Azstarys

Introduction

Written by Sarah Lewis, PharmD
Medically reviewed by Alex Brewer, PharmD, MBA
Updated on October 16, 2023

Azstarys (az star’ is) is a brand-name medication prescribed for attention deficit hyperactivity disorder (ADHD) in adults and certain children. Azstarys belongs to a group of drugs called central nervous system (CNS) stimulants.

Boxed warning: Risk of misuse and dependence

Azstarys oral capsule has a boxed warning about the risk of misuse and dependence. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

For details, see the “Interactions and warnings for Azstarys” section.

Common questions about Azstarys

Below you’ll find answers to a few commonly asked questions about Azstarys.

Is Azstarys similar to Adderall, Vyvanse, or Concerta?

Yes, Azstarys is similar to Adderall, Vyvanse, and Concerta. They’re all medications that treat attention deficit hyperactivity disorder (ADHD) in adults and children. They’re all central nervous system (CNS) stimulant medications. This means they have similar side effects and warnings, including the risk of misuse and dependence.

Azstarys, Concerta, and Vyvanse are all long-acting stimulants. Their effects last about 10–13 hours. Adderall comes in a long-acting form, as well, called Adderall XR.* But there’s also a short-acting form of Adderall that wears off after 4–6 hours.

They can all be taken with or without food. Azstarys, Adderall XR, and Vyvanse are capsules you can swallow or open and sprinkle on food. Vyvanse is also available as a chewable capsule. Concerta is a tablet you must swallow whole.

You can learn more about how these medications compare by talking with your doctor or pharmacist.

* XR stands for “extended release,” which means the drug is slowly released into your body over a long period of time.

How does Azstarys work? And how long does it take to start working?

Azstarys works as a stimulant in the CNS, which includes the brain and spinal cord. The exact way this helps treat ADHD isn’t clear. It’s believed that stimulants, including Azstarys, balance certain brain chemicals involved in attention, focus, concentration, and behavior.

Azstarys contains an immediate-acting stimulant and a long-acting stimulant. So it’ll start working very soon after you take it. Its effect should last about 12 hours.

If you’d like to know more about this, talk with your doctor or pharmacist.

Side effects of Azstarys

Azstarys may cause mild or serious side effects. More common mild side effects of Azstarys and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about Azstarys’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for Azstarys listed in the “Resources” section.

Mild side effects

More common mild side effects reported with Azstarys are listed below.

This article doesn’t include all possible mild side effects of the drug. To learn more about Azstarys’s side effects, refer to the prescribing information for Azstarys listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Azstarys’s mild side effects include:

• appetite loss
• indigestion
• nausea or vomiting
• abdominal pain
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for Azstarys” section.

Serious side effects

Serious side effects of Azstarys are listed below.

This article doesn’t include all possible serious side effects of the drug. To learn more about Azstarys’s side effects, refer to the prescribing information for Azstarys listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, Azstarys’s serious side effects include:

• blood circulation problems, including Raynaud’s phenomenon
• slowed growth in children
• increased heart rate or blood pressure
• new or worsening mental health problems, including triggering of mania (periods of very high energy that can interfere with life)
• priapism (an erection lasting longer than 4 hours that requires immediate medical care)
• serious heart and blood vessel problems, including heart attack, stroke, and sudden death
• boxed warning: risk of misuse and dependence*
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for Azstarys” section.

Uses of Azstarys

The Food and Drug Administration (FDA) approves prescription drugs such as Azstarys for certain conditions. Approved uses for Azstarys are described below.

Use for attention deficit hyperactivity disorder

Doctors may prescribe Azstarys oral capsule for treating attention deficit hyperactivity disorder (ADHD). It’s used for this purpose in children ages 6 years and older and adults. It’s usually prescribed as a long-term treatment.

ADHD is a condition that affects a person’s ability to focus, pay attention, and concentrate. It can also affect their behavior. Common symptoms include:

• acting without thinking
• being distracted easily
• having very high energy levels
• trouble listening
• trouble organizing or completing tasks

Everyone can have these problems sometimes. For people with ADHD, these problems happen often, can be intense, and interfere with daily life.

Interactions and warnings for Azstarys

Below you’ll find information about Azstarys’s possible interactions and warnings.

Interactions of Azstarys

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take Azstarys, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for Azstarys” section below.

Warnings for Azstarys

Some people should not take Azstarys, and others should take it cautiously.

Boxed warning: Risk of misuse and dependence

Azstarys has a boxed warning about the risk of misuse and dependence. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

Azstarys is a controlled substance. A controlled substance is a drug the government regulates due to the risk of dependence or misuse.

With misuse, you take Azstarys in a way other than how a doctor prescribes it. Misuse can lead to addiction, which is continuing to take a drug even though it may be causing harm.

Symptoms of addiction may include a strong desire for the drug and trouble managing your use of the drug. Misusing Azstarys can lead to serious or fatal side effects, including suicidal thoughts or actions.

If you experience misuse or addiction, tell your doctor. They’ll likely recommend ways to get help. If you have thoughts about hurting yourself, call 911.

Taking Azstarys can also lead to dependence. Dependence means the body needs the drug in order to function like usual.

Withdrawal symptoms can occur if you are dependent on a drug and you suddenly stop taking it. Due to this risk, doctors usually reduce dosage slowly over time to stop the drug.

Taking high doses of Azstarys for a long time increases the risk of dependence and withdrawal symptoms.

Withdrawal symptoms may include:

• anxiety and distress
• depression or other mood changes
• fatigue (low energy)
• increased appetite
• sleep problems
• unpleasant dreams

If you experience any of these symptoms, call your doctor right away or seek medical care.

To learn more, talk with your doctor or pharmacist.

Azstarys could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether Azstarys is a safe option for you.

Ask your doctor about specific warnings for Azstarys, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Suicide Prevention

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

• Call the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Textline at 741741.
• 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 are not in the same household, stay on the phone with them until help arrives.

Allergic reaction

Azstarys can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to Azstarys or any of its ingredients, your doctor will likely not prescribe Azstarys. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to Azstarys, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of Azstarys

You should not take more Azstarys than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much Azstarys, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and Azstarys

Information about Azstarys and pregnancy and breastfeeding is described below.

Azstarys and pregnancy

It’s not known whether Azstarys should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

If you take Azstarys during pregnancy, your doctor may talk with you about participating in the National Pregnancy Registry for ADHD Medications. Pregnancy registries help monitor the safety of medication use during pregnancy. You can learn more or sign up by calling 1-866-961-2388 or by visiting this website.

Azstarys and breastfeeding

It isn’t fully understood whether it’s safe to breastfeed while taking Azstarys. There are reports of side effects, including agitation and difficulty feeding, in breastfed children exposed to Azstarys. Talk with your doctor before breastfeeding if you’re taking Azstarys. Your doctor can review the risks and benefits with you.

What to ask your doctor

Let your doctor know if you have questions about Azstarys or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• How should I take Azstarys?
• How does Azstarys compare to other medications for ADHD?
• What is the most important information I need to know about Azstarys?

Resources

• Azstarys (serdexmethylphenidate and dexmethylphenidate) capsules, for oral use, CII. (2021). https://www.corium.com/products/AZSTARYS/AZSTARYS_PI_ENGLISH_US.pdf
• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm

Disclaimer: Optum Perks 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.