Medicine guide

Methylin

5 mg/5mL · Solution

Prescription only
Controlled substance · CII
Central Nervous System Stimulant

Active substance: Methylphenidate Hydrochloride
Used in: Pain, sleep, mood, epilepsy and the brain
Made by: SHIONOGI INC.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-11-01

The FDA lists a current shortage of methylphenidate hydrochloride

Not necessarily this product — shortages are reported per presentation. Your pharmacy will know. · Updated 2026-09-17 FDA drug shortages

What it is

Central Nervous System Stimulant

Used for

Attention Deficit Hyperactivity Disorder (ADHD) in
Attention Deficit Hyperactivity Disorder (ADHD) in
Adults and pediatric patients 6 years of age and older ( 1 ) Narcolepsy ( 1 )

The label’s usual adult dose

Starting dose is 5 mg twice daily (before breakfast and lunch); increase the dose 5 mg to 10 mg weekly; daily dosage above 60 mg is not recommended.

Maximum recommended daily dosage is 60 mg.

Full directions ↓

Serious warning

ABUSE, MISUSE, AND ADDICTION Methylin has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.

All warnings ↓

Good to know

Prescription only
Controlled substance (schedule II) — extra rules apply to prescribing and refills
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

200other products contain Methylphenidate Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Methylin is indicated for the treatment of:

Attention Deficit Hyperactivity Disorder (ADHD) in
adults and pediatric patients 6 years of age and older Narcolepsy Methylin is a central nervous system (CNS) stimulant indicated for the treatment of:
Attention Deficit Hyperactivity Disorder (ADHD) in
adults and pediatric patients 6 years of age and older ( 1 ) Narcolepsy ( 1 )

From the official label · 2023-11-01 · DailyMed

How it works

From this product’s own US prescribing label.

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

Half-life2.7 h

Mostly cleared after≈ 13.5 hfive half-lives — our arithmetic

How the body breaks it down

Methylphenidate is metabolized primarily by deesterification to alpha-phenyl-piperidine acetic acid (ritalinic acid), which has little or no pharmacologic activity.

With food

Effect of Food Ingestion of a high-fat meal with Methylin increased methylphenidate mean C max and AUC by about 13% and 25%, respectively.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-11-01

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

ABUSE, MISUSE, AND ADDICTION Methylin 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 Methylin, 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 Methylin, assess each patient’s 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 Methylin treatment, reassess each patient’s 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.
Methylin 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 Methylin, can result in overdose and death ( 5.1 , 9.2 , 10 ):
Before prescribing Methylin, assess each patient’s 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 treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Methylin is contraindicated in patients:
with known hypersensitivity to methylphenidate or other components of Methylin.
Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6 )] . receiving 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 )] .
Known hypersensitivity to methylphenidate or other components of Methylin ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Pediatric patients 6 years and older:
Starting dose is 5 mg twice daily (before breakfast and lunch); increase the dose 5 mg to 10 mg weekly; daily dosage above 60 mg is not recommended.
( 2.2 )
Adults:
Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals.
Average dosage is 20 to 30 mg daily.
Maximum recommended daily dosage is 60 mg.
( 2 )
2.1 Pretreatment Screening Prior to treating patients with Methylin, assess:
for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see Warnings and Precautions ( 5.10 )] .
2.2 General Dosing Information Pediatric Patients 6 years of Age and Older The recommended starting dosage is 5 mg orally twice daily before breakfast and lunch (preferably 30 to 45 minutes before meals).
Increase the dosage gradually, in increments of 5 mg to 10 mg weekly.
Daily dosage above 60 mg is not recommended.
Adults Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals.
The maximum recommended daily dose is 60 mg.
The average dosage is 20 to 30 mg daily.
For adult patients who are unable to sleep if medication is taken late in the day, administer the last dose before 6 p.m.
2.3 Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage, or, if necessary, discontinue Methylin.
If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue Methylin.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

