{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T07:14:56Z","timestamp":1791357296909,"version":"4.3.1"},"reference-count":49,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,11,5]],"date-time":"2018-11-05T00:00:00Z","timestamp":1541376000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2018,12]]},"abstract":"Summary<\/jats:title>Objective<\/jats:title>Stevens\u2010Johnson syndrome (SJS<\/jats:styled-content>) and toxic epidermal necrolysis (TEN<\/jats:styled-content>) 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<\/jats:styled-content>\/TEN<\/jats:styled-content> reactions is antiepileptic drugs (AED<\/jats:styled-content>s). We sought to quantify the risk of SJS<\/jats:styled-content>\/TEN<\/jats:styled-content> associated with AED<\/jats:styled-content>s as a class, as well as individual AED<\/jats:styled-content>s, in the United States.<\/jats:p><\/jats:sec>Methods<\/jats:title>An analysis was performed of the US Food and Drug Administration Adverse Event Reporting System (FAERS<\/jats:styled-content>) from July 2014 through December 2017. Rates of SJS<\/jats:styled-content>\/TEN<\/jats:styled-content> were calculated for each AED<\/jats:styled-content> compared with all other non\u2010AED<\/jats:styled-content>s. Reporting odds ratios (ROR<\/jats:styled-content>s), proportional reporting ratios (PRRs<\/jats:styled-content>), and 95% confidence intervals (CI<\/jats:styled-content>s) were calculated using OpenEpi.<\/jats:p><\/jats:sec>Results<\/jats:title>With 198 reports, AED<\/jats:styled-content>s had more reports of SJS<\/jats:styled-content>\/TEN<\/jats:styled-content> than any other medication class. AED<\/jats:styled-content>s as a class had an ROR<\/jats:styled-content> of 8.7 (95% CI<\/jats:styled-content> 7.5\u201010.2) and a PRR<\/jats:styled-content> of 8.7 (95% CI<\/jats:styled-content> 7.5\u201010.2) compared with all other non\u2010AED<\/jats:styled-content>s. The AED<\/jats:styled-content>s with the highest risk estimates were zonisamide (ROR<\/jats:styled-content> 70.2, 95% CI<\/jats:styled-content> 33.1\u2010148.7; PRR<\/jats:styled-content> 68.7, 95% CI<\/jats:styled-content> 32.9\u2010143.5), rufinamide (ROR<\/jats:styled-content> 60.0, 95% CI<\/jats:styled-content> 8.3\u2010433.5; PRR<\/jats:styled-content> 58.9, 95% CI<\/jats:styled-content> 8.4\u2010411.5), clorazepate (ROR<\/jats:styled-content> 56.0, 95% CI<\/jats:styled-content> 7.8\u2010404.1; PRR<\/jats:styled-content> 55.1, 95% CI<\/jats:styled-content> 7.8\u2010385.0), lamotrigine (ROR<\/jats:styled-content> 53.0, 95% CI 43.2\u201064.9; PRR<\/jats:styled-content> 52.2, 95% CI<\/jats:styled-content> 42.7\u201063.7), phenytoin (ROR<\/jats:styled-content> 26.3, 95% CI<\/jats:styled-content> 15.5\u201044.7; PRR<\/jats:styled-content> 26.1, 95% CI<\/jats:styled-content> 15.4\u201044.2), and carbamazepine (ROR<\/jats:styled-content> 24.5, 95% CI<\/jats:styled-content> 16.0\u201037.5; PRR<\/jats:styled-content> 24.3, 95% CI<\/jats:styled-content> 16.0\u201037.1).<\/jats:p><\/jats:sec>Significance<\/jats:title>Although AED<\/jats:styled-content>s as a class were associated with 9 times the risk of SJS<\/jats:styled-content>\/TEN<\/jats:styled-content> compared with non\u2010AED<\/jats:styled-content>s, there were 6 AED<\/jats:styled-content>s with risk estimates greater than 20. Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AED<\/jats:styled-content>s, along with education on early recognition of SJS<\/jats:styled-content>\/TEN<\/jats:styled-content> signs\/symptoms, may help mitigate the number and severity of these adverse events.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.14591","type":"journal-article","created":{"date-parts":[[2018,11,5]],"date-time":"2018-11-05T15:46:21Z","timestamp":1541432781000},"page":"2318-2324","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":86,"title":["Stevens\u2010Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs: An analysis of the US Food and Drug Administration Adverse Event Reporting System"],"prefix":"10.1111","volume":"59","author":[{"given":"Eric P.","family":"Borrelli","sequence":"first","affiliation":[{"name":"University of Rhode Island College of Pharmacy Kingston Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica Y.","family":"Lee","sequence":"additional","affiliation":[{"name":"University of Rhode Island College of Pharmacy Kingston Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew M.","family":"Descoteaux","sequence":"additional","affiliation":[{"name":"University of Rhode Island College of Pharmacy Kingston Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen J.","family":"Kogut","sequence":"additional","affiliation":[{"name":"University of Rhode Island College of Pharmacy Kingston Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4180-027X","authenticated-orcid":false,"given":"Aisling R.","family":"Caffrey","sequence":"additional","affiliation":[{"name":"University of Rhode Island College of Pharmacy Kingston Rhode Island"},{"name":"Veterans Affairs Medical Center Infectious Diseases Research Program Center of Innovation in Long Term Services and Supports Providence Rhode Island"},{"name":"Brown University School of Public Health Providence Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,11,5]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199512143332404"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2008-1923"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0068231"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1081-1206(10)61112-X"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/archderm.1990.01670250049006"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0165933"},{"issue":"62","key":"e_1_2_9_8_1","first-page":"468","article-title":"Stevens\u2010Johnson syndrome and toxic epidermal necrolysis: a review","volume":"2016","author":"Wong A","year":"1992","journal-title":"Rev Assoc Med Bras"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2016.03.023"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2012.510"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-2295"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.15360"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/00019052-200304000-00008"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.1993.tb02586.x"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1586\/ern.13.57"},{"key":"e_1_2_9_16_1","unstructured":"Carbamazepine[package insert].North Wales PA:Teva Pharmaceuticals USA Inc.;2015."},{"key":"e_1_2_9_17_1","unstructured":"Lamotrigine[package insert].Salisbury MD:Jubilant Cadista Pharmaceuticals Inc.;2017."},{"key":"e_1_2_9_18_1","unstructured":"Oxcarbazepine[package insert].Hawthorne NY:Taro Pharmaceutics U.S.A. 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