Strattera Atomoxetine hydrochloride 60 mg Capsule, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Norepinephrine Reuptake Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Atomoxetine is used as part of a total treatment program to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD. Atomoxetine is in a class of medications called selective norepinephrine reuptake inhibitors. It works by increasing the levels of norepinephrine, a natural substance in the brain that is needed to control behavior.
Read the full MedlinePlus article ↗- No — atomoxetine is not a stimulant. It works differently from medications like amphetamines or methylphenidate. Instead of stimulating the brain directly, it blocks the reuptake o...
- Is atomoxetine a stimulant like other ADHD medications?
- Atomoxetine typically takes several weeks to reach its full effect — it's not something you'll feel on the first day. Your prescriber will usually start you on a lower dose and gra...
- How long does it take before I notice atomoxetine working?
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🧪 Inactive Ingredients / Excipients
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Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $13.658 | $409.75 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $14.41 | $432.39 / 30 capsules |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Atomoxetine 60 mg 00093-3546-56 | Teva | 30 capsules | $0.498 | AB | Availability likely | save 96% |
| atomoxetine 60 mg 16714-0759-01 | Northstar | 30 capsules | $0.498 | AB | Availability likely | save 96% |
| Atomoxetine 60 mg 31722-0718-30 | Camber | 30 capsules | $0.498 | AB | Availability likely | save 96% |
| Atomoxetine Hydrochloride 60 mg 50268-0059-13 | AvPAK | 30 capsules | $0.498 | AB | Availability likely | save 96% |
| Atomoxetine Hydrochloride 60 mg 60505-2834-03 | Apotex | 30 capsules | $0.498 | AB | Availability likely | save 96% |
| Atomoxetine 60 mg 64380-0476-01 | Strides | 30 capsules | $0.498 | AB | Availability likely | save 96% |
| Atomoxetine 60 mg 64980-0377-03 | Rising | 30 capsules | $0.498 | AB | Availability likely | save 96% |
| Atomoxetine 60 mg 72603-0439-01 | NorthStar | 30 capsules | $0.498 | AB | Availability likely | save 96% |
| Strattera 60 mgthis 00002-3239-30 | Eli | 30 capsules | $13.658 | — | Availability likely | — |
| Atomoxetine 60 mg 42291-0068-30 | AvKARE | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine 60 mg 50090-6254-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine 60 mg 50090-6444-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| atomoxetine 60 mg 50090-7397-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine Hydrochloride 60 mg 51407-0104-30 | Golden | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine 60 mg 55111-0522-05 | Dr. | 500 capsules | — | AB | FDA listed | — |
| Atomoxetine 60 mg 63629-9428-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine 60 mg 65862-0242-30 | Aurobindo | 30 capsules | — | AB | FDA listed | — |
| atomoxetine 60 mg 68462-0269-23 | Glenmark | 2000 capsules | — | AB | FDA listed | — |
| atomoxetine 60 mg 71335-2361-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine 60 mg 71335-9702-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine 60 mg 72162-2545-03 | Bryant | 30 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00002-3239-30 You're viewing this | 30 CAPSULE in 1 BOTTLE (0002-3239-30) | 2003-01-10 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER All STRATTERA-treated pediatric patients 6 years of age or older should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes. Families and caregivers should be advised of the need for close observation and communication with the health care provider. Consider stopping STRATTERA in patients who experience emergent suicidal thoughts and behavior [see Warnings and Precautions ( 5.1 )].
STRATTERA increased the risk of suicidal ideation in pediatric patients aged 6 years of age and older with attention-deficit/hyperactivity disorder (ADHD) in short-term studies. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER See full prescribing information for complete boxed warning. All STRATTERA-treated pediatric patients 6 years of age or older should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes ( 5.1 ) Consider stopping STRATTERA in patients who experience emergent suicidal thoughts and behavior ( 5.1 ) STRATTERA increased the risk of suicidal ideation in pediatric patients aged 6 years of age and older with attention-deficit/hyperactivity disorder (ADHD) in short-term studies ( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. STRATTERA ® is a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Prior to initiating treatment with STRATTERA, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 , 5.6 ) See table below for the recommended STRATTERA dosage. ( 2.3 ) 1 Administer either as once daily dosage in the morning or as evenly divided twice daily dosage in the morning and late afternoon/early evening.
