DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans

Concordance of the toxicity of pharmaceuticals in humans and in animals

Olson, H., Betton, G., Robinson, D., Thomas, K., Monro, A., Kolaja, G., Lilly, P., Sanders, J., Sipes, G., Bracken, W., et al. (2000) · Regulatory Toxicology and Pharmacology · doi:10.1006/rtph.2000.1399 · Cited by 2,050

Idiosyncratic drug hepatotoxicity

Kaplowitz, N. (2005) · Nature Reviews Drug Discovery · doi:10.1038/nrd1750 · Cited by 1,054

Timing of new black box warnings and withdrawals for prescription medications

Lasser, K. E. (2002) · JAMA · doi:10.1001/jama.287.17.2215 · Cited by 1,005

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

Drug-Induced Liver Injury: An Analysis of 461 Incidences Submitted to the Spanish Registry Over a 10-Year Period

ANDRADE, R., LUCENA, M., FERNANDEZ, M., PELAEZ, G., PACHKORIA, K., GARCIARUIZ, E., GARCIAMUNOZ, B., GONZALEZGRANDE, R., PIZARRO, A., & DURAN, J. (2005) · Gastroenterology · doi:10.1016/j.gastro.2005.05.006 · Cited by 856

Cellular Imaging Predictions of Clinical Drug-Induced Liver Injury

Xu, J. J., Henstock, P. V., Dunn, M. C., Smith, A. R., Chabot, J., & de Graaf, D. (2008) · Toxicological Sciences · doi:10.1093/toxsci/kfn109 · Cited by 505

Mitochondrial toxicity of nrti antiviral drugs: an integrated cellular perspective

Lewis, W., Day, B. J., & Copeland, W. C. (2003) · Nature Reviews Drug Discovery · doi:10.1038/nrd1201 · Cited by 496

In vitro models for liver toxicity testing

Soldatow, V. Y., LeCluyse, E. L., Griffith, L. G., & Rusyn, I. (2012) · Toxicology Research · doi:10.1039/c2tx20051a · Cited by 482

FDA-approved drug labeling for the study of drug-induced liver injury

Chen, M., Vijay, V., Shi, Q., Liu, Z., Fang, H., & Tong, W. (2011) · Drug Discovery Today · doi:10.1016/j.drudis.2011.05.007 · Cited by 406

Relationship between daily dose of oral medications and idiosyncratic drug-induced liver injury: Search for signals

Lammert, C. S., Einarsson, S., Saha, C., Niklasson, A., Bjornsson, E. S., & Chalasani, N. (2008) · Hepatology · doi:10.1002/hep.22272 · Cited by 389

High lipophilicity and high daily dose of oral medications are associated with significant risk for drug-induced liver injury

Chen, M., Borlak, J., & Tong, W. (2013) · Hepatology · doi:10.1002/hep.26208 · Cited by 348

LiverTox: A website on drug-induced liver injury

Hoofnagle, J. H., Serrano, J., Knoben, J. E., & Navarro, V. J. (2012) · Hepatology · doi:10.1002/hep.26175 · Cited by 255

Categorization of drugs implicated in causing liver injury: Critical assessment based on published case reports

Björnsson, E. S., & Hoofnagle, J. H. (2016) · Hepatology · doi:10.1002/hep.28323 · Cited by 245

Use of Micropatterned Cocultures to Detect Compounds That Cause Drug-Induced Liver Injury in Humans

Khetani, S. R., Kanchagar, C., Ukairo, O. T., Krzyzewski, S., Moore, A., Shi, J., Aoyama, S., Aleo, M. D., & Will, Y. (2012) · Toxicological Sciences · doi:10.1093/toxsci/kfs326 · Cited by 218

Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump

Aleo, M. D., Luo, Y., Swiss, R., Bonin, P. D., Potter, D. M., & Will, Y. (2014) · Hepatology · doi:10.1002/hep.27206 · Cited by 215

Developing Structure−Activity Relationships for the Prediction of Hepatotoxicity

Greene, N., Fisk, L., Naven, R. T., Note, R., Patel, M. L., & Pelletier, D. J. (2010) · Chemical Research in Toxicology · doi:10.1021/tx1000865 · Cited by 174

Drugs Associated with Hepatotoxicity and their Reporting Frequency of Liver Adverse Events in VigiBase™

Suzuki, A., Andrade, R. J., Bjornsson, E. S., Lucena, M. I., Lee, W. M., Yuen, N., Hunt, C. M., & Freston, J. W. (2010) · Drug Safety · doi:10.2165/11535340-000000000-00000 · Cited by 170

Causality assessment methods in drug induced liver injury: Strengths and weaknesses

García-Cortés, M., Stephens, C., Lucena, M. I., Fernández-Castañer, A., & Andrade, R. J. (2011) · Journal of Hepatology · doi:10.1016/j.jhep.2011.02.007 · Cited by 169

Toward Predictive Models for Drug-Induced Liver Injury in Humans: Are we There Yet?

