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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: atomoxetine (at oh MOX i teen)
Brand name(s): STRATTERA
GENERIC: not available FAMILY: Central Nervous System Stimulators
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Atomoxetine caused fetal harm in animal studies, including fetal resorptions, atypical or missing arteries in the heart, incomplete bone formation of the spine, as well as decreases in pup weight and survival. Because of the potential for serious adverse effects to the fetus, this drug should not be used by pregnant women.

Breast-feeding Warning

Atomoxetine was excreted in animal milk. It is likely that this drug, like many others, is also excreted in human milk, and because of the potential for serious adverse effects in nursing infants, you should not take this drug while nursing.

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

Suicidal Ideation in Children and Adolescents — STRATTERA (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 STRATTERA in a child or adolescent must balance this risk with the clinical need. 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. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA 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 STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials.[1]

Drug treatment is not suitable for all children with attention deficit hyperactivity disorder (ADHD). Drug treatment is not intended for use in patients who exhibit symptoms of the disorder that result primarily from environmental factors (school, home), learning disabilities, and/or other psychiatric disorders, including psychosis.

Facts About This Drug [top]

Atomoxetine (STRATTERA) is approved by the Food and Drug Administration (FDA) to treat attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Atomoxetine increases function of the neurotransmitter norepinephrine. The drug is intended to be part of a therapy that includes educational, psychological and social measures.[2] It may control, but does not cure, ADHD.

The prescription information for atomoxetine includes an FDA black-box warning concerning suicidal...

Atomoxetine (STRATTERA) is approved by the Food and Drug Administration (FDA) to treat attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Atomoxetine increases function of the neurotransmitter norepinephrine. The drug is intended to be part of a therapy that includes educational, psychological and social measures.[2] It may control, but does not cure, ADHD.

The prescription information for atomoxetine includes an FDA black-box warning concerning suicidal thinking in children and adolescents and additional warning statements that alert health care providers to the increased risk of liver damage, heart-related problems and psychiatric symptoms when taking this drug.[3] These four concerns are highlighted in the FDA-approved Medication Guide for atomoxetine (and in the "Side effects" section below), which advises patients of the risks associated with the drug and precautions that can be taken to help patients use this drug more safely.[4]

Atomoxetine is one of a limited number of drugs for which the FDA requires an FDA-approved Medication Guide to be dispensed when the prescription is filled or refilled. (Click here to view the Medication Guide for this drug.) An FDA advisory committee has unanimously recommended that all prescription drugs be accompanied by such Medication Guides, but currently, less than 5 percent of drugs are. The other 95 percent of drugs are accompanied by unregulated, often dangerously incomplete, information leaflets not approved by the FDA.

The editors of The Medical Letter on Drugs and Therapeutics, an independent source of drug information written for pharmacists and physicians, reviewed atomoxetine on Aug. 16, 2004, and concluded:

There is no convincing evidence that atomoxetine (STRATTERA) is as effective or as well tolerated as stimulants such as methylphenidate (CONCERTA, and others) for treatment of ADHD. As The Medical Letter recommended when the drug was first marketed, until more data become available, atomoxetine is best reserved for patients who have not responded to or cannot tolerate stimulants, and for those who do not want to take, or have their children take, a controlled substance.[5]

Side effects

Common side effects with atomoxetine include indigestion, fatigue, dizziness, decreased appetite and mood swings. Side effects that have caused adults to discontinue atomoxetine include chest pain, insomnia and urinary retention, while children and adolescents were more apt to stop due to aggression, drowsiness, irritability and vomiting.

In 2010, an FDA advisory stated that allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria and rash have been reported in patients taking atomoxetine. The advisory also noted that these allergic reactions may be uncommon.[6]

Liver damage

In some patients, atomoxetine can cause severe liver injury that may progress to liver failure, potentially resulting in death or the need for a liver transplant. Atomoxetine should be stopped and the prescribing physician notified immediately if you or a family member develops any of the following symptoms of potential liver toxicity:

  • Pruritus (itchy skin)
  • Jaundice (yellowing of the skin or whites of the eyes)
  • Dark urine
  • Abdominal pain (on the upper right side, location of the liver)
  • Unexplained flu-like symptoms[1],[4]

