Post-marketing safety profile of lumacaftor/ivacaftor in cystic fibrosis treatment: a pharmacovigilance analysis based on FAERS

This study provides a detailed real-world safety profile of LUM/IVA, identifying both known and unexpected adverse events. Our findings underscore the importance of continuous post-marketing surveillance and the need for updated drug label to reflect associated risks, particularly those related to psychiatric symptoms and long-term adverse effects. Personalized treatment strategies based on patient characteristics, including sex, are recommended to optimize safety during LUM/IVA therapy.