Atomoxetine
Atomoxetine Hydrochloride · Say it: a-toe-MOX-e-teen
A prescription capsule used to treat ADHD. Its boxed warning covers suicidal thoughts in children and teens, so the label asks for close monitoring.
Brand names: StratteraATONCY
⬛ Boxed warning (the FDA's strongest warning)
The boxed warning is about suicidal ideation (suicidal thoughts) in children and adolescents. In short-term studies, atomoxetine increased the risk of suicidal thoughts in children and teens with ADHD compared to placebo. In those studies, 0.4% of patients on atomoxetine (5 of 1,357) had suicidal thoughts, compared to none on placebo. No suicides occurred in these trials. The label says anyone considering atomoxetine for a child or adolescent must weigh this risk against the need for treatment. Patients who start the medicine should be watched closely for suicidal thoughts and behavior, clinical worsening, and unusual changes in behavior. Families and caregivers should be told to watch closely and stay in touch with the prescriber. The label also says atomoxetine is not approved for major depressive disorder.
Used for
The label says atomoxetine is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents, and adults. It is meant to be part of a total treatment program for ADHD that may include counseling or other therapies. The label says it is not approved for major depressive disorder, and the Medication Guide says it has not been studied in children younger than 6.
Comes as
Capsules containing atomoxetine: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg
Common side effects
In children and adolescents: nausea, vomiting, tiredness (fatigue), decreased appetite, stomach (abdominal) pain, and sleepiness (somnolence), In adults: constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and difficulty starting to urinate (urinary hesitation)
| Generic name | Atomoxetine Hydrochloride |
|---|---|
| Brand names | Strattera, ATONCY |
| Type of medicine | A selective norepinephrine reuptake inhibitor, a medicine used to treat attention-deficit/hyperactivity disorder (ADHD) |
| How it is sold | Prescription oral capsule |
| Comes as | Capsules containing atomoxetine: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg |
| Route | oral |
| Boxed warning | Yes, see below |
| Label date | 2026-06-25 |
💊 What is Atomoxetine used for?
- The label says atomoxetine is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents, and adults. It is meant to be part of a total treatment program for ADHD that may include counseling or other therapies. The label says it is not approved for major depressive disorder, and the Medication Guide says it has not been studied in children younger than 6.
How it works
The label describes atomoxetine as a selective norepinephrine reuptake inhibitor. The Medication Guide says it may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
How it is usually taken
- The label says the dose depends on body weight and age, and that treatment usually starts at a low total daily dose and is increased after at least 3 days. The label describes taking it either once daily in the morning or split into doses in the morning and late afternoon or early evening. The label says the dose may be adjusted over time. Follow the instructions from your prescriber or pharmacist for your own dose and schedule.
Comes as
- Capsules containing atomoxetine: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg
⚠️ Atomoxetine side effects
Common side effects
- In children and adolescents: nausea, vomiting, tiredness (fatigue), decreased appetite, stomach (abdominal) pain, and sleepiness (somnolence)
- In adults: constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and difficulty starting to urinate (urinary hesitation)
Get medical help right away if
- Get medical help right away if you notice signs of liver problems: itching, pain in the upper right belly, dark urine, yellow skin or eyes, or unexplained flu-like symptoms.
- Get medical help right away if you have chest pain, shortness of breath, or fainting. The label also lists sudden death, stroke, and heart attack as reported with atomoxetine.
- Get medical help right away if you notice suicidal thoughts or actions, or new anxiety, agitation, panic attacks, trouble sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, mania, or depression. The label says these signs are especially important to report if they are new, sudden, or severe.
- Get medical help right away if you notice new psychotic symptoms (such as hearing voices, believing things that are not true, or being suspicious) or new manic symptoms.
- Get prompt medical attention if you suspect priapism (a prolonged, painful erection). The label says this requires prompt medical attention.
🛑 Who should not take Atomoxetine, and who should be careful
The label says not to take it if
- You are taking, or have taken within the past 14 days, a monoamine oxidase inhibitor (MAOI) antidepressant. The label gives examples: Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), and Emsam (selegiline transdermal system).
- You have narrow angle glaucoma.
- You have or have had a pheochromocytoma (a rare tumor).
- You are allergic to atomoxetine or any other ingredient in the product.
- You have a severe cardiovascular disorder that could get worse with clinically important increases in heart rate and blood pressure.
Tell your doctor before taking it if
- Tell your doctor about any history of suicidal thoughts or actions, including a family history.
- Tell your doctor about any heart problems, heart defects, irregular heartbeat, high blood pressure, low blood pressure, or a family history of these. The label says the doctor should check the heart carefully before starting and check blood pressure and heart rate during treatment.
- Tell your doctor about any mental health conditions, including psychosis, mania, bipolar illness, or depression. The label says the prescriber should screen for bipolar disorder.
- Tell your doctor about liver problems.
- Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed.
- Tell your doctor about any eye problems, especially narrow angle glaucoma.
- The label says height and weight should be monitored in children and adolescents, and that the medicine may cause urinary hesitancy or retention.
🔀 Atomoxetine with other medicines, food and alcohol
The label says to discuss these with your doctor or pharmacist
- MAOIs: The label warns of serious, sometimes fatal reactions when atomoxetine is combined with an MAOI or other drugs that affect brain monoamine levels. Atomoxetine should not be taken with an MAOI or within 2 weeks after stopping one.
- CYP2D6 inhibitors, such as paroxetine, fluoxetine, and quinidine: These can raise atomoxetine levels in the body to levels similar to those seen in people who process the drug slowly. The label says dose adjustment may be needed.
