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Why is there a black box warning for Yervoy?

Yervoy (ipilimumab) has a "black box" warning from the U.S. Food and Drug Administration because some of its side effects are serious. They include inflammation of the intestines, liver, skin, hormone-producing glands and/or eyes. In some cases, a reaction to the medication may lead to paralysis and even death. If you experience any signs or symptoms of side effects, contact your healthcare provider immediately.

Signs that may signal serious problems include:
  • diarrhea, loose stools or stomach pain
  • yellowing of the skin or eyes
  • tea-colored urine
  • nausea and/or vomiting
  • easy bleeding
  • pain on the right side of the stomach
  • skin rashes, peeling or blistering
  • mouth sores
  • numbness or tingling in the limbs or face
  • blurry or double vision
  • eye redness or pain
  • headaches
  • tiredness
  • dizziness
  • weight gain
  • changes in mood or thinking

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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.