May 23 2022

Classification of the active ingredient Doxorubicin


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

Doxorubicin can cause fetal harm when administered to a pregnant woman.

Data from animal experiments indicate that the drug can cause injury to the embryo and fetus at doses less than thirteen times the human therapeutic. Possible malformations include esophageal and intestinal atresia, tracheoesophageal fistula, hypoplastic bladder and cardiovascular anomalies.

When concur gestation and treatment with doxorubicin, pregnant should be advised of the potential harm to the fetus. In women who could become pregnant should be advised of the need to avoid pregnancy while undergoing treatment with this drug.

Update 18.07.2009

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.