Profile of adverse drug reactions in patients on anti-tubercular drugs in a sub Himalayan rural tertiary care teaching hospital

Atal Sood, Rekha Bansal, Aradhna Sharma, Himani H, Suruchi Bhagra, Dinesh Kansal


Background: Tuberculosis is a major public health problem, with one out of three people in the world are infected with Mycobacterium tuberculosis. The prevalence of MDR TB in India is 2-3% among new cases and 12-17% in reinfection cases. One of the reasons for MDR may be noncompliance to treatment due to adverse drug reactions. The present study was conducted to find out ADRs in patients on antitubercular treatment (ATT) under pharmacovigilance programme of India (PvPI).

Methods: This was a retrospective observational study. Data was collected through voluntary reporting by health-care professionals (HCP) in standard IPC-PvPI prescribed suspected ADR reporting form and analyzed for 100 patients on ATT. Causality assessment was done using WHO causality assessment scale.

Results: The maximum ADRs were reported in adults with a mean age of 40.79±16.79 years. Males (n=66) outnumbered females (n=34). There were 62% MDR-TB on DOTS-plus regimen, followed by 35% on Cat1 ATT for pulmonary and extrapulmonary tuberculosis cases and XDR-TB accounted for 3% of the total cases. The commonest ADRs in patients on MDR treatment were related to CNS 44 (27.5%), followed by Gastrointestinal system 31 (19%), psychiatric 20 (12.5%) otovestibular 13 (8%) and ophthalmic ADRs being the least in frequency 1 (0.6%). In contrast patients on Cat 1 ATT the ADRs involving Gastrointestinal system 44 (44%) followed by CNS 12 (12%), psychiatric 0% and ADRs related to otovestibular manifestations being the least 1 (1%) frequency.

Conclusions: ADRs involving different organ systems were seen in both categories with varied frequency. Adverse drug reactions add to hospitalization expenses, insurance costs and increase in work loss days besides addition to patient suffering and loss of compliance. Prior knowledge can help in better prescriptions and prevent valuable resource loss.


Adverse drug reactions, MDR-TB, Cat1 ATT, Pharmacovigilance

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World Health Organization. Fact Sheet No. 104: Tuberculosis. 2007.

WHO. Global Tuberculosis Control: WHO Report 2011. 2011. [November 15, 2011]. publications/ 2011/ 9789241564380_eng.pdf.

World Health Organisation (2006). Press release: "WHO Global Task Force outlines measures to combat XDR-TB worldwide.

WHO. Global Tuberculosis Control: WHO Report 2010. 2010. [September 18, 2011]. tb/ publications/ global_report/ 2010/en/index.html.

World Health Organization. Technical report series no. 425. Geneva, Switzerland: World Health Organization; 1966. International drug monitoring: the role of the hospital. 1-24.

Hire R, Kale AS, Dakhale GN, Gaikwad N. A Prospective, Observational Study of Adverse Reactions to Drug Regimen for Multi-Drug Resistant Pulmonary Tuberculosis in Central India. Mediterr J Hematol Infect Dis. 2014;6(1):e2014061.

Kapadia VK, Tripathi SB. Analysis of 63 patients of MDR TB on DOTS plus regimen: An LG hospital, TB unit, Ahmedabad experience. Guj Med J. 2013;68(2):52-7.

Sinha K, Marak IR, Singh WA. 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 Assoc Chest Physicians. 2013;1:50-3.

Lonnroth K, Williams BG, Stadlin S, Jaramillo E, Dye C. Alcohol use as a risk factor for tuberculosis ‑ a systematic review. BMC Public Health. 2008;8:289.

Torun T, Gungor G, Ozmen I, Maden E, Bicakci B, Atac G, et al. Side effects associated with the treatment of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2005;9(12):1373-7.

ThomasA, Ramchandra R, Rehaman F, Jaggarajamma K, Santha T, Selvakumar N, et al. Management of multi-drug resistant tuberculosis in the field- Tuberculosis Research Centre experience. Indian J Tuberc. 2007;54:117-24.

Yew WW, Chan CK, Chau CH, Tam CM, Leung CC, Wong PC, et al. Outcomes of Patients With Multidrug-Resistant Pulmonary Tuberculosis Treated With Ofloxacin/ Levofloxacin-Containing Regimens. Chest. 2000;117:744-51.

Vega P, Sweetland A, Acha J, Castillo H, Guerra D, Smith Fawzi MC, et al. Psychiatric issues in the management of patients with multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2004;8:749-58.

De Jager P, Van Altena R. Hearing loss and nephrotoxicity in long-term aminoglycoside treatment in patients with tuberculosis. Int J Tuberc Lung Dis. 2002;6:622-7.

Arora VK, Tumbanatham A. Severe arthropathy with ofloxacin in two cases of MDR tuberculosis. Int J tuberc lung dis. 1998;2(11):941-6.

Wen-Chung Tsai, Yun-Ming Yang. Fluoro-quinolone-associated Tendinopathy. Chang Gung Med J. 2011;34:461-7.

Schaberg T, Rebhan K, Lode H. Risk factors for side-effects of isoniazid, rifampin and pyrazinamide in patients hospitalized for pulmonary tuberculosis. Eur Respir J. 1996;9:2026-30.

Reider HL. Interventions for tuberculosis control and elimination. International union against tuberculosis and lung disease, Paris, France. 2002:1-251.

Kahana LM. Toxic ocular effects of ethambutol. Can Med Assoc J. 1987;137:213-6.

Athira B, Manju CS, Jyothi E. A study on adverse drug reactions to first line antitubercular drugs in DOTS therapy. Int J Pharmacol and ClinSci. 2015;4:7-11.

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.

Gumbo T. Chemotherapy of Tuberculosis, Mycobacterium Avium complex Disease, and Leprosy. In: Brunton LL, Chabner B, Knollman B editors. Goodman & Gilman’s. The Pharmacological Basis of Therapeutics.12thed. New York: McGraw Hill; 2011;1549-70.

Pande JN, Pande A, Singh SPN. Acetylator status, drug metabolism and disease. Natl Med J India. 2003;16:24-6.

Roy PD, Majumder M, Roy B. Pharmacogenomics of anti-TB drug-related hepatotoxicity. Pharma-cogenomics. 2008;9:311-21.