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In animal studies on clozapine and pregnancy, the drug did not appear to cause any problems. As a result, the FDA has classified it as a pregnancy Category B medication. However, animals do not always respond to medicines in the same way as humans, so if you are taking clozapine and pregnancy occurs, your healthcare provider will consider the risks and benefits in your particular situation.

Is Clozapine Safe During Pregnancy? -- An Overview

Clozapine (Clozaril®, FazaClo®) is probably safe for women who are pregnant. Animal studies on clozapine and pregnancy did not show any problems.

Clozapine and Pregnancy Category B

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been studied in pregnant humans but that do not appear to cause harm to the fetus in animal studies.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if her healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.

Recommendations for Clozapine and Pregnancy

If you are taking clozapine and pregnancy occurs (or if you are thinking of becoming pregnant while taking the drug), let your healthcare provider know. He or she will consider both the benefits and risks of taking the drug while pregnant before making a recommendation in your particular situation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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