Published: 2019-04-23

A prospective observational pharmacovigilance study of adverse drug reaction monitoring in patients of tuberculosis receiving category I and II treatment regimens at tertiary care hospital

Monali Raghunath Kale, Mirza Shiraz Baig, Avinash Lamb


Background: First line Anti-TB therapy with rifampicin, isoniazid, pyrazinamide, and ethambutol / streptomycin is very effective. However, major adverse reactions to antituberculous drugs can cause significant morbidity and mortality. One of the main reasons for non‑adherence to anti‑TB therapy (ATT) is ADRs, even under DOTS. Present study was carried out in tertiary care hospital. The objective of the study was to evaluate types and frequency of ADRs in intensive and continuation phase of category I and II Anti-TB medication.

Methods: A prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India.  All the TB patients reporting at DOTS Center of institute were enrolled and monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire.

Results: Total, n = 241 tuberculosis patients on DOTS therapy were enrolled for the study. Out of 241 patients, 17 were dropouts so 224 patients assessed for ADRs. 127 (56.69%) developed adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40 yrs followed by 21-30 yrs, ADRs were more common in men.  Pulmonary TB (73.66%) cases were more common than extra pulmonary TB. Majority of adverse drug reactions were Gastrointestinal (GI) problems (30.92%), followed by Liver dysfunction and Hepatotoxicity (20.39%) and skin problems (17.10%). The causality of ADRs, in majority cases were found to be Probable (56.57%). Around 19 patients require treatment interruption and most of the patients were managed with supportive medication without removing anti tubercular drug from regimen.

Conclusions: ADRs are major limiting factor for completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.


Adverse drug reactions, Antitubercular drugs, Causality assessment, Severity assessment

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