Ustekinumab Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 1, 2020.
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 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
Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal pain
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%): 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
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)
Very common (10% or more): Infections (up to 27%)
Common (1% to 10%): About 6% of patients developed antibodies to this drug, dental infections
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
- 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?
- What blood tests are needed for Stelara?
- How is Stelara injected or administered?
More about ustekinumab
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- 210 Reviews
- Drug class: interleukin inhibitors
- Patient Information
- Ustekinumab Subcutaneous (Advanced Reading)
- Ustekinumab Intravenous Infusion
- Ustekinumab Subcutaneous Injection
- Other brands
Related treatment guides
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.