Concerta
Methylphenidate hydrochloride · Tablet, Extended Release · Oral
Current shortage
Concerta, Tablet, Extended Release, 54 mg (NDC 50458-587-01) – Available (Janssen Pharmaceuticals, updated Sep 17, 2026)
Concerta, Tablet, Extended Release, 18 mg (NDC 50458-585-01) – Available (Janssen Pharmaceuticals, updated Sep 17, 2026)
Concerta, Tablet, Extended Release, 36 mg (NDC 50458-586-01) – Available (Janssen Pharmaceuticals, updated Sep 17, 2026)
Concerta, Tablet, Extended Release, 27 mg (NDC 50458-588-01) – Available (Janssen Pharmaceuticals, updated Sep 17, 2026)
Uses
1 INDICATIONS AND USAGE CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA 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) ]. CONCERTA is 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 CONCERTA 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 ).
Dosage and administration
Prior to initiating CONCERTA treatment assess for ( 2.1 ): the presence of cardiac disease for family history of tics or Tourette' syndrome and clinically evaluate patients for motor or verbal tics or Tourette's syndrome Administer once daily in the morning with or without food. Swallow whole with liquids; do not chew, divide, or crush. ( 2.2 ) Recommended dosage in pediatric patients 6 to 17 years of age new to methylphenidate: starting dosage is18 mg once daily. May be increased weekly in 18 mg increments. Maximum dosage for pediatric patients ( 2.3 ): 6 to 12 years: 54 mg once daily 13 to 17 years: 72 mg once daily Recommended dosage in adults (up to 65 years of age) new to methylphenidate: starting dosage is 18 mg or 36 mg once daily. May be increased weekly in 18 mg increments, up to 72 mg once daily. ( 2.3 ) Patients currently using immediate-release methylphenidate: starting CONCERTA dosage is based on current dosage regimen. ( 2.4 ) 2.1 Pretreatment Screening Prior to treating patients with CONCERTA, assess: For the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ]. The family history for tics or Tourette' syndrome and clinically evaluate patients for motor or verbal tics or Tourette's syndrome [see Warnings and Precautions (5.11) ]. 2.2 Important Administration Instructions Administer CONCERTA orally once daily in the morning with or without food. Swallow CONCERTA whole with liquids. Do not split, crush, or chew the extended-release tablets because doing so will compromise the extended-release characteristics of CONCERTA and may compromise the effectiveness or safety of CONCERTA. 2.3 Recommended CONCERTA Dosage in Patients New to Methylphenidate See Table 1 for the recommended once-daily dosage of CONCERTA in patients who were not taking a methylphenidate product. In patients who have not achieved an optimal response at a lower dosage, increase the CONCERTA dosage in 18 mg increments at weekly intervals. However, if a slower titration is recommended for patients who have not achieved an optimal response taking 18 mg of CONCERTA once daily, increase their daily dosage to 27 mg once per day. Table 1: Recommended CONCERTA Dosage in Patients New to Methylphenidate Patient Population Recommended Starting Dosage Dosage Range Pediatric patients 6 to 12 years of age 18 mg once daily 18 mg to 54 mg once daily Pediatric patients 13 to 17 years of age 18 mg once daily 18 mg to 72 mg once daily (not to exceed 2 mg/kg/day) Adults 18 to 65 years of age 18 or 36 mg once daily 18 mg to 72 mg once daily 2.4 Recommended CONCERTA Dosage in Patients Switching from Another Methylphenidate Product See Table 2 for the recommended starting dosage of CONCERTA in patients switching from an immediate-release methylphenidate product administered twice daily or three times daily (total daily dosage of 10 to 60 mg/day). Table 2: Recommended Starting Dosage in Patients Switching from Another Methylphenidate Product Previous Immediate-release Methylphenidate Daily Dosage Recommended CONCERTA Starting Dosage 5 mg twice daily or three times daily 18 mg every morning 10 mg twice daily or three times daily 36 mg every morning 15 mg twice daily or three times daily 54 mg every morning 20 mg twice daily or three times daily 72 mg every morning Only for patients 13–65 years of age. In patients who have not achieved an optimal response at a lower dosage, increase the CONCERTA dosage in 18 mg increments at weekly intervals. The maximum recommended dosage in pediatric patients 6 to 12 years of age is 54 mg/day, and the maximum recommended dosage in patients 13–65 years old is 72 mg/day. 2.5 Dosage Reduction and Discontinuation If paradoxical aggravation of ADHD symptoms or CONCERTA-associated adverse reactions occur, reduce the CONCERTA dosage or, if necessary, discontinue CONCERTA. If ADHD improvement is not observed after appropriate dosage modification over a one-month period, discontinue CONCERTA.