Age and Body Weight Starting Dosage Target Dosage 1 Maximum Total Daily Dose 1 Pediatrics who weigh less than 70 kg 0.5 mg/kg/day 1.2 mg/kg/day 1.4 mg/kg/day or 100 mg/day (whichever is less) Pediatrics who weigh 70 kg or more and adults 40 mg/day 80 mg/day 100 mg/day For the recommended dosage in patients with hepatic impairment, see Full Prescribing Information. ( 2.4 ) For the recommended dosage with concomitant use of a strong CYP2D6 inhibitor or in CYP2D6 poor metabolizers, see Full Prescribing Information. ( 2.5 )
2.1Recommendations Prior to Initiating STRATTERA Treatment Prior to initiating treatment with STRATTERA, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.6 )].
2.2Administration Instructions STRATTERA may be taken with or without food. Take STRATTERA capsules whole; do not open the capsules.
2.3Recommended Dosage Table 1 includes the recommended STRATTERA dosage in adult patients and pediatric patients 6 years of age and older for acute treatment of ADHD. Table 1: Recommended Dosage of STRATTERA for Acute Treatment of ADHD a Administer either as once daily dosage in the morning or as evenly divided twice daily dosage in the morning and late afternoon/early evening. b No additional benefit has been demonstrated with STRATTERA dosages higher than 1.2 mg/kg/day [see Clinical Studies ( 14 )] . c If a patient has not achieved an optimal response at 80 mg/day after 2 to 4 additional weeks, may increase the dosage to a maximum of 100 mg/day.
There is no data that supports increased effectiveness at a dosage higher than 100 mg/day [see Clinical Studies ( 14 )] . Age and Body Weight Starting Dosage Titration Interval Target Dosage Maximum Dosage Pediatric patients who weigh less than 70 kg 0.5 mg/kg/day Minimum of 3 days 1.2 mg/kg/day a,b 1.4 mg/kg/day or 100 mg/day, whichever is less a Pediatric patients who weigh 70 kg or more and adult patients 40 mg/day Minimum of 3 days 80 mg/day a 100 mg/day a,c The health care provider who elects to use STRATTERA for extended periods should periodically reevaluate the long-term usefulness of STRATTERA for the individual patient.
2.4Recommended Dosage in Patients with Hepatic Impairment For patients aged 6 years of age or older with: Severe hepatic impairment (HI) (Child-Pugh Class C), the recommended initial and target STRATTERA dosage is 25% of recommended dosage in patients with normal hepatic function [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] . Moderate HI (Child-Pugh Class B), the recommended initial and target STRATTERA dosage is 50% of the recommended dosage in patients with normal hepatic function [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .
Mild HI (Child-Pugh Class A), the recommended initial and target STRATTERA dosage is the same as those with normal hepatic function.
2.5Recommended Dosage with Concomitant Use of Strong CYP2D6 Inhibitors or in CYP2D6 Poor Metabolizers Consider genetic testing to determine the patient's CYP2D6 metabolizer status. In patients taking a concomitant strong CYP2D6 inhibitor or who are CYP2D6 poor metabolizers, a longer titration interval of 4 weeks is recommended, if ADHD symptoms fail to improve and the initial STRATTERA dosage is well tolerated. The recommended starting, target, and maximum STRATTERA dosages are the same as outlined in Table 1 [ see Dosage and Administration ( 2.3 ) ].
