ArticleBMC pharmacology & toxicology2023
A disproportionality analysis of adverse events associated to pertuzumab in the FDA Adverse Event Reporting System (FAERS).
Article in BMC pharmacology & toxicology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 citing papers in PubMed, 20 citations in OpenAlex.
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- Mining the FAERS database reveals new safety signals for 120 mg denosumab in oncology practice.PloS one · 2026Article
- Review
- Real-world pharmacovigilance assessment of hepatotoxicity risk with HER2-Targeted drugs using FAERS database analysis.Scientific reports · 2025Article
- Cardiotoxicity Assessment of EGFR Tyrosine Kinase Inhibitors Using Human iPS Cell-Derived Cardiomyocytes and FDA Adverse Events Reporting System.Clinical and translational science · 2025Article
- A retrospective research of adverse event reporting system events for voxelotor based on the FAERS database.BMC pharmacology & toxicology · 2025Article
- Risk assessment of the top 50 drugs associated with drug-induced orthostatic hypotension: a disproportionality analysis of the FAERS and JADER databases.Scientific reports · 2025Article
- Article
- Comparative safety analysis of Riluzole, Edaravone and Tofersen in ALS management: insights from FAERS database.Frontiers in pharmacology · 2025Article
- A disproportionality analysis of FDA adverse event reporting system (FAERS) events for filgotinib.PloS one · 2025Article
- IL-6R Inhibitors and Gastrointestinal Perforations: A Pharmacovigilance Study and a Predicting Nomogram.Biomedicines · 2024Article
- Delayed immune-related adverse events profile associated with immune checkpoint inhibitors: a real-world analysis.Frontiers in pharmacology · 2024Article
- Signal mining of adverse events of proteasome inhibitors in multiple myeloma based on FAERS.Frontiers in pharmacology · 2024Article
- A disproportionality analysis of adverse events caused by GnRHas from the FAERS and JADER databases.Frontiers in pharmacology · 2024Article
- Evaluating drug withdrawal syndrome risks through food and drug administration adverse event reporting system: a comprehensive disproportionality analysis.Frontiers in pharmacology · 2024Article
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPertuzumab is widely used for the treatment of HER2 + breast cancer. But its safety in the real world should be continuously monitored. So, we evaluated the safety of pertuzumab by pharmacovigilance analyze based on related adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) and find whether potential or uncertain adverse events were present.
methodsIn disproportionality analysis, four algorithms were employed to detect the signals of pertuzumab from the FAERS between 2012 and 2022. In addition, we also used MYSQL 8.0, Navicat Premium 15, and Microsoft EXCEL 2019 to analyze the potential and high-ROR (reporting odds ratio) signals of pertuzumab. We also collected the onset times of pertuzumab-associated AEs.
resultsFrom January 2012 to December 2022, there are 39,190,598 AEs reported from the FAERS database, of which 14,707 AEs listed pertuzumab as the 'primary suspected (PS)' drug. A total of 115 (46 potential) significant disproportionality preferred terms (PTs) conforming to the four algorithms were retained. Finally, we detected that the pertuzumab-induced AEs occurred in 12 organ systems. For pertuzumab, unexpected and significant PTs of AEs were found, including but not limited to below PTs: haematotoxicity, cardiotoxicity, cardiomyopathy, mitral valve incompetence, tachycardia, intestinal perforation, hemorrhoids, erysipelas, dehydration, pneumonitis, skin toxicity, onychomadesis, cyanosis, and circulatory collapse. We found there were 9 strong signals (5 potential safety signals) and 68 medium intensity signals (21 potential safety signals) according to IC
conclusionAnalysis of FAERS data identified pertuzumab-associated AEs, and our findings supported continuous clinical monitoring, pharmacovigilance, and further studies of pertuzumab. A significant association was detected between pertuzumab and some potential adverse events which should be regarded with some care. We have to pay attention to the first month after pertuzumab therapy and prepare emergency measures, especially for the elderly and patients with cardiovascular diseases.
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