The study of adverse drug reactions in indoor patients of tuberculosis taking standardized antitubercular therapy (directly observed treatment short-course and programmatic management of drug resistant tuberculosis) in a tertiary care hospital at Surat

Payal P. Naik, Arvindsingh Panwar, Swati Patel


Background: Tuberculosis is a serious public health issue in India. The treatment regimen followed is Directly observed treatment short-course (DOTS) and Programmatic Management of Drug resistant Tuberculosis (PMDT) approach. In a long period of treatment adverse drug reactions (ADRs) can be an important programmatic issue. Thus, study was undertaken to assess the ADRs caused by antitubercular therapy in indoor patients in a tertiary care hospital at Surat.

Methods: The Observational, prospective study was carried out for one year period. The causality was determined by WHO UMC scale and severity was determined by Modified Hartwig and Siegel scale. Chi square test was applied for statistical analysis.

Results: Among 255 tuberculosis patients, 85 (33.3%) patients developed ADRs. Occurrence of ADRs was more among females (46.6%). The commonly involved systems are gastrointestinal (40.6%) followed by haematological (17.9%). The most common ADRs observed were nausea and vomiting (21.7%). High percentage of ADRs causing drugs were isoniazid (30.6%) followed by rifampicin (26.1%). Causality assessment showed 60.4% ADRs were possible, 37.7% ADRs were probable and 1.9% ADRs was certain. Severity assessment scale showed 81.1% of moderate, 12.3% of mild and 6.6% of severe grading. Occurrence of ADRs was more among PMDT (60%) in comparison to DOTS therapy (31.06%) [p value = 0.0084 (significant p value < 0.05)].

Conclusions: Antitubercular treatment is safer but early detection, management and reporting of ADRs is required to prevent it at initial stage and helps to decrease default rate.


Adverse drug reaction, DOTS, PMDT, Antitubercular drugs

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