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. Objectives: 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.