Risk Evaluation and Mitigation Strategies (REMS) Summary

Goals of the Isotretinoin REMS Program

The goals of the isotretinoin risk evaluation and mitigation strategy are:

1. To prevent fetal exposure to isotretinoin

2. To inform prescribers, pharmacists, and patients about isotretinoin's serious risks and safe-use conditions

REMS Elements

• Medication Guide

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms