Methylphenidate

Generic name: methylphenidate hydrochloride · Brand names: Ritalin (immediate-release tablet; MedlinePlus marks it with: This branded product is no longer on the market. Generic alternatives may be available.), Methylin, Other methylphenidate brands listed by MedlinePlus for other forms: Adhansia XR, Aptensio XR, Concerta, Cotempla XR-ODT, Jornay PM, Metadate CD, Metadate ER, Methylin ER, Quillichew ER, Quillivant XR, Relexxii ER, Ritalin LA, Ritalin SR (not covered here)

Quick facts

Drug class
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28 Highlights
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Also
MedlinePlus: Methylphenidate is in a class of medications called central nervous system (CNS) stimulants.
Also url
https://medlineplus.gov/druginfo/meds/a682188.html
Source text (exact source wording)
Methylphenidate Hydrochloride Tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
Rx or otc
Rx
Controlled schedule
Value
Schedule II (CII)
Section
9.1 Controlled Substance
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Methylphenidate Hydrochloride Tablets contains methylphenidate hydrochloride, a Schedule II controlled substance.
Forms and strengths
  • Tablets: 5 mg, 10 mg, and 20 mg (Highlights, section 3)
  • Label's description: 5 mg, white to off white, round, flat-faced radius edge uncoated tablets, debossed with '126' on one side and 'U' on the other side. 10 mg ... debossed with 'U' over '127' ... bisected on the other side. 20 mg ... debossed with 'U' over '128' ... bisected on the other side. (section 3)
Generic available
Value
Yes. This is a generic (Aurolife/Aurobindo) label of the immediate-release tablet; many other generic labelers exist on DailyMed.
Source
DailyMed spls.json list https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=methylphenidate&pagesize=100 ; https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Common use one line
Stimulant medicine for ADHD and narcolepsy (label: ADHD in pediatric patients 6 years and older and adults, and narcolepsy).

What it is used for

Methylphenidate tablets treat ADHD in children 6 years and older and in adults, and they treat narcolepsy.
Section
1 INDICATIONS & USAGE
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
Methylphenidate Hydrochloride Tablets is indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy

How it works

Methylphenidate is a CNS stimulant. How it helps ADHD and narcolepsy is not known. It blocks the reuptake of norepinephrine and dopamine into nerve cells and increases the release of these chemicals outside the cell.
Section
12.1 Mechanism of Action; 12.2 Pharmacodynamics
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known. Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

Dosage: adults

Adults usually take 20 to 30 mg a day, split into 2 or 3 doses, ideally 30 to 45 minutes before meals. The most allowed is 60 mg a day. If sleep is a problem, take the last dose before 6 p.m. If symptoms get worse or there is no improvement after one month of dose changes, the drug should be stopped.
Section
2.2 General Dosing Information
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
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: If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Methylphenidate Hydrochloride Tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Dosage: children

Children 6 years and older start with 5 mg twice daily, before breakfast and lunch, and the dose goes up by 5 to 10 mg each week. More than 60 mg a day is not recommended. It is established for ages 6 to 17 and has not been established for children under 6.
Section
2.2 General Dosing Information; 8.4 Pediatric Use
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
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. 8.4: The safety and effectiveness of Methylphenidate Hydrochloride Tablets for the treatment of ADHD have been established in pediatric patients aged 6 to 17 years. The safety and effectiveness of Methylphenidate Hydrochloride Tablets in pediatric patients less than aged 6 years have not been established.

