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Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving Avodart and at a higher incidence than subjects receiving placebo. Compared with placebo, Avodart was associated with a statistically significantly lower incidence of AUR (1. If Avodart is used during pregnancy or if the patient becomes pregnant while taking Avodart, the patient should be apprised of the potential hazard to the fetus. The relationship between long-term use of Avodart and male breast neoplasia is currently unknown. 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. , serious skin reactions, angioedema) to Avodart or other 5α-reductase inhibitors.

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