Published: 2017-10-25

Adverse drug reaction monitoring of antitubercular drugs at tertiary care medical college hospital: prospective study

Shubha Revanna, Chinmayi Kaggere Harish, Gramle Amol


Background: To study the socio-demographic profile of patients receiving DOTS and to estimate the prevalence of adverse drug reaction and casualty in patients receiving DOTS.

Methods: This is a self reporting prospective study , trained personnel instructed patients about treatment and possible adverse drug reaction and patient telephone number was noted and pamphlet with information about possible ADR’S and containing contact number of the staff in-charge was distributed among the patients and they were instructed to contact staff if any mild or severe ADR’S was noticed and also staff in-charge himself contacted patients regularly for update of neglected ADR’S and noted information was tabulated ,analyzed using and frequency table with percentage and chi-square test of significance was calculated and causality was assessed using Noranjo scale and severity using modified Hartwig and Siegal scale.

Results: The commonest ADRs received were gastritis in 32 (20%) patients, followed by myalgia in 25 (15.6%) and fatigue in 21(13.12%) patients. Major adverse events included chest pain, joint pain, edema, blurring of vision and mental depression. It was surprising that none of the patients reported with any untoward skin reactions. In a small sample of 64 subjects, 160 ADRs were noted and among the ADRs there by received, the statistically significant value obtained was only with that of gastritis (p= 0.025).

Conclusions: Incidence of fatal ADR’s in DOTS is none with extremely low incidence of severe ADR’s with only mild to moderate ADR’S reported DOTS is relatively safe in treatment of tuberculosis.


Adverse drug reaction monitoring study, Antitubercular drug treatment, Adverse drug reaction in DOTS treatment, DOTS study, Pharmacovigilance

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