A study of adverse drug reactions among pulmonary tuberculosis patients treated under dots in a tertiary care hospital

Priyadarshini Bai G., Ravikumar P., Umme Salma


Background: DOTS under RNTCP is the current treatment available for Pulmonary Tuberculosis. This treatment exhibit a greater level of efficacy with a small degree of toxicity. The present study aims to determine demography of patients with pulmonary tuberculosis and to study the ADRs caused by anti tubercular drugs and to assess the causality and severity of the reported ADRs.

Methods: We studied cases of Pulmonary Tuberculosis diagnosed and treated under category I DOTS at Department of Pulmonary Medicine for the period of one year (during 2015). Adverse effects observed during treatment course were recorded in standard ‘Adverse Drug Event Reporting Form’. ADRs were also assessed for their causality and severity by using WHO-UMC criteria and Hartwig’s scale.

Results: Pulmonary cases accounted for 67.6% of total TB cases. Among 434 cases of pulmonary tuberculosis 33 (7.6%) patients were defaulters; among them 3(9.5%) cases were defaulters due to ADRs. In our study 96 patients developed 123 ADRs of various types and most of the ADRs noted within first 2 weeks of initiation of treatment. Gastritis was the most common ADRs (28/22.7%) followed by anorexia (26/21.1%).

Conclusions: In our study 22.1% of patients developed ADRs. ADRs recorded in our study were categorised under ‘probable’ and ‘possible’ causes and severity assessment showed 48% are moderate and 52% are ‘mild’ in nature. Still ADRs accounted for 9% default rate. Hence implementations of good patient care oriented programs are needed for early diagnosis and to reduce default rate and drug resistance.


Hartwig’s scale, Naranjo’s causality assessment scale, Pulmonary Tuberculosis

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