Use and safety of azithromycin in neonates: a systematic review

BMJ Open. 2015 Dec 9;5(12):e008194. doi: 10.1136/bmjopen-2015-008194.


Objectives: To identify the use and adverse drug reactions associated with azithromycin in neonates.

Setting: Databases MEDLINE (1948-August 2015), EMBASE (1980-August 2015) and Pubmed (August 2015) were searched for studies on azithromycin in neonates.

Participants: All studies involving neonates (<28 days old) who have received at least a single dose of azithromycin for which safety was evaluated.

Primary and secondary outcome measures: The primary outcome was adverse event (AE) associated with use of azithromycin. Use of azithromycin in neonates was the secondary outcome.

Results: A total of 11 articles involving 473 neonates were identified. 371 AEs were reported. Adverse events were mainly respiratory (358/1000 neonate), neurological (273/1000 neonates) and gastrointestinal (196/1000 neonates) in origin. Azithromycin significantly reduced the risk of bronchopulmonary dysplasia (BPD) in extremely premature neonates (RR=0.83, 95% CI 0.71 to 0.98, p=0.02). There was no significant difference in the incidence of elevated liver enzymes between the azithromycin and placebo group (p=0.76). There were four cases of infantile hypertrophic pyloric stenosis (IHPS).

Conclusions: Azithromycin significantly reduces the risk of BPD in preterm neonates. The relationship between azithromycin and IHPS requires further investigation.


Publication types

  • Research Support, Non-U.S. Gov't
  • Review
  • Systematic Review

MeSH terms

  • Anti-Bacterial Agents / adverse effects*
  • Anti-Bacterial Agents / pharmacokinetics
  • Anti-Bacterial Agents / therapeutic use*
  • Azithromycin / adverse effects*
  • Azithromycin / pharmacokinetics
  • Azithromycin / therapeutic use*
  • Bronchopulmonary Dysplasia / prevention & control*
  • Humans
  • Infant, Extremely Premature
  • Infant, Newborn
  • Risk Factors


  • Anti-Bacterial Agents
  • Azithromycin