 2009.
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.
