Medicine guide

Ritalin

5 mg · Tablet

Prescription only
Controlled substance · CII
Central Nervous System Stimulant

Active substance: Methylphenidate Hydrochloride
Used in: Pain, sleep, mood, epilepsy and the brain
Made by: Sandoz 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 · 2025-02-05

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 Disorders (ADHD) in pediatric patients 6 years and older and

The label’s usual adult dose

Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5- to 10-mg increments. Dosages above 60 mg/day are not recommended ( 2.2 ).

Average daily dosage is 20 mg to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg ( 2.2 ). 2.1 Pretreatment Screening Prior to treating patients with Ritalin, assess:

Full directions ↓

Serious warning

ABUSE, MISUSE, AND ADDICTION Ritalin 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 Ritalin, can result in overdose and…

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

Ritalin is indicated for the treatment of:

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

From the official label · 2025-02-05 · DailyMed

How it works

From this product’s own US prescribing label.

Methylphenidate hydrochloride is a CNS stimulant.
The mode of therapeutic action in ADHD and narcolepsy is not known.

Peak level after2 h

How the body breaks it down

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

How it leaves the body

After oral administration, 78% to 97% of the dose is excreted in the urine and 1% to 3% in feces in the form of metabolites within 48 to 96 hours.

With food

Effect of Food Ingestion with food has no relevant effect on absorption of Ritalin.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-02-05

Serious warning

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

ABUSE, MISUSE, AND ADDICTION Ritalin 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 Ritalin, 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 Ritalin, 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 Ritalin 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. Ritalin 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 Ritalin, can result in overdose and death ( 5.1 , 9.2 , 10 ):
Before prescribing Ritalin, 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

Hypersensitivity to methylphenidate or other components of Ritalin. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6 )] .
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 product components of Ritalin ( 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:
Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5- to 10-mg increments. Dosages above 60 mg/day are not recommended ( 2.2 ).
Adults:
Average daily dosage is 20 mg to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg ( 2.2 ). 2.1 Pretreatment Screening Prior to treating patients with Ritalin, 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 before initiating Ritalin [see Warnings and Precautions ( 5.10 )]. 2.2 General Dosing Information Pediatric Patients 6 years and Older :
Start with 5 mg orally twice daily (before breakfast and lunch). Increase dosage gradually, in increments of 5-to 10-mg weekly. Daily dosage above 60 mg is not recommended.
Adults :
Average dosage is 20 to 30 mg daily. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m. 2.3 Dosage Reduction and Discontinuation If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Ritalin. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