Dosage adjustments

Drug interaction caps
The label gives no fixed dose caps. Blood pressure drug doses may need adjusting, and risperidone dose changes call for monitoring for movement side effects.
Section
7.1 Table 1
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
Antihypertensive Drugs: Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Risperidone: 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). Monitor for signs of EPS.
Kidney
Not studied in people with kidney problems. The label expects little effect. The label gives no kidney dose adjustment.
Section
12.3 Pharmacokinetics, Patients with Renal Impairment
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
Methylphenidate Hydrochloride Tablets has not been studied in renally-impaired patients. Renal impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since less than 1% of a radiolabeled dose is excreted in the urine as unchanged compound, and the major metabolite (ritalinic acid), has little or no pharmacologic activity.
Liver
Not studied in people with liver problems. The label expects little effect. The label gives no liver dose adjustment.
Section
12.3 Pharmacokinetics, Patients with Hepatic Impairment
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
Methylphenidate Hydrochloride Tablets has not been studied in patients with hepatic impairment. Hepatic impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since it is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body.
Elderly
The tablets have not been studied in older adults.
Section
8.5 Geriatric Use
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
Methylphenidate Hydrochloride Tablets has not been studied in the geriatric population.

Missed dose

Label
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Medlineplus
Take a missed dose when you remember it. Ask your doctor or pharmacist how late in the day is okay so it does not disturb sleep. If it is almost time for the next dose, skip the missed one. Never double up.
Source
MedlinePlus Methylphenidate
Url
https://medlineplus.gov/druginfo/meds/a682188.html
Section
What should I do if I forget a dose?
Source text (exact source wording)
Take the missed dose as soon as you remember it. Talk to your doctor or pharmacist about how late in the day you should take a missed dose of your medication so that it will not cause difficulty in falling asleep or staying asleep. However, if it is almost time for your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Confidence
medium

Overdose

An overdose can cause heart rhythm problems, high or low blood pressure, agitation, confusion, hallucinations, seizures, coma, and a dangerous fever (greater than 104°F). Dialysis is not useful. Call Poison Help at 1-800-222-1222.
Section
10 OVERDOSAGE
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
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.
Medlineplus source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Storage

Store at 20° to 25°C (68° to 77°F) and protect from light. Keep it in a safe place, preferably locked, and do not give it to anyone else. This is from the Aurolife label; other labelers may differ.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Advise patients to store Methylphenidate Hydrochloride Tablets in a safe place, preferably locked, and instruct patients to not give Methylphenidate Hydrochloride Tablets to anyone else. (5.1)

Boxed warning

Methylphenidate has a high chance of abuse and misuse, which can lead to addiction, overdose, and death. The risk is higher with higher doses or with snorting or injecting. Doctors should check each patient's risk before and during treatment, and patients and families should learn about safe storage and disposal.
Section
BOXED WARNING
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
WARNING: ABUSE, MISUSE, AND ADDICTION. Methylphenidate Hydrochloride Tablets 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 Methylphenidate Hydrochloride Tablets, 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 Methylphenidate Hydrochloride Tablets, 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 Methylphenidate Hydrochloride Tablets 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)].

Contraindications

Do not use if allergic to methylphenidate or any ingredient. Severe allergic reactions such as angioedema and anaphylaxis have been reported.
Section
4 CONTRAINDICATIONS
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Hypersensitivity to methylphenidate or other components of Methylphenidate Hydrochloride Tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see Adverse Reactions (6)].
Do not use with an MAOI or within 14 days after stopping one, because of the risk of hypertensive crises (dangerously high blood pressure).
Section
4 CONTRAINDICATIONS
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
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)].

Warnings and precautions

High potential for abuse and misuse, which can lead to addiction, and it can be diverted for non-medical use. Store it in a safe, preferably locked, place and never give it to anyone else.
Heading
5.1 Abuse, Misuse, and Addiction
Section
5.1 Abuse, Misuse, and Addiction
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Methylphenidate Hydrochloride Tablets have a high potential for abuse and misuse. The use of Methylphenidate Hydrochloride Tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Methylphenidate Hydrochloride Tablets can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)]. Advise patients to store Methylphenidate Hydrochloride Tablets in a safe place, preferably locked, and instruct patients to not give Methylphenidate Hydrochloride Tablets to anyone else.
Sudden death has been reported in people with structural heart problems or other serious heart disease who take CNS stimulants. Avoid use in people with serious heart disease.
Heading
5.2 Risks to Patients with Serious Cardiac Disease
Section
5.2 Risks to Patients with Serious Cardiac Disease
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
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 Methylphenidate Hydrochloride Tablets use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
Blood pressure goes up by about 2 to 4 mmHg and heart rate by about 3 to 6 beats per minute on average, and some people have larger increases. Blood pressure and pulse should be monitored.
Heading
5.3 Increased Blood Pressure and Heart Rate
Section
5.3 Increased Blood Pressure and Heart Rate
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
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 Methylphenidate Hydrochloride Tablets -treated patients for hypertension and tachycardia.
Stimulants can worsen existing psychosis, trigger mania in people with bipolar disorder, and cause new psychotic or manic symptoms. In pooled studies this happened in approximately 0.1% of stimulant-treated patients and 0% on placebo. Stopping the drug may be considered.
Heading
5.4 Psychiatric Adverse Reactions
Section
5.4 Psychiatric Adverse Reactions
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating Methylphenidate Hydrochloride Tablets treatment, screen patients for risk factors for developing a manic episode. 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 Methylphenidate Hydrochloride Tablets.
Long, painful erections have been reported, sometimes needing surgery. Get medical help right away for sustained or frequent painful erections.
Heading
5.5 Priapism
Section
5.5 Priapism
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients. Methylphenidate Hydrochloride Tablets -treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Stimulants can cause circulation problems in fingers and toes, including Raynaud's phenomenon, usually mild but sometimes with sores or tissue breakdown. Watch for changes in the fingers and toes.
Heading
5.6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon
Section
5.6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
CNS stimulants, including Methylphenidate Hydrochloride Tablets, 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. Careful observation for digital changes is necessary during Methylphenidate Hydrochloride Tablets treatment.
Stimulants can cause weight loss and slow growth in children. Height and weight should be watched closely, and treatment may be paused if growth is not as expected.
Heading
5.7 Long-Term Suppression of Growth in Pediatric Patients
Section
5.7 Long-Term Suppression of Growth in Pediatric Patients
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in Methylphenidate Hydrochloride Tablets -treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
Angle closure glaucoma has been reported. People at risk, such as those with significant farsightedness, should be seen by an eye doctor.
Heading
5.8 Acute Angle Closure Glaucoma
Section
5.8 Acute Angle Closure Glaucoma
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
There have been reports of angle closure glaucoma associated with methylphenidate treatment. Methylphenidate Hydrochloride Tablets -treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
Eye pressure increases have been reported. People with open-angle glaucoma or high eye pressure should use it only if the benefit outweighs the risk, with close monitoring.
Heading
5.9 Increased Intraocular Pressure and Glaucoma
Section
5.9 Increased Intraocular Pressure and Glaucoma
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Prescribe Methylphenidate Hydrochloride Tablets to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor Methylphenidate Hydrochloride Tablets -treated patients with a history of abnormally increased IOP or open angle glaucoma.
Stimulants can start or worsen tics and Tourette's syndrome. Family history is checked before starting, patients are monitored, and treatment is stopped if appropriate.
Heading
5.10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome
Section
5.10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
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. Before initiating Methylphenidate Hydrochloride Tablets, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor Methylphenidate Hydrochloride Tablets -treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.

Pregnancy and breastfeeding

Section
8.1 Pregnancy; 8.2 Lactation
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Confidence
high
Source text (exact source wording)
8.1: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Methylphenidate Hydrochloride Tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388. Published studies and post marketing 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). 8.2: 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. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

