Risk Evaluation and Mitigation Strategy (REMS)
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Indication and Patient Selection

Qsymia is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:

  • Adults and pediatric patients aged 12 years and older with obesity
  • Adults with overweight in the presence of at least one weight-related comorbid condition

Limitations of use:

  • The effect of Qsymia on cardiovascular morbidity and mortality has not been established
  • The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.