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  • What Is Azstarys?What Is Azstarys?
  • Used to TreatUsed to Treat
  • AlternativesAlternatives
  • Side EffectsSide Effects
  • Warnings & PrecautionsWarnings & Precautions
  • InteractionsInteractions
  • Cost & PricesCost & Prices
  • DosagesDosages
  • How To TakeHow To Take
  • Addictiion RiskAddictiion Risk
  • OverdoseOverdose
  • Questions to AskQuestions to Ask
  • In My ExperienceIn My Experience
  • Additional ResourcesAdditional Resources

Azstarys: Uses, Side Effects, Dosage, & More

Headshot Max Ruvinov PharmD MBA

Author: Max Ruvinov, PharmD, MBA

Headshot Max Ruvinov PharmD MBA

Max Ruvinov PharmD, MBA

Max Ruvinov is an accomplished pharmacist and an expert in medication management for multiple mental health conditions. His areas of expertise include weight loss, sexual health, and mood disorders.

See My Bio Editorial Policy
Headshot of Heidi Moawad, MD

Medical Reviewer: Heidi Moawad, MD Licensed medical reviewer

Headshot of Heidi Moawad, MD

Heidi Moawad MD

Heidi Moawad, MD is a neurologist with 20+ years of experience focusing on
mental health disorders, behavioral health issues, neurological disease, migraines, pain, stroke, cognitive impairment, multiple sclerosis, and more.

See My Bio Editorial Policy
Published: August 25, 2023
  • What Is Azstarys?What Is Azstarys?
  • Used to TreatUsed to Treat
  • AlternativesAlternatives
  • Side EffectsSide Effects
  • Warnings & PrecautionsWarnings & Precautions
  • InteractionsInteractions
  • Cost & PricesCost & Prices
  • DosagesDosages
  • How To TakeHow To Take
  • Addictiion RiskAddictiion Risk
  • OverdoseOverdose
  • Questions to AskQuestions to Ask
  • In My ExperienceIn My Experience
  • Additional ResourcesAdditional Resources
Max-Ruvinov-PharmD-MBA-headshot
Written by:

Max Ruvinov

PharmD, MBA
Headshot of Benjamin Troy, MD
Reviewed by:

Heidi Moawad

MD
Brand name:
Azstarys
Generic name:
None
Class of drug:
Stimulant
Boxed warning:
Yes
FDA-approved treatments:
ADHD
Common Off-label Uses (non-FDA approved):
Treatment-resistant Depression
Common alternatives:

Adderall, Ritalin, Vyvanse

View Drug Class, FDA-Approved Uses, Off-Label Uses, and more

*An off-label use of a medication is a use that is not FDA-approved. Prescribers can decide to use a medication off-label because, in their professional judgment, they believe it may offer a benefit to someone.

Azstarys is a medication used to treat attention-deficit hyperactivity disorder (ADHD) in both children and adolescents. It is a combination of two active ingredients, serdexmethylphenidate, and dexmethylphenidate, which work together to improve focus and reduce impulsivity and hyperactivity. However, like all medications, Azstarys may have potential side effects.

If you’re considering Azstarys, you will be limited in your options for obtaining an assessment and prescription online. Circle Medical is an online psychiatry platform that can and will prescribe stimulant medications, which are controlled substances. They can provide an assessment and may offer you an Azstarys prescription if they determine the medication may help your symptoms.

Boxed Warning: Serdexmethylphenidate and dexmethylphenidate (Azstarys) – Risk of abuse and dependence

Click here to open and close the box warning container.

Serdexmethylphenidate and dexmethylphenidate, the active ingredients in Azstarys, have a black box warning. This is the most serious type of warning from the Food and Drug Administration (FDA). Serdexmethylphenidate and dexmethylphenidate have a risk of abuse and dependence.

Azstarys is a controlled substance, which means that it’s more likely to be misused or cause dependence. There are federal and state laws that limit the amount of medication that can be prescribed or dispensed within a certain period of time.

What Is Azstarys?

Azstarys is an ADHD medication in the class of central nervous system (CNS) stimulants. It is prescribed to treat ADHD in patients aged 6 years and older.1 This medication works by stimulating certain areas of the brain to improve focus, reduce impulsivity, and control hyperactivity.

However, it’s important to note that Azstarys is a brand-name drug, and as of now, there is no generic version available. If you or someone you know is considering this medication, consult a healthcare professional for proper guidance and usage.

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How Does Azstarys Work?

Azstarys, as an ADHD medication, works by acting as a central nervous system stimulant. It affects certain chemicals in the brain, such as dopamine and norepinephrine, which play essential roles in regulating attention and behavior. By increasing the levels of these neurotransmitters, Azstarys helps improve focus, reduce impulsivity, and control hyperactivity, ultimately alleviating ADHD symptoms and enhancing the patient’s ability to manage daily tasks and activities.

