Abstract: OBJECTIVE To detect and evaluate adverse drug event(ADE) associated with interstitial lung disease(ILD) using the Openvigil pharmacovigilance data analysis website data, so as to provide references for safe clinical drug use. METHODS The Openvigil 2.1-MedDRA-v24 (data 2004Q1-2022Q3) online analysis system was used to analyze data from the US FDA Adverse Event Reporting System from the first quarter of 2004 to the third quarter of 2022. Data with preferred terms(PT) as “interstitial lung disease” were extracted, and the RxNav website was queried for brand name and generic name searches. Duplicate generic drug names were merged, and the values of DE, De, dE, de, PRR, and Chi_squared were recalculated for the merged drugs. Entries with DE≥30, PRR＞2, and Chi_squared＞4 were selected. Drug names were matched with ATC codes for classification and presented in a sunburst chart. The authenticity of the ADE signals was analyzed by comparing with SIDER, drug package inserts, and foreign and domestic literature.RESULTS During the specified time period, a total of 113 854 reports of drugs causing ILD were reported in the US FDA Adverse Event Reporting System. The top five systems that caused the strongest ILD signals were antineoplastic and immunomodulating agents(L), drugs affecting the gastrointestinal system and metabolism(A), systemic anti-infective drugs(J), cardiovascular system drugs(C), and drugs affecting the musculoskeletal system(M). Based on drug package inserts, the international adverse reaction database, and domestic and foreign literature reports, gefitinib, biclutamide, paclitaxel, alphatinib, oxaliplatin, docetaxel, everolimus, trastuzumab emtansine, tacrolimus, imatinib, denosumab, compound sulfamethoxazole, dapsone, denosumab, tegafur/gimeracil/oteracil, and ribavirin were identified as the most likely drugs to cause ILD adverse reactions. CONCLUSION ADE signals are explored using the Openvigil drug surveillance data analysis website, and through rigorous medical evaluation, 16 drugs are identified as the most likely to cause ILD adverse reactions. This can provide early warning for clinicians to promptly detect and discontinue drugs, and actively provide targeted treatment, in order to reduce the harm of drug-induced adverse reactions.