Levofloxacin: Analysis of Information on Adverse Reactions from Russian Spontaneous Report Database

Abstract

The main objective of this study was to analyze the adverse drug reactions (ADRs) associated with the use of levofloxacin. We analyzed ADR reports submitted to the Russian Spontaneous Report Database from 2009 to 2017. A significant difference in the number of spontaneous reports between different brands of levofloxacin was detected. Almost three quarters (74.1%) of all ADRs occurred in adults (18-64 years of age). Approximately 24% of reported ADRs were serious including two fatal cases. The most frequently reported reactions to levofloxacin involved the skin disorders (32.5%), hypersensitivity reactions (30.8%), gastrointestinal disorders (29.0%), general disorders and administration site conditions (26.3%). The results obtained may indicate a different profile of drug safety, even within the same international nonproprietary name.

Keywords

• levofloxacin
• pharmacovigilance
• adverse drug reactions
• drug safety