Real-world pharmacovigilance and clinical risks of fluvoxamine: A disproportionality analysis based on FAERS data

Fluvoxamine is a widely used treatment for depressive disorders, yet real-world safety data remain understudied. This study aimed to evaluate the safety profile of fluvoxamine by analyzing adverse events (AEs) reported in the FAERS pharmacovigilance database. Data on fluvoxamine-related AEs were collected from the first quarter of 2008 to the second quarter of 2025. Disproportionality analyses were performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM) methods. A total of 694 AEs reports related to fluvoxamine were identified, spanning 27 different System Organ Classes and 99 Preferred Terms. Psychiatric disorders were the most frequently reported AEs. Notably, signals for eye disorders and ear and labyrinth disorders were stronger but not related to the pharmacological properties of fluvoxamine, thus warranting special clinical attention. Oscillopsia, neonatal behavioural syndrome, and activation syndrome ranked among the top three signals and require vigilance. Drug interactions were observed, leading to increased antipsychotic drug levels and extrapyramidal symptoms, such as slow speech, akinesia, and tardive dyskinesia. Cardiac-related AEs such as Brugada syndrome, long QT syndrome, and electrocardiogram abnormalities were also identified. Homicidal ideation and impulsive behaviour necessitate clinical risk management. Additionally, significant symptoms of serotonin syndrome were observed, including tic and clonus. Our study also uncovered AEs not previously documented in product labels, such as Cushing's syndrome, disinhibition, and vasoplegia syndrome. These findings provide a comprehensive overview of the real-world safety profile of fluvoxamine, highlighting both known and previously unreported AEs. Clinicians should remain vigilant for psychiatric, neurological, ocular, and cardiac AEs, as well as potential drug interactions. This study offers valuable evidence to inform clinical monitoring, risk management, and future research aimed at optimizing the safe use of fluvoxamine in diverse patient populations.