Introduction. Favipiravir, originally developed for influenza, has been widely used off-label for the treatment of COVID-19. However, ongoing safety concerns have emerged regarding its use and large-scale applicability.
The objective of the study was to provide an in-depth analysis of suspected adverse drug reactions (ADRs) associated with favipiravir, as recorded in the EUDRAVIGILANCE database.
Materials and methods. ADRs reports for favipiravir up to 12th of January 2025 were extracted and analyzed. A descriptive evaluation of demographic distribution, case severity, and geographic trends was performed.
Results. A total of 157 individual case safety reports were identified, accounting for 332 ADRs. Most cases (58.6%) involved adults aged 18–64 years, and ADRs were more frequently reported in males (59.2%). The geographic distribution was nearly equal between European Economic Area (EEA) (47.8%) and non-EEA (52.2%) regions. Serious cases accounted for 86.4% of ADRs, with the most affected organ systems including hepatic, renal, cardiovascular, and nervous systems. Notably, all ADRs in cardiac, vascular, metabolic, and respiratory disorders were classified as serious. A significant difference in case severity was observed between EEA and non-EEA regions (p < 0.001), suggesting variations in patient populations, pharmacovigilance practices, or drug utilization patterns.
Conclusions. The high proportion of serious ADRs highlights potential safety concerns regarding favipiravir use, especially in vulnerable populations.
Keywords: favipiravir, adverse drug reactions, pharmacovigilance, EUDRAVIGILANCE, COVID-19.
Full text sources https://doi.org/10.31688/ABMU.2025.60.1.07
How to cite
Email to Author
Address for correspondence:
Delia M. TIT
Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Oradea
Address: 29, N. Jiga Str., 410028, Oradea, Romania
Email: mirela_tit@yahoo.com
