Adverse drug reactions of macrolide therapy: analysis of spontaneous reports according to the Pharmacovigilance system

Objective. To perform pharmacoepidemiological analysis of spontaneous reports adverse drug reactions (ADRs) occurred during macrolide group antibiotics prescription and registered in the “Pharmacovigilance 2.0” subsystem Federal Service for Surveillance Healthcare. Materials Methods. A retrospective ADRs arising from use all azalide Russia electronic database Healthcare period 01.04.2019 to 30.11.2022 was performed. Results. Analysis number ADRs, their structure, outcomes severity criteria The most clinically significant were identified, occurrence which reported pharmacovigilance bodies. results a showed that development complications pharmacotherapy cases associated with azithromycin clarithromycin. main clinical manifestations skin subcutaneous tissue disorders, gastrointestinal as well general disorders injection site reactions. Conclusions. It found events generally corresponded spectrum typical individual representatives antibiotics.