Report of the Russian database on adverse drug reactions for COVID-19-related drugs with a focus on favipiravir

Objective. The purpose of this study is to systematize and comprehensively evaluate safety data on the drug favipiravir using the national pharmacovigilance database of the Russian Federation. Materials and Methods. The report is based on spontaneous reports in the national automated information system of pharmacovigilance of the Russian Federation for the reporting period from 01.01.2020 – 04.07.2022. To identify safety signals we used disproportionality analysis, to estimate consumption of favipiravir – indicator of the number of consumed DDDs, we additionally performed review of concomitant therapy as a risk factor for serious adverse reactions. Results. A total of 412 reports of 585 adverse reactions was included in the analytic phase. The largest number of reports referred to liver and biliary tract disorders – 166 (38%), gastrointestinal disorders – 93 (16%), changes in laboratory and instrumental data – 53 (9%), and immune system disorders – 44 (7%). A total consumption of oral favipiravir expressed in the number of maintenance daily doses for 2021 was 46,417,274.87, i.e. 30 times the consumption of remdesivir and 6 times the consumption of hydroxychloroquine. One potential statistical safety signal such as hypercreatininemia was identified. Conclusions. Development of hypercreatininemia is a potential statistical safety signal of favipiravir, which requires further validation.