Pregnancy: Clinical data on exposed pregnancies with Esomeprazole Tablets 20 mg are insufficient. With the racemic mixture, omeprazole, data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor foetotoxic effect. Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal/foetal development.
Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative or foetal/neonatal toxicity of Esomeprazole. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Breast-feeding: It is not known whether esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Therefore Esomeprazole should not be used during breast-feeding.
Fertility: Animal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility.