ADHD Medication and Treatment Reviews

Focalin XR

Focalin XR is an extended-release stimulant ADHD medication used to treat symptoms of attention deficit hyperactivity disorder in children and adults. Learn about it uses, side effects, and dosages here.
Generic Name: dexmethylphenidate HCL

By Janice Rodden Medically reviewed by Jasmine Reese, M.D., M.P.H. Reviewed on October 20, 2023
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What is the ADHD Medication Focalin XR?

Focalin XR (Generic Name: dexmethylphenidate HCL) is a once-daily central nervous system stimulant ADHD medication primarily used to treat attention deficit hyperactivity disorder (ADHD or ADD) in children ages 6-12, adolescents, and adults. Focalin XR may improve focus, and decrease impulsivity and hyperactive behavior, hallmark ADHD symptoms. It contains the same active ingredient as medications like Ritalin and Daytrana. According to the FDA, Focalin XR is a federally controlled substance (CII) because it can be abused or lead to dependence. It has not been studied in children under the age of 6.

The American Academy of Pediatrics recommends treatment with behavioral therapy for ADHD before medication for children under the age of 6. For children ages 6 to 11, the AAP says “The primary care clinician should prescribe US Food and Drug Administration–approved medications for ADHD and/or evidence-based parent- and/or teacher-administered behavior therapy as treatment for ADHD, preferably both.” Likewise, the National Institute of Mental Health finds the most successful treatment plans use a combination of ADHD medication, like Focalin XR, and behavior therapies.

Focalin XR can also be used to treat narcolepsy.

How Is Focalin XR Used to Treat ADHD Symptoms?

Before starting or refilling a Focalin XR prescription, read the medication guide included with your pills, as it may be updated with new information.

This guide should not replace a conversation with your doctor, who has a holistic view of your or your child’s medical history, other diagnoses, and other prescriptions. If you have questions, ask your doctor or pharmacist before you begin taking the medication.

What Dosage of Focalin XR Is Used to Treat ADHD Symptoms?

The optimal dosage of Focalin XR varies by patient. For updated information about dosages, interactions, and precautions, see the Focalin XR drug monograph on WebMD.

During treatment, your doctor may periodically ask you to stop taking Focalin XR so that he or she can monitor ADHD symptoms; check vital statistics including blood, heart, and blood pressure; or evaluate height and weight. If any problems are found, your doctor may recommend discontinuing treatment.

As with all medications, follow your Focalin XR prescription instructions exactly. Focalin XR is taken orally, with or without food, once daily. The medication is typically taken first thing in the morning; it should be taken at the same time each day for the best results.

Capsules should be swallowed whole with water or other liquids. If your child is unable to swallow the capsule, it can be opened and sprinkled over a spoonful of applesauce. Taken this way, the mixture should be swallowed whole without chewing, followed by a drink of water or other liquid. Capsules should never be crushed or chewed. The time-release formulation is designed to maintain a steady level of medication in your body throughout the day.

Some patients report developing a tolerance to Focalin XR after long-term use. If you notice that your dosage is no longer controlling your symptoms, talk to your doctor to plan a course of action.

Focalin XR Side Effects

Side effects of Focalin XR may include:

  • stomach ache
  • headache
  • nausea
  • decreased appetite
  • sleep disturbances
  • anxiety
  • dry mouth
  • dizziness
  • serious allergic reaction
  • seizures
  • eyesight changes or blurred vision
  • priapism

There has been some concern that stimulants may cause a slowing of growth in children and adolescents, however research findings are mixed. Some studies show no impact on growth at all,1 while others find what is considered “negligible” slowing of growth.2 If you find evidence of suppressed growth in your child, talk to your doctor about what steps might help.

Taking Focalin XR may impair your or your teenager’s ability to drive, operate machinery, or perform other potentially dangerous tasks. This side effect usually wears off with time. If side effects are bothersome, or do not go away, talk to your doctor. Most people taking this medication do not experience any of these side effects.

Report to your doctor any heart-related problems or a family history of heart and blood pressure problems before beginning any new prescription. Patients with structural cardiac abnormalities and other serious heart problems have experienced sudden death, stroke, heart attack, and increased blood pressure while taking Focalin XR. Stimulants can increase blood pressure and heart rate. Physicians should monitor these vital signs closely during treatment. Call your doctor immediately if you or your child experiences warning signs such as chest pain, shortness of breath, or fainting while taking Focalin XR.

Also disclose to your physician all mental health issues including any family history of suicide, bipolar illness, tics, or depression. Focalin XR may create new or exacerbate existing behavior problems, bipolar illness, or Tourette’s syndrome. It can cause psychotic or manic symptoms in children and teenagers. Call your doctor immediately if you or your child experiences new or worsening mental health symptoms including hallucinations or sudden suspicions.

Discuss circulation problems with your doctor before taking Focalin XR, which has been known to cause numbness, coolness, or pain in fingers or toes, including Raynaud’s phenomenon. Report to your doctor any new blood-flow problems, pain, skin color changes, or sensitivities to temperature while taking Focalin XR.

Stimulants like Focalin XR have a high potential for abuse and self-medication, especially among people who do not have ADHD. It is a “Schedule II” stimulant, a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse. Other Schedule II drugs include Dexedrine, Ritalin, and cocaine. People with a history of drug abuse should use caution when trying this medication. Taking the medication exactly as prescribed can reduce potential for abuse.

The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.

What Precautions Are Associated with Focalin XR?

Store Focalin XR in a secure place out of reach of children, and at room temperature. Do not share your Focalin XR prescription with anyone, even another person with ADHD. Sharing prescription medication is illegal, and can cause harm.

You should not take Focalin XR if you or your child have:

  • glaucoma
  • tics or Tourette’s syndrome
  • a history of drug abuse
  • severe feelings of anxiety, tension, or agitation
  • an allergy to stimulant medications or any other ingredients in Focalin XR
  • taken or plan to take a monoamine oxidase inhibitor (MAOI) within 14 days

If you are thinking of becoming pregnant, discuss the use of Focalin XR with your doctor. Animal studies indicate potential harm to a fetus. It is not known if Focalin XR is passed through breastmilk, so it is recommended that mothers do not nurse while taking it.

What Interactions Are Associated with Focalin XR?

Before taking Focalin XR, discuss all other active prescription medications with your doctor. Focalin XR can have a dangerous, possibly fatal, interaction with antidepressants including MAOIs.

Tell your doctor if you are taking seizure medications, blood thinners, blood pressure medication, antacids, or any medication containing a decongestant.

Share a list of all vitamin or herbal supplements, and prescription and non-prescription medications you take with the pharmacist when you fill your prescription, and let all doctors and physicians know you are taking Focalin XR before having any surgery or laboratory tests. The above is not a complete list of all possible drug interactions.

Focalin XR and Other ADHD Medications: More Information

Sources:

1Pediatrics (2014.) “ADHD, Stimulant Treatment, and Growth: A Longitudinal Study.” https://publications.aap.org/pediatrics/article-abstract/134/4/e935/77034/ADHD-Stimulant-Treatment-and-Growth-A-Longitudinal

2Journal of the American Academy of Child & Adolescent Psychiatry. (2019.) “Trajectories of Growth Associated With Long-Term Stimulant Medication in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder.” https://www.jaacap.org/article/S0890-8567(19)31443-1/fulltexthttp://www.fda.gov/downloads/drugs/drugsafety/ucm088600.pdf

https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/focalinXR_PPI.pdf
https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/focalinXR.pdf
https://www.focalinxr.com