- Antihypertensive drugs and pressor agents (such as dopamine and dobutamine): These may affect blood pressure, so the label says atomoxetine should be used cautiously with them.
- Albuterol and other beta 2 agonists: Atomoxetine may increase the effect of these drugs on heart rate and blood pressure, so the label says to use it with caution.
Alcohol and food
The label does not say.
🤰 Atomoxetine in pregnancy and breastfeeding
Pregnancy
The label says it is not known if atomoxetine will harm an unborn baby. Available published studies in pregnant women are not enough to establish whether there is a risk of major birth defects, miscarriage, or other problems. Some animal studies showed adverse developmental effects. The label says there is a pregnancy registry for females exposed to ADHD medicines, including atomoxetine. Talk to your doctor if you are pregnant or plan to become pregnant. Registration information: National Pregnancy Registry for ADHD Medications, 1-866-961-2388.
Breastfeeding
The label says it is not known if atomoxetine passes into breast milk. Talk to your doctor about the best way to feed your baby.
🗓️ Storage, missed doses and taking too much
Storage
Store at 20 to 25 degrees C (68 to 77 degrees F). The label says short excursions between 15 and 30 degrees C (59 and 86 degrees F) are permitted.
If a dose is missed
The label does not say.
If too much is taken
The label says there is limited clinical trial experience with atomoxetine overdose. There have been no reported deaths from atomoxetine alone, including intentional overdoses. Deaths have been reported in mixed overdoses with at least one other drug. Seizures have been reported in some overdose cases. The most common symptoms were stomach problems, sleepiness, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. If you think someone has taken too much, get emergency medical help right away.
🗒️ Questions to ask about Atomoxetine
🎯 Check what you understood
1. The boxed warning about suicidal thoughts focuses on which group?
2. Which drug class should atomoxetine not be taken with?
3. How does the label say atomoxetine capsules should be stored?
❓ Atomoxetine: frequently asked questions
Is atomoxetine approved for depression?
The label says atomoxetine is approved for ADHD in pediatric and adult patients. It is not approved for major depressive disorder.
Is the risk of suicidal thoughts the same throughout treatment?
The label says a greater risk of suicidal ideation was seen early during treatment in children and adolescents. It also says the chance may be higher during dose adjustments.
Can atomoxetine affect the liver?
The label says atomoxetine can cause liver injury in some patients. Signs to report include itching, right upper belly pain, dark urine, yellow skin or eyes, and unexplained flu-like symptoms.
What ages has this medicine been studied in?
The label says effectiveness was established in trials of patients ages 6 to 18 and in adults. The Medication Guide says it has not been studied in children younger than 6.
What should I know about pregnancy?
The label says it is not known if atomoxetine will harm an unborn baby, and there is a pregnancy registry for people taking ADHD medicines. Talk to your doctor if you are pregnant or plan to become pregnant.
🧪 Tests and reports linked to Atomoxetine
The label text mentions these. If you have one of these reports, get every line of it explained.
- Kidney function tests
a test or report linked to this medicine
- Metabolic panel (BMP, CMP)
a test or report linked to this medicine
- Culture and sensitivity
a test or report linked to this medicine
- Urinalysis
a test or report linked to this medicine
- Liver function tests
a test or report linked to this medicine
- ECG (EKG) reports
a test or report linked to this medicine
📖 Medical words used on this page
- Angina
Angina is chest pain or tightness caused by the heart muscle not getting enough blood and oxygen, usually from narrowed heart arteries.
- Antibiotic
An antibiotic is a medicine that kills bacteria or stops them growing; it treats bacterial infections, not viral ones like colds or flu.
- Antidepressant
An antidepressant is a medicine used to treat depression, and often anxiety, pain and other conditions, by acting on chemical messengers in the brain.
- Antihistamine
An antihistamine is a medicine that blocks histamine, used for allergy symptoms like sneezing, itching and hives. Some cause drowsiness.
- Antihypertensive
An antihypertensive is any medicine used to lower high blood pressure, such as ACE inhibitors, ARBs, calcium channel blockers or diuretics.
- Arrhythmia
An arrhythmia is a heartbeat that is too fast, too slow or irregular, because the heart's electrical signals are not working in their usual pattern.
- Boxed warning
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
- Congenital malformations
Congenital malformations are differences in the structure of the body that are present at birth, such as heart, spine or lip and palate defects.
- Contraindication
A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.
- Erectile dysfunction
Erectile dysfunction (ED) means difficulty getting or keeping an erection firm enough for sex. It is common and often treatable.
- Exacerbation
An exacerbation is a flare-up: a period when a long-term condition, such as asthma, COPD or hepatitis, suddenly gets worse.
- Glaucoma
Glaucoma is a group of eye conditions where the optic nerve is damaged, often linked to raised pressure inside the eye, which can affect sight.
- Hypertension
Hypertension means high blood pressure: the force of blood against artery walls stays higher than it should over time.
- Hypotension
Hypotension means low blood pressure. It can cause dizziness or fainting, and some medicines can lower blood pressure too far.
📖 Medical words on this page
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- Full official label on DailyMed ↗
US National Library of Medicine: the complete FDA label this page is based on
- Atomoxetine on MedlinePlus ↗
US National Library of Medicine's patient drug information
- Search the NHS website for Atomoxetine ↗
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Source: official FDA drug label (label updated 2026-06-25). Read the full label on DailyMed
MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.