Side effects

Common
Common side effects are fast heartbeat, pounding heartbeat, headache, trouble sleeping, anxiety, heavy sweating, weight loss, decreased appetite, dry mouth, nausea, and stomach pain.
Threshold
The label gives no percentage threshold; Highlights list 'Common adverse reactions'.
Section
Highlights, Adverse Reactions (6)
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain (6).
Less common
The label lists many other reactions without how often they happen, including dizziness, tremor, drowsiness, blurred vision, cough, vomiting, indigestion, itching, hives, hair loss, joint pain, and muscle cramps.
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Section
6 ADVERSE REACTIONS
Serious
Label
Serious problems named in the label include abuse and addiction, heart problems and sudden death in people with serious heart disease, severe allergic reactions, psychosis and mania, seizures, stroke-type events, serotonin syndrome with serotonergic drugs, liver injury, blood cell drops, severe skin reactions, muscle breakdown, and painful long erections.
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Section
6; 5.1-5.10
Source text (exact source wording)
Adverse Reactions Reported with Methylphenidate Hydrochloride Tablets: Blood and the Lymphatic System Disorders: leukopenia, thrombocytopenia, anemia. Immune System Disorders: hypersensitivity reactions, including angioedema, and anaphylaxis. Psychiatric Disorders: psychosis (sometimes with visual and tactile hallucinations). Nervous System Disorders: convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs. Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury. Skin and Subcutaneous Tissue Disorders: exfoliative dermatitis, erythema multiforme rash, thrombocytopenic purpura. Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis. 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. Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients.
Medlineplus
MedlinePlus says to call your doctor or get emergency care for heart symptoms, chest pain, shortness of breath, fainting, vision changes, seeing or hearing things that are not real, new tics, mood changes, erections lasting longer than 4 hours, finger or toe color changes or wounds, or allergic signs.
Source
MedlinePlus Methylphenidate
Url
https://medlineplus.gov/druginfo/meds/a682188.html
Section
What side effects can this medication cause?
Source text (exact source wording)
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: fast, pounding, or irregular heartbeat; chest pain; shortness of breath; excessive tiredness; or fainting. changes in vision or blurred vision. agitation, believing things that are not true, feeling unusually suspicious of others, hallucinating (seeing things or hearing voices that do not exist). motor tics or verbal tics. depression, abnormally excited mood, or mood changes. frequent, painful erections or erection that lasts longer than 4 hours. numbness, pain, or sensitivity to temperature in the fingers or toes; skin color change from pale to blue to red in the fingers or toes; or unexplained wounds on the fingers or toes. hives; rash; itching; blistering or peeling skin, swelling of the eyes, face, lips, mouth, tongue, or throat; difficulty breathing or swallowing; or hoarseness.

Interactions

Drugs
Do not use with an MAOI or within 14 days after one. The combination can cause a hypertensive crisis with outcomes that include death, stroke, and heart attack.
Name
Monoamine oxidase inhibitors (MAOI)
Section
7.1 Table 1
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Concomitant use of MAOIs and CNS stimulants, including Methylphenidate Hydrochloride Tablets can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications (4)]. Concomitant use of Methylphenidate Hydrochloride Tablets with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.
It may make blood pressure medicines work less well. Blood pressure should be monitored and the dose adjusted if needed.
Name
Antihypertensive drugs
Section
7.1 Table 1
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Methylphenidate Hydrochloride Tablets may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions (5.3)]. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.
Using it with certain anesthetics may cause sudden blood pressure and heart rate increases during surgery. Avoid use on the day of surgery.
Name
Halogenated anesthetics
Section
7.1 Table 1
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Concomitant use of halogenated anesthetics and Methylphenidate Hydrochloride Tablets may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of Methylphenidate Hydrochloride Tablets in patients being treated with anesthetics on the day of surgery.
When the dose of either methylphenidate or risperidone changes, the risk of movement side effects (EPS) may go up. Monitor for signs of EPS.
Name
Risperidone
Section
7.1 Table 1
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
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). Monitor for signs of EPS
Serotonin syndrome has been reported when methylphenidate is combined with serotonergic drugs.
Name
Serotonergic drugs
Section
6 ADVERSE REACTIONS
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Nervous System Disorders: ... serotonin syndrome in combination with serotonergic drugs
Food and alcohol
Food does not change how much is absorbed, but the label prefers doses 30 to 45 minutes before meals.
Name
Food
Section
12.3 Effect of Food; 2.2
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Ingestion with food has no relevant effect on absorption of Methylphenidate Hydrochloride Tablets. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals.
Ask your doctor about alcohol, which can make side effects worse.
Name
Alcohol (MedlinePlus)
Section
What special precautions should I follow?
Source
MedlinePlus Methylphenidate
Url
https://medlineplus.gov/druginfo/meds/a682188.html
Source text (exact source wording)
ask your doctor about the safe use of alcoholic beverages while you are taking methylphenidate. Alcohol can make the side effects from methylphenidate worse.

