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Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The effect of febuxostat in human fertility is unknown.
Lactation: It is not known if febuxostat is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when administering febuxostat to breastfeeding women.
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