Introduction: Digoxin is an inotropic drug indicated for Congestive Heart Failure (CHF) and cardiac arrhythmias. It has a narrow therapeutic index. Predisposing factors and drug-drug interactions causes digoxin toxicity at normal therapeutic doses. Hence we report a case on the adverse drug reaction of digoxin induced sinus bradycardia due to the co-administration of amiodarone with digoxin. Case report: An 83years old female patient with the known case of paroxysmal atrial fibrillation and heart failure with preserved ejection fraction. She is a known case of type 2 diabetes mellitus and hypertension. She was on treatment with digoxin (0.25mg) 5 days in a week along with amiodarone 200mg BD and other drugs. With ECG report indicating sinus bradycardia and the laboratory investigations the physician’s diagnosis as an ADR caused by the drug-drug interaction resulting from the concomitant use of digoxin and amiodarone. Causality assessment was done and the drugs were withdrawn from the drug regimen. After which the patient improved symptomatically. Discussion: Sinus bradycardia is one of the early signs of digoxin toxicity. The drug interaction with amiodarone which has the potency to increase the digoxin concentration must be considered and individualization of medicines in such cases is of prime importance in order to avoid the undesired side effects or toxicity. Conclusion: Low margin of safety drug like digoxin should be prescribed with the consideration of all aspects pertaining to the individual patient. Monitoring for drug-drug interactions and also periodic Therapeutic Drug Monitoring (TDM) is beneficial.

Background: An Adverse drug reaction (ADR) is an injury caused by taking medication. ADRs are major threat to patient therapy as it results in significant morbidity, mortality and health care costs. Objective: To monitor and evaluate the ADRs in a tertiary care hospital. Methods: This observational and cross-sectional study was conducted for 10 months from January 2019 to October 2019 in an inpatient setting of a tertiary care hospital in Mangalore using ADR reporting form. Patients of all age groups, either sex and only inpatients were included. Results: ADR’s caused by Intravenous route were the highest occurring comprising of 60.46% followed by 29.53% causing by oral route of administration. Among the organ systems skin membrane were mostly affected which is of 60.46% and 13.95% of ADR’s were present as CNS and neurological disorders. Drug categories suspected to cause ADRs were related to antibiotics (39.53%), G1 drugs (16.27%), and the remaining classes of drugs like anti-diabetics, anti-coagulants etc.11 (26%) ADR’s were found to be mild, 25 (58%) were moderate and 7 (16%) of ADR’s were found to be severe according to severity assessment. Conclusion: Adverse drug reaction is a significant limitation to the success of therapeutics and to deal with this problem pharmacovigilance program is initiated to emphasise the importance of monitoring and reporting of ADRs to ensure the safety use of drugs. However the quality and quantity of the ADR reports can be improvised only through educational programs that guide the healthcare providers in recognising and reporting the ADRs efficiently.