Patient tips

Label medication guide
Never give your medicine to anyone else, keep it in a safe place, and dispose of unused medicine properly. Tell your provider about any past abuse of alcohol or drugs. Get help right away for chest pain, shortness of breath, fainting, or new mental symptoms. Do not take it if you are allergic to it.
Source
Medication Guide in the Aurolife label https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Do not give Methylphenidate Hydrochloride Tablets to anyone else. Keep Methylphenidate Hydrochloride Tablets in a safe place and properly dispose of any unused medicine. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems, such as chest pain, shortness of breath, or fainting while taking Methylphenidate Hydrochloride Tablets. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking Methylphenidate Hydrochloride Tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. Methylphenidate Hydrochloride Tablets should not be taken if you or your child: are allergic to methylphenidate hydrochloride, or any of the ingredients in Methylphenidate Hydrochloride Tablets.
Medlineplus
Call your doctor if symptoms worsen or do not improve after 1 month. Do not switch products without asking. Never sell or share it, and keep track of how much is left. Tell your doctor if you take or recently stopped an MAO inhibitor.
Source
MedlinePlus Methylphenidate
Url
https://medlineplus.gov/druginfo/meds/a682188.html
Labeled by
MedlinePlus
Source text (exact source wording)
Your condition should improve during your treatment. Call your doctor if your symptoms worsen at any time during your treatment or do not improve after 1 month. Some methylphenidate products may not be able to be substituted for another. Do not sell, give away, or let anyone else take your medication. Keep track of how much medication is left so you will know if any is missing. tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors.
Confidence
medium

Alternatives

Pharmacologic class
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Url
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=35be77db-fbe3-487e-a220-a08a11aaec28&type=display
Source text (exact source wording)
Methylphenidate Hydrochloride Tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
Note
No recommendation is made.

Frequently asked questions

Question
What is methylphenidate used for?
Answer
Methylphenidate tablets treat ADHD in children 6 years and older and in adults, and they treat narcolepsy.
Source section
1 INDICATIONS & USAGE
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Question
When should I take it?
Answer
Adults usually take it in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Children 6 years and older start with 5 mg twice daily, before breakfast and lunch. If sleep is a problem, take the last dose before 6 p.m.
Source section
2.2
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Question
What if I miss a dose?
Answer
The label has no missed-dose rule. MedlinePlus says to take it when you remember, ask your doctor how late in the day is okay, skip it if it is almost time for the next dose, and never double up.
Source section
MedlinePlus What should I do if I forget a dose?
Source
MedlinePlus Methylphenidate
Question
Can I drink alcohol with it?
Answer
Ask your doctor. MedlinePlus says alcohol can make the side effects worse.
Source section
MedlinePlus special precautions
Source
MedlinePlus Methylphenidate
Question
What are the common side effects?
Answer
The label lists fast heartbeat, pounding heartbeat, headache, trouble sleeping, anxiety, heavy sweating, weight loss, decreased appetite, dry mouth, nausea, and stomach pain.
Source section
Highlights, Adverse Reactions
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Question
Can I use it while pregnant or breastfeeding?
Source section
8.1; 8.2
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Question
What should I not combine with methylphenidate?
Answer
Do not use an MAOI or take one within 14 days. Tell your doctor about blood pressure medicines, risperidone, and any anesthesia planned for surgery.
Source section
4; 7.1
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28
Question
Is methylphenidate habit-forming?
Answer
Yes. It is a Schedule II controlled substance with a high potential for abuse and misuse that can lead to addiction, overdose, and death. Never share it and store it in a safe, preferably locked, place.
Source section
Boxed Warning; 9.1; 5.1
Source
DailyMed label, Methylphenidate Hydrochloride Tablets (immediate-release), Aurolife Pharma, LLC, set ID 35be77db-fbe3-487e-a220-a08a11aaec28

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug