{ "query": "dexmethylphenidate", "ingredient": "dexmethylphenidate", "slug": "dexmethylphenidate", "rxcui": "352372", "brands": [ "Focalin" ], "names": [ "dexmethylphenidate", "dexmethylphenidate hydrochloride" ], "classes": [ { "id": "N06BA", "name": "Centrally acting sympathomimetics" } ], "alternatives": [ "amphetamine", "armodafinil", "atomoxetine", "dextroamphetamine", "fenethylline", "fenozolone", "lisdexamfetamine", "methamphetamine", "methylphenidate", "modafinil", "pemoline", "solriamfetol" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 40 }, "boxed_warning": "WARNING: ABUSE, MISUSE, AND ADDICTION Dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride, 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 dexmethylphenidate hydrochloride, assess each patient\u2019s 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 dexmethylphenidate hydrochloride 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 ( 9.2 )] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Dexmethylphenidate hydrochloride has a high potential for abuse and misuse, which can lead to the development of a substance use disorder...", "indications_and_usage": "Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).", "contraindications": "Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6.1 )] . Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions ( 7.1 )] . Known hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride tablets ( 4 ). Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 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 dexmethylphenidate hydrochloride tablets, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing dexmethylphenidate hydrochloride 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 : Careful observation for digital changes is necessary during dexmethylphenidate hydrochloride 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 gainin...", "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 , 9.3 )] Known hypersensitivity to methylphenidate or other ingredients of dexmethylphenidate hydrochloride tablets [see Contraindications ( 4 )] Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] 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 )] Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.8 )] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions ( 5.9 )] Motor and Verbal Tics, and Worsening of Tourette\u2019s Syndrome [see Warnings and Precautions ( 5.10 )] The most ...", "drug_abuse_and_dependence": "9.1 Controlled Substance Dexmethylphenidate hydrochloride tablets contains dexmethylphenidate hydrochloride, a Schedule II controlled substance. 9.2 Abuse Dexmethylphenidate hydrochloride 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 )] . Dexmethylphenidate hydrochloride can be diverted for non-medical use into illicit channels or distribution. 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 may cause increased heart rate, respira...", "controlled_substance": "9.1 Controlled Substance Dexmethylphenidate hydrochloride tablets contains dexmethylphenidate hydrochloride, a Schedule II controlled substance.", "recent_major_changes": "Boxed Warning 10/2023 Dosage and Administration ( 2.1 , 2.2 ) 10/2023 Warnings and Precautions ( 5.1 , 5.2 , 5.8 , 5.9 , 5.10 ) 10/2023", "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 dexmethylphenidate hydrochloride, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 ), Overdosage ( 10 )] . Advise patients to store dexmethylphenidate hydrochloride tablets in a safe place, preferably locked, and instruct patients to not give dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride 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 Instruct patients that dexmethylphenidate hydrochloride tablets can cause elevations of their blood pressure and pulse ra...", "spl_medguide": "MEDICATION GUIDE This Medication Guide has been approved by the U.S. Food and Drug Administration Revised:11/2023 MEDICATION GUIDE Dexmethylphenidate Hydrochloride Tablets CII ( dex-meth-ill-FEN-ih-date) What is the most important information I should know about Dexmethylphenidate hydrochloride tablets? Dexmethylphenidate hydrochloride tablets may cause serious side effects, including: Abuse, misuse, and addiction. Dexmethylphenidate hydrochloride tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride 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 dexmethylphenidate hydrochloride tablets and will monitor you or your child during treatment. Dexmethylphenidate hydrochloride tablets may lead to ph...", "clinical_studies": "The efficacy of