Frequency of side effects among patients with drug resistant tuberculosis (DR-TB) by resistance pattern in a high burden country

<b>Background:</b> Tuberculosis (TB) is a global public health concern with increasing challenge of drug resistance. India is a high burden country for DR-TB but treatment is complicated by frequent side effects. <b>Methods:</b> Patients with DR-TB were enrolled in a prospective observational cohort at a private tertiary care hospital in Mumbai, India. Side effects were self-reported during follow-up. Lab values were deemed abnormal if they exceeded the local reference range. Side effect frequency was stratified by resistance to isoniazid and rifampicin (MDR), MDR resistant to quinolones or injectables (pre-XDR) or to both (XDR). Difference in side effect rate by resistance profile was assessed by Fisher’s exact test. <b>Method:</b> 517 patients were included. 141 (27.3%) had MDR-TB, 260 (50.3%) had pre-XDR-TB and 116 (22.4%) had XDR-TB. It was a young, female predominant (N=324, 62.7%) cohort with median age of 26 years. 407 had pulmonary TB (78.7%) and 3 had HIV (0.6%). Hypothyroidism was the most common side effect (N=320, 61.9%) followed by kidney injury (N=131, 25.3%), dark skin (N=111, 21.4%), peripheral neuropathy (N=100, 19.3%), hearing loss (N=88, 17.0%) and nausea (N=79, 15.3%). These were not significantly different across resistance profiles. <b>Conclusion:</b> Treatment associated side effects are common. Overall frequency of common side effects did not differ significantly by resistance profile.