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Prescription medicine (Schedule II controlled substance)A CNS stimulant, a medicine that increases activity in the central nervous system

Methylphenidate Hydrochloride

Methylphenidate hydrochloride · Say it: meth-ul-FEN-i-date hye-droh-KLOR-ide

A prescription stimulant used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. This summary is based on the oral solution label, which lists a grape-flavored liquid. The brand names listed above may refer to other forms of this medicine.

Brand names: CONCERTAMETADATE CDRELEXXII

Reading levelLanguage

⬛ Boxed warning (the FDA's strongest warning)

The boxed warning says this medicine has a high potential for abuse and misuse, which can lead to a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including this medicine, can cause overdose and death. This risk is higher with higher doses or with unapproved methods of use, such as snorting or injection. Before prescribing, the prescriber should assess each person's risk for abuse, misuse, and addiction. Patients and families should be taught about these risks, safe storage, and proper disposal of unused medicine. The risk should be rechecked throughout treatment.

Used for

The label says it is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and in children 6 years of age and older, and to treat narcolepsy.

Comes as

Oral solution, 5 mg per 5 mL; Oral solution, 10 mg per 5 mL

Common side effects

Decreased appetite, Trouble sleeping (insomnia), Headache

Key facts
Generic nameMethylphenidate hydrochloride
Brand namesCONCERTA, METADATE CD, RELEXXII
Type of medicineA CNS stimulant, a medicine that increases activity in the central nervous system
How it is soldPrescription medicine (Schedule II controlled substance)
Comes asOral solution, 5 mg per 5 mL; Oral solution, 10 mg per 5 mL; Colorless, grape-flavored liquid supplied in 500 mL bottles
Routeoral
Boxed warningYes, see below
Label date2026-05-11

💊 What is Methylphenidate Hydrochloride used for?

  • The label says it is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and in children 6 years of age and older, and to treat narcolepsy.

How it works

The label describes methylphenidate as a CNS stimulant. It says the medicine may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. The label does not explain its mechanism in more detail.

How it is usually taken

  • The medicine is taken by mouth as an oral solution. The label says it is usually given in divided doses, two or three times a day, preferably 30 to 45 minutes before meals. For adults who have trouble sleeping when the medicine is taken late in the day, the label says the last dose should be given before 6 p.m. Follow the instructions from your prescriber or pharmacist.

Comes as

  • Oral solution, 5 mg per 5 mL
  • Oral solution, 10 mg per 5 mL
  • Colorless, grape-flavored liquid supplied in 500 mL bottles

⚠️ Methylphenidate Hydrochloride side effects

Common side effects

  • Decreased appetite
  • Trouble sleeping (insomnia)
  • Headache
  • Dizziness
  • Nausea, vomiting, or stomach pain
  • Dry mouth
  • Anxiety or restlessness
  • Tiredness (fatigue)
  • Tremor
  • Fast heartbeat or palpitations

Get medical help right away if

  • Get medical help right away if you have chest pain, shortness of breath, or fainting during treatment. The label links these signs to possible heart problems.
  • Get medical help right away if you have new or worsening mental symptoms, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
  • Seek immediate medical attention for erections that are prolonged, painful, or happen often.
  • Get emergency help right away if an overdose is suspected. The label describes overdose signs such as a racing or irregular heartbeat, agitation, confusion, hallucinations, seizures, very high body temperature, and coma.
  • Abuse, misuse, or addiction can lead to overdose and death. Tell your provider if you have ever abused or depended on alcohol, prescription medicines, or street drugs.

🛑 Who should not take Methylphenidate Hydrochloride, and who should be careful

The label says not to take it if

  • You or your child are allergic to methylphenidate hydrochloride or any ingredient in the solution.
  • You are taking a monoamine oxidase inhibitor (MAOI), or have stopped one within the past 14 days.

Tell your doctor before taking it if

  • Tell your provider if you or your child have heart problems, heart disease, heart defects, or high blood pressure. The label says sudden death has happened in people with serious heart disease.
  • Tell your provider about any mental health problems, including psychosis, mania, bipolar illness, or depression, or a family history of suicide, bipolar illness, or depression.
  • Tell your provider about circulation problems in the fingers and toes, eye problems (including glaucoma or increased eye pressure), and any history of tics or Tourette's syndrome.
  • Tell your provider if you are pregnant, plan to become pregnant, or are breastfeeding.
  • Tell your provider about all medicines, including over-the-counter medicines, vitamins, and herbal supplements.
  • Keep the medicine in a safe place to protect it from theft, and never give it to anyone else.

🔀 Methylphenidate Hydrochloride with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

  • Monoamine oxidase inhibitors (MAOIs): combining them can cause a hypertensive crisis. The label says this combination is not allowed.
  • Antihypertensive drugs (blood pressure medicines): this medicine may reduce their effectiveness. Blood pressure should be monitored.
  • Halogenated anesthetics: the label says the medicine should be avoided on the day of surgery for patients being treated with these anesthetics.
  • Risperidone: changes in the dose of either medicine may increase the risk of extrapyramidal symptoms, so the provider should watch for these signs.
  • Serotonergic drugs: the label lists serotonin syndrome as a possible reaction when used with serotonergic drugs.

Alcohol and food

The label does not give specific guidance about alcohol. It says the medicine is usually taken 30 to 45 minutes before meals. It also says to tell your provider if you have ever abused alcohol.

🤰 Methylphenidate Hydrochloride in pregnancy and breastfeeding

Pregnancy

The label says it is not known if this medicine will harm an unborn baby. It also says published studies and post-marketing reports have not identified a drug-associated risk of major birth defects, miscarriage, or adverse outcomes. The label also says there may be risks to the fetus with CNS stimulants during pregnancy. Discuss this with your healthcare provider.

Breastfeeding

The label says this medicine passes into breast milk. Talk with your healthcare provider about the best way to feed the baby during treatment.

🗓️ Storage, missed doses and taking too much

Storage

Store at 20 to 25 degrees C (68 to 77 degrees F), with brief excursions allowed between 15 and 30 degrees C (59 to 86 degrees F). Keep in a tight container with a child-resistant closure. The label advises keeping the medicine in a safe place, preferably locked, and disposing of unused medicine properly.

If a dose is missed

The label does not say.

If too much is taken

The label describes overdose effects of CNS stimulants as including fast or irregular heartbeat, high or low blood pressure, agitation, confusion, hallucinations, serotonin syndrome, seizures, stroke, and coma. Very high body temperature and muscle breakdown (rhabdomyolysis) may also develop. The label says dialysis is not useful because the medicine has a large volume of distribution and is rapidly metabolized. Seek emergency medical help right away if an overdose is suspected.

🗒️ Questions to ask about Methylphenidate Hydrochloride

🎯 Check what you understood

1. According to the boxed warning, what increases the risk of overdose and death with this medicine?

2. Which medicine class is this medicine NOT allowed to be taken with, according to the label?

3. What does the label say about when the medicine is usually taken?

❓ Methylphenidate Hydrochloride: frequently asked questions

What is this medicine used for?

The label says it is used to treat ADHD in adults and in children 6 years of age and older. It is also used to treat narcolepsy.

Is this medicine a controlled substance?

Yes. The label says it is a federally controlled substance (CII) because it can be a target for people who abuse prescription medicines or street drugs.

Can this medicine pass into breast milk?

The label says it passes into breast milk. It advises talking with your healthcare provider about the best way to feed the baby during treatment.

What should I do if I think someone has taken too much?

The label describes serious overdose effects, including heart and brain problems, seizures, and coma. Seek emergency medical help right away if an overdose is suspected.

How should I store this medicine?

The label says to store it at 20 to 25 degrees C (68 to 77 degrees F) in a tight, child-resistant container. It also says to keep it in a safe place, preferably locked.

🧪 Tests and reports linked to Methylphenidate Hydrochloride

The label text mentions these. If you have one of these reports, get every line of it explained.

📖 Medical words used on this page

  • Angina

    Angina is chest pain or tightness caused by the heart muscle not getting enough blood and oxygen, usually from narrowed heart arteries.

  • Antihypertensive

    An antihypertensive is any medicine used to lower high blood pressure, such as ACE inhibitors, ARBs, calcium channel blockers or diuretics.

  • Arrhythmia

    An arrhythmia is a heartbeat that is too fast, too slow or irregular, because the heart's electrical signals are not working in their usual pattern.

  • Boxed warning

    A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.

  • Congenital malformations

    Congenital malformations are differences in the structure of the body that are present at birth, such as heart, spine or lip and palate defects.

  • Contraindication

    A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.

  • Controlled substance

    A controlled substance is a medicine or drug whose making, prescribing and supply are tightly regulated by law because it can be misused or cause dependence.

  • Dialysis

    Dialysis is a treatment that removes waste and extra fluid from the blood when the kidneys can no longer do this well enough.

  • Exacerbation

    An exacerbation is a flare-up: a period when a long-term condition, such as asthma, COPD or hepatitis, suddenly gets worse.

  • Glaucoma

    Glaucoma is a group of eye conditions where the optic nerve is damaged, often linked to raised pressure inside the eye, which can affect sight.

  • Hypertension

    Hypertension means high blood pressure: the force of blood against artery walls stays higher than it should over time.

  • Hypotension

    Hypotension means low blood pressure. It can cause dizziness or fainting, and some medicines can lower blood pressure too far.

  • Impression

    The impression is the summary at the end of a scan report, where the radiologist gives their main conclusions.

  • Major depressive disorder

    Major depressive disorder is a common medical condition with low mood or loss of interest that lasts at least two weeks and affects daily life.

📖 Medical words on this page

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Source: official FDA drug label (label updated 2026-05-11). Read the full label on DailyMed

MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.