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Erika Prouty, PharmD, is a professional community pharmacist who aids patients in medication management and pharmacy services in North Adams, Massachusetts.

Focalin has a high risk of abuse and dependence. Use this medication only as directed by your healthcare provider. Inform your healthcare provider if you have ever abused or become dependent on drugs or alcohol.

Focalin (dexmethylphenidate ) is a Schedule II controlled substance. It belongs to the drug class known as central nervous system stimulants. Dexmethylphenidate is a prescription drug used to treat attention deficit hyperactivity disorder (ADHD). It is approved for use in people 6 years and older. It is available as immediate-release (IR) tablets and extended-release (ER) capsules.

Dexmethylphenidate increases the level of certain chemicals (norepinephrine and dopamine) in the brain, which helps with behavior, attention, and focus.

Brand Name(s): Focalin, Focalin XR

Therapeutic Classification: Central nervous system stimulants

Controlled Substance: Schedule II

Dosage Form(s): Tablet, Capsule

Focalin (dexmethylphenidate) treats attention deficit hyperactivity disorder (ADHD), a frequently diagnosed condition in child and adolescent psychiatry. It is a neurodevelopmental condition (affects the brain and/or nerves) that may linger into adulthood. Symptoms can include absent-mindedness, low energy, and sluggishness.

According to a national 2016 survey of parents, the estimated number of children diagnosed with ADHD in the United States was 6.1 million (9.4%). According to a global study, the prevalence of ADHD among children and adolescents hovers around 7.2% worldwide.

In a 2020 global study, the prevalence of persistent adult ADHD (still having ADHD in adulthood after being diagnosed with it in childhood) was 2.58%, and that of symptomatic adult ADHD (not diagnosed in childhood) was 6.76%, or 139.84 million, and 366.33 million affected adults around the world.

Immediate-release tablets: Take with or without food twice daily, at least four hours apart. Do not take this medicine close to your sleep time to avoid difficulty falling asleep.

Extended-release capsules: Take with or without food once in the morning—swallow whole. Do not crush or chew the drug. You may open up the capsule for people who cannot easily swallow. Sprinkle the contents of the pill over a spoonful of applesauce. Take it immediately without chewing. Do not store for future use. 

Keep taking your medicine, even if you feel better. Please do not stop taking Focalin all of a sudden. Doing so may cause harmful side effects like agitation, insomnia, and mood changes.

Speak to your healthcare provider if your symptoms do not get any better.

Store Focalin at room temperature (68 to 77 degrees Fahrenheit (F)) in a dry place away from light and moisture. When traveling, you may store it between cool and mildly hot temperatures (59 to 86 degrees F). Protect from light and moisture. Do not store it in your bathroom.

Store Focalin in a locked box, where other people, children, or pets cannot get to it.

Discard your unused and expired drugs properly. Do not toss them down the sink, toilet, or drain. Ask your healthcare provider the best ways to dispose of your medicine. There may be drug take-back programs near you.

If you travel with Focalin, get familiar with your final destination's regulations. In general, be sure to make a copy of your Focalin prescription. Keep your medication in its original container from your pharmacy with your name on the label. Ask your pharmacist or healthcare provider if you have any questions about traveling with your medicine.

It takes Focalin about one to two hours to start working in your system. Focalin IR lasts about three to five hours, while Focalin XR lasts for nine to 12 hours per dose. These times may vary from person to person. Be sure to check with your healthcare provider or pharmacist if you have any questions.

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

Common side effects of Focalin include but are not limited to:

Focalin can cause many side effects. Some may be life-threatening. Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you have a medical emergency. Severe side effects include:

Note: This is not all the side effects of Focalin. Speak to your healthcare provider if you have questions.

Growth suppression may occur in children. Growth should be watched while using stimulant medications, especially Focalin. Children who are not developing or gaining weight as they should be may require their treatment to be discontinued.

Animal studies show that Focalin may cause liver cancer in males. No human studies have been conducted to validate or disprove this risk.

Withdrawal symptoms may also happen in people who have been on Focalin for extended periods. Hence, you may have to slowly wean off this medicine to avoid withdrawal symptoms like agitation, insomnia, etc.

Focalin may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The following modifications (changes) should be kept in mind when using Focalin:

Pregnancy: There is limited data for Focalin use in pregnant people. Use caution. Speak to your healthcare provider if you plan to become pregnant or are pregnant.

Breastfeeding: It is not known if dexmethylphenidate is present in breast milk. Before starting this medicine, your healthcare provider must weigh the benefits and possible effects on your breastfed infant. Exposure to this drug may cause the following in infants:

Adults over age 65:  Focalin has not been studied in older adults.

Children: Focalin may be used in children over 6 years old. Unfortunately, it is associated with severe effects like slowed growth rate, including sudden death in children and adolescents.

If you mistakenly missed a dose, skip the missed dose and go back to your regular time. Do not take two doses at the same time or extra doses.

