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​​Azithromycin (Z-Pak®)​

March 1, 2026

Selected References:  

  • Abdellatif M, et al. 2019. Association between exposure to macrolides and the development of infantile hypertrophic pyloric stenosis: a systematic review and meta-analysis. Eur J Pediatr. 178:301–314.  
  • Antonucci R, et al. 2022. Use of Azithromycin in Pregnancy: More Doubts than Certainties. Clinical drug invest. 42(11): 921–935.  
  • Bakheit, AH, et al. 2014. Azithromycin. Profiles of Drug Substn, Excip, and Rel Methodol. 39:1-40. 
  • Bérard A et al. 2015. Use of macrolides during pregnancy and the risk of birth defects: a population-based study. Pharmacoepidemiol Drug Saf 24(12):1241–1248. 
  • Cooper WO, et al. 2002. Prenatal prescription of macrolide antibiotics and infantile hypertrophic pyloric stenosis. Obstet Gynecol; 100:101–106.  
  • Cooper WO, et al. 2009. Antibiotics potentially used in response to bioterrorism and the risk of major congenital malformations. Paediatr Perinat Epidemiol. 23(1):18-28.  
  • Damkier P, et al. 2019. In utero exposure to antibiotics and risk of congenital malformations: a population-based study. Am J Obstet Gynecol 221(6):648.e1–648.e15. 
  • Fan H, et al. 2020. Associations between macrolide antibiotics prescribing during pregnancy and adverse child outcomes in the UKL Population based cohort study. BMJ 368:m331.  
  • Figueroa-Romero A, et al. 2022. Drugs for intermittent preventive treatment of malaria in pregnancy: current knowledge and way forward. Trop. Med. Infect. Dis. 8(7): 152. 
  • Goldstein LH, et al. 2009. The safety of macrolides during lactation. Breastfeed Med, 4(4):197-200.  
  • Heikkinen T., et al. 2005. The transplacental transfer of the macrolide antibiotics erythromycin, roxithromycin and azithromycin. BJOG: An Intern Jour of Obstet and Gynaecol. 107(6):770-775. 
  • Hume-Nixon M, et al. 2021. A systematic review and meta-analysis of the effect of administration of azithromycin during pregnancy on perinatal and neonatal outcomes. EClinicalMedicine 40:101123.  
  • Leke, AZ, et al. 2021. Macrolide and lincosamide antibiotic exposure in the first trimester of pregnancy and risk of congenital anomaly: A European case-control study. Reprod Toxicol 100:101–108. 
  • Lund M, et al. 2014. Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study. BMJ. 348:g1908.  
  • Mårdh PA. 2002. Influence of infection with chlamydia trachomatis on pregnancy outcome, infant health and life-long sequelae in infected offspring. Best Pract and Research Clin Obstet and Gynaec. 16(6): 847-864. 
  • Muanda FT, et al. 2017. Use of antibiotics during pregnancy and risk of spontaneous abortion. CMAJ. 189(17):625-633. 
  • Pfizer Labs. 2021. Zithromax (azithromycin) label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050670s036,050710s051,050711s050,050784s037lbl.pdf. Accessed 4 Nov 2025.  
  • Rahangdale L, et al. 2006. An observational cohort study of Chlamydia trachomatis treatment in pregnancy. Sex Transm Dis. 33(2):106-110. 
  • Sandman Z., Iqbal OA. 2024. Azithromycin. StatPearls. Available at: https://www.ncbi.nlm.nih.gov/books/NBK557766/. Accessed 4 Nov 2025.  
  • Sarkar M, et al. 2006. Pregnancy outcome following gestational exposure to azithromycin. BMC Pregnancy Childbirth. 6:18.  
  • Sørensen HT, et al. 2003. Risk of infantile hypertrophic pyloric stenosis after maternal postnatal use of macrolides. Scand J Infect Dis. 35(2):104-106.  
  • Sutton A, et al. 2014. Azithromycin accumulates in breast milk following a single dose for cesarean prophylaxis. AJOG. 210(1):S235.  
  • Tellem R, et al. 2005. Pregnancy outcome after gestational exposure to the new macrolides: a prospective controlled cohort study. Reprod Toxicol.;20(3):484-485.  
  • U.S. Centers for Disease Control and prevention. 2021. Chlamydia Infections – STI Treatment Guidelines. Available at: https://www.cdc.gov/std/treatment-guidelines/chlamydia.htm. Accessed 4 Nov 2025. 
  • Wilton LV, et al. 1998. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol. 105(8): 882–889. 

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