Uses
What is Azstarys used for?
Azstarys (serdexmethylphenidate/dexmethylphenidate) is commonly used to treat attention deficit hyperactivity disorder (ADHD).
Learn more about Azstarys for ADHD.
Azstarys may also be used for other conditions as determined by your healthcare provider.
How does Azstarys work (mechanism of action)?
Azstarys works by increasing the level of norepinephrine and dopamine in the body by stopping these chemicals from getting taken up by the nervous system.
How is Azstarys supplied (dosage forms)?
Azstarys is available in the following dosage forms that are taken by mouth.
- 26.1mg/5.2mg oral capsules
- 39.2mg/7.8mg oral capsules
- 52.3mg/10.4mg oral capsules
How should I store Azstarys?
Azstarys should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Protect from moisture.
It is recommended to store Azstarys in a safe, preferably locked place.
Side Effects
What are the most common side effects of Azstarys?
The most common side effects of Azstarys are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Decreased appetite
- Trouble sleeping
- Nausea, vomiting, upset stomach, stomach pain
- Weight loss
- Anxiety
- Dizziness
- Irritability
- Mood swings
- Fast heartbeat
- High blood pressure
There may be other side effects of Azstarys that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Azstarys?
While less common, the most serious side effects of Azstarys are described below, along with what to do if they happen.
Severe Allergic Reactions. Azstarys may cause allergic reactions, which can be serious. Stop taking Azstarys and get help right away if you or your child have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Risk of Misuse and Addiction. Misusing Azstarys can lead to serious side effects like coma or death. Misuse means taking a medicine in a way other than how it was prescribed. Azstarys can also lead to dependence. Dependence is when you feel like you cannot function normally without the medicine and your body relies on the medicine. Take Azstarys exactly as prescribed. Tell your healthcare provider if you or your child feel that Azstarys is not working. Call your healthcare provider right away or go to the nearest emergency room if you or your child experience any of the following serious symptoms.
- Sudden confusion or feeling disoriented
- Feeling paranoid
- Suicidal thoughts or actions
- Seizures
- Trouble breathing, fast breathing
- Fast heartbeat
- High blood pressure
- Sweating
- Dilated pupils
- Restlessness
- Trouble sleeping
- Decreased appetite
- Tremors
- Flushed skin
- Vomiting
- Stomach pain
- Anxiety
Heart Problems. Azstarys can increase the risk of death in people who have serious heart problems. Talk to your healthcare provider if you or your child have heart problems, heart disease, or heart defects. Call your healthcare provider right away if you or your child develop any of the following symptoms.
- Chest pain
- Shortness of breath
- Fainting
Heart Rate and Blood Pressure. Azstarys may cause you or your child’s heart rate and blood pressure to increase. Your healthcare provider may monitor you or your child while taking Azstarys.
Mental Problems. Azstarys may cause you or your child to develop psychiatric problems. Call your healthcare provider right away if you or your child experience any of the following symptoms.
- Hearing voices
- Seeing or believing things that are not real
- Extreme changes in mood, energy, activity, or behavior (mania)
Painful, Prolonged Erection (Priapism). Azstarys may cause an unwanted erection that is persistent, painful, and that may occur without sexual arousal. Permanent damage to the penis may occur if priapism is not treated quickly. Stop taking Azstarys and get emergency help right away if you or your child have any of the following symptoms of priapism.
- Erection lasting for more than 4 hours
- Erection that is unrelated to sexual stimulation
- Painful or tender penis
Circulation Problems. Azstarys may cause a condition called Raynaud's phenomenon, which occurs when the blood vessels in your fingers and toes overreact and lead to low blood flow. Call your healthcare provider right away if you or your child have any of the following symptoms.
- Fingers or toes feeling numb, cool, or painful
- Fingers or toes changing color from pale, to blue, to red
- Numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
- Unexplained wounds on fingers or toes
Slowed Growth in Children. If your child is taking Azstarys, they may be at a higher risk of having height and weight problems. Children taking Azstarys may experience weight loss and a slow growth rate. Your healthcare provider may monitor your child’s height and weight while they are taking Azstarys.
Glaucoma. Azstarys may increase pressure inside the eye and cause or worsen narrow-angle glaucoma, which can lead to blindness. Tell your healthcare provider right away if you have any of the following symptoms of glaucoma.
- Changes in your vision, including loss of vision
- Eye pain, redness, or swelling
- Severe headache or vomiting
- Seeing bright, colorful circles around lights (vision halos)
Tics. Azstarys may cause sudden, repetitive movements or sounds (tics) in either you or your child. Call your healthcare provider right away if you or your child develop tics.
