Pregnancy: No clinical data on exposed pregnancies are available. The potential risk for humans is unknown.
Women of child-bearing potential should avoid pregnancy during treatment with PRADAXA and when pregnant, women should not be treated with PRADAXA unless the expected benefit is greater than the risk.
Lactation: No clinical data are available. As a precaution, breast-feeding should be stopped.
Fertility: No clinical data available. Non-clinical reproductive studies did not show any adverse effects on fertility or postnatal development of the neonate.