{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T11:15:13Z","timestamp":1790162113496,"version":"4.1.0"},"reference-count":13,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,1,26]],"date-time":"2016-01-26T00:00:00Z","timestamp":1453766400000},"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":["Fundamemntal Clinical Pharma"],"published-print":{"date-parts":[[2016,4]]},"abstract":"Abstract<\/jats:title>Etifoxine chlorhydrate is a benzoxazine derivative approved for the treatment of psychosomatic manifestations of anxiety since 1979. Previously labeled adverse drug reactions (ADR<\/jats:styled-content>s) only include drowsiness, benign cutaneous reactions, and acute hypersensitivity reactions. The objectives were to examine recent data on etifoxine\u2010related ADR<\/jats:styled-content> by reviewing Individual Case Safety Reports (ICSR<\/jats:styled-content>s) recorded in France especially unexpected ADR<\/jats:styled-content>s. Etifoxine\u2010related ICSR<\/jats:styled-content>s were extracted from the French Pharmacovigilance database from 1 January 2000 to 30 April 2012 and data from the marketing authorization holder up to 31 December 2011 were also obtained. Of the 350 cases retained for analysis, 123 (35%) were considered serious. Dermatological or acute hypersensitivity reactions were the most frequent ADR<\/jats:styled-content>s (59%) mainly isolated cutaneous eruptions. However, there were 24 cases of severe toxidermia (DRESS<\/jats:styled-content> in 5, erythema multiforme in 10 and Stevens\u2013Johnson syndrome in 5) with etifoxine as the most suspected drug in 11 patients, and seven cases of vasculitis or serum sickness\u2010like reaction. Liver disorders were reported in 34 patients of whom 25 developed acute hepatitis with a cytolytic biological pattern in 16. Other unexpected ADR<\/jats:styled-content>s included 16 reversible cases of metrorrhagia with positive rechallenge in 5, and three cases of biopsy\u2010proven microscopic colitis of which one recurred after etifoxine re\u2010administration. Although etifoxine has been marketed for more than 30 years, this survey identified a number of unexpected and sometimes serious ADR<\/jats:styled-content>s, in particularly severe toxidermia and acute cytolytic hepatitis. A recent update of the French etifoxine summary of the product characteristics (SPC<\/jats:styled-content>) was based on these findings.<\/jats:p>","DOI":"10.1111\/fcp.12169","type":"journal-article","created":{"date-parts":[[2015,11,20]],"date-time":"2015-11-20T16:04:42Z","timestamp":1448035482000},"page":"147-152","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Safety profile of etifoxine: A French pharmacovigilance survey"],"prefix":"10.1111","volume":"30","author":[{"given":"Judith","family":"Cottin","sequence":"first","affiliation":[{"name":"Regional Pharmacovigilance Center of Lyon University Hospitals 162 avenue Lacassagne, 69003 Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aurore","family":"Gouraud","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Lyon University Hospitals 162 avenue Lacassagne, 69003 Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie\u2010Jos\u00e8phe","family":"Jean\u2010Pastor","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Marseille H\u00f4pital Sainte\u2010Marguerite, University Hospitals (AP\u2010HM), 270 Boulevard de Sainte\u2010Marguerite 13274 Marseille Cedex 09 France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne Disson\u2010","family":"Dautriche","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Dijon University Hospitals 14 rue Paul Gaffarel, 21079 Dijon Cedex, BP 779008 France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charl\u00e8ne","family":"Boulay","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Rouen University Hospitals Service de pharmacologie, 76 031 Rouen Cedex France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e9l\u00e8ne","family":"Geniaux","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Bordeaux University Hospitals H\u00f4pital Pellegrin, 33076 Bordeaux Cedex France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marine","family":"Auffret","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Lille University Hospitals 1 Place de Verdun, 59045 Lille Cedex France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Bernard","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Lyon University Hospitals 162 avenue Lacassagne, 69003 Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques","family":"Descotes","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Lyon University Hospitals 162 avenue Lacassagne, 69003 Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Vial","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center of Lyon University Hospitals 162 avenue Lacassagne, 69003 Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,1,26]]},"reference":[{"key":"e_1_2_6_2_1","first-page":"523","article-title":"Modulation of GABAergic synaptic transmission by the non\u2010benzodiazepine anxiolytic etifoxine","volume":"391","author":"Schlichter R.","year":"2000","journal-title":"Neuropharmacology"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0028-3908(03)00187-4"},{"key":"e_1_2_6_4_1","first-page":"1050","article-title":"Etifoxine chlorhydrate\u2010induced acute hepatitis","volume":"27","author":"Mennecier D.","year":"2003","journal-title":"Gastroenterol. 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Drug\u2010induced liver disorders: report of an international consensus meeting","volume":"28","author":"B\u00e9nichou C.","year":"1990","journal-title":"Int. J. Clin. Pharmacol. Ther. 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