Real-World Pharmacovigilance Analysis of Drug-Induced Liver Injury in 18-60 Years: Based on the FDA Adverse Event Reporting System (FAERS)

Xinlong Wang; Yingying Wang; Ting Hu; Kaijuan Wang

doi:10.54254/2753-8818/2026.31816

Article Information

Received: 11 February 2026

Published: 24 February 2026

DOI: https://doi.org/10.54254/2753-8818/2026.31816

Article Type: Research Article

Cite this article

Wang,X.;Wang,Y.;Hu,T.;Wang,K. (2026). Real-World Pharmacovigilance Analysis of Drug-Induced Liver Injury in 18-60 Years: Based on the FDA Adverse Event Reporting System (FAERS). Theoretical and Natural Science,161,58-69.

Data availability

The datasets used and/or analyzed during the current study will be available from the authors upon reasonable request.

Disclaimer/Publisher's Note

The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of EWA Publishing and/or the editor(s). EWA Publishing and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.

About this Volume

Volume Title: TNS Vol.161

Part of Series: Theoretical and Natural Science

ISSN: 2753-8818 (Print) / 2753-8826 (Online)

Copyright & License

[1]Kaplowitz N. Idiosyncratic drug hepatotoxicity. Nat Rev Drug Discov. 2005; 4: 489–99. doi: 10.1038/nrd1750

[2]Navarro VJ, Senior JR. Drug-related hepatotoxicity. N Engl J Med. 2006; 354: 731–9. doi: 10.1056/NEJMra052270

[3]Andrade RJ, Chalasani N, Björnsson ES, et al. Drug-induced liver injury. Nat Rev Dis Primers. 2019; 5: 58. doi: 10.1038/s41572-019-0105-0

[4]Shen T, Liu Y, Shang J, et al. Incidence and Etiology of Drug-Induced Liver Injury in Mainland China. Gastroenterology. 2019; 156: 2230-2241.e11. doi: 10.1053/j.gastro.2019.02.002

[5]Yu S, Li J, He T, et al. Age-related differences in drug-induced liver injury: a retrospective single-center study from a large liver disease specialty hospital in China, 2002–2022. Hepatol Int. 2024; 18: 1202–13. doi: 10.1007/s12072-024-10679-1

[6]P N, Gp A, Es B, et al. Association of Liver Injury From Specific Drugs, or Groups of Drugs, With Polymorphisms in HLA and Other Genes in a Genome-Wide Association Study. Gastroenterology. 2017; 152. doi: 10.1053/j.gastro.2016.12.016

[7]Zhu B, Chen S, Li X, et al. Real-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS database. Sci Rep. 2025; 15: 4783. doi: 10.1038/s41598-025-89272-x

[8]He Q, Li Y, Liu S, et al. Drug-induced liver injury associated with pretomanid, bedaquiline, and linezolid: Insights from FAERS database analysis. British Journal of Clinical Pharmacology. 2025; 91: 799–807. doi: 10.1111/bcp.16318

[9]Lakhani M, Kwan ATH, Mihalache A, et al. Drugs Associated with Floppy Iris Syndrome: A Real-World Population-Based Study. American Journal of Ophthalmology. 2025; S0002939425001394. doi: 10.1016/j.ajo.2025.03.023

[10]Rana P, Aleo MD, Wen X, et al. Hepatotoxicity reports in the FDA adverse event reporting system database: A comparison of drugs that cause injury via mitochondrial or other mechanisms. Acta Pharm Sin B. 2021; 11: 3857–68. doi: 10.1016/j.apsb.2021.05.028

[11]Klotz U. Pharmacokinetics and drug metabolism in the elderly. Drug Metab Rev. 2009; 41: 67–76. doi: 10.1080/03602530902722679

[12]Strassburg CP, Strassburg A, Kneip S, et al. Developmental aspects of human hepatic drug glucuronidation in young children and adults. Gut. 2002; 50: 259–65. doi: 10.1136/gut.50.2.259

[13]Stevens JC. New perspectives on the impact of cytochrome P450 3A expression for pediatric pharmacology. Drug Discov Today. 2006; 11: 440–5. doi: 10.1016/j.drudis.2006.03.002

[14]Cohen EB, Patwardhan M, Raheja R, et al. Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative. Drug Saf. 2024; 47: 301–19. doi: 10.1007/s40264-023-01390-5

[15]Kullak-Ublick GA, Andrade RJ, Merz M, et al. Drug-induced liver injury: recent advances in diagnosis and risk assessment. Gut. 2017; 66: 1154–64. doi: 10.1136/gutjnl-2016-313369

[16]Lai R, Li X, Zhang J, et al. Drug-induced liver injury in children: A nationwide cohort study from China. JHEP Reports. 2024; 6: 101102. doi: 10.1016/j.jhepr.2024.101102