Warnings & Precautions
Who should not use Azstarys?
Allergies to Ingredients. People who are allergic to any of the following should not take Azstarys.
- Azstarys
- Serdexmethylphenidate
- Dexmethylphenidate
- Methylphenidate
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Azstarys.
Drug Interactions. Azstarys should not be taken while you are using certain other medicines. Before taking Azstarys, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
What should I know about Azstarys before using it?
Do not stop taking Azstarys without talking to your healthcare provider. Stopping Azstarys suddenly or taking a lower dose after taking a higher dose for long periods of time may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms and have not taken Azstarys.
- Uneasiness
- Depression
- Tiredness
- Vivid dreams
- Changes in sleeping habits
- Increased appetite
- Irritability
- Slow thinking/body movements
Keep Azstarys out of the reach of children. Azstarys is a controlled substance because it can be misused or lead to dependence. Store Azstarys in a safe place to protect it from theft. It is illegal to sell or give away this medicine.
Take Azstarys or give Azstarys to your child once in the morning with or without food. If you or your child cannot swallow Azstarys capsules, you can sprinkle the contents inside the capsule in either 50 mL of water or 2 tablespoons of applesauce. Swallow the applesauce/medicine or water/medicine mixture immediately or within 10 minutes of mixing. Do not store the applesauce/medicine or water/medicine mixture.
If you have medicine that you no longer need or is expired, you can take it to an authorized DEA-registered collection site. If one is not available, you can mix the medicine with dirt, coffee grounds, or cat litter to make it less appealing to children and pets. You can then place the mixture in a sealed plastic bag and throw it away.
Do not take Azstarys unless it has been prescribed to you or your child, by a healthcare provider. Take it as prescribed.
Do not share Azstarys with other people, even if they have the same condition as you. It may harm them.
Keep Azstarys out of the reach of children who are not prescribed this medicine.
What should I tell my healthcare provider before using Azstarys?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Azstarys is right for you.
In particular, make sure that you discuss any of the following.
Abuse and Misuse. Talk to your healthcare provider if you or your child have ever abused or have been dependent on alcohol, prescription medicines, or street drugs. Azstarys has a risk of being abused and misused.
Heart Problems. Talk to your healthcare provider if you or your child have heart problems, heart disease, heart defects, or high blood pressure. Taking Azstarys may increase you or your child’s risk of death.
Mental Conditions. Talk to your healthcare provider if you or your child have mental conditions, including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression. Taking Azstarys can worsen you or your child’s mental conditions.
Circulation Problems. Talk to your healthcare provider if you or your child have blood circulation problems in the fingers and toes. Taking Azstarys can worsen this condition in you or your child.
Eye Problems. Talk to your healthcare provider if you or your child have eye problems including, high pressure in your eye (glaucoma) or problems with your close-up vision (farsightedness). Keep all appointments with your eye doctor. Taking Azstarys can worsen your or your child’s eye problems.
Tics. Talk to your healthcare provider if you or your child have tics, which are repeated movements or sounds, have Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome. Taking Azstarys can worsen you or your child’s tics or Tourette’s syndrome.
Surgery. Talk to your healthcare provider if you or your child have any upcoming surgeries where you will be put to sleep (with an anesthetic). If your doctor gives you or your child an anesthetic before your surgery and you or your child are also taking Azstarys, you or your child’s blood pressure and heart rate may increase during surgery.
Pregnancy. It is not known if or how Azstarys could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Azstarys while you are pregnant or trying to get pregnant. If you become pregnant while taking Azstarys, you can register for the National Pregnancy Registry for Psychostimulants by calling 866-961-2388. This registry collects safety information about the use of psychiatric medicines during pregnancy.
Breastfeeding. Azstarys passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Azstarys while breastfeeding.
How can I get more information about Azstarys?
For more information about Azstarys, you can visit the manufacturer’s website at azstarys.com/ or call them at 800-910-8432.
Interactions
Does Azstarys interact with foods or drinks?
There are no known interactions between Azstarys and foods or drinks.
It is unknown if drinking alcohol will affect Azstarys.
Does Azstarys interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Azstarys.
- A monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease
- A blood pressure medicine, which is used to lower your blood pressure
- An anesthetic, which is a medicine that is used to put you to sleep before surgery.
- Risperidone, which is a medicine used to treat schizophrenia, bipolar disorder, and irritability seen with autism
This may not be a complete list of medicines that can interact with Azstarys. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Azstarys?
If you or someone else has used too much Azstarys, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Azstarys?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.