Last reviewed · How we verify
Ritalin (methylphenidate)
At a glance
| Generic name | methylphenidate |
|---|---|
| Sponsor | Novartis |
| Target | Alpha-2A adrenergic receptor, Alpha-2B adrenergic receptor, Alpha-2C adrenergic receptor |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
Approved indications
- Attention deficit hyperactivity disorder
- Narcolepsy
Boxed warnings
- WARNING: ABUSE AND DEPENDENCE C N S stimulants, including methylphenidate hydrochloride extended-release capsules , other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] . WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including methylphenidate hydrochloride extended-release capsules , other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence ( 5.1 , 9.2 , 9.3 ). Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy ( 5.1 , 9.2 ).
Common side effects
- Appetite decreased
- Insomnia
- Nausea
- Weight decreased
- Anorexia
- Vomiting
- Tic
- Affect lability
- Dizziness
- Abdominal pain
- Application site reaction
- Headache
Serious adverse events
- Tics
- Application site reaction
Key clinical trials
- A Multicenter Open Trial to Evaluate the Effectiveness and Quality of Life in Adults With Attention Deficit /Hyperactivity Disorder (ADHD) Treated With Long Acting Methylphenidate (CONCERTA) (Phase 4)
- A Randomized, Phase II Placebo-controlled Study of the Use of Extended-release Methylphenidate or Modafinil for the Treatment of Excessive Daytime Sleepiness in Children Following Cancer Therapy (Phase 2)
- The Effectiveness of Atomoxetine on Brain Imaging, Neuropsychological, and Social Functions in Adults With Attention Deficit/Hyperactivity Disorder (N/A)
- Psilocybin and Affective Function in Chronic Lower Back Pain Depression (Phase 1)
- NCT00773916 (Phase 4)
- A Randomized, Double-Blind Comparison of the Time Course of Response to Two Extended-Release Oral Delivery Systems for Methylphenidate in Pediatric Patients With Attention Deficit Hyperactivity Disord (Phase 4)
- Methylphenidate for the Treatment of Gain Impairment in Parkinson's Disease: a Randomized Double-Blind, Placebo-Controlled, Cross-over Study (Phase 4)
- Group Therapy for Adolescents With Attention-Deficit/Hyperactivity Disorder: a Randomized Multicenter Controlled Trial (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 11166947 | 2038-01-25 | Method of Use |
| 9072680 | 2032-06-28 | Formulation |
| 9089496 | 2032-06-28 | Formulation |
| 8840924 | 2026-06-05 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |