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Avodart is contraindicated for use in women of childbearing potential and during pregnancy. During the first 2 years, 1,623 subjects received monotherapy with Avodart; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. Avodart Capsules should not be handled by women who are pregnant or who may become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Avodart. To avoid potential fetal exposure, women who are pregnant or may become pregnant should not handle Avodart Soft Gelatin Capsules. Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving Avodart and at a higher incidence than subjects receiving placebo.

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