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.
Prior to initiating Methylin, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing Methylin.
( 5.4 ) Priapism :
If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention.
Careful observation for digital changes is necessary during Methylin treatment.
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
Closely monitor (height and weight) in pediatric patients.
Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted.
Methylin-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
( 5.8 ) Increased Intraocular Pressure (IOP) and Glaucoma :
Prescribe Methylin 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.
Before initiating Methylin, 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 treatment if clinically appropriate.
( 5.10 )
5.1 Abuse, Misuse, and Addiction Methylin has a high potential for abuse and misuse.
The use of Methylin exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
Methylin can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence ( 9.2 )] .
Educate patients and their families about these risks and proper disposal of any unused drug.
Advise patients to store Methylin in a safe place, preferably locked, and instruct patients to not give Methylin to anyone else.
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 Methylin use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrythmia, coronary artery disease, or other serious cardiac disease.
5.3 Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm).
Some patients may have larger increases.
Monitor all Methylin-treated patients for hypertension and tachycardia.
5.4 Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Induction of a Manic Episode in Patients with Bipolar Illness CNS stimulants may induce a manic or mixed mood episode in patients.
Prior to initiating Methylin treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
New Psychotic or Manic Symptoms CNS stimulants, at the recommended dosages, 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 Methylin.
5.5 Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients.
Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often subsequent to an increase in dosage.
Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation).
Methylin-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
5.6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon CNS stimulants, including Methylin, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon.
Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown.
Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports and at the therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment.
Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.
Careful observation for digital changes is necessary during Methylin treatment.
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Methylin-treated patients who develop signs or symptoms of peripheral vasculopathy.
5.7 Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.
Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication-treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that pediatric patients who received methylphenidate for 7 days per week throughout the year had a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period.
Closely monitor growth (weight and height) in Methylin-treated pediatric patients.
Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
The safety and effectiveness of Methylin have not been established in pediatric patient less than 6 years of age.
5.8 Acute Angle Closure Glaucoma There have been reports of angle closure glaucoma associated with methylphenidate treatment.
Although the mechanism is not clear, Methylin-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 and Glaucoma There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions ( 6.2 )] .
Prescribe Methylin to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor Methylin-treated patients with a history of abnormally increased IOP or open-angle glaucoma.
5.10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics.
Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions ( 6.2 )] .
Before initiating Methylin, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor Methylin-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Methylin, during pregnancy.
Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
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 12 and 19 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to
adults on a mg/m 2 basis.
However, spina bifida was observed in rabbits at a dose 65 times the MRHD given to
adults.
A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 7 times the MRHD given to
adults (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, 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 Methylin, can cause vasoconstriction and thereby decrease placental perfusion.
No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses 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 of up to 75 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 65 times the MRHD of 60 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 (19 times the MRHD given to
adults on a mg/m 2 basis).
There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (12 times the MRHD of 60 mg/day given to
adults on a mg/m 2 basis), which was also maternally toxic.
The no effect level for embryo-fetal development in rats was 25 mg/kg/day (4 times the MRHD on a mg/m 2 basis).
When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (7 times the MRHD of 60 mg/day given to
adults on a mg/m 2 basis), but no other effects on postnatal development were observed.
The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to
adults on a mg/m 2 basis).
IN SPECIFIC POPULATIONS
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Methylin, during pregnancy.
Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.
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 12 and 19 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to
adults on a mg/m 2 basis.
However, spina bifida was observed in rabbits at a dose 65 times the MRHD given to
adults.
A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 7 times the MRHD given to
adults (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, 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 Methylin, can cause vasoconstriction and thereby decrease placental perfusion.
No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses 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 of up to 75 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 65 times the MRHD of 60 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 (19 times the MRHD given to
adults on a mg/m 2 basis).
There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (12 times the MRHD of 60 mg/day given to
adults on a mg/m 2 basis), which was also maternally toxic.
The no effect level for embryo-fetal development in rats was 25 mg/kg/day (4 times the MRHD on a mg/m 2 basis).
When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (7 times the MRHD of 60 mg/day given to
adults on a mg/m 2 basis), but no other effects on postnatal development were observed.
The no effect level for pre- and postnatal development in rats was 15 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 milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7.
There are no reports of adverse effects on the breastfed infant and no effects on milk production.
Long-term neurodevelopmental effects on infants from stimulant exposure are unknown.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Methylin and any potential adverse effects on the breastfed infant from Methylin or from the underlying maternal condition.
Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
8.4 Pediatric Use The safety and effectiveness of Methylin for the treatment of ADHD have been established in pediatric patients six years of age and older.
The safety and effectiveness of Methylin in pediatric patients under six years of age have not been established.
The long-term efficacy of methylphenidate in pediatric patients has not been established.
Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including Methylin.
Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.6)] .
Juvenile Animal Toxicity Data 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 -14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children 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 (8 times the MRHD given to children on a mg/m 2 basis).
The no effect level for juvenile neurobehavioral development in rats (5 mg/kg/day) is less than the MRHD given to children on a mg/m 2 basis.
The clinical significance of the long-term behavioral effects observed in rats is unknown.
8.5 Geriatric Use Methylin has not been studied in the geriatric population.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Antihypertensive Drugs: Monitor blood pressure.
Adjust dosage of antihypertensive drug as needed.
( 7.1 )
7.1 Clinically Important Drug Interactions with Methylin Table 1 presents clinically important drug interactions with Methylin.
Table 1:
Clinically Important Drug Interactions with Methylin Monoamine Oxidase Inhibitors (MAOI) Clinical Impact:
Concomitant use of MAOIs and CNS stimulants, including Methylin, can cause hypertensive crisis.
Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications ( 4 )] .
Intervention:
Concomitant use of Methylin with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment is contraindicated.
Antihypertensive Drugs Clinical Impact:
Methylin may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions ( 5.3 )] .
Intervention:
Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.
Halogenated Anesthetics Clinical Impact:
Concomitant use of halogenated anesthetics and Methylin may increase the risk of sudden blood pressure and heart rate increase during surgery.
Intervention:
Avoid use of Methylin in patients being treated with anesthetics on the day of surgery.
Risperidone Clinical Impact:
Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS).
Intervention: Monitor for signs of EPS.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

