ArticleScientific reports2025
A real-world safety signal detection study of ondansetron based on FAERS reports from 2014 to 2024.
Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Post-marketing safety profile of bictegravir/emtricitabine/tenofovir alafenamide: a FAERS pharmacovigilance study with EudraVigilance validation and mechanistic investigation of pancreatitis.Virology journal · 2026Article
- Comparative safety signals of carboplatin and cisplatin in lung cancer: a pharmacovigilance study based on FAERS.Frontiers in medicine · 2026Article
- Safety profile of entrectinib in NSCLC: Multi-source pharmacovigilance analysis using FAERS and JADER.PloS one · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. Disproportionality analysis was utilized with four algorithms-proportional reporting ratio (PRR), reporting odds ratio (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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.