Medication Guide App

Atomoxetine

Pronunciation

Generic Name: atomoxetine (A-toe-MOX-e-teen)
Brand Name: Strattera

Atomoxetine may increase the risk of suicidal thoughts or actions in children and teenagers with attention deficit hyperactivity disorder (ADHD). Talk with the patient's doctor to be sure that the benefits of using atomoxetine outweigh the risks.

Families and caregivers must closely watch patients who take atomoxetine. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms such as worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.


Atomoxetine is used for:

Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.

Atomoxetine is a selective norepinephrine reuptake inhibitor. Exactly how it works to treat ADHD is not known. Atomoxetine increases certain chemicals in the brain that may help improve attention span and behavior.

Do NOT use atomoxetine if:

  • you are allergic to any ingredient in atomoxetine
  • you have certain severe heart problems (eg, heart defect, heart muscle problems), certain types of irregular heartbeat, severe blood vessel problems, severe or uncontrolled high blood pressure, or narrow-angle glaucoma
  • you have a history of a certain type of adrenal gland tumor (pheochromocytoma)
  • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using atomoxetine:

Some medical conditions may interact with atomoxetine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you or a family member has a history of bipolar disorder (manic depression) or other mental or mood problems (eg, depression), suicidal thoughts or actions, or alcohol or substance abuse
  • if you have a history of heart problems (eg, heart failure; heart defects; fast, slow, or irregular heartbeat), a heart attack, an abnormal electrocardiogram (ECG), stroke, or high or low blood pressure, or if a family member has a history of any of these problems or sudden death
  • if you have a history of blood or bleeding problems, seizures, or increased pressure in the eye or glaucoma
  • if you have liver problems, trouble urinating, or Raynaud syndrome
  • if you take a decongestant (eg, pseudoephedrine, phenylephrine) or medicine for high blood pressure

Some MEDICINES MAY INTERACT with atomoxetine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • MAOIs (eg, phenelzine) because severe and sometimes fatal side effects, including severe high blood pressure, high fever, muscle problems, severe agitation, and coma, may occur
  • Quinidine or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine) because they may increase the risk of atomoxetine's side effects
  • Albuterol because the risk of its side effects may be increased by atomoxetine

This may not be a complete list of all interactions that may occur. Ask your health care provider if atomoxetine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use atomoxetine:

Use atomoxetine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Atomoxetine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get atomoxetine refilled.
  • Take atomoxetine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow atomoxetine whole. Do not break, crush, chew, or open the capsules. Tell your doctor if you cannot swallow atomoxetine whole.
  • Taking atomoxetine at the same time each day will help you remember to take it.
  • Continue to take atomoxetine even if you feel well. Do not miss any doses.
  • If you miss a dose of atomoxetine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use atomoxetine.

Important safety information:

  • Atomoxetine may cause dizziness, drowsiness, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use atomoxetine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Atomoxetine may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Atomoxetine should be used as a part of a treatment program that includes a variety of treatment measures (eg, psychological, educational, social). Be sure to follow the program given to you by your doctor or health care provider.
  • Do NOT take more than the recommended dose or take for longer than prescribed without checking with your doctor.
  • Serious side effects, including a heart attack, a stroke, and sudden death, have occurred with the use of atomoxetine in patients with heart defects or other serious heart problems. If you have a heart defect or other serious heart problem, talk with your doctor about other therapies to treat your condition.
  • Children and teenagers who take atomoxetine may be at increased risk of suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take atomoxetine closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; agitation; hostility; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Do not try to open the capsules or take them apart. If a capsule breaks, do not touch it. Wash your hands and any surfaces that touched a broken capsule. Do not get atomoxetine in your eye; it may irritate your eye if you do. If you get atomoxetine in your eyes or nose, rinse at once with cool water.
  • Atomoxetine may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems, such as impotence. Contact your doctor right away if this happens.
  • Tell your doctor or dentist that you take atomoxetine before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including heart rate, blood pressure, and liver function, may be performed while you take atomoxetine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Atomoxetine may affect the growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take atomoxetine.
  • Atomoxetine should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking atomoxetine while you are pregnant. It is not known if atomoxetine is found in breast milk. If you are or will be breast-feeding while you take atomoxetine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of atomoxetine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; decreased appetite; decreased sexual desire; dizziness; drowsiness; dry mouth; flushing; headache; mild stomach pain or upset; nausea; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts (delusions) or elevated mood (mania); burning, numbness, or tingling; change in feeling of touch or other senses (eg, smell, taste); chest pain; confusion; decreased or difficult urination; decreased sexual ability (eg, impotence, ejaculation problems); fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; menstrual changes; new or worsening mental, mood, or behavior changes (eg, aggression, agitation, anxiety, depression, hostility, impulsivity, irritability, nervousness, restlessness); one-sided weakness; panic attacks; prolonged or painful erection; seizure; severe or persistent headache or dizziness; severe or persistent trouble sleeping or tiredness; shortness of breath; stomach pain or tenderness; sudden, severe nausea or vomiting; suicidal thoughts or attempts; symptoms of liver problems (eg, yellowing of the skin or eyes, itching, dark urine, pale stools, persistent loss of appetite, right upper stomach pain, unexplained flu-like symptoms); tremor; unusual sweating; unusual vision or speech changes; unusual weight loss; unusually cold or blue fingers or toes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal behavior; agitation; enlarged pupils; fast or irregular heartbeat; hallucinations; hyperactivity; mental or mood changes (eg, disorientation); nausea, vomiting, or diarrhea; seizures; severe dizziness, sleepiness, or drowsiness; severe dry mouth; severe or persistent headache; tremor.

Proper storage of atomoxetine:

Store atomoxetine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep atomoxetine out of the reach of children and away from pets.

General information:

  • If you have any questions about atomoxetine, please talk with your doctor, pharmacist, or other health care provider.
  • Atomoxetine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take atomoxetine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about atomoxetine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to atomoxetine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using atomoxetine.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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