Methylphenidate
Also known as: methylphenidate hydrochloride · Tuzulby · CONCERTA · METADATE CD · RELEXXII
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In short
In the European Union, methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old when remedial measures alone prove insufficient. In the United States, methylphenidate hydrochloride extended-release tablets are a central nervous system stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy in adults and pediatric patients 6 years and older. Methylphenidate is listed by the cited source as having an approved use for attention deficit hyperactivity disorder, presentation unspecified.
From: Source: European Medicines Agency (EMA), Tuzulby — EPAR, 14/08/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- EMA
- EMEA/H/C/005975
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
FDA (USA) METHYLPHENIDATE HYDROCHLORIDE
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets in adults and pediatric patients 6 years and older are indicated for the treatment of: Attention deficit hyperactivity disorder (ADHD) Narcolepsy Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) and Use in Specific Populations (8.4) ] . Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant indicated for the treatment of adults and pediatric patients 6 years and older ( 1 ): • Attention deficit hyperactivity disorder (ADHD) and • Narcolepsy. Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).
Data provided by the U.S. Food and Drug Administration.
Document date: 20260818 · Official document →
EMA (EU) Tuzulby
Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.
Source: European Medicines Agency (EMA), Tuzulby — EPAR, 14/08/2026. © European Medicines Agency.
Document date: 14/08/2026 · Official document →
Related terms in the cited sources
Has an official indication for
- ADHD (hyperkinetic disorders) Condition
In alphabetical order.
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Methylphenidate approved for in the European Union?
Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms. (Source: European Medicines Agency (EMA), Tuzulby — EPAR, 14/08/2026. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Data provided by the U.S. Food and Drug Administration.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Tuzulby — EPAR, 14/08/2026. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
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