Azstarys (dexmethylphenidate/serdexmethylphenidate) is a prescription drug used to treat attention deficit hyperactivity disorder (ADHD). Azstarys can cause side effects that range from mild to serious. Examples include decreased appetite, nausea, and trouble sleeping.

Specifically, Azstarys is used to treat ADHD in adults and children ages 6 years and older.

The active ingredients in Azstarys are dexmethylphenidate and serdexmethylphenidate. (Active ingredients are what make a drug work.) Azstarys comes as an oral capsule.

Keep reading to learn about the common, mild, and serious side effects Azstarys can cause. For a general overview of the drug, including details about its uses, see this article.

Some people may experience mild to serious side effects during Azstarys treatment. Here are a few examples of the drug’s commonly reported side effects:

* To learn more about this side effect, see the “Side effects explained” section below.

Mild side effects have been reported with Azstarys. These include:

* To learn more about this side effect, see the “Side effects explained” section below.
† An allergic reaction is possible after taking Azstarys. This side effect was only reported after the FDA approved Azstarys for public use.

These side effects are usually temporary. And some can be managed by:

  • taking Azstarys in the morning after breakfast
  • adjusting your diet
  • taking over-the-counter medications
  • using home remedies

If you have ongoing or bothersome symptoms, talk with your doctor or pharmacist. But do not stop taking Azstarys unless your doctor recommends it.

Azstarys may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

Serious side effects have been reported with Azstarys. These include:

* With misuse, a person takes a drug in a way or for a reason other than how or why it was prescribed. Misuse can lead to addiction, in which a drug is taken even if it’s causing harmful effects. To learn more about this side effect, see the “Azstarys and misuse” section below.
To learn more about this side effect, see the “Side effects explained” section below.
‡An allergic reaction is possible after taking Azstarys. This side effect was only reported after the FDA approved Azstarys for public use.

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.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Azstarys, visit MedWatch.

Azstarys is used to help treat ADHD in children ages 6 years and older. Children taking this medication typically have the same side effects as adults.

One exception seen in the drug’s studies was slowed growth occurring in children. Slowed growth may result in lower weight and shorter height than average measurements for their age.

For more information about potential side effects of Azstarys in children, talk with your doctor or pharmacist.

Get answers to some frequently asked questions about side effects of Azstarys.

Are side effects of Azstarys similar to those of Vyvanse or Adderall XR?

Azstarys, Adderall XR, and Vyvanse are medications prescribed for the treatment of ADHD. They all belong to a group of drugs known as central nervous system stimulants.

Because they are from the same class, they have similar side effects, such as:

  • loss of appetite
  • nausea and vomiting
  • weight loss
  • anxiety
  • nervousness
  • insomnia

Azstarys and Vyvanse may have a slightly lower risk of misuse compared with Adderall. This is because Azstarys and Vyvanse are prodrugs, meaning the body must convert them to active medication before they can work. When the body has to process a prodrug, it cannot be taken or used by inappropriate methods (such as snorting or injecting) in order to achieve a quicker effect.

How long do side effects of Azstarys usually last?

In many cases, side effects caused by Azstarys should be temporary. And mild side effects often go away on their own or can be easily treated. Once Azstarys is stopped, it takes your body 2–3 days to completely rid itself of the drug, so side effects should resolve within a few days after stopping. If you have any bothersome or ongoing side effects, talk with your doctor or pharmacist.

Can Azstarys cause weight gain?

Weight gain was not a side effect reported in studies of Azstarys, but weight loss was common.

If you have concerns about your weight and taking Azstarys, check with your doctor or pharmacist for more information.

Learn more about some of the side effects Azstarys may cause.

Decreased appetite

Decreased appetite was a common side effect reported in studies of Azstarys. Decreased appetite may cause symptoms such as:

  • fatigue (low energy) and weakness
  • dizziness
  • irritability
  • headache
  • weight loss

Factors that can increase the risk of decreased appetite when taking this drug include:

  • taking other supplements or prescription or over-the-counter drugs that can suppress appetite
  • consuming caffeine
  • having a chronic disease that can suppress appetite, such as dementia or liver or kidney disease

What might help

If you have decreased appetite during Azstarys treatment, try to eat high calorie, nutritious foods. You may need to schedule snacks and meals and stick to the schedule, even if you don’t feel hungry. Consider the following options to help boost your meal plan:

  • Take Azstarys during or after breakfast and make breakfast the largest-calorie meal of the day.
  • Always pair a protein with a carbohydrate at meals and snacks, such as peanut butter with an apple, and cheese and crackers.
  • Use fruit smoothies to incorporate healthy fats and vegetables.
  • Seek meal and snack planning help from a dietitian; some insurance plans have a dietitian on staff.

If you’re having trouble getting enough calories, talk with your doctor. They’ll likely recommend a break from the medication or switch you to a different treatment. But do not stop taking Azstarys without your doctor’s approval.