What Are Azstarys Used to Treat?

Azstarys is FDA-approved to treat attention-deficit hyperactivity disorder (ADHD) in patients aged 6 years and older.2 FDA approval means that after rigorous testing and evaluation, the U.S. Food and Drug Administration has determined that Azstarys is safe and effective for treating ADHD. This medication specifically targets ADHD symptoms, such as inattention, impulsivity, and hyperactivity, helping patients manage their condition and improve daily functioning.

Azstarys may be used off-label in some cases. Off-label use involves using the medication for conditions or age groups not specifically approved by the FDA based on clinical judgment and expertise.

Alternatives to Azstarys for ADHD

Several medications, including stimulants like methylphenidate and amphetamine-based medications, are FDA-approved to treat ADHD symptoms1 Non-stimulant medications like atomoxetine are also approved for ADHD treatment4

Consulting with a healthcare provider is essential to determine the best medication for each individual’s unique needs and medical history, ensuring effective ADHD management.

Side Effects of Azstarys

Azstarys may cause both persistent side effects and temporary effects during adjustment, such as decreased appetite, nausea, insomnia, anxiety, and increased blood pressure.2

Some severe side effects, including abuse and dependence risks, heart-related issues, and psychiatric problems, require immediate attention.2 Consult a healthcare provider to monitor and address any side effects during Azstarys treatment.

Common Side Effects of Azstarys

Azstarys may cause mild and common side effects like difficulty sleeping, dizziness, and loss of appetite, which usually improve as the body adjusts. If these side effects persist or become bothersome, consult a healthcare provider for guidance.

Common side effects of Azstarys include:*1

  • Decreased appetite
  • Nausea
  • Insomnia
  • Anxiety
  • Increased blood pressure
  • Abdominal pain
  • Dizziness

All medications, including Azstarys, can cause side effects that can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and understand the potential side effects and benefits of any medication.

Serious Side Effects of Azstarys

While Azstarys can be beneficial for treating ADHD, it may also lead to some potentially serious side effects like abuse, mental health issues, and painful penis erection that require immediate medical attention. These effects should be closely monitored to ensure the safety of the patient.

Serious side effects of Azstarys may include:1

  • Abuse and Dependence
  • Serious Cardiovascular Reactions
  • Psychiatric Adverse Reactions
  • Priapism (prolonged and painful erection)
  • Long-Term Suppression of Growth

If any of these side effects are experienced while taking Azstarys, it is crucial to seek prompt medical care to address the issue appropriately.

All medications, including Azstarys, can cause side effects that can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and understand the potential side effects and benefits of any medication.

Allergic Reactions to Azstarys

Allergic reactions to Azstarys can happen if someone is sensitive to serdexmethylphenidate, methylphenidate, or other parts of the medication. People with bad reactions to other methylphenidate products might also be at risk. Allergic symptoms may include rash, itching, and sometimes serious symptoms that need urgent attention.

Allergic reactions to Azstarys may include:1

  • Bronchospasm (constriction of the airways)
  • Rash
  • Pruritus (itching)
  • Angioedema (swelling under the skin, often around the face and throat)
  • Anaphylactic reactions (severe and potentially life-threatening allergic responses)

If someone experiences any allergic reaction to Azstarys, it is crucial to seek immediate medical attention. Depending on the individual’s medical history and specific allergic response, alternative medications may be considered for managing ADHD symptoms.

Azstarys Warnings & Precautions

Before taking Azstarys, be aware of potential warnings and precautions for safe usage. Evaluate medical history and health status carefully with healthcare providers before starting the medication.

Precautions for taking Azstarys include:1

  • Potential for abuse and dependence: Azstarys, like other CNS stimulants, can have a high potential for abuse and dependence. Healthcare providers should assess the risk of abuse before prescribing and monitor patients for signs of abuse or dependence during treatment.
  • Serious cardiovascular reactions: There have been reports of sudden death, stroke, and heart attacks in adults on CNS stimulant treatment. Patients with structural heart abnormalities and serious heart issues should avoid using Azstarys.
  • Blood pressure and heart rate increases: CNS stimulants can cause an increase in blood pressure and heart rate.
  • Psychiatric adverse reactions: Azstarys may also induce manic episodes in individuals with bipolar disorder.
  • Priapism: Prolonged and painful erections, known as priapism, have been reported in some patients taking methylphenidate products.
  • Peripheral vasculopathy, including Raynaud’s phenomenon: Patients may experience intermittent and mild symptoms of feeling numb and cold, but careful observation is necessary. Seek medical evaluation for certain patients.
  • Long-term suppression of growth: Pediatric patients on CNS stimulants may experience weight loss and slowed growth rate.

Interactions With Azstarys

It’s essential to be cautious about combining Azstarys with other medications, substances, or herbs, as it may lead to harmful effects. To ensure your safety, inform your healthcare provider about all the medicines and supplements you are taking.

4 substances you should avoid while taking Azstarys include:1

  • Monoamine Oxidase Inhibitors (MAOIs): Taking MAOIs with Azstarys can lead to a serious problem called hypertensive crisis, which can cause stroke or heart issues.
  • Antihypertensive drugs: Azstarys might make drugs used for high blood pressure less effective, leading to uncontrolled blood pressure.
  • Halogenated anesthetics: Using halogenated anesthetics with Azstarys during surgery can raise blood pressure and heart rate suddenly, which can be dangerous.
  • Risperidone: If you take Azstarys and risperidone together and change the dose of either medicine, you might experience unwanted movements that need close monitoring.

To avoid any troubles, make sure to share all your medications and supplements with your healthcare provider before starting Azstarys.

Azstarys Cost & Prices

Azstarys can cost between $300 to $600 per month without insurance, and even with insurance, the out-of-pocket expenses can be significant. To reduce costs, patients can explore manufacturer savings programs, discount cards, or patient assistance programs. Unlike Adderall, Azstarys does not have a generic version available, making the brand version the only option, which may impact affordability for some patients.5

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Azstarys Dosages for FDA-Approved Treatment

Azstarys is FDA-approved for ADHD treatment in pediatric patients (6 to 12 years) and adults and older pediatric patients (13 to 17 years) The typical starting dose for pediatric patients is 39.2 mg/7.8 mg once daily in the morning, which can be adjusted after one week up to a maximum of 52.3 mg/10.4 mg once daily. 1,6

Adults and older pediatric patients start with the same dose and may increase to 52.3 mg/10.4 mg once daily after one week. Dosages vary based on age, weight, and individual response, so consult a healthcare provider for personalized guidance.

Azstarys Forms & Strengths

Azstarys comes in three capsule strengths: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, and 52.3 mg/10.4 mg, taken orally. The appropriate form and strength are determined based on factors like age, weight, and medical condition. Dosages may vary due to individual differences in medication metabolism. The effects typically begin within a few hours after ingestion.

Azstarys is available in the following forms and strengths:2

  • 26.1 mg/5.2 mg (blue cap/grey body, imprinted with “286” on the cap and “KP415” on the body)
  • 39.2 mg/7.8 mg (dark blue cap/grey body, imprinted with “429” on the cap and “KP415” on the body)
  • 52.3 mg/10.4 mg (orange cap/grey body, imprinted with “5612” on the cap and “KP415” on the body)

How Should I Take Azstarys?

To take Azstarys, follow your healthcare provider’s instructions carefully. You can take it with or without food. The capsules should be swallowed whole, but if needed, you can open them and sprinkle the contents onto applesauce or mix them with water. However, never substitute Azstarys with other methylphenidate products without proper guidance, as this can lead to dosage errors and potential overdosage. It’s crucial to take medications as prescribed to ensure their effectiveness and safety.1

What Happens If I Miss a Dose of Azstarys?

If you miss a dose of Azstarys, take it as soon as you remember unless it’s almost time for the next dose. Don’t take extra doses to catch up, and avoid stopping the medication abruptly. Consult your healthcare provider if you have concerns about missed doses or usage.

Can You Become Addicted to Azstarys?

Azstarys, similar to other CNS stimulants, carry a risk of abuse and addiction, even when used as prescribed. Prescribers should assess the risk and provide close monitoring, education on storage, and regular follow-up visits.

For those facing addiction, medical detox or supervised discontinuation may be necessary. Watch for signs of abuse like increased heart rate and hyperactivity, and seek medical attention if noticed.

Can You Overdose on Azstarys?

Yes, it is possible to overdose on Azstarys. An overdose can occur when too much of the medication is taken, leading to excessive stimulation of the central nervous system and sympathetic effects. Signs of an overdose may include nausea, vomiting, restlessness, confusion, hallucinations, convulsions, rapid heartbeat, high body temperature, and muscle twitching. If you suspect an overdose or notice these symptoms, seek immediate medical attention.1

What Should You Do If You Take Too Much Azstarys?

If you take too much Azstarys, seek immediate medical help. Contact your healthcare provider or go to the nearest emergency room. In case of an overdose, medical professionals will provide supportive care and closely monitor your condition.1 They may employ general measures used for overdosage management, ensuring proper breathing, oxygen supply, and monitoring vital signs and heart rhythm.

