Adverse events associated with inclisiran: a real-world disproportionality analysis based on the FAERS database

Randomized clinical trials have reported some safety profiles in inclisiran, but adverse events in real-world remain insufficient. We aim to evaluate the safety of inclisiran in real-world by collecting the data from the FDA Adverse Event Reporting System database.

Disproportionality analysis was performed by utilizing both Frequency method and Bayesian method to mine adverse event signals of inclisiran. A positive signal was deemed significant when adverse event met the criteria of the aforementioned methods simultaneously.

We gathered a total of 2309 adverse event reports. Among these cases, adverse events were more common in females and ≥ 65 years age group. After data analysis, 51 positive signals from 11 system organ classes were identified, involving "Musculoskeletal and connective tissue disorders," "General disorders and administration site conditions," "Gastrointestinal disorders," etc. At the preferred term level, the top three frequently reported adverse events were arthralgia, injection site pain and myalgia. We also found some uncommon but significantly strong adverse event signals (bladder discomfort and sinus pain) which should be taken prudently.

In this study, we analyzed the real-world adverse events of inclisiran more comprehensively and reported some new adverse events, hoping that can offer more safety information for clinical medication.