Pregnancy: Clinical data on exposed pregnancies with Esomeprazole are insufficient. With neither racemic mixture omeprazole data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor fetotoxic 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) indicate no malformative or foeto/neonatal toxicity of esomeprazole.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Lactation: It is not known whether esomeprazole is excreted in human breast milk. There is insufficient information on the effects of esomeprazole in newborns/infants. Esomeprazole should not be used during breast-feeding.
Fertility: Animal studies with racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility.