Azstarys
Azstarys (serdexmethylphenidate / dexmethylphenidate) is a combination stimulant medication that's used for attention deficit-hyperactivity disorder (ADHD). It has two ingredients: serdexmethylphenidate (an extended-release stimulant) and dexmethylphenidate (an immediate-release stimulant). This combination of ingredients allows Azstarys (serdexmethylphenidate / dexmethylphenidate) to start working quickly and also last throughout the day. Common side effects of the medication include low appetite, keeping you awake at night, and raised blood pressure and heart rate. Azstarys (serdexmethylphenidate / dexmethylphenidate) can be used for adults and children 6 years and older.
What is Azstarys (serdexmethylphenidate / dexmethylphenidate)?
What is Azstarys (serdexmethylphenidate / dexmethylphenidate) used for?
ADHD in adults and children ages 6 years and older
How Azstarys (serdexmethylphenidate / dexmethylphenidate) works
Azstarys (serdexmethylphenidate / dexmethylphenidate) is a combination of two medications.
Dexmethylphenidate is a stimulant. It's not exactly known how dexmethylphenidate helps to improve attention and focus. But, it's thought to work by raising the levels of chemicals in your brain called norepinephrine and dopamine.
Serdexmethylphenidate is a prodrug of dexmethylphenidate. It gets changed to dexmethylphenidate in the body.
Drug Facts
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What are the risks and warnings for Azstarys (serdexmethylphenidate / dexmethylphenidate)?
Azstarys (serdexmethylphenidate / dexmethylphenidate) 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.
Misuse and dependence
Risk factors: History of substance or alcohol use disorder | Taking more Azstarys (serdexmethylphenidate / dexmethylphenidate) than prescribed
Azstarys (serdexmethylphenidate / dexmethylphenidate) has risks of misuse and dependence. Misuse can lead to addiction. Misusing this medication can also raise your risk for other serious side effects, such as fast heart rate, high blood pressure, anxiety, aggressive behavior, and even thoughts of hurting yourself or others. You can also develop physical dependence to Azstarys (serdexmethylphenidate / dexmethylphenidate) if you take it for a long period of time. This raises your risk for withdrawal symptoms if you stop the medication suddenly. Take Azstarys (serdexmethylphenidate / dexmethylphenidate) exactly as prescribed to you. Don't change the dose or how often you take it without talking to your provider first.
Serious heart-related problems
Risk factors: History of heart problems
There have been reports of sudden death, stroke, and heart attack in people who took stimulant medications like Azstarys (serdexmethylphenidate / dexmethylphenidate) at the recommended doses. The risk might be higher in people with heart problems. Azstarys (serdexmethylphenidate / dexmethylphenidate) can also raise your blood pressure and heart rate. Tell your provider if you have a history of heart problems before starting Azstarys (serdexmethylphenidate / dexmethylphenidate) to make sure it's safe for you. Before you start treatment, your provider will check for heart problems by asking you a few questions and giving you a physical exam. If you experience unexplained fainting, chest pain with physical activity, or irregular heartbeat while taking Azstarys (serdexmethylphenidate / dexmethylphenidate), contact your provider.
Aggressive behavior and psychosis
Risk factors: History of psychotic episodes or other mental health conditions
Some people who've taken a stimulant medication like Azstarys (serdexmethylphenidate / dexmethylphenidate) can have new or worsening mental health problems, such as hallucinations (seeing or hearing things that aren't there), aggressive behavior, unclear thinking, and mania. This can happen even if you haven't had these mood or behavior problems before. If you develop any mental health symptoms while taking Azstarys (serdexmethylphenidate / dexmethylphenidate), talk to your provider right away because you might have to stop taking it.
Prolonged and painful erection
Although rare, some people taking medications similar to Azstarys (serdexmethylphenidate / dexmethylphenidate) have had prolonged and painful erections that sometimes required surgery. These cases happened after taking the medication for some time and sometimes even after stopping the medication. If you develop a prolonged or painful erection that lasts longer than 4 hours, stop taking Azstarys (serdexmethylphenidate / dexmethylphenidate) and get medical attention right away.
