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Erythromycin topical Pregnancy and Breastfeeding Warnings

Erythromycin topical is also known as: A/T/S, Akne-Mycin, E-Solve 2, Emcin Clear, Emgel, Ery Pads, Ery-Sol, Erycette, Eryderm, Erygel, Erymax, Erythra-Derm, Romycin, Staticin, T-Stat, Theramycin, Theramycin Z

Medically reviewed by Drugs.com. Last updated on Apr 3, 2020.

Erythromycin topical Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity and other adverse effects on reproduction in female animal models given erythromycin base at doses up to 0.25% of the diet before and during mating, during gestation, and through lactation. There are no controlled data in human pregnancy.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: A
US FDA pregnancy category: B

See references

Erythromycin topical Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes (oral and parenteral formulations); Unknown (topical formulations)
Excreted into animal milk: Data not available (topical formulations)

Comments:
-The American Academy of Pediatrics (AAP) considers this drug compatible with breastfeeding.
-Some experts state that ointments should not be applied to the breast prior to breastfeeding; if necessary, water-miscible cream or gel products may be used, but the products should not be applied to the nipple area.

Risk to the nursing infant is considered low, as only a negligible amount is absorbed after topical application.

See references

References for pregnancy information

  1. "Product Information. A/T/S 2% Topical Gel (erythromycin topical)" Hoechst Marion-Roussel Inc, Kansas City, MO.
  2. Agencia Española de Medicamentos y Productos Sanitarios Healthcare "Centro de información online de medicamentos de la AEMPS - CIMA. Available from: URL: https://cima.aemps.es/cima/publico/home.html." ([2018]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Akne-Mycin (erythromycin topical)" Healthpoint, Fort Worth, TX.

References for breastfeeding information

  1. National Library of Medicine (US) "Drugs and Lactation Database (LactMed) Available from: URL: https://www.ncbi.nlm.nih.gov/books/NBK501922/" (2006):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Agencia Española de Medicamentos y Productos Sanitarios Healthcare "Centro de información online de medicamentos de la AEMPS - CIMA. Available from: URL: https://cima.aemps.es/cima/publico/home.html." ([2018]):
  4. "Product Information. A/T/S 2% Topical Gel (erythromycin topical)" Hoechst Marion-Roussel Inc, Kansas City, MO.
  5. "Product Information. Akne-Mycin (erythromycin topical)" Healthpoint, Fort Worth, TX.
  6. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.