Who should not take AZSTARYS?

Do not take AZSTARYS if you or your child are:

• allergic to serdexmethylphenidate, methylphenidate, or any of the ingredients in AZSTARYS.
• taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

AZSTARYS may cause serious side effects, including:

• Risks for people with serious cardiac disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your HCP should check you or your child carefully for heart problems before starting treatment with AZSTARYS. Tell your HCP if you or your child have any heart problems, heart disease, or heart defects. Call your HCP or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with AZSTARYS.
• Increased blood pressure and heart rate. Your HCP should check you or your child’s blood pressure and heart rate regularly during treatment with AZSTARYS.
• Mental (psychiatric) problems, including: new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real), or new manic symptoms. Tell your HCP about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your HCP right away if you or your child have any new or worsening mental symptoms or problems during treatment with AZSTARYS, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develop priapism, get medical help right away.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your HCP if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. Call your HCP right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with AZSTARYS.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with AZSTARYS. AZSTARYS treatment may be stopped if your child is not growing or gaining weight.
• Eye problems (increased pressure in the eye and glaucoma). Tell your HCP if you or your child have eye problems, including increased pressure in your eye, glaucoma, or problems with your close-up vision (farsightedness). Call your HCP right away if you or your child develop changes in your vision, eye pain, swelling, or redness.
• New or worsening tics or worsening Tourette’s syndrome. Tell your HCP if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with AZSTARYS.

Before taking AZSTARYS, tell your HCP about all medical conditions including if you or your child are pregnant or plan to become pregnant, because it is not known if AZSTARYS will harm the unborn baby, or are breastfeeding or plan to breastfeed, as AZSTARYS passes into breast milk.

Tell your HCP about all the medicines you or your child take, especially if you or your child take blood pressure medicines (anti-hypertensive). Do not start any new medicine during treatment with AZSTARYS without talking to your HCP first.

What are the most common side effects of AZSTARYS?

The most common side effects of AZSTARYS include:

These are not all the possible side effects of AZSTARYS. Call your HCP for medical advice about side effects.

What is AZSTARYS?

AZSTARYS is a central nervous system (CNS) stimulant prescription medicine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. AZSTARYS may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD.

It is not known if AZSTARYS is safe and effective in children younger than 6 years of age.

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.