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Generic Name: ustekinumab (YOO sti KIN ue mab)
Brand Names: Stelara, Stelara PFS
Stelara is used to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Learn about side effects, interactions and indications.
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Drug Information:
Stelara (ustekinumab) is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation. Stelara is used to treat plaque psoriasis in adults and children who are at least 12 years old. It is also used to treat psoriatic arthritis in adults, and is sometimes given with another medicine called Methotrexate. Stelara is used in adults to treat moderate to severe Crohn's disease after other medicines have been tried without success. Stelara is also used in adults to treat moderate to severe active ulcerative colitis. Learn more

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Stelara Side Effects

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



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.

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

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Facial palsy


Common (1% to 10%): Fatigue


Common (1% to 10%): Diarrhea, nausea


Common (1% to 10%): Back pain, myalgia, arthralgia


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)


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


Common (1% to 10%): Depression


Common (1% to 10%): Malignancies (1.7%)

Postmarketing reports: Rapidly appearing, multiple cutaneous squamous cell carcinomas


Uncommon (0.1% to 1%): Hypersensitivity reactions (including rash, urticaria)

Rare (less than 0.1%): Serious hypersensitivity reactions (including anaphylaxis and angioedema)


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

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Stelara (www.drugs.com/stelara.html).