Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions (≥5% and at least twice the incidence of placebo patients) Child and Adolescent Clinical Trials - Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence.
(6.1) Adult Clinical Trials - Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp.
at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Atomoxetine was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies.
During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months.
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.
Child and Adolescent Clinical Trials Reasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trials — In acute child and adolescent placebo-controlled trials, 3.0% (48/1613) of atomoxetine subjects and 1.4% (13/945) placebo subjects discontinued for adverse reactions.
For all studies, (including open-label and long-term studies), 6.3% of extensive metabolizer (EM) patients and 11.2% of poor metabolizer (PM) patients discontinued because of an adverse reaction.
Among atomoxetine-treated patients, irritability (0.3%, N=5);
5 WARNINGS AND PRECAUTIONS Suicidal Ideation - Monitor for suicidality, clinical worsening, and unusual changes in behavior.
(5.1) Severe Liver Injury- Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury.
(5.2) Serious Cardiovascular Events - Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment.
Patients should have a careful history and physical exam to assess for presence of cardiovascular disease.
Atomoxetine generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects.
Like all medications, Atomoxetine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: