ArticleEClinicalMedicine2023
Psychiatric disorders associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.
Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 131 papers, 3 of them syntheses that pooled it.
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Who cites it
131 citing papers in PubMed, 3 syntheses or guidelines pooled it, 179 citations in OpenAlex.
- Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment.Scientific reports · 2025Pooled it
- Microbiota boost immunotherapy? A meta-analysis dives into fecal microbiota transplantation and immune checkpoint inhibitors.BMC medicine · 2025Pooled it
- Romosozumab adverse event profile: a pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) from 2019 to 2023.Aging clinical and experimental research · 2025Pooled it
- Bipolar disorder in oncology: Considerations for the psychiatrist.Journal of mood and anxiety disorders · 2026Review
- Identification of Drug Associated Factors for Gingival Disorders: A Real-World Pharmacovigilance Study.International dental journal · 2026Article
- The Real-World Safety Profile of Immune Checkpoint Inhibitors in Melanoma: FAERS Pharmacovigilance Analysis Complemented by Randomized Trial Evidence.Health science reports · 2026Article
- Renal adverse events in EGFR-TKI treatment: Comprehensive characterization of clinical patterns and molecular underpinnings.Genes & diseases · 2026Article
- Depression and suicide-related events associated with tenofovir use in chronic hepatitis B: A pharmacovigilance analysis.Clinical and molecular hepatology · 2026Article
- Long-term ovarian function risks associated with combined oral contraceptive administration in polycystic ovary syndrome: multisource data integration and protective mechanisms of metformin.Journal of translational medicine · 2026Article
- A pharmacovigilance data-driven approach to reveal high fatal adverse events following checkpoint immunotherapy.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Mechanistic insights into taxane-induced psychiatric adverse events: a global pharmacovigilance and experimental investigation.Molecular psychiatry · 2026Article
- A case of diverse psychiatric and functional impairments following immune checkpoint inhibitor therapy.PCN reports : psychiatry and clinical neurosciences · 2026Article
- Bridging FDA Adverse Event Reporting System (FAERS) and Clinical Practice: Comprehensive Characterization of Immune Checkpoint Inhibitors Toxicities in Geriatric Lung Cancer Patients.Thoracic cancer · 2026Article
- Article
- Integrating digital solutions improves mental health management in cancer care.Communications medicine · 2026Review
- Fluoroquinolone-Associated Psychiatric and Ocular Adverse Events: A Disproportionality Analysis Using Real-World Data From FAERS (2011-2024).Pharmacology research & perspectives · 2026Article
- Adverse events associated with statin co-use in breast cancer patients: a disproportionality analysis based on the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2026Article
- Synergistic toxicity and clinical prioritization of docetaxel combined with nintedanib for non-small cell lung cancer: a real-world safety analysis using the FAERS database.Frontiers in oncology · 2026Article
- Haematological toxicity associated with antineoplastic drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database.Frontiers in immunology · 2026Article
- Increased reporting of interstitial pneumonitis with combined EGFR-TKI and PD-1/PD-L1 inhibitor therapy in NSCLC: a pharmacovigilance analysis of 67,818 reports.Frontiers in immunology · 2026Observational
71 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: With the increasing use of immune checkpoint inhibitors (ICIs) for tumour immunotherapy, the immune-related adverse events (irAEs) caused by their collateral effect on the immune system pose a key challenge for the clinical application of ICIs. Psychiatric adverse events are a class of adverse events associated with ICIs that are realistically observed in the real world. We aim to provide a comprehensive study and summary of psychiatric adverse events associated with ICIs. Methods: We obtained ICI adverse reaction reports during January 2012-December 2021 from the FDA Adverse Event Reporting System (FAERS) database. ICI reports underwent screening to minimize the influence of other adverse reactions, concomitant medications, and indications for medication use that may also contribute to psychiatric disorders. Disproportionality analysis was performed to find psychiatric adverse events associated with ICIs by comparing ICIs with the full FAERS database using the reporting odds ratio (ROR). Influencing factors were explored based on univariate logistic regression analysis. Finally, the Cancer Genome Atlas (TCGA) pan-cancer transcriptome data were combined to explore the potential biological mechanisms associated with ICI-related pAEs. Findings: Reports of psychiatric adverse events accounted for 2.71% of the overall ICI adverse event reports in the FAERS database. Five categories of psychiatric adverse events were defined as ICI-related psychiatric adverse events (pAEs). The median age of reports with ICI-related pAEs was 70 (interquartile range [IQR] 24-95), with 21.54% of reports having a fatal outcome. Cases with indications for lung cancer, skin cancer and kidney site cancer accounted for the majority. The odds of ICI-related pAEs increased in older patients (65-74: OR = 1.44 [1.22-1.70], Interpretation: This study investigated psychiatric adverse events highly associated with ICI treatment, their influencing factors and potential biological mechanisms, which provides a reliable basis for further in-depth study of ICI-related pAEs. However, as an exploratory study, our findings need to be further confirmed in a large-scale prospective study. Funding: This work was supported by the Natural Science Foundation of Guangdong Province (2018A030313846 and 2021A1515012593), the Science and Technology Planning Project of Guangdong Province (2019A030317020) and the National Natural Science Foundation of China (81802257, 81871859, 81772457, 82172750 and 82172811). Guangdong Basic and Applied Basic Research Foundation (Guangdong - Guangzhou Joint Fouds) (2022A1515111212). This work was supported by Key Research and Development Projects of Sichuan Science and Technology (2022YFS0221, 2022YFS0074, 2022YFS0156 and 2022YFS0378). Sichuan Provincial People's Hospital Hospital Young Talent Fund (2021QN08).
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