Insomnia

Insomnia was a common side effect reported in studies of Azstarys and may cause symptoms such as:

  • trouble falling or staying asleep
  • waking up many times during the night
  • waking up too early
  • feeling sleepy during the day
  • headache
  • feeling grouchy or hostile
  • fatigue
  • falls or accidents
  • poor work or school performance

Factors that can make trouble sleeping worse when taking this drug include:

  • not keeping to the same bedtime each night
  • eating a large meal before bedtime
  • ingesting alcohol or caffeine before bedtime
  • using nicotine before bedtime

What might help

If you have insomnia during Azstarys treatment, give these sleep tips a try:

  • avoid screen time before bed
  • read or listen to music

If you’re having trouble managing your sleep quality on your own, talk with your doctor. They may suggest taking a break from the medication or switching to a different medication. But do not stop taking Azstarys without your doctor’s approval.

Allergic reaction

Like most drugs, Azstarys can cause an allergic reaction in some people. This side effect was only reported after the FDA approved Azstarys for public use. Symptoms can be mild to serious and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin (usually in your eyelids, lips, hands, or feet)
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an oral antihistamine, such as Benadryl (diphenhydramine)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Azstarys, they’ll decide whether you should continue taking it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Azstarys, they may have you switch to a different treatment.

Keeping track of side effects

During your Azstarys treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start taking a new drug or using a combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how your symptoms affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help them learn more about how Azstarys affects you. They can then use this information to adjust your treatment plan if needed.

Below is important information you should consider before starting Azstarys.

Boxed warning: Risk of misuse and addiction

Azstarys has a boxed warning for the risk of misuse and addiction. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

To learn more, see the “Azstarys and misuse” section below.

Other warnings

Azstarys can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether this drug is a good treatment option for you.

Talk with your doctor about your health history before starting Azstarys. Be sure to tell them if any of the following factors apply to you:

Alcohol and Azstarys

There are no known interactions between alcohol and Azstarys, and studies show alcohol does not affect the release of Azstarys into the body.

However, alcohol can cause some side effects similar to those of Azstarys, such as dizziness, nausea, headache, and vomiting. So taking them together may cause these side effects to worsen.

Taking Azstarys while misusing alcohol may increase your risk of misusing Azstarys. Check with your doctor or pharmacist if you have any questions about consuming alcohol while taking this medication.

Pregnancy and breastfeeding with Azstarys

Azstarys is usually prescribed for someone who’s pregnant or breastfeeding only if the benefits of treatment outweigh the potential risks to the fetus or child.

Pregnancy

It’s not known whether it’s safe to take Azstarys during pregnancy. There are few studies on central nervous system (CNS) stimulant use during pregnancy. (CNS stimulants are the group of drugs that Azstarys belongs to.) Some studies show there are no risks, but others show rare instances of problems with fetal development.

There are also reports of low birthweight and premature delivery of infants in people who take CNS stimulants during pregnancy.

When deciding whether to take Azstarys during pregnancy, the harm to the fetus from the mother’s untreated ADHD must also be considered.

If you take this drug while pregnant, consider signing up for the National Pregnancy Registry for Psychiatric Medications by visiting the website or calling 866-961-2388. A pregnancy registry collects information about the safety of certain drugs when used during pregnancy.

If you’re pregnant or planning to become pregnant, talk with your doctor before starting treatment with Azstarys.

Breastfeeding

It isn’t known whether Azstarys is safe to take while breastfeeding. No studies have been done on the level of Azstarys present in human breast milk, how it affects milk production, or how it affects infants who are breastfed.

For people who are breastfeeding while taking Azstarys, watch breastfeeding infants for side effects such as fussiness, lack of appetite, and too little weight gain.

If you’re breastfeeding or planning to do so, talk with your doctor before starting this medication.

Azstarys has a boxed warning for the risk of misuse and addiction. With misuse, a person takes a drug in a way or for a reason other than how or why it was prescribed. Examples of misuse include taking the drug more often or at higher dosages than prescribed by your doctor.

The misuse of Azstarys has the potential to result in substance use disorder, including addiction. (This is when a drug is taken even if it’s causing harmful effects.)

Because of the high risk of misuse, theft, and illegal sale, Azstarys is a Schedule II controlled substance.

Before prescribing Azstarys, your doctor will evaluate your risk of misuse and addiction. And they’ll continue to monitor you closely for signs of misuse and addiction throughout your treatment.

You should only take Azstarys as your doctor has prescribed. Misuse increases the risk of overdose, which can lead to:

Do not share Azstarys with anyone else, even if your symptoms seem the same. Doing so can cause harm or death to others. Proper storage and disposal of Azstarys can prevent misuse, theft, and illegal sale. Check with your pharmacist for suggestions on storage ideas and disposal options in your area.

Like most drugs, Azstarys can cause a number of side effects that range from mild to serious. But most are temporary and go away after a few days to weeks. If you have questions about side effects Azstarys can cause, talk with your doctor. Examples of questions to help get you started include:

  • Will I have side effects if I suddenly stop taking Azstarys?
  • Can Azstarys cause depression?
  • Which side effects of Azstarys should I call you about?

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Disclaimer: Healthline 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.