ArticleFrontiers in pharmacology2025
Signal detection and safety analysis of three tyrosine kinase inhibitors for HER-2 positive breast cancer: a retrospective study based on the FAERS database.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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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
6 citing papers in PubMed.
- Drug-induced adverse events in modern pharmacotherapy: mechanisms, clinical manifestations, and implications for risk assessment and management.Frontiers in pharmacology · 2026Review
- Signal mining and safety profile analysis of lapatinib: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.Journal of pharmaceutical policy and practice · 2026Article
- Article
- Review
- Will the introduction of β-lactamase inhibitors alter the adverse event profile of parent penicillins antibiotics? a pharmacovigilance study based on amoxicillin-clavulanate and ampicillin-sulbactam.Frontiers in pharmacology · 2026Article
- Risk Signals of Antibody-Drug Conjugates in Bladder Cancer: A Real-World FAERS Study.Clinical epidemiology · 2025Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: To identify adverse event (ADE) signals of three tyrosine kinase inhibitors (TKIs) (Tucatinib, Lapatinib, and Neratinib) used for HER-2 positive breast cancer by utilizing the FAERS database, and to analyze their safety profiles to provide references for clinical risk management. Methods: Data from the FAERS database spanning Q1 2015 to Q3 2024 were retrieved, including reports where Tucatinib, Lapatinib, or Neratinib was identified as the primary suspect drug. Disproportionality analysis (ROR, PRR) and the Comprehensive Standard method were employed to detect potential ADE signals. The distribution of ADEs across different System Organ Classifications (SOCs) was also analyzed. Results: A total of 7,848 ADE reports were analyzed, identifying 557 significant signals. The primary ADEs were concentrated in gastrointestinal disorders, general conditions, administration site reactions, and skin and subcutaneous tissue disorders. Neratinib exhibited higher gastrointestinal toxicity, Lapatinib was associated with notable skin toxicities, and Tucatinib showed specific adverse reactions linked to combination therapies. Conclusion: The three TKIs demonstrated distinct ADE signal profiles, with gastrointestinal, systemic, and skin toxicities being the major areas of concern. Future research should validate these findings and develop effective management strategies to enhance treatment safety and improve the quality of life for HER-2 positive breast cancer patients.
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Registered trials
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 Socratic graph.