{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T19:23:14Z","timestamp":1789759394049,"version":"4.0.1"},"reference-count":73,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T00:00:00Z","timestamp":1766361600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100018647","name":"RUDN University","doi-asserted-by":"crossref","award":["032105-0-000"],"award-info":[{"award-number":["032105-0-000"]}],"id":[{"id":"10.13039\/501100018647","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background\/Objectives: Cutaneous adverse drug reactions (CADRs) represent the most common manifestations of drug-induced allergy, with most unfavorable clinical outcomes seen in severe cutaneous adverse reactions (SCARs). To manage SCARs immediate cessation of the offending drug is needed; therefore, it is crucial to identify the list of medications associated with SCARs in real-world clinical practice. The objective of this study was to evaluate the structure of drugs associated with SCARs and to analyze drug-induced SCAR signals by calculating the reporting odds ratio (ROR) and proportional reporting ratio (PRR) based on spontaneous reports extracted from the Russian national pharmacovigilance database. Methods: A retrospective, descriptive pharmacoepidemiological analysis of spontaneous reports (SRs) registered in the pharmacovigilance database from 1 April 2019 to 31 March 2025. Results: A total of 7011 SRs with SCARs were finally revealed, with 907 identified drug triggers. The most frequently reported were antibacterial drugs for systemic use (22.8%), antineoplastic agents (17.8%), and antiepileptics (6.0%). The top five drugs involved in SCARs were dupilumab (2.14%, n = 244), piperacillin and beta-lactamase inhibitor (2.0%, n = 227), pembrolizumab (1.98%, n = 225), levofloxacin (1.95%, n = 222), and linagliptin (1.93%, n = 220). The strongest signals were detected for linagliptin (PRR = 15.37, 95% CI: 13.54\u201317.44; ROR = 17.24, 95% CI: 14.95\u201319.88), followed by clindamycin (PRR = 12.44, 95% CI: 10.89\u201314.21; ROR = 13.62, 95% CI: 11.77\u201315.77) and by piperacillin and beta-lactamase inhibitor (PRR = 10.02, 95% CI: 8.86\u201311.43; ROR = 10.81, 95% CI: 9.42\u201312.40). Conclusions: Pharmacovigilance databases facilitate the identification of diverse phenotypes of SCARs and the list of culprit drugs. The accumulated data serve as a valuable tool to enhance clinical practice outcomes and strengthen overall healthcare monitoring.<\/jats:p>","DOI":"10.3390\/ph19010021","type":"journal-article","created":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T11:43:31Z","timestamp":1766403811000},"page":"21","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Real-World Data on Severe Cutaneous Adverse Reactions to Drugs"],"prefix":"10.3390","volume":"19","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 University), 6 Miklukho-Maklaya St., 117198 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1272-8042","authenticated-orcid":false,"given":"Elizaveta","family":"Terehina","sequence":"additional","affiliation":[{"name":"Department of General and Clinical Pharmacology, Peoples\u2019 Friendship University of Russia Named After Patrice Lumumba (RUDN University), 6 Miklukho-Maklaya St., 117198 Moscow, Russia"},{"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\/0000-0001-7729-2169","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 University), 6 Miklukho-Maklaya St., 117198 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6641-7752","authenticated-orcid":false,"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 University), 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 Srt. 10, 127015 Moscow, Russia"},{"name":"Department of Immunology, Russian National Research Medical University Named After N.I. Pirogov, St. Ostrovityanova, 1, 117997 Moscow, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,12,22]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"734","DOI":"10.4103\/0378-6323.102367","article-title":"An epidemiological and clinical analysis of cutaneous adverse drug reactions seen in a tertiary hospital in Johor, Malaysia","volume":"78","author":"Choon","year":"2012","journal-title":"Indian J. Dermatol. Venereol. Leprol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1016\/j.ejim.2015.11.017","article-title":"Adverse drug reactions and organ damage: The skin","volume":"28","author":"Marzano","year":"2016","journal-title":"Eur. J. Intern. Med."