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In animal studies on pregnancy and mirtazapine, there was an increased risk of miscarriage, lower birth weights, and a decrease in survival rates. As a result, the FDA has classified the drug as a pregnancy Category C medication. However, depression in the mother may affect the baby, so if you are taking this medicine and pregnancy occurs, your healthcare provider will weigh the benefits and risks before making a recommendation.

Mirtazapine and Pregnancy: An Overview

Mirtazapine (Remeron®) is a pregnancy Category C medicine, meaning that it could potentially cause harm to your unborn child.

Pregnancy Category C

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 C is given to medicines that show side effects to the fetus in animal studies but for which no human studies in pregnant women have been done. However, a pregnancy Category C medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh the possible risks to the unborn child.
In animal studies, giving mirtazapine to pregnant rats increased the chance of miscarriage. Mirtazapine also caused low birth weights and decreased the survival rates of newborn rats.

Final Thoughts on Pregnancy and Mirtazapine

If pregnancy occurs while you are taking mirtazapine, or if you are thinking of becoming pregnant while taking the drug, let your healthcare provider know. Depression in the mother may not be healthy for a baby, so your healthcare provider will consider the benefits and risks before making a recommendation for your particular situation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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