Dexmethylphenidate

Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.

• Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )]. Dexmethylphenidate hydrochloride extended-release is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).ICD-10: F90.9

• Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6.1 )].contraindicated

Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning ( 2.2) . Patients currently on methylphenidate: Dexmethylphenidate hydrochloride extended-release dosage is half (1/2) the current total daily dosage of methylphenidate ( 2.2 ). Patients currently on dexmethylphenidate immediate-release tablets: Give the same daily dose of dexmethylphenidate hydrochloride extended-release ( 2.2 ). Titrate weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients ( 2.2 ). Maximum recommended daily dose: 30 mg in pediatric patients and 40 mg in adults ( 2.2 ). Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce ( 2.3 ). 2.1 Pretreatment Screening Prior to treating patients with dexmethylphenidate hydrochloride extended-release, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )]. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating dexmethylphenidate hydrochloride extended-release [see Warnings and Precautions ( 5.10 )].

Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ). Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse ( 5.3 ). Psychiatric Adverse Reactions : Prior to initiating dexmethylphenidate hydrochloride extended-release, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing dexmethylphenidate hydrochloride extended-release ( 5.4 ). Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention ( 5.5 ). Peripheral Vasculopathy, including Raynaud’s Phenomenon : Careful observation for digital changes is necessary during dexmethylphenidate hydrochloride extended-release treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ). Long-Term Suppression of Growth in Pediatric Patients : Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted ( 5.7 ). Acute Angle Closure Glaucoma: Dexmethylphenidate hydrochloride extended-release -treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist ( 5.8 ).

The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Known hypersensitivity to methylphenidate or other ingredients of dexmethylphenidate hydrochloride extended-release [see Contraindications ( 4 )] Hypertensive Crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions ( 5.2 )] Increased Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.4 )] Priapism [see Warnings and Precautions ( 5.5 )] Peripheral Vasculopathy, Including Raynaud’s Phenomenon [see Warnings and Precautions ( 5.6 )] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions ( 5.7 )] Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.8 )] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions ( 5.9 )] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.10 )] The most common adverse reactions (greater than or equal to 5% and twice the rate of placebo): Pediatric patients 6 to 17 years: dyspepsia, decreased appetite, headache, and anxiety ( 6.1 ). Adults: dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including dexmethylphenidate hydrochloride extended-release, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants during pregnancy ( see Clinical Considerations ). Embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (MRHD) of 20 mg/day given to adults based on plasma levels. A decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the MRHD of 20 mg/day given to adults based on plasma levels ( see Data ).

Metabolism

Absorption Dexmethylphenidate hydrochloride extended-release produces a bi-modal plasma concentration-time profile (i.e., 2 distinct peaks approximately 4 hours apart) when orally administered to healthy adults. The initial rate of absorption for dexmethylphenidate hydrochloride extended-release is similar to that of dexmethylphenidate tablets as shown by the similar rate parameters between the 2 formulations, i.e., first peak concentration (C max1 ), and time to the first peak (t max1 ), which is reached in 1.5 hours (typical range 1 to 4 hours).

Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of dexmethylphenidate hydrochloride extended-release should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

• Nov 13, 2001NDANDA021278Sandoz
• May 26, 2005NDANDA021802Sandoz
• Nov 18, 2013ANDAANDA078992Platinum
• Nov 19, 2013ANDAANDA202731Teva Pharms Usa
• Nov 19, 2013ANDAANDA078908Teva Pharms Usa
• Nov 21, 2013ANDAANDA079108Impax Labs Inc
• Sep 24, 2015ANDAANDA201231Sun Pharm Industries
• Mar 2, 2021NDANDA212994Commave Sub

1. 1Drug Ineffective83617%
2. 2Anxiety2334.8%
3. 3Nausea2304.7%
4. 4Headache2284.7%
5. 5Fatigue1954.0%
6. 6Decreased Appetite1873.9%
7. 7Abnormal Behaviour1853.8%
8. 8Disturbance In Attention1853.8%
9. 9Feeling Abnormal1813.7%
10. 10Insomnia1803.7%
11. 11Aggression1623.3%
12. 12Off Label Use1613.3%
13. 13Depression1563.2%
14. 14Vomiting1563.2%
15. 15Irritability1553.2%

