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The following safety information provides essential warnings about the use of Stelara (ustekinumab). Please read these points carefully and consult your healthcare provider if you have any questions or concerns.

• Infections: Stelara (ustekinumab) may increase your risk of developing infections. This risk is heightened if you are also taking other immunosuppressants or have certain medical conditions. It is important to inform your healthcare provider of your medical history, particularly if you have had tuberculosis (TB) or viral infections. Be vigilant for signs of infection such as fever, chills, muscle aches, diarrhea, or fatigue. Should you develop a serious infection while on Stelara, it may be necessary to discontinue the medication.

• Cancer Risk: This medication can suppress your immune system, potentially increasing your risk of certain cancers, notably skin cancer. This risk is higher for individuals with a history of skin cancer or preexisting conditions that predispose them to cancer. Monitor your skin for any new growths or changes and inform your healthcare provider about any concerns.

• Posterior Reversible Encephalopathy Syndrome (PRES): Though rare, PRES is a possible side effect of Stelara, and symptoms can manifest anytime from a few days to over a year after starting treatment. Symptoms include headache, confusion, visual changes, and seizures. Promptly report these symptoms to your healthcare provider.

• Vaccination Considerations: While taking Stelara, you can receive non-live or inactivated vaccines, but be aware that your body's response may differ. Avoid live vaccines during treatment, as they might cause illness. Ensure all your vaccinations are current before beginning therapy with Stelara.

• Pulmonary Symptoms: Some individuals have experienced lung swelling while on Stelara, characterized by coughing and difficulty breathing, typically after one to three doses. In severe cases, this can require hospitalization. Immediate medical attention is advised if these symptoms occur.

These warnings are crucial for the safe use of Stelara. Always communicate openly with your healthcare provider about any symptoms or concerns.

When using this medication, you may encounter some common side effects that are usually mild and temporary. These include bruising, itching, pain, redness, swelling, or hardening of the skin at the injection site, which generally subside within a day or two. Headaches, back pain, sinus or throat pain, and mild nausea might also occur. If any of these symptoms persist or worsen, it's advisable to consult your healthcare provider.

There are also some less common side effects that may arise, such as joint pain, upper respiratory tract infections, and inflammation of the nasal passages. While these are generally not severe, you should inform your healthcare provider if they become bothersome.

More serious side effects, though rare, require immediate medical attention. These include persistent cough, shortness of breath, severe infections, and symptoms of a serious allergic reaction such as rash, severe dizziness, or trouble breathing. Additionally, there is a rare risk of developing posterior reversible encephalopathy syndrome (PRES), which presents as persistent headaches, seizures, sudden vision changes, or confusion. There is also a potential risk of developing cancer, including skin cancer, linked to this medication. Be vigilant for symptoms like unusual lumps, skin changes, swollen glands, or unexplained weight loss.

Always be alert to signs of new or worsening infections, such as fever, chills, or painful urination, and seek medical help promptly. While serious allergic reactions are uncommon, immediate medical care is crucial if you notice any related symptoms. If you experience any side effects not mentioned here, contact your healthcare provider for guidance.