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.
Overdose Management Consider the possibility of multiple drug ingestion.
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.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

9.1 Controlled Substance Methylin contains methylphenidate hydrochloride, a Schedule II controlled substance.
9.2 Abuse Methylin has 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)] .
Methylin 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 healthcare 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, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain.
Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse.
Misuse and abuse of CNS stimulants, including Methylin, can result in overdose and death [see Overdosage ( 10 )] , and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection
9.3 Dependence Physical Dependence Methylin may produce physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including Methylin include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Tolerance Methylin may produce tolerance.
Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).
Methylin contains methylphenidate hydrochloride, a Schedule II controlled substance.

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

The safety and effectiveness of Methylin for the treatment of ADHD have been established in pediatric patients six years of age and older.
The safety and effectiveness of Methylin in pediatric patients under six years of age have not been established.
The long-term efficacy of methylphenidate in pediatric patients has not been established.
Long-Term Suppression of Growth Growth should be monitored during treatment with stimulants, including Methylin.
Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.6)] .
Juvenile Animal Toxicity Data 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 -14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children 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 (8 times the MRHD given to children on a mg/m 2 basis).
The no effect level for juvenile neurobehavioral development in rats (5 mg/kg/day) is less than the MRHD given to children on a mg/m 2 basis.
The clinical significance of the long-term behavioral effects observed in rats is unknown.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Methylin has not been studied in the geriatric population.

Quoted from the official label, section “Geriatric Use”.

