Stelara Side Effects
Generic Name: ustekinumab
Note: This document contains side effect information about ustekinumab. Some of the dosage forms listed on this page may not apply to the brand name Stelara.
More frequent side effects include: headache. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to ustekinumab: parenteral injection
FDA approved a REMS for ustekinumab to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of ustekinumab and consists of the following: communication plan. See the FDA REMS page ([Web]).
Side effects include:
Patients with psoriasis: Nasopharyngitis, upper respiratory tract infection, headache, fatigue, diarrhea, back pain, dizziness, pharyngolaryngeal pain, pruritus, injection site erythema, myalgia, depression.
For Healthcare Professionals
Applies to ustekinumab: intravenous solution, subcutaneous solution
Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal pain
Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Facial palsy[Ref]
Common (1% to 10%): Fatigue[Ref]
Common (1% to 10%): Diarrhea, nausea[Ref]
Common (1% to 10%): Back pain, myalgia, arthralgia[Ref]
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]
Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Pustular psoriasis, skin exfoliation
Rare (less than 0.1%): Exfoliative dermatitis
Common (1% to 10%): Depression[Ref]
Common (1% to 10%): Malignancies (1.7%)
Postmarketing reports: Rapidly appearing, multiple cutaneous squamous cell carcinomas[Ref]
Uncommon (0.1% to 1%): Hypersensitivity reactions (including rash, urticaria)
Very common (10% or more): Infections (up to 27%)
Common (1% to 10%): About 6% of patients developed antibodies to this drug, dental infections
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Stelara (ustekinumab)." Centocor Inc, Malvern, PA.
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.
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More about Stelara (ustekinumab)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
- Pricing & Coupons
- 184 Reviews
- Drug class: interleukin inhibitors
- FDA Approval History