},{"key":"ref_3","first-page":"770","article-title":"Incidence and risk factors for cutaneous adverse drug reactions in an intensive care unit","volume":"57","year":"2005","journal-title":"Rev. Investig. Clin."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1838","DOI":"10.1111\/bcp.15490","article-title":"Drugs and the skin: A concise review of cutaneous adverse drug reactions","volume":"90","year":"2024","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"375","DOI":"10.1016\/j.mjafi.2013.01.007","article-title":"Severe cutaneous adverse drug reactions","volume":"69","author":"Verma","year":"2013","journal-title":"Med. J. Armed Forces India"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"577","DOI":"10.1016\/j.mcna.2021.04.001","article-title":"Recognition and Management of Severe Cutaneous Adverse Drug Reactions (Including Drug Reaction with Eosinophilia and Systemic Symptoms, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis)","volume":"105","author":"Owen","year":"2021","journal-title":"Med. Clin. N. Am."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"684","DOI":"10.1111\/j.1365-2125.2010.03774.x","article-title":"Epidemiology and risk factors for drug allergy","volume":"71","author":"Thong","year":"2011","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Heerfordt, M., Middelboe, M., H\u00e6rskjold, A., Horwitz, A., Olsen, R.H., and Horwitz, H. (J. Dermatol., 2025). Toxic Epidermal Necrolysis and Mortality: A Danish Cohort Study With 30\u2009Years of Follow-Up, J. Dermatol., early view.","DOI":"10.1111\/1346-8138.70040"},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Li, D., Gou, J., Zhu, J., Zhang, T., Liu, F., Zhang, D., Dai, L., Li, W., Liu, Q., and Qin, C. (2023). Severe cutaneous adverse reactions to drugs: A real-world pharmacovigilance study using the FDA Adverse Event Reporting System database. Front. Pharmacol., 14.","DOI":"10.3389\/fphar.2023.1117391"},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Lu, Y., Zhou, L., Zou, Y., Wei, H., Zhou, Y., Guo, X., Li, Q., Ye, Y., and Zhang, L. (2024). Antibiotic-induced severe cutaneous adverse reactions: A single-center retrospective study over ten years. Front. Immunol., 15.","DOI":"10.3389\/fimmu.2024.1415830"},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Zyryanov, S., Asetskaya, I., Butranova, O., Terekhina, E., Polivanov, V., Yudin, A., and Samsonova, K. (2024). Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Analysis of the Russian Database of Spontaneous Reports. Pharmaceuticals, 17.","DOI":"10.3390\/ph17060675"},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Shan, H., Wei, C., Zhang, J., and Wu, B. (2025). Severe cutaneous adverse reactions associated with antifungal agents: A pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) database. Expert Opin. Drug Saf., 1\u20138.","DOI":"10.1080\/14740338.2024.2438744"},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Liang, C., An, P., Zhang, Y., Liu, X., and Zhang, B. (2024). Fatal outcome related to drug reaction with eosinophilia and systemic symptoms: A disproportionality analysis of FAERS database and a systematic review of cases. Front. Immunol., 15.","DOI":"10.3389\/fimmu.2024.1490334"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1159\/000545623","article-title":"Adverse Cutaneous Reactions to Monoclonal Antibodies: Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Erythema Multiforme, and Fixed Drug Eruption\u2014A Systematic Review","volume":"10","author":"Kherallah","year":"2025","journal-title":"Biomed. Hub"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"5376476","DOI":"10.1155\/2018\/5376476","article-title":"Anticancer Drugs Induced Severe Adverse Cutaneous Drug Reactions: An Updated Review on the Risks Associated with Anticancer Targeted Therapy or Immunotherapies","volume":"2018","author":"Ng","year":"2018","journal-title":"J. Immunol. Res."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"6922","DOI":"10.1016\/j.vaccine.2023.10.025","article-title":"Background rates for severe cutaneous reactions in the US: Contextual support for safety assessment of COVID-19 vaccines and novel biologics","volume":"41","author":"Gubernot","year":"2023","journal-title":"Vaccine"},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Yang, S.C., Chen, C.B., Lin, M.Y., Zhang, Z.Y., Jia, X.Y., Huang, M., Zou, Y.F., and Chung, W.H. (2021). Genetics of Severe Cutaneous Adverse Reactions. Front. Med., 8.","DOI":"10.3389\/fmed.2021.652091"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"867","DOI":"10.3904\/kjim.2018.126","article-title":"Genetic markers of severe cutaneous adverse reactions","volume":"33","author":"Jung","year":"2018","journal-title":"Korean J. Intern. Med."},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Wang, C.W., Preclaro, I.A.C., Lin, W.H., and Chung, W.H. (2022). An Updated Review of Genetic Associations with Severe Adverse Drug Reactions: Translation and Implementation of Pharmacogenomic Testing in Clinical Practice. Front. Pharmacol., 13.","DOI":"10.3389\/fphar.2022.886377"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"NP1","DOI":"10.1177\/12034754231177582","article-title":"The Role of Sex and Gender in Dermatology\u2014From Pathogenesis to Clinical Implications","volume":"27","author":"Prosty","year":"2023","journal-title":"J. Cutan. Med. Surg."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1699","DOI":"10.1093\/ced\/llae183","article-title":"Risk factors for the development of Stevens-Johnson syndrome\/toxic epidermal necrolysis following drug administration: A systematic review and meta-analysis","volume":"49","author":"Fathima","year":"2024","journal-title":"Clin. Exp. Dermatol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1007\/s40629-015-0052-6","article-title":"Guideline for the diagnosis of drug hypersensitivity reactions: S2K-Guideline of the German Society for Allergology and Clinical Immunology (DGAKI) and the German Dermatological Society (DDG) in collaboration with the Association of German Allergologists (AeDA), the German Society for Pediatric Allergology and Environmental Medicine (GPA), the German Contact Dermatitis Research Group (DKG), the Swiss Society for Allergy and Immunology (SGAI), the Austrian Society for Allergology and Immunology (\u00d6GAI), the German Academy of Allergology and Environmental Medicine (DAAU), the German Center for Documentation of Severe Skin Reactions and the German Federal Institute for Drugs and Medical Products (BfArM)","volume":"24","author":"Brockow","year":"2015","journal-title":"Allergo J. Int."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1197","DOI":"10.1002\/cpt.2172","article-title":"A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring","volume":"109","author":"Lavertu","year":"2021","journal-title":"Clin. Pharmacol. Ther."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"581","DOI":"10.1111\/bjd.19677","article-title":"The value of case reports and spontaneous reporting systems for pharmacovigilance and clinical practice","volume":"184","author":"Raschi","year":"2021","journal-title":"Br. J. Dermatol."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"1187","DOI":"10.1136\/annrheumdis-2017-212905","article-title":"Racial\/ethnic variation and risk factors for allopurinol-associated severe cutaneous adverse reactions: A cohort study","volume":"77","author":"Keller","year":"2018","journal-title":"Ann. Rheum. Dis."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"S7","DOI":"10.21037\/atm.2018.08.42","article-title":"HLA-B*58:01 is not the only risk factor associated with allopurinol-induced severe cutaneous adverse drug reactions","volume":"6","year":"2018","journal-title":"Ann. Transl. Med."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"579","DOI":"10.1111\/ijd.15416","article-title":"A retrospective, 5-year, clinicoepidemiological study of severe cutaneous adverse reactions (SCARs)","volume":"60","author":"Singh","year":"2021","journal-title":"Int. J. Dermatol."},{"key":"ref_28","first-page":"e55318","article-title":"Causes and Management of Cutaneous Adverse Drug Reactions: A Comprehensive Review","volume":"16","author":"Sutaria","year":"2024","journal-title":"Cureus"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1111\/cea.13513","article-title":"Aetiopathogenesis of severe cutaneous adverse reactions (SCARs) in children: A 9-year experience in a tertiary care pediatric hospital setting","volume":"50","author":"Liccioli","year":"2020","journal-title":"Clin. Exp. Allergy"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"e70103","DOI":"10.1111\/pai.70103","article-title":"Clinical diagnosis and management of drug reaction with eosinophilia and systemic symptoms (DRESS) in children: An EAACI position paper","volume":"36","author":"Kuyucu","year":"2025","journal-title":"Pediatr. Allergy Immunol."