A real-world safety signal detection study of ondansetron based on FAERS reports from 2014 to 2024

Aug 26, 2025Scientific reports

Real-world safety monitoring of ondansetron using reports from 2014 to 2024

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Abstract

A total of 9,413 adverse event reports related to Ondansetron were identified in the FAERS database from Q1 2014 to Q1 2024.

The majority of reports (59.7%) were linked to females, while 27.0% were linked to males.
Strong signals were identified for congenital, familial, and genetic disorders (n = 4725; 30.33) and pregnancy-related conditions (n = 1277; ROR 5.53).
Congenital heart disease and fetal exposure during pregnancy were among the most frequently reported adverse events.
Newly recognized signals included infections (ROR 1.24), psychiatric disorders (ROR 1.14), and metabolic disturbances (ROR 1.29).
In males, injury and congenital heart disease were more prevalent, while pregnancy-related and emotional disorders were more common in females.

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Ondansetron is widely acknowledged for its effectiveness in preventing and treating postoperative nausea and vomiting. Nevertheless, comprehensive research on its adverse effects is still limited. This study intends to explore the adverse events (AEs) related to Ondansetron, making use of data from the FDA Adverse Event Reporting System (FAERS) in the past decade. A pharmacovigilance analysis was carried out using FAERS data from January 2014 to March 2024. was utilized with four algorithms-proportional reporting ratio (PRR), (ROR), information component (IC), and empirical Bayesian geometric mean (EBGM)-to detect signals related to Ondansetron-related AEs. From Q1 2014 to Q1 2024, 9,413 adverse event (AE) reports were linked to Ondansetron as the primary suspect drug in the FAERS database, with a higher proportion in females (59.7%) than males (27.0%). Disproportionality analysis identified strong signals in several system organ classes (SOCs), most notably congenital, familial, and genetic disorders (n = 4725; ROR 30.33) and pregnancy-related conditions (n = 1277; ROR 5.53). At the preferred term (PT) level, congenital heart disease and fetal exposure during pregnancy were among the most frequently reported and strongly associated events. Additionally, previously underrecognized signals emerged, including infections (ROR 1.24), psychiatric disorders (ROR 1.14), and metabolic disturbances (ROR 1.29). Sex-stratified analysis revealed distinct patterns: injury, congenital heart disease predominated in males, while pregnancy-related and emotional disorders are more common in females. Our study synthesizes the adverse effects of Ondansetron, which have been reported in the FAERS database for nearly a decade. The vast majority of adverse effects are known and reported, yet some new ones deserve attention and some are controversial. These results will support the use of clinical agents.

Key numbers

9413

Adverse Event Reports

Total reports linked to Ondansetron as the primary suspect drug.

30.33

Congenital Disorders Signal Strength

for congenital, familial, and genetic disorders linked to Ondansetron.

5.53

Pregnancy-Related Conditions Signal Strength

for pregnancy-related conditions associated with Ondansetron.

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A real-world safety signal detection study of ondansetron based on FAERS reports from 2014 to 2024

Abstract

Key numbers

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