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Ustekinumab Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 1, 2020.

In Summary

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

For the Consumer

Applies to ustekinumab: parenteral injection, parenteral injection concentrate

Side effects include:

Patients with psoriasis: Nasopharyngitis, upper respiratory tract infection, headache, fatigue.

Patients with psoriatic arthritis: Adverse effects similar to those in patients with psoriasis.

Patients with Crohn's disease: 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: 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

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. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

Frequently asked questions

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.