Nitrostat and Pregnancy

If you are pregnant, Nitrostat (nitroglycerin tablets) may not be safe to take due to the unknown risks. Although animal studies on the active ingredient in the drug did not result in any significant problems, humans may not respond to the drug in the same way. If you are pregnant, talk to your healthcare provider about whether the benefits outweigh the potential risks.

Can Pregnant Women Use Nitrostat?

Nitrostat® (nitroglycerin tablets) is a prescription medicine approved for the treatment of chest pain (angina). Based on the information currently available, it is unclear if the drug is safe for use during pregnancy.
 

What Is Pregnancy Category C?

Nitrostat is classified as a pregnancy Category C drug. 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 have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
 
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
When given to pregnant rats, nitroglycerin, the active ingredient in Nitrostat, did not cause any problems for the mothers or babies, except slight developmental delays at high doses. However, it cannot be assumed that the same is true for humans, as animals do not always respond to medicines in the same way that humans do.
 
Therefore, a pregnancy Category C medicine, including Nitrostat, should only be given to a pregnant woman if her healthcare provider believes that the benefits to her outweigh any possible risks to her unborn child.
 
Various forms of nitroglycerin have been used to control high blood pressure during pregnancy. This drug has also been used to help stop preterm labor by relaxing the uterus. Due to the rapid and short action of the tablet form of nitroglycerin, Nitrostat is probably inappropriate for such uses.
 
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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