Patient Education: Dexmethylphenidate (Focalin, Focalin XR)
Your healthcare provider has prescribed dexmethylphenidate for your child based on current evidence-based guidelines to best address their mental health condition. While this medication is effective, it is important to understand that it may come with potential side effects. As a patient or caregiver, being informed about these risks and benefits is crucial. Additionally, knowing how to monitor for side effects and understanding strategies to reduce or manage them is essential. This guide aims to provide you with this knowledge, ensuring you are well-informed and confident in managing your child’s treatment.
This document covers all formulations of dexmethylphenidate, which are available under various brand names including, Focalin & Focalin XR. These brands represent different release formulations of dexmethylphenidate, affecting how long they last and how the medication is released. For example, Focalin XR is 50% immediate release and 50% extended release over 12 hours, while Focalin is 100% immediate release. Your provider has chosen a specific brand based on your child’s unique needs and how their symptoms need to be managed throughout the day. |
What is Dexmethylphenidate?
Dexmethylphenidate belongs to a group of medicines known as stimulants. Stimulants help improve ADHD symptoms by increasing the levels of certain chemicals in the brain, called dopamine and norepinephrine, which help with focus and attention.
When is Dexmethylphenidate prescribed to Children & Adolescents?
Your doctor may prescribe dexmethylphenidate for
- ADHD combined
- ADHD predominantly inattentive type
What is the Dose of Dexmethylphenidate?
To find the right dose for your child, we start with a low dose and gradually increase it. Initial doses typically begin at around 0.15 to 0.3 mg/kg per day. We adjust the dose until there is a significant improvement in ADHD symptoms or until side effects prevent further increases. The maximum recommended daily dose for dexmethylphenidate is around 1 mg/kg per day. The FDA has also set specific maximum daily doses for each formulation of dexmethylphenidate.
What can be the possible
side-effects from the medication?
Evidence shows that dexmethylphenidate is quite safe when prescribed to healthy children and used under medical supervision. Most of the side effects from dexmethylphenidate are easily manageable.
Common Side-Effects:
Loss of Appetite & Weight Loss
Some kids may lose their appetite and weight when starting dexmethylphenidate. This usually gets better after 4-6 months. Some studies suggest that long-term use might slightly reduce expected height (up to 0.5 inches), but many studies show no significant long-term effects on expected height.
How to Manage this side effect?
- Monitor Growth: Your provider will check your child’s growth at each visit. Measure your child’s height and weight before each visit and enter the information into the MindWeal app. You will receive reminders to do this. For in-person visits, the provider will take the measurements.
- Timing of Meals: Appetite loss usually happens when the medication starts working. Give the morning dose with or after breakfast, and make sure breakfast is high in calories and protein. As the medication wears off in the afternoon, your child might get hungry later than usual. Be flexible with dinner time and offer healthy, calorie-dense snacks in the evening.
- Drug Holidays: If your child is growing normally, no changes are needed even if they lose their appetite. If growth slows down, we may suggest "drug holidays" (taking breaks from the medication) or reducing the dose on weekends, vacations, and school breaks.
- Appetite-Stimulating Medications: If none of the above measures help, appetite-stimulating medications like Mirtazapine, Periactin, or Quetiapine can be used.
Insomnia
Many kids with ADHD have trouble sleeping, even if they're not taking any medication for it. They might be too energetic and restless at night to go to bed. Additionally, they may be restless while sleeping, which can cause them to wake up in the middle of the night.
How to Manage This Side Effect
- Follow Sleep Hygiene Practices: Encourage your child to follow sleep hygiene practices to improve sleep. Click here to learn more about how to create a sleep hygiene schedule for your child.
- Timing of Medication: Ensure your child takes their medication in a way that it wears off by bedtime. Learn about your child’s dexmethylphenidate formulation and its duration of action. Make sure they take it as prescribed and not too late in the day.
