The DOI matches its Crossref record.
Drug-Induced Liver Injury: An Analysis of 461 Incidences Submitted to the Spanish Registry Over a 10-Year Period
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Expert judgement is the approach used to assess causality in large prospective DILI registries such as the Spanish, Latin American, European, and DILIN registries.
“Expert judgement is the approach used to assess causality in large prospective DILI registries such as the Spanish, the Latin American, the European, or the DILIN.”
From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [53]
In response to limitations of expert judgement, the Spanish, LATINDILI and Pro-Euro DILI networks combined evaluation of suspected DILI cases by three experts with further assessment using causality scales, while DILIN developed a structured expert opinion process.
“In response to these limitations, the Spanish, LATINDILI and Pro‐Euro DILI networks have combined the evaluation of suspected DILI cases by three experts and further assessment using causality scales, while the DILIN has developed a structured expert opinion process.”
From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [53]
Females have been reported to have increased, unchanged, or even decreased incidence of DILI.
“females have been reported to have increased, 8,26,27,31 unchanged, 9,30 or even decreased 12,21 incidence of DILI (Table 4).”
From Incidence and Etiology of Drug-Induced Liver Injury in Mainland China (2019) · cites this paper as [21]
Cholestatic injury accounts for 20-32% of DILI cases and presents with ALP or GGT elevation.
“Cholestatic injury is also a typical phenotype and accounts for 20-32% of DILI cases, which present with ALP or gamma-glutamyl transferase (GGT) elevation.”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [5]
The DILI fatality rate in our study was much lower than has been observed in other registries.
“It is therefore interesting that the DILI fatality rate in our study was much lower than has been observed in other registries 21,[23][24][25][26] .”
From Incidence and Etiology of Drug-Induced Liver Injury in Mainland China (2019) · cites this paper as [21]
Hepatocellular injury accounts for 42-59% of DILI cases and is the most common clinical phenotype.
“Hepatocellular injury accounts for 42-59% of DILI cases and is the most common clinical phenotype, which presents with an acute-hepatitislike significant elevation of ALT or AST level following administration of the suspected drug.”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [5]
Approximately 10% of cases that fulfill Hy's law will progress to ALF.
“Studies have shown that approximately 10% of cases that fulfill Hy's law will progress to ALF [5,64], and is associated increased mortality or need for liver transplantation [65][66][67][68].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [5]
Approximately 7-24% of acute DILI cases can transition to chronic injury.
“Approximately 7-24% of acute DILI cases can transition to chronic injury, which presents with signs of chronic DILI [3,5,21,24,25].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [5]
Current evidence does not support the opinion that diabetes or obesity increase susceptibility to all-cause DILI.
“Current evidence does not support the opinion that diabetes or obesity increase susceptibility to all-cause DILI [5], although they may increase the risk of liver injury induced by certain drugs such as tamoxifen and methotrexate [44,45].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [5]
Overall, a 10% mortality rate is reported for DILI.
“Overall, a 10% mortality rate is reported for DILI.[25–27]”
From Drug-induced liver injury: Diagnosis, management and the role of liver transplantation (2025) · cites this paper as [25]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
No references could be resolved yet.
Research works printed but not linked: 38
- Bakke OM, Manocchia M, De Abajo F, Kaitin KI, Lasagna L. Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: a regulatory perspective. Clin Pharmacol Ther 1995;58:108 -117.
- Larrey D. Epidemiology and individual susceptibility to adverse drug reactions affecting the liver. Semin Liver Dis 2002;22:145- 155.
- Sgro C, Clinard F, Ouazir K, Chanay H, Allard C, Guilleminet C, Lenoir C, Lemoine A, Hillon P. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology 2002;36: 451-455.
- Aithal GP, Rawlins MD, Day CP. Accuracy of hepatic adverse drug reaction reporting in one English health region. BMJ 1999;319: 1541.
- Zimmerman HJ. Hepatotoxicity. The adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott Williams & Wilkins, 1999.
- Andrade RJ, Lucena MI, Martín-Vivaldi R, Fernandez MC, Nogu- eras F, Pelaez G, Gomez-Outes A, Garcia-Escaño MD, Bellot V, Hervás A, Cárdenas F, Bermudez F, Romero M, Salmerón J. Acute liver injury associated with the use of ebrotidine, a new H 2 - receptor antagonist. J Hepatol 1999;31:641-646.
