Adverse Drug Reactions and their Determinants among Tuberculosis Patients Receiving Treatment at a Tertiary Care Centre in South India

Introduction

Tuberculosis (TB) remains a major public health challenge, exacerbated by Adverse Drug Reactions (ADRs) associated with anti-TB treatment. ADRs can lead to treatment discontinuation, drug resistance, and poor clinical outcomes. This study evaluates the incidence, nature, and determinants of ADRs among newly diagnosed TB patients under weight-based dosing guidelines in India.

Materials and Methods

A prospective study was conducted at a tertiary care hospital from January to December 2022. Newly diagnosed pulmonary and extrapulmonary TB patients were recruited. Demographic, clinical, and laboratory data were collected. ADRs were systematically documented during the intensive and continuation phases. Statistical analysis, including chi-square and Fisher's exact tests, was performed using SPSS 16.

Results

Among 203 patients, 113 (55.7%) experienced ADRs. The most common ADRs were gastrointestinal side effects in 65 (32%), itching in 38 (18.7%), and liver function test abnormalities in 25 (12.3%). Other ADRs included joint pain in 6 (2.9%), peripheral neuropathy in 3 (1.5%), and rashes in 5 (2.5%). The 35-49 kg weight group had the highest ADR incidence at 63 (69.2%, p=0.001). ADRs were also more frequent in patients with diabetes (46, 22.7%) and alcohol use (36, 17.7%). Multivariable analysis revealed that older age, lower body weight (35-49 kg: AOR 2.75, p=0.04), sputum AFB positivity (AOR 2.38, p=0.02), Alcohol (AOR=3.25, p=0.006) and comorbidities (AOR 2.05, p=0.02) were significant predictors of ADR.

Conclusion

Optimizing weight-based dosing, early ADR monitoring, and integrating comorbidity management into TB programs can improve treatment adherence and outcomes.