Atomoxetine — $0 on Listed Strengths

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What Atomoxetine is approved for (FDA label)

Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies (14) ]. 1.2 Diagnostic Considerations A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years.

Source: Read the full FDA label on DailyMed. Label effective date: September 4, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Atomoxetine (FDA label)

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 hydrochloride 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 hydrochloride is approved for ADHD in pediatric and adult patients. Atomoxetine hydrochloride is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine hydrochloride in children and adolescents (a total of 12 trials involving over 2,200 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 hydrochloride compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine hydrochloride was 0.4% (5/1,357 patients), compared to none in placebo-treated patients (851 patients).

Source: FDA prescribing information (DailyMed). Set ID: d7002d75-edad-4141-91bf-7eebf50ad1aa. SPL document ID: 5aad6cf5-cd78-0a6c-e063-6394a90a7d06. Label effective date: September 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Atomoxetine (FDA label)

Each capsule contains atomoxetine HCl equivalent to 100 mg (Opaque dark brown, opaque dark brown) of atomoxetine. Each capsule contains atomoxetine HCl equivalent to 100 mg mg of atomoxetine.

Source: FDA prescribing information (DailyMed). Set ID: d7002d75-edad-4141-91bf-7eebf50ad1aa. SPL document ID: 5aad6cf5-cd78-0a6c-e063-6394a90a7d06. Label effective date: September 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Atomoxetine (FDA label)

Most common adverse reactions (≥ 5% and at least twice the incidence of placebo patients) Child and Adolescent Clinical Trials- Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. (6.1) Adult Clinical Trials - Constipation, dry mouth, nausea, fatigue, decreased appetite, dizziness, erectile dysfunction and urinary hesitation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Atomoxetine hydrochloride was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months.

Source: FDA prescribing information (DailyMed). Set ID: d7002d75-edad-4141-91bf-7eebf50ad1aa. SPL document ID: 5aad6cf5-cd78-0a6c-e063-6394a90a7d06. Label effective date: September 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Atomoxetine (FDA label)

Hypersensitivity to atomoxetine or other constituents of product. (4.1) Atomoxetine hydrochloride use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. ( 4.2 , 7.1 ) Narrow Angle Glaucoma. (4.3) Pheochromocytoma or history of pheochromocytoma. (4.4) Severe Cardiovascular Disorders that might deteriorate with clinically important increases in HR and BP. (4.5) 4.1 Hypersensitivity Atomoxetine capsules are contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product [see Warnings and Precautions (5.8) ]. 4.2 Monoamine Oxidase Inhibitors (MAOI) Atomoxetine capsules should not be taken with an MAOI, or within 2 weeks after discontinuing an MAOI. Treatment with an MAOI should not be initiated within 2 weeks after discontinuing atomoxetine capsules.

Source: FDA prescribing information (DailyMed). Set ID: d7002d75-edad-4141-91bf-7eebf50ad1aa. SPL document ID: 5aad6cf5-cd78-0a6c-e063-6394a90a7d06. Label effective date: September 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Atomoxetine (FDA label)

Suicidal Ideation - Monitor for suicidality, clinical worsening, and unusual changes in behavior. (5.1) Severe Liver Injury - Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. (5.2) Serious Cardiovascular Events- Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease. Atomoxetine hydrochloride generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects.

Source: FDA prescribing information (DailyMed). Set ID: d7002d75-edad-4141-91bf-7eebf50ad1aa. SPL document ID: 5aad6cf5-cd78-0a6c-e063-6394a90a7d06. Label effective date: September 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Atomoxetine (FDA label)

Monoamine Oxidase Inhibitors. ( 4.2 , 7.1 ) CYP2D6 Inhibitors - Concomitant use may increase atomoxetinesteady-state plasma concentrations in EMs. (7.2) Antihypertensive Drugs and Pressor Agents - Possible effects on blood pressure. (7.3) Albuterol (or other beta 2 agonists) - Action of albuterol on cardiovascular system can be potentiated. (7.4) 7.1 Monoamine Oxidase Inhibitors With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) when taken in combination with an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome.

Source: FDA prescribing information (DailyMed). Set ID: d7002d75-edad-4141-91bf-7eebf50ad1aa. SPL document ID: 5aad6cf5-cd78-0a6c-e063-6394a90a7d06. Label effective date: September 4, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.