Abstract
Background: Drug resistance tuberculosis (DRTB) is an important concern in India as it accounts, one-fourth of global burden. DRTB regimen is associated with adverse drug reactions (ADRs) accounting for significant mortality, non-adherence, and treatment discontinuation. Hence, the present study emphasis to be vigilant about these ADRs.

Aims and Objectives: The aim of the study was to estimate the incidence, various types, and risk factors associated with adverse reactions in DRTB in Northern Karnataka district.

Materials and Methods: A Prospective observational cohort study was conducted at Nodal DRTB center. All diagnosed and treatment initiated pulmonary DRTB patients during January–March 2021 aged ≥18 years of either sex were included, which constituted 70 patients. A pre-designed case report form was used to collect details like sociodemographic information, past history, personal history, and drug regimen along with their contact information of the DRTB patients.

Results: Of 70 study participants, 64% were males and mean age was 36.7 ± 14.5 years with majority being resistant to rifampicin (52%). Incidence of ADR was 32 (46%) and commonly reported ADR were nausea (30%), gastritis (24%), vomiting (21%), arthralgia (9%), and peripheral neuropathy (9%). Causality assessment was done using “Naranjo algorithm,” majority were probable (79.01%) and as per the modified Hartwig and Siegel severity scale most ADR were mild (87.65%). The past history of TB and exposure to ATT was the major risk factor associated and was statistically significant (P = 0.009).

Conclusion: ADRs are common in DRTB regimen early recognition and appropriate management might determine treatment adherence, prevent complications, and improve overall treatment outcome.

Key words: Adverse Reactions Monitoring; Multidrug Resistance Tuberculosis; Risk Factors