Skip to Content

Azacitidine Pregnancy and Breastfeeding Warnings

Azacitidine is also known as: Vidaza

Azacitidine Pregnancy Warnings

Azacitidine has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of an increased frequency of intrauterine embryonal death, developmental abnormalities in the brain, embryotoxicity, fetal death, and fetal anomalies including CNS anomalies, limb anomalies, and others. There are no controlled data in human pregnancy. Azacitidine should only be given during pregnancy when there are no alternatives and benefit outweighs risk. Because of the effects of azacitidine exposure on male fertility and embryonic viability, men should be advised not to father a child while receiving treatment with azacitidine.

Female partners of male patients receiving azacitidine should not become pregnant.

See references

Azacitidine Breastfeeding Warnings

There are no data on the excretion of azacitidine into human milk. Because of the potential for tumorigenicity shown in animal studies and the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into consideration the importance of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. Vidaza (azacitidine)." Pharmion Corporation, Boulder, CO.

References for breastfeeding information

  1. "Product Information. Vidaza (azacitidine)." Pharmion Corporation, Boulder, CO.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.