Atomoxetine

Atomoxetine is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine belongs to a group of drugs called selective norepinepherine reuptake inhibitors, which are thought to work by increasing levels of norepinepherine, a natural chemical in the brain.

CYP2D6 is a protein in your body that is involved in the elimination of atomoxetine and other drugs from your body. Some patients have less of this protein in their bodies, affecting how much of the drug gets eliminated. Levels of CYP2D6 can vary greatly between individuals, and those having less of this protein are known as "poor metabolizers." 

CYP2D6 testing is done to determine whether you are a poor metabolizer. If you are a poor metabolizer, the levels of atomoxetine in your blood can become too high. As a result you may be at an increased risk of having more side effects from atomoxetine.

Your doctor may adjust your dose of atomoxetine if you are a poor metabolizer.

Atomoxetine is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine may increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. 

Atomoxetine may be found in some form under the following brand names:

• Strattera

Serious side effects have been reported. See "Drug Precautions" section.

Common side effects in children and teenagers include:

• upset stomach
• decreased appetite
• nausea or vomiting
• dizziness
• tiredness
• mood swings

Common side effects in adults include:

• constipation
• dry mouth
• nausea
• decreased appetite
• dizziness
• trouble sleeping
• sexual side effects
• menstrual cramps
• problems passing urine


Other serious side effects include:

• serious allergic reactions (call your doctor if you have trouble breathing, see swelling or hives, or experience other allergic reactions)
• slowing of growth (height and weight) in children
• problems passing urine including
• trouble starting or keeping a urine stream
• cannot fully empty the bladder


Other information for children, teenagers, and adults:

• Erections that won't go away (priapism) have occurred rarely during treatment with atomoxetine. If you have an erection that lasts more than 4 hours, seek medical help right away. Because of the potential for lasting damage, including the potential inability to have erections, priapism should be evaluated by a doctor immediately.
• Atomoxetine may affect your ability to drive or operate heavy machinery. Be careful until you know how atomoxetine affects you.
• Talk to your doctor if you have side effects that are bothersome or do not go away.

Tell your doctor about all the medicines that you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Atomoxetine and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine can be taken with other medicines.

Especially tell your doctor if you take:

• asthma medicines
• anti-depression medicines including MAOIs
• blood pressure medicines
• cold or allergy medicines that contain decongestants


Know the medicines that you take. Keep a list of your medicines with you to show your doctor and pharmacist. Do not start any new medicine while taking atomoxetine without talking to your doctor first.

The following serious side effects have been reported with use of atomoxetine:

1. Suicidal thoughts and actions in children and teenagers (see Black Box Warning). Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from atomoxetine clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager's doctor if your child or teenager has (or there is a family history of):

• bipolar illness (manic-depressive illness)
• suicide thoughts or actions before starting atomoxetine

The chance for suicidal thoughts and actions may be higher:

• early during atomoxetine treatment
• during dose adjustments

Prevent suicidal thoughts and action in your child or teenager by:

• paying close attention to your child or teenager's moods, behaviors, thoughts, and feelings during atomoxetine treatment
• keeping all follow-up visits with your child or teenager's doctor as scheduled

Watch for the following signs in your child or teenager during atomoxetine treatment:

• anxiety
• agitation
• panic attacks
• trouble sleeping
• irritability
• hostility
• aggressiveness
• impulsivity
• restlessness
• mania
• depression
• suicide thoughts

Call your child or teenager's doctor right away if they have any of the above signs, especially if they are new, sudden, or severe. Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.

2. Severe liver damage. Atomoxetine can cause liver injury in some patients. Call your doctor right away if you have the following signs of liver problems:

• itching
• right upper belly pain
• dark urine
• yellow skin or eyes
• unexplained flu-like symptoms

3. Heart-related problems.

• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate

Tell your doctor if you have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you carefully for heart problems before starting atomoxetine.

Your doctor should check your blood pressure and heart rate regularly during treatment with atomoxetine.

Call your doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking atomoxetine.

4. New mental (psychiatric) problems in children and teenagers.

• new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms

Call your child or teenager's doctor right away about any new mental symptoms because adjusting or stopping atomoxetine treatment may need to be considered.

Do not take atomoxetine if you:

• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate) and Emsam (selegiline transdermal system)
• have an eye problem called narrow angle glaucoma
• are allergic to anything in atomoxetine
• have or have had a rare tumor called pheochromocytoma


Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of atomoxetine there are no specific foods that you must exclude from your diet when receiving atomoxetine.

Tell your doctor if you:

• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate) and Emsam (selegiline transdermal system).
• have an eye problem called narrow angle glaucoma
• are allergic to anything in atomoxetine
• have or have had a rare tumor called pheochromocytoma


Before starting atomoxetine tell your doctor about all health conditions (or a family history of) including if you:

• have or had suicide thoughts or actions
• have heart problems, heart defects, irregular heart beat, high blood pressure, or low blood pressure
• have mental problems, psychosis, mania, bipolar illness, or depression
• have liver problems

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Tell your doctor about all the medicines that you take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if atomoxetine will harm your unborn baby. Atomoxetine has not been studied in pregnant women. Atomoxetine should be used during pregnancy only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if atomoxetine is excreted in human breast milk or if it will harm your nursing baby.

• Take atomoxetine exactly as prescribed. Atomoxetine comes in different dose strength capsules.Your doctor may adjust the dose until it is right for you.
• Do not chew, crush, or open the capsules. Swallow atomoxetine capsules whole with water or other liquids. Tell your doctor if you cannot swallow atomoxetine whole. A different medicine may need to be prescribed.
• Avoid touching a broken atomoxetine capsule. Wash hands and surfaces that touched an open atomoxetine capsule. If any of the powder gets in your eyes rinse them with water right away and call your doctor.
• Atomoxetine can be taken with or without food.
• Atomoxetine is usually taken once or twice a day. Take atomoxetine at the same time each day to help you remember. If you miss a dose of atomoxetine, take it as soon as you remember that day. If you miss a day of atomoxetine, do not double your dose the next day. Just skip the day you missed.
• From time to time, your doctor may stop atomoxetine treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking atomoxetine. Children should have their height and weight checked often while taking atomoxetine. Atomoxetine treatment may be stopped if a problem is found during these check-ups.

Take atomoxetine exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

If you take too much atomoxetine, call your local Poison Control Center or seek emergency medical attention right away.

• Store atomoxetine in a safe place at room temperature, 59 to 86°F (15 to 30°C).
• Keep atomoxetine and all medicines out of the reach of children.

WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS

Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Atomoxetine is approved for ADHD in pediatric and adult patients. Atomoxetine is not approved for major depressive disorder.

Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials.