Comparative Real-world Adverse Drug Reactions of Fluoxetine and Sertraline in Outpatients with Depression

Background Selective serotonin reuptake inhibitors (SSRIs), including fluoxetine and sertraline, are widely prescribed for depression due to their favorable safety profiles compared to older anti-depressants. However, these medications are associated with various adverse drug reactions (ADRs) that may affect patient adherence and treatment outcomes. Purpose This study evaluates the prevalence and characteristics of ADRs in outpatients treated with fluoxetine and sertraline, comparing ADR rates in real-world clinical settings. Materials and Methods A prospective cross-sectional study was conducted at a tertiary care psychiatric hospital from July to December 2018, involving 65 outpatients with depression who had been on fluoxetine ( n = 47) or sertraline ( n = 18) for at least 4 weeks. Data on ADRs were collected using a validated questionnaire, and comparisons were performed using chi-square and Fisher’s exact tests. Results The mean age of participants was 47.55 ± 16.14 years for fluoxetine and 45.16 ± 19.47 years for sertraline, with no significant differences in gender or treatment duration. Common ADRs included sedation, insomnia, and gastrointestinal symptoms. Anorexia was significantly more frequent in the fluoxetine group (21.28%, p = .05), while nausea/vomiting was higher in the sertraline group (27.78%, p = .001). Other ADRs, including sexual dysfunction and cardiovascular effects, were similar between the groups. Conclusion These findings underscore the importance of recognizing distinct ADR profiles to optimize treatment decisions for outpatients with depression.