An article published in the FDA newsletter in 2009 discussed six additional cases of serious liver injury that were reported to the FDA between January 2005 and March 2008. These case reports were received after the 2004 atomoxetine drug label update on serious liver injury associated with atomoxetine use.[7]

Heart-related problems

There have been reports to the FDA of several heart-related problems in individuals taking doses of ADHD medications as prescribed: sudden death in patients who have an underlying serious heart problem or defect, stroke and heart attack in adults, and increased blood pressure and heart rate. When considering atomoxetine treatment, doctors should carefully check patients for heart problems and check patients’ blood pressure and heart rate regularly during treatment. Patients and their caregivers should call their doctor immediately if someone taking atomoxetine has any signs of heart problems, such as chest pain, shortness of breath or fainting.[4]

In 2011, Health Canada, an agency similar to the FDA, issued an advisory concerning the use of atomoxetine and the risk of increased blood pressure and increased heart rate.[8] In May 2012, the U.K.’s Medicines and Healthcare products Regulatory Agency also issued an advisory concerning these same risks.[9]

Psychiatric symptoms

New psychotic symptoms (such as hearing voices, believing things that are not true and being suspicious) and new manic symptoms have been reported in patients using atomoxetine. Parents should contact the doctor right away if new mental symptoms develop.[4]

Increased risk of suicidal thinking has been reported in children and adolescents being treated with this medication. Pediatric patients being treated with atomoxetine should be closely observed for clinical worsening as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial months of a drug-therapy course or at times of dose increases or decreases.[10]

In 2013, the Therapeutic Goods Administration, a branch of the Australian government’s Department of Health, stated that as of July 2013, it had received 74 reports of psychiatric disorders associated with atomoxetine use and that suicidal ideation was reported in more than half of these cases.[11]

In 2015, Health Canada updated the warning section of the labels of drugs used to treat ADHD on the risk of suicidal thoughts and behaviors. The advisory stated that Health Canada had received reports that included thoughts of suicide, suicide attempts and, in a very small number of cases, suicide. [12]

Other concerns with atomoxetine

Atomoxetine should not be used by people with narrow-angle glaucoma.[2]

Concern exists about the effects of long-term atomoxetine medication on the growth of children. Short-term studies show that children gain less height and weight when using atomoxetine.[2],[13] If height and weight gain in children are below normal, consideration should be given to interrupting therapy.

The drug has not been studied in children younger than 6 or in the elderly. The effectiveness of taking atomoxetine beyond nine weeks in children or 10 weeks in adults has not been evaluated. The safety of taking atomoxetine beyond one year has not been studied in controlled trials. Long-term effects of the drug are not known.[2]

Regulatory actions surrounding atomoxetine

2012: The FDA updated the information on the drug product label of atomoxetine, noting post-marketing reports of severe liver injury associated with atomoxetine use.[14]

In 2012, the FDA also updated the information on the drug product label of atomoxetine, indicating that the drug should not be used in patients with severe cardiovascular disorders. This includes patients whose condition would likely deteriorate with increases in blood pressure or heart rate.[15]

2013: The FDA issued another advisory that atomoxetine should not be used in patients with severe cardiovascular disorders whose condition would likely deteriorate with increases in blood pressure or heart rate.

Before You Use This Drug [top]

Do not use if you have or have had:

  • allergy to atomoxetine or any of its components

Tell your doctor if you have or have had:

  • high blood pressure
  • glaucoma
  • heart problems
  • liver problems
  • pregnancy or are breast-feeding

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Do not drive or operate hazardous equipment until you know whether atomoxetine causes you to be dizzy.
  • Make regular visits to your doctor to see how you are doing and decide if you should continue using the drug.
  • Tell your doctor if you are nursing, pregnant, or thinking of becoming pregnant.
  • Tell your doctor right away if you get swelling, hives, or any symptoms that concern you.
  • Reduce distractions; for example, sit toward the front of classrooms, or make lists of several small deadlines at work.
  • Select schools that have structured rules and expectations and that provide regular feedback.
  • Seek education about ADHD and counseling for skills development, or join support groups.
  • Augment treatment with biofeedback, cognitive-behavioral therapy, educational skills training, parenting skills, and/or social skills.
  • Try parent counseling to increase self-confidence and learn to discipline consistently and appropriately, reinforcing good behavior with immediate rewards, reducing disruptive behavior, and decreasing family stress.
  • Tell any doctor, dentist, emergency help, or pharmacist you see that you take atomoxetine.
  • Use sugarless candy or gum, ice, or a saliva substitute for dry mouth, but check with your doctor if dry mouth continues for more than two weeks.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as you remember, but do not take more than your daily dose within 24 hours. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Swallow capsules whole with water. Take with or without food, but it is best to be consistent. High-fat meals may slow the rate at which atomoxetine is absorbed.
  • If you are prescribed a second dose in a day, take the second dose by late afternoon or early evening.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

