Focalin XR, Focalin

Introduction

Written by Patricia Weiser, PharmD
Medically reviewed by Amber Watson, PharmD
Updated on September 22, 2023

Dexmethylphenidate (dex METH il FEN i date) is a generic medication prescribed for treating attention deficit hyperactivity disorder (ADHD) in adults and some children. Dexmethylphenidate belongs to a group of drugs called stimulants.

This article doesn’t provide coupons for all forms of dexmethylphenidate. To find coupons for dexmethylphenidate extended-release* oral capsule, see this article.

* “Extended release” means the drug is slowly released into your body over a long period of time.

Boxed warning: Risk of misuse and dependence

Dexmethylphenidate has a boxed warning about the risk of misuse and dependence. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

For details, see the “Interactions and warnings for dexmethylphenidate” section.

Side effects of dexmethylphenidate

Dexmethylphenidate may cause mild or serious side effects. More common mild side effects of dexmethylphenidate and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about dexmethylphenidate’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for dexmethylphenidate listed in the “Resources” section.

Mild side effects

More common mild side effects reported with some forms of dexmethylphenidate are listed below. These side effects may differ based on the form of dexmethylphenidate you take.

This article doesn’t include all possible mild side effects of the drug. To learn more about dexmethylphenidate’s side effects based on the form, refer to the prescribing information for dexmethylphenidate listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Dexmethylphenidate oral tablet’s mild side effects include:

• pain in your abdomen
• not feeling as hungry as usual
• nausea
• fever
• mild allergic reaction*

Dexmethylphenidate extended-release* oral capsule’s mild side effects include:

• dry mouth
• indigestion (upset stomach)
• headache
• anxiety
• mild allergic reaction†

* “Extended release” means the drug is slowly released into your body over a long period of time.
† For details about this side effect, see the “Interactions and warnings for dexmethylphenidate” section.

Serious side effects

Serious side effects of dexmethylphenidate are listed below.

This article doesn’t include all possible serious side effects of the drug. To learn more about dexmethylphenidate’s side effects based on the form, refer to the prescribing information for dexmethylphenidate listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, dexmethylphenidate’s serious side effects include:

• high blood pressure
• rapid heart rate
• serious heart and blood vessel problems, such as heart attack or stroke
• prolonged erections that may be painful
• extreme changes in mood or behavior
• circulation problems in your hands and feet, which may feel numb or very cold
• boxed warning: risk of misuse and dependence*
• slowed growth rate (in children)†
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for dexmethylphenidate” section.
† This side effect is specific to children taking dexmethylphenidate rather than adults. For details, see dexmethylphenidate’s prescribing information in the “Article resources” section below.

Common questions about dexmethylphenidate

Below you’ll find answers to a few commonly asked questions about dexmethylphenidate.

Is dexmethylphenidate similar to methylphenidate?

Yes. Dexmethylphenidate and methylphenidate belong to the same group of drugs known as stimulants. They can be used to treat attention deficit hyperactivity disorder (ADHD).

These drugs are both available as oral tablets and extended-release* oral capsules. Methylphenidate is also available in additional forms, such as a transdermal film (skin patch), a chewable tablet, an extended-release oral tablet, and an oral liquid solution.

To determine whether dexmethylphenidate or methylphenidate may be a better choice for you, talk with your doctor.

* “Extended release” means the drug is slowly released into your body over a long period of time.

What brand names are available for dexmethylphenidate?

Focalin is the brand name of dexmethylphenidate oral tablets. Focalin XR is the brand name of dexmethylphenidate extended-release* oral capsules.

Dexmethylphenidate is a generic medication. A generic medication is an identical copy of the active drug in a brand-name medication. (An active drug is the ingredient that makes a medication work.) Generic drugs are believed to be as effective and safe as brand-name drugs. And generic drugs typically cost less compared to brand-name drugs.

Talk with your doctor or pharmacist to learn more about brand-name and generic drugs.

* “Extended release” means the drug is slowly released into your body over a long period of time.

How does dexmethylphenidate work? And how long does it take to start working?

It isn’t clear exactly how dexmethylphenidate works to treat ADHD. The drug increases levels of certain brain chemicals. This may improve your ability to pay attention and manage your behavior.

Dexmethylphenidate oral tablet starts working to treat ADHD symptoms within 1–1.5 hours after you take a dose. Dexmethylphenidate extended-release* oral capsule starts working 1–4 hours after you take a dose. The effects of the medication wear off more quickly with the tablet than the capsule. Because of this, your doctor may prescribe the tablet twice a day. The capsule is usually taken just once a day in the morning.

If you’d like to know more about this, talk with your doctor or pharmacist.

* “Extended release” means the drug is slowly released into your body over a long period of time.

Interactions and warnings for dexmethylphenidate

Below you’ll find information about dexmethylphenidate’s possible interactions and warnings.

