OBJECTIVE To mine signals of adverse events(AEs) related to sotatercept, an innovative drug for pulmonary hypertension, based on the FDA Adverse Event Reporting System(FAERS) and World Health Organization drug adverse event case reporting database(WHO-VigiAccess), so as to provide references for the safe and rational application of sotatercept.

METHODS Based on the FAERS and VigiAccess database spanning from the first quarter of 2024 to the fourth quarter of 2024, AE reports concerning sotatercept as the primary suspect drug were collected. AE signals were mined by reporting odds ratio(ROR) method and Bayesian confidence propagation neural network(BCPNN) methods.

RESULTS Identified 615 sotatercept-associated reports comprising 1695 individual AEs in FAERS, and 347 sotatercept-associated reports comprising 1060 individual AEs in VigiAccess. After removing the AEs unrelated to the adverse events of the drug itself, 52 positive signals involving 14 system organ class(SOC) in FAERS and 40 positive signals involving 14 system organ class(SOC) in VigiAccess were screened, mainly focusing on investigations, nervous system disorders, gastrointestinal disorders, respiratory thoracic and mediastinal disorders, general disorders and administration site conditions etc. Twenty newly discovered AEs not recorded in the instructions were excavated such as jaw pain, haematocrit increased and so on.

CONCLUSION When using sotatercept in clinical practice, it should pay close attention to drug safety, conduct risk assessment and pharmaceutical care well, and ensure the safety of patients.