Dosage forms and strengths
Extended-Release Tablets: 18 mg: yellow, imprinted with "alza 18" 27 mg: gray, imprinted with "alza 27" 36 mg: white, imprinted with "alza 36" 54 mg: brownish-red, imprinted with "alza 54" Extended-release tablets: 18, 27, 36, and 54 mg ( 3 )
Contraindications
4 CONTRAINDICATIONS CONCERTA is contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of CONCERTA. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with CONCERTA. [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 CONCERTA ( 4 ) Receiving concomitant monoamine oxidase inhibitors and within 14 days following discontinuation of treatment with a MAO inhibitor ( 4 )
Warnings and precautions
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 CONCERTA, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing CONCERTA. ( 5.4 ) Priapism : If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention ( 5.5 ) Peripheral Vasculopathy, including Raynaud's Phenomenon : Carefully assess for digital changes during CONCERTA 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 gaining height or weight as expected may need to have their CONCERTA treatment interrupted. ( 5.7 ) Risk of Gastrointestinal (GI) Obstruction in Patients with GI Narrowing: Only use in patients able to swallow the extended-release tablet whole, and should not ordinarily be used in patients with pre-existing severe GI narrowing. ( 5.8 ) Acute Angle Closure Glaucoma: CONCERTA-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. ( 5.9 ) Increased Intraocular Pressure (IOP) and Glaucoma : Prescribe CONCERTA to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor patients with a history of increased IOP or open angle glaucoma. ( 5.10 ) Motor and Verbal Tics, and Worsening of Tourette's Syndrome : Before initiating CONCERTA, assess the family history and clinically evaluate patients for tics or Tourette's syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette's syndrome. Discontinue CONCERTA treatment if clinically appropriate. ( 5.11 ) 5.1 Abuse, Misuse, and Addiction CONCERTA has a high potential for abuse and misuse. The use of CONCERTA exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction [see Drug Abuse and Dependence (9.1 , 9.2) ] . Misuse and abuse of CNS stimulants, including CONCERTA, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher dosage or unapproved methods of administration, such as snorting or injection. Before prescribing CONCERTA, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store CONCERTA in a safe place, preferably locked, and instruct patients to not give CONCERTA to anyone else. Throughout CONCERTA treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 5.2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid CONCERTA use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 5.3 Increased Blood Pressure and Heart Rate CNS stimulants may cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 beats per minute) [see Adverse Reactions (6) ] . Some patients may have larger increases. Monitor all CONCERTA-treated patients for hypertension and tachycardia. 5.4 Psychiatric Adverse Reactions Exacerbation of Psychosis in Patients with a Psychotic Disorder CNS stimulants, including CONCERTA, may exacerbate behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants, including CONCERTA, may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating CONCERTA treatment, screen patients for risk factors for developing a manic episode (e.g., history of depressive symptoms or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms in Patients without a History of a Bipolar or Psychotic Disorder CNS stimulants (including CONCERTA), at the recommended dosage, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing CONCERTA. 5.5 Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in adult and pediatric male patients [see Adverse Reactions (6) ] . Although priapism was not reported with methylphenidate initiation, priapism occurred in patients treated with methylphenidate after some time, often subsequent to an increase in dosage. Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation). CONCERTA-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Side effects
