{
 "query": "methylphenidate",
 "ingredient": "methylphenidate",
 "slug": "methylphenidate",
 "rxcui": "6901",
 "brands": [
  "Concerta",
  "Ritalin",
  "Daytrana",
  "Relexxii",
  "Methylin",
  "Aptensio",
  "Cotempla",
  "Jornay",
  "Metadate",
  "QuilliChew",
  "Quillivant"
 ],
 "names": [
  "methylphenidate",
  "methylphenidate hydrochloride"
 ],
 "classes": [
  {
   "id": "N06BA",
   "name": "Centrally acting sympathomimetics"
  }
 ],
 "alternatives": [
  "amphetamine",
  "armodafinil",
  "atomoxetine",
  "dexmethylphenidate",
  "dextroamphetamine",
  "fenethylline",
  "fenozolone",
  "lisdexamfetamine",
  "methamphetamine",
  "modafinil",
  "pemoline",
  "solriamfetol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 74,
   "TRANSDERMAL": 3
  },
  "boxed_warning": "WARNING: ABUSE, MISUSE, AND ADDICTION Methylphenidate HCl Extended-Release Tablets have 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 HCl Extended-Release Tablets, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with a higher dosage or unapproved methods of administration, such as snorting or injection. Before prescribing Methylphenidate HCl Extended-Release Tablets, assess each patient\u2019s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of Methylphenidate HCl Extended-Release Tablets, and proper disposal of any unused drug. Throughout Methylphenidate HCl Extended-Release Tablets treatment, reassess each patient\u2019s 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 (9.1, 9.2 ) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Methylphenidate HCl Extended-Release Tablets h...",
  "indications_and_usage": "Methylphenidate HCl Extended-Release Tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of Methylphenidate HCl Extended-Release Tablets is 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 HCl Extended-Release Tablets are a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. ( 1 ) Limitations of Use The use of Methylphenidate HCl Extended-Release Tablets is 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 ).",
  "contraindications": "Methylphenidate HCl Extended-Release Tablets are contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of Methylphenidate HCl Extended-Release Tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with Methylphenidate HCl Extended-Release Tablets [see Adverse Reactions (6) ] . Receiving concomitant monoamine oxidase inhibitors (MAOIs), and within 14 days following discontinuation of treatment with a MAO inhibitor because of the risk of a hypertensive crisis [see Drug Interactions (7) ] . Known hypersensitivity to methylphenidate or other components of Methylphenidate HCl Extended-Release Tablets ( 4 ) Receiving concomitant monoamine oxidase inhibitors and within 14 days following discontinuation of treatment with a MAO inhibitor ( 4 )",
  "warnings_and_cautions": "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 Methylphenidate HCl Extended-Release Tablets, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Methylphenidate HCl Extended-Release Tablets. ( 5.4 ) Priapism : If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. ( 5.5 ) Peripheral Vasculopathy, including Raynaud\u2019s Phenomenon : Carefully assess for digital changes during Methylphenidate HCl Extended-Release Tablets 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 ga...",
  "warnings": "",
  "adverse_reactions": "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) ] Hypersensitivity Reactions [see Contraindications (4) ] Monoamine Oxidase Inhibitors [see Contraindications (4) , Drug Interactions (7) ] 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\u2019s Phenomenon [see Warnings and Precautions (5.6) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.7) ] Risks of Gastrointestinal Obstruction in Patients with Gastrointestinal Narrowing [see Warnings and Precautions (5.8) ] Acute Angle Closure Glaucoma [see Warnings and Precautions (5.9) ] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.10) ] Motor and Verbal Tics, and Worsening of Tourette\u2019s Syndrome [see Warnings and Precautions (5.11) ] The most common adverse reaction...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Methylphenidate HCl Extended-Release Tablets contain methylphenidate, a Schedule II controlled substance. 9.2 Abuse Methylphenidate HCl Extended-Release Tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1) ] . Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of Methylphenidate HCl Extended-Release Tablets may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insom...",
  "controlled_substance": "9.1 Controlled Substance Methylphenidate HCl Extended-Release Tablets contain methylphenidate, a Schedule II controlled substance.",
  "recent_major_changes": "Boxed Warning 10/2023 Indications and Usage ( 1 ) 10/2023 Dosage and Administration ( 2.1 , 2.6 ) 10/2023 Dosage and Administration, Maintenance/Extended Treatment ( 2.5 ) Removed 10/2023 Contraindications ( 4 ) 10/2023 Warnings and Precautions ( 5.1 , 5.2, 5.3 , 5.4 , 5.6 , 5.7 , 5.8 , 5.11 , 5.12 , 5.13 ) 10/2023 Warnings and Precautions ( 5.7 ) Removed 10/2023 Indications and Usage ( 1 ) 09/2025 Dosage and Administration ( 2.3 , 2.4 ) 02/2026 Warnings and Precautions: Long-Term Suppression of Growth in Pediatric Patients 09/2025 Warnings and Precautions: Removal Seizures and Hematologic Monitoring 02/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of Methylphenidate HCl Extended-Release Tablets, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.1 , 9.2) , Overdosage (10) ] . Advise patients to store Methylphenidate HCl Extended-Release Tablets in a safe place, preferably locked, and instruct patients to not give Methylphenidate HCl Extended-Release Tablets to anyone else. Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with Methylphenidate HCl Extended-Release Tablets use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2) ] . Increased Blood Pressure and Heart Rate Advise patients and their caregivers that Methylphenidate HCl Extended-Release Tablets can cause...",
