ADVERSE DRUG REACTIONS OF SELECTIVE SEROTONIN REUPTAKE INHIBITORS IN GENERALIZED ANXIETY DISORDER: A PROSPECTIVE OBSERVATIONAL STUDY FROM A TERTIARY CARE HOSPITAL IN RURAL INDIA

Abstract

Background: Generalized anxiety disorder (GAD) affects approximately 6% of the population globally, with selective serotonin reuptake inhibitors (SSRIs) representing first-line pharmacotherapy. However, adverse drug reaction (ADR) profiles in real-world settings, particularly in rural Indian populations with GAD, remain inadequately documented.

Methods: This prospective observational study was conducted over 12 months in the psychiatry outpatient department. Forty-five drug-naïve adult patients with newly diagnosed GAD (ICD-10 criteria) prescribed SSRI monotherapy were enrolled using systematic random sampling. ADRs were monitored using structured proformas and assessed using 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 45 GAD patients (mean age 36.0 ± 1.92 years; M:F = 0.95:1), 88 ADRs were reported. Escitalopram was most frequently implicated (53.3%), followed by paroxetine (28.9%). Central nervous system ADRs predominated (50%), with headache (11.4%), dizziness (10.2%), and drowsiness (9.1%) being most common. Gastrointestinal ADRs accounted for 33%. Most ADRs were mild (88.6%) and non-preventable (90.9%). All ADRs were classified as "possible" by

causality assessment. Tobacco use showed significant association with multiple ADR occurrence (p=0.035).

Conclusion: SSRIs demonstrate an acceptable safety profile in GAD management with predominantly mild, manageable ADRs. Enhanced pharmacovigilance, patient education regarding lifestyle modifications, and routine cognitive monitoring may optimize therapeutic outcomes in rural populations.