Last reviewed 2026-04-20 · How we verify

DEXTROAMPHETAMINE

Dextroamphetamine is a small molecule CNS stimulant primarily used for ADHD and narcolepsy. It acts by increasing dopamine and norepinephrine levels in the brain, enhancing focus and alertness. Approved by the FDA, it is a well-established treatment with a strong market presence. However, it has a high potential for abuse and misuse, necessitating careful patient selection and monitoring. Competitors like methylphenidate offer alternative treatment options, but dextroamphetamine remains a cornerstone therapy due to its efficacy and long-term safety profile.

At a glance

Approved indications

• Attention Deficit Hyperactivity Disorder (ADHD) — 1L
• Narcolepsy — 1L

Pipeline indications

• Cocaine Use Disorder — Phase 2
• Binge Eating Disorder — Phase 3
• Obesity — Phase 3
• Chronic Fatigue Syndrome — Phase 4
• Autism Spectrum Disorder — Phase 4

Boxed warnings

• WARNING: ABUSE, MISUSE, AND ADDICTION DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction (see WARNINGS and DRUG ABUSE AND DEPENDENCE).

Common side effects

• Palpitations
• Tachycardia
• Elevation of blood pressure
• Psychotic episodes
• Overstimulation
• Restlessness
• Irritability
• Euphoria
• Dyskinesia
• Dysphoria
• Depression
• Tremor

Drug interactions

• MAOIs
• Serotonergic drugs
• CYP2D6 inhibitors

Key clinical trials

• Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder (PHASE2)
• A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (PHASE1)
• Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users (PHASE2)
• Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b) (PHASE2, PHASE3)
• Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression (PHASE2)
• Vyvanse in Children Aged 6 to 12 Years (EARLY_PHASE1)
• Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment (PHASE3)
• Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia (PHASE2)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• DEXTROAMPHETAMINE CI brief — competitive landscape report
• DEXTROAMPHETAMINE updates RSS · CI watch RSS