pharmacopeia
GET
/api/v1/drug/methylphenidate

Boxed 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 ).

2D structure
methyl 2-phenyl-2-piperidin-2-ylacetate
SMILES COC(=O)C(C1CCCCN1)C2=CC=CC=C2
InChIKey DUGOZIWVEXMGBE-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.

Dopamine UptakeMonoamine OxidaseNorepinephrine Uptake

Indications

Sourced from openFDA
  • Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies ( 14 )] . Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age.ICD-10: F90.9

Contraindications

Sourced from openFDA
  • Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ s ee Adverse Reactions ( 6.1 )].contraindicated

Dosage & administration

Sourced from openFDA

Administer orally once daily in the morning. ( 2.2 ) Capsules may be swallowed whole, or opened and the entire contents sprinkled on applesauce. ( 2.2 ) Should not be crushed, chewed, or divided. ( 2.2 ) Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10-mg increments. Doses above 60 mg daily are not recommended. ( 2.3 ) For patients currently using methylphenidate hydrochloride tablets or methylphenidate hydrochloride extended-release tablets: Dosage is based on current dose regimen. ( 2.4 ) If switching from other methylphenidate products, discontinue treatment and titrate with methylphenidate hydrochloride extended-release capsules. ( 2.4 ) 2.1 Pretreatment Screening Prior to initiating treatment with central nervous system (CNS) stimulants, including methylphenidate hydrochloride extended-release capsules, assess for the presence of cardiac disease (i.e., perform a careful history including family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions ( 5.2 )] . Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for methylphenidate hydrochloride extended-release capsules use [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9 )].

Warnings & precautions

Sourced from openFDA

Serious Cardiovascular Events : Sudden death has been reported in association with CNS-stimulant treatment at usual doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm arrhythmias, or coronary artery disease. ( 5.2 ) B lood Pressure and Heart Rate Increases : Monitor blood pressure and pulse. Consider the benefits and risk in patients for whom an increase in blood pressure or heart rate would be problematic. ( 5.3 ) Psychiatric Adverse Reactions : Use of stimulants may cause psychotic or manic symptoms in patients with no prior history or exacerbation of symptoms in patients with preexisting psychiatric illness. Evaluate for preexisting psychotic or bipolar disorder prior to methylphenidate hydrochloride extended-release capsules use. ( 5.4 ) P riapis m : Cases of painful and prolonged penile erections, and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed. ( 5.5 ) Pe ripheral Vasculopathy, including Raynaud’s Phenomenon : Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

Adverse reactions

Sourced from openFDA

The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride extended-release capsules [see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] Serious cardiovascular reactions [see Warnings and Precautions ( 5.2 )] Blood pressure and heart rate increases [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 [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (greater than 5% during incidence) were headache, insomnia, upper abdominal pain, decreased appetite, and anorexia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Use in specific populations

Sourced from openFDA

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy registry for ADHD medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/. 8.1 Pregnancy Risk Summary 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 use during pregnancy (see Clinical Considerations) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents.

Pharmacokinetics

Sourced from openFDA
Metabolism
Methylphenidate hydrochloride extended-release capsules produce a bi-modal plasma concentration-time profile (i.e., 2 distinct peaks approximately 4 hours apart) when administered orally to children diagnosed with ADHD and healthy adults.

Overdosage

Sourced from openFDA

Human Experience Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (which may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis. Overdose Management Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.

Approval history

Sourced from openFDA
  • Dec 5, 1955NDANDA010187Sandoz
  • Aug 1, 2000NDANDA021121Janssen Pharms
  • Apr 3, 2001NDANDA021259Aytu Biopharma
  • Jun 5, 2002NDANDA021284Sandoz
  • Dec 19, 2002NDANDA021419Specgx Llc
  • Apr 6, 2006NDANDA021514Noven Pharms Inc
  • Sep 27, 2012NDANDA202100Nextwave
  • Apr 17, 2015NDANDA205831Rhodes Pharms

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Methylphenidate, Film, Extended Release, 10 mg (NDC 0574-2410-65)Active
    Sponsor: Noven Pharmaceuticals, Inc.
    Updated
  • Methylphenidate, Film, Extended Release, 15 mg (NDC 0574-2415-65)Active
    Sponsor: Noven Pharmaceuticals, Inc.
    Updated
  • Methylphenidate, Film, Extended Release, 20 mg (NDC 0574-2420-65)Active
    Sponsor: Noven Pharmaceuticals, Inc.
    Updated
  • Methylphenidate, Film, Extended Release, 30 mg (NDC 0574-2430-65)Active
    Sponsor: Noven Pharmaceuticals, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
72,541 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use7,75111%
  2. 2Drug Ineffective7,55110%
  3. 3No Adverse Event7,0219.7%
  4. 4Product Quality Issue5,5887.7%
  5. 5Fatigue3,2844.5%
  6. 6Headache3,1404.3%
  7. 7Nausea3,0744.2%
  8. 8Anxiety2,9504.1%
  9. 9Insomnia2,4033.3%
  10. 10Depression2,4003.3%
  11. 11Decreased Appetite2,1403.0%
  12. 12Disturbance In Attention2,0942.9%
  13. 13Drug Dose Omission2,0852.9%
  14. 14Somnolence1,9672.7%
  15. 15Drug Administration Error1,9542.7%

Literature

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

Clinical trials

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The 10 most recently updated of 534 ClinicalTrials.gov registrations naming Methylphenidate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Methylphenidate. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2D6CPIC C (provisional)ClinPGx 3

Frequently asked questions

How does Methylphenidate work?
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant. The mode of therapeutic action in ADHD is not known.
What is Methylphenidate used for?
According to FDA labeling, Methylphenidate carries indications including: Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies ( 14 )] . Methylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Methylphenidate?
Methylphenidate 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 Methylphenidate?
Methylphenidate is marketed under brand names including Aptensio, Concerta, Cotempla, Daytrana, Jornay, Metadate, Methylin, QuilliChew.
What are the contraindications for Methylphenidate?
Methylphenidate labeling lists contraindications including: Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [ s ee Adverse Reactions ( 6.1 )].. Always consult the full prescribing information and a clinician.
Note. Data for methylphenidate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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