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Methylphenidate 8-Hour: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Controlled substance Schedule II Boxed warning
Strength:
10 mg, 20 mg
Brand names:
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Methylphenidate 8-Hour

What is the most important information I should know about Methylphenidate hydrochloride extended-release tablets?

Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including:

  • Abuse, misuse, and addiction. Methylphenidate hydrochloride extended-release tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of methylphenidate hydrochloride extended-release tablets, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of methylphenidate hydrochloride extended-release tablets or when it is used in ways that are not approved, such as snorting or injection.
  • Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with methylphenidate hydrochloride extended-release tablets and will monitor you or your child during treatment.
  • Methylphenidate hydrochloride extended-release tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
  • Do not give methylphenidate hydrochloride extended-release tablets to anyone else because it may cause death or harm them. See " What are Methylphenidate hydrochloride extended-release tablets?" for more information.
  • Keep methylphenidate hydrochloride extended-release tablets in a safe place and properly dispose of any unused medicine. See " How should I store Methylphenidate Hydrochloride Extended-Release Tablets?" for more information.
  • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with methylphenidate hydrochloride extended-release tablets.

Tell your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any signs of heart problems, such as chest pain, shortness of breath, or fainting during treatment with methylphenidate hydrochloride extended-release tablets.

  • Increased blood pressure and heart rate.

Your healthcare provider should check your or your child's blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release tablets.

  • Mental problems (psychiatric reactions), including:
  • worsening behavior or thought problems in people with thought or psychotic disorders
  • maniac episodes in people with bipolar disorder
  • new psychotic or manic symptoms in people without bipolar or psychotic disorders

Tell your healthcare provider right away if any mental symptoms or problems develop or worsen during treatment with methylphenidate hydrochloride extended-release tablets, including:

  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
  • seeing or hearing things that are not real (hallucinations).

See " What are the possible side effects of methylphenidate hydrochloride extended-release tablets?" for more information about side effects.

What are Methylphenidate hydrochloride extended-release tablets?

Methylphenidate hydrochloride extended-release tablets is a central nervous system (CNS) stimulant prescription medicine used for the treatment of:

  • Attention deficit hyperactivity disorder (ADHD) in people 6 years of age and older.

Methylphenidate hydrochloride extended-release tablets may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

  • A sleep disorder called narcolepsy.

Methylphenidate hydrochloride extended-release tablets are not recommended for use in children under 6 years of age.

Methylphenidate hydrochloride extended-release tablets is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.

Who should not take Methylphenidate hydrochloride extended-release tablets?

Do not take Methylphenidate hydrochloride extended-release tablets if you or your child are:

  • allergic to methylphenidate hydrochloride, or any of the ingredients in Methylphenidate hydrochloride extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in Methylphenidate hydrochloride extended-release tablets.
  • taking or have taken within the past 14 days, a medicine called a monoamine oxidase inhibitor or MAOI.
  • have a condition called pheochromocytoma (a rare tumor that usually grows in the adrenal glands which are above your kidneys).

Before taking methylphenidate hydrochloride extended-release tablets, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:

  • have heart problems, heart disease, heart defects, or high blood pressure, or have a family history of sudden death or heart problems
  • have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
  • have circulation problems in fingers and toes
  • have had a blockage or narrowing of the intestines
  • have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness)
  • have or had repeated uncontrolled movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome

  • are pregnant or plan to become pregnant. Methylphenidate hydrochloride extended-release tablets may harm the unborn baby.

  • There is a pregnancy exposure registry for women are exposed to methylphenidate hydrochloride extended-release tablets during pregnancy. The purpose of the registry is to collect information about the health of women exposed to methylphenidate hydrochloride extended-release tablets and their baby. If you or your child becomes pregnant during treatment with methylphenidate hydrochloride extended-release tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.
  • are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride passes into the breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with methylphenidate hydrochloride extended-release tablets. If you breastfeed during treatment with methylphenidate hydrochloride extended-release tablets, monitor your baby for agitation, poor sleeping patterns, changes in feeding, and reduced weight gain.

Tell your doctor about all of the medicines that you or your child take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Methylphenidate hydrochloride extended-release tablets and some medicines may interact with each other and cause serious side effects or affect the way methylphenidate hydrochloride extended-release tablets or other medicines work. Sometimes the doses of other medicines will need to be changed during treatment with Methylphenidate hydrochloride extended-release tablets.
  • Your healthcare provider will decide whether Methylphenidate hydrochloride extended-release tablets can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • a medicine to treat blood pressure (anti-hypertensive)
  • risperidone

Know the medicines that you or your child takes. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

Do not start any new medicine during treatment with Methylphenidate hydrochloride extended-release tablets without first talking to your healthcare provider.

