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Pregnancy: Data are inadequate regarding use of febuxostat in pregnant women. Animal reproduction studies using febuxostat have not revealed evidence of fetal harm at exposure greater than those attained with maximum recommended human dosage.
Lactation: Febuxostat is distributed into milk in rats at concentrations up to approximately 7 times plasma concentrations of the drug. It is not known whether febuxostat distributes into human milk, affects the breast-fed infant, or affects milk production.
