Strattera

[atomoxetine HCl]

Side Effects & Drug Interactions
ADVERSE REACTIONS

STRATTERA was administered to 2067 children or adolescent patients with ADHD and 270 adults with ADHD in clinical studies. During the ADHD clinical trials, 169 patients were treated for longer than 1 year and 526 patients were treated for over 6 months.

The data in the following tables and text cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with data obtained from other clinical investigations involving different treatments, uses, or investigators. The cited data provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence in the population studied.

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Child and Adolescent

Clinical Trials Reasons for discontinuation of treatment due to adverse events in child and adolescent clinical trials — In acute child and adolescent placebo-controlled trials, 3.5% (15/ 427) of atomoxetine subjects and 1.4% (4/ 294) placebo subjects discontinued for adverse events. For all studies, (including open-label and long-term studies), 5% of extensive metabolizer (EM) patients and 7% of poor metabolizer (PM) patients discontinued because of an adverse event.

Among STRATTERA-treated patients, aggression (0.5%, N= 2); irritability (0.5%, N= 2); somnolence (0.5%, N= 2); and vomiting (0.5%, N= 2) were the reasons for discontinuation reported by more than 1 patient. Commonly observed adverse events in acute child and adolescent, placebo-controlled trials —

Commonly observed adverse events 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 1 for the BID trials. Results were similar in the QD trial except as shown in Table 2, which shows both BID and QD results
for selected adverse events. The most commonly observed adverse events in patients treated with STRATTERA (incidence of 5% or greater and at least twice the incidence in placebo patients, for either BID or QD dosing) were: dyspepsia, nausea, vomiting, fatigue, appetite decreased, dizziness, and mood swings (see Tables 1 and 2).

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