Analysis of the associations of sex, age, and prescription medications with suicide-related adverse events and drug-related depression by using the Japanese Adverse Drug Event Report database

We investigated the associations of suicide-related adverse events (SRAEs) and drug-related depression (DRD) with sex, age, and medications by using the Japanese Adverse Drug Event Report (JADER) database. SRAEs and DRD cases for April 2004 to January 2025 were extracted from the JADER database by using the preferred terms of the Medical Dictionary for Regulatory Activities. SRAEs were evaluated as drug-related completed suicides (DRCSs), drug-related suicide attempts (DRSAs), and drug-related suicidal ideation (DRSI) and associations with sex, age, and causative drugs were evaluated. Drugs were categorized using the Anatomical Therapeutic Chemical Classification System, and their associations with sex and age were visualized using mosaic plots. Disproportionality was assessed using reporting odds ratios (RORs) and proportional reporting ratios (PRRs); adjusted RORs were additionally estimated using multivariable logistic regression with reporting year, sex, and age group as covariates. Among 965,285 reports, 1,061 DRCSs, 2,316 DRSAs, 1,093 DRSI cases, and 1,658 DRD cases were identified. Male individuals accounted for 59.2%, 38.7%, 42.3%, and 42.3% of DRCS, DRSA, DRSI, and DRD cases, respectively. Additionally, patients aged ≥60 years accounted for 32.0%, 19.2%, 24.8%, and 44.9% of the corresponding cases. The frequently reported suspected drugs included paroxetine and aripiprazole for DRCS, zolpidem and paroxetine for DRSA, paroxetine and aripiprazole for DRSI, and interferon preparations and ribavirin for DRD. DRCS was relatively more frequent in males and older adults, whereas DRSA/DRSI were more prominent in females and younger individuals; neuropsychiatric agents predominated in SRAEs, while interferon-based therapies were prominent in DRD. • Associations with sex, age, and drugs were shown in suicide and depression cases • Antidepressants and antipsychotics were frequently reported in suicide-related events • Interferon and ribavirin were frequent in drug-related depression reports