Atomoxetine Hydrochloride Medication Guide

Conditions This Medication May Treat

Based on Bridgeway's clinical use. See the FDA "Uses" section below for approved indications.

ADHD (Attention-Deficit/Hyperactivity Disorder)

Uses (FDA Indications) (FDA source)

1 INDICATIONS AND USAGE Atomoxetine capsules are a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older. ( 1 ) Atomoxetine capsules are indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.

Dosage Forms & Strengths (FDA source)

3 DOSAGE FORMS AND STRENGTHS Each capsule contains atomoxetine hydrochloride, USP equivalent to: 10 mg of atomoxetine (Opaque White, Opaque White) 18 mg of atomoxetine (Opaque Gold, Opaque White) 25 mg of atomoxetine (Opaque Blue, Opaque White) 40 mg of atomoxetine (Opaque Blue, Opaque Blue) 60 mg of atomoxetine (Opaque Blue, Opaque Gold) 80 mg of atomoxetine (Opaque Orange, Opaque White) 100 mg of atomoxetine (Opaque Orange, Opaque Orange) Capsules: contain 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. ( 3 , 11 , 16 )

Warnings & Precautions (FDA source)

5 WARNINGS AND PRECAUTIONS Severe Liver Injury: Atomoxetine capsules should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ( 5.2 ) Serious Cardiovascular Reactions: Prior to atomoxetine capsules treatment, patients should have a careful history and physical exam to assess for presence of cardiovascular (CV) disease. Atomoxetine capsules generally should not be used in pediatric patients with known serious cardiac abnormalities, cardiomyopathy, serious arrhythmias. Consideration should be given to not using atomoxetine capsules in adults with clinically significant cardiac abnormalities. Patients who develop symptoms suggestive of cardiac disease during atomoxetine capsules treatment should stop atomoxetine capsules and undergo a prompt cardiac evaluation. ( 5.3 ) Increase in Blood Pressure and Heart Rate: Heart rate and blood pressure should be measured at baseline, following atomoxetine dosage increase, and periodically while on therapy. ( 5.4 ) New Psychotic or Manic Symptoms and Activation of Mania: If psychotic or manic symptoms occur, consider discontinuing atomoxetine capsules. ( 5.5 ) Aggressive Behavior or Hostility: Monitor for the appearance or worsening of aggressive behavior or hostility. ( 5.7 ) Effects on Urine Outflow: Urinary retention or hesitancy may occur. ( 5.9 ) Priapism: Prompt medical attention is required in the event of suspected priapism. ( 5.10 ) Effect on Growth in Pediatric Patients: Closely monitor growth (e.g., weight, height) in pediatric patients. ( 5.11 ) 5.1 Suicidal Thoughts and Behaviors in Pediatric Patients 6 Years of Age and Older All atomoxetine-treated pediatric patients should be monitored and observed closely for clinical worsening, suicidal thoughts and behavior, and unusual changes in behavior, especially during the initial few months of atomoxetine therapy, or at times of dosage changes, either increases or decreases. …

Common Side Effects (FDA source)

6 ADVERSE REACTIONS Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): Pediatric Clinical Studies: Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) Adult Clinical Studies: Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) Patients should be instructed to use caution when driving a car or operating hazardous machinery (because of somnolence) until they are reasonably certain that their performance is not affected by atomoxetine capsules. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Atomoxetine was administered to 5,382 pediatric patients 6 years of age and older in clinical ADHD studies (Studies 1, 2, 3, 4, and 5) [see Clinical Studies ( 14.1 )] and 1,007 adults in clinical ADHD studies (Studies 6 and 7) [see Clinical Studies ( 14.2 )] . In the ADHD clinical trials, 2,529 pediatric patients were treated for over 6 months which included 1,625 pediatric patients who were treated for longer than 1 year. Adverse Reactions in the Clinical Trials of Pediatric Patients 6 Years of Age and Older with ADHD Discontinuation of Treatment Due to Adverse Reactions in the Clinical Studies of Pediatric Patients 6 Years of Age and Older: In the acute placebo-controlled studies of pediatric patients 6 years of age and older with ADHD, 3% (48/1,613) of atomoxetine-treated pediatric patients and 1.4% (13/945) of placebo-treated pediatric patients discontinued due to an adverse reaction. …

Drug Interactions (FDA source)

