Pharmacovigilance study on signal detection of adverse drug reactions associated with selective serotonin reuptake inhibitors using spontaneous reporting system data
LÜ Ya-lan
LI Xin-hong
Abstract：Objective:To detect adverse drug reaction(ADR)signals of selective serotonin reuptake inhibitors(SSRIs)based on the FDA Adverse Event Reporting System(FAERS)database,and to provide a reference for the safety evaluation of these drugs.Methods:The proportional reporting ratio(PRR),reporting odds ratio(ROR),and Bayesian confidence propagation neural network(BCPNN)methods were used to detect ADR signals.Results:The adverse reaction reports of SSRIs mainly involved the following system organ classes:psychiatric disorders,nervous system disorders,general disorders and administration siteconditions,injury,poisoning and procedural complications,and gastrointestinal disorders.A total of 70 positive signals were detected.Fluvoxamine showed potential ADR signals for galactorrhea(IC 95%CI lower limit 0.79,PRR 95%CI lower limit 3.88,ROR 95%CI lower limit 3.88)and hyperprolactinemia(IC 95%CI lower limit 0.78,PRR 95%CI lower limit 3.57,ROR 95%CI lower limit 3.57).The other four SSRIs all showed potential ADR signals of fetal exposure during pregnancy.Citalopram showed a potential ADR signal for small for gestational age(IC 95%CI lower limit 3.38,PRR 95%CI lower limit 2.47,ROR 95%CI lower limit 2.48).Conclusion:This study identified potential ADR signals of SSRIs,suggesting that caution should be exercised when using SSRIs during pregnancy and that patients receiving fluvoxamine should be monitored for galactorrhea or hyperprolactinemia,so as to provide a reference for clinical safe medication.
Keywords：selective serotonin reuptake inhibitorsadverse drug reactionFAERS
Publication Date：2026-07-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1440-1446 )