Spectrum and Predictors of Adverse Drug Reactions in Patients Receiving Standard Antitubercular Therapy: A Prospective Study from Pakistan

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Abstract

Background Antitubercular therapy (ATT)-induced adverse drug reactions (ADRs) pose challenges to treatment adherence in high-burden settings like Pakistan, were malnutrition and hepatitis coinfection influence drug metabolism. This study evaluates the incidence, spectrum, and pharmacological predictors of ADRs in a Pakistani cohort. Methods A prospective observational study was conducted at Nasir Ullah Khan Baber Memorial Hospital, Peshawar (September 2023–October 2024), enrolling 250 patients on standard ATT (HRZE/HR). ADRs were assessed using WHO-UMC causality criteria and CTCAE severity grading, analyzed with SPSS version 24 via chi-square and multivariate logistic regression. Results Of 250 patients (52% male, 48% female), 68% experienced ADRs, with higher rates in females (87.5% vs. 50%, p < 0.001) and pediatric patients (80%). Gastrointestinal (73.5%) and dermatological (50%) reactions predominated, with severe ADRs (5.9%) including hepatotoxicity. Risk factors included hepatitis coinfection (aOR 3.0 for hepatotoxicity), pediatric age (aOR 3.1 for neurotoxicity), and female sex (aOR 2.8 for cutaneous reactions). Supportive care managed 70.6% of ADRs. Conclusion This study highlights a high ADR burden in Pakistan, driven by pharmacokinetic factors like hepatitis and malnutrition. It supports tailored ATT monitoring and dosing strategies to enhance drug safety and adherence in resource-limited settings.

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