Blood circulation problem (Raynaud's phenomenon)
Azstarys (serdexmethylphenidate / dexmethylphenidate) 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 to the fingers and toes, which can cause the skin to turn pale and to feel cold, numb, or painful. If this happens, symptoms are typically mild. But rarely, it can cause sores or ulcers in more serious cases. Let your healthcare provider know if you notice symptoms of circulation problems, such as bouts of numbness or pain in your fingers or toes. Your provider might need to lower your dose of Azstarys (serdexmethylphenidate / dexmethylphenidate) or ask you to consider switching to a different medication.
Slowed growth in children
In studies, children taking Azstarys (serdexmethylphenidate / dexmethylphenidate) had slowed growth (both height and weight). Your child's provider will keep track of your child's growth closely. If they suspect slowed growth, they might pause or stop your child's Azstarys (serdexmethylphenidate / dexmethylphenidate) treatment. Talk to your child's provider if you have concerns about their growth and development.
What are the side effects of Azstarys (serdexmethylphenidate / dexmethylphenidate)?
Common Side Effects
- Nausea
- Stomach pain
- Indigestion
- Vomiting
- Low appetite
- Weight loss
- Difficulty sleeping
- Dizziness
- Anxiety
- Sudden changes in emotions
- High blood pressure
- Fast heart rate
Other Side Effects
- Dry mouth
- Blurry vision
- Muscle pain
- Joint pain
Serious Side Effects
- Heart problems: heart attack, fast heart rate, high blood pressure
- Brain-related problems: seizures, stroke
- Mental health-related problems: manic episodes, changes in thoughts or behavior, hallucinations
Source: DailyMed
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
- 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 Azstarys (serdexmethylphenidate / dexmethylphenidate)
Pros
Taken once per day
Can take with or without food
Can open capsules and sprinkle contents into water or applesauce
Starts to work within 30 minutes and lasts throughout the day
Cons
Has risks of misuse and dependence
Is a controlled medication, so there are special requirements to get the prescription filled
Dose needs to be adjusted slowly to avoid side effects
Available as a brand-name medication only
Pharmacist tips for Azstarys (serdexmethylphenidate / dexmethylphenidate)
Take your first dose of Azstarys (serdexmethylphenidate / dexmethylphenidate) as soon as you wake up. If you take the medication too late in the day, you might have trouble sleeping at night.
Swallow the capsule whole with or without food. If you're having trouble swallowing the capsule, you can open it up and sprinkle the contents into 2 ounces (50 mL) of water or onto 2 tablespoons of applesauce. Be sure you drink or eat all of the mixture within 10 minutes. Don't save any mixture for later use.
Take Azstarys (serdexmethylphenidate / dexmethylphenidate) exactly as prescribed. Don't change your dose or stop taking the medication without talking to your provider first. Doing so can result in bothersome withdrawal symptoms, such as tiredness, trouble sleeping, irritability, and depression.
Avoid alcohol while taking Azstarys (serdexmethylphenidate / dexmethylphenidate). Alcohol can make your ADHD symptoms worse and potentially make your medication not work as well. This combination can also cause dangerous side effects, including heart problems.
Avoid driving the first few days after you start Azstarys (serdexmethylphenidate / dexmethylphenidate) and after dose changes until you know how this medication affects you. Azstarys (serdexmethylphenidate / dexmethylphenidate) might cause dizziness and blurry vision.
Azstarys (serdexmethylphenidate / dexmethylphenidate) can lower your appetite, which can potentially lead to some weight loss. Make sure to follow a healthy and balanced diet. If you notice that you're not eating enough or losing too much weight while taking Azstarys (serdexmethylphenidate / dexmethylphenidate), let a provider know.
