Dexmethylphenidate and serdexmethylphenidate is a combination stimulant called Azstarys, which is used to treat attention deficit hyperactivity disorder (ADHD) in adults and children at least 6 years old.

Dexmethylphenidate and serdexmethylphenidate may also be used for purposes not listed in this medication guide.

You should not take this medicine if you are allergic to dexmethylphenidate, serdexmethylphenidate, or methylphenidate (Ritalin, Concerta).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with Azstarys could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• blood circulation problems in the hands or feet; or
• alcoholism or drug addiction.

Becoming dependent on this medicine during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Azstarys on the baby.

If you are breastfeeding, tell your doctor if you notice agitation, feeding problems, or reduced weight gain in the nursing baby.

Not approved for use by anyone younger than 6 years old.

Use Dexmethylphenidate And Serdexmethylphenidate (Azstarys) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: fever; hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis--hallucinations (seeing or hearing things that are not real), new thought or behavior problems, aggression, hostility, paranoia;
• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Azstarys can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common side effects may include:

• loss of appetite, weight loss;
• indigestion, stomach pain, nausea, vomiting;
• dizziness, fast heart rate, increased blood pressure;
• mood changes, feeling anxious or irritable;
• sleep problems (insomnia); or
• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.