Risk Evaluation and Mitigation Strategies (REMS) Summary

Goal of the Addyi (flibanserin) Tablets REMS Program

The goal of the Addyi REMS is to mitigate the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol by:

• Ensuring prescribers and pharmacists are educated about the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol and the need to counsel patients about this risk.
• Informing patients of the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol.

REMS Elements

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms