ArticleScientific reports2022
A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib.
Article in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 5 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
78 citing papers in PubMed, 5 syntheses or guidelines pooled it, 90 citations in OpenAlex.
- Oral mucositis risk with EGFR tyrosine kinase inhibitor monotherapies and combination regimens in non-small cell lung cancer: a systematic review and network meta-analysis.Frontiers in immunology · 2026Pooled it
- Cardiovascular adverse events associated with epidermal growth factor receptor tyrosine kinase inhibitors inBMJ (Clinical research ed.) · 2025Pooled it
- Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment.Scientific reports · 2025Pooled it
- Safety of sulfamethoxazole-trimethoprim for the treatment of bacterial infection in outpatient settings: A systematic review and meta-analysis with active comparator disproportionality analysis.British journal of clinical pharmacology · 2025Pooled it
- Safety of sulfamethoxazole-trimethoprim for the treatment of bacterial infection in outpatient settings: A systematic review and meta-analysis with active comparator disproportionality analysis.British journal of clinical pharmacology · 2025Pooled it
- Phlegmasia Cerulea Dolens and Pulmonary Embolism in a Patient With NSCLC Receiving Dual EGFR/MET Targeted Therapy: A Case Report.JTO clinical and research reports · 2026Article
- Post-marketing safety surveillance and adverse event risk factors of abemaciclib: a pharmacoepidemiologic study.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Osimertinib-induced interstitial lung disease insights from faers signal detection and network toxicology analysis.BMC cancer · 2026Article
- Heterogeneity in adverse events associated with lumateperone: a study on potential subgroup-specific differences.The international journal of neuropsychopharmacology · 2026Article
- Global trends and research progress on immunotherapy forJournal of thoracic disease · 2026Article
- Adverse events associated with tirzepatide: a focus on subgroup-specific differences.BMC pharmacology & toxicology · 2026Article
- Exploring potential biomarkers and constructing prediction models of osimertinib based on a retrospective study.European journal of clinical pharmacology · 2026Article
- Sex-disparate safety profile of Obinutuzumab: a pharmacovigilance analysis using the FDA adverse event reporting system.Clinics (Sao Paulo, Brazil) · 2026Article
- Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database.Frontiers in endocrinology · 2026Article
- Pancreatitis induced by Peg-aspargase in children: a real-world pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS).Leukemia research reports · 2026Article
- Medication-related nephrotic syndrome: a real-world study from 2004 to 2024 based on the Food and Drug Administration Adverse Event Reporting System.Therapeutic advances in drug safety · 2026Article
- Dysregulated fibroblast-immune crosstalk drives statin-associated erectile dysfunction: integrative evidence from pharmacovigilance and single-cell transcriptomics.Frontiers in pharmacology · 2026Article
- Potential heterogeneity of epcoritamab associated adverse events in demographics and dosing regimens.Frontiers in medicine · 2026Article
- Real-world landscape of drug-related ocular injuries: a retrospective pharmacovigilance study.Frontiers in pharmacology · 2026Article
- Spectrum and signals of medication-associated cognitive disorder: a comprehensive disproportionality analysis with cross-database validation.Frontiers in pharmacology · 2026Article
18 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Osimertinib was a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which approved by the US Food and Drug Administration (FDA) in 2015 for treatment of non-small cell lung cancer (NSCLC). Our study was to explore the adverse events (AEs) caused by osimertinib through data mining of the US FDA Adverse Event Reporting System (FAERS), and provide reference for clinical safety. Data of osimertinib were collected from the FAERS database covering the period from first quarter of 2016 to the fourth quarter of 2021. Disproportionality analyses was employed to quantify the associated AE signals of osimertinib and detect the risk signals from the data in the FAERS database. Reporting odds ratio (ROR) was used to detect the risk signals from the data in the FAERS database. The definition relied on system organ class (SOCs) and preferred terms (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA). Totally, 9,704,33 reports were collected from the FAERS database, 10,804 reports of osimertinib were identified as the 'primary suspected (PS)' AEs. Osimertinib induced AEs occurred in 27 organ systems. 68 significant disproportionality PTs satisfying with the four algorithms were retained at the same time. Unexpected significant AEs such as scrotal volvulus, hepatic function abnormal, venous thromboembolisms might also occur. The median onset time of osimertinib-associated AEs was 58 days (interquartile range [IQR] 14-212 days), and the majority of the AEs occurred within the first 30 days after osimertinib initiation. Our study found significant new AEs signals of osimertinib and might provide support for clinical monitoring and risk identification of osimertinib.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.