- Rebound ADHD Symptoms: Most dexmethylphenidate formulations work for 4-12 hours. When the medicine wears off in the evening, your child might become more hyper, fidgety, and sometimes irritable. This is called rebound ADHD symptoms, which can cause trouble sleeping, not the medicine itself. If you notice this pattern, inform your provider. To help with these rebound symptoms, they might prescribe another medicine called an alpha agonist (like Clonidine or Guanfacine) or a small dose of a stimulant in the late afternoon and Clonidine at bedtime.
- Sensitivity to Dexmethylphenidate: If your child is very sensitive to dexmethylphenidate, or if they process this medicine slowly, they might still have trouble sleeping even when the medication is taken as prescribed. Inform your provider in this case. They may adjust the type, amount, or timing of the medicine.
- Additional Medications: If none of the above measures help, your provider might add a small dose of another medicine, like melatonin, Clonidine, mirtazapine (Remeron), or Trazodone, to help your child sleep better.
Nausea, stomach aches, stomach upset
Dexmethylphenidate can sometimes cause nausea and vomiting, especially if taken on an empty stomach.
How to Manage this side effect:
- Take with Food:
- Take the medication in the morning after breakfast.
- If the medication is taken in the afternoon, take it with a snack.
- If Nausea Persists:
- Take the medication 30 to 45 minutes after eating breakfast.
- Avoid milk and dairy products during the meal.
- Increase the portion of solid food in the meal.
- Add a banana to the meal.
- If Symptoms Continue:
- Consult your medical doctor to rule out other causes of nausea and vomiting.
- If no other medical causes are found, Pepcid (Famotidine) may help if approved by your pediatrician. Consult your pediatrician for the correct dose.
- Schedule a visit with us to discuss further treatment options.
Headaches
Headaches experienced later in the day may result from not drinking enough water or not eating enough food.
How to Manage This Side-Effect:
- Encourage your child to drink plenty of fluids throughout the day and eat regular meals, including a good breakfast.
- Contact your provider if headaches occur soon after taking the medication, as it may require changing the form (e.g., liquid or tablet) or the type of stimulant.
Blunting
Some children prescribed dexmethylphenidate may become unnaturally quiet and overly focused, sometimes called the “zombie” effect. Parents notice their child seems very different, and children might say they feel sad or can't have fun. This usually means the dose of dexmethylphenidate is too high for them.
How to manage this side-effect?
Contact your provider. They may reduce the dose of the medication or switch to another formulation that is longer-acting, releases slowly, and has a lower peak concentration compared to the current formulation.
Dry Mouth
Dexmethylphenidate can sometimes cause dry mouth. This can make your child feel uncomfortable.
How to Manage This Side Effect:
- Stay Hydrated: Encourage your child to drink plenty of water throughout the day to keep their mouth moist.
- Chew Sugar-Free Gum or Suck on Sugar-Free Lozenges: These can help stimulate saliva production and keep the mouth from feeling too dry.
- Oral Hygiene: Ensure your child practices good oral hygiene, including brushing their teeth regularly and using mouthwash, to prevent any dental issues that can arise from dry mouth.
- Avoid Caffeine and Sugary Drinks: These can make dry mouth worse. Stick to water and other hydrating beverages.
- Contact Your Provider: If dry mouth is severe or persistent, contact your provider. They may suggest adjusting the dose or trying a different medication to alleviate this side effect.
Irritability of Moodiness:
Afternoon & Evening Irritability: If your child becomes irritable in the afternoons and/or evenings while taking this medication, it is likely due to rebound ADHD symptoms, not a side effect of the medication. Rebound symptoms can make a child more hyperactive, fidgety, and irritable after 3-4 PM. Sometimes, children also become irritable by the end of the day because they haven’t had enough fluids or calories.
How to Manage This Side Effect?
- Contact Your Provider: They may recommend adding a short-acting stimulant or an alpha agonist (like guanfacine or clonidine) in the afternoon to help with these symptoms.
