METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate hydrochloride extended-release capsules are used for children and adolescents between the ages of 6 and 15 who have Attention Deficit Hyperactivity Disorder (ADHD). This medication helps patients with ADHD symptoms by acting as a stimulant for the central nervous system. It is specifically intended for this age group, as children under 6 years old may experience higher drug exposure and a greater risk of side effects like weight loss.
How METHYLPHENIDATE HYDROCHLORIDE Works
This medication works by stimulating the central nervous system. While it is classified as a CNS stimulant, the specific way it produces a therapeutic effect in patients with ADHD is not currently known.
Details
- Status
- Prescription
- First Approved
- 1977-12-23
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, SOLUTION, CAPSULE, EXTENDED RELEASE, TABLET, CHEWABLE, FOR SUSPENSION, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, CHEWABLE
Companies
METHYLPHENIDATE HYDROCHLORIDE Approval History
What METHYLPHENIDATE HYDROCHLORIDE Treats
1 indicationsMETHYLPHENIDATE HYDROCHLORIDE is approved for 1 conditions since its original approval in 1977. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention Deficit Hyperactivity Disorder
METHYLPHENIDATE HYDROCHLORIDE Boxed Warning
ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride extended-release 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 methylphenidate hydrochloride extended-release, 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 methylphe...
WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride extended-release 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 methylphenidate hydrochloride extended-release, 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 methylphenidate hydrochloride extended-release, 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 methylphenidate hydrochloride extended-release 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. Methylphenidate hydrochloride extended-release 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 methylphenidate hydrochloride extended-release , can result in overdose and death (5.1 , 9.2 , 10) : Before prescribing methylphenidate hydrochloride extended-release , 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.
METHYLPHENIDATE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to METHYLPHENIDATE HYDROCHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01628029 results posted | 2012-0120 NCI-2012-01352, 2012-0120 | Ph 2 | active not recruiting | Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer |
| NCT05185583 | 77169 | Ph 2 | completed | Methylphenidate in Childhood Apraxia of Speech |
| NCT06465641 KBGS_N_of_1 | 113883 | Ph 4 | recruiting | Methylphenidate in KBG Syndrome: N-of-1 Series |
| NCT04152629 reFOQus | CAN-MA-FOQ-001 | Ph 4 | completed | Real World Evidence of the Efficacy and Safety of FOQUEST |
| NCT00763971 results posted | SPD489-325 2008-000679-90 | Ph 3 | completed | Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 |
| NCT01552902 results posted | SPD489-406 2011-005452-34 | Ph 4 | completed | Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder |
| NCT01183234 results posted | SPD544-101 | Ph 1 | completed | SPD544 High Strength Bioequivalence Study |
| NCT01552915 results posted | SPD489-405 | Ph 4 | completed | Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder |
| NCT02247986 | 140193 14-M-0193 | Ph 1, Ph 2 | withdrawn | Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder |
| NCT01914822 | 275-13-RMB Ritalin version 5 | Ph 2 | completed | The Effect Methylphenidate Hydrochloride on Pain and Auditory Sensitivity in Healthy Subjects |
| NCT00376675 results posted | NCCTG-N05C7 NCI-2012-02701, CDR0000495148 | Ph 3 | completed | Methylphenidate in Treating Patients With Fatigue Caused by Cancer |
| NCT00593853 | LEUPR_L_01 07-0350-C | Ph 2 | terminated | Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy |
| NCT01348607 results posted | SCUSF 0803 SCUSF-0803, 5U10CA081920-11 | Ph 2 | terminated | Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy |
| NCT00730249 QUMEA | 6520-0650-13 | Ph 3 | completed | Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
METHYLPHENIDATE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)METHYLPHENIDATE HYDROCHLORIDE is indicated for the treatment of Attention Deficit Hyperactivity Disorder.
WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate hydrochloride extended-release 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 methylphenidate hydrochloride extended-rel...
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CONCERTA
Full clinical data, patents, trials, and competitive landscape for methylphenidate hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.