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 ( 5.3 ).
Psychiatric Adverse Reactions :
Prior to initiating Ritalin, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Ritalin ( 5.4 ).
Priapism :
If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention ( 5.5 ).
Careful observation for digital changes is necessary during Ritalin treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy ( 5.6 ).
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 treatment interrupted ( 5.7 ).
Acute Angle Closure Glaucoma:
Ritalin -treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist ( 5.8 ).
Prescribe Ritalin 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 ( 5.9 ).
Before initiating Ritalin, 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 Ritalin have a high potential for abuse and misuse. The use of Ritalin exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Ritalin can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence ( 9.2 )]. Misuse and abuse of CNS stimulants, including Ritalin, 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 Ritalin, 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 Ritalin in a safe place, preferably locked, and instruct patients to not give Ritalin to anyone else. Throughout Ritalin 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 are treated with CNS stimulants at the recommended ADHD dosage.
Avoid Ritalin use in patients with known serious 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 cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute). Some patients may have larger increases. Monitor all Ritalin-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 preexisting psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating Ritalin 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 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 to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing Ritalin. 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). Ritalin-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 Ritalin, 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 dosage 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 Ritalin treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Ritalin-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 pediatric patients 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 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 Ritalin-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. 5.8 Acute Angle Closure Glaucoma There have been reports of angle closure glaucoma associated with methylphenidate treatment. Although the mechanism is not clear, Ritalin -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 )]. Prescribe Ritalin to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor Ritalin-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 )]. Before initiating Ritalin, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor Ritalin-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 Ritalin, during pregnancy.
Healthcare providers are encouraged to register patients 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 postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations) .
No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis.
However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents.
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 6 times the MRHD given to adolescents (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 Ritalin, 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 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis.
The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents 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 (10 times the MRHD of 60 mg/day given to adolescents 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 (3 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 (6 times the MRHD of 60 mg/day given to adolescents 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 (approximately 2 times the MRHD given to adolescents 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 Ritalin, during pregnancy.
Healthcare providers are encouraged to register patients 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 postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations) .
No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis.
However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents.
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 6 times the MRHD given to adolescents (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 Ritalin, 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 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis.
The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the MRHD given to adolescents 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 (10 times the MRHD of 60 mg/day given to adolescents 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 (3 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 (6 times the MRHD of 60 mg/day given to adolescents 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 (approximately 2 times the MRHD given to adolescents 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 Ritalin and any potential adverse effects on the breastfed infant from Ritalin 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 Ritalin for the treatment of ADHD have been established in pediatric patients aged 6 to 17 years.
The safety and effectiveness of Ritalin in pediatric patients less than aged 6 years 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 Ritalin.
Pediatric patients who are not growing or gaining weight as expected may need to have their 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 60 mg/day given to children 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 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 was 5 mg/kg/day ( approximately 0.5 times 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 Ritalin 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 Ritalin Table 1 presents clinically important drug interactions with Ritalin.
Table 1:
Clinically Important Drug Interactions with Ritalin Monoamine Oxidase Inhibitors (MAOI) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including Ritalin 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 Ritalin with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.
Antihypertensive Drugs Clinical Impact Ritalin 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 Ritalin may increase the risk of sudden blood pressure and heart rate increase during surgery.
Intervention
Avoid use of Ritalin 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 Ritalin contains methylphenidate hydrochloride, a Schedule II controlled substance.
9.2 Abuse Ritalin 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 )] .
Ritalin 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 hydrochloride 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 Ritalin, 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.
9.3 Dependence Physical Dependence Ritalin 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 Ritalin include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Tolerance Ritalin 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).
Ritalin 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 Ritalin for the treatment of ADHD have been established in pediatric patients aged 6 to 17 years.
The safety and effectiveness of Ritalin in pediatric patients less than aged 6 years 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 Ritalin.
Pediatric patients who are not growing or gaining weight as expected may need to have their 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 60 mg/day given to children 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 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 was 5 mg/kg/day ( approximately 0.5 times 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

Ritalin has not been studied in the geriatric population.

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

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 , 9.3 )]
Known hypersensitivity to methylphenidate or other ingredients of Ritalin [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’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 Ritalin and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse Reactions Reported with Ritalin Infections and Infestations:
nasopharyngitis Blood and the Lymphatic System Disorders:
leukopenia, thrombocytopenia, anemia Immune System Disorders:
hypersensitivity reactions, including angioedema, and anaphylaxis 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, depression Nervous System Disorders:
headache, dizziness, tremor, dyskinesia, including choreoatheetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs Eye Disorders:
blurred vision, difficulties in visual accommodation Cardiac Disorders:
tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris Respiratory, Thoracic, and Mediastinal Disorders:
cough Gastrointestinal Disorders:
dry mouth, nausea, vomiting, abdominal pain, dyspepsia 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 Musculoskeletal and Connective Tissue Disorders:
arthralgia, muscle cramps, rhabdomyolysis, trismus Investigations:
weight loss (adult ADHD patients) Vascular Disorders:
peripheral coldness, Raynaud's phenomenon Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products The list below shows adverse reactions not listed for Ritalin that have been reported with other methylphenidate-containing products. Blood and Lymphatic Disorders:
pancytopenia Immune System Disorders:
hypersensitivity reactions, such as auricular swelling, bullous conditions, eruptions, exanthemas Psychiatric Disorders:
affect lability, mania, disorientation, and libido changes Nervous System Disorders:
migraine, motor and verbal tics Eye Disorders:
diplopia, increased intraocular pressure, mydriasis Cardiac Disorders:
sudden cardiac death, myocardial infarction, bradycardia, extrasystole Respiratory, Thoracic, and Mediastinal Disorders:
pharyngolaryngeal pain, dyspnea Gastrointestinal Disorders:
diarrhea, constipation Skin and Subcutaneous Tissue Disorders:
angioneurotic edema, erythema, fixed drug eruption Musculoskeletal, Connective Tissue, and Bone Disorders:
myalgia, muscle twitching Renal and Urinary Disorders:
hematuria Reproductive System and Breast Disorders:
gynecomastia General Disorders:
fatigue, hyperpyrexia Urogenital Disorders:
priapism 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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

