Pregnancy: Data on a very limited number of exposed pregnancies have not indicated any adverse effects of febuxostat on pregnancy or on the health of the foetus/new born child. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development or parturition (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for human is unknown. Febuxostat should not be used during pregnancy.
Breastfeeding: It is unknown whether febuxostat is excreted in human breast milk. Animal studies have shown excretion of this active substance in breast milk and an impaired development of suckling pups. A risk to a suckling infant cannot be excluded. Febuxostat should not be used while breastfeeding.
Fertility: In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). The effect of febuxostat on human fertility is unknown.