{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T10:24:44Z","timestamp":1792664684428,"version":"4.5.0"},"reference-count":73,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T00:00:00Z","timestamp":1716508800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>(1) Background: Stevens\u2013Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are extremely severe cutaneous adverse drug reactions which are relatively rare in routine clinical practice. An analysis of a national pharmacovigilance database may be the most effective method of obtaining information on SJS and TEN. (2) Methods: Design\u2014a retrospective descriptive pharmacoepidemiologic study of spontaneous reports (SRs) with data on SJS and TEN retrieved from the Russian National Pharmacovigilance database for the period from 1 April 2019 to 31 December 2023. Descriptive statistics was used to assess the demographic data of patients and the structure of suspected drugs. (3) Results: A total of 170 SRs on SJS and TEN were identified, of which 32.9% were SJS and 67.1%\u2014TEN. In total, 30% were pediatric SRs, 21.2%\u2014SRs of the elderly. There were 12 lethal cases, and all cases were TEN. The leading culprit drugs were anti-infectives for systemic use and nervous system agents. The top 10 involved drugs are as follows: lamotrigine (23.5%), ibuprofen (12.9%), ceftriaxone (8.8%), amoxicillin and amoxicillin with beta-lactam inhibitors (8.8%), paracetamol (7.6%), carbamazepine (5.9%), azithromycin (4.1%), valproic acid (4.1%), omeprazole (3.5%), and levetiracetam (3.5%). (4) Conclusions: Our study was the first study in Russia aimed at the assessment of the structure of the drugs involved in SJS and TEN on the national level.<\/jats:p>","DOI":"10.3390\/ph17060675","type":"journal-article","created":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T06:59:04Z","timestamp":1716533944000},"page":"675","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Stevens\u2013Johnson Syndrome and Toxic Epidermal Necrolysis: Analysis of the Russian Database of Spontaneous Reports"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6348-6867","authenticated-orcid":false,"given":"Sergey","family":"Zyryanov","sequence":"first","affiliation":[{"name":"Department of General and Clinical Pharmacology, Peoples\u2019 Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia"},{"name":"Moscow City Health Department, City Clinical Hospital No. 24, State Budgetary Institution of Healthcare of the City of Moscow, Pistzovaya Str. 10, 127015 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Asetskaya","sequence":"additional","affiliation":[{"name":"Department of General and Clinical Pharmacology, Peoples\u2019 Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7729-2169","authenticated-orcid":false,"given":"Olga","family":"Butranova","sequence":"additional","affiliation":[{"name":"Department of General and Clinical Pharmacology, Peoples\u2019 Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizaveta","family":"Terekhina","sequence":"additional","affiliation":[{"name":"Department of General and Clinical Pharmacology, Peoples\u2019 Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-5110-978X","authenticated-orcid":false,"given":"Vitaly","family":"Polivanov","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Center, Information and Methodological Center for Expert Evaluation, Record and Analysis of Circulation of Medical Products under the Federal Service for Surveillance in Healthcare, 4-1 Slavyanskaya Square, 109074 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3419-8521","authenticated-orcid":false,"given":"Alexander","family":"Yudin","sequence":"additional","affiliation":[{"name":"Moscow City Health Department, City Clinical Hospital No. 24, State Budgetary Institution of Healthcare of the City of Moscow, Pistzovaya Str. 10, 127015 Moscow, Russia"},{"name":"Russian National Research Medical University Named after N.I. Pirogov, St. Ostrovityanova, 1, 117997 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina","family":"Samsonova","sequence":"additional","affiliation":[{"name":"Department of General and Clinical Pharmacology, Peoples\u2019 Friendship University of Russia Named after Patrice Lumumba (RUDN), 6 Miklukho-Maklaya St., 117198 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,5,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1996","DOI":"10.1016\/S0140-6736(16)30378-6","article-title":"Severe cutaneous adverse reactions to drugs","volume":"390","author":"Duong","year":"2017","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"72","DOI":"10.5415\/apallergy.0000000000000101","article-title":"Drug-induced Stevens Johnson syndrome and toxic epidermal necrolysis: Interpreting the systematic reviews on immunomodulatory therapies","volume":"13","author":"Thong","year":"2023","journal-title":"Asia Pac. 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