What to discuss with your doctor

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 Ritalin, 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 Ritalin in a safe place, preferably locked, and instruct patients to not give Ritalin to anyone else.
Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patient with serious cardiac disease, including sudden death, with Ritalin 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 Ritalin can cause elevations of their blood pressure and pulse rate [see Warnings and Precautions ( 5.3 )] .
Psychiatric Adverse Reactions Advise patients that Ritalin, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions ( 5.4 )] .
Priapism Advise patients of the possibility of painful or prolonged penile erections (priapism).
Instruct them to seek immediate medical attention in the event of priapism [see Warnings and Precautions ( 5.5 )] .
Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon] Instruct patients about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms:
fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.
Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Ritalin.
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions ( 5.6 )] .
Long-Term Suppression of Growth in Pediatric Patients Advise patients that Ritalin may cause slowing of growth and weight loss [see Warnings and Precautions ( 5.7 )] .
Increased Intraocular Pressure (IOP) and Glaucoma Advise patients that IOP and glaucoma may occur during treatment with Ritalin [see Warnings and Precautions ( 5.9 )] .
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 treatment with Ritalin.
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 ( 5.10 )].
Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including RITALIN, during pregnancy [see Use in Specific Populations ( 8.1 )] .
Manufactured by Societal CDMO Gainesville, LLC Gainesville, GA 30504 for Sandoz Inc., Princeton, NJ 08540

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS
5 mg, round, yellow, flat with CIBA monogram on one side and NDC# 7 on the reverse side
10 mg, round, pale green, biconvex with CIBA monogram on one side and NDC# 3 and a partial bisection on the reverse side
20 mg, round, pale yellow, biconvex with CIBA monogram on one side and NDC# 34 and a partial bisection on the reverse side
Tablets: 5 mg, 10 mg, and 20 mg ( 3 )

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

What it looks like and how it is packed

5 mg tablets (NDC 66758-273-01) round, yellow, (imprinted "CIBA 7") supplied in bottles of 100
10 mg tablets (NDC 66758-274-01) round, pale green, scored, (imprinted "CIBA 3") supplied in bottles of 100
20 mg tablets (NDC 66758-275-01) round, pale yellow, scored, (imprinted "CIBA 34") supplied in bottles of 100
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP controlled room temperature]. Protect from light. Dispense in tight, light-resistant container (USP).

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

What is in it

Ritalin contains methylphenidate hydrochloride, a CNS stimulant.
It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration.
Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is:
Methylphenidate hydrochloride USP 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.
Its molecular weight is 269.77 g/mol.
Ritalin tablets contains the following inactive ingredients:
D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).
Methylphenidate hydrochloride structural formula.

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.

LactoselactoseMilk sugar: matters with lactose intolerance or a milk allergy.
Colour dyesD&C Yellow No. 10 (5-mg and 20-mg tablets); FD&C Green No. 3 (10-mg tablets)Some people react to dyes such as tartrazine (Yellow 5) or carmine.
SugarssucroseRelevant to diabetes and dental health.

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 (19)

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

Showing 19 of 19

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)

Canada2 matching products

Every strength and form (63)

Details

Made by	Sandoz Inc
Active substance	Methylphenidate Hydrochloride
Used in	Pain, sleep, mood, epilepsy and the brain
Strength	5 mg
Form	Tablet
Route	Oral
Packs	100 TABLET in 1 BOTTLE
NDC	66758-273

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

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

Tablet3 products
- 5 mg
- 10 mg
- 20 mg

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