Skip to main content

Azithromycin ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Azasite

Medically reviewed by Drugs.com. Last updated on Sep 18, 2023.

Azithromycin ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed; use is considered acceptable.

US FDA pregnancy category: B

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.

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.

See references

Azithromycin ophthalmic Breastfeeding Warnings

Use is considered acceptable; caution is recommended.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown; however, harmful effects would not be expected.

Limited data indicate azithromycin is excreted into breast milk. Due to the low dose and low systemic availability, doses taken by neonates are considered negligible; therefore, breastfeeding is possible during therapy.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2008) "Product Information. AzaSite (azithromycin ophthalmic)." Inspire Pharmaceuticals Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2008) "Product Information. AzaSite (azithromycin ophthalmic)." Inspire Pharmaceuticals Inc

Further information

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

Medical Disclaimer