- Andrade RJ, Lucena MI, Alcantara R, Fraile JM. Bentazepam- associated chronic liver disease. Lancet 1994;343:860.
- Andrade RJ, Lucena MI, Rodriguez-Mendizabal M. Hepatic injury caused by acarbose. Ann Intern Med 1996;124:931.
- Cahalan D. Quantifying alcohol consumption: patterns and prob- lems. Circulation 1981;64:7-14.
- Benichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol 1990;11:272-276.
- Kaplowitz N. Causality assessment versus guilt-by-association in drug hepatotoxicity. Hepatology 2001;33:308 -310.
- Danan G, Benichou C. Causality assessment of adverse reac- tions to drugs I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol 1993;46:1323-1330.
- Lucena MI, Camargo R, Andrade RJ, Perez-Sanchez C, Sanchez De La Cuesta F. Comparison of two clinical scales for causality assessment in hepatotoxicity. Hepatology 2001;33:123-130.
- Arnaiz JA, Carne X, Riba N, Codina C, Ribas J, Trilla A. The use of evidence in pharmacovigilance. Case reports as the reference source for drug withdrawals. Eur J Clin Pharmacol 2001;57:89 -91.
- Hoofnagle JH. Drug-induced liver injury network (DILIN). Hepatol- ogy 2004;40:773.
- Peire MA, Lucena MI, Ruiz-Extremera A, Jara P, Romero-Gonzalez J, Andrade RJ. Toxicidad hepatica por fármacos. Donde estamos y hacia donde caminamos. An Esp Pediatr 2002;56:434 -442.
- Ibáñez L, Pérez E, Vidal X, Laporte JR, the Grup d'Estudi Multi- centric d'Hepatotoxicitat Aguda de Barcelona (GEMHAB). Pro- spective surveillance of acute serious liver disease unrelated to infectious, obstructive, or metabolic diseases: epidemiological and clinical features, and exposure to drugs. J Hepatol 2002;37:592-600.
- Friis H, Andreasen PB. Drug-induced hepatic injury: an analysis of 1100 cases reported to the Danish Committee on Adverse Drug Reactions between 1978 and 1987. J Intern Med 1992;232: 133-138.
- Almdal TP, Sorensen TI. Incidence of parenchymal liver disease in Denmark, 1981 to 1985: analysis of hospitalization registry data. The Danish Association for the Study of the Liver. Hepatol- ogy 1991;13:650 -655.
- Ostapowicz G, Fontana RJ, Schiodt FV, Larson A, Davern TJ, Han SH, McCashland TM, Shakil AO, Hay JE, Hynan L, Crippin JS, Blei AT, Samuel G, Reisch J, Lee WM, and the U.S. Acute Liver Failure Study Group. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med 2002;137:947-957.
- Russo MW, Galanko JA, Shrestha R, Fried MW, Watkins P. Liver transplantation for acute liver failure from drug-induced liver in- jury in the United States. Liver Transpl 2004;10:1018 -1023.
- Garcia Rodriguez LA, Williams R, Derby LE, Dean AD, Jick H. Acute liver injury associated with nonsteroidal anti-inflammatory drugs and the role of risk factors. Arch Intern Med 1994;154: 311-316.
- de Abajo FJ, Montero D, Madurga M, Garcia Rodriguez LA. Acute and clinically relevant drug-induced liver injury: a population based case-control study. Br J Clin Pharmacol 2004;58:71-80.
- Pham B-N, Bernuau J, Durand F, Sauvanet A, Degott C, Prin L, Janin A. Eotaxin expression and eosinophil infiltrate in the liver of patients with drug-induced liver disease. J Hepatol 2001;34: 537-547.
- Larrey D. Drug-induced liver disease. J Hepatol 2000;32:77-88.
- Maria VA, Victorino RM. Immunological investigation in hepatic drug reactions. Clin Exp Allergy 1998;28:71-77.
- Andrade RJ, Lucena MI. Drug-induced hepatotoxicity. N Engl J Med 2003;349:1974 -1976.
- Andrade RJ, Lucena MI, Alonso A, Garcia-Cortes M, Garcia-Ruiz E, Benitez R, Fernandez MC, Pelaez G, Romero M, Corpas R, Duran JA, Jimenez M, Rodrigo L, Nogueras F, Martin-Vivaldi R, Navarro JM, Salmeron J, de la Cuesta FS, Hidalgo R. HLA class II geno- type influences the type of liver injury in drug-induced idiosyn- cratic liver disease. Hepatology 2004;39:1603-1612.
- Aithal PG, Day CP. The natural history of histologically proved drug induced liver disease. Gut 1999;44:731-735.
- Lopez-Torres E, Lucena MI, Andrade RJ, Garcia-Ruiz E, Fernandez MC, Pelaez G, Soria de la Cruz MJ, Pizarro A. Tetrabamate- induced hepatotoxicity. Report of seven cases and literature review. Gastroenterol Hepatol 2002;25:589 -593.
- Lucena MI, Andrade RJ, Gomez-Outes A, Rubio M, Cabello MR. Acute liver failure after treatment with nefazodone. Dig Dis Sci 1999;44:2577-2579.
- Price AB, Misiewicz JJ. Sydney classification for gastritis. Lancet 1991;337:174.
- Dixon MF, Genta RM, Yardley JH, Correa P. Classification and grading of gastritis. The updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol 1996;20:1161-1181.
- Rugge M, Genta RM. Staging and grading of chronic gastritis. Hum Pathol 2005;36:228 -233.
- Rugge M, Correa P, Dixon MF, Fiocca R, Hattori T, Lechago J, et al. Gastric mucosal atrophy: interobserver consistency using new criteria for classification and grading. Aliment Pharmacol Ther 2002;16:1249 -1259.
- Michael Vieth, Bayreuth, Germany; and Robert M. Genta, Geneva, Switzerland (the OLGA International Group). The Parma Consensus Meeting was supported by Guido Berlucchi Foundation for Cancer Research, Instituto Oncologico Veneto IOV- IRCCS, and the CCC-Cittadella Contro il Cancro Association. doi:10.1053/j.gastro.2005.09.056 · DOI
- Schreiber S, Rutgeerts P, Fedorak RN, Khaliq-Kareemi M, Kamm MA, Boivin M, Bernstein CN, Staun M, Thomsen O, Innes A, and the CDP870 Crohn's Disease Study Group. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology 2005;129:807-818.
- Andrade RJ, Lucena MI, Fernández MC, Pelaez G, Pachkoria K, García-Ruiz E, García-Muñoz B, González-Grande R, Pizarro A, Durán JA, Jiménez M, Rodrigo L, Romero-Gomez M, Navarro JM, Planas R, Costa J, Borras A, Soler A, Salmerón J, Martin-Vivaldi R. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology 2005;129:512-521.
Cited by
Sorted by citations
EASL Clinical Practice Guidelines: management of cholestatic liver diseases
European Association for the Study of the Liver (2009) · Journal of Hepatology · doi:10.1016/j.jhep.2009.04.009 · Cited by 1,729
EASL Clinical Practice Guidelines: Drug-induced liver injury
Andrade, R. J., Aithal, G. P., Björnsson, E. S., Kaplowitz, N., Kullak-Ublick, G. A., Larrey, D., & Karlsen, T. H. (2019) · Journal of Hepatology · doi:10.1016/j.jhep.2019.02.014 · Cited by 1,276
Self-citationIdiosyncratic drug hepatotoxicity
Kaplowitz, N. (2005) · Nature Reviews Drug Discovery · doi:10.1038/nrd1750 · Cited by 1,054
Features and outcomes of 899 patients with drug-induced liver injury: the DILIN Prospective Study
Chalasani, N., Bonkovsky, H. L., Fontana, R., Lee, W., Stolz, A., Talwalkar, J., Reddy, K. R., Watkins, P. B., Navarro, V., Barnhart, H., et al. (2015) · Gastroenterology · doi:10.1053/j.gastro.2015.03.006 · Cited by 925
Andrade, R. J., Chalasani, N., Björnsson, E. S., Suzuki, A., Kullak-Ublick, G. A., Watkins, P. B., Devarbhavi, H., Merz, M., Lucena, M. I., Kaplowitz, N., et al. (2019) · Nature Reviews Disease Primers · doi:10.1038/s41572-019-0105-0 · Cited by 924
Self-citationACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury
Chalasani, N. P., Hayashi, P. H., Bonkovsky, H. L., Navarro, V. J., Lee, W. M., & Fontana, R. J. (2014) · American Journal of Gastroenterology · doi:10.1038/ajg.2014.131 · Cited by 860
Björnsson, E. S., Bergmann, O. M., Björnsson, H. K., Kvaran, R. B., & Olafsson, S. (2013) · Gastroenterology · doi:10.1053/j.gastro.2013.02.006 · Cited by 865
