FDA label
What is Qsymia used for?
Qsymia contains phentermine and topiramate. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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.”
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Qsymia, capsule, extended release
Indications and Usage, quoted from the label by Vivus LLC (NDA022580). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 40dd5602-53da-45ac-bb4b-15789aba40f9, version 42, effective April 22, 2026. NDC 62541-201, one of 4 listings for this product.
Questions
What is Qsymia used for?
The FDA label says: “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.”
What drug class is Qsymia?
FDA lists phentermine and topiramate in the Sympathomimetic Amine Anorectic established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Qsymia
- Is Qsymia a controlled substance?Schedule IV
- Generic for QsymiaFDA Orange Book
- What is Phentermine and Topiramate used for?FDA label uses
- Is Phentermine and Topiramate a controlled substance?Schedule IV
- Sympathomimetic Amine Anorectics listFDA drug class
- NDC 62541-201Qsymia NDC record
- NDC 62541-202Qsymia NDC record
- NDC 62541-203Qsymia NDC record
- Schedule IV drugs listDEA schedule