[17]Yu RJ, Krantz MS, Phillips EJ, et al. Emerging Causes of Drug-Induced Anaphylaxis: A Review of Anaphylaxis-Associated Reports in the FDA Adverse Event Reporting System (FAERS). J Allergy Clin Immunol Pract. 2021; 9: 819-829.e2. doi: 10.1016/j.jaip.2020.09.021

[18]Metbulut AP, Haci İA, Can D, et al. Evaluation of drug-related anaphylaxis in children: multi-center study. Eur J Pediatr. 2025; 184: 230. doi: 10.1007/s00431-025-06068-x

[19]Lin G-T, Yan C, Li L-J, et al. Combining Apatinib and Oxaliplatin Remodels the Immunosuppressive Tumor Microenvironment and Sensitizes Desert-Type Gastric Cancer to Immunotherapy. Cancer Res. Published Online First: 7 March 2025. doi: 10.1158/0008-5472.CAN-24-2697

[20]Chane E, Wondifraw H, Hadgu R, et al. Assessment of liver function tests of women taking hormonal contraceptives at University of Gondar comprehensive specialized hospital and Family Guidance Association of Gondar (FGAE), 2022; a comparative cross-sectional study. PLoS One. 2023; 18: e0289746. doi: 10.1371/journal.pone.0289746

[21]She Y, Guo Z, Zhai Q, et al. CDK4/6 inhibitors in drug-induced liver injury: a pharmacovigilance study of the FAERS database and analysis of the drug-gene interaction network. Front Pharmacol. 2024; 15: 1378090. doi: 10.3389/fphar.2024.1378090

[22]Hahn KJ, Morales SJ, Lewis JH. Enoxaparin-Induced Liver Injury: Case Report and Review of the Literature and FDA Adverse Event Reporting System (FAERS). Drug Saf Case Rep. 2015; 2: 17. doi: 10.1007/s40800-015-0018-0

[23]Zeiss R, Schönfeldt-Lecuona C, Connemann BJ, et al. Hepatotoxicity of antipsychotics: an exploratory pharmacoepidemiologic and pharmacodynamic study integrating FAERS data and in vitro receptor-binding affinities. Front Psychiatry. 2024; 15: 1479625. doi: 10.3389/fpsyt.2024.1479625

[24]deLemos AS, Ghabril M, Rockey DC, et al. Amoxicillin-Clavulanate-Induced Liver Injury. Dig Dis Sci. 2016; 61: 2406–16. doi: 10.1007/s10620-016-4121-6

[25]Björnsson ES. Drug-induced liver injury due to antibiotics. Scand J Gastroenterol. 2017; 52: 617–23. doi: 10.1080/00365521.2017.1291719

[26]Sharma S, Anand A, Taneja S, et al. Pharmacokinetic assessment of rifampicin and des-acetyl rifampicin in carbon tetrachloride induced liver injury model in Wistar rats. J Complement Integr Med. 2024; 21: 38–45. doi: 10.1515/jcim-2023-0235

[27]Ostapowicz G, Fontana RJ, Schiødt FV, et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med. 2002; 137: 947–54. doi: 10.7326/0003-4819-137-12-200212170-00007

[28]Hoffmann JP, Liu JA, Seddu K, et al. Sex hormone signaling and regulation of immune function. Immunity. 2023; 56: 2472–91. doi: 10.1016/j.immuni.2023.10.008

[29]Schröder W, Sommer H, Gladstone BP, et al. Gender differences in antibiotic prescribing in the community: a systematic review and meta-analysis. J Antimicrob Chemother. 2016; 71: 1800–6. doi: 10.1093/jac/dkw054

[30]Perlman A, Wanounou M, Goldstein R, et al. Ischemic and Thrombotic Events Associated with Concomitant Xa-inhibiting Direct Oral Anticoagulants and Antiepileptic Drugs: Analysis of the FDA Adverse Event Reporting System (FAERS). CNS Drugs. 2019; 33: 1223–8. doi: 10.1007/s40263-019-00677-5

[31]Chi L, Liu C, Gribonika I, et al. Sexual dimorphism in skin immunity is mediated by an androgen-ILC2-dendritic cell axis. Science. 2024; 384: eadk6200. doi: 10.1126/science.adk6200

[32]Gao Q, Yin X, Tan B, et al. Drug-induced liver injury following the use of tocilizumab or sarilumab in patients with coronavirus disease 2019. BMC Infect Dis. 2022; 22: 929. doi: 10.1186/s12879-022-07896-0

[33]Bonkovsky HL, Ghabril M, Nicoletti P, et al. Drug‐induced liver injury ascribed to non‐steroidal anti‐inflammatory drugs in the —Update with genetic correlations. Liver International. 2024; 44: 1409–21. doi: 10.1111/liv.15892