- Ensure Proper Hydration and Nutrition: Encourage your child to eat a good breakfast and stay well-hydrated throughout the day.
Morning Irritability: If irritability occurs within a few hours of taking the medication, it might be a side effect of the medication.
How to Manage This Side Effect?
- Contact Your Provider. They may suggest lowering the dose, switching to another formulation, or combining this medication with alpha agonists (like clonidine or guanfacine) to reduce irritability.
Tics
People used to think stimulant medicines could make tics worse, which led to warnings about their use in kids with ADHD and tics or a family history of tics. However, research shows this isn't usually true. High doses of dextroamphetamine might make tics worse, but dexmethylphenidate and other stimulants usually do not.
It's important to know that tics might happen naturally in kids with ADHD. About 20% of kids with ADHD develop tic disorders, and about 50% of kids with chronic tics or Tourette syndrome also have ADHD. Often, ADHD starts one to two years before tics, so a child might be treated for ADHD and then develop tics as part of a tic disorder, not because of the stimulants. Since tics naturally come and go, new or worsening tics in kids taking stimulants might just be a coincidence, not caused by the medicine.
How to Manage This Side Effect?
- If your child has both ADHD and a tic disorder, we may suggest starting with an alpha agonist (like guanfacine or clonidine) because these medicines can help with both ADHD and tics.
- If tics develop while taking dexmethylphenidate, we may add an alpha agonist (like guanfacine or clonidine). This can help in two ways: it can treat tics and also allow a lower dose of dexmethylphenidate by helping with impulsivity and hyperactivity.
Skin picking
Some patients may experience increased skin picking, hair pulling, and nail biting behaviors while taking dexmethylphenidate.
How to manage this side-effect?
Contact your provider. Lowering the dose, switching to another formulation, or combining dexmethylphenidate with alpha agonists (like clonidine or guanfacine) may be required.
Anxiety
Patients with comorbid anxiety disorder may experience a worsening of anxiety symptoms with dexmethylphenidate.
How to manage this side-effect?
- Ensure Proper Hydration and Nutrition: Encourage your child to drink plenty of fluids throughout the day and eat regular meals, including a good breakfast.
- Avoid Caffeine: Stay away from caffeine in coffee, tea, and soda.
- Get Enough Sleep: Make sure your child is getting sufficient rest.
- Contact Your Provider: If these steps do not help, your provider may suggest lowering the dose or switching to another formulation.
Hyperhidrosis (Excessive Sweating)
Dexmethylphenidate can sometimes cause hyperhidrosis, which is excessive sweating. This can be uncomfortable and may affect daily activities.
How to Manage This Side Effect?
- Stay Cool: Encourage your child to wear lightweight, breathable clothing and stay in cool environments.
- Hygiene: Ensure your child practices good hygiene, including regular showers and using antiperspirants.
- Contact Your Provider: If the sweating is severe or bothersome, contact your provider. They may suggest adjusting the dose or trying a different medication.
Increase in Heart Rate
Sometimes, starting dexmethylphenidate or increasing the dose can cause a temporary increase in heart rate. Your child might report it as a "racing heartbeat." This usually improves within a few weeks.
How to Manage This Side Effect:
- Monitor Heart Rate: Heart rate (HR) checks are required before starting the medication, periodically on a stable dose, and with each dose adjustment. Measure your child’s HR before each visit and enter the information into the MindWeal app. You will receive reminders to do this. For in-person visits, the provider will take the measurements.
- Ensure Proper Hydration and Nutrition: Encourage your child to drink plenty of fluids throughout the day and eat regular meals, including a good breakfast.
- Avoid Caffeine: Make sure your child avoids caffeine, which can be found in some sodas, teas, and other beverages.
- Contact Your Provider: If the above measures don't help, your provider may recommend lowering the dose or changing the type of stimulant.
