STELARA (ustekinumab) is a prescription medicine that affects your immune system. STELARA can increase your chance of having serious side effects including:
STELARA may lower your ability to fight infections and may increase your risk of infections. While taking STELARA, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.
You should not start taking STELARA if you have any kind of infection unless your doctor says it is okay.
Before starting STELARA, tell your doctor if you think you have an infection or have symptoms of an infection such as:
After starting STELARA, call your doctor right away if you have any symptoms of an infection (see above).
STELARA can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL12) and interleukin 23 (IL23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. It is not known if people who take STELARA will get any of these infections because of the effects of STELARA on these proteins.
STELARA may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA. Tell your doctor if you have any new skin growths.
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.
Serious allergic reactions can occur. Get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, trouble breathing, throat or chest tightness, or skin rash.
Tell your doctor about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
When prescribed STELARA:
Common side effects of STELARA include: upper respiratory infections, headache, tiredness, joint pain, and nausea. These are not all of the possible side effects with STELARA. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1800FDA1088.
Please read the full Prescribing Informationincluding the Medication Guidefor STELARA, and discuss any questions you have with your doctor.
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