Try to find ways to help yourself remember to routinely take your medication. If you miss too many doses, Focalin might be less effective in treating your ADHD symptoms.

The symptoms of a suspected overdose of Focalin include:

If you think you or someone else may have overdosed on Focalin, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Focalin, call 911 immediately.

It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for any unwanted effects.

Do not use dexmethylphenidate together with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start using this medicine during the 2 weeks after you stop an MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, headaches, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions (seizures).

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Dexmethylphenidate may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, trouble breathing, or fainting while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may include:

This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine on the day you have your surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and especially those for appetite control, asthma, colds, cough, hay fever, allergies, or sinus problems.

Avoid taking Focalin if you have:

Focalin XR should not be used in people currently on or recently treated with MAO Inhibitors (MAOIs). This is because very high blood pressure may happen if taken together. Use caution when taking Focalin with the following medications:

Be sure to talk with your healthcare provider about all prescription and nonprescription medications, vitamins, supplements, and herbal products you are taking or plan to take.

Other drugs similar to Focalin used to treat ADHD include:

This list is a list of drugs also prescribed to treat ADHD. It is NOT a list of medicines recommended to take with Focalin. You should not take these drugs together unless your healthcare provider tells you to. Ask your pharmacist or a healthcare provider if you have questions.

Focalin treats attention deficit problems with hyperactivity in people 6 years and older.

Take Focalin in the morning or afternoon. Do not take it close to your bedtime to avoid trouble sleeping or insomnia.

Store Focalin at room temperature in a dry area. Keep it locked away from the reach of other people, children, or pets.

Skip the missed dose. Return to your regular dosing schedule. Do not take extra doses or double the amount.

Although Focalin helps you cope with ADHD, it may cause harmful reactions, including sudden death and seizure.

If you or your child are coping with ADHD, additional ways to support your family include behavioral therapy for both you and your children and organizational and social skills training. Studies have shown that biofeedback may be a viable therapy to help support the development of attention in adults and children. There is also evidence that ADHD may have roots in adverse childhood experiences. While it's not the root cause for everyone, addressing trauma with a licensed therapist may be a step in your healing process. Speak with your or your child's healthcare provider about different approaches and treatment options. 

It's important to note that several medical conditions can be mistaken for ADHD, for example, anemia (low iron levels), hypothyroidism (low thyroid function), or prolonged sleep disturbances. You and your healthcare provider must rule these out first to make a definitive diagnosis of ADHD. For example, studies show that sleep disturbances may increase a child's odds of developing ADHD over time. Your healthcare provider can help you discuss sleep hygiene and rule out or address any potential sleep disorders (ex., sleep apnea, restless leg syndrome) in yourself or your child before starting the process of an ADHD diagnosis. Other conditions that need to be ruled out before making a precise ADHD diagnosis include anxiety, depression, learning disorders (ex., dyslexia), and vision or hearing problems. Work with your or your child's healthcare provider to help figure out the root cause of your or your child's issue.

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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Food and Drug Administration. Focalin label

Drechsler R, Brem S, Brandeis D, Grünblatt E, Berger G, Walitza S. ADHD: current concepts and treatments in children and adolescents. Neuropediatrics. 2020;51(5):315-335. doi:10.1055/s-0040-1701658

Centers for Disease Control. Data and statistics about ADHD.

Wang T, Liu K, Li Z, et al. Prevalence of attention deficit/hyperactivity disorder among children and adolescents in China: a systematic review and meta-analysis. BMC Psychiatry 17. 2017;32.

Song P, Zha M, Yang Q, Zhang Y, Li X, Rudan I. The prevalence of adult attention-deficit hyperactivity disorder: a global systematic review and meta-analysis. J Glob Health. 2021;11:04009. doi:10.7189/jogh.11.04009

Food and Drug Administration. Focalin XR label

Tinello D, Kliegel M, Zuber S. Does heart rate variability biofeedback enhance executive functions across the lifespan? A systematic review. J Cogn Enhanc. 2022;6(1):126-142.

Brown NM, Brown SN, Briggs RD, Germán M, Belamarich PF, Oyeku SO. Associations between adverse childhood experiences and adhd diagnosis and severity. Acad Pediatr. 2017;17(4):349-355.

Carpena MX, Matijasevich A, Loret de Mola C, Santos IS, Munhoz TN, Tovo-Rodrigues L. The effects of persistent sleep disturbances during early childhood over adolescent ADHD, and the mediating effect of attention-related executive functions: data from the 2004 Pelotas Birth Cohort. J Affect Disord. 2022;296:175-182.

Waxmonsky JG, Pelham WE 3rd, Baweja R, Hale D, Pelham WE Jr. Predictors of changes in height, weight, and body mass index after initiation of central nervous system stimulants in children with Attention Deficit Hyperactivity Disorder. J Pediatr. 2022;241:115-125.e2. doi:10.1016/j.jpeds.2021.09.030

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