Signal mining and safety profile analysis of prucalopride: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database

Abstract Background Prucalopride is a highly selective 5-HT 4 agonist used for chronic idiopathic constipation and gastroparesis. Although clinical trials suggest a favorable safety profile, real-world data on rare adverse events (AEs) remain scarce. This study mined the FDA Adverse Event Reporting System (FAERS) to detect safety signals warranting clinical attention. Methods FAERS data from December 14, 2018 to September 30, 2025 were collected via OpenVigil 2.1. AEs were categorised using the Medical Dictionary for Regulatory Activities. Signal detection was performed using four specific algorithms: the Proportional Reporting Ratio (PRR), the Reporting Odds Ratio (ROR), the Multi-item Gamma Poisson Shrinker (MGPS), and the Bayesian Confidence Propagation Neural Network (BCPNN). Kappa consistency and sensitivity analyses were performed. Results We collected 1101 prucalopride-related reports and identified 35 positive adverse drug event (ADE) signals across 10 system organ classes. Gastrointestinal disorders dominated (12 signals, 373 cases), followed by psychiatric disorders (9 signals, 107 cases) and nervous system disorders (5 signals, 181 cases). Frequent reactions included headache, diarrhoea, nausea, dizziness and abdominal pain. Signal intensity varied across algorithms; gastrointestinal bacterial overgrowth emerged as a strong signal in all four. We found 19 ADEs that were not listed in the prescribing information of China, the United States, or Europe; serious unlabeled signals included intestinal obstruction and serotonin syndrome. Notably, depression, suicidal ideation, depressed mood, and nightmares appear only in the United States prescribing information. Conclusions Prucalopride-related ADEs involve multiple organ systems, predominantly presenting as gastrointestinal disorders, psychiatric disorders and nervous system disorders. Some ADEs not included in the instructions may be serious adverse events, require great attention from clinicians. For patients with underlying comorbidities or those undergoing combination therapy, close monitoring for potential severe adverse events is essential to ensure clinical medication safety.