Adverse Events of Alpelisib: A post-marketing study of the World Health Organization pharmacovigilance database.

AIM To explore and describe the adverse reaction signals in the safety reporting for alpelisib. METHODS We performed a disproportionality analysis of the World Health Organization's VigiBase® pharmacovigilance database from 1 January 2019 to 30 June 2021.Disproportionality analysis by information components (ICs) were used to evaluate the potential association between Adverse Events and Alpelisib. RESULTS A total of 33327 reports were extracted, 5695 of them were chosen with alpelisib as the suspected drug. After combining the same ID,687 cases left. The 45-64years group had the largest number of cases (N=203, 29.55%). We got 129 preferred terms (PTs) with significant signals in the end. Hyperglycaemia (IC025=6.74), breast cancer metastatic (IC025=5.85), metastases to liver (IC025=4.70), were top 3 adverse events with the strongest signal. AEs with top 3 cases was hyperglycaemia (N=595), rash(N=535), diarrhoea(N=475). CONCLUSION We established up a comprehensive list of adverse events (AEs) potentially associated with alpelisib. AEs with the most significant signals were hyperglycaemia, breast cancer metastatic, metastases to liver. Top 5 AEs with the most cases were hyperglycaemia, rash, diarrhoea, blood glucose increased, nausea.