Risk Evaluation and Mitigation Strategy (REMS)

Risk Evaluation and Mitigation Strategy (REMS)

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has required a REMS for Qsymia.

The purpose of the Qsymia REMS is to inform certified pharmacies and patients of reproductive potential about the:

  • Increased risk of embryo-fetal toxicity with major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being small for gestational age (SGA) in a fetus
  • Importance of pregnancy prevention for patients of reproductive potential receiving Qsymia
  • Need to discontinue Qsymia immediately if pregnancy occurs

Dispensed to Patients Through Certified Pharmacies

Qsymia is available only through certified pharmacies. Click Here to learn more.


Prescribing Information

Materials for Patients

Risk of Birth Defects with Qsymia patient brochure

Medication Guide

These materials can be downloaded and printed.