Azstarys (serdexmethylphenidate/dexmethylphenidate) is a brand-name oral capsule prescribed to treat ADHD in adults and certain children. As with other drugs, Azstarys can cause side effects, such as insomnia and decreased appetite.

Azstarys can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Azstarys in clinical trials:

Mild side effects can occur with Azstarys use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Azstarys’s prescribing information.

Mild side effects that have been reported with Azstarys include:

  • decrease in appetite
  • insomnia
  • dizziness
  • abdominal pain
  • irritability
  • decrease in weight
  • indigestion
  • nausea or vomiting
  • anxiety

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Azstarys and want to tell the FDA about it, visit MedWatch.

Azstarys may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to the drug’s prescribing information.

If you develop serious side effects while taking Azstarys, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported and their symptoms include:

* For more information about this side effect, see “Side effect specifics” below.
† Azstarys has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Side effect specifics” section below.
‡ An allergic reaction is possible after using Azstarys. This side effect wasn’t reported during clinical trials of Azstarys. However, there have been reports of allergic reaction in people taking the drug. To learn more, see the “Side effect specifics” section below.

Azstarys is approved to treat attention deficit hyperactivity disorder (ADHD) in children ages 6 years and older. The side effects reported in children taking Azstarys in clinical trials were similar to those in adults.

However, it’s possible that Azstarys can cause growth delays in children. Delayed growth means your child may not gain as much weight or height as they typically would while taking this medication. This side effect was reported in the drug’s clinical trials, but it’s not clear how often it occurred.

If your child’s doctor prescribes Azstarys, they’ll monitor your child’s height and weight during treatment. If there are signs of delayed growth, the doctor may pause or stop Azstarys treatment.

Talk with your doctor if you have concerns about side effects your child may have while taking Azstarys.

Azstarys may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

How do side effects of Azstarys compare with those seen with Vyvanse or Adderall?

The side effects of Azstarys are similar to those of Vyvanse (lisdexamfetamine dimesylate) and Adderall (amphetamine/dextroamphetamine). All three medications are central nervous system (CNS) stimulants that may be prescribed for ADHD. Some of the side effects they have in common include:

  • insomnia
  • weight loss
  • decreased appetite
  • anxiety
  • abdominal pain
  • nausea or vomiting

Another side effect they share is a risk of misuse,* similar to other CNS stimulants. However, the specific ingredients in Azstarys, Vyvanse, and Adderall are different. And because of these differences, the risk of misuse with Azstarys and Vyvanse may be lower than with Adderall.

Talk with your doctor if you’d like more information about how Azstarys compares to other ADHD medications.

* All three medications have a boxed warning for this risk. To learn more, see the prescribing information for Vyvanse and Adderall and the Azstarys “Side effect specifics“ section below.

Can Azstarys cause weight gain?

It’s unlikely, since weight gain was not a reported side effect in the drug’s clinical trials. However, decreased appetite and weight loss may occur while taking Azstarys.

Talk with your doctor if you have questions or concerns about weight changes while taking Azstarys.

Learn more about some of the side effects that Azstarys may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Azstarys.

Risk of misuse and dependence

Azstarys has a boxed warning about the risk of misuse and dependence. A boxed warning is the most serious warning from the FDA. The warning alerts doctors and patients about drug effects that may be dangerous.

Azstarys is in a class of drugs called CNS stimulants. CNS stimulants, including Azstarys, have a high risk of misuse. However, it’s not clear how often or whether this side effect occurred during clinical trials of Azstarys.

With misuse, a medication is taken or used in a way other than how it’s prescribed. This can mean taking it for a different purpose or at higher doses. The misuse of Azstarys can increase your risk of overdose and even death.

Symptoms of overdose can include:

  • confusion
  • high blood pressure
  • increased heart rate
  • tremors
  • anxiety
  • hallucinations (seeing or hearing things that aren’t real)
  • vomiting

In some cases, misuse could lead to dependence. This is when your body gets used to a medication and needs it to feel as usual. Dependence can happen if you take high doses of Azstarys or take the drug for a long time.

In addition, you may experience withdrawal symptoms if you stop taking a drug that your body is dependent on. Signs and symptoms of withdrawal from CNS stimulants, including Azstarys, can include depression, fatigue, and insomnia.

What you can do

Before prescribing Azstarys, your doctor will evaluate your risk of misuse and dependence. They’ll continue to monitor you closely for signs of misuse or dependence during Azstarys treatment.

It’s important to only take Azstarys as your doctor prescribes. Do not share Azstarys with anyone else. If you have any symptoms of overdose while taking Azstarys, tell your doctor right away.

Also, be sure to talk with your doctor first if you’re considering stopping Azstarys treatment. They can advise you on how to safely stop taking the medication.

Serious heart problems

There have been rare reports of heart attack and even sudden death in people taking CNS stimulants. Azstarys is a CNS stimulant. However, this side effect wasn’t reported in the drug’s clinical trials.

Certain factors increase the risk of serious heart problems from Azstarys and other CNS stimulants. These include structural heart anomalies (commonly known as heart defects), severe heart rhythm disorders, or other heart diseases.

Symptoms of a serious heart problem can include:

What you can do

If you have any symptoms of a heart problem, get medical help right away. If your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Before starting Azstarys, tell your doctor if you have heart problems or had them in the past. Your doctor will also check for heart problems by doing a physical exam and asking you a few questions before prescribing Azstarys. Your doctor likely won’t prescribe Azstarys if you have a history of heart problems.

Allergic reaction

As with most drugs, Azstarys can cause an allergic reaction in some people. This side effect wasn’t reported during clinical trials of Azstarys. However, there have been reports of allergic reaction after the drug was approved.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Azstarys. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

There are certain precautions for Azstarys treatment to consider before taking the medication.

Boxed warning: Risk of misuse and dependence

This drug has a boxed warning about risk of misuse and dependence. A boxed warning is the most serious warning from the FDA. For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you take Azstarys. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These include:

Heart problems: Taking Azstarys can increase your risk of serious heart problems, such as heart attack.* If you have a heart condition and take Azstarys, you may have an increased risk. Be sure to tell your doctor if you have heart problems. They may monitor you more closely while taking the drug or recommend a different treatment option for you.

Mood disorders: If you have a mood disorder, such as depression or bipolar disorder, taking Azstarys can worsen your condition. You may also have a higher risk of mood problems if you have a family history of them. Be sure to tell your doctor if you or your family has ever had a mood disorder, including suicidal thoughts or behaviors. Your doctor can decide whether this medication is the right option for you.

Problems with circulation: It’s possible for Azstarys to cause problems with circulation. Before taking Azstarys, tell your doctor if you have any circulation problems, including Raynaud’s disease. Taking Azstarys can worsen your condition. Your doctor may monitor you more closely during treatment or suggest a different treatment option for you.

High blood pressure: Azstarys can cause an increase in blood pressure. If you have high blood pressure, taking Azstarys could further increase it. Tell your doctor if you’ve ever had high blood pressure. Your doctor will likely check your blood pressure before and regularly during treatment with Azstarys.

Pregnancy or breastfeeding: It’s not known whether it’s safe to take Azstarys during pregnancy or while breastfeeding your child. Please talk with your doctor before taking Azstarys if you’re pregnant, planning to become pregnant, or breastfeeding.

If you become pregnant while taking Azstarys, you and your doctor should report your pregnancy to the National Pregnancy Registry for Psychiatric Medications. A pregnancy registry helps gather information on how certain drugs can affect pregnancy. To learn more, call 866-961-2388, visit the registry website, or talk with your doctor.

Allergic reaction: If you’ve ever had an allergic reaction to Azstarys or any of its ingredients, your doctor will likely not prescribe Azstarys. Ask your doctor what other medications may be better options for you.

Alcohol consumption: There aren’t any known interactions between Azstarys and alcohol. However, drinking alcohol can cause some similar side effects as Azstarys. In addition, consuming alcohol while taking Azstarys may increase your risk of certain Azstarys side effects. Examples include nausea, vomiting, and dizziness. Talk with your doctor about whether it’s safe to drink alcohol during treatment with Azstarys.

* This is a serious side effect of Azstarys. For details, see the “Side effect specifics” section above.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects if it’s safe to do so.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Find more links and local resources.

Was this helpful?

Like most medications, Azstarys can cause side effects. Most are mild and usually go away on their own after a few days to weeks. Azstarys can also cause some serious side effects. You should talk with your doctor if you have any side effects that last, are bothersome, or are serious.

If you’d like to learn more about Azstarys, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Azstarys: For details about other aspects of Azstarys, refer to this article.
  • Dosage: For information about the dosage of Azstarys, view this article.
  • A look at ADHD: For details about ADHD, see our ADHD hub.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.