| アブストラクト | Background Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed for depressive and anxiety disorders and may increase the risk of bleeding. However, comprehensive real-world data on the patterns and distribution of SSRI-related bleeding remain limited. This study aimed to characterize bleeding adverse events associated with individual SSRIs using large-scale pharmacovigilance data. Methods A retrospective, descriptive pharmacovigilance study was conducted using data from the US Food and Drug Administration Adverse Event Reporting System (FAERS), retrieved from the first quarter of 2004 to the fourth quarter of 2025. Reports containing sertraline, citalopram, escitalopram, fluoxetine, paroxetine, or fluvoxamine as suspect drugs were identified and filtered using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) "Vascular disorders" and the High-Level Group Term (HLGT) "Vascular hemorrhagic disorders NEC". Bleeding events were summarized at the Preferred Term (PT) level. Descriptive analyses were performed for demographic characteristics, geographic distribution, bleeding sites, and concomitant use of medications associated with bleeding risk. Results A total of 5,604 bleeding-related cases were identified across 380,241 total FAERS cases. Bleeding event rates varied by SSRI: escitalopram (2.85%), citalopram (1.93%), paroxetine (1.29%), sertraline (1.25%), fluvoxamine (1.05%), and fluoxetine (1.02%). Sertraline accounted for the highest absolute number of bleeding reports (1,352, 24.1%), followed by escitalopram (1,229, 21.9%) and citalopram (1,029, 18.4%). Among the cases with available age data, patients aged >65 years constituted the largest group (range: 17.1%-46.6%), followed by adults aged 18-65 years (range: 11.0%-24.0%). Female patients were predominant (2,926, 52.2%). Hemorrhage (unspecified) was the most frequently reported event (range: 5.99%-15.93%), followed by contusion (0.70%-10.24%) and hematoma (1.25%-4.52%). Gastrointestinal (GI) bleeding events, including GI hemorrhage (0.37%-1.45%) and rectal hemorrhage (0.31%-5.94%), and central nervous system bleeding, including cerebral hemorrhage (0.40%-1.27%) and subarachnoid hemorrhage (0.35%-1.16%), were consistently reported. Concomitant use of medications increasing bleeding risk was documented in 541 cases (9.7%), with antiplatelet agents being most frequent (246, 4.4%), followed by nonsteroidal anti-inflammatory drugs (NSAIDs) (143, 2.6%), direct oral anticoagulants (DOACs) (130, 2.3%), and warfarin (22, 0.4%). Conclusion This FAERS-based analysis demonstrated that bleeding represented a class-wide safety concern among SSRIs. There were differences in bleeding patterns within the FAERS data; however, these findings are descriptive and should not be interpreted as comparative risk differences. These findings underscore the importance of individualized risk assessment, careful medication reconciliation, and strengthened pharmacovigilance to support safer SSRI prescription in routine clinical practice. |
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