Cotempla XR
Cotempla XR ODT (methylphenidate ER) is a stimulant medication. It's approved for children ages 6 to 17 years old with ADHD (attention deficit-hyperactivity disorder). Cotempla XR ODT (methylphenidate ER) comes as an orally disintegrating tablet (ODT) that's dissolved on the tongue once per day in the morning. Side effects include low appetite and trouble sleeping.
What is Cotempla XR ODT (methylphenidate ER)?
What is Cotempla XR ODT (methylphenidate ER) used for?
ADHD (attention deficit-hyperactivity disorder) in children ages 6 to 17 years
How Cotempla XR ODT (methylphenidate ER) works
Cotempla XR ODT (methylphenidate ER) is a stimulant medication. It's not exactly known how the medication helps to improve attention and focus. But it's thought to workby raising the levels of chemicals in your brain called norepinephrine, dopamine, and serotonin.
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What are the risks and warnings for Cotempla XR ODT (methylphenidate ER)?
Cotempla XR ODT (methylphenidate ER) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk for misuse and addiction
Risk factors: History of substance or alcohol use disorder | Taking more Cotempla XR ODT (methylphenidate ER) than prescribed
Cotempla XR ODT (methylphenidate ER) has a risk for misuse and addiction. Misuse is when a medication is used differently than how it's prescribed. Misusing Cotempla XR ODT (methylphenidate ER) can raise the risk for serious side effects such as fast heart rate, high blood pressure, aggressive behavior, and even thoughts of hurting yourself. In addition, misusing Cotempla XR ODT (methylphenidate ER) can sometimes lead to addiction. Your child should take this medication exactly as prescribed to them. Speak with your child's prescriber if you're concerned about this risk.
Because of the risk for misuse and addiction, store Cotempla XR ODT (methylphenidate ER) in a safe place out of reach from children, pets, and visitors. Don't give the medication to anyone else. If your child no longer needs Cotempla XR ODT (methylphenidate ER), safely get rid of the medication through a take-back program.
Risk for dependence and withdrawal
Risk factors: Suddenly stopping Cotempla XR ODT (methylphenidate ER)
Taking Cotempla XR ODT (methylphenidate ER) for a long period of time can put people at risk for dependence. This means that over time, people can become physically dependent on the medication to function normally. Physical dependence is usually related to having withdrawal symptoms, like irritability, nightmares, and sleep problems, if people take the medication for a long time and then suddenly stop or suddenly lower the dose. Make sure your child takes Cotempla XR ODT (methylphenidate ER) exactly as prescribed. Don't change the dose or how often they take it without talking to the prescriber first.
Risks for people with serious heart problems
Risk factors: History of heart problems
There have been reports of sudden death and heart attack in people with a heart condition who took stimulant medications like Cotempla XR ODT (methylphenidate ER) at usual doses. This medication can also raise blood pressure and heart rate.
Tell your child's prescriber if your child has a history of heart problems before treatment starts to make sure Cotempla XR ODT (methylphenidate ER) is safe to take. Your child's prescriber will check for heart problems before starting treatment. Your child might not be able to take Cotempla XR ODT (methylphenidate ER) if they have serious heart problems.
Let your child's prescriber or primary care provider know if your child experiences unexplained fainting, chest pain with physical activity, or irregular heartbeat during treatment with Cotempla XR ODT (methylphenidate ER). The care team can check your child's heart to make sure everything is okay.
Aggressive behavior and psychosis
Risk factors: History of psychotic episodes, bipolar disorder, or other mental health or mood-related conditions
Some people who've taken a stimulant like Cotempla XR ODT (methylphenidate ER) can have mental health problems, such as hallucinations (seeing things that aren't really there), aggressive behavior, unclear thinking, and mania. This medication can worsen mood-related problems that your child already has, but these changes in behavior can also happen even if they haven't had these problems before. Talk to your child's prescriber right away if your child develops these mood or behavior changes during treatment with Cotempla XR ODT (methylphenidate ER). Your child might have to stop the medication.
Slowed growth in children
In studies, stimulants like Cotempla XR ODT (methylphenidate ER) slowed the growth rate (both in height and weight) and caused weight loss in children. Let your child's pediatrician or primary care provider know that your child is taking Cotempla XR ODT (methylphenidate ER). They'll need to check your child's growth progress closely. Your child might need to briefly stop or completely stop taking Cotempla XR ODT (methylphenidate ER) if there's a possibility of any slowed growth that's happened. Talk to your child's primary care provider if you have any concerns.
Blood circulation problems (such as Raynaud's phenomenon)
Cotempla XR ODT (methylphenidate ER) might be linked to poor blood circulation problems, such as Raynaud's phenomenon. People with Raynaud's phenomenon can have episodes of poor blood flow in the fingers and toes, which can cause the skin to turn pale and to feel cold, numb, or painful. Symptoms are usually mild. But in some rare and more serious cases, it can cause sores or ulcers. Let your child's prescriber know if your child complains about instances of numbness or pain in the fingers or toes. Your child's prescriber might need to lower the Cotempla XR ODT (methylphenidate ER) dose or consider a different medication.
Risk for high pressure in the eye and for glaucoma
Risk factors: Open-angle glaucoma | High pressure in the eye
Although rare, some people who took methylphenidate medications like Cotempla XR ODT (methylphenidate ER) reported developing higher pressure in the eyes, which can lead to glaucoma. Make sure your child visits their optometrist for regular eye exams. Speak with the optometrist if your child reports any changes in vision during treatment.
Drug interactions
Cotempla XR ODT (methylphenidate ER) can interact with many medications. For example, Cotempla XR ODT (methylphenidate ER) can counteract (work against) the effects of many blood pressure medications. This means that blood pressure medications might not work as well if they're taken with Cotempla XR ODT (methylphenidate ER). Additionally, taking Cotempla XR ODT (methylphenidate ER) with monoamine oxidase inhibitors (MAOIs) can raise the risk of having severely high blood pressure, so it's best to avoid this combination.
Discuss with your child's care team about all the medications they take (including over-the-counter medications and supplements) before and during treatment with Cotempla XR ODT (methylphenidate ER).
What are the side effects of Cotempla XR ODT (methylphenidate ER)?
Common Side Effects
- Low appetite
- Stomach pain
- Nausea
- Indigestion
- Trouble sleeping
- Nervousness
- Restlessness
- Easily irritable
- Dizziness
- Blurry vision
- Higher blood pressure
- Fast heart rate
- Sweating
- Fever
Other Side Effects
- Muscle pain
- Joint pain
- Chest pain or discomfort
- Double vision
- Other changes in vision
Serious Side Effects
- Allergic reaction: hives, rash, blisters, skin reddening, swelling of the lips or tongue, difficulty breathing
- Heart problem: heart attack, high blood pressure, fast heart rate
- Mental health problems: manic episodes, delusional thinking, hallucinations
- Prolonged and painful erection (erection lasting longer than 4 hours)
- Serotonin syndrome (when taken with certain medications): fast heart rate, sweating, muscle stiffness or spasms, fever, confusion
- Accidentally take too much medication (overdose): restlessness, quick breathing, fast heartbeat, irritability, aggression, fever
Source: DailyMed
More on Cotempla XR ODT (methylphenidate ER) side effects
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Increase in blood pressure
- Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
- Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
- Prolonged or painful erection
- Raynaud syndrome—cool, numb, or painful fingers or toes that may change color from pale, to blue, to red
- Seizures
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Dry mouth
- Headache
- Loss of appetite with weight loss
- Nausea
- Stomach pain
- Trouble sleeping
Pros and cons of Cotempla XR ODT (methylphenidate ER)
Pros
First-choice treatment for ADHD in children
Available as a grape-flavored tablet that immediately dissolves on the tongue
Starts working within an hour and lasts all day
Cons
A controlled substance that has a warning for misuse and dependence
Dose needs to be adjusted slowly to avoid side effects and withdrawal symptoms
No lower-cost generic available; brand-name medication only
Pharmacist tips for Cotempla XR ODT (methylphenidate ER)
Cotempla XR ODT (methylphenidate ER) is an orally disintegrating tablet. It can easily dissolve when water or moisture touches it. Make sure anyone touching the tablet has dry hands.
