Study of adverse drug reactions among tuberculosis patients in a tertiary care hospital: a retrospective observational study

Sahana M. Mogali, Jagadishchandra S. Ratnakar, Basavaraj C. Kotinatot


Background: The aims of the study was to study adverse drug reactions (ADRs) among tuberculosis (TB) patients in a tertiary care hospital and to determine causality, severity and outcome of ADRs.

Methods: A retrospective observational study was conducted in a tertiary care hospital over a period of 6 months. Data was collected from records of TB patients in RNTCP centre of a tertiary care hospital regarding information of patients, drugs used, ADRs. It was evaluated using appropriate scales. Simple descriptive statistics was used for analysis.

Results: Out of 37 patients who experienced ADRs, 22 (59.45%) were male and 15 (40.54%) were female. Majority of patients were in the age group of 36 to 45 years (37.83%). 36 (97.3%) patients were diagnosed with pulmonary TB and 1 (2.7%) patient had extra pulmonary TB. Among 37 ADRs gastrointestinal (GI) reactions were most common 11 (29.72%) followed by musculoskeletal 9 (24.32%). Causality assessment showed 19 (51.35%) as probable and 18 (48.65%) ADRs as possible, Severity assessment was 24 (64.8%) reactions were in mild, 10 (27.02%) in moderate and 3 (8.1%) in severe grades. Outcome assessment was 26 (70.3%) patients were recovering from reactions, 9 (24.32%) had recovered and 2 (5.4%) did not recover at the time of reporting.

Conclusions: Proper monitoring of ADRs helps in reducing patient’s burden of repeated hospital visits and expense occurring due to admissions. This can be prevented by educating patients about early reporting of ADRs.


ADRs, ATT, Musculoskeletal, Tuberculosis

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