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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

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

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

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." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Stelara (ustekinumab)." Centocor Inc, Malvern, PA.

Further information

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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