Rilpivirine (Edurant) Risk List

The following serious and life-threatening side effects have been associated with the use of rilpivirine:

  • Severe skin rash and allergic reactions. If you get a rash with any of the following symptoms, stop taking RPV and call the study doctor or your healthcare provider right away:
    • Fever
    • Blistering on the skin or ulcers/sores in the mouth
    • Eye redness or
    • Swelling of the face, mouth, tongue, throat or other parts of the body
  • Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:
    • Feeling sad or hopeless
    • Feeling anxious or restless
    • Have thoughts of hurting yourself (suicide) or have tried to hurt yourself.
  • Liver problems:
    • Yellowing of your skin or the whites of your eyes
    • Dark urine (looks like tea))
    • Light-colored bowel movements
    • Loss of appetite
    • Nausea/vomiting
    • Pain, aching, or tenderness in the right side of your stomach (abdominal) area
    • Your healthcare provider may inform you that you have an elevated liver-related function test. People with a history of liver disease may have an increased risk of liver problems.

       

Additional side effects may include:

  • Headache
  • Trouble sleeping
  • Feeling tired

 

Document Date

Thursday, October 1, 2020