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's 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's Syndrome [see Warnings and Precautions (5.11) ] The most common adverse reactions (≥5%) in double-blind clinical trials were: Pediatric patients 6 to 17 years: upper abdominal pain. ( 6.1 ) Adults up to 65 years of age: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, tachycardia, and hyperhidrosis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 clinical trials of another drug and may not reflect the rates observed in clinical practice. The data below is based on a total of 3,906 patients in clinical studies who received CONCERTA. Patients aged 6 up to 65 years old with ADHD were evaluated in 6 controlled clinical studies and 11 open-label clinical studies [see Table 3 ]. Table 3: CONCERTA-treated Patients in Double-Blind and Open-Label Clinical Studies Patient Population N Dosage Range Pediatric patients 6 to 12 years of age 2,216 18 to 54 mg once daily Adolescents 502 18 to 72 mg once daily Adults up to 65 years of age 1,188 18 to 108 mg once daily The most common adverse reactions (≥5%) in double-blind clinical trials were: Pediatric patients: upper abdominal pain [see Table 4 ] . Adults: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, tachycardia, and hyperhidrosis [see Table 5 ] . The most common adverse reactions associated with CONCERTA discontinuation (≥1%) from the pediatric and adult clinical trials were anxiety, irritability, insomnia, and increased blood pressure . Most Common Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials: Adverse reactions in either the pediatric or adult double-blind adverse reactions tables may be relevant for both patient populations. Adverse Reactions in Pediatric Patients Aged 6 years and Older Table 4 displays adverse reactions reported in 2% or more of CONCERTA-treated pediatric patients ages 6 and older with ADHD in 4 placebo-controlled, double-blind clinical trials. Table 4: Most Common Adverse Reactions Reported in ≥ 2% of CONCERTA-treated patients in Pediatric Patients 6 Years of Age and Older with ADHD in 4 Placebo-Controlled, Double-Blind Clinical Trials CONCERTA (n=321) Placebo (n=318) Upper abdominal pain 6% 4% Insomnia Initial insomnia (CONCERTA=0.6%) and insomnia (CONCERTA=2.2%) terms were combined into Insomnia. 3% 1% Nasopharyngitis 3% 2% Vomiting 3% 2% Pyrexia 2% 1% Adverse Reactions in Adults Table 5 lists the adverse reactions reported in 2% or more of CONCERTA-treated adults with ADHD in 2 placebo-controlled, double-blind clinical trials. Table 5: Most Common Adverse Reactions Reported in ≥ 2% of CONCERTA-treated patients in Adults with ADHD in 2 Placebo-Controlled, Double-Blind Clinical Trials CONCERTA Included dosages up to 108 mg/day (1.5 times the maximum recommended dosage). (n=415) Placebo (n=212) Decreased appetite 25% 7% Headache 22% 16% Dry mouth 14% 4% Nausea 13% 3% Insomnia 12% 6% Anxiety 8% 2% Decreased weight 7% 3% Dizziness 7% 5% Irritability 6% 1% Tachycardia 5% 0% Hyperhidrosis 5% 1% Depressed mood 4% 1% Initial insomnia 4% 3% Restlessness 3% 0% Palpitations 3% 1% Nervousness 3% 1% Tremor 3% 1% Upper respiratory tract infection 2% 1% Agitation 2% 1% Dyspepsia 2% 1% Other Adverse Reactions Observed in Clinical Trials of CONCERTA The following adverse reactions occurred in less than 2% of CONCERTA-treated patients ages 6 to 65 years of age in the double-blind and open-label clinical ADHD trials.
Drug interactions
Table 6 describes clinically significant drug interactions with CONCERTA. Table 6: Clinically Significant Drug Interactions Monoamine Oxidase Inhibitors Prevention or Management Concomitant use of CNS stimulants, including CONCERTA, with MAOIs or within 14 days after discontinuing an MAOI is contraindicated [ see Contraindications (4) ]. Mechanism and Clinical Effect(s) Concomitant use of MAOIs and CNS stimulants, including CONCERTA, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Antihypertensive Drugs Prevention or Management Increase monitoring for blood pressure and adjust the dosage of the antihypertensive drug, as needed. Mechanism and Clinical Effect(s) CONCERTA may decrease effectiveness of drugs used to treat hypertension [see Warnings and Precautions 5.3 ]. Halogenated Anesthetics Prevention or Management Avoid use of CONCERTA in patients being treated with anesthetics on the day of surgery. Mechanism and Clinical Effect(s) Concomitant use of halogenated anesthetics and CONCERTA may increase the risk of sudden blood pressure and heart rate increase during surgery. Risperidone Prevention or Management Monitor for signs of extrapyramidal symptoms. Mechanism and Clinical Effect(s) The risk of risperidone-associated extrapyramidal symptoms may increase in patients taking concomitant CONCERTA when there is a change in the CONCERTA or risperidone dosage. Antihypertensive drugs : Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7 ) See additional clinically significant drug interactions, in the DRUG INTERACTIONS section ( 7 ).
