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Atomoxetine (Strattera, Atoncy): Uses, Side Effects and Dosage

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Status:
Prescription (Rx) Boxed warning
Strength:
10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Atomoxetine

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

Atomoxetine capsules can cause serious side effects, including:

  • Suicidal thoughts and actions in children 6 years of age and older. Atomoxetine capsules can increase the risk of suicidal thoughts and actions in children ages 6 and older with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed.

How can I watch for and try to prevent suicidal thoughts and actions?

○ Pay close attention to, and tell your healthcare provider right away about, any changes, especially sudden changes, in mood, behavior, actions, thoughts, or feelings, or suicidal thoughts or actions. This is very important when atomoxetine capsules are started or when the dose is changed.

○ Keep all follow-up visits with the healthcare provider as scheduled. Tell your healthcare provider about symptoms between visits as needed, especially if you have concerns.

Tell your healthcare provider right away if any of the following symptoms develop during treatment, especially if they are new, worse, or worry you:

  • anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping
  • irritability
  • hostility or being angry or violent
  • acting aggressive
  • impulsivity
  • suicide attempts
  • extreme increase in activity or talking (mania)
  • depression
  • panic attacks
  • thoughts about suicide or dying
  • unusual decrease in activity (hypomania)
  • restlessness or feeling like you have to move
  • other unusual changes in mood or behavior

See "What are the possible side effects of atomoxetine capsules?" for more information about side effects

What are atomoxetine capsules?

Atomoxetine capsules are a prescription medicine used to treat ADHD in adults and children 6 years of age and older. Atomoxetine capsules may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

Atomoxetine capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

It is not known if atomoxetine capsules are safe and effective in children less than 6 years old.

Who should not take atomoxetine capsules?

Do not take atomoxetine capsules if you or your child:

  • are allergic to atomoxetine or any of the ingredients in atomoxetine capsules. See the end of this Medication Guide for a complete list of ingredients in atomoxetine capsules.
  • are taking or have stopped taking within the past 14 days a medicine called a monoamine oxidase inhibitor (MAOI).
  • have an eye problem called narrow angle glaucoma.
  • have or had a rare tumor called pheochromocytoma.
  • have severe heart or blood vessel problems that could get worse if your blood pressure or heart rate increases.

Before taking atomoxetine capsules, tell your healthcare provider about all medical conditions, including if you or your child:

  • Double click here to open Word Application.
  • have, or have a family history of, suicide thoughts or attempts, bipolar disorder, depression, mania, or hypomania.
  • have liver problems.
  • have, or have a family history of, heart problems, heart defects, irregular heartbeat, or sudden death.
  • have high blood pressure or low blood pressure.
  • have problems urinating such as trouble starting urination, weak stream, or not fully emptying the bladder.
  • have glaucoma.

  • are pregnant or plan to become pregnant. It is not known if atomoxetine capsules will harm the unborn baby.

    • Tell your healthcare provider right away if you or your child become pregnant or plan to become pregnant during treatment with atomoxetine capsules
  • are breastfeeding or plan to breastfeed. It is not known if atomoxetine passes into the breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with atomoxetine capsules.

Tell your healthcare provider about all the medicines that you or your child take, including prescription and over- the-counter medicines, vitamins, and herbal supplements.

Atomoxetine capsules and some medicines may interact with each other and cause serious side effects. Your healthcare provider will decide whether atomoxetine capsules can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

  • a MAOI, including linezolid and intravenous methylene blue
  • medicines that increase or decrease blood pressure
  • asthma medicines

Know the medicines you or your child take. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start any new medicines during treatment with atomoxetine capsules without talking to your healthcare provider first.

How should I take atomoxetine capsules?

  • Take atomoxetine capsules exactly as your healthcare provider tells you. Your healthcare provider may adjust the dose until it is right for you or your child.

  • Take atomoxetine capsules with or without food.

  • Swallow atomoxetine capsules whole. Do not open the capsules.
  • Atomoxetine capsules are usually taken 1 time a day in the morning, or 2 times a day, in the morning and in the late afternoon or early evening.
  • If you miss a dose of atomoxetine capsules, take the dose as soon as possible. Do not take more atomoxetine capsules than your healthcare provider prescribes in a 24-hour period.
  • If you take too much atomoxetine capsules, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking atomoxetine capsules?

  • Do not drive or operate heavy machinery until you know how atomoxetine capsules affects you. Atomoxetine capsules can cause sleepiness.
  • Do not get atomoxetine capsules in or near the eyes. Atomoxetine capsules can irritate the eyes. If atomoxetine capsules gets into the eyes, rinse them with water right away and tell your healthcare provider. If a capsule breaks, avoid touching the contents and wash your hands and any surfaces that they come in contact with as soon as possible.

What are possible side effects of atomoxetine capsules?

Atomoxetine capsules can cause serious side effects, including:

  • See "What is the most important information I should know about atomoxetine capsules?"
  • Severe liver damage.Your healthcare provider will check the blood levels of liver enzymes if symptoms of liver damage develop. Tell your healthcare provider right away if any of the following symptoms develop at any time during treatment:
  • itching
  • right upper stomach pain
  • dark urine
  • the skin or the white part of the eyes turns yellow
  • unexplained flu-like symptoms
  • Serious heart-related side effects.Atomoxetine capsules may increase the risk of serious heart problems including sudden death, heart attack, and stroke in adults and children who have serious heart problems or heart defects. Your healthcare provider should check for heart problems before starting treatment with atomoxetine capsules. Stop taking atomoxetine capsules and tell your healthcare provider or get medical help right away if any of the following symptoms develop during treatment:
  • chest pain
  • numbness of weakness, especially on one side of the body
  • loss of consciousness (fainting)
  • slurred speech
  • shortness of breath
  • vision changes
  • heart palpitations or fast heart rate
  • severe headache
  • Increases in blood pressure and heart rate. Your healthcare provider should check blood pressure and heart rate before starting treatment, if the dose is increased, and as needed during treatment.
  • New psychotic problems, manic symptoms, or mania episodes. People with bipolar disorder, or who have a higher risk of developing bipolar disorder, have an increased risk of developing mania. Tell your healthcare provider if any of the following symptoms develop during treatment:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
  • seeing or hearing things that are not real (hallucinations)
  • unusual decrease in activity
  • depression
  • Aggressive behavior or hostility. New or worsening aggressive behavior or hostility can happen during treatment.
  • Allergic reactions. Tell your healthcare provider right away if trouble breathing, hives, rash, or swelling of the face, eyes, lips, or throat develop during treatment.
  • Problems with urination. Atomoxetine capsules may cause problems with urination including decreased urine flow or trouble starting urination (urinary hesitation) or being unable to pass any urine (urinary retention). Tell your healthcare provider if any problems with urination develop during treatment.
  • Painful and prolonged erections (priapism). Priapism has happened in male children and adults who take atomoxetine capsules. Priapism is a serious problem that can cause lasting damage to the penis and may require surgery. Tell your healthcare provider and get medical help right away if you or your child develop priapism during treatment.
  • Effect on growth (height and weight) in children. Children should have their height and weight checked often during treatment.

The most common side effects of atomoxetine capsules in children include:

  • nausea
  • decreased appetite
  • vomiting
  • stomach (abdominal) pain
  • tiredness
  • sleepiness

The most common side effects of atomoxetine capsules in adults include:

  • constipation
  • dizziness
  • dry mouth
  • erectile dysfunction
  • nausea
  • urinary hesitation
  • decreased appetite

Atomoxetine capsules may cause sexual problems (dysfunction).Talk to your healthcare provider if any of the following symptoms develop:

Symptoms in males may include:Symptoms in females may include:
  • delayed ejaculation or inability to have an ejaculation
  • decreased sex drive
  • decreased sex drive
  • delayed orgasm or inability to have an orgasm
  • problems getting or keeping an erection

Your healthcare provider may stop atomoxetine capsules treatment if serious side effects develop during treatment.

These are not all of the possible side effects atomoxetine capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store atomoxetine capsules?

  • Store atomoxetine capsules at room temperature between 59 to 86°F (15 to 30°C).
  • Keep atomoxetine capsules and all medicines out of the reach of children.

General information about safe and effective use of atomoxetine capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine capsules for a condition for which it was not prescribed. Do not give atomoxetine capsules to other people, even if they have the same condition. It may harm them. You can ask your pharmacist or healthcare provider for information about atomoxetine capsules that is written for health professionals.

What are the ingredients in atomoxetine capsules?

Active ingredient:atomoxetine hydrochloride, USP.

Inactive ingredients:pregelatinized starch.

The capsule shell for atomoxetine capsules USP, 10 mg contain gelatin, titanium dioxide and sodium lauryl sulfate.

The capsule shell for atomoxetine capsules USP, 18 mg contain titanium dioxide, gelatin, iron oxide yellow and sodium lauryl sulfate.

The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contain titanium dioxide, gelatin, FD & C Blue No. 2 and sodium lauryl sulfate.

The capsule shell for atomoxetine capsules USP, 60 mg contain titanium dioxide, gelatin, iron oxide yellow, FD & C Blue No. 2 and sodium lauryl sulfate.

The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contain titanium dioxide, gelatin, iron oxide red, and sodium lauryl sulfate.

The imprinting ink for atomoxetine capsules USP, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg have the following components: black iron oxide, potassium hydroxide, propylene glycol, and shellac.

Manufactured by:

V-Ensure Pharma Technologies Pvt. Ltd

Raigad, Maharashtra 410206, India.

Distributed by:

Creekwood Pharmaceuticals LLC.

Parsippany, NJ 07054.

PA1150102

Revised: 08/2026

This Medication Guide has been approved by US Food and Drug administration.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 218875 · View the label on DailyMed

Revision date stated in the text: August 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Atomoxetine

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Norepinephrine Reuptake Inhibitor
Active ingredient Atomoxetine hydrochloride
Dosage form Capsule
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) PHARMAZONE
FDA approval ANDA 218875Abbreviated New Drug Application (ANDA) – generic drug Approved June 16, 2026
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 14 labelers list this drug on DailyMed
Recalls
  • April 30, 2026: Class II recall: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
  • January 29, 2025: Class II recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
  • January 29, 2025: Class II recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Show more recalls (2)+
  • January 29, 2025: Class II recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
  • January 29, 2025: Class II recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Packages (NDC)
Package
10 mg – 30 in 1 bottle NDC 82619-115-01
10 mg – 500 in 1 bottle NDC 82619-115-02
18 mg – 30 in 1 bottle NDC 82619-116-01
18 mg – 500 in 1 bottle NDC 82619-116-02
25 mg – 30 in 1 bottle NDC 82619-117-01
25 mg – 500 in 1 bottle NDC 82619-117-02
40 mg – 30 in 1 bottle NDC 82619-118-01
40 mg – 500 in 1 bottle NDC 82619-118-02
60 mg – 30 in 1 bottle NDC 82619-119-01
60 mg – 1000 in 1 bottle NDC 82619-119-02
80 mg – 30 in 1 bottle NDC 82619-120-01
80 mg – 1000 in 1 bottle NDC 82619-120-02
Show more packages (2)+
100 mg – 30 in 1 bottle NDC 82619-121-01
100 mg – 500 in 1 bottle NDC 82619-121-02

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.