Make sure your healthcare provider and pharmacist has an up-to-date list of all the medications you take or plan to take, including over-the-counter products and supplements. Azstarys (serdexmethylphenidate / dexmethylphenidate) can interact with certain medications, so your providers can check that you can take all your medications safely. Some medications (like for blood pressure) might not work well when taken with Azstarys (serdexmethylphenidate / dexmethylphenidate). And you might be at risk of dangerous side effects when you take Azstarys (serdexmethylphenidate / dexmethylphenidate) with others (like with monoamine oxidase inhibitors and the risk of severely high blood pressure).
Frequently asked questions about Azstarys (serdexmethylphenidate / dexmethylphenidate)
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Azstarys (serdexmethylphenidate / dexmethylphenidate) dosage forms
Typical dosing for Azstarys (serdexmethylphenidate / dexmethylphenidate)
The typical starting dose is 39.2 mg/7.8 mg (serdexmethylphenidate / dexmethylphenidate) by mouth once daily in the morning. The maximum daily dose is 52.3 mg/10.4 mg (serdexmethylphenidate / dexmethylphenidate).
Your provider will adjust your dose based on how well the medication is helping your ADHD symptoms and if you're having side effects.
Azstarys (serdexmethylphenidate / dexmethylphenidate) contraindications
Currently taking or have taken an monoamine oxidase inhibitor (MAOI), such as selegiline, phenelzine (Nardil), or tranylcypromine (Parnate), in the last two weeks
Allergy to methylphenidate or dexmethylphenidate
What are alternatives to Azstarys (serdexmethylphenidate / dexmethylphenidate)?
ADHD in adults and children ages 6 years and older
Attention-deficit hyperactivity disorder (ADHD)
Attention-deficit hyperactivity disorder (ADHD) in people 6 years and older
What is the latest news about Azstarys (serdexmethylphenidate / dexmethylphenidate)?
Azstarys (serdexmethylphenidate / dexmethylphenidate) images
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References
Best studies we foundChildress, A.C., et al. (2023). Safety and tolerability of serdexmethylphenidate/dexmethylphenidate capsules in children with attention-deficit/hyperactivity disorder: A 12-month, open-label safety study. Journal of Child and Adolescent Psychopharmacology.
Corium, Inc. (n.d.). Dosing information and how to take AZSTARYS.
Corium, Inc. (2021). U.S. Food and Drug Administration approves novel once-daily capsule Azstarys (serdexmethylphenidate and dexmethylphenidate), first and only product containing dexmethylphenidate prodrug for ADHD in patients age 6 years and older. PR Newswire.
Corium, Inc. (2022). AZSTARYS- serdexmethylphenidate and dexmethylphenidate capsule [package insert]. DailyMed.
Food and Drug Administration. (2021). Some medicines and driving don’t mix.
Mattingly, G.W., et al. (2023). Serdexmethylphenidate/dexmethylphenidate effects on sleep in children with attention-deficit/hyperactivity disorder. Frontiers in Psychiatry.
MedlinePlus. (n.d.). Drug use and addiction.
MGH Center for Women’s Mental Health. (n.d.). The National Pregnancy Registry for ADHD Medications.
Nanda, A., et al. (2023). Adverse effects of stimulant interventions for attention deficit hyperactivity disorder (ADHD): A comprehensive systematic review. Cureus.
National Institute of Mental Health. (2022.). Attention-deficit/hyperactivity disorder.
National Institute on Drug Abuse. (2018). Prescription stimulants DrugFacts.
Ordean, A., et al. (2014). Clinical presentation and management of neonatal abstinence syndrome: An update. Research and Reports in Neonatology.
Robinson, D. M., et al. (2006). Dexmethylphenidate extended release: In attention-deficit hyperactivity disorder. Drugs.
Shram, M. J., et al. (2022). Oral, intranasal, and intravenous abuse potential of serdexmethylphenidate, a novel prodrug of d-methylphenidate. Current Medical Research and Opinion.
Steingard, R., et al. (2019). New formulations of stimulants: An update for clinicians. Journal of Child and Adolescent Psychopharmacology.
Stevens, J.R., et al. (2013). Using stimulants for attention-deficit/hyperactivity disorder: Clinical approaches and challenges. The Primary Care Companion for CNS Disorders.
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