Use in specific populations
Caution should be exercised if administered to nursing mothers (8.3) Safety and efficacy has not been established in children less than six years old or elderly patients greater than 65 years of age ( 8.4 and 8.5 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including CONCERTA, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ . Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the fetus associated with the use of central nervous system (CNS) stimulants 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 throughout organogenesis at doses up to 4 and 16 times, respectively, the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 54 times the MRHD given to adults. A slight decrease in body weight was observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD given to adults). In a pre- and postnatal development study in which rats were treated with oral administration of methylphenidate throughout pregnancy and lactation, a decrease in pup body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD given to adults on a mg/m 2 basis) (see Data ) . The background risk of major birth defects and miscarriage in those with ADHD is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions: CNS stimulants, such as CONCERTA, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of a therapeutic dosage of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine dependent mothers. Data Animal Data: In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses up to 30 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 54 times the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times the MRHD given to adults on a mg/m 2 basis). There was no evidence of changes in morphological development in rats, although a reduction in maternal body weight was observed at the highest dose of 30 mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m 2 basis). The no effect level for maternal body weight in rats is 5 mg/day (equal to the MRHD for adults on a mg/m 2 basis); and the no effect level for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 30 mg/kg/day, decreases in offspring body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD of 72 mg/day, given to adults on a mg/m 2 basis). The no effect level for pre- and post-natal development in rats was 12.5 mg/kg/day (2 times the MRHD given to adults on a mg/m 2 basis). 8.2 Lactation Risk Summary Limited published literature, based on breast milk sampling from a small number of methylphenidate-treated lactating women, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted methylphenidate dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on the breastfed infant or effects on milk production. Long-term neurodevelopmental effects on infants from CNS stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CONCERTA and any potential adverse effects on the breastfed child from CONCERTA or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding infants of CONCERTA-treated lactating women for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. 8.4 Pediatric Use The safety and effectiveness of CONCERTA for the treatment of ADHD have been established in pediatric patients 6 years of age and older. The safety and effectiveness of CONCERTA have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth (weight and height) should be monitored in pediatric patients during treatment with CNS stimulants, including CONCERTA.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including CONCERTA, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ . Risk Summary Published studies and post-marketing reports on methylphenidate use during pregnancy have inconsistent findings about a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the fetus associated with the use of central nervous system (CNS) stimulants 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 throughout organogenesis at doses up to 4 and 16 times, respectively, the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis. However, spina bifida was observed in rabbits at a dose 54 times the MRHD given to adults. A slight decrease in body weight was observed in pregnant rats at the highest dose of 30 mg/kg/day (4 times the MRHD given to adults). In a pre- and postnatal development study in which rats were treated with oral administration of methylphenidate throughout pregnancy and lactation, a decrease in pup body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD given to adults on a mg/m 2 basis) (see Data ) . The background risk of major birth defects and miscarriage in those with ADHD is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions: CNS stimulants, such as CONCERTA, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of a therapeutic dosage of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine dependent mothers. Data Animal Data: In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses up to 30 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 54 times the maximum recommended human dose (MRHD) of 72 mg/day given to adults on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (16 times the MRHD given to adults on a mg/m 2 basis). There was no evidence of changes in morphological development in rats, although a reduction in maternal body weight was observed at the highest dose of 30 mg/kg/day (4 times the MRHD of 72 mg/day given to adults (on a mg/m 2 basis). The no effect level for maternal body weight in rats is 5 mg/day (equal to the MRHD for adults on a mg/m 2 basis); and the no effect level for embryo-fetal development is 30 mg/kg/day (4 times the MRHD for adults on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 30 mg/kg/day, decreases in offspring body weight, alterations in sensory and neuromotor performance, and deficits in learning and memory were observed in both sexes at the highest dose (4 times the MRHD of 72 mg/day, given to adults on a mg/m 2 basis). The no effect level for pre- and post-natal development in rats was 12.5 mg/kg/day (2 times the MRHD given to adults on a mg/m 2 basis).
Pediatric use
8.4 Pediatric Use The safety and effectiveness of CONCERTA for the treatment of ADHD have been established in pediatric patients 6 years of age and older. The safety and effectiveness of CONCERTA have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth (weight and height) should be monitored in pediatric patients during treatment with CNS stimulants, including CONCERTA. Pediatric patients who are not growing or gaining weight as expected may need to have their CONCERTA treatment interrupted [see Warnings and Precautions (5.7) ] . Juvenile Animal Toxicity Data Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 4 times the MRHD of 54 mg/day given to pediatric patients 6 to 12 years of age on a mg/m 2 basis. In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 54 mg/day given to pediatric patients 6 to 12 years of age on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (9 times the MRHD given to pediatric patients 6 to 12 years of age on a mg/m 2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.4 times the MRHD given to pediatric patients 6 to 12 years of age on a mg/m 2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.
