Strattera

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 )
• 2.1 Recommendations 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 )].
• 2.2 Administration Instructions STRATTERA may be taken with or without food.
• Take STRATTERA capsules whole; do not open the capsules.
• 2.3 Recommended 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.
• 2.4 Recommended 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.
• 2.5 Recommended 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 titration interval (minimum of 3 days), as outlined in Table 1 [see Dosage and Administration ( 2.3 )].
• 2.6 Switching to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of STRATTERA.
• In addition, at least 14 days must elapse after stopping STRATTERA before starting an MAOI antidepressant.
• 2.7 Recommendations for a Missed Dose If a STRATTERA dose is missed, take the dose as soon as possible, but
• do not take more than the prescribed total daily amount of STRATTERA in any 24-hour period.
• 2.8 Recommendations for Discontinuation When discontinuing STRATTERA, no taper is needed [see Drug Abuse and Dependence ( 9.2 , 9.3 )].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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.
• 6.1 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.
• 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 statistically significant Breslow-Day tests).
• Table 3:
• Common Adverse Reactions in Acute Studies (up to 18 weeks) in Pediatric Patients 6 Years and Older with ADHD a Abdominal pain included the terms:
• upper abdominal pain, and epigastric discomfort. b Mood swings didn't meet the statistical significance on Breslow-Day test at 0.05 level, but p-value was <0.1 (trend). c Constipation didn't meet the statistical significance on Breslow-Day test but is included in the table because of pharmacologic plausibility.
• Adverse Reaction ADHD Studies with Twice Daily Dosing ADHD Studies with Once Daily Dosing STRATTERA (N=715) Placebo (N=434) STRATTERA (N=882) Placebo (N=500) Abdominal pain a 17% 13% 18% 7% Vomiting 11% 8% 11% 4% Nausea 7% 6% 13% 4% Fatigue 6% 4% 9% 2% Mood swings b 2% 0% 1% 1% Constipation c 2% 1% 1% 0% Common Adverse Reactions by CYP2D6 Metabolizer Status in the Clinical Studies of Pediatric Patients 6 Years of Age and Older:
• Table 4 displays adverse reactions that occurred in at least 2% of STRATTERA-treated pediatric patients who were CYP2D6 poor metabolizers and were statistically significantly more frequent in CYP2D6 poor metabolizers compared with other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate).
• Table 4:
• Common Adverse Reactions a in STRATTERA-treated Pediatric Patients 6 Years and Older with ADHD by CYP2D6 Metabolizer Types a Adverse reactions that occurred in at least 2% of STRATTERA-treated pediatric patients who were CYP2D6 poor metabolizers and were statistically significantly more frequent in poor metabolizers compared with other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate). b Depression included the following terms:
• major depression, depressive symptoms, depressed mood, dysphoria.
• Adverse Reaction STRATTERA CYP2D6 Poor Metabolizers (N=355) STRATTERA Other CYP2D6 Metabolizer Types (N=5,019) Insomnia 11% 6% Decreased weight 7% 4% Constipation 7% 4% Depression b 7% 4% Tremor 5% 1% Excoriation 4% 2% Sedation 4% 2% Middle insomnia 3% 1% Conjunctivitis 3% 1% Syncope 3% 1% Early morning awakening 2% 1% Mydriasis 2% 1% Less Common Adverse Reactions in the Clinical Studies of Pediatric Patients 6 Years of Age and Older:
• The following reactions did not meet this criterion but were reported by more STRATTERA-treated patients than placebo-treated patients and are possibly related to STRATTERA treatment:
• blood pressure increased, early morning awakening (terminal insomnia), flushing, mydriasis, sinus tachycardia, asthenia, palpitations, mood swings, constipation, and dyspepsia.
• The following reactions were reported by at least 2% of patients treated with STRATTERA, and equal to or less than placebo:
• pharyngolaryngeal pain, insomnia (insomnia includes the terms, insomnia, initial insomnia, middle insomnia).
• The following reaction did not meet this criterion but shows a statistically significant dose relationship:
• pruritus.
• Seizures in the Clinical Studies of Pediatric Patients 6 Years of Age and Older:
• STRATTERA has not been systematically evaluated in pediatric patients with seizure disorder as these patients were excluded from STRATTERA studies.
• In the clinical development program, seizures were reported in 0.2% (12/5,073) of STRATTERA-treated pediatric patients whose average age was 10 years old (range 6 to 16 years of age).
• In these clinical trials, the seizure incidence among CYP2D6 poor metabolizers was 0.3% (1/293) compared to 0.2% (11/4,741) for other CYP2D6 metabolizer types.
• Heart Rate and Blood Pressure Increases in the Clinical Studies of Pediatric Patients 6 Years of Age and Older:
• Additional data from ADHD clinical trials (controlled and uncontrolled) has shown that approximately 5 to 10% of pediatric patients experienced potentially clinically important changes in heart rate (≥20 beats per minute) or blood pressure (≥15 to 20 mm Hg) [see Contraindications ( 4 ) and Warnings and Precautions ( 5.4 )] .
• Adverse Reactions in the Clinical Trials of
• Adults with ADHD Discontinuation of Treatment Due to Adverse Reactions in the Clinical Studies of
• Adults:
• In the acute adult placebo-controlled trials, 11.3% (61/541) STRATTERA-treated patients and 3% (12/405) placebo-treated patients discontinued for adverse reactions.
• Among STRATTERA-treated patients, insomnia (0.9%, N=5); nausea (0.9%, N=5); chest pain (0.6%, N=3); fatigue (0.6%, N=3); anxiety (0.4%, N=2); erectile dysfunction (0.4%, N=2); mood swings (0.4%, N=2); nervousness (0.4%, N=2); palpitations (0.4%, N=2); and urinary retention (0.4%, N=2) were the reasons for discontinuation reported by more than 1 patient.
• Common Adverse Reactions in the Clinical Studies of
• Adults:
• Commonly observed adverse reactions associated with the use of STRATTERA (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (STRATTERA incidence greater than placebo) are listed in Table 5 .
• The most commonly observed adverse reactions in patients treated with STRATTERA (incidence of 5% or greater and at least twice the incidence in placebo patients) were:
• constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation ( see Table 5 ).
• Table 5:
• Common Adverse Reactions a Associated in Acute Studies (up to 25 weeks) of Adult Patients with ADHD a Reactions reported by at least 2% of patients treated with STRATTERA, and greater than placebo.
• The following reactions did not meet this criterion but were reported by more STRATTERA-treated patients than placebo-treated patients and are possibly related to STRATTERAtreatment:
• peripheral coldness, tachycardia, prostatitis, testicular pain, orgasm abnormal, flatulence, asthenia, feeling cold, muscle spasm, dysgeusia, agitation, restlessness, micturition urgency, pollakiuria, pruritus, urticaria, flushing, tremor, menstruation irregular, rash, and urinary retention. b Insomnia includes the terms initial insomnia, middle insomnia, terminal insomnia and other related terms. c Based on total number of males (STRATTERA group, N=943; placebo group, N=869). d Somnolence includes related terms. e Abdominal pain includes the terms:
• upper abdominal pain and other related terms. f Urinary hesitation includes the term decreased urine flow. g Based on total number of females (STRATTERA, N=754; placebo, N=691).
• Adverse Reaction STRATTERA (N=1,697) Placebo (N=1,560) Nausea 26% 6% Dry mouth 20% 5% Decreased appetite 16% 3% Insomnia b 15% 8% Fatigue 10% 6% Erectile dysfunction c 8% 1% Constipation 8% 3% Dizziness 8% 3% Somnolence d 8% 5% Abdominal pain e 7% 4% Urinary hesitation f 6% 1% Irritability 5% 3% Ejaculation delayed c and/or ejaculation disorder c 4% 1% Hyperhidrosis 4% 1% Dyspepsia 4% 2% Vomiting 4% 2% Abnormal dreams 4% 3% Chills 3% 0% Paraesthesia 3% 0% Hot flush 3% 0% Palpitations 3% 1% Libido decreased 3% 1% Sleep disorder 3% 1% Dysmenorrhea g 3% 2% Dysuria 2% 0% Thirst 2% 1% Weight decreased 2% 1% Feeling jittery 2% 1% Common Adverse Reactions by CYP2D6 Metabolizer Status in the Clinical Studies of
• Adults:
• Table 6 displays adverse reactions that occurred in at least 2% of STRATTERA-treated adult patients who were CYP2D6 poor metabolizers and were statistically significantly more frequent compared to other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate).
• Table 6:
• Common Adverse Reactions a in STRATTERA-treated Adult Patients with ADHD by CYP2D6 Metabolizer Types a Adverse reactions that occurred in at least 2% of STRATTERA-treated adult patients who were CYP2D6 poor metabolizers and were statistically significantly more frequent in CYP2D6 poor metabolizers compared with other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate).
• Adverse Reaction STRATTERA CYP2D6 Poor Metabolizers (N=203) STRATTERA Other CYP2D6 Metabolizer Types (N=3,599) Dry mouth 35% 17% Decreased appetite 23% 15% Erectile dysfunction 21% 9% Insomnia 19% 11% Hyperhidrosis 15% 7% Constipation 11% 7% Sleep disorder 7% 3% Urinary retention 6% 1% Ejaculation disorder 6% 2% Tremor 5% 1% Feeling jittery 5% 2% Middle insomnia 5% 3% Blurred vision 4% 1% Terminal insomnia 3% 1% Peripheral coldness 3% 1% Less Common Adverse Reactions in the Clinical Studies of
• Adults:
• The following reactions did not meet this criterion but were reported by more STRATTERA-treated patients than placebo-treated patients and are possibly related to STRATTERA treatment:
• peripheral coldness, tachycardia, prostatitis, testicular pain, orgasm abnormal, flatulence, asthenia, feeling cold, muscle spasm, dysgeusia, agitation, restlessness, micturition urgency, pollakiuria, pruritus, urticaria, flushing, tremor, menstruation irregular, rash, and urinary retention.
• Seizures in the Clinical Studies of
• Adults:
• STRATTERA has not been systematically evaluated in adult patients with a seizure disorder as these patients were excluded from clinical studies during the product's premarket testing.
• In the clinical development program, seizures were reported on 0.1% (1/748) of adult patients.
• In these clinical trials, no CYP2D6 poor metabolizers (0/43) reported seizures compared to 0.1% (1/705) for other CYP2D6 metabolizer types.
• Heart Rate and Blood Pressure Increases in the Clinical Studies of
• Adults:
• Table 7 displays the proportion of STRATTERA-treated and placebo-treated patients who had an increase in diastolic blood pressure (DBP) ≥15 mm Hg, systolic blood pressure (SBP) ≥20 mm Hg, or heart rate ≥ 20 bpm in short-term, placebo-controlled clinical studies in pediatric and adult patients with ADHD [see Warnings and Precautions ( 5.4 )].
• Table 7:
• Proportion of ADHD Patients With an Increase of ≥ 15 mm Hg in DBP, ≥20 mm Hg in SBP, or ≥ 20 bpm in Heart Rate a a Abbreviations:
• bpm=beats per minute;
• DBP=diastolic blood pressure;
• HR=heart rate; mm Hg=millimeters mercury;
• SBP=systolic blood pressure. b Proportion of patients meeting threshold at any one time during the clinical studies.
• Pediatric Acute ADHD Studies Adult Acute ADHD Studies Maximum b Endpoint Maximum b Endpoint STRATTERA Placebo STRATTERA Placebo STRATTERA Placebo STRATTERA Placebo DBP (≥15 mm Hg) 22% 14% 9% 5% 13% 9% 5% 4% SBP (≥20 mm Hg) 13% 9% 5% 3% 12% 8% 4% 3% HR (≥20 bpm) 23% 12% 12% 4% 22% 8% 10% 2% Additional data from ADHD clinical trials (controlled and uncontrolled) showed that approximately 5 to 10% of adult patients had potentially clinically important changes in heart rate (≥20 beats per minute) or blood pressure (≥15 to 20 mm Hg) [see Contraindications ( 4 ) and Warnings and Precautions ( 5.4 )] .
• Male and Female Sexual Dysfunction in the Clinical Studies of
• Adults :
• STRATTERA impaired sexual function in some patients.
• Estimates of the incidence of untoward sexual experience and performance in these studies are likely to underestimate their actual incidence because patients and health care providers may be reluctant to discuss them.
• Table 5 displays the incidence of sexual adverse reactions (reported by at least 2% of STRATTERA-treated adult patients in the placebo-controlled studies of
• adults with ADHD (i.e., erectile dysfunction, dysmenorrhea, and ejaculation delayed and/or ejaculation disorder).
• There are no adequate and well-controlled studies examining sexual dysfunction with STRATTERA treatment.
• While it is difficult to know the precise risk of sexual dysfunction associated with the use of STRATTERA, health care providers should routinely inquire about sexual dysfunction.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of STRATTERA.
• Unless otherwise specified, these adverse reactions have occurred in
• adults and pediatric patients.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Cardiovascular system: QT prolongation, syncope.
• Peripheral vascular effects: Raynaud's phenomenon.
• General disorders and administration site conditions: Lethargy.
• Musculoskeletal system: Rhabdomyolysis.
• Nervous system disorders:
• Hypoaesthesia; paraesthesia in pediatric patients; sensory disturbances; tics.
• Psychiatric disorders: Depression and depressed mood; anxiety, libido changes.
• Seizures:
• Seizures have been reported and included patients with pre-existing seizure disorders, those with identified risk factors for seizures, and patients with neither a history of nor identified risk factors for seizures.
• The exact relationship between STRATTERA and seizures is difficult to evaluate due to uncertainty about the background risk of seizures in ADHD patients.
• Skin and subcutaneous tissue disorders: Alopecia, hyperhidrosis.
• Urogenital system:
• Male pelvic pain; urinary hesitation in pediatric patients; urinary retention in pediatric patients.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How 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
• Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
• 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

Quoted from the official label, section “How Supplied”.

How to store it

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “Storage and Handling”.

What is in it

• 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

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

7 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Atomoxetine Hydrochloride