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"125","DOI":"10.1111\/pde.14446","article-title":"Pediatric drug reaction with eosinophilia and systemic symptoms: A systematic review of the literature, with a focus on relapsing cases","volume":"38","author":"Afiouni","year":"2021","journal-title":"Pediatr. Dermatol."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1007\/s40257-024-00867-y","article-title":"Management and long-term outcomes of drug reaction with eosinophilia and systemic symptoms (DReSS) in children: A scoping review","volume":"25","author":"Cherepacha","year":"2024","journal-title":"Am. J. Clin. Dermatol."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"208","DOI":"10.3349\/ymj.2019.60.2.208","article-title":"Analysis of Individual Case Safety Reports of Severe Cutaneous Adverse Reactions in Korea","volume":"60","author":"Kang","year":"2019","journal-title":"Yonsei Med. J."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"929","DOI":"10.1016\/j.jaip.2020.09.011","article-title":"A Nationwide Study of Severe Cutaneous Adverse Reactions Based on the Multicenter Registry in Korea","volume":"9","author":"Kang","year":"2021","journal-title":"J. Allergy Clin. Immunol. Pract."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"709","DOI":"10.4168\/aair.2019.11.5.709","article-title":"Severe Cutaneous Adverse Reactions to Antiepileptic Drugs: A Nationwide Registry-Based Study in Korea","volume":"11","author":"Park","year":"2019","journal-title":"Allergy Asthma Immunol. Res."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"e17","DOI":"10.3346\/jkms.2020.35.e17","article-title":"Adverse Skin Reactions with Antiepileptic Drugs Using Korea Adverse Event Reporting System Database, 2008\u20132017","volume":"35","author":"Kim","year":"2020","journal-title":"J. Korean Med. Sci."},{"key":"ref_37","doi-asserted-by":"crossref","unstructured":"Kim, D., and Lee, S. (2024). A Real-World Safety Profile in Neurological, Skin, and Sexual Disorders of Anti-Seizure Medications Using the Pharmacovigilance Database of the Korea Adverse Event Reporting System (KAERS). J. Clin. Med., 13.","DOI":"10.20944\/preprints202406.0844.v1"},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"41","DOI":"10.4103\/ijpvm.ijpvm_132_24","article-title":"The Prevalence of Stevens-Johnson Syndrome Complications due to Antiepileptic Drug Use: A Systematic Review and Meta-Analysis","volume":"16","author":"Tardeh","year":"2025","journal-title":"Int. J. Prev. Med."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"e70118","DOI":"10.1111\/cts.70118","article-title":"Risk Factors Analysis of Cutaneous Adverse Drug Reactions Caused by Targeted Therapy and Immunotherapy Drugs for Oncology and Establishment of a Prediction Model","volume":"18","author":"Zhang","year":"2025","journal-title":"Clin. Transl. Sci."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"1377","DOI":"10.1093\/cid\/ciu126","article-title":"Severe cutaneous adverse reactions related to systemic antibiotics","volume":"58","author":"Lin","year":"2014","journal-title":"Clin. Infect. Dis."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"756","DOI":"10.1111\/cts.12944","article-title":"In Silico Approach to Predict Severe Cutaneous Adverse Reactions Using the Japanese Adverse Drug Event Report Database","volume":"14","author":"Ambe","year":"2021","journal-title":"Clin. Transl. Sci."},{"key":"ref_42","doi-asserted-by":"crossref","unstructured":"Zhou, L., Yang, J., Xiao, M., Shan, H., Liu, M., Lu, Y., Zou, Y., and Wu, B. (2023). Severe cutaneous adverse reactions due to antibiotics therapy: A pharmacovigilance analysis of FDA adverse event reporting system events. Expert Opin. Drug Saf., 1\u20138.","DOI":"10.1080\/14740338.2023.2278685"},{"key":"ref_43","doi-asserted-by":"crossref","first-page":"20240931","DOI":"10.1515\/med-2024-0931","article-title":"Adverse reactions of piperacillin: A literature review of case reports","volume":"19","author":"Zhang","year":"2024","journal-title":"Open Med."},{"key":"ref_44","doi-asserted-by":"crossref","first-page":"829","DOI":"10.1016\/j.jaip.2016.10.008","article-title":"HLA B62 as a possible risk factor for drug reaction with eosinophilia and systemic symptoms to piperacillin\/tazobactam","volume":"5","author":"Rutkowski","year":"2017","journal-title":"J. Allergy Clin. Immunol. Pract."},{"key":"ref_45","doi-asserted-by":"crossref","unstructured":"Wang, T., Yang, J., Yang, F., Cheng, Y., Huang, Z., Li, B., Yang, L., Xing, Q., and Luo, X. (2024). The association between HLA-B variants and amoxicillin-induced severe cutaneous adverse reactions in Chinese han population. Front. Pharmacol., 15.","DOI":"10.3389\/fphar.2024.1400239"},{"key":"ref_46","doi-asserted-by":"crossref","unstructured":"Wattanachai, P., Amornpinyo, W., Konyoung, P., Purimart, D., Khunarkornsiri, U., Pattanacheewapull, O., Tassaneeyakul, W., and Nakkam, N. (2023). Association between HLA alleles and beta-lactam antibiotics-related severe cutaneous adverse reactions. Front. Pharmacol., 14.","DOI":"10.3389\/fphar.2023.1248386"},{"key":"ref_47","doi-asserted-by":"crossref","first-page":"83","DOI":"10.23822\/EurAnnACI.1764-1489.329","article-title":"Clavulanic acid sensitization seems more involved in cutaneous than systemic reactions in amoxicillinclavulanate drug reactions","volume":"57","author":"Rivolta","year":"2025","journal-title":"Eur. Ann. Allergy Clin. Immunol."},{"key":"ref_48","first-page":"e86372","article-title":"Levofloxacin-Induced Generalized Fixed Drug Eruption","volume":"17","year":"2025","journal-title":"Cureus"},{"key":"ref_49","first-page":"e70098","article-title":"Severe Cutaneous Reaction Induced by Clindamycin: A Case Report of Toxic Epidermal Necrolysis","volume":"16","author":"Scally","year":"2024","journal-title":"Cureus"},{"key":"ref_50","doi-asserted-by":"crossref","first-page":"e20389","DOI":"10.1097\/MD.0000000000020389","article-title":"Clindamycin-induced acute generalized exanthematous pustulosis: A case report","volume":"99","author":"Aiempanakit","year":"2020","journal-title":"Medicine"},{"key":"ref_51","doi-asserted-by":"crossref","first-page":"91","DOI":"10.23822\/EurAnnACI.1764-1489.117","article-title":"Two case reports of delayed-allergic reactions to clindamycin confirmed with a positive lymphocyte transformation test","volume":"52","author":"Quirce","year":"2020","journal-title":"Eur. Ann. Allergy Clin. Immunol."},{"key":"ref_52","doi-asserted-by":"crossref","first-page":"e230077","DOI":"10.1136\/bcr-2019-230077","article-title":"Symmetrical drug-related intertriginous and flexural exanthema due to clindamycin","volume":"12","year":"2019","journal-title":"BMJ Case Rep."},{"key":"ref_53","doi-asserted-by":"crossref","first-page":"omaa020","DOI":"10.1093\/omcr\/omaa020","article-title":"Clindamycin induced toxic epidermal necrolysis versus Staphylococcal scalded skin syndrome: A case report","volume":"2020","author":"Davey","year":"2020","journal-title":"Oxf. Med. Case Rep."},{"key":"ref_54","doi-asserted-by":"crossref","first-page":"100951","DOI":"10.1016\/j.eclinm.2021.100951","article-title":"Stevens-Johnson syndrome\/toxic epidermal necrolysis in patients treated with immune checkpoint inhibitors: A safety analysis of clinical trials and FDA pharmacovigilance database","volume":"37","author":"Zhu","year":"2021","journal-title":"EClinicalMedicine"},{"key":"ref_55","doi-asserted-by":"crossref","first-page":"e007324","DOI":"10.1136\/jitc-2023-007324","article-title":"Management of immune-related cutaneous adverse events with dupilumab","volume":"11","author":"Kuo","year":"2023","journal-title":"J. Immunother. Cancer"},{"key":"ref_56","unstructured":"(2025, November 01). Dupixent (Dupilumab) Injection. Available online: https:\/\/www.dupixenthcp.com\/atopicdermatitis\/about\/mechanism-of-action."},{"key":"ref_57","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1080\/14740338.2024.2326480","article-title":"Dupilumab in real-life settings: A review of adverse events and their pathogenesis","volume":"23","author":"Camela","year":"2024","journal-title":"Expert Opin. Drug Saf."},{"key":"ref_58","doi-asserted-by":"crossref","unstructured":"Huang, J., Jia, Y., Sun, S., and Meng, L. (2020). Adverse event profiles of dipeptidyl peptidase-4 inhibitors: Data mining of the public version of the FDA adverse event reporting system. BMC Pharmacol. Toxicol., 21.","DOI":"10.1186\/s40360-020-00447-w"},{"key":"ref_59","doi-asserted-by":"crossref","first-page":"1099","DOI":"10.1080\/14740338.2019.1668373","article-title":"Bullous pemphigoid induced by dipeptidyl peptidase-4 (DPP-4) inhibitors: A pharmacovigilance-pharmacodynamic\/pharmacokinetic assessment through an analysis of the vigibase\u00ae","volume":"18","author":"Carnovale","year":"2019","journal-title":"Expert Opin. Drug Saf."},{"key":"ref_60","doi-asserted-by":"crossref","first-page":"891","DOI":"10.1007\/s40257-021-00625-4","article-title":"DPP-4 Inhibitors and Increased Reporting Odds of Bullous Pemphigoid: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS) from 2006 to 2020","volume":"22","author":"Jedlowski","year":"2021","journal-title":"Am. J. Clin. Dermatol."