dexmethylphenidate hydrochloride tablets for the treatment of ADHD was established in two double-blind, parallel-group, placebo-controlled trials in untreated or previously treated patients (ages 6 to 17 years old) who met The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD inattentive, hyperactive-impulsive, or combined inattentive/hyperactive-impulsive subtypes. The sample was predominantly younger (ages 6 to 12 years); thus, the findings are most pertinent to this age group. In Study 1, patients were randomized to receive either dexmethylphenidate hydrochloride tablets (5, 10, or 20 mg/day total dose), racemic methylphenidate HCl (10, 20, or 40 mg/day total dose), or placebo in a multicenter, 4-week, parallel group study in 132 pediatric patients. Patients received study medication twice daily separated by a 3.5 to 5.5 hours interval. Treatment was initiated with the lowest dose, and doses could be doubled at weekly intervals, depending on clinical response and tolerability, up to the maximum dose. The primary outcome was change from baseline to week 4 of the average score (an average of 2 ratings during the week) ...", "brand_name": "Dexmethylphenidate Hydrochloride", "manufacturer": "Bryant Ranch Prepack", "application_number": "ANDA207901", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20240201", "set_id": "17950616-ab96-4d7e-be48-f36cae547de0", "has_boxed_warning": true, "controlled": true, "mentions_rems": false }, "faers": { "total": 4201, "serious": 1344, "death": 56, "hospitalization": 385, "primary_suspect": 4191, "top_reactions": [ [ "Drug Ineffective", 848 ], [ "Anxiety", 206 ], [ "Nausea", 200 ], [ "Headache", 195 ], [ "Fatigue", 172 ], [ "Product Substitution Issue", 170 ], [ "Off Label Use", 168 ], [ "Disturbance In Attention", 167 ], [ "Decreased Appetite", 157 ], [ "Feeling Abnormal", 157 ], [ "Abnormal Behaviour", 153 ], [ "Insomnia", 137 ], [ "Vomiting", 130 ], [ "Somnolence", 129 ], [ "Aggression", 123 ] ], "by_year": { "2019": 358, "2020": 317, "2021": 228, "2022": 301, "2023": 386, "2024": 329, "2025": 343, "2026": 153 }, "by_year_primary": { "2019": 357, "2020": 317, "2021": 227, "2022": 297, "2023": 385, "2024": 329, "2025": 341, "2026": 153 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class III", "date": "20260601", "reason": "Labeling: Incorrect or Missing Lot and/or Exp Date", "firm": "Sandoz Inc", "status": "Ongoing" } ], "recall_total": 1, "drugsfda": { "applications": 23, "nda": 2, "anda": 21, "first_approval": "20011113", "rems": false, "rems_last": "", "labeling_supplements": 36, "labeling_recent": 7, "sponsors": [ "ABHAI LLC", "ADARE PHARMS INC", "ALKEM LABS LTD", "ASCENT PHARMS INC", "AUROLIFE PHARMA LLC", "BIONPHARMA", "CEDIPROF INC", "GRANULES" ], "unapproved": false, "first_approval_fmt": "11/13/2001" }, "trials": { "total": 34, "completed": 29, "terminated": 2, "with_results": 18, "industry": 23, "phase3": 11, "results_share": 0.6206896551724138, "terminated_share": 0.058823529411764705 }, "pubmed": { "rct": 25, "meta": 0, "recent_rct": 3, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "dexmethylphenidate", "Focalin" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 78457, "beneficiaries": 15229, "spend": 6406160.119999999, "by_brand": [ { "brand": "Dexmethylphenidate HCl ER", "claims": 44752, "per_claim": 97.873478951, "is_generic": false }, { "brand": "Dexmethylphenidate HCl", "claims": 28862, "per_claim": 29.797995634, "is_generic": true }, { "brand": "Focalin XR", "claims": 3848, "per_claim": 276.40713098, "is_generic": false }, { "brand": "Focalin", "claims": 995, "per_claim": 102.99678392, "is_generic": false } ], "per_claim": 81.65186178416201 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 60, "letter": "D", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "Federally controlled substance: dependence and misuse risk (-10)", "Death share in reports is near or below the FAERS average (0.1x)" ], "weight": 0.35 }, "evidence": { "score": 25, "letter": "F", "why": [ "25 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 87, "letter": "B", "why": [ "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 21 generic makers (-0)", "7 label changes approved since 2021: the safety story is still moving (-8)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (21 applications)", "12 same-class alternatives exist" ], "weight": 0.1 } }, "total": 65, "grade": "C", "questions": [ "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 anxiety, nausea, headache. How would we recognize and handle those?", "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.)" ] }