Pattern of adverse drug reactions in new smear positive patients of pulmonary tuberculosis treated under directly observed treatment short course

Background: Directly observed treatment short course (DOTS), a combination therapy, drugs are administered for six to eight months in patients diagnosed with tuberculosis, increases the risk of adverse drug reactions. The objective of this study was to study the adverse drug reaction profile of new sputum smear positive (NSP) patients of pulmonary tuberculosis (PTB) treated under DOTS. A prospective observational study was carried out in Dr. RPGMC Kangra at Tanda, Himachal Pradesh, India over a period of six months. Methods: The study included 130 newly diagnosed TB patients on anti‑TB treatment under DOTS. A symptom based approach was followed for monitoring ADRs. The severity was assessed by Modified Hartwig scale and causality by WHO-UMC probability scale. Data was expressed as percentages for discrete variables using Microsoft excel. Results: Out of the total 130, 84 patients experienced ADRs with an overall incidence of 64.6%. 45 (34.6%) patients showed single ADR whereas 39 (30%) patients had two or more ADRs. Gastritis alone was present in 36 (27.8%) patients followed by itching 2 (1.5%), hypersensitivity 2 (1.5%), arthralgia 2 (1.5%), generalized weakness 2 (1.5%) and jaundice in 1 (0.8%) patients. Vomiting was present in 29 (22.2%) patients, neuropathy in 4 (3.1%) patients, arthralgia in 2(1.5%) patients, hypersensitivity, jaundice, itching and generalized weakness in 1 (0.8%) patient each. 21 (16.2%) patients experienced mild , 56 (43.1%) had moderate and only 7 (5.4%) had severe ADRs. All the ADRs were possible in nature. Conclusions: The incidence of ADRs was 64.6% and GI irritation was found to be most common ADR reported by 57.6% patients.