If your child reports a racing heartbeat that is excessive and persistent and seems irregular, contact your provider immediately to rule out heart rhythm disturbances. If it is after hours, call 911 or go to urgent care, as immediate intervention might be required. |
Increase in Blood Pressure
Dexmethylphenidate may increase blood pressure, particularly in older patients.
How to Manage This Side Effect?
- Monitor Blood Pressure: Blood pressure (BP) checks are required before starting the medication, periodically on a stable dose, and with each dose adjustment. Measure your child’s BP before each visit and enter the information into the MindWeal app. You will receive reminders to do this. For in-person visits, the provider will take the measurements.
Misuse & Diversion
A common myth is that stimulants may increase the risk of later substance use problems. However, research shows that treating ADHD with medication can actually reduce the risk of future substance abuse. When ADHD symptoms are well-managed, children and adolescents are less likely to turn to drugs or alcohol to cope with their challenges. They are also more likely to make thoughtful and less impulsive decisions, further reducing the risk of substance use. Effective management of ADHD symptoms with medication helps children succeed in school, build better relationships, and develop healthy habits, all of which decrease the likelihood of substance abuse later in life. |
Having said that, dexmethylphenidate is classified as Schedule II-controlled substances and has the potential to be misused or diverted, particularly among high school and college students, especially those who are also using other substances. Misuse includes taking medication in larger amounts, more often, or in a different way than prescribed. Diversion involves giving, trading, or selling prescribed medication to others.
How to Manage This Risk?
- Following Strict Guidelines: We follow strict guidelines, including an initial negative urine drug screen (UDS) for children ages 14 and older before starting stimulant medication, and an annual negative UDS for patients ages 14 and older on stimulant medications.
Parental Involvement: Parents should stay actively involved in their child's treatment. This includes carefully monitoring the medication, storing it securely, attending all visits with the child's provider, and reporting any suspicious changes in behavior.
Serious but Rare Side-Effects
Heart Rhythm Disturbances
Dexmethylphenidate can sometimes cause heart rhythm disturbances, which can feel like a racing, irregular, or skipped heartbeat. This side effect is rare and usually happens in patients who are more likely to have it due to their genes.
How to Minimize the Risk of This Side Effect:
- If your child has a history of heart rhythm disturbances, we will recommend non-stimulant medications as the first treatment option for ADHD. If non-stimulant medications are not effective, stimulants will only be considered after getting approval from a cardiologist.
- If there is a family history of heart rhythm disturbances or sudden unexplained cardiac deaths, we will require a normal EKG before starting the medication.
If your child experiences any irregular or skipped heartbeats, or persistent racing heartbeats, contact your provider immediately. If it is after hours, call 911 or go to urgent care, as immediate intervention might be required. |
Psychosis
In patients with a genetic predisposition or history of psychosis, dexmethylphenidate can potentially worsen symptoms depending on the dosage. We do not prescribe this medication to patients with a history of psychosis.
How to Manage This Side Effect?
- Unusual Behavior: If your child starts talking to themselves or acting strangely, contact your provider right away to check for psychosis. If it is an emergency, go to urgent care or call 911.
- Hearing Voices or Seeing Things: If your child says they hear voices or see things but you don't notice any other changes, call your provider to schedule an early appointment. This could be a side effect of the medication or a sign of anxiety, and only your child’s provider can tell for sure. Do not ignore this symptom.
Lowering of Seizure threshold
In patients with a seizure disorder, Dexmethylphenidate may potentially lower the seizure threshold, although current data are contradictory.
How to Manage This Risk?
- Neurologist Approval: If your child has an active seizure disorder, approval from their neurologist is required before starting stimulant medication.
Close Collaboration: We will maintain ongoing communication with your child’s neurologist throughout the treatment process to reduce the risk of this side effect.
To learn more about this medication please visit MedlinePlus, a official US government website, part of National Library of Medicine and managed by National Institute of Health by clicking HERE