Interactions of dexmethylphenidate

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take dexmethylphenidate, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for dexmethylphenidate” section below.

Warnings for dexmethylphenidate

Some people should not take dexmethylphenidate, and others should take it cautiously.

Boxed warning: Risk of misuse and dependence

Dexmethylphenidate has a boxed warning about the risk of misuse and dependence. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

As with other stimulant medications, taking dexmethylphenidate may lead to misuse and dependence.

Misuse means taking a drug in a way other than how a doctor prescribes it. Signs and symptoms of stimulant misuse may include:

• increases in heart rate, breathing rate, and blood pressure
• sweating more than usual
• insomnia (trouble sleeping)
• decreased appetite
• changes in mood or behavior, such as aggression

Dependence means the body needs the drug in order to function like usual. The risk of dependence can increase with misuse of dexmethylphenidate. Dependence can lead to withdrawal symptoms that happen between doses or if you suddenly stop taking the drug. These symptoms may include:

• fatigue (low energy)
• vivid dreams or nightmares
• sleepiness or trouble sleeping
• increased appetite
• agitation (feeling on edge)

Dexmethylphenidate is classified as a Schedule 2 controlled substance in the United States. A controlled substance is a drug the government regulates due to the risk of misuse or dependence. This means doctors and pharmacists must follow strict rules when prescribing and dispensing the drug. These rules are in place to help reduce the risk of misuse or dependence.

It isn’t clear if or how often misuse or dependence occurred in studies of dexmethylphenidate.

Due to these risks, doctors usually don’t prescribe dexmethylphenidate to people with substance or alcohol use disorder. These conditions, either currently or in the past, increase the risk of misuse and dependence with dexmethylphenidate.

If you have concerns about misuse or dependence during dexmethylphenidate treatment, tell your doctor. They’ll recommend ways to get help. They may also switch you to a nonstimulant medication for your ADHD.

Other warnings

Dexmethylphenidate could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether dexmethylphenidate is a safe option for you.

Ask your doctor about specific warnings for dexmethylphenidate, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Dexmethylphenidate can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to dexmethylphenidate or any of its ingredients, your doctor will likely not prescribe dexmethylphenidate. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to dexmethylphenidate, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of dexmethylphenidate

You should not take more dexmethylphenidate than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much dexmethylphenidate, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and dexmethylphenidate

Information about dexmethylphenidate and pregnancy and breastfeeding is described below.

Dexmethylphenidate and pregnancy

It’s not known whether dexmethylphenidate should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

If you become pregnant while taking dexmethylphenidate, tell your doctor. They’ll likely have you stop the medication. They may also encourage you to participate in a pregnancy registry. This registry collects information about the effects of ADHD medications taken during pregnancy. Learn more about the National Pregnancy Registry for ADHD medications by calling 1-866-961-2388 or visiting the website.

Dexmethylphenidate and breastfeeding

There are risks to taking dexmethylphenidate while breastfeeding. But there are also risks with having unmanaged ADHD during this time. (Keep in mind that dexmethylphenidate is used for treating ADHD.)

For instance, dexmethylphenidate may cause trouble sleeping or decreased appetite in a child who is breastfed.

If you’re planning to breastfeed, talk with your doctor about ADHD treatment options. Together, you can discuss the risks and benefits of your treatment options and decide whether or not you should take dexmethylphenidate during this time. Your doctor may recommend other ways to feed your child while taking dexmethylphenidate.

Uses of dexmethylphenidate

The Food and Drug Administration (FDA) approves prescription drugs such as dexmethylphenidate for certain conditions. Approved uses for dexmethylphenidate are described below.

Use for attention deficit hyperactivity disorder

Doctors may prescribe dexmethylphenidate for treating attention deficit hyperactivity disorder (ADHD). It’s used for this purpose in children ages 6 years and older and adults. It’s usually prescribed as a long-term treatment.

With ADHD, people may have challenges with certain thoughts or behaviors. Symptoms may include:

• trouble focusing
• overlooking or forgetting tasks
• interrupting others or not waiting for their turn
• talking excessively
• being easily distracted

What to ask your doctor

Let your doctor know if you have questions about dexmethylphenidate or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• How does dexmethylphenidate compare with other treatments that I may be able to take for ADHD?
• What time should I take each dose of dexmethylphenidate to get the best results?
• How will we find out whether dexmethylphenidate is causing side effects that affect growth or the heart?
• Does my health history increase my risk of having side effects with dexmethylphenidate?

Resources

• Dexmethylphenidate hydrochloride extended-release capsules, for oral use, CII. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/a0133bf5-3cb3-4405-a007-43fbcf957333/spl-doc
• Dexmethylphenidate hydrochloride tablets, for oral use, CII. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/779ece39-b6fa-4977-8df5-d018d39d4d0d/spl-doc
• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.