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Azithromycin Pregnancy and Breastfeeding Warnings

Azithromycin is also known as: Azithromycin Dose Pack, Z-Pak, Zithromax, Zmax

Medically reviewed on September 29, 2017

Azithromycin Pregnancy Warnings

Animal models given moderately maternally toxic doses have failed to reveal evidence of feto- or teratogenicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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.

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

See references

Azithromycin Breastfeeding Warnings

This drug should be used only if clearly needed.

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for gastrointestinal side effects (e.g., diarrhea, fungal infections, sensitization)
-Some experts recommend discontinuing breastfeeding during treatment and discarding milk during and up to 2 days after discontinuation; other experts recommend use if alternative agents are not available (e.g., clarithromycin, erythromycin).
-Infants exposed during the first 90 days after delivery may have up to a 3.5-fold increased risk of developing infantile hypertrophic pyloric stenosis than infants who were not exposed.

Infants of women given 500 mg orally every 12 hours were predicted to receive a 0.1 mg/kg/day dose, and would reach steady state in 3 days.

See references

References for pregnancy information

  1. Lukas DS "Some aspects of the distribution and disposition of digitoxin in man." Ann N Y Acad Sci (1971): 338-61
  2. "Product Information. Azithromycin Product Information (azithromycin)." Pfizer US Pharmaceuticals, New York, NY.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Zithromax (azithromycin)." Pfizer US Pharmaceuticals, New York, NY.

References for breastfeeding information

  1. "Product Information. Zithromax injection (azithromycin)" Pfizer US Pharmaceuticals, New York, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  5. "Product Information. Zithromax (azithromycin)." Pfizer US Pharmaceuticals, New York, NY.
  6. "Product Information. Azithromycin Product Information (azithromycin)." Pfizer US Pharmaceuticals, New York, NY.

Further information

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

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