Risk factors for drug-related non-infectious pneumonia: insights from the FDA adverse event reporting system (FAERS)

Non-infectious pneumonitis (NIP) is a severe adverse drug reaction. To better understand drug-induced NIP, improve patient safety, and inform clinical decision-making, this study aims to utilize the FDA Adverse Event Reporting System (FAERS) database to evaluate the association between medications and NIP, identify potential risk factors, and offer clinical alerts.

We reviewed the FAERS database from the 2004 through the second quarter of 2024. Using 'NIP' as the search term, we sorted, counted, and analyzed cases by generic drug name and trends of reports related to NIP submitted to FAERS database. We employed four statistical methods to identify drugs associated with the NIP.

From 21,433,114 reported drug adverse events (AEs), 9,224 cases were classified as NIP. Our analysis identified 20 drugs associated with NIP, with the main categories being antineoplastic agents, antibiotics and immunosuppressants. Daptomycin, methotrexate, and tacrolimus had the highest NIP-related deaths. Trends in AEs reporting indicate that the drugs showing the fastest increase in NIP reports are daptomycin, methotrexate, sertraline, and amiodarone.

These findings could assist clinicians in the early identification of drug-related NIP and provide valuable insights for future research into the mechanisms underlying drug-related NIP.