STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder.
Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [see Warnings and Precautions].
STRATTERA® (atomoxetine HCl) is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl is the R (-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N -Methyl-3-phenyl-3-(o -tolyloxy)-propylamine hydrochloride.
STRATTERA® is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1)
STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The efficacy of STRATTERA Capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies].
A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder.
The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, on the go, excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.
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 this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.
Media Articles Related to Strattera (Atomoxetine)
Atomoxetine improves critical reading skills in children with dyslexia
Source: Dyslexia News From Medical News Today [2016.09.09]
A new study shows significant improvement in critical components of reading, including decoding and vocabulary, among children treated with atomoxetine compared to placebo.
UF researchers find ADHD drug does not heighten suicide risk despite FDA warning
Source: ADHD / ADD News From Medical News Today [2016.04.27]
For more than a decade, a black box warning from the Food and Drug Administration has accompanied the ADHD drug atomoxetine cautioning users of an increased risk of suicidal thoughts.
Published Studies Related to Strattera (Atomoxetine)
Drug-specific laterality effects on frontal lobe activation of atomoxetine and
methylphenidate in attention deficit hyperactivity disorder boys during working
CONCLUSIONS: The study shows both shared and drug-specific effects. ATX
Acute neuropharmacological effects of atomoxetine on inhibitory control in ADHD
children: a fNIRS study. 
The object of the current study is to explore the neural substrate for effects of
atomoxetine (ATX) on inhibitory control in school-aged children with attention
deficit hyperactivity disorder (ADHD) using functional near-infrared spectroscopy
(fNIRS)... This promising technique will enhance early clinical diagnosis
and treatment of ADHD in children, especially in those with a
Atomoxetine improved attention in children and adolescents with
attention-deficit/hyperactivity disorder and dyslexia in a 16 week, acute,
randomized, double-blind trial. 
working memory, life performance, and self-concept... CONCLUSIONS: Atomoxetine treatment improved ADHD symptoms in subjects with ADHD+D
A meta-analysis of the consistency of atomoxetine treatment effects in pediatric
patients with attention-deficit/hyperactivity disorder from 15 clinical trials
across four geographic regions. 
geographic regions... CONCLUSIONS: Atomoxetine was demonstrated as an effective treatment for ADHD in
Does atomoxetine improve executive function, inhibitory control, and
hyperactivity? Results from a placebo-controlled trial using quantitative
measurement technology. 
The primary objective of this study was to evaluate the efficacy of atomoxetine
(ATX) on attention-deficit/hyperactivity disorder (ADHD)-related symptoms
assessed as standard variables of a computer-based continuous performance test
(cb-CPT) combined with a motion-tracking (MT) device... The results of this study
show that ATX for 8 weeks significantly reduced ADHD-related symptoms as measured
by the cb-CPT/MT.
Clinical Trials Related to Strattera (Atomoxetine)
The Effects of Atomoxetine on Cognition and Brain Function Based on Catechol-O-methyltransferase(COMT) Genotype [Terminated]
This study will evaluate whether Atomoxetine improves cognition in healthy volunteers as
well as patients with schizophrenia. Atomoxetine is a drug that has been Food and Drug
Administration (FDA) approved for Attention Deficit Disorder and allegedly increase the
amount of the neurotransmitter dopamine in the frontal cortex of the brain.
Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS) [Completed]
This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the
treatment of adults with attention deficit hyperactivity disorder not otherwise specified.
The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive
to Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1. 5
mg/kg/day, whichever is less) in adults with ADHD NOS will be safe and well tolerated.
Atomoxetine, Placebo and Parent Management Training in Autism [Active, not recruiting]
The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent
Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive
Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention
Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where
the atomoxetine will have a dose titration over a 6 week period. All children will be seen
weekly during this titration period, with additional visits at Week 8 and Week 10. Families
assigned to the PMT arm will have an additional weekly meeting with a clinician for a total
of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with
their children. Subjects who are clinical responders (ADHD Responders and Compliance
Responders) from the 10 week study period will be followed every 4 weeks in a 24-week
extension study. Subjects who are clinical nonresponders will continue in PMT if they
received PMT during the double-blind phase, and they will receive an open trial of
atomoxetine if they were on placebo during the double-blind phase. All subjects (responders
and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for
24 weeks after the completion of the double-blind phase.
Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI) [Completed]
Atomoxetine is the only medication that is currently approved by the FDA for the treatment
of attention deficit hyperactivity disorder in adults. It has gained recent interest as an
alternative medication for treating attentional problems related to traumatic brain injury
(TBI), but it's effectiveness in this population has not been studied. There are a number
of advantages of Atomoxetine over traditional neuro-stimulant medications currently used for
attentional disorders after traumatic brain injury. This study will use a randomized
double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine
to improve attention, behavioral function, and depression in adults with TBI
An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD). [Completed]
The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric
patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder
(ODD). The primary aim of the study is to evaluate the efficacy of atomoxetine in improving
ADHD and ODD symptoms in patients non responders to a previous psychological intervention
with parent support. Moreover, the potential role of atomoxetine in treating other
psychiatric comorbid conditions associated with ADHD and ODD will be assessed.
Reports of Suspected Strattera (Atomoxetine) Side Effects
Suicidal Ideation (54),
Electrocardiogram QT Prolonged (20),
OFF Label USE (15),
Irritability (13), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 18 ratings/reviews, Strattera has an overall score of 6.17. The effectiveness score is 7 and the side effect score is 6.56. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Strattera review by 26 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || ADHD|
|Dosage & duration:|| || 60 mg taken once daily for the period of 4 YRS|
|Other conditions:|| || None|
|Other drugs taken:|| || ALLEGRA|
|Benefits:|| || Stratterra enabled me to concentrate and focus on tasks at hand. It makes a world of difference in my daily life. After four years of using Stratterra, I would never switch to a different ADHD medication.|
|Side effects:|| || Stratterra surpresses my appetite and makes me feel quite dependent on the drug to function. If I take with my multivitamin, I often feel nauseous. |
|Comments:|| || I take 1 60 mg of Stratterra in the morning daily.|
Strattera review by care giver of 51 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || ADHD|
|Dosage & duration:|| || 20 -25 mg taken 1 x day for the period of 2 tears|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || Slowed down hyperactivity in a nine year old boy; increased attending a little bit although not strongly. It does not interfere with sleep which many of the stimpulant meds do. There were no mood swings until the dosage was increased. |
|Side effects:|| || When the dose was raised, the patient suffered suicidal ideation! This was bad. At lower dose it seemed to be ok. Dosage takes 2-3 weeks to take affect. Side effects also will not be observed until dose builds up in the system. You may see lesser instances of self denegration first. Watch for that. |
|Comments:|| || Take pill once a day|
Strattera review by 21 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Ineffective|
|Side effects:|| || Extremely Severe Side Effects|
|Condition / reason:|| || ADHD|
|Dosage & duration:|| || 10mg taken 1/day for the period of 8 days|
|Other conditions:|| || IDDM|
|Other drugs taken:|| || insulin|
|Benefits:|| || none|
|Side effects:|| || visual disturbances, weight gain, insomnia, anxiety, hyperglycemia, headaches, mild hallucinations, water retention, difficulty concentrating, memory lapses, erratic behaviour. these side effects lasted for several weeks after I stopped taking the medication, and my vision did not return to normal for almost a month. my doctor said it was an anti-cholinergic reaction. |
|Comments:|| || i started at a very low dose, to be worked up gradually. treatment ended before this could happen.|
Page last updated: 2016-09-09