Stelara Side Effects
Generic name: ustekinumab
Note: This document contains side effect information about ustekinumab. Some dosage forms listed on this page may not apply to the brand name Stelara.
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.
Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal pain
Uncommon (0.1% to 1%): Nasal congestion[Ref]
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
Postmarketing reports: Erythrodermic psoriasis[Ref]
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)
Rare (less than 0.1%): Serious hypersensitivity reactions (including anaphylaxis and angioedema)[Ref]
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
- What causes Plaque Psoriasis?
- What food should I avoid while on Stelara?
- Stelara and the Covid Vaccine: What should I know?
- Does Stelara cause hair loss?
- Does Stelara treat ulcerative colitis?
- Is Stelara an immunosuppressant?
- Is Stelara a biologic?
- What are the new drugs for the treatment of plaque psoriasis?
- 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?
More about Stelara (ustekinumab)
- Check interactions
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- Reviews (226)
- Drug images
- Dosage information
- Patient tips
- During pregnancy
- Support group
- FDA approval history
- Drug class: interleukin inhibitors
- Drug Information
- Stelara (Ustekinumab Intravenous Infusion)
- Stelara (Ustekinumab Subcutaneous Injection)
Related treatment guides
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 (2009):
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.