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Stelara is a prescription medicine used to treat the symptoms of Plaque Psoriasis, Psoriatic Arthritis, Ulcerative Colitis and Crohn Disease. Stelara may be used alone or with other medications.

Stelara belongs to a class of drugs called Antipsoriatics, Systemic; Monoclonal Antibodies; Interleukin Inhibitors.

It is not known if Stelara is safe and effective in children younger than 6 years of age.

Stelara may cause serious side effects including:

• a mole that has changed in size or color,
• swelling, pain, warmth or redness anywhere on your body,
• stomach pain that is sudden and severe,
• gradual stomach pain,
• diarrhea,
• constipation,
• new or worsening cough,
• sudden chest pain,
• shortness of breath,
• pain or burning when you urinate,
• severe headache,
• confusion,
• change in mental status,
• vision problems, and
• seizures

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Stelara include:

• fever,
• flu-like symptoms,
• itching,
• stomach pain,
• nausea,
• vomiting,
• diarrhea,
• vaginal itching or discharge,
• pain or burning when you urinate,
• cough with mucus,
• shortness of breath,
• chest discomfort,
• headache,
• tiredness, and
• redness where the medication was injected

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Stelara. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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