Drug-induced eosinophilic pneumonia: a real-world data mining study of the FAERS and Vigibase database reveals potential safety signals and risk patterns

Background: Eosinophilic pneumonia (EP) is an uncommon, idiopathic interstitial lung disease distinguished by the atypical accumulation of eosinophils within the pulmonary parenchyma and airways. The condition often presents insidiously and is frequently overlooked or misdiagnosed; pharmacological agents are among the acknowledged precipitants of this disorder. Methods: This is a retrospective pharmacovigilance investigation. We utilized the FAERS and Vigibase databases to detect adverse reactions associated with drug-related EP. Results: We identified a total of 15,374 cases of drug-induced EP in FAERS. The incidence was highest, at 24.1%, among individuals aged 45 to 64 years, with 35.4% of the affected patients requiring hospitalization. In terms of the numerical composition of PTs, pneumonitis was the most predominant PT. Although the proportion of PTs varied for each drug and pneumonitis remained the most common, antibacterials exhibited a higher prevalence of "eosinophilic pneumonia" and "pulmonary eosinophilia." Notable observations include significant signal variations between the two databases for certain drugs, yet all positive signal drugs identified by FAERS can be confirmed by Vigibase. Initial screening identified 302 suspect drugs; following disproportionality filtering, univariate analysis, and lasso shrinkage, 56 agents were retained. Nivolumab was the most frequently reported drug (1,377 reports), followed by pembrolizumab (1,070 reports) and daptomycin (758 reports), with daptomycin exhibiting the most significant statistical signal in FAERS. Time-to-onset analysis indicated that EP typically manifested early. Multivariable modeling identified higher body weight, advancing age, and polypharmacy as associated factors. The drugs most strongly associated with EP were daptomycin (OR 12.50, 95% CI 9.40-16.75), durvalumab (OR 5.17, 95% CI 3.74-7.14), fam-trastuzumab deruxtecan (OR 4.86, 95% CI 3.32-7.04), idelalisib (OR 4.74, 95% CI 3.13-7.07), and osimertinib (OR 3.21, 95% CI 2.11-4.79). Conclusion: The early discontinuation of the offending drug, timely initiation of corticosteroid therapy, and multidisciplinary collaboration are fundamental to achieving improved outcomes in cases of drug-induced eosinophilic pneumonia. This study offers substantial real-world evidence to facilitate the early identification and optimal management of eosinophilic pneumonia.

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Journal
Frontiers in Medicine
Published
2026-04-22
DOI
https://doi.org/10.3389/fmed.2026.1788843
Primary Topic
Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
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article

Drug-induced eosinophilic pneumonia: a real-world data mining study of the FAERS and Vigibase database reveals potential safety signals and risk patterns

Sisi Wang, Yao Sun, Xiangrong Zuo, Cong Cheng et al.
Frontiers in Medicine
Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
article

Drug-induced eosinophilic pneumonia: a real-world data mining study of the FAERS and Vigibase database reveals potential safety signals and risk patterns

Sisi Wang, Yao Sun, Xiangrong Zuo, Cong Cheng, Yun Liu, Jing Hu
article en

Abstract

Background: Eosinophilic pneumonia (EP) is an uncommon, idiopathic interstitial lung disease distinguished by the atypical accumulation of eosinophils within the pulmonary parenchyma and airways. The condition often presents insidiously and is frequently overlooked or misdiagnosed; pharmacological agents are among the acknowledged precipitants of this disorder. Methods: This is a retrospective pharmacovigilance investigation. We utilized the FAERS and Vigibase databases to detect adverse reactions associated with drug-related EP. Results: We identified a total of 15,374 cases of drug-induced EP in FAERS. The incidence was highest, at 24.1%, among individuals aged 45 to 64 years, with 35.4% of the affected patients requiring hospitalization. In terms of the numerical composition of PTs, pneumonitis was the most predominant PT. Although the proportion of PTs varied for each drug and pneumonitis remained the most common, antibacterials exhibited a higher prevalence of "eosinophilic pneumonia" and "pulmonary eosinophilia." Notable observations include significant signal variations between the two databases for certain drugs, yet all positive signal drugs identified by FAERS can be confirmed by Vigibase. Initial screening identified 302 suspect drugs; following disproportionality filtering, univariate analysis, and lasso shrinkage, 56 agents were retained. Nivolumab was the most frequently reported drug (1,377 reports), followed by pembrolizumab (1,070 reports) and daptomycin (758 reports), with daptomycin exhibiting the most significant statistical signal in FAERS. Time-to-onset analysis indicated that EP typically manifested early. Multivariable modeling identified higher body weight, advancing age, and polypharmacy as associated factors. The drugs most strongly associated with EP were daptomycin (OR 12.50, 95% CI 9.40-16.75), durvalumab (OR 5.17, 95% CI 3.74-7.14), fam-trastuzumab deruxtecan (OR 4.86, 95% CI 3.32-7.04), idelalisib (OR 4.74, 95% CI 3.13-7.07), and osimertinib (OR 3.21, 95% CI 2.11-4.79). Conclusion: The early discontinuation of the offending drug, timely initiation of corticosteroid therapy, and multidisciplinary collaboration are fundamental to achieving improved outcomes in cases of drug-induced eosinophilic pneumonia. This study offers substantial real-world evidence to facilitate the early identification and optimal management of eosinophilic pneumonia.

Frontiers in MedicineVol. 13
Xuzhou Medical College (CN), Lianyungang Oriental Hospital (CN), Second Affiliated Hospital of Nanjing Medical University (CN), Jiangsu Province Hospital (CN), Nanjing Medical University (CN)
Good health and well-being
Openalex Percentile: Top 22%
Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
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