Last reviewed 2026-04-20 · How we verify

Focalin (DEXMETHYLPHENIDATE)

Focalin works by blocking the dopamine transporter, allowing more dopamine to be available in the brain.

Focalin (Dexmethylphenidate) is a central nervous system stimulant developed by Novartis and currently owned by Sandoz. It targets the sodium-dependent dopamine transporter to increase dopamine levels in the brain, treating attention deficit hyperactivity disorder (ADHD). Focalin is a small molecule modality, approved by the FDA in 2001, and is now off-patent with 19 generic manufacturers. Key safety considerations include its potential for abuse and dependence. As a stimulant, it can also increase heart rate and blood pressure.

At a glance

Mechanism of action

Dexmethylphenidate hydrochloride, the active ingredient, is central nervous system stimulant. Dexmethylphenidate, the more pharmacologically active d-enantiomer of racemic methylphenidate, is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known.

Approved indications

• Attention deficit hyperactivity disorder

Boxed warnings

• WARNING: ABUSE, MISUSE, AND ADDICTION AZSTARYS 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 AZSTARYS, can result in overdose and death [see Overdosage ( 10 )], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing AZSTARYS, 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 AZSTARYS 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 Precautions ( 5.1 ) and Drug Abuse and Dependence ( 9.2 )]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. AZSTARYS 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 AZSTARYS, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing AZSTARYS, 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 treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Common side effects

• Abdominal Pain
• Nausea
• Anorexia
• Fever
• Tachycardia
• Twitching
• Insomnia
• Rhabdomyolysis
• Hypersensitivity reactions
• Angioedema
• Anaphylaxis
• Nervousness

Key clinical trials

• Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301 (PHASE3)
• Treating Young Children With Attention Deficit Hyperactivity Disorder (PHASE4)
• AWARE: Management of ADHD in Autism Spectrum Disorder (PHASE4)
• A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD (PHASE4)
• Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301 (PHASE3)
• Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301. (PHASE3)
• In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted) (PHASE1)
• Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (PHASE4)

Primary sources

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