Investigation of infection risk associated with Janus kinase inhibitors: a pharmacovigilance analysis using the Food and Drug Administration’s Adverse Event Reporting System database

To our knowledge, this is the most comprehensive real-world analysis of iAEs linked to oral JAKis to date. While infection risks varied across agents, both common and rare but serious events were identified. Findings highlight the importance of individualized monitoring and preventive strategies, and reinforce the value of postmarketing surveillance in ensuring safe JAKi use.