Acne Home > Azelex and Pregnancy

Azelex (azelaic acid cream) does not appear to be particularly dangerous during pregnancy. Because it comes in the form of a skin cream, only small amounts of the medication are absorbed into the bloodstream. Therefore, Azelex is classified as a pregnancy Category B medication, which means that it is probably safe for use in women who are expecting.

Can Pregnant Women Use Azelex?

Azelex® (azelaic acid cream) is a prescription skin medication used for the treatment of acne. Based on information from animal studies, this drug does not appear to be particularly dangerous during pregnancy, although the possible risks to humans are largely unknown at this time.

What Is Pregnancy Category B?

The United States 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 adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
In addition, medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Category B rating.
In studies, when high doses of azelaic acid (the active ingredient in Azelex) were given to pregnant animals by mouth, the medication did not cause birth defects. Some toxicity to embryos was seen, but only at doses high enough to cause toxicity in the mothers as well.
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 the healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Applying Azelex on the skin does not appear to increase the blood levels of azelaic acid beyond the normal range (it is normal to find azelaic acid in the blood, as this compound is found naturally in wheat, barley, and rye). Because only small amounts of the drug are absorbed into the bloodstream, there is minimal risk to a developing fetus.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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