How should I take Methylphenidate hydrochloride extended-release tablets?

  • Take Methylphenidate hydrochloride extended-release tablets exactly as prescribed by your or your child’s healthcare provider
  • Your healthcare provider may change the dose or tell you to stop taking methylphenidate hydrochloride extended-release tablets if needed.
  • Take Methylphenidate hydrochloride extended-release tablets 30 to 45 minutes before a meal. The effect of a dose of Methylphenidate hydrochloride extended-release tablets usually lasts about 8 hours.
  • Swallow methylphenidate hydrochloride extended-release tablets whole with water or other liquids. Do not split, crush, or chew or crush the extended-release tablets. Tell your healthcare provider if you or your child cannot swallow Methylphenidate hydrochloride extended-release tablets whole. A different medicine may need to be prescribed.
  • From time to time, your doctor may stop Methylphenidate hydrochloride extended-release tablets treatment for a while to check ADHD or narcolepsy symptoms.
  • Your healthcare provider may do regular checks of the blood, heart, and blood pressure while taking Methylphenidate hydrochloride extended-release tablets.
  • Children should have their height and weight checked often while taking Methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets treatment may be stopped if a problem is found during these check-ups.
  • If you or your child take too much methylphenidate hydrochloride extended-release tablets, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of Methylphenidate hydrochloride extended-release tablets?

Methylphenidate hydrochloride extended-release tablets may cause serious side effects, including:

  • See “What is the most important information I should know about Methylphenidate hydrochloride extended-release tablets?”
  • Painful and prolonged erections (priapism). Priapism that may require surgery has happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.

  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your healthcare provider if any of the following signs and symptoms of circulation problems develop during treatment:

    • fingers or toes feel numb, cool, painful
    • fingers or toes change color from pale, to blue, to red
    • sensitivity to temperature in fingers or toes

    Tell your healthcare provider right away if any unexplained wounds appear on the fingers or toes during treatment with methylphenidate hydrochloride extended-release tablets.

    • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tablets treatment may be stopped if your child is not growing or gaining weight as expected.
    • Eye problems (increased pressure in the eye and glaucoma). Tell your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
    • New or worsening tics or worsening Tourette's syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette's syndrome during treatment with methylphenidate hydrochloride extended-release tablets.

    The most common side effects of methylphenidate hydrochloride extended-release tablets include:

    • fast heart beat
  • abnormal heartbeat (palpitations)
  • headache
  • trouble sleeping
  • nervousness
  • sweating a lot
  • decreased appetite
  • dry mouth
  • nausea

  • stomach pain

    These are not all the possible side effects of methylphenidate hydrochloride extended-release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Methylphenidate hydrochloride extended-release tablets?

  • Store Methylphenidate hydrochloride extended-release tablets in a safe place, like a locked cabinet, and in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C).
  • Protect from moisture.
  • Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Methylphenidate hydrochloride extended-release tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Methylphenidate hydrochloride extended-release tablets in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
  • Keep Methylphenidate hydrochloride extended-release tablets and all medicines out of the reach of children.

General information about the safe and effective use of Methylphenidate hydrochloride extended-release tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylphenidate hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give Methylphenidate hydrochloride extended-release tablets to other people, even if they have the same symptoms. It may harm them.

What are the ingredients in Methylphenidate hydrochloride extended-release tablets?

Active ingredient: methylphenidate hydrochloride

Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate.

Manufactured by:

Granules Pharmaceuticals Inc.

Chantilly, VA 20151

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 08/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 210992 · View the label on DailyMed

Revision date stated in the text: August 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Methylphenidate 8-Hour

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IISchedule II: high potential for abuse; abuse may lead to severe psychological or physical dependence.
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Central Nervous System Stimulant
Active ingredient Methylphenidate hydrochloride
Dosage form Tablet, extended release
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) GRANULES
FDA approval ANDA 210992Abbreviated New Drug Application (ANDA) – generic drug Approved November 21, 2018
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Concerta, Methylphenidate 24-Hour with the same TE code
Manufacturers 5 labelers list this drug on DailyMed
Packages (NDC)
Package
10 mg – 100 in 1 bottle, plastic NDC 70010-042-01
10 mg – 30 in 1 bottle, plastic NDC 70010-042-03
20 mg – 100 in 1 bottle, plastic NDC 70010-043-01
20 mg – 30 in 1 bottle, plastic NDC 70010-043-03

Source: FDA drug labeling via NLM DailyMed, data as of November 3, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.