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.

Boxed warning: Risk of misuse and addiction

Azstarys has a boxed warning about risk of misuse and addiction. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section.

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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 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 that follows 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 serious heart problems, see the “Side effect specifics” section later in this article.

Azstarys has a boxed warning for risk of misuse and addiction. This is the most serious warning from the FDA. To learn more, see the “Side effect specifics” section.

Allergic reaction 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.

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 and addiction, similar to other CNS stimulants. 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.

However, the specific ingredients in Azstarys, Vyvanse, and Adderall are different. And because of these differences, the risk of misuse and addiction 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.

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.

Do the side effects of Azstarys go away?

It depends on the side effect.

Some mild side effects of Azstarys, such as nausea or vomiting, usually go away within a few days to weeks.

However, Azstarys can also cause more serious side effects, such as increased heart rate or blood pressure. These effects typically go away if the medication is stopped. However, people with existing heart conditions may have a higher risk of complications. Serious heart problems are rare but should be taken seriously.

If you have side effects that don’t go away or that bother you, talk with your doctor. They may recommend ways to help manage your symptoms or adjust your medication.

If you experience symptoms of a serious side effect, such as chest pain, fainting, or severe allergic reaction, seek emergency medical help right away. Your doctor can tell you more about what symptoms to watch out for 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 addiction

Azstarys has a boxed warning about the risk of misuse and addiction. 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:

Misusing Azstarys can increase the risk of addiction. Addiction is a condition in which someone continues using a drug even when it causes harm. While addiction is more likely with misuse, some people may develop a substance use disorder even when taking the drug as prescribed, especially if they have a history of addiction.

Long-term use of Azstarys can also lead to drug dependence. With drug dependence, your body gets used to a medication and needs it to feel as usual. If you suddenly stop taking a drug that your body is dependent on, you may experience withdrawal symptoms such as fatigue, depression, or difficulty sleeping. Dependence is more likely if Azstarys is taken at high doses or for a long time.

What you can do

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

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

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.

Glaucoma: Azstarys can increase pressure inside the eye, which may worsen glaucoma. Because of this, your doctor will likely not prescribe Azstarys if you have glaucoma, especially narrow-angle glaucoma. If you have glaucoma or high eye pressure, tell your doctor before starting Azstarys. They can determine whether this medication is safe for you or if another treatment option would be better.

Tourette syndrome or motor or verbal tics: Azstarys may cause new tics or worsen existing tics and Tourette syndrome. If you have a history of tics or Tourette syndrome, tell your doctor before starting this medication. Your doctor may monitor you more closely for new or worsening tics while you’re taking Azstarys. If tics become severe or bothersome, they may adjust your treatment plan or recommend stopping the medication.

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

If you become pregnant while taking Azstarys, consider asking your doctor about joining the National Pregnancy Registry for ADHD 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.

Help is out there

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

  • Call or text the 988 Lifeline at 988 or chat at 988lifeline.org. Caring counselors are available to listen and provide free and confidential support 24/7.
  • Text HOME to the Crisis Text Line at 741741 to connect with a volunteer crisis counselor for free and confidential support 24/7.
  • Not in the United States? Find a helpline in your country with Befrienders Worldwide.
  • Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you’re not in the same household, stay on the phone with them until help arrives.

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.