Questions to Ask Your Healthcare Provider About Azstarys

If you or a loved one have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and are considering treatment options, you might want to know more about Azstarys. It is essential to discuss Azstarys with your doctor, psychiatrist, and therapist to make informed decisions about your ADHD management.

Questions to ask your care team about Azstarys include:

  • How will Azstarys help manage my ADHD symptoms?
  • What are the potential side effects of Azstarys, and how can they be managed?
  • Is Azstarys safe to take with other medications I am currently using for anxiety or depression?
  • What is the recommended dosage for me, and how should I take it (with or without food)?
  • Are there any specific precautions I should take while on Azstarys?
  • How long does it typically take for Azstarys to start working effectively?
  • What should I do if I miss a dose?
  • Can I open the capsules and sprinkle them on applesauce or add them to water if swallowing is difficult?
  • Are there any potential drug interactions I should be aware of?
  • Should I continue my therapy sessions while taking Azstarys, and should I discuss this medication with my therapist?
  • If I experience any sexual side effects while on Azstarys, when should I reach out to my psychiatrist?
  • Are there any lifestyle changes or behavioral strategies that can complement the effects of Azstarys?

If you need to change prescribers or prefer a more convenient option, online psychiatry services can be a good alternative for obtaining a new prescription or seeking advice from a qualified psychiatrist.

In My Experience

In my experience, discussing Azstarys with your doctor, psychiatrist, and therapist is crucial when considering ADHD treatment options. It’s essential to have an open dialogue about the benefits and potential side effects of the medication.

Seeking professional guidance ensures that you receive personalized care and the most appropriate dosage for your specific needs. Remember that managing ADHD involves a comprehensive approach, including therapy and support.

If you or someone you know is dealing with ADHD, know that there are effective treatments available, and seeking help is a positive step towards improving daily functioning and overall well-being. Trust your care team, follow their guidance, and be proactive in managing your ADHD to lead a fulfilling life.

Additional Resources

To help our readers take the next step in their mental health journey, Choosing Therapy has partnered with leaders in mental health and wellness. Choosing Therapy is compensated for marketing by the companies included below.

Online Psychiatry

Circle Medical – ADHD Diagnosis and Treatment. Affordable and accessible ADHD evaluations and treatment, including possible controlled substances medication if clinically appropriate. Diagnosis and prescription over video. Insurance accepted. Same & next day appointments available. Visit Circle Medical

Talkiatry – Get help from a real doctor who takes your insurance. Talkiatry offers medication management and online visits with expert psychiatrists. Take the online assessment and have your first appointment in days. Free Assessment

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Brightside Health – Different people experience ADHD in different ways. That’s why Brightside Health develops personalized plans that are unique to you and offers 1-on-1 support from start to finish. Brightside Health accepts United Healthcare, Anthem, Cigna, and Aetna. No controlled substances. Appointments in as little as 24 hours. Start your free assessment.

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For Further Reading

  • 10 Tips for Healthy Living With ADHD as an Adult
  • ADHD in Men: Signs, Symptoms, & Treatments
  • What is ADHD?
  • Azstarys Vs Adderall XR: What Is the Difference?

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Sources

ChoosingTherapy.com strives to provide our readers with mental health content that is accurate and actionable. We have high standards for what can be cited within our articles. Acceptable sources include government agencies, universities and colleges, scholarly journals, industry and professional associations, and other high-integrity sources of mental health journalism. Learn more by reviewing our full editorial policy.

  • National Institutes of Health. (2022). DailyMed – azstarys- serdexmethylphenidate and dexmethylphenidate capsule. U.S. National Library of Medicine. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm

  • Access Data. (n.d.). HIGHLIGHTS OF PRESCRIBING INFORMATION. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212994s000lbl.pdf

  • Lakhan, S. E., & Kirchgessner, A. (2012, September). Prescription stimulants in individuals with and without attention deficit hyperactivity disorder: Misuse, cognitive impact, and adverse effects. Brain and behavior. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3489818/ 

  • Budur, K., Mathews, M., Adetunji, B., Mathews, M., & Mahmud, J. (2005, July). Non-stimulant treatment for attention deficit hyperactivity disorder. Psychiatry (Edgmont (Pa. : Township)). Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3000197/

  • GoodRx. (n.d.) Azstarys prices, Coupons & savings tips. Retrieved from https://www.goodrx.com/azstarys 

  • Center for Drug Evaluation and Research. (2023). Drug trials snapshot azstarys. U.S. Food and Drug Administration. Retrieved from https://cacmap.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-azstarys 

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