7 DRUG INTERACTIONS Monoamine Oxidase Inhibitors: Concomitant use contraindicated. ( 4 , 7 ) Strong CYP2D6 Inhibitors: With concomitant use of atomoxetine capsules and strong CYP2D6 inhibitors, increase the titration intervals. ( 7 ) Antihypertensives: Increase the frequency of monitoring blood pressure and adjust atomoxetine capsules dosage as clinically appropriate. ( 7 ) Albuterol (or other beta2 agonists): Increase the frequency of monitoring blood pressure and heart rate. ( 7 ) See Table 8 for clinically significant drug interactions with atomoxetine and other drugs. Table 8: Clinically Significant Drug Interactions with Atomoxetine and Other Drugs Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management Atomoxetine is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue, or in patients who stopped an MAOI within 14 days. Mechanism and Clinical Effect(s) As with other drugs affecting brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability with fluctuations of vital signs, extreme agitation progressing to delirium/coma) with concomitant use of atomoxetine and an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Strong CYP2D6 Inhibitors Prevention or Management With concomitant use of atomoxetine and a strong CYP2D6 inhibitor, increase the titration interval [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. Mechanism and Clinical Effect(s) Atomoxetine is a CYP2D6 substrate. The concomitant use of atomoxetine and a strong CYP2D6 inhibitor increases atomoxetine exposure [see Clinical Pharmacology ( 12.3 )]. …

Interactions With Other Medications We Cover

FDA label text for Atomoxetine Hydrochloride or a related medication mentions the following combinations. Check any two medications with our interaction tool →

• Atomoxetine Hydrochloride + Sertraline Hydrochloride — Moderate
• Atomoxetine Hydrochloride + Paroxetine Hydrochloride — Minor

About this interaction data. These interactions were identified by automatically scanning FDA prescribing-label text for medications in Bridgeway's library. This is not a complete list and is not a substitute for review by your prescriber or pharmacist, who use comprehensive clinical databases. Always share your full medication list with your care team. How we source this data →

Contraindications (FDA source)

4 CONTRAINDICATIONS Contraindicated in patients ( 4 ): With known hypersensitivity to atomoxetine or other constituents of atomoxetine capsules. Taking or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) With narrow angle glaucoma With pheochromocytoma or history of pheochromocytoma With severe cardiac or vascular disorders whose condition would be expected to deteriorate with clinically important increases in blood pressure or heart rate Atomoxetine capsules are contraindicated in patients: With known hypersensitivity reaction to atomoxetine or other constituents of atomoxetine capsules. Hypersensitivity reactions included anaphylaxis, angioneurotic edema, urticaria, and rash [see Warnings and Precautions ( 5.8 )]. Taking, or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) [see Drug Interactions ( 7 )]. With narrow angle glaucoma. In clinical trials, atomoxetine capsules use was associated with an increased risk of mydriasis. With pheochromocytoma or a history of pheochromocytoma. …

Use in Specific Populations (FDA source)

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Increased exposure (AUC) to atomoxetine in subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase) compared to subjects with normal liver function. ( 8.6 and 12.3 ) Use in Genomic Subgroups: CYP2D6 poor metabolizers have higher systemic exposures which may increase the risks of atomoxetine capsules-related adverse reactions compared to other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) ( 8.7 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including atomoxetine, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ Risk Summary Available published studies with atomoxetine use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Some animal reproduction studies of atomoxetine had adverse developmental outcomes. One of 3 studies in pregnant rabbits dosed during organogenesis resulted in decreased live fetuses and an increase in early resorptions, as well as slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery. …

Most-Reported Adverse Events (FAERS)

Of 26,970 adverse-event reports mentioning Atomoxetine Hydrochloride submitted to the FDA, the most frequently reported reactions are:

• Drug Ineffective — 2,955 reports
• Nausea — 2,251 reports
• Fatigue — 2,246 reports
• Headache — 1,843 reports
• Vomiting — 1,815 reports
• Off Label Use — 1,799 reports
• Dizziness — 1,708 reports
• Insomnia — 1,618 reports
• Depression — 1,478 reports
• Somnolence — 1,461 reports

Source: FDA Adverse Event Reporting System (FAERS). These are voluntary, unverified reports from patients and providers worldwide — they do not mean the medication caused the reaction, and report counts reflect how widely a drug is used as much as its safety profile.

Recent FDA Recalls

There are 15 ongoing FDA recalls involving Atomoxetine Hydrochloride. See full medication safety feed →