Label Changes for:
Edurant (Rilpivirine) Tablets
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINNGS AND PRECAUTIONS
- Depressive Disorders: The adverse reaction depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) has been reported with Edurant…
- Hepatotoxicity: Hepatic adverse events have been reported in patients receiving a Rilpivirine containing regimen.,,