Side effects

The following adverse reactions are discussed in more detail in other sections of the labeling:
Abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Known hypersensitivity to methylphenidate or other components of Methylin [see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with 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 )] 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’s syndrome [see Warnings and Precautions ( 5.10 )] The following adverse reactions associated with the use of methylphenidate containing products were identified in clinical studies, postmarketing reports, or literature.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Infections and infestations:
nasopharyngitis Blood and the lymphatic system disorders:
leukopenia, thrombocytopenia, anemia, pancytopenia Immune system disorders:
hypersensitivity reactions, including angioedema and anaphylaxis, auricular swelling, bullous conditions, eruptions, exanthemas Metabolism and nutrition disorders:
decreased appetite, reduced weight gain and suppression of growth during prolonged use in pediatric patients Psychiatric disorders:
insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood, affect lability, mania, disorientation, libido changes Nervous system disorders:
headache, dizziness, tremor, dyskinesia including choreoatheetoid movements, drowsiness, convulsions, cerebral arteritis and/or occlusion, serotonin syndrome in combination with serotonergic drugs, migraine, motor and verbal tics Eye disorders:
blurred vision, difficulties in visual accommodation, diplopia, mydriasis, increased intraocular pressure Cardiac disorders:
tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris, sudden cardiac death, myocardial infarction, bradycardia, extrasystole Respiratory, thoracic and mediastinal disorders:
cough, pharyngolaryngeal pain, dyspnea Gastrointestinal disorders:
dry mouth, nausea, vomiting, abdominal pain, dyspepsia, diarrhea General disorders:
fatigue, hyperpyrexia Hepatobiliary disorders:
abnormal liver function, ranging from transaminase elevation to severe hepatic injury Skin and subcutaneous tissue disorders:
hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura angioneurotic edema, erythema, fixed drug eruption Musculoskeletal and connective tissue disorders:
arthralgia, muscle cramps, rhabdomyolysis, myalgia, muscle twitching Renal and urinary disorders:
hematuria Reproductive system and breast disorders:
gynecomastia Urogenital disorders:
priapism Vascular disorders:
peripheral coldness, Raynaud’s phenomenon Investigations:
weight loss Common adverse reactions:
tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain.
( 6 ) To report SUSPECTED ADVERSE REACTIONS contact Shionogi Inc. at 1-800-849-9707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

FORMS AND STRENGTHS Methylin oral solution is a colorless, grape flavored liquid available in a 500 mL bottle in the following strengths:
5 mg per 5 mL 10 mg per 5 mL Oral solution:
5 mg per 5 mL and 10 mg per 5 mL. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

How Supplied Methylin oral solution is a colorless, grape flavored liquid available in the following strengths:
5 mg per 5 mL Bottles of 500 mL.................NDC 59630-750-50 10 mg per 5 mL Bottles of 500 mL.................NDC 59630-755-50 Storage and Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container with child-resistant closure.

Quoted from the official label, section “How Supplied”.

What is in it

Methylin contains methylphenidate hydrochloride a CNS stimulant.
It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration.
Chemically, methylphenidate hydrochloride is ( d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is:
Methylphenidate hydrochloride is a white, odorless, fine 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.
Each mL of Methylin 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP.
Each mL of Methylin 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP.
Methylin also contains the following inactive ingredients:
citric acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified water.
Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (10)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 10 of 10

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (1)

CanadaNo exact match for this strength and form

Every strength and form (63)

Details

Made by	SHIONOGI INC.
Active substance	Methylphenidate Hydrochloride
Used in	Pain, sleep, mood, epilepsy and the brain
Strength	5 mg/5mL
Form	Solution
Route	Oral
Packs	500 mL in 1 BOTTLE
NDC	59630-750

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Solution2 products
- 5 mg/5mL
- 10 mg/5mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Concerta18 mgPrescription onlyTablet, Extended Release Janssen Pharmaceuticals, Inc. · Methylphenidate Hydrochloride Concerta36 mgPrescription onlyTablet, Extended Release Janssen Pharmaceuticals, Inc. · Methylphenidate Hydrochloride Concerta54 mgPrescription onlyTablet, Extended Release Janssen Pharmaceuticals, Inc. · Methylphenidate Hydrochloride Concerta27 mgPrescription onlyTablet, Extended Release Janssen Pharmaceuticals, Inc. · Methylphenidate Hydrochloride Jornay Pm Extended-Release20 mgPrescription onlyCapsule Ironshore Pharmaceuticals Inc. · Methylphenidate Hydrochloride Jornay Pm Extended-Release40 mgPrescription onlyCapsule Ironshore Pharmaceuticals Inc. · Methylphenidate Hydrochloride

See every product with Methylphenidate Hydrochloride