Skip to Content

Zonisamide Pregnancy and Breastfeeding Warnings

Zonisamide is also known as: Zonegran

Zonisamide Pregnancy Warnings

Although the effects of metabolic acidosis from zonisamide on the fetus are not clearly known, metabolic acidosis in pregnancy (due to other causes) may affect fetal development (i.e., decreased fetal growth, decreased fetal oxygenation and fetal death) and the ability of the fetus to tolerate labor. To provide information regarding the effects of in utero exposure to zonisamide, physicians are advised to recommend that pregnant patients taking zonisamide enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website

Zonisamide has been assigned to pregnancy category C. Animal studies have revealed evidence of teratogenicity. Fetal abnormalities or embryo-fetal deaths have been reported in animal tests at zonisamide dosage and maternal plasma levels similar to, or lower than human therapeutic levels. Therefore, use of this drug in human pregnancy may expose the fetus to significant risk. There are no controlled data in human pregnancy. Zonisamide is only recommended for use during pregnancy if potential benefits are felt to outweigh potential risks.

See references

Zonisamide Breastfeeding Warnings

There are no data on the excretion of zonisamide into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from zonisamide, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Significant amounts of zonisamide can appear in the breast milk of nursing women taking zonisamide, and the effects of this exposure on the infant from metabolic acidosis, or any other cause, are unknown.

See references

References for pregnancy information

  1. "Product Information. Zonegran (zonisamide)" Elan Pharmaceuticals, S. San Francisco, CA.

References for breastfeeding information

  1. "Product Information. Zonegran (zonisamide)" Elan Pharmaceuticals, S. San Francisco, CA.

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.