Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 10/19/2025

Acne Treatment During Pregnancy

Safety Profile

  • Azelaic acid is classified as FDA pregnancy category B, indicating minimal systemic absorption and no expected fetal harm, making it a safer choice for treating acne vulgaris during pregnancy, according to the American Academy of Dermatology 1, 2, 3
  • The American Academy of Dermatology guidelines do not explicitly classify the pregnancy safety category of benzoyl peroxide, but it is considered to have low risk during pregnancy 1, 4

Clinical Efficacy

  • Azelaic acid provides multiple mechanisms, including antimicrobial activity, comedolytic effects, and anti-inflammatory properties, making it effective for treating acne, as recommended by the American Academy of Dermatology 1
  • Azelaic acid 20% cream is effective in reducing total lesion count, with 28% more patients achieving 50-100% reduction compared to vehicle at 3 months, according to the American Academy of Dermatology 3
  • The American Academy of Dermatology strongly recommends benzoyl peroxide for acne treatment, though this recommendation is not pregnancy-specific, with moderate certainty evidence 4

Treatment Algorithm

  • The American Academy of Dermatology recommends starting with topical azelaic acid 20% cream applied twice daily as baseline monotherapy for mild acne in pregnancy 3
  • A thin film of azelaic acid should be gently massaged into affected areas, as recommended by the American Academy of Dermatology 2, 3

Side Effects Management

  • Azelaic acid commonly causes pruritus, burning, stinging, tingling, and erythema upon initial application, but these effects typically diminish with continued use, according to the American Academy of Dermatology 2, 3

Contraindications

  • The American Academy of Dermatology advises against using oral or topical retinoids during pregnancy due to teratogenicity, with an absolute contraindication (pregnancy category X) 1

Lactation Considerations

  • Azelaic acid is minimally distributed into breast milk after topical application and can be used with caution during lactation, as recommended by the American Academy of Dermatology 2

REFERENCES

1

guidelines of care for the management of acne vulgaris. [LINK]

Journal of the American Academy of Dermatology, 2016

2

guidelines of care for the management of acne vulgaris. [LINK]

Journal of the American Academy of Dermatology, 2016

3

Azelaic Acid in Acne Treatment [LINK]

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

4

guidelines of care for the management of acne vulgaris. [LINK]

Journal of the American Academy of Dermatology, 2024