For other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate), follow the recommended dosage, including the recommended…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Capsules: 10 mg of atomoxetine (opaque white, opaque white) 18 mg of atomoxetine (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, gold) 80 mg of atomoxetine (opaque brown, opaque white) 100 mg of atomoxetine (opaque brown, opaque brown) Capsules: contain 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. ( 3 , 11 , 16 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS STRATTERA is contraindicated in patients: With known hypersensitivity reaction to atomoxetine or other constituents of STRATTERA. 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, STRATTERA use was associated with an increased risk of mydriasis. With pheochromocytoma or a history of pheochromocytoma.
Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received STRATTERA. With severe cardiac or vascular disorders whose condition would be expected to deteriorate if they had a clinically important increase in blood pressure or heart rate (e.g., 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate) [see Warnings and Precautions ( 5.4 )] . Contraindicated in patients ( 4 ): With known hypersensitivity to atomoxetine or other constituents of STRATTERA 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
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Severe Liver Injury: STRATTERA should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ( 5.2 ) Serious Cardiovascular Reactions: Prior to STRATTERA treatment, patients should have a careful history and physical exam to assess for presence of cardiovascular (CV) disease. STRATTERA generally should not be used in pediatric patients with known serious cardiac abnormalities, cardiomyopathy, serious arrhythmias.
Consideration should be given to not using STRATTERA in adults with clinically significant cardiac abnormalities. Patients who develop symptoms suggestive of cardiac disease during STRATTERA treatment should stop STRATTERA 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 STRATTERA 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 STRATTERA. ( 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 )
5.1Suicidal Thoughts and Behaviors in Pediatric Patients 6 Years of Age and Older All STRATTERA-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 STRATTERA therapy, or at times of dosage changes, either increases or decreases. Families and caregivers of STRATTERA-treated pediatric patients should be alerted about the need to monitor patients daily for the emergence of agitation, irritability, unusual changes in behavior, and mental health-related symptoms, as well as the emergence of suicidal thoughts and behavior, and to report such symptoms immediately to a health care provider.
Consider changing the therapeutic regimen, including stopping STRATTERA, in patients who experience emergent suicidality or symptoms that might be precursors to emerging suicidal thoughts and behavior, especially if these symptoms are severe or abrupt in onset, or were not part of the patient's presenting symptoms. STRATTERA increased the risk of suicidal ideation in pediatric patients 6 years and older with ADHD in pooled placebo-controlled short-term studies (6 to 18 weeks). In 12 studies (11 studies in patients with ADHD and 1 study in another population) with over 2,200 pediatric patients, the mean incidence of suicidal ideation in STRATTERA-treated pediatric patients was 0.4% (5/1,357) (including one patient with a suicide attempt) compared to 0% (0/851) in placebo-treated pediatric patients.
No suicides occurred in these studies. All the suicidal ideations occurred in pediatric patients 6 to 12 years of age, and all occurred during the first month of STRATTERA treatment. It is unknown whether the risk of suicidal ideation in pediatric patients extends to longer-term use.
A similar analysis in adult patients treated with STRATTERA for ADHD did not reveal an increased risk of suicidal ideation or behavior. The following psychiatric symptoms have been reported with STRATTERA: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania and mania. Although a causal link between the emergence of such symptoms and the emergence of suicidal impulses has not been established, there is a concern that such symptoms may represent precursors to emerging suicidality.
5.2Severe Liver Injury STRATTERA should be discontinued and not restarted in patients with jaundi…
🤒 Adverse Reactions ▾
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 STRATTERA.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. STRATTERA 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 STRATTERA-treated pediatric patients and 1.4% (13/945) of placebo-treated pediatric patients discontinued due to an adverse reaction.
Among STRATTERA-treated patients, irritability (0.3%, N=5); somnolence (0.3%, N=5); aggression (0.2%, N=4); nausea (0.2%, N=4); vomiting (0.2%, N=4); abdominal pain (0.2%, N=4); constipation (0.1%, N=2); fatigue (0.1%, N=2); feeling abnormal (0.1%, N=2); and headache (0.1%, N=2) were the reasons for discontinuation reported by more than one patient. For all studies, (including open-label and long-term studies), 6% of STRATTERA-treated pediatric patients who were other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) and 11% of those who were CYP2D6 poor metabolizers discontinued due to an adverse reaction.
