Skip to Content

Clozapine Pregnancy and Breastfeeding Warnings

Clozapine is also known as: Clopine, Clozapine Synthon, Clozaril, Denzapine, FazaClo, Versacloz, Zaponex

Clozapine Pregnancy Warnings

High dose animal studies have failed to reveal evidence of specific teratogenic effects. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Clozapine is only recommended for use during pregnancy when benefit outweighs risk. As of December, 1990, at least 14 women were known to have been exposed to clozapine during pregnancy. No adverse effects have been reported in the offspring of those pregnancies. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no controlled studies in pregnant women.

FDA pregnancy category: B Potential benefit should outweigh the potential risk.

Clozapine Breastfeeding Warnings

A single case report has suggested that clozapine is excreted into human breast milk and achieves milk levels which are 2 to 3 times maternal plasma levels. The clinical implications in breast-fed infants is unknown. The authors of the case report however, suggest that breast-feeding be avoided if possible in women taking clozapine.

Use of clozapine should be avoided. Excreted into human milk: Yes Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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.