Published: 2022-10-27

A study of adverse drug reactions in tuberculosis patients in a tertiary care hospital

Shilpa L. Todkar, Smita Tiwari


Background: Tuberculosis is the most rambling communicable infectious disease on earth. It is the single most common cause of death in individuals aged 15-49 years. Adverse drug reactions to antitubercular drugs causing significant morbidity, mortality, incurring substantial additional costs because of added outpatient visits, tests, and hospitalizations. Study was carried out with objectives of assessing the rate and type of adverse drug reactions (ADRs) and detecting serious and preventable ADRs with collection of demographic details of patients taking antitubercular drugs and developing ADRS.

Methods: A cross sectional, prospective, observational study conducted in department of chest and TB of a tertiary Health care and teaching hospital in both IPD and OPD patients for a period of 18 months. 480 patients monitored.

Results: Among 480 patients 120 i.e., 25% developed ADR. frequency being significantly higher in males (58%) and adult age group (>18 years) amongst hospitalized comparing to outdoor patients the gastrointestinal tract [GIT] (39%) followed by, generalized body disorders (19%) hepatobiliary system (17%) were organ systems most affected Majority (56%) ADRs reported in 0-2 month of starting therapy (63%) of cases were in “probable according to Naranjo causality assessment (37%) being possible. 55% ADRs were moderate in severity followed by 36% mild and 9% severe. 30% of ADRs were definitely preventable followed by 20% of probably prevented according to schumock thronstone preventability scale

Conclusions: Study highlights the importance of routine monitoring and robust pharmacovigilance system for success of national tuberculosis programmes in India as well as worldwide.


Adverse drug reactions, Tuberculosis, Pharmacovigilance

Full Text:



Dale DC. Infectious disease: the clinician's guide to diagnosis, treatment and prevention. In.New York: WebMD Inc; 2003.

Patidar D, Rajput M, Nirmal N, Savitri W. Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India. Interdisciplin Toxicol. 2013;6(1):41-6.

Global Tuberculosis Report 2018. Available at: ttps:// Accessed on 20 October 2021.

Granich R, Chauhan L. The revised national tuberculosis control programme [RNTCP]. In: Sharma S, editor. Tuberculosis. 2nd ed. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd.; 2009: 894-917.

An expanded DOTS framework for effective tuberculosis control Stop TB Communicable Diseases. Available at: http://www.whqlibdoc. Accessed on 20 October 2021.

Agarwal S, Chauhan L. History of tuberculosis control in India: glimpses through decade. Available at: 20Control%20in%20India-Final.pdf. Accessed on 20 October 2021.

Zaka-Ur-Rehman Z, Jamshaid M, Chaudhry A. Clinical evaluation and monitoring of adverse effects for fixed multidose combination against single drug therapy in pulmonary tuberculosis patients. Pak J Pharm Sci. 2008;21:185-94.

Singh A, Prasad R, Balasubramanian V, Gupta N, Gupta P. Prevalence of adverse drug reaction with first-line drugs among patients treated for pulmonary tuberculosis. Clin Epidemiol Global Health. 2015;3: S80-90.

Yee D, Valiquette C, Pelletier M, Parisien I, Rocher I, Menzies D. Incidence of serious side effects from fi rst-line antituberculosis drugs among patients treated for activetuberculosis. Am J Respir Crit Care Med. 2003;167:1472-6.

Marra F, Marra CA, Bruchet N, Richardson K, Moadebi S, Elwood RK, et al. Adverse drug reactions associated with first-line anti-tuberculosis drug regimens. Int J Tuberc Lung Dis. 2007;11:868-75.

Dalal NP, Karandikar YS, Pandit VA. Safety evaluation of directly observed treatment short course (DOTS) regimen in a tertiary care hospital, Pune. Int J Basic Clin Pharmacol. 2014;3:369-76

Dhingra VK, Rajpal S, Aggarwal N, Aggarwal JK, Shadab K, Jain SK. Adverse drug reactions observed during DOTS. J Commun Dis. 2004;36:251-9

Edwards R, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255-9.

Ditto AM. Drug allergy. In Grammar LC, Greenberger PA, eds. Patterson’s allergic diseases. 6th ed.; Philadelphia: Lippincott Williams and Wilkins; 2002;295.

A practical handbook on the pharmacovigilance of medicines used in the treatment of tuberculosis: enhancing the safety of the TB Patient. Geneva: World Health Organization; 2012. Available at: Pharmaco_TB_web_v3.pdf. Accessed on 20 October 2021.

Lal M, Pushpawati B, Mushtaq J, Vijay A, Moghe V, Gandhi M, et al. Comparison of outcomes of two anti tubercular regimens in pulmonary tuberculosis at tertiary care hospital. Indian J Res. 2013;3(4):275-7.

Leape LL. Errors in medicine. JAMA. 1994;272: 1851-7.

Bai GP, Ravikumar P. A study of adverse drug reactions among pulmonary tuberculosis patients treated under dots in a tertiary care hospital. IJBCP. 2017;6(4):1-4.

Nanda GS, Singh H, Sharma B, Arora A. Adverse reactions due to directly observed treatment short course therapy: an indian prospective study. IAIM. 2016;3(1):6-12

Athira B, Cs M, Jyothi E. A study on adverse drug reactions to first line antitubercular drugs in DOTS Ther. 2015;4(1):7-11.

Anusha N, Isabella T, Anil JP. Adverse drug reactions monitoring among TB patients on anti-tubercular drugs under RNTCP in Pondicherry. Int Adv Res. 2014; 2(12):165-73.

Koju D, Rao BS, Shrestha B, Shakya R, Makaju R. Occurrence of side effects from anti- tuberculosis drugs in urban Nepalese population under DOTS treatment. Kathmandu Uni J Sci Eng Technol, 2005; 23:1.

Tak DK, Acharya LD, Gowrinath K, Rao Padma GM, Subish P. Safety evaluation of anti- tubercular therapy under revised national Tuberculosis Control Progpamme in India. J Clin Diag Res. 2009;3:1395-401.

Dedun A, Patel D. A profile of adverse effects of anti-tubercular drugs. J Clin Diag Res. 2016;9:37-41

Sinha K. Adverse drug reactions in tuberculosis patients due to directly observed treatment strategy therapy: Experience at an outpatient clinic of a teaching hospital in the city of Imphal, Manipur, India. J Clin Diag Res. 2013;1(2):12-5.

Gholami K, Kamali E, Hajiabdolbagh Mi, Shalviri G. Evaluation of antituberculosis induced adverse reactions in hospitalized patients. Pharm Pract. 2006; 4:134-8.

Hassan MK, A ASP, Nagar G, Chas P, Bokaro D, et al. Incidence of adverse drug reaction among the tuberculosis patients treated under directly observed treatment short course (DOTS) Regimen in North India. 2016;7:598-600.

Sreekanth AS. A Pharmacovigilance study on antitubercular therapy in the department of pulmonary medicine at a tertiary care hospital. IOSR J Dent Med Sci. 2015;14(8):2279-861.