},{"key":"ref_61","doi-asserted-by":"crossref","unstructured":"Kowalska, J., and Wrze\u015bniok, D. (2024). Skin-Related Adverse Reactions Induced by Oral Antidiabetic Drugs\u2014A Review of Literature and Case Reports. Pharmaceuticals, 17.","DOI":"10.3390\/ph17070847"},{"key":"ref_62","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1186\/s40842-024-00165-w","article-title":"Dermatological side effects of dipeptidyl Peptidase-4 inhibitors in diabetes management: A comprehensive review","volume":"10","author":"Zaresharifi","year":"2024","journal-title":"Clin. Diabetes Endocrinol."},{"key":"ref_63","doi-asserted-by":"crossref","first-page":"97","DOI":"10.3390\/diabetology3010008","article-title":"Cutaneous Reactions to Antidiabetic Agents: A Narrative Review","volume":"3","author":"Boccardi","year":"2022","journal-title":"Diabetology"},{"key":"ref_64","doi-asserted-by":"crossref","first-page":"1283","DOI":"10.1111\/ced.15144","article-title":"Dipeptidyl peptidase-4 inhibitor-associated cutaneous eruptions: A retrospective observational study","volume":"47","author":"Duraisamy","year":"2022","journal-title":"Clin. Exp. Dermatol."},{"key":"ref_65","doi-asserted-by":"crossref","first-page":"857","DOI":"10.1007\/s40264-023-01329-w","article-title":"Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study","volume":"46","author":"Fusaroli","year":"2023","journal-title":"Drug Saf."},{"key":"ref_66","unstructured":"European Medicines Agency (2025, November 01). ICH E2B (R3) Electronic Transmission of Individual Case Safety Reports (ICSRs)\u2014Data Elements and Message Specification\u2014Implementation Guide\u2014Scientific Guideline. Available online: https:\/\/www.ema.europa.eu\/en\/ich-e2b-r3-electronic-transmission-individual-case-safety-reports-icsrs-data-elements-message."},{"key":"ref_67","unstructured":"(2025, November 01). MedDRA. Available online: https:\/\/www.meddra.org\/how-to-use\/support-documentation\/english."},{"key":"ref_68","doi-asserted-by":"crossref","first-page":"617","DOI":"10.2165\/00002018-200730070-00009","article-title":"Standardised MedDRA queries: Their role in signal detection","volume":"30","author":"Mozzicato","year":"2007","journal-title":"Drug Saf."},{"key":"ref_69","doi-asserted-by":"crossref","first-page":"7","DOI":"10.30895\/2312-7821-2023-11-1-7-13","article-title":"New Edition of the EAEU Good Pharmacovigilance Practice: What Has Changed?","volume":"11","author":"Rozhdestvensky","year":"2023","journal-title":"Saf. Risk Pharmacother."},{"key":"ref_70","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1002\/pds.677","article-title":"Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports","volume":"10","author":"Evans","year":"2001","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"ref_71","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1016\/j.orcp.2025.01.011","article-title":"Semaglutide: Nonarteritic Anterior Ischemic Optic Neuropathy in the FDA adverse event reporting system\u2014A disproportionality analysis","volume":"19","author":"Azab","year":"2025","journal-title":"Obes. Res. Clin. Pract."},{"key":"ref_72","doi-asserted-by":"crossref","first-page":"519","DOI":"10.1002\/pds.1001","article-title":"The reporting odds ratio and its advantages over the proportional reporting ratio","volume":"13","author":"Rothman","year":"2004","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"ref_73","unstructured":"European Medicines Agency (2025, November 01). Guideline on Good Pharmacovigilance Practices (GVP) Module VI\u2014Collection, Management and Submission of Reports of Suspected Adverse Reactions to Medicinal Products (Rev 2). Available online: https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf."}],"container-title":["Pharmaceuticals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1424-8247\/19\/1\/21\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,24]],"date-time":"2025-12-24T05:16:28Z","timestamp":1766553388000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1424-8247\/19\/1\/21"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,22]]},"references-count":73,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,1]]}},"alternative-id":["ph19010021"],"URL":"https:\/\/doi.org\/10.3390\/ph19010021","relation":{},"ISSN":["1424-8247"],"issn-type":[{"value":"1424-8247","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,22]]}}}