Anti-tubercular Drugs Dominate Drug-Induced Liver Injury in Northern India: An Observational, Cross-Sectional Study of 100 Cases Using the Revised Electronic Causality Assessment Method (RECAM) and Drug-Induced Liver Injury Network (DILIN) Criteria

Background: Drug-induced liver injury (DILI) is a major cause of acute liver failure in India, yet prospective data from northern India are rare. We analyzed drugs, clinical patterns, severity, and risk factors associated with DILI in a tertiary care hospital. Methods: This observational, cross-sectional study (IEC letter no. XXII-PGTSC-IIA/P9; March 2023-February 2024) included 100 patients with DILI (alanine transaminase (ALT)≥5×upper limit of normal (ULN) or ALT≥3×ULN plus bilirubin≥2×ULN). Causality assessment was performed using the Revised Electronic Causality Assessment Method (RECAM), and severity was classified by the Drug-Induced Liver Injury Network (DILIN) scale. Multivariate logistic regression identified predictors of moderate-to-severe DILI (grades 3-5). Results: Average age was 52.6±16.1 years, with 51% male. Anti-tubercular therapy (ATT) was implicated in 39 (39%) cases, antibiotics in 20 (20%), antiepileptics in 17 (17%), and complementary/alternative medicines (CAM) in 7 (7%) cases. Hepatocellular injury was the most common pattern, observed in 46 (46%) patients, followed by mixed injury in 36 (36%) and cholestatic injury in 18 (18%) patients. Regarding severity, 58 (58%) patients had Grade 1+, 19 (19%) had Grade 2+, 15 (15%) had Grade 3+, 6 (6%) had Grade 4+, and 2 (2%) had Grade 5+ injury. Hypertension (adjusted odds ratio (aOR) 4.14; 95% CI 1.65-57.40), diabetes (aOR 2.18; 95% CI 1.30-10.80), and CAM use (aOR 1.80; 95% CI 1.20-7.32) were independently associated with moderate-to-severe DILI. No clinical variable significantly predicted injury pattern. Conclusions: ATT remains the foremost DILI trigger in northern India. Metabolic comorbidities and CAM use were associated with increased severity. RECAM-guided causality and DILIN grading enhance bedside risk stratification.