Chen, M., Bişğin, H., Tong, L., Hong, H., Fang, H., Borlak, J. T., & Tong, W. (2014) · Biomarkers in Medicine · doi:10.2217/bmm.13.146 · Cited by 136

Preclinical Strategy to Reduce Clinical Hepatotoxicity Using in Vitro Bioactivation Data for >200 Compounds

Sakatis, M. Z., Reese, M. J., Harrell, A. W., Taylor, M. A., Baines, I. A., Chen, L., Bloomer, J. C., Yang, E. Y., Ellens, H. M., Ambroso, J. L., et al. (2012) · Chemical Research in Toxicology · doi:10.1021/tx300075j · Cited by 121

Quantitative Structure-Activity Relationship Models for Predicting Drug-Induced Liver Injury Based on FDA-Approved Drug Labeling Annotation and Using a Large Collection of Drugs

Chen, M., Hong, H., Fang, H., Kelly, R. J., Zhou, G., Borlak, J. T., & Tong, W. (2013) · Toxicological Sciences · doi:10.1093/toxsci/kft189 · Cited by 121

Phenotypic anchoring: linking cause and effect.

Paules, R. S. (2003) · Environmental Health Perspectives · doi:10.1289/ehp.111-a338 · Cited by 117

Modeling Liver-Related Adverse Effects of Drugs Using kNearest Neighbor Quantitative Structure−Activity Relationship Method

Rodgers, A. D., Zhu, H., Fourches, D., Rusyn, I., & Tropsha, A. (2010) · Chemical Research in Toxicology · doi:10.1021/tx900451r · Cited by 116

Comparisons betweenin vitrowhole cell imaging andin vivozebrafish-based approaches for identifying potential human hepatotoxicants earlier in pharmaceutical development

Hill, A., Mesens, N., Steemans, M., Xu, J. J., & Aleo, M. D. (2012) · Drug Metabolism Reviews · doi:10.3109/03602532.2011.645578 · Cited by 104

Drug-induced liver injury and drug development: industry perspective

Regev, A. (2014) · Seminars in Liver Disease · doi:10.1055/s-0034-1375962 · Cited by 102

Evaluation of the use of imaging parameters for the detection of compound-induced hepatotoxicity in 384-well cultures of HepG2 cells and cryopreserved primary human hepatocytes

Garside, H., Marcoe, K. F., Chesnut-Speelman, J., Foster, A. J., Muthas, D., Gerry Kenna, J., Warrior, U., Bowes, J., & Baumgartner, J. (2014) · Toxicology in Vitro · doi:10.1016/j.tiv.2013.10.015 · Cited by 93

“Black box” 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk

Murphy, S., & Roberts, R. (2005) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2005.10.031 · Cited by 93

The application of 3D cell models to support drug safety assessment: Opportunities & challenges

Roth, A. B., & Singer, T. (2014) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2013.12.005 · Cited by 89

The Liver Toxicity Knowledge Base: A Systems Approach to a Complex End Point

Chen, M., Zhang, J., Wang, Y., Liu, Z., Kelly, R. J., Zhou, G., Fang, H., Borlak, J. T., & Tong, W. (2013) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2013.16 · Cited by 87

Antidepressant-induced hepatotoxicity

Lucena, M. I., Carvajal, A., Andrade, R. J., & Velasco, A. (2003) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2.3.249 · Cited by 78

A Correlation Between the In Vitro Drug Toxicity of Drugs to Cell Lines That Express Human P450s and Their Propensity to Cause Liver Injury in Humans

Gustafsson, F., Foster, A. J., Sarda, S., Bridgland-Taylor, M. H., & Kenna, J. G. (2014) · Toxicological Sciences · doi:10.1093/toxsci/kft223 · Cited by 77

Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data

Zhu, X., & Kruhlak, N. L. (2014) · Toxicology · doi:10.1016/j.tox.2014.03.009 · Cited by 75

Developing a QSAR model for hepatotoxicity screening of the active compounds in traditional Chinese medicines

Huang, S.-H., Tung, C.-W., Fülöp, F., & Li, J. (2015) · Food and Chemical Toxicology · doi:10.1016/j.fct.2015.01.020 · Cited by 70

Detection of Hepatotoxicity Potential with Metabolite Profiling (Metabolomics) of Rat Plasma