  "spl_medguide": "MEDICATION GUIDE Methylphenidate (meth\u201d il fen\u2019 i date ) HCl Extended-Release Tablets, USP for oral use, CII What is the most important information I should know about Methylphenidate HCl Extended-Release Tablets? Methylphenidate HCl Extended-Release Tablets may cause serious side effects, including: Abuse, misuse, and addiction. Methylphenidate HCl Extended-Release Tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of Methylphenidate HCl Extended-Release Tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Methylphenidate HCl Extended-Release Tablets or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child\u2019s risk for abuse, misuse, and addiction before starting treatment with Methylphenidate HCl Extended-Release Tablets and will monitor you or your child during treatment. Methylphenidate HCl Extended-Release Tablets may lead to physical dependence after prolonged use, even if taken as directed by...",
  "clinical_studies": "14.1 Overview of Clinical Trials Methylphenidate HCl Extended-Release Tablets were demonstrated to be effective in the treatment of ADHD in patients who met the Diagnostic and Statistical Manual 4 th edition (DSM-IV) criteria for ADHD in the following trials: Three trials in pediatric patients 6 to 12 years old (Studies 1, 2, and 3), One trial in adolescents (13 to 18 years old), Two trials in adults (18 to 65 years old). 14.2 Clinical Trials in Pediatric Patients 6 to 12 Years Three double-blind, active- and placebo-controlled trials were conducted in 416 pediatric patients 6 to 12 years of age with ADHD: (1) two single-center, crossover trials (patients received each treatment for one week) (Studies 1 and 2) and (2) a multicenter, 4-week, parallel-group comparison trial (Study 3). In these trials, patients were randomized to receive: 18 mg, 36 mg, or 54 mg of oral Methylphenidate HCl Extended-Release Tablets given once daily, 5 mg, 10 mg, or 15 mg of oral immediate-release methylphenidate given three times daily (15, 30, or 45 mg total daily dosage) over 12 hours, and Placebo The primary comparison of interest in all three trials was the Methylphenidate HCl Extended-Release Table...",
  "brand_name": "Methylphenidate Hydrochloride",
  "manufacturer": "Lannett Company, Inc.",
  "application_number": "ANDA091695",
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  "effective_time": "20260501",
  "set_id": "3d1f5aff-5d39-496c-b5ed-7f3c70ec641c",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": false
 },
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   {
    "pmid": "41342306",
    "title": "Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)",
    "year": "2025"
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   {
    "pmid": "36971690",
    "title": "Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)",
    "year": "2023"
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   {
    "pmid": "35201607",
    "title": "Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults",
    "year": "2022"
   },
   {
    "pmid": "33460048",
    "title": "Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults",
    "year": "2021"
   },
   {
    "pmid": "29744873",
    "title": "Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverse events in non-randomised studies",
    "year": "2018"
   },
   {
    "pmid": "29159857",
    "title": "Methylphenidate for children and adolescents with autism spectrum disorder",
    "year": "2017"
   },
   {
    "pmid": "27228176",
    "title": "WITHDRAWN: Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults",
    "year": "2016"
   },
   {
    "pmid": "26599576",
    "title": "Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)",
    "year": "2015"
   },
   {
    "pmid": "25230710",
    "title": "Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults",
    "year": "2014"
   }
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  {
   "date": "20150624",
   "title": "FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm452244.htm",
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  },
  {
   "date": "20131217",
   "title": "FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm375796.htm",
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   "letter": "F",
   "why": [
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    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2015 (-16)",
    "10,344 FDA reports naming it as the suspect drug per million Medicare fills, 3.7x the median drug on this site (-11)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death share in reports is near or below the FAERS average (0.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
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   "why": [
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    "9 independent Cochrane review(s) exist",
    "Only 43% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
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   "weight": 0.25
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   "score": 80,
   "letter": "B",
   "why": [
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    "49 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
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   "weight": 0.15
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   "score": 100,
   "letter": "A",
   "why": [
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    "Not named in any pending federal MDL"
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   "weight": 0.15
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  "options": {
   "score": 100,
   "letter": "A",
   "why": [
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    "12 same-class alternatives exist"
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   "weight": 0.1
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 "grade": "C",
 "questions": [
  "In 2015 the FDA issued a safety communication about this drug (FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal ). Does that risk apply to me?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "The most-reported problems in FDA's adverse event data are no adverse event, fatigue. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over amphetamine, armodafinil, atomoxetine? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}