Azstarys side effects: A detailed guide

This article describes possible side effects of Azstarys. You can explore this overview article to learn more about Azstarys, including the drug’s uses, dosage, ways to save on cost, and more.

Azstarys is a brand-name medication that comes as an oral capsule. It isn’t available in a generic version.

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).

For details, see the “Misuse and Azstarys” section below.

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More common side effects of Azstarys

Azstarys may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of Azstarys include:

• decreased appetite
• insomnia (difficulty falling or staying asleep)
• nausea and vomiting
• indigestion (upset stomach)
• abdominal pain

Mild side effects of Azstarys

Azstarys may cause certain mild side effects. Most often, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of Azstarys that have been reported include:

• abdominal pain
• decreased appetite
• decreased weight
• dizziness
• feeling anxious
• feeling irritable
• indigestion
• insomnia
• quick and intense changes in mood
• nausea and vomiting
• mild allergic reaction*

* An allergic reaction is possible with Azstarys. But it wasn’t reported in the drug’s studies. To learn more about this side effect, see the “Side effects of Azstarys in detail” section below.

Azstarys may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

Serious side effects of Azstarys

Azstarys may cause certain serious side effects. If you have any serious side effects from Azstarys, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with Azstarys.

Serious side effects of Azstarys that have been reported include:

• increased pressure in the eye, which can cause glaucoma
• new or worsening motor or verbal tics (involuntary, irregular, repetitive movements or sounds)
• prolonged, painful erection that requires immediate medical care
• risk of misuse and addiction*
• new or worsening mental health symptoms†
• heart-related side effects†
• blood circulation problems†
• severe allergic reaction†‡

* Azstarys has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Misuse and Azstarys” section below.
† To learn more about this side effect, see the “Side effects of Azstarys in detail” section below.
‡ An allergic reaction is possible with Azstarys. But it wasn’t reported in the drug’s studies.

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Side effects of Azstarys in children

For children, doctors prescribe Azstarys to treat ADHD. The drug is used for this purpose in children ages 6 years and older.

In studies, slowed growth was common in children taking Azstarys. This can cause a child to grow more slowly, leading to a lower weight or height than expected for their age.

Your child’s doctor will closely monitor your child’s weight and height during treatment with Azstarys. Based on your child’s growth during treatment, they may lower your child’s Azstarys dosage. Or they may temporarily pause or permanently stop your child’s treatment with Azstarys.

If you’d like to know more about side effects in children taking Azstarys, talk with your doctor or pharmacist.

Common questions about side effects of Azstarys

Here are answers to some common questions about side effects of Azstarys. If you have other questions, talk with your doctor or pharmacist.

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

Azstarys and Vyvanse have similar side effects. They’re both stimulant drugs that doctors use to treat ADHD in adults and some children. Vyvanse is also prescribed to help treat binge eating disorder in adults.

Some common mild side effects of Azstarys and Vyvanse include decreased appetite, irritability, and abdominal pain. Diarrhea can also occur with Vyvanse treatment, but not with Azstarys.

Serious side effects of Azstarys and Vyvanse include slowed growth in children* and heart-related side effects.† Both medications also have a boxed warning for the risk of misuse and addiction. A boxed warning is the most serious warning from the FDA. To learn more, see the “Misuse and Azstarys” section below.

Talk with your doctor or pharmacist if you’d like to learn more about how the side effects of Azstarys and Vyvanse compare.

* For more details about this side effect, see the “Side effects of Azstarys in children” section above.
† To learn more about this side effect, see the “Side effects of Azstarys in detail” section below.

Are weight gain and anger possible side effects of Azstarys?

Weight gain isn’t an expected side effect of Azstarys. Studies have reported people experiencing decreased appetite and decreased weight. These are known side effects of stimulant drugs. (Azstarys is a stimulant drug.)

Anger is a possible side effect of Azstarys. There are some reports of quick and intense changes in mood and irritability in people taking the drug. Irritability or sudden mood changes could cause anger in some people.

Talk with your doctor if you have concerns about your weight or emotions while taking Azstarys. They can review your symptoms and determine the best way to manage them.

Does Azstarys cause long-term side effects?

Yes, in some cases, Azstarys may cause long-term side effects. These can occur if you take the drug for a long time, or last for a while after you’ve stopped taking the drug.

Examples of long-term side effects reported with Azstarys include:

• increased pressure in the eye, which can cause glaucoma
• prolonged, painful erection that requires immediate medical care
• slowed growth in children*
• risk of misuse and addiction†
• blood circulation problems‡
• new or worsening mental health symptoms‡

Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of Azstarys may last.

* For more details about this side effect, see the “Side effects of Azstarys in children” section above.
† Azstarys has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Misuse and Azstarys” section below.
‡ To learn more about this side effect, see the “Side effects of Azstarys in detail” section below.

Misuse and Azstarys

Like other stimulant drugs, Azstarys has a boxed warning regarding the risk of misuse and addiction. A boxed warning is the most serious warning from the FDA.

With misuse, a drug is taken in a way other than how it’s prescribed. Misusing Azstarys can lead to a substance use disorder, including addiction to the medication. With addiction, you’re unable to stop taking a drug even when it’s causing harm. In some cases, misuse of Azstarys can lead to a life threatening drug overdose.

Before prescribing Azstarys, your doctor will evaluate your risk of misuse and addiction. If you have a substance use disorder, they may prescribe a treatment other than Azstarys. If they do prescribe Azstarys, they’ll monitor you closely for signs of misuse and addiction during treatment.

