ADVERSE DRUG REACTIONS OF SELECTIVE SEROTONIN REUPTAKE INHIBITORS IN PATIENTS WITH DEPRESSION: A PROSPECTIVE OBSERVATIONAL STUDY FROM A TERTIARY CARE HOSPITAL IN RURAL INDIA

Abstract

Background: Selective serotonin reuptake inhibitors (SSRIs) are widely used as first-line treatment for depression; however, their adverse drug reaction (ADR) profile in rural Indian populations remains underreported. Understanding real-world safety patterns is crucial for optimizing therapeutic outcomes and strengthening pharmacovigilance in resource-limited settings.

Methods: This 12-month prospective observational study included drug-naïve adults with newly diagnosed depression attending a tertiary care hospital in rural Haryana. Patients prescribed SSRI monotherapy were followed at 3 and 6 weeks to identify ADRs using structured questionnaires and patient interviews. ADRs were evaluated using the WHO-UMC causality scale, Modified Hartwig and Siegel severity scale, and Schumock and Thornton preventability criteria. Data were analyzed using descriptive statistics and chi-square tests.

Results: Among 51 patients (mean age: 34.8 ± 11.2 years), Escitalopram was the most frequently prescribed SSRI (60.8%) and accounted for the highest proportion of ADRs (57.1%). A total of 119 ADRs were reported, predominantly affecting the central nervous system (52.1%), followed by gastrointestinal manifestations (32.8%). The most common ADRs were headache (12.6%), dizziness (11.7%), nausea (10.9%), dry mouth (9.2%), and drowsiness (8.4%). All ADRs were categorized as “possible” on causality assessment. Most ADRs were mild (74.8%) and non-preventable (79.8%), while 25.2% were moderate and 20.2% were probably preventable. Tobacco use (p = 0.047) and tobacco/paan consumption (p = 0.032) showed significant associations with multiple ADR occurrence, whereas age, gender, BMI, and marital status showed no significant associations.

Conclusion: SSRIs demonstrated a favorable and largely manageable safety profile in this rural cohort, with predominantly mild central nervous system and gastrointestinal ADRs. The association of tobacco use with increased ADR frequency highlights the need for integrated lifestyle counseling. Strengthened patient education and enhanced pharmacovigilance practices may further improve treatment adherence and safety in rural Indian settings.