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On June 30, 2025, FDA issued a drug safety communication about a risk of weight loss in patients younger than 6 years of age taking extended-release stimulants for ADHD and will be revising the labeling for all these products to reflect this new safety information. Although extended-release stimulants are not approved for children younger than 6 years, health care professionals can prescribe them "off label" to treat ADHD. For additional information, see http://www.fda.gov/media/187347/download.
Methylphenidate can be habit-forming. Take methylpenidate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you take too much methylphenidate, the medication may no longer work as well and you may feel a need to take more of it, and you may experience unusual changes in your behavior. Tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.
Do not stop taking methylphenidate without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression if you suddenly stop taking methylphenidate after overusing it. Your doctor may need to monitor you carefully after you stop taking methylphenidate, even if you have not overused the medication, because your symptoms may worsen when treatment is stopped.
Do not sell, give away, or let anyone else take your medication. Selling or giving away methylphenidate may harm others and is against the law. Store methylphenidate in a safe place so no one else can take it accidentally or on purpose. Keep track of how much medication is left so you will know if any is missing.
You will be given the manufacturer's patient information sheet Medication Guide when you begin treatment with methylphenidate and each time you get more medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm or the manufacturer's website to obtain the Medication Guide.
WHY is this medicine prescribed?
Methylphenidate is used to control symptoms of attention deficit hyperactivity disorder (ADHD; condition that makes it hard to pay attention, control your behavior, and remain still or quiet) and to treat narcolepsy (condition that causes people to be very sleepy during the day and to fall asleep suddenly). Methylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by changing the amounts of certain natural substances in the brain.
HOW should this medicine be used?
Methylphenidate comes as a tablet, a chewable tablet, a solution (liquid), a suspension (liquid), an orally disintegrating tablet (tablet that dissolves quickly in the mouth), a long-acting (extended-release) tablet, and a long-acting capsule to take by mouth. Your doctor will tell you how often to take methylphenidate and how you should take it. This depends on the dosage form that you are taking. Ask your doctor or pharmacist if you have questions about taking methylphenidate.
Do not try to push the orally disintegrating tablet through the blister pack foil. Instead, use dry hands and peel back the foil. Immediately take out the tablet and place it in your mouth. The tablet will quickly dissolve and can be swallowed with saliva; no water is needed to swallow the tablet.
Swallow the long-acting tablets and capsules whole; do not split, chew, or crush them. Tell your doctor if you have problems swallowing. Your doctor will tell you how to take methylphenidate.
If you are taking the suspension, your doctor with give you the manufacturer's instructions for use. These instructions describe how to measure and take a dose of the suspension. Read these instructions and follow them carefully. Be sure to ask your pharmacist or doctor if you have any questions.
Your doctor may start you on a low dose of methylphenidate and gradually increase your dose, not more often than once every week.
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.
Your doctor may tell you to stop taking methylphenidate from time to time to see if the medication is still needed. Follow these directions carefully.
Some methylphenidate products may not be able to be substituted for another. Ask your pharmacist if you have any questions about the type of methylphenidate product your doctor has prescribed.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking methylphenidate,
What should I do IF I FORGET to take a dose?
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.
If you are taking methylphenidate at night, take the missed dose as soon as you remember it that night. However, if it is already the next morning, skip the missed dose of the long-acting capsule and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Methylphenidate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment:
Methylphenidate may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your child's doctor about the risks of giving methylphenidate to your child.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light and excess heat and moisture (not in the bathroom). Store methylphenidate in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules or how much liquid is left so you will know if any medication is missing.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reachhttp://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
What OTHER INFORMATION should I know?
If you are taking methylphenidate long-acting tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.
Keep all appointments with your doctor and the laboratory. Your doctor may check your blood pressure and heart rate and order certain lab tests to check your response to methylphenidate.
This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
¶ This branded product is no longer on the market. Generic alternatives may be available.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: July 15, 2025.