{"doi":"10.3390/ph16010098","title":"Cardiovascular Toxicities of Ibrutinib: A Pharmacovigilance Study Based on the United States Food and Drug Administration Adverse Event Reporting System Database","abstract":"<jats:p>Background: Although ibrutinib has been widely used to treat haematological malignancies, many studies have reported associated cardiovascular events. These studies were primarily animal experiments and clinical trials. For more rational clinical drug use, a study based on post-marketing data is necessary. Aim: Based on post-marketing data, we investigated the clinical features, time to onset, and outcomes of potential cardiovascular toxicities of ibrutinib. Methods: This disproportionality study utilised data from the 2014–2021 United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. We used two disproportionality methods information component (IC) and reporting odds ratio (ROR)) to detect the potential cardiovascular toxicities of ibrutinib. Positive signals were defined as IC025 &gt; 0 and ROR025 &gt; 1. Results: A total of 10 cardiovascular events showed positive signals: supraventricular tachyarrhythmias, haemorrhagic central nervous system vascular conditions, ventricular tachyarrhythmias, cardiac failure, ischaemic central nervous system vascular conditions, cardiomyopathy, conduction defects, myocardial infarction, myocardial infarction disorders of sinus node function, and torsade de pointes/QT prolongation. Cardiomyopathy and supraventricular tachyarrhythmias were the two most common signals. Disorders of sinus node function were observed for the first time, which may be a new adverse effect of ibrutinib. Conclusions: This pharmacovigilance study systematically explored the adverse cardiovascular events of ibrutinib and provided new safety signals based on past safety information. Attention should be paid to some high-risk signals.</jats:p>","journal":"Pharmaceuticals","year":2023,"id":633434,"datarank":0.37273599746820013,"base_score":2.4849066497880004,"endowment":2.4849066497880004,"self_citation_contribution":0.37273599746820013,"citation_network_contribution":0.0,"self_endowment_contribution":0.37273599746820013,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":11,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":156772,"name":"Xiaojing Guo","orcid":null,"position":1,"is_corresponding":false},{"id":156773,"name":"Chenxin Chen","orcid":null,"position":2,"is_corresponding":false},{"id":1642299,"name":"Lijie Chi","orcid":null,"position":3,"is_corresponding":false},{"id":402781,"name":"Zhijian Guo","orcid":"0009-0001-4722-6117","position":4,"is_corresponding":false},{"id":1563708,"name":"Jizhou Liang","orcid":null,"position":5,"is_corresponding":false},{"id":156771,"name":"Lianhui Wei","orcid":"0000-0002-7155-8111","position":6,"is_corresponding":false},{"id":1326009,"name":"Xiao Chen","orcid":"0009-0007-1123-8152","position":7,"is_corresponding":false},{"id":852565,"name":"Xiaofei Ye","orcid":"0000-0002-7678-1152","position":8,"is_corresponding":false},{"id":63918,"name":"Jia He","orcid":null,"position":9,"is_corresponding":false},{"id":45506,"name":"Yi Zheng","orcid":"0000-0002-2685-3680","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Cardiovascular Toxicities of Ibrutinib: A Pharmacovigilance Study Based on the United States Food and Drug Administration Adverse Event Reporting System Database","abstract":"<jats:p>Background: Although ibrutinib has been widely used to treat haematological malignancies, many studies have reported associated cardiovascular events. These studies were primarily animal experiments and clinical trials. For more rational clinical drug use, a study based on post-marketing data is necessary. Aim: Based on post-marketing data, we investigated the clinical features, time to onset, and outcomes of potential cardiovascular toxicities of ibrutinib. Methods: This disproportionality study utilised data from the 2014–2021 United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. We used two disproportionality methods information component (IC) and reporting odds ratio (ROR)) to detect the potential cardiovascular toxicities of ibrutinib. Positive signals were defined as IC025 &gt; 0 and ROR025 &gt; 1. Results: A total of 10 cardiovascular events showed positive signals: supraventricular tachyarrhythmias, haemorrhagic central nervous system vascular conditions, ventricular tachyarrhythmias, cardiac failure, ischaemic central nervous system vascular conditions, cardiomyopathy, conduction defects, myocardial infarction, myocardial infarction disorders of sinus node function, and torsade de pointes/QT prolongation. Cardiomyopathy and supraventricular tachyarrhythmias were the two most common signals. Disorders of sinus node function were observed for the first time, which may be a new adverse effect of ibrutinib. Conclusions: This pharmacovigilance study systematically explored the adverse cardiovascular events of ibrutinib and provided new safety signals based on past safety information. Attention should be paid to some high-risk signals.</jats:p>","is_dataset_classified":null,"base_score":2.4849066497880004,"endowment":2.4849066497880004,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"36678594","pmcid":"PMC9863914","openalex_id":"https://openalex.org/W4313897973","authors":[],"funders":[{"funder_name":"National Nature Science Foundation of China","grant_id":"No. 82073671","title":null},{"funder_name":"National Nature Science Foundation of China","grant_id":"GWV-10.2-YQ33","title":null},{"funder_name":"National Nature Science Foundation of China","grant_id":"03","title":null},{"funder_name":"National Nature Science Foundation of China","grant_id":"CPA-CDCER-2021-001","title":null},{"funder_name":"Big Data and Artificial Intelligence Application，and Military Key Discipline Construction Project (Health Service-Naval Health Service Organization and Command)","grant_id":"No.03","title":null},{"funder_name":"the Leading Talents of Public Health in Shanghai","grant_id":"No. GWV-10.2-XD22","title":null},{"funder_name":"three-year Action Program of Shanghai Municipality for Strengthening the Construction of Public Health System","grant_id":"GWV-10.1-XK05","title":null},{"funder_name":"the Excellent Young Scholars of public health in Shanghai","grant_id":"No. GWV-10.2-YQ33","title":null}],"total_grants":8,"fwci":1.8353,"citation_percentile":0.84729429,"influential_citations":0,"citation_trend":[{"year":2023,"count":2},{"year":2024,"count":3},{"year":2025,"count":5},{"year":2026,"count":1}],"oa_status":"gold","license":"cc-by","oa_locations":[{"url":"https://www.mdpi.com/1424-8247/16/1/98/pdf?version=1674143182","host_type":"journal"},{"url":"https://www.mdpi.com/1424-8247/16/1/98/pdf?version=1674143182","host_type":"publisher"},{"url":"https://www.mdpi.com/1424-8247/16/1/98/pdf","host_type":"publisher"},{"url":"https://doi.org/10.3390/ph16010098","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/36678594","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/9863914","host_type":"repository"},{"url":"https://doaj.org/article/a98546c67af540538eb8dcb572f1140d","host_type":"repository"},{"url":"https://dx.doi.org/10.3390/ph16010098","host_type":"repository"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9863914/pdf/pharmaceuticals-16-00098.pdf","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC9863914","host_type":"Europe_PMC"},{"url":"https://europepmc.org/articles/PMC9863914?pdf=render","host_type":"Europe_PMC"}],"fields_of_study":["Chronic Lymphocytic Leukemia Research","HER2/EGFR in Cancer Research","Monoclonal and Polyclonal Antibodies Research"],"mesh_terms":[],"keywords":["Pharmacovigilance","Adverse Event Reporting System","Food and drug administration","Medicine","Ibrutinib","Adverse effect","Database","Adverse drug event","Pharmacology","Drug","Adverse drug reaction","Internal medicine","Computer science","Cardiovascular events","Faers","Disproportionality Analysis","Pharmacovigilance Study"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-06T12:03:49.896708Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}