Doxepin and Pregnancy

Doxepin may potentially be unsafe to use during pregnancy. In animal studies, the medicine was shown to cause negative effects to a fetus when it was used at very high doses. However, healthcare providers may still recommend doxepin if they believe that the benefits to the pregnant woman outweigh any possible risks to the unborn child. If you are taking doxepin and pregnancy occurs, be sure to let your healthcare provider know.

 

Is Doxepin During Pregnancy Safe? -- An Overview

For women who are pregnant, doxepin hydrochloride (Sinequan®) may not be safe. This is based on animal studies that looked at the effects of doxepin during pregnancy, as well as a few reports of birth defects in humans.
 

Doxepin and Pregnancy Risk

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. However, the FDA has not given doxepin a pregnancy risk classification (as is common with older medications). However, other sources have suggested that the risk to the fetus due to doxepin is low.
 
Animal studies have not shown any negative effects to a fetus, except when doxepin is used at very high doses. One small study showed that doxepin use during pregnancy may be associated with certain birth defects (including heart defects, cleft palate, and extra fingers or toes), although this has not been confirmed in other studies.
 

Recommendations for Using Doxepin During Pregnancy

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know.
 Your healthcare provider will consider both the benefits and risks of using doxepin during pregnancy before making a recommendation for your particular situation.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;