Related Experiment Video
Updated: Dec 26, 2025

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
Published on: April 19, 2024
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.
Objective:
To determine the safety of ceftriaxone in paediatric patients and systematically evaluate the categories and incidences of adverse drug reactions (ADRs) of ceftriaxone in paediatric patients.
Methods:
We performed a systematic search in Medline, PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, International Pharmaceutical Abstracts and bibliographies of relevant articles up to December 2018 for all types of studies that assessed the safety of ceftriaxone in paediatric patients aged ≤18 years.
Results:
112 studies met the inclusion criteria involving 5717 paediatric patients who received ceftriaxone and reported 1136 ADRs. The most frequent ADRs reported in prospective studies were gastrointestinal (GI) disorders (37.4 %, 292/780), followed by hepatobiliary disorders (24.6%, 192/780). Serious ADRs leading to withdrawal or discontinuation of ceftriaxone were reported in 86 paediatric patients. Immune haemolytic anaemia (34.9%, 30/86) and biliary pseudolithiasis (26.7%, 23/86) were the two major causes. Haemolytic anaemia following intravenous ceftriaxone led to death in 11 children whose primary disease was sickle cell disease. Almost all biliary pseudolithiasis are reversible. However, the incidence was high affecting one in five paediatric patients (20.7%).
Conclusions:
GI ADRs are the most common toxicity of ceftriaxone in paediatric patients. Immune haemolytic anaemia and biliary pseudolithiasis are the most serious ADRs and the major reasons for discontinuation of ceftriaxone. Immune haemolytic anaemia is more likely in children with sickle cell disease and may cause death. Ceftriaxone should be used with caution in children with sickle cell disease.
Trial Registration Number:
CRD42017055428.
Related Concept Videos
Pharmacokinetics in Pediatric Patients: Drug Excretion
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Pharmacokinetics in Pediatric Patients: Drug Distribution
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
Drug Dosing: Infants and Children
Pharmacokinetics in Pediatric Patients: Drug Metabolism

