Respiratory Adverse Reactions to Tyrosine Kinase Inhibitors: A Disproportionality Analysis of Spontaneous Reports from European Countries

(1) Background: Tyrosine kinase inhibitors (TKIs) asciminib, bosutinib, dasatinib, imatinib, nilotinib, ponatinib have been approved for the therapy of chron-ic myelogenous leukemia (CML). Pharmacovigilance reports associated with these drugs are not consistent and homogenous and have been associated with pulmonary toxicity that could limit their utilization. To give a contribution for a more clear definition of TKIs pulmonary risk, we conducted a research investigating on adverse events sus-pected to be caused by TKIs asciminib, bosutinib, dasatinib, imatinib, nilotinib, ponatinib used for CML, using the european database EudraVigilance. (2) Methods: Suspected adverse reactions to TKIs in the data system EudraVigilance (2020–2024) coming from European countries and United Kingdom were analyzed and compared through a di-sproportionality analysis. (3) Results: most frequent alerts concerned the respiratory di-sorders “Pleural effusion” (PE) and Pulmonary arterial hypertension” (PAH) related to dasatinib and bosutinib. Among the category of TKIs, prescription of dasatinib is asso-ciated with a higher occurrence of PE and PAH, while prescription of bosutinib induces with minor frequency PE but it exposes at a significant risk for PAH, occurring more often in women. (4) Conclusions: Results indicate that respiratory disorders induced by the TKIs dasatinib and bosutinib need to be punctually and rapidly diagnosed and suggest caution before prescription of these TKIs in patients affected by CML with pulmonary comorbidities.