Adverse drug reactions due to fixed dose combinations: an observational cross sectional study


  • Roshi . Department of Pharmacology, Government Medical College, Jammu
  • Vishal R. Tandon Department of Pharmacology, Government Medical College, Jammu



Compliance, Irrational FDCs, Essential medicine list, ADR


Background: In modern world, poor compliance has been the main reason of therapeutic failure. Many factors may be responsible for this. The reasons highlighted may be adverse drug reactions (ADRs), pill burden or economic reasons. Fixed drug combinations (FDC) have helped to solve this problem. The present study was conducted to see the ADR due to fixed dose combinations.

Methods: After approval from institutional ethics committee, an observational study was conducted over a period of six months in December 2018 to May 2019 in adverse drug monitoring centre, GMC Jammu.

Results: A total number of 112 ADRs were reported during the study period. FDCs were responsible for ADRs in 64 patients and single drug was responsible in 48 patients. As per latest WHO essential drug list, irrational FDC were responsible for ADRs in 44 patients and rational FDCs were responsible for ADRs in 20 patients.

Conclusions: The results of present study underscores that drug combinations, FDC rational as well as irrational substantially contribute towards the pool of total ADRs.


Gautam CS, Saha L. Fixed dose drug combinations: rational or irrational: a view point. Br J Clin Pharmacol. 2008;65(5):795-6.

Sreedhar D, Subramanian G, Udupa N. Combination drugs: are they rational. Curr Sci. 2006;91:406.

Roy V, Malhotra R, Tayal V, Bansal A, Gupta KS. Fixed dose combinations for cough and common cold in India: an assessment of availability and rationality. Fundam Clin Pharmacol. 2011;25(2):258-66.

Goswami N, Gandhi A, Patel P, Dikshit R. An evaluation of knowledge, attitude and practices about prescribing fixed dose combinations among resident doctors. Perspect Clin Res. 2013;4(2):130-5.

Desai P, Patel S, Shah R, Desai S. A comprehensive evaluation of rationality of cough and cold medicines available in Indian market. J Indian Med Assoc. 2013;111(2):94-8.

Poudel A, Palaian S, Shankar PR, Jayasekera J, Izham MI. Irrational fixed dose combinations in Nepal: need for intervention. Kathmandu Univ Med J (KUMJ). 2008;6(23):399-405.

Field TS, Gurwitz JH, Avom J, McCormick D, Jain S, Eckler M, et al. Risk factors for adverse drug events among nursing home residents. Arch Intern Med. 2001;161:1629- 34.

Edwards IR, Arsonson JK. Adverse drug reactions: definitions, diagnosis and management. Lancet. 2000;3:1255-9.

Naranjo CA, Busto U, Sellers EM, S, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981; 30:239-45.

Tandon VR, Sharma S, Mahajan S, Khajuria V, Mahajan V, Prakash C. Antihypertensive drug prescription patterns, rationality, and adherence to Joint National Committee-7 hypertension treatment guidelines among Indian postmenopausal women. J Midlife Health. 2014 ;5(2):78-83.

Tandon VR, Chandail V, Khajuria V, Gillani Z. Gastrointestinal bleed induced by a fixed dose combination of rabeprazole and diclofenac sodium. Indian J Pharmacol. 2014;46(5):555-6.

Tandon VR, Mahajan A, Khajuria V, Gillani ZH. Angioedema due to fixed dose combination of telmisartan plus ramipril. J Pharmacol Pharmacother. 2014;5(3):214-6.

Wirtz VJ, Mol PG, Verdijk J, Vander Stichele RH, Taxis K. Use of antibacterial fixed-dose combinations in the private sector in eight Latin American Countries between 1999 and 2009. Trop Med Int Health. 2013;18(4):416-25.

Khjauria V, Tandon VR, Rani N, Roshi, Gupta S, Choudhary S, et al. Profile of adverse drug reactions with fixed drug combinations: how big is the problem?. JK Science. 2015;17(1):33-7.




How to Cite

., R., & Tandon, V. R. (2019). Adverse drug reactions due to fixed dose combinations: an observational cross sectional study. International Journal of Basic & Clinical Pharmacology, 8(11), 2412–2415.



Original Research Articles