Drug-Induced Acute Liver Failure: Results of a U.S. Multicenter, Prospective Study
Reuben, A., Koch, D. G., & Lee, W. M. (2010) · Hepatology · doi:10.1002/hep.23937 · Cited by 772
Drug-induced liver injury—types and phenotypes
Hoofnagle, J. H., & Björnsson, E. S. (2019) · New England Journal of Medicine · doi:10.1056/nejmra1816149 · Cited by 652
Incidence and Etiology of Drug-Induced Liver Injury in Mainland China
Shen, T., Liu, Y., Shang, J., Xie, Q., Li, J., Yan, M., Xu, J., Niu, J., Liu, J., Watkins, P. B., et al. (2019) · Gastroenterology · doi:10.1053/j.gastro.2019.02.002 · Cited by 615
Self-citationDrug-Induced Liver Injury Network (DILIN) Prospective Study: Rationale, Design and Conduct
Fontana, R. J., Watkins, P. B., Bonkovsky, H. L., Chalasani, N., Davern, T., Serrano, J., & Rochon, J. (2009) · Drug Safety · doi:10.2165/00002018-200932010-00005 · Cited by 486
ACG Clinical Guideline: Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury
Chalasani, N. P., Maddur, H., Russo, M. W., Wong, R. J., Reddy, K. R., & on behalf of the Practice Parameters Committee of the American College of Gastroenterology (2021) · American Journal of Gastroenterology · doi:10.14309/ajg.0000000000001259 · Cited by 430
Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network
Navarro, V. J., Barnhart, H., Bonkovsky, H. L., Davern, T., Fontana, R. J., Grant, L., Reddy, R. K., Seeff, L. B., Serrano, J., Sherker, A. H., et al. (2014) · Hepatology · doi:10.1002/hep.27317 · Cited by 418
Chen, M., Suzuki, A., Thakkar, S., Yu, K., Hu, C., & Tong, W. (2016) · Drug Discovery Today · doi:10.1016/j.drudis.2016.02.015 · Cited by 398
Daly, A. K., Aithal, G. P., Leathart, J. B. S., Swainsbury, R. A., Dang, T. S., & Day, C. P. (2007) · Gastroenterology · doi:10.1053/j.gastro.2006.11.023 · Cited by 348
Risk Factors for Idiosyncratic Drug-Induced Liver Injury
Chalasani, N., & Björnsson, E. (2010) · Gastroenterology · doi:10.1053/j.gastro.2010.04.001 · Cited by 347
AASLD practice guidance on drug, herbal, and dietary supplement–induced liver injury
Fontana, R. J., Liou, I., Reuben, A., Suzuki, A., Fiel, M. I., Lee, W., & Navarro, V. (2023) · Hepatology · doi:10.1002/hep.32689 · Cited by 340
Andrade, R. J., Lucena, I. M., Kaplowitz, N., García-Muņoz, B., Borraz, Y., Pachkoria, K., García-Cortés, M., Fernández, C. M., Pelaez, G., Rodrigo, L., et al. (2006) · Hepatology · doi:10.1002/hep.21424 · Cited by 309
Self-citationAcute Liver Failure Including Acetaminophen Overdose
Fontana, R. J. (2008) · Medical Clinics of North America · doi:10.1016/j.mcna.2008.03.005 · Cited by 249
Idiosyncratic drug-induced liver injury: an overview
Hussaini, S. H., & Farrington, E. A. (2007) · Expert Opinion on Drug Safety · doi:10.1517/14740338.6.6.673 · Cited by 183
Drug-induced liver injury: Asia Pacific Association of Study of Liver consensus guidelines
Devarbhavi, H., Aithal, G., Treeprasertsuk, S., Takikawa, H., Mao, Y., Shasthry, S. M., Hamid, S., Tan, S. S., Philips, C. A., George, J., et al. (2021) · Hepatology International · doi:10.1007/s12072-021-10144-3 · Cited by 181
Hepatotoxicity by Dietary Supplements: A Tabular Listing and Clinical Characteristics
García-Cortés, M., Robles-Díaz, M., Ortega-Alonso, A., Medina-Caliz, I., & Andrade, R. (2016) · International Journal of Molecular Sciences · doi:10.3390/ijms17040537 · Cited by 179
Self-citationA revised electronic version of RUCAM for the diagnosis of DILI
