OBJECTIVES: Adverse drug reactions (ADRs) are one of the leading causes of morbidity and mortality worldwide. Anesthetics might inflict a significant number of potential ADRs which require consistent monitoring. The aim of the study was to detect, assess and report the suspected adverse drug reactions (ADRs) observed in patients who received at least one anesthetic drug. .

METHODS: A prospective observational study spanning six months was carried out on inpatients admitted to the Department of General Surgery of a tertiary health care hospital. The suspected ADRs were documented and analyzed for causality, severity and preventability using relevant validated scales.

RESULTS: A total of 180 patients were studied, out of which 139 (77%) developed at least one ADR due to anesthesia. General Anesthesia (GA) included a combination of drugs like Propofol, midazolam, fentanyl etc., while Local Anesthesia (LA) mainly comprised of either Bupivacaine or Lidocaine. Among the total 212 ADRs observed , GA contributed to 135(64%) reactions and LA caused 77(36%) of them. Cardiovascular system (71%) was most commonly affected followed by respiratory system (13%). Logistic regression analysis showed that smokers are 8.6 times more likely to develop ADRs in the peri operative period when compared to non- smokers. The causality assessment using Naranjo’s scale revealed that 126(59%) ADRs were probable.124 (58%) ADRs were moderate and 8(4%) were severe according to Hartwig and Siegel’s severity assessment scale. As per Schumack and Thornton Preventability assessment scale, 181(85%) ADRs were probably preventable.

CONCLUSIONS: Anesthetics can induce potential adverse drug reactions which require prompt management and continuous reporting. Thus, pharmacovigilance plays a prominent role in optimizing therapeutic outcomes, which will substantially reduce the financial burden on patients.