FDA label
What is lisdexamfetamine used for?
The FDA-approved uses of lisdexamfetamine, 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: “Lisdexamfetamine dimesylate capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; Moderate to severe binge eating disorder (BED) in adults; The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a hig...”
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Lisdexamfetamine Dimesylate, capsule
Indications and Usage, quoted from the label by SpecGx LLC (ANDA211840). Cross-references to other label sections are left out.
Lisdexamfetamine dimesylate capsules are indicated for the treatment of:
- Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
- Moderate to severe binge eating disorder (BED) in adults.
Limitations of Use:
- The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.
- Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established.
Source: DailyMed label, set id 806a1c15-0842-4787-b2ad-09a21fd96b37, version 6, effective September 16, 2026. NDC 0406-5111, one of 124 listings for this product.
Lisdexamfetamine Dimesylate, tablet, chewable
Indications and Usage, quoted from the label by SpecGx LLC (ANDA218850). Cross-references to other label sections are left out.
Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of:
- Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
- Moderate to severe binge eating disorder (BED) in adults.
Limitations of Use:
- The use of lisdexamfetamine dimesylate chewable tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.
- Lisdexamfetamine dimesylate chewable tablets are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate chewable tablets for the treatment of obesity have not been established.
Source: DailyMed label, set id 3a79b2ab-4131-4978-99a0-0119df57d5fe, version 6, effective September 24, 2026. NDC 0406-5124, one of 36 listings for this product.
Questions
What is lisdexamfetamine used for?
The FDA label says: “Lisdexamfetamine dimesylate capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; Moderate to severe binge eating disorder (BED) in adults; The use of lisdexamfetamine dimesylate capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a hig...”
What drug class is lisdexamfetamine?
FDA lists lisdexamfetamine in the Central Nervous System Stimulant 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.
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