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Flomax - Side Effects & Drug Interactions

[Tamsulosin]

ADVERSE REACTIONS

The incidence of treatment-emergent adverse events has been ascertained from six short-term U. S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg FLOMAX capsules were used. These studies evaluated safety in 1783 patients treated with FLOMAX capsules and 798 patients administered placebo. Table 3 summarizes the treatment-emergent adverse events that occurred in . 2% of patients receiving either FLOMAX capsules 0.4 mg, or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U. S. trials (US92-03A and US93-01) conducted in 1487 men.

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Signs and Symptoms of Orthostasis

In the two U. S. studies, symptomatic postural hypotension was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group, and by no patients in the placebo group.

Syncope was reported by 0.2% of patients (1 of 502) in the 0.4 mg group, 0.4% of patients (2 of 492) in the 0.8 mg group and 0.6% of patients (3 of 493) in the placebo group.

Dizziness was reported by 15% of patients (75 of 502) in the 0.4 mg group, 17% of patients (84 of 492) in the 0.8 mg group, and 10% of patients (50 of 493) in the placebo group.

Vertigo was reported by 0.6% of patients (3 of 502) in the 0.4 mg group, 1% of patients (5 of 492) in the 0.8 mg group and by 0.6% of patients (3 of 493) in the placebo group.

Multiple testing for orthostatic hypotension was conducted in a number of studies. Such a test was considered positive if it met one or more of the following criteria:

(1) a decrease in systolic blood pressure of . 20 mmHg upon standing from the supine position during the orthostatic tests;

(2) a decrease in diastolic blood pressure . 10mmHg upon standing, with the standing diastolic blood pressure <65 mmHg during the orthostatic test;

(3) an increase in pulse rate of . 20 bpm upon standing with a standing pulse rate . 100 bpm during the orthostatic test; and

(4) the presence of clinical symptoms (faintness, lightheadedness/ lightheaded, dizziness, spinning sensation, vertigo, or postural hypotension) upon standing during the orthostatic test.