J Pharmacoepidemiol Risk Manage.  2021 Mar;13(1):17-23. 10.56142/2022.13.1.17.

Analysis of Adverse Drug Reactions to Common Drugs Administered to COVID-19 Patients: The Role of Pharmacovigilance System in Public Medical Centers

  • 1Drug Safety Monitoring Center, National Medical Center, Seoul, Korea
  • 2Department of Epidemiology and Health Informatics, School of Public Health, Korea University, Seoul, Korea
  • 3Department of Anesthesiology and Pain Medicine, National Medical Center, Seoul, Korea
  • 4Department of Pharmacy, National Medical Center, Seoul, Korea


The world is experiencing the coronavirus disease (COVID-19) pandemic. Although no drug has been developed against the disease, doctors are administering antiviral agents, antibiotics, antipyretics, and other drugs depending on the situation. As the pandemic is prolonged, we must evaluate not only the efficacy of drugs but also their safety.
From March to May 2020, we collected data of patients diagnosed with COVID-19 from the National Medical Center and 52 local public medical centers. Additionally, we analyzed the adverse drug reactions (ADRs) to prescription ratio for hydroxychloroquine and lopinavir/ritonavir in patients at the National Medical Center.
We collected data of 118 ADR cases from 79 patients. Of these, 42 (53.2%) patients were women with an average age of 54.4 ± 15.9 years, and 37 (46.8%) were men with an average age of 50.0 ± 19.9 years. Among the 118 ADR cases, the most frequently reported drugs are lopinavir/ritonavir (53 cases, 44.9%) and hydroxychloroquine (22 cases, 18.6%). Classified by systemic organ classes, the most frequent ADRs were 61 (51.7%) cases of gastrointestinal system disorders and 24 (20.3%) cases of liver and biliary system disorders. At the National Medical Center, the ADR/prescription ratio was 22.6% for hydroxychloroquine and 38.6% for lopinavir/ritonavir.
The clinical aspects of COVID-19 are still being determined as it is a new infectious disease. Hence, using a pharmacovigilance system will help to better understand the disease.


Adverse reactions; Pharmacovigilance; Public medical center
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