Antidepressants-related cardiovascular adverse events using the adverse event reporting system

Psychiatry Res. 2018 Oct:268:441-446. doi: 10.1016/j.psychres.2018.07.044. Epub 2018 Aug 4.


The aim of this study was to evaluate clinical manifestations and the age and sex distribution of cardiovascular adverse events (CVAEs) related to antidepressants. The FDA Adverse Event Reporting System (FAERS) and Korea Adverse Event Reporting System (KAERS) database records on patients prescribed antidepressants were used. The frequency of CVAEs was compared between adults (19-64 years) and an older (age ≥ 65 years) group. In total, 75,608 CVAEs from 43,824 patients and 325 CVAEs from 313 patients in FAERS and KAERS, respectively, were included in the analysis. Among them, 7066 (16.08%) and 103 (32.91%) patients were 65 years of age or older in FAERS and KAERS, respectively. Serious AEs were significantly more common among older patients compared to adults in both the FAERS and KAERS datasets. CVAEs were frequently reported with paroxetine and duloxetine in the FAERS, while amitriptyline and duloxetine were reported in the KAERS. The two most frequent CVAEs were "ventricular arrhythmias and cardiac arrest" and "rate and rhythm disorders" in the FAERS, while "hypotension", and "oedema", were found in the KAERS. Several CVAEs were detected by the reporting odds ratios and proportional reporting ratios methods. The serious AEs associated with antidepressants might have a significant impact on older patients.

Keywords: Adverse events; Antidepressants; Cardiovascular disorders.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Age Distribution
  • Aged
  • Antidepressive Agents / adverse effects*
  • Cardiovascular Diseases / chemically induced*
  • Cardiovascular Diseases / epidemiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Odds Ratio
  • Proportional Hazards Models
  • Republic of Korea / epidemiology
  • Sex Distribution
  • United States / epidemiology
  • United States Food and Drug Administration


  • Antidepressive Agents