Don't remove the Cotempla XR ODT (methylphenidate ER) tablets from the blister pack until your child is ready to take their dose. Also don't push the tablet through the blister pack because it could break.
It's recommended to have your child take Cotempla XR ODT (methylphenidate ER) in the morning. Your child might have trouble sleeping at night if they take the medication later during the day.
How to take Cotempla XR ODT (methylphenidate ER): Place the tablet on the tongue. The saliva on the tongue will make the tablet dissolve. Once dissolved, swallow the medication. You don't need to drink any liquid to take Cotempla XR ODT (methylphenidate ER).
You can take Cotempla XR ODT (methylphenidate ER) with or without food. Once you decide, it's recommended that you consistently take the medication that way.
Make sure to include a variety of nutritious foods in your child's diet and encourage healthy eating habits to help them grow. Keep in mind that stimulants like Cotempla XR ODT (methylphenidate ER) might lower appetite. Speak with your child's prescriber or primary care provider if your child doesn't seem to be as hungry as usual or seems to be losing weight during treatment. Your child's prescriber might lower the dose or stop the medication.
If your child can drive, your child should avoid driving during the first few days after they start taking Cotempla XR ODT (methylphenidate ER) and after any dose changes until they know how the medication affects them. This medication might cause dizziness and blurry vision, which can affect their ability to drive safely.
Cotempla XR ODT (methylphenidate ER) might worsen tics and Tourette syndrome. Talk to a healthcare professional if your child has these problems so they can see whether this medication is right for them.
Your child should take Cotempla XR ODT (methylphenidate ER) exactly as prescribed. Don't change the dose or have them stop taking the medication without talking to the prescriber first. Otherwise, your child might have uncomfortable withdrawal symptoms, such as changes in sleep patterns and irritability.
Accidentally taking too much Cotempla XR ODT (methylphenidate ER) can lead to an overdose. Symptoms of an overdose include restlessness, quick breathing, fast heartbeat, irritability, aggression, and fever. It's important for you and your loved ones to know how to recognize an overdose so it can be treated right away. Call 911 if you think an overdose has happened.
More on Cotempla XR ODT (methylphenidate ER) tips
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Cotempla XR ODT (methylphenidate ER) dosage forms
Typical dosing for Cotempla XR ODT (methylphenidate ER)
The typical starting dose is 17.3 mg dissolved on the tongue once daily in the morning. Your child's prescriber will adjust the dose after a week depending on how well the medication is working. The maximum dose is 51.8 mg once daily.
How much does Cotempla XR ODT (methylphenidate ER) cost?
Cotempla XR ODT (methylphenidate ER) contraindications
Allergy to methylphenidate-containing products
Currently take or have taken a monoamine oxidase inhibitor (MAOI) in the last 14 days
What are alternatives to Cotempla XR ODT (methylphenidate ER)?
ADHD (attention deficit-hyperactivity disorder) in children ages 6 to 17 years
Attention-deficit hyperactivity disorder (ADHD)
Attention-deficit hyperactivity disorder (ADHD) in adults and children age 6 years and older
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References
Best studies we foundCenters for Disease Control and Prevention. (2024). Diagnosis for tic disorders.
MedlinePlus. (2023). Prescription drug misuse.
National Institute of Neurological Disorders and Stroke. (2024). Tourette syndrome.
Neos Therapeutics Brands, LLC. (2021). Cotempla XR-ODT- methylphenidate tablet, orally disintegrating [package insert]. DailyMed.
Shoptaw, S. J., et al. (2009). Treatment for amphetamine withdrawal. The Cochrane Database of Systematic Reviews.
Steingard, R., et al. (2019). New formulations of stimulants: An update for clinicians. Journal of Child and Adolescent Psychopharmacology.
U.S. Food and Drug Administration. (2022). Drug disposal: Drug take back locations.
U.S. Food and Drug Administration. (2024). Some medicines and driving don’t mix.
Verghese, C., et al. (2023). Methylphenidate. StatPearls.
Wolraich, M. L., et al. (2019). Clinical Practice Guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics.
Zukkoor Zorn, S., et al. (2015). The safety of stimulant medication use in cardiovascular and arrhythmia patients. American College of Cardiology.
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