Adverse Drug Reaction to First-Line Oral Antitubercular Drugs: An 8-Year Analysis from a Tertiary Centre in Eastern India

BACKGROUND: Tuberculosis (TB) is caused by Mycobacterium tuberculosis. Treatment regimen with the first-line anti-tubercular drug remains the foundation of treatment for drug-sensitive TB. The fixed-dose combination of drugs regime is associated with adverse drug reactions (ADRs) such as drug-induced liver injury (DILI), myalgia, arthralgia, hearing loss, gastrointestinal disturbances, visual disturbances, central nervous disorders and hypersensitivity reactions. AIMS: This study aimed to analyse the spectrum and severity of ADRs with emphasis on DILI. METHODS: This retrospective study was conducted from 2015 to 2023 at a tertiary care teaching hospital. A total of 108 patients were included in the study. The spectrum of ADRs was classified as per the World Health Organization systems organ classes. The seriousness of the reaction was classified as serious and non-serious. The severity of DILI was categorized into five grades. RESULTS: A total of 126 ADRs were reported. DILI was the most reported ADR followed by vomiting and itching. CONCLUSION: This study seeks to enhance the clinicians' understanding of the diverse ADRs linked to anti-TB treatment, encouraging them to provide better patient counselling, prioritise safety and actively report even mild ADRs.