Background: As with the profile of adverse drug reactions (ADRs) due to directly observe treatment, short course (DOTS), there is no report available in patients receiving anti tuberculosis (antiTB) chemotherapy in Warangal region, Telangana, India. One of the main reasons for non-adherence to antiTB therapy (ATT) is adverse drug reactions (ADRs), even under DOTS. Objective: This main objective of the study was to determine the incidence and prognosis of ADRs due to DOTS therapy, and to evaluate their impact on anti-TB treatment in Warangal district, Telangana State. Methods: A prospective population-based study was performed from January 2014-August 2014. Sputum smear positive pulmonary tuberculosis patients who received DOTS therapy were included and followed up for six months. The suspected ADRs were recorded. Results: A total of 120 Tuberculosis patients were included in this study. 70 patients (58.3%) showed at least one ADR due to anti tubercular regimens. The incidence (count) of ADR based on affected organ was: gastrointestinal disorders in 35 patients (41.17%), anemia in 30 patients (42.85%), ototoxicity and giddiness in 19 patients (27.14%), Liver dysfunction in 17 patients (24.28%), allergic reactions in 12 patients (17.14%), Muscle weakness in 11 patients (12.94%). No ADRs were observed in CVS. Most cases of ADRs (53%) had a good clinical outcome. Conclusions: The incidence of ADRs due to DOTS therapy was 58.3%. These ADRs had a substantial impact on TB control in Warangal. This highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely.
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