May 23 2022

Classification of the active ingredient everolimus

Risk level in pregnancy: This medicine is classified as Category D.

There are no studies on the possible influence of everolimus on pregnancy, the pregnant woman or the fetus. However, it is known that the drug can cause fetal harm when administered to a pregnant woman.

This substance may cause damage to the fetus of experimental animals at doses lower than those used in human medicine. Probable injuries include bone resorption, decreased survival, sternal anomalies, and delayed bone maturation.

Update 14.12.2010

Meaning of category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.