ArticleBMC pharmacology & toxicology2025
The real-world safety profile of empagliflozin: a disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database.
Article in BMC pharmacology & toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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.
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Who cites it
5 citing papers in PubMed.
- Article
- Post-marketing safety profile of bictegravir/emtricitabine/tenofovir alafenamide: a FAERS pharmacovigilance study with EudraVigilance validation and mechanistic investigation of pancreatitis.Virology journal · 2026Article
- A Real-World Disproportionality Analysis of FDA Adverse Event Reporting System Events for Tazemetostat.Therapeutic innovation & regulatory science · 2026Article
- Post-marketing safety concerns with pirfenidone and nintedanib: an analysis of individual case safety reports from the FDA adverse event reporting system database and the Japanese adverse drug event report databases.Frontiers in pharmacology · 2025Article
- Explore the Causal Effect of SGLT2 Inhibition on Venous Thromboembolism Events: A Drug-Target Mendelian Randomization Study With Pharmacovigilance Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
objectiveThis study aimed to investigate the entire adverse events (AEs) spectrum and to identify some new or rare AEs associated with empagliflozin based on the FAERS database.
methodsA retrospective analysis was conducted on AE reports extracted from the FAERS, spanning from the first quarter of 2004 to that of 2023. Disproportionality analysis methods, including the ROR, PRR, BCPNN, and MGPS, were employed to quantify signals of AEs associated with empagliflozin. Additionally, demographic characteristics and time to onset were further elucidated.
resultsThe results showed a total of 20,734 AE reports related to empagliflozin, identifying 322 significant preferred terms (PTs) covering 27 System Organ Classes (SOCs). Empagliflozin was significantly associated with pre-specified AEs compared to other novel antidiabetic medications. Beyond common AEs, unexpected significant AEs such as pancreatitis, gastroenteritis, cerebral infarction, and cardiac operations were identified. The median onset time for empagliflozin-related AEs was 28 days (interquartile range (IQR) 4-154 days), with the majority of AE cases (n = 2,112, 10.19%) occurring within the first month following initiation of empagliflozin therapy.
conclusionThe clinically observed AEs, along with potential new AE signals associated with empagliflozin were identified based on the FAERS database, which could provide valuable evidence for clinical monitoring, risk identification, and further safety studies of identification.
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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 Socratic graph.