OBJECTIVES: The work is based on data obtained during the registration of spontaneous messages from the automated information system of Rozdravnadzor (AIS RZN) in the Russian Federation

METHODS: A retrospective analysis of data from the national database on the safety of drugs included in the interim local guidelines for the treatment of new coronavirus infection version 6 dated 28.04.2020 and version 7 dated 03.06.2020 with the following with the following drugs: Hydroxychloroquine, Lopinavir + Ritonavir, Mefloquine, Tocilizumab, Azithromycin, Baricitinib, Olokizumab, Tofacitinib, Favipiravir.

RESULTS: 1985 messages were unloaded from the national database during the reporting period. After checking the messages for duplication of information, the correctness of the indicated indication for prescribing a drug, and checking the necessary minimum of reported information, the final analysis included 196 messages containing information about 284 adverse drug reactions, for hydroxychloroquine-70 reports, Lopinavir + Ritonavir -20 messages, mefloquine-4 messages,tocilizumab-27 messages, azithromycin-41 messages, baricitinib-3 messages, olokizumab 71 messages, tofacitinib: 1 message, favipiravir-46 messages.

CONCLUSIONS: Reports submitted to the information system of the Russian Health Service cannot be considered valid due to the lack of the necessary amount of information: the dates of the onset of the disease, the date of administration of the suspected drug, etc. are not specified. Due to the above, it is not possible to correctly assess the causal relationship between the occurrence of an event and the use of the estimated drugs. However, it is possible to assess the safety profile for these drugs. hydroxychloroquine safety profile for patients with COVID-19 is rated as "unfavorable", so use of this drug in a group of patients with COVID-19 debatable. For other drugs, the safety profile in a group of patients with COVID-19 corresponds to the data of post-marketing use for existing indications.