To investigate and analyze the adverse drug event (ADE) signals associated with ceftriaxone in children in the real world, and provide references for the safety evaluation of ceftriaxone in children.

ADE reports in the US FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2022 involving children aged 0-17 years with ceftriaxone as the primary suspected drug were extracted. ADEs were classified into organ systems using the Medical Dictionary for Regulatory Activities (MedDRA). The reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were utilized to identify ADE signals associated with ceftriaxone.

A total of 999 ADE reports were collected for children aged 0-17 years with ceftriaxone as the primary suspected drug. There were 139 related ADE signals affecting 18 organ systems. The top 3 ADEs in terms of frequency were acute kidney injury, cholelithiasis, and postrenal acute renal failure. The top 3 ADEs in terms of signal strength were postrenal acute renal failure, ureteral calculus, and intravascular hemolysis. The top 10 ADEs in terms of signal strength for ceftriaxone in different age groups of children primarily involved the hepatobiliary system, renal and urinary system, and the blood and lymphatic system. After the update of the ceftriaxone package insert in July 2007, the proportion of pediatric stone-related ADEs caused by ceftriaxone decreased from 5.88% to 5.61% among all ADEs. Among the top 10 concomitant medications reported in ADEs, other types of antibiotics and nonsteroidal anti-inflammatory drugs were the most commonly used.

When ceftriaxone is used in children, caution should be exercised regarding its potential adverse events on the liver, gallbladder, and renal system. Additionally, attention should be paid to the risk of adverse events when used in combination with other medications.