J&J Medical Connect
STELARA®

(ustekinumab)

This information is intended for US patients and caregivers to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended to promote the use of our products, nor to provide medical advice.

What Are the Possible Side Effects of STELARA?

Last Updated: 10/02/2024

summary

Here is a passage from the STELARA MEDICATION GUIDE, which may be helpful to address your question:

What is the most important information I should know about STELARA?

  • STELARA is a medicine that affects your immune system. STELARA can increase your risk of having serious side effects, including1:
  • Serious infections. STELARA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections while taking STELARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.1
  • Before starting STELARA, tell your doctor if you:
    • think you have an infection or have symptoms of an infection such as1:
      • fever, sweat, or chills
      • muscle aches
      • cough
      • shortness of breath
      • blood in phlegm
      • weight loss
      • warm, red, or painful skin or sores on your body
      • diarrhea or stomach pain
      • burning when you urinate or urinate more often than normal
      • feel very tired
    • are being treated for an infection or have any open cuts.1
    • get a lot of infections or have infections that keep coming back.1
    • have TB, or have been in close contact with someone with TB.1
  • After starting STELARA, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA can make you more likely to get infections or make an infection that you have worse.1
  • People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. People who take STELARA may also be more likely to get these infections.1
  • Cancers. STELARA may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving STELARA and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with STELARA, tell your doctor if you develop any new skin growths.1
  • Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including1:
      • headache
      • confusion
      • seizures
      • vision problems

What are the possible side effects of STELARA?

  • STELARA may cause serious side effects, including1:
    • Serious allergic reactions. Serious allergic reactions can occur with STELARA. Stop using STELARA and get medical help right away if you have any of the following symptoms of a serious allergic reaction:
      • feeling faint
      • chest tightness
      • swelling of your face, eyelids, tongue, or throat
      • skin rash
    • Lung inflammation. Cases of lung inflammation have happened in some people who receive STELARA and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA.

Common side effects of STELARA include1:

  • nasal congestion, sore throat, and runny nose
  • redness at the injection site
  • upper respiratory infections
  • vaginal yeast infections
  • fever
  • urinary tract infections
  • headache
  • sinus infection
  • tiredness
  • bronchitis
  • itching
  • diarrhea
  • nausea and vomiting
  • stomach pain

These are not all of the possible side effects of STELARA. Call your doctor for medical advice about side effects. You may report side effects to Food and Drug Administration (FDA) at
1-800-FDA-1088. You may also report side effects to Johnson & Johnson Medical Information at 1-800-526-7736.1

additional information

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest using it in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the MEDICATION GUIDE for STELARA.1

 

References

1 STELARA (ustekinumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf.