Strattera - Side Effects & Drug Interactions

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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).

The following adverse events occurred in at least 2% of PM patients and were either twice as frequent or statistically significantly more frequent in PM patients compared with EM patients:

decreased appetite (23% of PMs, 16% of EMs); insomnia (13% of PMs, 7% of EMs); sedation (4% of PMs, 2% of EMs); depression (6% of PMs, 2% of EMs); tremor (4% of PMs,

1% of EMs); early morning awakening (3% of PMs, 1% of EMs); pruritus (2% of PMs, 1% of EMs); mydriasis (2% of PMs, 1% of EMs).

Adult Clinical Trials Reasons for discontinuation of treatment due to adverse events in acute adult placebo-controlled trials —

In the acute adult placebo-controlled trials, 8.5% (23/ 270) atomoxetine subjects and 3.4% (9/ 266) placebo subjects discontinued for adverse events. Among STRATTERA-treated patients, insomnia (1.1%, N= 3); chest pain (0.7%, N= 2); palpitations (0.7%, N= 2); and urinary retention (0.7%, N= 2) were the reasons for discontinuation reported by more than 1 patient. Commonly observed adverse events in acute adult 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 3. 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) were: constipation, dry mouth, nausea, appetite decreased, dizziness, insomnia, decreased libido, ejaculatory problems, impotence, urinary hesitation and/ or urinary retention and/ or difficulty in micturition, and dysmenorrhea (see Table 3).