Common Adverse Reactions in the Clinical Studies of Pediatric Patients 6 Years of Age and Older: Common adverse reactions (incidence of 2% or greater in STRATTERA-treated patients and with a higher incidence in STRATTERA-treated patients compared to placebo-treated patients) in pediatric patients 6 years of age and older with ADHD are listed in Table 2 . The most commonly observed adverse reactions in STRATTERA-treated patients (incidence of ≥5% and ≥ twice the incidence in placebo-treated patients), for either twice daily or once daily dosing were: nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence ( see Tables 2 and 3 ).
Table 2: Common Adverse Reactions a in Acute Studies (up to 18 weeks) in Pediatric Patients 6 Years and Older with ADHD a Adverse reactions reported by at least 2% of STRATTERA-treated patients and greater than placebo-treated patients. b Abdominal pain includes the terms: upper abdominal pain, and epigastric discomfort. c Somnolence includes the term sedation. Adverse Reaction STRATTERA (N=1,597) Placebo (N=934) Headache 19% 15% Abdominal pain b 18% 10% Decreased appetite 16% 4% Somnolence c 11% 4% Vomiting 11% 6% Nausea 10% 5% Fatigue 8% 3% Irritability 6% 3% Dizziness 5% 2% Decreased weight 3% 0% Anorexia 3% 1% Rash 2% 1% Adverse reaction in the STRATTERA-treated patients who received twice daily, and once daily dosing are shown in Table 3 (adverse reactions based on sta…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS See Table 8 for clinically significant drug interactions with STRATTERA and other drugs. Table 8: Clinically Significant Drug Interactions with STRATTERA and Other Drugs Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management STRATTERA 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 STRATTERA and an MAOI.
Some cases presented with features resembling neuroleptic malignant syndrome. Strong CYP2D6 Inhibitors Prevention or Management With concomitant use of STRATTERA 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 STRATTERA and a strong CYP2D6 inhibitor increases atomoxetine exposure [see Clinical Pharmacology ( 12.3 )] . Antihypertensive Drugs Prevention or Management Increase the frequency of monitoring blood pressure and adjust STRATTERA dosage as clinically appropriate. Mechanism and Clinical Effect(s) Because of increased risk of increased blood pressure, STRATTERA should be used cautiously with antihypertensive drugs, other drugs that increase blood pressure or pressor drugs (e.g., dopamine, dobutamine).
Albuterol or Other Beta2 Agonists Prevention or Management Increase the frequency of monitoring blood pressure and heart rate and adjust STRATTERA dosage as clinically appropriate. Mechanism and Clinical Effect(s) Systemically administered albuterol (e.g., oral) can be potentiated by atomoxetine, resulting in increases in heart rate and blood pressure. [see Clinical Pharmacology ( 12.3 )]. Monoamine Oxidase Inhibitors: Concomitant use contraindicated.
( 4 , 7 ) Strong CYP2D6 Inhibitors: With concomitant use of STRATTERA and strong CYP2D6 inhibitors, increase the titration intervals. ( 7 ) Antihypertensives: Increase the frequency of monitoring blood pressure and adjust STRATTERA dosage as clinically appropriate. ( 7 ) Albuterol (or other beta2 agonists): Increase the frequency of monitoring blood pressure and heart rate.
( 7 )
👥 Use in Specific Populations ▾
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 STRATTERA-related adverse reactions compared to other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) ( 8.7 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including STRATTERA, 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 STRATTERA 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. These effects were observed at plasma levels (AUC) 3 times and 0.4 times the human plasma levels in other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) and poor metabolizers receiving the maximum recommended human dose (MRHD), respectively.
In rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m 2 basis. In one of 2 studies in which rats were dosed prior to mating through the periods of organogenesis and lactation, decreased pup weight and decreased pup survival were observed at doses corresponding to 5-6 times the MRHD on a mg/m 2 basis. No adverse fetal effects were seen in pregnant rats dosed during the organogenesis period (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data: Pregnant rabbits were treated with up to 100 mg/kg/day of atomoxetine by gavage throughout the period of organogenesis. At this dose, in 1 of 3 studies, a decrease in live fetuses and an increase in early resorptions was observed. Slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery were observed.
These findings were observed at doses that caused slight maternal toxicity. The no-effect dose for these findings was 30 mg/kg/day. The 100 mg/kg dose is approximately 23 times the MRHD on a mg/m 2 basis; plasma levels (AUC) of atomoxetine at this dose in rabbits are estimated to be 3.3 times (other CYP2D6 metabolizer types) or 0.4 times (CYP2D6 poor metabolizers) those in humans receiving the MRHD.
Rats were treated with up to approximately 50 mg/kg/day of atomoxetine (approximately 6 times the MRHD on a mg/m 2 basis) in the diet from 2 weeks (females) or 10 weeks (males) prior to mating through the periods of organogenesis and lactation. In 1 of 2 studies, decreases in pup weight and pup survival were observed. The decreased pup survival was also seen at 25 mg/kg (but not at 13 mg/kg).
In a study in which rats were treated with atomoxetine in the diet from 2 weeks (females) or 10 weeks (males) prior to mating throughout the period of organogenesis…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including STRATTERA, 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 STRATTERA 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. These effects were observed at plasma levels (AUC) 3 times and 0.4 times the human plasma levels in other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) and poor metabolizers receiving the maximum recommended human dose (MRHD), respectively.
In rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m 2 basis. In one of 2 studies in which rats were dosed prior to mating through the periods of organogenesis and lactation, decreased pup weight and decreased pup survival were observed at doses corresponding to 5-6 times the MRHD on a mg/m 2 basis. No adverse fetal effects were seen in pregnant rats dosed during the organogenesis period (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data: Pregnant rabbits were treated with up to 100 mg/kg/day of atomoxetine by gavage throughout the period of organogenesis. At this dose, in 1 of 3 studies, a decrease in live fetuses and an increase in early resorptions was observed. Slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery were observed.
These findings were observed at doses that caused slight maternal toxicity. The no-effect dose for these findings was 30 mg/kg/day. The 100 mg/kg dose is approximately 23 times the MRHD on a mg/m 2 basis; plasma levels (AUC) of atomoxetine at this dose in rabbits are estimated to be 3.3 times (other CYP2D6 metabolizer types) or 0.4 times (CYP2D6 poor metabolizers) those in humans receiving the MRHD.
Rats were treated with up to approximately 50 mg/kg/day of atomoxetine (approximately 6 times the MRHD on a mg/m 2 basis) in the diet from 2 weeks (females) or 10 weeks (males) prior to mating through the periods of organogenesis and lactation. In 1 of 2 studies, decreases in pup weight and pup survival were observed. The decreased pup survival was also seen at 25 mg/kg (but not at 13 mg/kg).
In a study in which rats were treated with atomoxetine in the diet from 2 weeks (females) or 10 weeks (males) prior to mating throughout the period of organogenesis, a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at 40 mg/kg/day (approximately 5 times the MRHD on a mg/m 2 basis) but not at 20 mg/kg/day. No adverse fetal effects were seen when pregnant rats were treated with up to 150 mg/kg/day (approximately 17 times the MRHD on a mg/m 2 basis) by gavage throughout the period of organogenesis.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of STRATTERA for the treatment of ADHD have been established in pediatric patients 6 years of age and older. Anyone considering the use of STRATTERA in a pediatric patient should balance the potential risks with the clinical need [see Boxed Warning and Warnings and Precautions ( 5.1 , 5.3 , 5.4 , 5.10 )] . The atomoxetine pharmacokinetics in pediatric patients 6 years of age and older were similar to those in adults.
The safety and effectiveness of STRATTERA in pediatric patients less than 6 years of age have not been established. Juvenile Toxicity Animal Data A study was conducted in young rats to evaluate the effects of atomoxetine on growth and neurobehavioral and sexual development. Rats were treated with 1, 10, or 50 mg/kg/day (approximately 0.2, 2, and 8 times, respectively, the maximum human dose on a mg/m 2 basis) of atomoxetine given by gavage from the early postnatal period (Day 10 of age) through adulthood.
Slight delays in onset of vaginal patency (all doses) and preputial separation (10 and 50 mg/kg), slight decreases in epididymal weight and sperm number (10 and 50 mg/kg), and a slight decrease in corpora lutea (50 mg/kg) were seen, but there were no effects on fertility or reproductive performance. A slight delay in onset of incisor eruption was seen at 50 mg/kg. A slight increase in motor activity was seen on Day 15 (males at 10 and 50 mg/kg and females at 50 mg/kg) and on Day 30 (females at 50 mg/kg) but not on Day 60 of age.
There were no effects on learning and memory tests. The significance of these findings to humans is unknown.
🧓 Geriatric Use ▾
8.5Geriatric Use The safety, efficacy and pharmacokinetics of STRATTERA in geriatric patients have not been evaluated. Clinical studies of STRATTERA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE During postmarketing use, there have been fatalities reported involving a mixed ingestion overdose of STRATTERA and at least one other drug. There have been no reports of death involving overdose of STRATTERA alone, including intentional overdoses at amounts up to 1,400 mg (14 times the maximum recommended dosage). The most commonly reported symptoms with acute and chronic overdoses of STRATTERA were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior.
Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most events were mild to moderate.
In some cases of overdose involving STRATTERA, seizures have been reported. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations [see Clinical Pharmacology ( 12.2 )] . If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of STRATTERA overdose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The precise mechanism by which STRATTERA produces its therapeutic effects in ADHD is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.
12.2Pharmacodynamics An exposure-response analysis of STRATTERA (0.5, 1.2 or 1.8 mg/kg/day) or placebo demonstrated atomoxetine exposure correlates with efficacy as measured by the ADHD Rating Scale-IV-Parent Version: Investigator administered and scored. The exposure-efficacy relationship was similar to that observed between STRATTERA dosage and efficacy with median atomoxetine exposures at the two highest doses resulting in near maximal changes from baseline [see Clinical Studies ( 14.2 )] . Cardiac Electrophysiology The effect of STRATTERA on QTc interval prolongation was evaluated in a randomized, double-blinded, positive-(moxifloxacin 400 mg) and placebo-controlled, cross-over study in healthy male CYP2D6 poor metabolizers.
A total of 120 healthy subjects were administered STRATTERA (20 mg and 60 mg) twice daily for 7 days. No large changes in QTc interval (i.e., increases >60 msec from baseline, absolute QTc >480 msec) were observed in the study. However, small changes in QTc interval cannot be excluded from this study, because the study failed to demonstrate assay sensitivity.
There was a slight increase in QTc interval with increased atomoxetine concentration. Pharmacodynamic Drug Interaction Studies Consumption of ethanol with STRATTERA did not change the intoxicating effects of ethanol. Concomitant use of STRATTERA with methylphenidate did not increase cardiovascular effects beyond those seen with methylphenidate alone.
Albuterol 600 mcg given intravenously over 2 hours (albuterol is not approved for intravenous use) induced heart rate and blood pressure increases; these effects were potentiated when co-administered with STRATTERA (60 mg twice daily for 5 days), particularly initially [see Drug Interactions ( 7 )].
12.3Pharmacokinetics Pharmacokinetic parameters for atomoxetine and its metabolites in CYP2D6 poor metabolizers and other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) are presented in Table 9 . Table 9: Atomoxetine and Metabolite Pharmacokinetics in Adult CYP2D6 Poor Metabolizers and Other CYP2D6 Metabolizer Types Abbreviations : C max,ss = maximum atomoxetine plasma concentration at steady state; T max = time to peak concentration a In this analysis, other CYP2D6 metabolizer types were defined as individuals who were not CYP2D6 poor metabolizers and included CYP2D6 ultrarapid, normal, and intermediate metabolizers. b CYP2D6 poor metabolizers were defined as individuals with two nonfunctional alleles (e.g., CYP2D6*3/*4, CYP2D6*5/*5 ), and as a result no CYP2D6 enzyme activity. c Primarily formed by CYP2D6.The major oxidative metabolite formed, regardless of CYP2D6 metabolizer type, and is further glucuronidated.
4-Hydroxyatomoxetine is equipotent to atomoxetine as an inhibitor of the norepinephrine transporter. d 4-hydroxyatomoxetine is formed at a slower rate by several other cytochrome P450 enzymes. e Formed by CYP2C19 and other cytochrome P450 enzymes but has substantially (20-fold) less pharmacological activity compared with atomoxetine. Parameter Other CYP2D6 Metabolizer Types a CYP2D6 Poor Metabolizers b Absorption Dose proportionality 10-120 mg Accumulation 1.1-fold 3.3-fold Absolute bioavailability 63% 94% T max median 1 hour 2.5 hour Effect of Food AUC: Unchanged; C max : Decreased 37%; T max : Delayed 3 hours Distribution Protein Binding 98% Volume of distribution
0.85L/kg Elimination Atomoxetine half-life 5.2 hours 21.6 hours Atomoxetine apparent oral clearance
0.35 L/hr/kg
0.03L/hr/kg 4-Hydroxyatomoxetine half-life 6 to 8 hours -- N-Desmethylatomoxetine half-life 6 to 8 hours 34 to 40 hours Metabolism Primary metabolic pathways CYP2D6 Other CYP enzymes 4-Hydrox…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The precise mechanism by which STRATTERA produces its therapeutic effects in ADHD is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Table 10 displays the available STRATTERA (atomoxetine) capsules strengths. Table 10: STRATTERA (atomoxetine) Capsules Strengths a Strength is based on the base (atomoxetine). Strength a Color Identification NDC 10 mg opaque white, opaque white LILLY 3227 0002-3227-30 18 mg gold, opaque white LILLY 3238 0002-3238-30 25 mg opaque blue, opaque white LILLY 3228 0002-3228-30 40 mg opaque blue, opaque blue LILLY 3229 0002-3229-30 60 mg opaque blue, gold LILLY 3239 0002-3239-30 80 mg opaque brown, opaque white LILLY 3250 0002-3250-30 100 mg opaque brown, opaque brown LILLY 3251 0002-3251-30
16.2Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
16.1How Supplied Table 10 displays the available STRATTERA (atomoxetine) capsules strengths. Table 10: STRATTERA (atomoxetine) Capsules Strengths a Strength is based on the base (atomoxetine). Strength a Color Identification NDC 10 mg opaque white, opaque white LILLY 3227 0002-3227-30 18 mg gold, opaque white LILLY 3238 0002-3238-30 25 mg opaque blue, opaque white LILLY 3228 0002-3228-30 40 mg opaque blue, opaque blue LILLY 3229 0002-3229-30 60 mg opaque blue, gold LILLY 3239 0002-3239-30 80 mg opaque brown, opaque white LILLY 3250 0002-3250-30 100 mg opaque brown, opaque brown LILLY 3251 0002-3251-30
📦 Storage and Handling ▾
16.2Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R (-) isomer as determined by x-ray diffraction and its chemical designation is (-)- N -Methyl-3-phenyl-3-( o -tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NO•HCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water.
STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone.
The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients: FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicide Risk Patients, their families, and their caregivers should be alerted about the need to monitor patients daily for the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during STRATTERA treatment and when the dosage is adjusted.