Recent PubMed references pinned to Dexmethylphenidate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Drug detection in oral fluid and urine after single therapeutic doses of dexamphetamine, lisdexamphetamine, and methylphenidate in healthy volunteers.
  Journal of analytical toxicology · 2025 · Helland A, Muller S, Spigset O, et al.
  PMID 39697138DOI 10.1093/jat/bkae097
• Risk of Major Malformations in Infants After First-Trimester Exposure to Stimulants: Results From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications.
  Journal of clinical psychopharmacology · 2023 · Szpunar MJ, Freeman MP, Kobylski LA, et al.
  PMID 37235505DOI 10.1097/JCP.0000000000001702
• Evaluating serdexmethylphenidate and dexmethylphenidate capsules as a once-daily treatment option for ADHD.
  Expert opinion on pharmacotherapy · 2023 · Barnhardt EA, Narayanan AR, Coury DL, et al.
  PMID 37226489DOI 10.1080/14656566.2023.2218544
• Analysis of Growth Velocity in Children with Attention-Deficit/Hyperactivity Disorder Treated for up to 12 Months with Serdexmethylphenidate/Dexmethylphenidate.
  Journal of child and adolescent psychopharmacology · 2023 · Childress AC, Cutler AJ, Patel M, et al.
  PMID 37204277DOI 10.1089/cap.2023.0012
• Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study.
  Journal of child and adolescent psychopharmacology · 2023 · Childress AC, Marraffino A, Cutler AJ, et al.
  PMID 36809150DOI 10.1089/cap.2022.0076
• Short-Term Vision-Related Ocular Side Effects of Treatment with Dexmethylphenidate for Attention-Deficit/Hyperactivity Disorder.
  Journal of child and adolescent psychopharmacology · 2022 · Fainberg G, Leitner Y, Zur D, et al.
  PMID 36548361DOI 10.1089/cap.2022.0074
• Dose Proportionality and Steady-State Pharmacokinetics of Serdexmethylphenidate/Dexmethylphenidate, a Novel Prodrug Combination to Treat Attention-Deficit/Hyperactivity Disorder.
  Journal of child and adolescent psychopharmacology · 2022 · Braeckman R, Guenther S, Mickle TC, et al.
  PMID 35666231DOI 10.1089/cap.2022.0015
• Elevation of sweat chloride levels in a patient with CFTR-related metabolic syndrome receiving dexmethylphenidate and guanfacine.
  Pediatric pulmonology · 2022 · Bucher BM, Wright BA, Weiner RL, et al.
  PMID 35570399DOI 10.1002/ppul.25975

The 10 most recently updated of 34 ClinicalTrials.gov registrations naming Dexmethylphenidate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD
  Completed · Phase 4 · Interventional · 123 enrolled · Corium, Inc.
  NCT05721235updated 2026-05-08
• Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301
  Suspended · Phase 3 · Interventional · 45 enrolled · Cingulate Therapeutics
  NCT05924594updated 2026-05-05
• Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301
  Completed · Phase 3 · Interventional · 103 enrolled · Cingulate Therapeutics
  NCT05286762updated 2026-01-22
• Treating Young Children With Attention Deficit Hyperactivity Disorder
  Not yet recruiting · Phase 4 · Interventional · 370 enrolled · Children's Hospital Medical Center, Cincinnati
  NCT07300956updated 2026-01-07
• AWARE: Management of ADHD in Autism Spectrum Disorder
  Recruiting · Phase 4 · Interventional · 500 enrolled · Daniel Coury
  NCT05916339updated 2025-10-29
• Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.
  Completed · Phase 3 · Interventional · 21 enrolled · Cingulate Therapeutics
  NCT05631626updated 2025-08-14
• In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted)
  Completed · Phase 1 · Interventional · 25 enrolled · Cingulate Therapeutics
  NCT07119073updated 2025-08-12
• Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
  Completed · Phase 4 · Interventional · 29 enrolled · NYU Langone Health
  NCT06000501updated 2025-07-29
• An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD
  Completed · Phase 4 · Interventional · 246 enrolled · Corium, Inc.
  NCT05685732updated 2025-05-13
• Stimulant Effects on Disruptive Behavior
  Recruiting · Phase 4 · Interventional · 10 enrolled · Matthew J O'Brien, PhD, BCBA-D
  NCT03420339updated 2025-03-17

Frequently asked questions

How does Dexmethylphenidate work?

Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.

What is Dexmethylphenidate used for?

According to FDA labeling, Dexmethylphenidate carries indications including: Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )]. Dexmethylphenidate hydrochloride extended-release is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dexmethylphenidate?

Dexmethylphenidate is classified as Centrally acting sympathomimetics, Central Nervous System Stimulant, Dopamine Uptake Inhibitors, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Bronchodilation, Central Nervous System Stimulation, Increased Cerebral Cortex Dopamine Activity, Increased Cerebral Cortex Norepinephrine Activity.

What are the brand names for Dexmethylphenidate?

Dexmethylphenidate is marketed under brand names including Azstarys, Focalin.

What are the contraindications for Dexmethylphenidate?

Dexmethylphenidate labeling lists contraindications including: Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6.1 )].. Always consult the full prescribing information and a clinician.