Pregnancy: There are limited data from the use of JARDIANCE in pregnant women. Nonclinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure it is recommended to avoid the use of JARDIANCE during pregnancy unless clearly needed.
Lactation: No data in humans are available on excretion of empagliflozin into milk. Available nonclinical data in animals have shown excretion of empagliflozin in milk. A risk to human newborns/infants cannot be excluded. It is recommended to discontinue breast feeding during treatment with JARDIANCE.
Fertility: No studies on the effect on human fertility have been conducted for JARDIANCE. Nonclinical studies in animals do not indicate direct or indirect harmful effects with respect to fertility.