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