Exploring risk signals of association between drugs and suicide: a retrospective investigation from 2004 to 2024

Background Suicide is a serious public health issue associated with the interaction of biological, psychological and social factors. Although relevant studies are relatively mature, research on the association between drugs and suicide remains limited and lacks systematic analysis. Objective This study aimed to explore the potential association signals between drugs and suicide-related adverse events (SAEs) using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods This study collected data from the FAERS database spanning the first quarter of 2004 to the fourth quarter of 2024. We associated 10 suicide-related preferred terms with the primary suspected drug, employed a disproportionality method for risk signal detection, used cumulative distribution curves to assess time to onset characteristics after drug use, and conducted subgroup analyses by age and gender. Results This study collected 247,657 reports of SAEs involving 193 drugs. The drug class most closely associated with SAEs were central nervous system medications; the majority of these drugs exhibited an early failure type, meaning that SAEs were more likely to occur during the initial stages of medication use. Among individuals <18 years old, the top three drugs by reported cases were montelukast, isotretinoin, and sertraline; hydrocodone/acetaminophen showed significantly higher ROR in individuals ≥65 years old. Quetiapine and paracetamol showed positive signals across all age groups, with ROR strength increasing with age. Conclusion Significant differences exist in SAEs timing and associated drug classes across age groups and genders. These findings support targeted drug safety monitoring for high-risk populations. Combining multiple datasets in future research could deepen mechanistic understanding, improve risk assessment systems, and further ensure public drug use safety.