ABSTRACT
Objective: The objective of this study is to assess adverse drug reaction (ADR) profile of the drugs prescribed to treat Coronavirus Disease (COVID-19) positive patients and to determine whether ADRs are associated with any comorbidities. Methods: A cross-sectional study was done with Laboratory confirmed COVID-19 positive patients who experienced ADRs during their admission period at tertiary care center, Rajkot from April 2020 to March 2021. All the necessary information including ADRs information was obtained from patient's case record file and filled in suspected ADR reporting form. Suspected ADRs were assessed for demographic parameters and causality, preventability, and severity using World Health Organization (WHO) scale and Naranjo algorithm, modified Schumock and Thornton's criteria, and modified Hartwig's criteria, respectively. Results: Out of the 100 patients there were 60 males. The mean age of the patients was 52.65±13.95 year. Fourty-six patients had comorbidities. The most common type of ADR was GI disorders. Among the single suspected medication, most common drug was methylprednisolone and among the two drugs, azithromycin was common. According to the WHO and Naranjo scale, Probable ADRs were 70% and 36%, respectively. The percentage for mild, moderate and severe ADRs were 44%, 39%, 17%, respectively. Eighty-six percent ADRs were definitely preventable. Fifty-one patients were recovered from adverse reactions. Conclusions: Seriousness of reactions is mainly associated with co-morbid conditions. This indicates that patients with comorbidity should be closely monitored to avoid harmful consequences. These ADRs monitoring and reporting program will help physicians to choose their therapy sensibly and decrease chances of mortality in this pandemic era.