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
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]
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2009) "Product Information. Stelara (ustekinumab)." Centocor Inc
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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.
Some side effects may not be reported. You may report them to the FDA.
