Safety of ceftriaxone in paediatrics: a systematic review

Linan Zeng1,2, Chao Wang3, Min Jiang4

  • 1Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.

Insights

Ceftriaxone commonly causes gastrointestinal issues in children. Serious adverse drug reactions like immune hemolytic anemia and biliary pseudolithiasis necessitate caution, especially in children with sickle cell disease.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety and Pharmacovigilance
  • Antibiotic Therapeutics

Background:

  • Ceftriaxone is a widely used antibiotic in pediatric care.
  • Understanding its adverse drug reactions (ADRs) in children is crucial for safe clinical practice.

Purpose of the Study:

  • To systematically evaluate the safety of ceftriaxone in pediatric patients.
  • To identify the categories and incidence of adverse drug reactions (ADRs) associated with ceftriaxone use in children.

Main Methods:

  • A comprehensive systematic search was conducted across multiple major medical databases up to December 2018.
  • Inclusion criteria focused on studies assessing ceftriaxone safety in patients aged 18 years or younger.

Main Results:

  • 112 studies involving 5717 pediatric patients reported 1136 ADRs.
  • Gastrointestinal disorders (37.4%) were the most frequent ADRs, followed by hepatobiliary disorders (24.6%).
  • Serious ADRs included immune hemolytic anemia (34.9%) and biliary pseudolithiasis (26.7%), leading to drug discontinuation. Fatal hemolytic anemia occurred in 11 children with sickle cell disease.

Conclusions:

  • Gastrointestinal ADRs are the most common toxicity of ceftriaxone in pediatric patients.
  • Immune hemolytic anemia and biliary pseudolithiasis represent the most serious ADRs, often requiring ceftriaxone discontinuation.
  • Ceftriaxone use demands caution in children with sickle cell disease due to the risk of fatal immune hemolytic anemia.
Abstract

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