Pharmacovigilance analysis based on FDA Adverse Event Reporting System Database:a comparative study on Inclisiran and commonly used lipid-lowering drugs
YE Bangyi
GUAN Shikui
HUANG Peng
ZHANG Jing
LI Donghua
WANG Qingwang
Abstract：Objective To analyze adverse drug events(ADE)of inclisiran using the FDA Adverse Event Reporting System(FAERS)to provide references for its clinical use.Methods ADE reports for inclisiran and other lipid-lowering drugs were retrieved from FAERS database from 2021 to 2023.The reporting odds ratio(ROR)was used for adverse event signal detection.Inclisiran was compared with conventional lipid-lowering drugs in the same therapeutic field(statins,ezetimibe,alirocumab and evolocumab).Results Inclisiran showed significant signals in musculoskeletal and connective tissue disorders(A:2030,ROR:2.64).The most frequent adverse event with a significant signal was"injection site pain"(A:677,ROR:14.49).For liver injury,significant signals were observed for"liver disease"(A:32,ROR:3.70)and"liver pain"(A:9,ROR:9.58).In glucose metabolism,significant signals were detected for"diabetes"(A:36,ROR:2.73)and"poor diabetic control"(A:8,ROR:3.62).The most frequent musculoskeletal adverse event with a significant signal was"arthralgia"(A:432,ROR:3.83).Conclusion Inclisiran generally demonstrates a favorable safety profile,with the most common adverse events being injection site reactions.However,there are potential risks related to liver injury,glucose metabolism and musculoskeletal systems,warranting further long-term and large-scale clinical observational studies.
Keywords：inclisiranFDA adverse event reporting system databaselipid-lowering therapydismutation analysisdrug safety
Publication Date：2025-10-20
Online Publishing Date：2025-12-03(First online date of this platform, not the publication date of the document)
Pages：7( 1178-1183,1208 )