TO STUDY THE ADVERSE DRUG REACTION MONITORING OF COMMONLY PRESCRIBED FIRST LINE ANTITUBERCULAR DRUGS IN PATIENTS AT RAMA MEDICAL COLLEGE, HOSPITAL & RESEARCH CENTRE, KANPUR.

Abstract

Tuberculosis (TB) remains a significant public health concern in India, and the first-line antitubercular drugs (ATDs)—Isoniazid, Rifampicin, Pyrazinamide, Ethambutol, and Streptomycin—form the cornerstone of TB treatment. However, these drugs are associated with a range of adverse drug reactions (ADRs), which may affect treatment adherence and outcomes. This study aims to monitor and evaluate the ADRs associated with first-line ATDs among patients receiving treatment at Rama Medical College, Hospital & Research Centre, Kanpur.

Objectives:

1. To identify and categorize adverse drug reactions associated with first-line antitubercular therapy.


2. To assess the incidence, severity, and causality of reported ADRs.


3. To promote awareness about pharmacovigilance among healthcare providers.

Methods:
A prospective observational study was conducted over a specified period among TB patients receiving first-line antitubercular drugs at the Department of Pulmonology and Internal Medicine. Patients were monitored regularly through clinical evaluation, laboratory investigations, and follow-up visits. ADRs were documented, categorized by system organ class, and assessed for severity (using Hartwig’s Scale) and causality (using WHO-UMC and Naranjo algorithms).

Results:
Preliminary data indicate a significant incidence of ADRs, with hepatotoxicity, gastrointestinal disturbances, and hypersensitivity reactions being the most commonly reported. Most reactions were mild to moderate in severity, with a few requiring modification or discontinuation of therapy. The majority of ADRs were deemed “possible” or “probable” in causality assessments