Such symptoms should be reported to the patient's health care provider immediately [see Warnings and Precautions ( 5.1 )] . Severe Liver Injury Patients initiating STRATTERA should be cautioned that severe liver injury may develop. Patients should be instructed to contact their healthcare provider immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained “flu-like” symptoms [see Warnings and Precautions ( 5.2 )] .
Serious Cardiovascular Reactions Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during STRATTERA treatment should stop STRATTERA and contact a health care provider [see Warnings and Precautions ( 5.3 )] . Increased Blood Pressure or Heart Rate STRATTERA can increase blood pressure and heart rate [see Warnings and Precautions ( 5.4 )]. Emergence of New Psychotic or Manic Symptoms and Activation of Mania Instruct patients and their caregivers to look for signs of activation of mania/hypomania and psychosis [see Warnings and Precautions ( 5.5 )] .
Aggression or Hostility Instruct patients and their caregivers to contact their healthcare provider as soon as possible should they notice an increase in aggression or hostility [see Warnings and Precautions ( 5.7 )] . Priapism The parents or guardians of pediatric patients taking STRATTERA and adult patients taking STRATTERA should be instructed that priapism requires prompt medical attention [see Warnings and Precautions ( 5.10 )] . Ocular Irritant STRATTERA is an ocular irritant.
STRATTERA capsules are not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.
Drug-Drug Interactions Patients should be instructed to consult a healthcare provider if they are taking or plan to take any prescription or over-the-counter drugs, dietary supplements, or herbal remedies [see Drug Interactions ( 7 )] . Sexual Dysfunction Advise patients that STRATTERA may impair sexual function. Advise patients if they experience sexual dysfunction, they should contact their health care provider [see Adverse Reactions ( 6.1 )].
Pregnancy Registry Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to atomoxetine during pregnancy [see Use in Specific Populations ( 8.1 )]. Food Patients may take STRATTERA with or without food. Missed Dose If patients miss a dose, they should be instructed to take it as soon as possible but should not take more than the prescribed total daily amount of STRATTERA in any 24-hour period.
Somnolence The incidence of somnolence was higher in STRATTERA-treated patients than placebo-treated patients [ see Adverse Reactions ( 6.1 )]. Patients should be instructed to use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by STRATTERA. Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA Copyright © 2002, 2026, Eli Lilly and Company.
All rights reserved. STR-0006-USPI-20260629
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2026 STR-0002-MG-20260629 MEDICATION GUIDE STRATTERA® (Stra-TAIR-a) (atomoxetine) capsules for oral use What is the most important information I should know about STRATTERA?
STRATTERA can cause serious side effects, including: Suicidal thoughts and actions in children 6 years of age and older. STRATTERA 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 STRATTERA is 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 trouble sleeping acting aggressive extreme increase in activity or talking (mania) unusual decrease in activity (hypomania) feeling agitated or restless irritability impulsivity depression panic attacks restlessness or feeling like you have to move panic attacks hostility or being angry or violent suicide attempts thoughts about suicide or dying other unusual changes in mood or behavior See “ What are the possible side effects of STRATTERA? ” for more information about side effects.
What is STRATTERA? STRATTERA is a prescription medicine used to treat ADHD in adults and children 6 years of age and older. STRATTERA may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
STRATTERA 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 STRATTERA is safe and effective in children less than 6 years old. Who should not take STRATTERA?
Do not take STRATTERA if you or your child: are allergic to atomoxetine or any of the ingredients in STRATTERA. See the end of this Medication Guide for a complete list of ingredients in STRATTERA. 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 STRATTERA, tell your healthcare provider about all medical conditions, including if you or your child: 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 STRATTERA 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 STRATTERA. There is a pregnancy exposure registry for women who are exposed to ADHD medicines, including STRATTERA, during pregnancy.
The purpose of the registry is to collect information about the health of women exposed to STRATTERA and their baby. If you or your child become pregnant during treatment with STRATTERA, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD Medications at 1-866-961-2388 or visit online at https:/…