Signs to watch for include:

• vomiting
• agitation
• confusion
• flushing (temporary warmth, redness, or deepening of skin color)
• sweating
• muscle twitching
• hallucinations
• seizures
• loss of consciousness

Azstarys is a controlled substance because of its risk of misuse and addiction. This means there are strict rules in place for how doctors and pharmacists prescribe and dispense Azstarys. These rules are in place to help prevent misuse and addiction. While taking Azstarys, it’s important to store your prescription in a secure place where others can’t access it. Do not give your Azstarys prescription to anyone else.

If you have questions about this warning, talk with your doctor or pharmacist to learn more.

Side effects of Azstarys in detail

Below you’ll find details on some of the side effects of Azstarys.

New or worsening mental health symptoms

New or worsening mental health symptoms have been reported with stimulant drugs, including those that contain methylphenidate. (Azstarys is a stimulant drug and contains different forms of methylphenidate as the active ingredient. An active ingredient is what makes a drug work.) These side effects are rare but may be serious.

New or worsening mental health symptoms reported with Azstarys include:

• new or worsening bipolar disorder, including mania
• new or worsened depression
• hallucinations or delusions
• other unusual changes to your behaviors or thoughts
• feeling anxious or irritable
• quick and intense mood changes

Certain factors can increase the risk of new or worsening mental health symptoms with Azstarys. These include having an existing mental health condition, such as bipolar disorder or depression.

Ways to manage

If you experience symptoms of new or worsening mental health symptoms, immediately tell your doctor. They’ll recommend the best way to treat your symptoms. This may include stopping treatment with Azstarys.

Heart-related side effects

New or worsening heart-related side effects have been reported with stimulant drugs, including those that contain methylphenidate, such as Azstarys. These side effects include increased heart rate and increased blood pressure.

You may notice symptoms such as palpitations or dizziness with increased heart rate. But for many people, the increase in heart rate or blood pressure is mild and won’t cause symptoms.

However, in rare cases, these increases can be large and cause fast heart rate or high blood pressure. And in people with existing heart problems, these increases can worsen your condition. They may raise your risk of serious heart problems, including heart attack or sudden death.

Certain factors can increase the risk of heart-related side effects with Azstarys. These include having:

• cardiomyopathy (weakening of the heart muscle)
• irregular heart rhythm
• coronary artery disease
• structural heart disease (problems with the heart’s structure, such as unusual connections in the heart or problems within the ventricles)

Ways to manage

Before starting treatment with Azstarys, be sure to tell your doctor about any heart condition or problem you may have. They’ll determine whether it’s safe for you to take Azstarys.

Let your doctor know right away if you notice symptoms of increased heart rate or notice your blood pressure readings are higher than usual. You should also immediately tell your doctor if you experience dizziness or fainting while taking Azstarys. They can check your symptoms and determine the best way to treat them. This may include stopping treatment with Azstarys temporarily or permanently.

If you develop chest pain that feels serious or life threatening while taking Azstarys, immediately call 911 or your local emergency number. Or go to the closest emergency room.

Blood circulation problems

Blood circulation problems, such as Raynaud phenomenon, have been reported with stimulant drugs, including those that contain methylphenidate, such as Azstarys. These side effects are usually mild but can be serious in rare cases, or in certain people.

Blood circulation problems reduce blood flow to outer parts of the body besides the brain or heart. Examples include decreased blood flow to your arms, fingers, legs, or toes.

Symptoms can include:

• numbness or weakness in the affected area
• weakened pulse in your legs or feet
• bluish or reddish color or other discoloration in your fingers or toes

If you have an existing blood circulation problem, taking Azstarys may worsen your condition.

Ways to manage

If you experience symptoms of blood circulation problems, tell your doctor right away. They’ll likely recommend reducing your Azstarys dosage. They may also suggest stopping treatment and exploring other options for managing your condition.

Allergic reaction

For some people, Azstarys can cause an allergic reaction. But this side effect wasn’t reported in the drug’s studies.

However, allergic reaction has been reported with other stimulant drugs that contain methylphenidate. (Azstarys is a stimulant drug and contains different forms of methylphenidate.)

Symptoms can be mild or serious, and they may include:

• itchiness
• skin rash
• swelling under the skin, usually affecting eyelids, lips, hands, or feet
• swelling of the mouth, tongue, or throat, which can make it hard to breathe
• flushing

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Azstarys, your doctor may recommend taking a different medication instead.

Warnings for Azstarys

Below are some factors you may want to discuss with your doctor before taking 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 FDA.

For details, see the “Misuse and Azstarys” section above.

Other warnings

It may not be safe for you to take Azstarys if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether Azstarys is a safe treatment option for you.

Before taking Azstarys, tell your doctor about your health and medications you take. Things to consider include:

• blood circulation problems in your fingers or toes
• eye problems, particularly increased pressure in your eye or glaucoma
• heart disease or heart defects
• high blood pressure
• mental health conditions, especially bipolar disorder or depression
• fast heart rate
• Tourette syndrome or other conditions that cause motor or verbal tics
• past allergic reaction to Azstarys

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 and your doctor decide you’ll take Azstarys during pregnancy, consider joining the National Pregnancy Registry for ADHD medications. Pregnancy registries help collect information about the safety of using certain medications during pregnancy. You can learn more or join the registry by calling 866-961-2388. You can also talk with your doctor or pharmacist to learn more.

Azstarys and breastfeeding

It’s not known whether Azstarys should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

Azstarys and alcohol

Azstarys is not known to interact with alcohol.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with Azstarys.

What to ask your doctor

This article describes common and serious side effects of Azstarys. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.

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

• How do the side effects of Azstarys compare with the side effects of Adderall?
• Based on my health history, do I have a higher risk of side effects if I take Azstarys?
• Does my risk of heart-related side effects depend on the Azstarys dosage I take?

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.