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

Abstract

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.