An observational study to find out incidence and pattern of adverse drug reactions among multidrug resistant tuberculosis patients treated under revised national TB control program of India

Preet Lakhani, Shireen Barua, Divya Singh, Suchi Jain, Surya Kant, Ajay Verma, Amod K. Sachan, Rajendra Nath, Rakesh K. Dixit


Background: Between 2006 and 2015, the prevalence of MDR-TB has been found to be as high as 39.9% in some states. Approximately 35.8% of all previously treated patients developed MDR-TB. The objective of the present study was to identify demographic and health characteristics of patients as well as incidence and pattern of the adverse drug reactions caused by antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.

Methods: This 12 months study of observational study was conducted at a DOTS centre. MDR-TB diagnosed patients treated with DOTS Plus regimen were enrolled after getting informed consent. Patient information was recorded. Patient follow-up was conducted to identify the incidence and pattern of ADRs.

Results: A total of 115 patients were enrolled. Maximum number of cases were in the 31-40 age group (25.21%) followed by the 41-50 age group (20.86%). 76 (66.08%) were males and 39 (33.91%) were females. 52 patients (45.21%) had concomitant diseases, out of which 15 (13.04%) were HIV positive and 21 (18.26%) were diabetic. 70 patients (60.86%) developed ADRs. The adverse drug reaction that were seen are -38 (38.76%) cases of gastrointestinal adverse drug reactions, 8 (8.16%) jaundice/hepatitis, 7 (7.14%) impaired hearing/vertigo, 21 (21.24%) central nervous system adverse drug reaction, 6 (6.12%) peripheral neuropathy, 6 (6.12%) rash and itching, 5 (5.10%) arthralgia, 3 (3.06%) renal impairment, 2 (2.04%) hypothyroidism and 2 (2.04%) blurred vision.

Conclusions: Determining which population groups are affected most by ADRs can help physicians to better monitor and make an early diagnosis to reduce ADR-related morbidity and mortality.


ADR, DOTS-Plus, MDR-TB, RNTCP, Tuberculosis

Full Text:



Goyal V, Kadam V, Narang P, Singh V. Prevalence of drug-resistant pulmonary tuberculosis in India: systematic review and meta-analysis. BMC Public Health. 2017;17(1):817.

Global Health Education. Multi Drug Resistant TB - What is MDR, statistics, treatment. Available at: Accessed 31 October 2018.

World Health Organization. (2015). A brief history of tuberculosis control in India. Geneva: World Health Organization; 2015. Available at:;jsessionid=28B4670D77CBEE7F0D0654DCC221580Esequence=1 Accessed 31 October 2018.

Global Health Education. TB Statistics India - National, treatment outcome, state. Available at: Accessed 31 October 2018.

World Health Organization (2018). Tuberculosis. Geneva: World Health Organization; 2018 Available at: Accessed 31 October 2018.

World Health Organization. (2016). Updated and interim estimates of TB disease burden in India and plans for a national TB prevalence survey in 2017/2018. Available at: Accessed 31 October 2018.

Central TB Division. 2017. TB India 2017 Revised National Tuberculosis Control Programme. Annual Status Report. New Delhi: Central TB Division. Available at: Accessed 28 October 2018.

Paramasivan C, Venkataraman P, Chandrasekaran V, Shripad B, Narayanan P. Surveillance of drug resistance in tuberculosis in two districts of South India. Int J Tuberculosis Lung Dis. 2002 Jun 1;6(6):479-84.

World Health Organization (2017). Revised National Tuberculosis Control Programme Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India. Geneva: World Health Organization. Available at: Accessed 31 October 2018.

Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: An observational study. J Natural Sci Biol Med. 2013 Jan;4(1):191-6

Cavanaugh JS, Kazennyy BY, Nguyen ML, Kiryanova EV, Vitek E, Khorosheva TM, et al. Outcomes and follow-up of patients treated for multidrug-resistant tuberculosis in Orel, Russia. Int J Tuberc Lung Dis. 2012;16(8):1069-74.

Masjedi MR, Tabarsi P, Chitsaz E, Baghaei P, Mirsaeidi M, Amiri MV, et al. Outcome of treatment of MDR-TB patients with standardised regimens, Iran, 2002-2006. Int J Tuberculosis Lung Dis. 2008 Jul 1;12(7):750-5.

Datta BS, Hassan G, Kadri SM, Qureshi W, Kamili MA, Singh H, et al. Multidrug-resistant and extensively drug resistant tuberculosis in Kashmir, India. J Infection Developing Countries. 2010;4(01):019-23.

Bhatt GS, Vyas S, Trivedil K. An epidemiological study of multi drug resistant tuberculosis cases registered under Revised National Tuberculosis Control Programme of Ahmedabad City. Indian J Tuberc. 2012 Jan;59(1):18-27.

Chiang CY, Enarson DA, Yu MC, Bai KJ, Huang RM, Hsu CJ, et al. Outcome of pulmonary multidrug-resistant tuberculosis: a 6-yr follow-up study. Eur Respir J. 2006;28(5):980-5.

Sobhy KA, Elawady S, Latef SA, Zeid AA, Said M. Patterns of drug resistance in cases of smear positive pulmonary tuberculosis in Giza and Cairo governorates. Egyptian J Chest Dis Tuberculosis. 2012 Oct 1;61(4):343-8.

Furin JJ, Mitnick CD, Shin SS, Bayona J, Becerra MC, Singler J, et al. Occurrence of serious adverse effects in patients receiving community-based therapy for multidrug-resistant tuberculosis, Tuberculosis. Int J Tuberc Lung Dis. 2001 Jul;5(7):648-55.

Bloss E, Kukša L, Holtz TH, Riekstina V, Skripčonoka V, Kammerer S, et al. Adverse events related to multidrug-resistant tuberculosis treatment, Latvia, 2000-2004. Int J f Tuberc Lung Dis. 2010 Mar 1;14(3):275-81.

Nathanson E, Gupta R, Huamani P, Leimane V, Pasechnikov AD, Tupasi TE, et al. Adverse events in the treatment of multidrug-resistant tuberculosis: results from the DOTS-Plus initiative. Int J f Tuberc Lung Dis. 2004 Nov 1;8(11):1382-4.