Interactions with Other Drugs [top]

Atomoxetine is a relatively new drug, and information about drug interactions is scant. People in clinical trials are usually on few other drugs and have few other conditions. Listed are potentially serious interactions in FDA-approved labeling and other medical references that are known or suspected to date. New scientific techniques allow researchers to predict some drug interactions before they have been documented in people. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. The number of new drugs approved for marketing increases the chance of drug interactions, and new drug interactions are being identified with old drugs. Be vigilant. Make sure to tell your doctor and pharmacist the drugs you are taking and tell your doctor if you are taking any of these interacting drugs:

Drugs that inhibit monoamine oxidase (MAO inhibitors) may cause serious, at times fatal reactions, such as extreme agitation, rapid fluctuations of mental status, rigid muscles, twitching, or coma. Do not take atomoxetine within two weeks of: deprenyl, ELDEPRYL, furazolidone, FUROXONE, isocarboxazid, MARPLAN, MATULANE, NARDIL, PARNATE, phenelzine, procarbazine, selegiline, tranylcypromine.

Using atomoxetine with asthma drugs called beta agonists may add to adverse effects of the heart and circulation: albuterol, PROVENTIL, VENTOLIN, VOLMAX.

If you use atomoxetine with these drugs, your doctor may adjust your doses: CARDIOQUIN, fluoxetine, PAXIL, paroxetine, PROZAC, QUINAGLUTE, QUINIDEX, quinidine, quinidine gluconate, quinidine polygalacturonate, quinidine sulfate.

Using atomoxetine with anticholinergic drugs (see p. 617) could add to the adverse effect of urinary retention: amitriptyline, AMOXAPINE, antidepressants (tricyclic), antihistamines, ARTANE, ASENDIN, atropine, AVENTYL, belladonna, benztropine, clidinium, COGENTIN, cyclobenzaprine, desipramine, DETROL, dicyclomine, DITROPAN, doxepin, ELAVIL, FLEXERIL, glycopyrrolate, hyoscyamine, imipramine, LIBRAX, NORPRAMIN, nortriptyline, oxybutin, PROBANTHINE, propantheline, protriptyline, scopolamine, SINEQUAN, SURMONTIL, TOFRANIL, tolterodine, TRANS-DERM SCOP, trihexyphenidyl, trimpramine, VISTARIL, VIVACTIL.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • irregular heart rate
  • itching or skin rash
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Call your doctor if these symptoms continue:

  • appetite decrease
  • stomach pain
  • coldness of hands or feet
  • constipation
  • diarrhea
  • fatigue
  • chills, cold sweats, confusion
  • gas
  • indigestion
  • menstruation changes
  • mood swings, irritability
  • sinus headache
  • joint pain or swollen joints
  • muscle aches
  • nausea or vomiting
  • enlarged pupils
  • sleep changes, such as insomnia or early awakening
  • tics
  • difficult or less frequent urination
  • undesirable weight change
  • pain, cramps, heavy bleeding
  • loss of sexual ability or drive
  • unusual tiredness or weakness
  • hot flushes
  • itching

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

By your doctor:

  • blood pressure
  • height and weight (in children)
  • pulse
  • reevaluation of continued need for therapy, dose of medication, and signs of dependence or abuse
  • Test of Variables of Attention (TOVA)

By your parent(s):

  • rating scales, such as Achenbach’s Child Behavior Checklist, Conner’s Parent Questionnaire

By your teacher(s):

  • rating scales, such as Child Attention Problems, Conner’s Teacher Rating Scale

last reviewed May 31, 2021