Safety and tolerability of azithromycin in pediatric infectious diseases: 2003 update

Pediatr Infect Dis J. 2004 Feb;23(2 Suppl):S135-9. doi: 10.1097/01.inf.0000112528.75956.41.


Oral azithromycin suspension has been prescribed to >80 million patients. Children find the color and taste of the oral suspension of azithromycin agreeable, and the drug is well-tolerated. On average 9% of patients have treatment-related adverse events, which are most frequently gastrointestinal complaints. The side effects are mild to moderate and very seldom necessitate withdrawal of the treatment. In addition to the conventional 3-day 10-mg/kg/day regimen and the 10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5 regimens, single dose 30 mg/kg and 3-day 20-mg/kg/day regimens are well-tolerated, although these new dosages are associated with more adverse effects.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Administration, Oral
  • Adolescent
  • Azithromycin / administration & dosage*
  • Azithromycin / adverse effects
  • Child
  • Child, Preschool
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Infant
  • Male
  • Maximum Tolerated Dose*
  • Otitis Media / diagnosis
  • Otitis Media / drug therapy*
  • Randomized Controlled Trials as Topic
  • Respiratory Tract Infections / diagnosis
  • Respiratory Tract Infections / drug therapy*
  • Treatment Outcome


  • Azithromycin