Occurrence and spectrum of cutaneous adverse drug reactions to anti-tubercular drugs among patients of drug-sensitive and drug-resistant tuberculosis-changing trends at a tertiary care center in central India

Abstract

Background: Tuberculosis (TB) continues to pose a significant public health burden, particularly in resource-limited settings. Anti-tubercular therapy (ATT), though effective, is frequently associated with cutaneous adverse drug reactions (CADRs), which can lead to treatment discontinuation and adverse outcomes. Aims and Objectives: The aim of the study was to estimate the occurrence and its evolving trends clinical spectrum, and causative agents of CADRs among TB patients on ATT, and to assess associated demographic and clinical variables. Materials and Methods: A prospective observational cross-sectional study was conducted at Maharani Laxmi Bai Medical College, Jhansi, from April 2024 to March 2025. Sixty TB patients with CADRs were enrolled after meeting the inclusion criteria. Data on demographics, clinical presentation, investigations, and implicated drugs were collected and analyzed. Results: CADRs were most common among patients aged 16–30 years (43.3%), with a male predominance (55%). Most patients were from rural (65%) and lower socioeconomic backgrounds (50%). Pulmonary TB accounted for 75.01% of cases, while Extrapulmonary TB accounted for 24.99% of cases. The most frequent CADRs were morbilliform eruptions (40%), skin discoloration/ichthyosis (33.3%), and pruritus (16.7%). Severe CADRs like Stevens-Johnson syndrome/Toxic epidermal necrolysis were rare (1.7%) due to early detection and management. Isoniazid (38.3%) and clofazimine (33.3%) were the most common offending agents. Diabetes mellitus was the only comorbidity observed (6.7%). Most cases responded to symptomatic treatment and drug discontinuation. Conclusion: CADRs are prevalent among TB patients receiving ATT, especially in young adults and those with multidrug-resistant TB (MDR-TB). Isoniazid and clofazimine were frequently implicated. Early recognition and management are essential to minimize complications and ensure treatment adherence. Clofazimine being integral part of the MDR TB Regiment so accounted for increased CADRs.