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What is the most important information I should know about atomoxetine?

Do not use atomoxetine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use atomoxetine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to atomoxetine, or if you have glaucoma. Some ADHD medicines have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Tell your doctor if you have any heart problems.

You may have suicidal thoughts or behavior while taking atomoxetine. Watch for symptoms of depression, unusual behavior, or thoughts of hurting yourself. Your doctor may need to check you at regular visits while you are taking this medication.

In addition to you watching for changes in your mood or behavior, your family or caregivers should be alert to changes in your mood or symptoms.

Do not use an open or broken capsule. If the medicine from inside the capsule gets into your eyes, rinse thoroughly with water and call your doctor. Atomoxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What is atomoxetine?

Atomoxetine affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Atomoxetine is used to treat attention deficit hyperactivity disorder (ADHD).

Atomoxetine may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking atomoxetine?

Do not use this medication if you are allergic to atomoxetine or if you have glaucoma.

Do not take atomoxetine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use atomoxetine before the MAO inhibitor has cleared from your body. Some ADHD medicines have caused sudden death in children and adolescents with serious heart problems or congenital heart defects.

Before using atomoxetine, tell your doctor if you are allergic to any drugs, or if you have:

• a congenital heart defect;

• heart disease, a heart rhythm disorder, or recent heart attack;

• coronary artery disease;

• a history of stroke, blood clots, or heart attack;

• high or low blood pressure;

• liver disease;

• problems with urination;

• a personal or family history of mental illness, psychotic disorder, bipolar illness, depression, or suicide attempt; or

• if anyone in your family has died suddenly from a heart problem.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take atomoxetine.

You may have suicidal thoughts or behavior while taking atomoxetine. Watch for symptoms of depression, unusual behavior, or thoughts of hurting yourself. Your doctor may need to check you at regular visits while you are taking this medication.

In addition to you watching for changes in your mood or behavior, your family or caregivers should be alert to changes in your mood or symptoms.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether atomoxetine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Atomoxetine is not meant for long-term use. Because ADHD may be a long-term condition, especially in children and young adults, your doctor may recommend another ADHD medication after you stop taking atomoxetine.

Long-term use of atomoxetine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Do not give atomoxetine to a child younger than 6 years old without the advice of a doctor.