ArticleFrontiers in immunology2025
Emerging causes of anticancer therapies-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: evidence from disproportionality analysis of the FDA adverse event reporting system.
Article in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Pharmacovigilance insights into drug-induced hypercalcemia: evidence from the U.S. FDA Adverse Event Reporting System (FAERS) database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Observational
- Tisotumab vedotin-associated Stevens-Johnson syndrome in a patient with recurrent vulvar cancer: Vulnerability and antibody drug conjugate toxicity considerations.Gynecologic oncology reports · 2026Article
- Unveiling the hidden cardiovascular risk of sipuleucel-T: a pharmacovigilance analysis using the FDA Adverse Event Reporting System, 2010-2025.Frontiers in immunology · 2025Article
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Authors and funding
4 authors.
Funding
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Abstract
Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are potentially fatal cutaneous adverse events of drug treatment. Evidence for SJS/TEN risk from current anticancer therapies in population-based studies is scarce. Objective: The present study aims to characterize the profiles and risk factors of SJS/TEN related to contemporary anticancer regimens. Methods: Reported odds ratios (ROR) were employed to identify anticancer drugs associated with SJS/TEN development using FAERS data from January 2004 to September 2024. Single factor, LASSO, and multivariable logistic regression analysis were performed to explore the risk factors of SJS/TEN related to anticancer therapies. Weibull shape parameter analysis was applied to the onset time of reported SJS/TEN. Results: A total of 3471 unique SJS/TEN events were identified for 159 anticancer drug pairs, of which 31 drugs were identified as significantly disproportionate. Targeted therapies accounted for 35.93% of pairs, chemotherapies for 35.52%, and immunotherapies for 21.52%. The median onset time of SJS/TEN with anticancer therapies was 17 days. Moreover, multivariable logistic regression showed that age exceeding 65, female gender, and 10 anticancer drugs were significant risk factors for anticancer therapy-related SJS/TEN. Conclusions: This study provides real-world evidence regarding the burden of SJS/TEN associated with anticancer therapies. Addressing this knowledge gap will facilitate the optimization of clinical management for SJS/TEN. Further research to establish causality and inform clinical decision-making related to anticancer therapy-associated SJS/TEN is urgently needed.
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