Apo-Atomoxetine Warnings

The following have been reported with use of atomoxetine and also with stimulant medications: Suicidal thoughts and actions in children and teenagers: Some children and teenagers may have a higher chance of having suicidal thoughts or actions. Tell the child or teenager's doctor if the child or teenager (or there is a family history of): has bipolar illness (manic-depressive illness); had suicide thoughts or actions before starting atomoxetine.
The chance for suicidal thoughts and actions are higher: early during atomoxetine treatment; during dose adjustments.
Prevent suicidal thoughts and action in the child or teenager by: paying close attention to the child or teenager's moods, behaviours, thoughts, and feelings during atomoxetine treatment; keeping all follow-up visits with the child or teenager's doctor as scheduled.
Watch for the following signs in the child or teenager during atomoxetine treatment: anxiety, agitation, panic attacks, trouble sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, mania, depression, suicide thoughts.
Call the child or teenager's doctor right away if they have any of the previously mentioned signs, especially if they are new, sudden, or severe. The child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.
Severe liver damage: Call the doctor right away if the following signs of liver problems are present: itching, right upper belly pain, dark urine, yellow skin or eyes, unexplained flu-like symptoms.
Heart-related problems: sudden death in patients who have heart problems or heart defects as well as in patients without pre-existing cardiac disease; stroke and heart attack in adults; increased blood pressure and heart rate.
Tell the doctor if any heart problems, heart defects, high blood pressure, or a family history of these problems are present. The doctor may wish to carefully check for heart problems before starting APO-ATOMOXETINE.
The doctor may wish to check the blood pressure and heart rate regularly during treatment with atomoxetine.
Call the doctor right away if there are any signs of heart problems such as chest pain, irregular heart rate, palpitations, shortness of breath, dizziness or fainting while taking APO-ATOMOXETINE.
New mental (psychiatric) problems in children and teenagers: new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms.
Call the child or teenager's doctor right away about any new mental symptoms. APO-ATOMOXETINE treatment may be stopped.