JPERM

Objective: The purpose of this study was to detect for the signals of rosuvastatin calcium applying a data mining analysis based on data of domestic adverse drug reaction reporting system and to check the detected signals listed in the drug label. Methods: This study used the database based on drug-related side effects and adverse reactions, reported spontaneously to the Ministry of Food and Drug Safety (MFDS) through pharmacovigilance centers between Jul. 2009 and Dec. 2010. The database contains 46,231 reports of adverse drug events (ADEs) and 153,557 drug-adverse events (AEs) pairs reconstituted. Data mining analysis by proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) conducted to detect signals of rosuvastatin calcium. Results: The data which attributed to rosuvastatin calcium was 199 ADEs and 297 drug-AE pairs. There were 76 types of AEs in 297 drug-AE pairs. The AEs detected as signals of rosuvastatin calcium were 36 out of 76 AEs. The signals that did not include in the label of rosuvastatin calcium were 15 out of 36 signals (41.7%). Most of the unlabeled signals were AEs that rosuvastatin calcium reported as concomitant drugs. Unlabeled signals based on more than two drug-AE pairs were bradycardia, hyperkalemia, and azotemia. Conclusion: The detected signals of rosuvastatin calcium were 36 reports. The detected signals not listed on the domestic and foreign drug labels were 41.7% among them, which was 19.7% of all reported types of rosuvastatin calcium adverse events. (JPERM 2020;12:85-90): Adverse drug reaction reporting systems; Drug-related side effects and adverse reactions; Data mining Rosuvastatin calcium, drug labeling

Keywords Adverse drug reaction reporting systems, Drug-related side effects and adverse reactions, Data mining Rosuvastatin calcium, drug labeling