Geriatric use
8.5 Geriatric Use CONCERTA is not indicated for use in patients greater than 65 years of age.
Overdosage
10.1 Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. 10.2 Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of CONCERTA should be considered when treating patients with overdose. Because methylphenidate has a large volume of distribution and is rapidly metabolized, dialysis is not useful. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Description
11 DESCRIPTION CONCERTA ® is a central nervous system (CNS) stimulant. CONCERTA is available in four strengths. Each extended-release tablet for oral administration contains 18, 27, 36, or 54 mg of methylphenidate hydrochloride, USP. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride, its empirical formula is C 14 H 19 NO 2 ∙HCl, and its structural formula is: Methylphenidate hydrochloride, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. CONCERTA also contains the following inactive ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin. It is possible that CONCERTA extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Methylphenidate is a central nervous system (CNS) stimulant. The mode of therapeutic action of methylphenidate in the treatment of ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.
How supplied
16 HOW SUPPLIED/STORAGE AND HANDLING CONCERTA ® (methylphenidate hydrochloride) extended-release tablets are available in 18 mg, 27 mg, 36 mg, and 54 mg strengths: 18 mg: yellow and imprinted with "alza 18", 100-count bottle (NDC 50458-585-01) 27 mg: gray and imprinted with "alza 27", 100-count bottle (NDC 50458-588-01) 36 mg: white and imprinted with "alza 36", 100-count bottle (NDC 50458-586-01) 54 mg: brownish-red and imprinted with "alza 54", 100-count bottle (NDC 50458-587-01) Storage and Handling Store at 25 °C (77 °F); excursions permitted to 15–30 °C (59–86 °F) [see USP Controlled Room Temperature] . Protect from humidity.
Storage
Storage and Handling Store at 25 °C (77 °F); excursions permitted to 15–30 °C (59–86 °F) [see USP Controlled Room Temperature] . Protect from humidity.
Patient information
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 CONCERTA, 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 CONCERTA in a safe place, preferably locked, and instruct patients to not give CONCERTA 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 CONCERTA 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 CONCERTA can cause elevations in blood pressure and heart rate [see Warnings and Precautions (5.3) ]. Psychiatric Risks Advise patients and their caregivers that CONCERTA, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4) ]. Priapism Advise patients, caregivers, and family members of CONCERTA-treated males of the possibility of priapism. Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.5) ] . Peripheral Vasculopathy, including Raynaud's Phenomenon Instruct patients about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms; to report to their health care provider any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes; to call their health care provider immediately with any signs of unexplained wounds appearing on fingers or toes while taking CONCERTA [see Warnings and Precautions (5.6) ] . Long-term Suppression of Growth in Pediatric Patients Advise patients, caregivers, and family members that CONCERTA may cause slowing of growth and weight loss in pediatric patients [see Warnings and Precautions (5.7) ] . Glaucoma and Increased Intraocular Pressure Advise patients that increased intraocular pressure and glaucoma may occur during CONCERTA treatment [see Warnings and Precautions (5.10) ] . Motor and Verbal Tics, and Worsening of Tourette's Syndrome Advise patients that motor and verbal tics and worsening of Tourette's Syndrome may occur during CONCERTA treatment. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette's syndrome occurs [see Warnings and Precautions (5.11) ] . Administration Instructions Instruct patients to swallow CONCERTA whole with liquids, and not to split, crush, or chew, the extended-release tablets. Advise patients not to be concerned if they occasionally notice a tablet-appearing substance in their stool. Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CONCERTA during pregnancy [see Use in Specific Populations (8.1) ] . Lactation Advise CONCERTA-treated breastfeeding women to monitor their infants for agitation, poor sleeping patterns, changes in feeding, and reduced weight gain [see Use in Specific Populations (8.2) ] .
Label text from the FDA structured product label by Janssen Pharmaceuticals, Inc. (revised Apr 20, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Methylphenidate Hydrochloride in 4 products
Concerta NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50458-585 | Methylphenidate Hydrochloride 18 mg/1 Tablet, Extended Release | Janssen Pharmaceuticals, Inc. | NDA · DEA CII |
| 50458-586 | Methylphenidate Hydrochloride 36 mg/1 Tablet, Extended Release | Janssen Pharmaceuticals, Inc. | NDA · DEA CII |
| 50458-587 | Methylphenidate Hydrochloride 54 mg/1 Tablet, Extended Release | Janssen Pharmaceuticals, Inc. | NDA · DEA CII |
| 50458-588 | Methylphenidate Hydrochloride 27 mg/1 Tablet, Extended Release | Janssen Pharmaceuticals, Inc. | NDA · DEA CII |
Frequently asked questions
What is Concerta used for?
1 INDICATIONS AND USAGE CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA 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…
What are the side effects of Concerta?
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… See the full label for the complete list.
Who makes Concerta?
Concerta is listed by 1 labeler in the FDA NDC directory, including Janssen Pharmaceuticals, Inc..