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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.

In Summary

More frequent side effects include: headache. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ustekinumab: parenteral injection

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.

Patients with psoriatic arthritis: Arthralgia, nausea, dental infections.

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]

Nervous system

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]


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.

Some side effects of Stelara may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.