Mattes, W., Davis, K., Fabian, E., Greenhaw, J., Herold, M., Looser, R., Mellert, W., Groeters, S., Marxfeld, H., Moeller, N., et al. (2014) · Toxicology Letters · doi:10.1016/j.toxlet.2014.07.021 · Cited by 65

A comprehensive study of the association between drug hepatotoxicity and daily dose, liver metabolism, and lipophilicity using 975 oral medications

Weng, Z., Wang, K., Li, H., & Shi, Q. (2015) · Oncotarget · doi:10.18632/oncotarget.4400 · Cited by 63

A testing strategy to predict risk for drug-induced liver injury in humans using high-content screen assays and the ‘rule-of-two’ model

Chen, M., Tung, C.-W., Shi, Q., Guo, L., Shi, L. M., Fang, H., Borlak, J. T., & Tong, W. (2014) · Archives of Toxicology · doi:10.1007/s00204-014-1276-9 · Cited by 62

Is Toxicogenomics a More Reliable and Sensitive Biomarker than Conventional Indicators from Rats To Predict Drug-Induced Liver Injury in Humans?

Zhang, M., Chen, M., & Tong, W. (2011) · Chemical Research in Toxicology · doi:10.1021/tx200320e · Cited by 60

Predictivity of dog co-culture model, primary human hepatocytes and HepG2 cells for the detection of hepatotoxic drugs in humans

Atienzar, F., Novik, E., Gerets, H. H. J., Parekh, A., Delatour, C., Cardenas, A., MacDonald, J. S., Yarmush, M. L., & Dhalluin, S. (2013) · Toxicology and Applied Pharmacology · doi:10.1016/j.taap.2013.11.022 · Cited by 55

Identification of structure–activity relationships for adverse effects of pharmaceuticals in humans. Part A: Use of FDA post-market reports to create a database of hepatobiliary and urinary tract toxicities

Ursem, C. J., Kruhlak, N. L., Contrera, J. F., MacLaughlin, P. M., Benz, R. D., & Matthews, E. J. (2009) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2008.12.009 · Cited by 51

Analysis of Pfizer Compounds in EPA’s ToxCast Chemicals-Assay Space

Shah, F., & Greene, N. (2013) · Chemical Research in Toxicology · doi:10.1021/tx400343t · Cited by 49

Predicting idiosyncratic drug-induced liver injury – some recent advances

Chen, M., Borlak, J. T., & Tong, W. (2014) · Expert Review of Gastroenterology & Hepatology · doi:10.1586/17474124.2014.922871 · Cited by 42

63 Years and 715 Days to the “Boxed Warning”: Unmasking of the Propylthiouracil Problem

Rivkees, S. A. (2010) · International Journal of Pediatric Endocrinology · doi:10.1155/2010/658267 · Cited by 41

Multiparametric assay using HepaRG cells for predicting drug-induced liver injury

貴文, 富., Okamura, H., Satsukawa, M., Yokoi, T., & Konno, Y. (2015) · Toxicology Letters · doi:10.1016/j.toxlet.2015.04.014 · Cited by 38

Drug-induced liver disease

Roberts, E. A. (2014) · Cambridge University Press eBooks · doi:10.1017/cbo9781139012102.023 · Cited by 37

Hepatotoxicity of Psychotropic Drugs and Drugs of Abuse

Larrey, D. G., & Ripault, M. (2013) · Elsevier eBooks · doi:10.1016/b978-0-12-387817-5.00025-x · Cited by 29

63 Years and 715 Days to the "Boxed Warning": Unmasking of the Propylthiouracil Problem

Rivkees, S. (2010) · International Journal of Pediatric Endocrinology · doi:10.1186/1687-9856-2010-658267 · Cited by 22

Drug-induced liver injury classification model based on in vitro human transcriptomics and in vivo rat clinical chemistry data

Jennen, D. G. J., Polman, J. E. M., Bessem, M., Coonen, M. L. J., van Delft, J. H. M., & Kleinjans, J. C. S. (2014) · Systems Biomedicine · doi:10.4161/sysb.29400 · Cited by 13

DRUG-INDUCED HEPATIC INJURY: MARPLAN HEPATITIS

Knight, J. A. (1961) · American Journal of Psychiatry · doi:10.1176/ajp.118.1.73 · Cited by 6

PubChem 2023 update

Kim, S., Chen, J., Cheng, T., Gindulyte, A., He, J., He, S., Li, Q., Shoemaker, B. A., Thiessen, P. A., Yu, B., et al. (2023) · Nucleic Acids Research · doi:10.1093/nar/gkac956 · Cited by 3,443

ProTox-II: a webserver for the prediction of toxicity of chemicals

Banerjee, P., Eckert, A. P., