Adverse event reporting patterns of selective serotonin reuptake inhibitors (SSRIs): disproportionality analysis using the European spontaneous reporting system

Abstract Objective We analysed adverse event reporting patterns associated with SSRIs using data from the European pharmacovigilance database, EudraVigilance. Methods A descriptive analysis of individual case safety reports (ICSRs) was conducted between January 2020, 1st and December 2024, 31st. Disproportionality analysis were conducted for the two most frequently reported system organ classes (SOCs) and the three most frequently reported preferred terms (PTs). Results During the study period, 21,665 ICSRs reporting at least one SSRI as suspected drug were retrieved. A total of 78,132 adverse events were identified, and sertraline ( N = 26,161; 33.5%) was the most reported SSRI. Most events were not serious, and the most reported criterion was Other Medically Important Condition ( N = 19,603; 25.1%). The most frequent outcome was “Unknown” ( N = 27,555). In the disproportionality analysis, for the SOC “Psychiatric Disorders”, escitalopram and fluvoxamine showed a higher disproportionate reporting (ROR 1.08; 95% CI 1.03–1.13; ROR 1.15; 95% CI 1.01–1.31, respectively). For the SOC “Nervous System Disorders”, paroxetine showed a higher disproportionate reporting (ROR 1.10; 95% CI 1.04–1.16). Headache higher disproportionate reporting with sertraline (ROR 1.17; 95% CI 1.04–1.30), while dizziness with escitalopram (ROR 1.42; 95% CI 1.25–1.61), and somnolence with fluvoxamine and paroxetine (ROR 1.86; 95% CI 1.27–2.72; ROR 1.58; 95% CI 1.33–1.89, respectively). Conclusions SSRIs showed homogeneous adverse event reporting patterns, with relatively few differences in disproportional reporting between individual drugs. These results reinforce the importance of continuous pharmacovigilance monitoring.