What are the serious side effects of Stelara?

Stelara (ustekinumab) is a biologic medication that works on your immune system to treat certain inflammatory conditions. It is administered by subcutaneous injection and is effective when taken correctly. While most side effects are mild, Stelara can rarely cause more serious side effects.

The serious side effects of Stelara can include:

  • Serious allergic reactions, including anaphylaxis. Seek immediate medical help if you have:
    • Hives (swollen, itchy welts)
    • Swelling of your face, tongue, or throat
    • Shortness of breath or trouble breathing
  • Increased risk of infections, including serious infections that can require hospitalization
  • Increased risk of certain types of cancer (malignancies), such as skin cancer. Let your healthcare provider know if you have a history of skin cancer before starting Stelara. Notify them of any unusual growths, skin changes (including sores that won’t heal or changes in moles), unexplained weight loss, or swollen glands
  • Nervous system effects such as posterior reversible encephalopathy syndrome (PRES). PRES causes swelling in your brain and can lead to neurologic side effects. Seek immediate medical attention if you experience:
    • Confusion
    • Headaches
    • Blurred vision or other vision changes
    • Sudden increases in your blood pressure
    • Seizures

Serious infections reported in clinical trials included:

  • Appendicitis (infection in your appendix)
  • Cellulitis (an infection affecting your skin)
  • Pneumonia (a serious lung infection)
  • Osteomyelitis (infection in your bones)
  • Reactivation of tuberculosis
  • Severe urinary tract infections

Notify your healthcare provider immediately if you have symptoms of an active infection, including fever, night sweats, cough, loss of appetite, weight loss, or extreme fatigue.

Stelara FAQs

What is Stelara used for?

Stelara (ustekinumab) is FDA-approved to treat:

  • Adults with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy
  • Adults with active psoriatic arthritis (PsA)
  • Adults with moderate to severe active ulcerative colitis (UC)
  • Adults with moderate to severe active Crohn’s disease (CD)
  • Children 6 years and older with moderate to severe plaque psoriasis or active psoriatic arthritis

How does Stelara work?

Stelara is a monoclonal antibody that targets interleukin-12 (IL-12) and interleukin-23 (IL-23), proteins involved in inflammation. By blocking these proteins, it reduces inflammation and relieves symptoms.

How is Stelara given?

Your healthcare provider will determine the appropriate dose:

  • Crohn’s disease & ulcerative colitis: Initial IV infusion, then subcutaneous injection every 8 weeks.
  • Psoriasis & psoriatic arthritis (ages 6+): Subcutaneous injection—initial dose, second dose at week 4, then every 12 weeks. Rotate injection sites and avoid red, bruised, tender, or hard skin.

What drug interactions are there with Stelara?

Ask your provider if any medications, OTC drugs, vitamins, or supplements you take may interact with Stelara, including warfarin, cyclosporine, and live vaccines (e.g., BCG).

What are the possible side effects of Stelara?

Common side effects in clinical trials included:

  • Runny or stuffy nose, sore throat
  • Upper respiratory infection, sinus infection, bronchitis
  • Injection site reactions (itching, irritation, pain, redness)
  • Headache
  • Tiredness
  • Nausea, vomiting, itchiness
  • Urinary tract and vaginal yeast infections

Other possible side effects:

  • Abdominal pain
  • Diarrhea
  • Back pain
  • Dizziness
  • Muscle pain
  • Depression

These are not all possible side effects. Seek medical advice for any concerns. Report to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Who should not take Stelara?

Avoid Stelara if you have an allergy to ustekinumab or any inactive ingredients.

What should you tell your healthcare provider before using Stelara?

Disclose if you have:

  • A latex allergy (syringe cap contains latex)
  • Recent or planned live vaccinations
  • New or changing skin lesions
  • History of phototherapy for psoriasis
  • Allergy shots (may be less effective)
  • Pregnancy or plans to become pregnant
  • Breastfeeding or plans to breastfeed

How do you store Stelara?

Store prefilled syringes in the refrigerator (36–46 °F / 2–8 °C) in the original carton. Do not shake or freeze. You may store a syringe at room temperature (up to 86 °F / 30 °C) for up to 30 days—record the date removed from refrigeration. Do not return to the fridge and discard after 30 days.

When should you stop taking Stelara?

Your healthcare provider will decide treatment duration. Seek medical attention if you experience:

  • An allergic reaction
  • Neurologic effects (confusion, headaches, vision changes, seizures)
  • Signs of infection (fever, chills, cough, extreme fatigue)
  • Skin changes (sores that won’t heal, mole changes, swollen glands, unexplained weight loss)

Related Medications

  • Humira (adalimumab)
  • Cosentyx (secukinumab)
  • Dupixent (dupilumab)
  • Fasenra (benralizumab)
  • Nucala (mepolizumab)

Sources