Hayashi, P. H., Lucena, M. I., Fontana, R. J., Bjornsson, E. S., Aithal, G. P., Barnhart, H., Gonzalez‐Jimenez, A., Yang, Q., Gu, J., Andrade, R. J., et al. (2022) · Hepatology · doi:10.1002/hep.32327 · Cited by 160
Self-citationSundaram, V., & Björnsson, E. S. (2017) · Hepatology Communications · doi:10.1002/hep4.1088 · Cited by 138
Drug-induced liver injury: a clinical update
Ghabril, M., Chalasani, N., & Björnsson, E. (2010) · Current Opinion in Gastroenterology · doi:10.1097/mog.0b013e3283383c7c · Cited by 123
Fluoroquinolone therapy and idiosyncratic acute liver injury: a population-based study
Paterson, J. M., Mamdani, M. M., Manno, M., & Juurlink, D. N. (2012) · Canadian Medical Association Journal · doi:10.1503/cmaj.111823 · Cited by 62
Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update
Mao, Y., Ma, S., Liu, C., Liu, X., Su, M., Li, D., Li, Y., Chen, G., Chen, J., Chen, J., et al. (2024) · Hepatology International · doi:10.1007/s12072-023-10633-7 · Cited by 62
Rathi, C., Pipaliya, N., Patel, R., Ingle, M., Phadke, A., & Sawant, P. (2017) · Annals of Hepatology · doi:10.5604/01.3001.0009.8600 · Cited by 61
Pachkoria, K., Lucena, M. I., Ruiz‐Cabello, F., Crespo, E., Cabello, M. R., Andrade, R. J., & on behalf of the Spanish Group for the Study of Drug‐Induced Liver Disease (Grupo de Estudio para las Hepatopatías Asociadas a Medicamentos (GEHAM) (2007) · British Journal of Pharmacology · doi:10.1038/sj.bjp.0707122 · Cited by 49
Self-citationDhillon, A., Singh, A., Vohra, H., Ellis, C., Varghese, B., & Gill, S. S. (2022) · Enterprise Information Systems · doi:10.1080/17517575.2020.1820583 · Cited by 32
Abid, A., Subhani, F., Kayani, F., Awan, S., & Abid, S. (2020) · PLOS ONE · doi:10.1371/journal.pone.0231398 · Cited by 22
Agreement Among Different Scales for Causality Assessment in Drug-Induced Liver Injury
Das, S., Behera, S. K., Xavier, A. S., Velupula, S., Dkhar, S. A., & Selvarajan, S. (2018) · Clinical Drug Investigation · doi:10.1007/s40261-017-0601-5 · Cited by 19
Evidence of drug-induced hepatotoxicity in the Maghrebian population
Bourhia, M., Ullah, R., S. Alqahtani, A., & Ibenmoussa, S. (2022) · Drug and Chemical Toxicology · doi:10.1080/01480545.2020.1797088 · Cited by 16
Methods for causality assessment of idiosyncratic drug‐induced liver injury
García‐Cortés, M., Matilla‐Cabello, G., & Lucena, M. I. (2025) · Liver International · doi:10.1111/liv.16083 · Cited by 15
Self-citationDrug-induced liver injury: Diagnosis, management and the role of liver transplantation
Ozturk, N. B., Uskudar, E., Toruner, M. D., Simsek, C., & Gurakar, A. (2025) · Hepatology Forum · doi:10.14744/hf.2024.2024.0003 · Cited by 9
Characteristics of Drug-Induced Liver Injury in Northeast China: Disease Spectrum and Drug Types
Zhang, C., Wu, Y., Yuan, S., Dou, X., Sheng, Q., Wang, J., Tian, W., Yao, L., & Ding, Y. (2020) · Digestive Diseases and Sciences · doi:10.1007/s10620-019-06030-6 · Cited by 6
Shamseddeen, H., Vilar-Gomez, E., Chalasani, N., Myers, R. P., Subramanian, G. M., Shlevin, H. H., Allgood, A. E., & Orman, E. S. (2020) · Drug Safety · doi:10.1007/s40264-019-00896-1 · Cited by 6
Metadata
- Authors
- ANDRADE, R., LUCENA, M., FERNANDEZ, M., PELAEZ, G., PACHKORIA, K., GARCIARUIZ, E., GARCIAMUNOZ, B., GONZALEZGRANDE, R., PIZARRO, A., & DURAN, J.
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2005-08
- Volume
- 129
- Issue
- 2
- Pages
- 512-521
- ISSN
- 0016-5085
- Cited by
- 856
- References
- 0
- Language
- en
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review