ArticleBMC psychiatry2024
Exploring adverse events of Vilazodone: evidence from the FAERS database.
Article in BMC psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed.
- Comprehensive analysis of etrasimod-related adverse events based on the FDA Adverse Event Reporting System database.Indian journal of pharmacology · 2026Article
- Thromboembolic adverse events associated with TPO-RA in ITP treatment: a pharmacovigilance analysis of the FDA Adverse Event Reporting System.Frontiers in immunology · 2026Article
- Drug-induced intestinal obstruction: insights from the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2026Article
- Safety profile of ramelteon from the perspective of physicians and pharmacists: a 20-year real-world pharmacovigilance analysis based on the FAERS database.BMC psychiatry · 2025Article
- Analysis and mining of Dupilumab adverse events based on FAERS database.Scientific reports · 2025Article
- Safety assessment of ripretinib: a real-world adverse event analysis from the food and drug administration adverse event reporting system.Frontiers in oncology · 2025Article
- A real-world pharmacovigilance analysis of adverse events associated with irbesartan using the FAERS and JADER databases.Frontiers in pharmacology · 2024Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
objectiveThis study aims to conduct an exhaustive evaluation of Vilazodone's safety in clinical application and to unearth the potential adverse event (AE) risks associated with its utilization based on FDA Adverse Event Reporting System (FAERS) database.
methodsThis research employed data spanning from the first quarter of 2011 to the third quarter of 2023 from the FAERS database. Various signal detection methodologies, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), were utilized to ascertain the correlation between Vilazodone and specific AEs.
resultsThe study compiled a total of 17,439,268 reports of drug AEs, out of which 5,375 were related to Vilazodone. Through signal mining, 125 Preferred Terms (PTs) encompassing 27 System Organ Classes (SOCs) were identified. The findings indicated a higher prevalence among females and patients within the 45 to 65 age bracket. The principal categories of AEs included Psychiatric disorders, Nervous system disorders, and Gastrointestinal disorders, with prevalent incidents of Diarrhoea, Nausea, and Insomnia. Moreover, the study identified robust signals of novel potential AEs, notably in areas such as sleep disturbances (Sleep paralysis, Hypnagogic hallucination, Rapid eye movements sleep abnormal, Sleep terror, Terminal insomnia, Tachyphrenia), sexual dysfunctions (Female orgasmic disorder, Orgasm abnormal, Disturbance in sexual arousal, Spontaneous penile erection, Anorgasmia, Sexual dysfunction, Ejaculation delayed), and other symptoms and injuries (Electric shock sensation, Violence-related symptom, Gun shot wound).
conclusionAlthough Vilazodone presents a positive prospect in the management of MDD, the discovery of AEs linked to its use, particularly the newly identified potential risks such as sleep and sexual dysfunctions, necessitates heightened vigilance among clinicians.
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Registered trials
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