Is Azelaic Acid Safe in Pregnancy?

Azelaic acid is a common ingredient found in many dermatological products, used to address various skin concerns. When pregnancy occurs, individuals often review their skincare routines to ensure the safety of both mother and developing baby. Understanding the role and safety of azelaic acid during this period provides clarity for expecting parents to make informed decisions about skincare during pregnancy.

Azelaic Acid’s Safety Profile

Azelaic acid is generally considered safe for use throughout pregnancy and while breastfeeding. This safety profile is primarily due to its low systemic absorption when applied topically to the skin. Only a small amount, typically between 3.6% and 8% of the applied dose, enters the bloodstream. This minimal absorption means very little of the active ingredient reaches the developing fetus.

The U.S. Food and Drug Administration (FDA) has historically classified azelaic acid as Pregnancy Category B. This classification indicates that animal reproduction studies have not demonstrated a risk to the fetus, although well-controlled studies in pregnant women are limited. While very high oral doses in animal studies showed some embryotoxicity, these effects were observed at levels significantly exceeding typical human topical exposure, and no birth defects were noted. Current clinical experience and available research support its safe use during pregnancy.

Common Skin Concerns During Pregnancy

Pregnancy often brings about various skin changes, with conditions like acne, melasma, and rosacea frequently appearing or worsening due to hormonal fluctuations. Acne can become more pronounced as androgen levels increase, particularly during the second and third trimesters. Melasma, often called the “mask of pregnancy,” manifests as brown or gray patches on the face, triggered by elevated estrogen, progesterone, and melanocyte-stimulating hormone levels. Rosacea symptoms, such as redness and inflammation, can also be exacerbated during this time.

Azelaic acid is a recommended and effective treatment option for these pregnancy-related skin issues. It works by reducing inflammation, exhibiting antibacterial properties, and inhibiting melanin production, which helps to lighten dark spots. This makes it a suitable choice for managing these common dermatological challenges without posing significant risk during pregnancy.

Practical Application and Precautions

Before incorporating azelaic acid or any new skincare product into a routine during pregnancy, it is important to consult with a healthcare provider, such as a dermatologist or obstetrician. They can provide personalized guidance based on individual health history and specific skin concerns. Azelaic acid is commonly available in over-the-counter strengths, often around 10%, and in prescription formulations at 15% or 20% concentrations. Many dermatologists consider the 15% to 20% range effective for treating various conditions without causing excessive irritation.

For optimal use, azelaic acid is typically applied to the affected areas of the skin twice daily. Users might experience mild, localized side effects such as burning, stinging, tingling, dryness, redness, or itching, especially during the initial weeks of treatment. These sensations are usually temporary and tend to subside as the skin adjusts. In rare instances, changes in skin color, particularly hypopigmentation in darker complexions, have been reported, requiring observation. If severe irritation or any signs of an allergic reaction like hives or swelling occur, it is important to seek immediate medical attention.