ArticleEpilepsia2018
Stevens-Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs: An analysis of the US Food and Drug Administration Adverse Event Reporting System.
Article in Epilepsia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 93 citations in OpenAlex.
- Stevens-Johnson syndrome and toxic epidermal necrolysis: A systematic review of PubMed/MEDLINE case reports from 1980 to 2020.Frontiers in medicine · 2022Pooled it
- Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures.Neurology · 2020Trial
- Cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, phase 3, multicenter, open-label safety study.Epilepsia · 2020Trial
- Pharmacovigilance analysis of severe cutaneous adverse reactions associated with antiseizure medications: a FAERS database study with time-to-onset evaluation.Frontiers in pharmacology · 2026Article
- An international scoping review of epidemiologic studies on severe cutaneous adverse reactions.The World Allergy Organization journal · 2026Article
- Research progress on potential high-risk drugs for Stevens-Johnson syndrome and toxic epidermal necrolysis with insights from adverse drug reaction database mining.Frontiers in pharmacology · 2026Review
- Successful management of pembrolizumab-associated Stevens-Johnson syndrome/toxic epidermal necrolysis in a patient with uterine serous carcinoma: a case report.Frontiers in immunology · 2026Article
- Antiseizure Medications and Bone Health.Neurology and therapy · 2025Review
- Drug hypersensitivity reactions in children in clinical practice: A WAO Statement.The World Allergy Organization journal · 2025Review
- A review of the immunogenetics of Stevens-Johnson syndrome and toxic epidermal necrolysis.Global medical genetics · 2025Review
- Article
- Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database.Acta epileptologica · 2025Article
- Peripheral Blood Mononuclear Cells Cytokine Profile in a Patient with Toxic Epidermal Necrolysis Triggered by Lamotrigine and COVID-19: A Case Study.International journal of molecular sciences · 2025Article
- Severe Cutaneous Adverse Reaction to Lamotrigine: A Case of Stevens-Johnson Syndrome in a Psychiatric Patient.Cureus · 2025Article
- Hypersensitivity Reactions to Anticonvulsants.Current allergy and asthma reports · 2025Review
- What drives hyperammonemic encephalopathy in AED users: monotherapy risks or polypharmacy perils?Frontiers in pharmacology · 2025Article
- Emerging causes of anticancer therapies-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: evidence from disproportionality analysis of the FDA adverse event reporting system.Frontiers in immunology · 2025Article
- The Prevalence of Stevens-Johnson Syndrome Complications due to Antiepileptic Drug Use: A Systematic Review and Meta-Analysis.International journal of preventive medicine · 2025Review
- Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Analysis of the Russian Database of Spontaneous Reports.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Toxic epidermal necrolysis caused by phenobarbital: a case report and literature review.Frontiers in pharmacology · 2024Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
objectiveStevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare and potentially fatal adverse skin reactions that are most commonly triggered by certain medications. One class of medications that has been highly associated with SJS/TEN reactions is antiepileptic drugs (AEDs). We sought to quantify the risk of SJS/TEN associated with AEDs as a class, as well as individual AEDs, in the United States.
methodsAn analysis was performed of the US Food and Drug Administration Adverse Event Reporting System (FAERS) from July 2014 through December 2017. Rates of SJS/TEN were calculated for each AED compared with all other non-AEDs. Reporting odds ratios (RORs), proportional reporting ratios (PRRs), and 95% confidence intervals (CIs) were calculated using OpenEpi.
resultsWith 198 reports, AEDs had more reports of SJS/TEN than any other medication class. AEDs as a class had an ROR of 8.7 (95% CI 7.5-10.2) and a PRR of 8.7 (95% CI 7.5-10.2) compared with all other non-AEDs. The AEDs with the highest risk estimates were zonisamide (ROR 70.2, 95% CI 33.1-148.7; PRR 68.7, 95% CI 32.9-143.5), rufinamide (ROR 60.0, 95% CI 8.3-433.5; PRR 58.9, 95% CI 8.4-411.5), clorazepate (ROR 56.0, 95% CI 7.8-404.1; PRR 55.1, 95% CI 7.8-385.0), lamotrigine (ROR 53.0, 95% CI 43.2-64.9; PRR 52.2, 95% CI 42.7-63.7), phenytoin (ROR 26.3, 95% CI 15.5-44.7; PRR 26.1, 95% CI 15.4-44.2), and carbamazepine (ROR 24.5, 95% CI 16.0-37.5; PRR 24.3, 95% CI 16.0-37.1). SIGNIFICANCE: Although AEDs as a class were associated with 9 times the risk of SJS/TEN compared with non-AEDs, there were 6 AEDs with risk estimates greater than 20. Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS/TEN signs/symptoms, may help mitigate the number and severity of these adverse events.
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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 OpenQuestion graph.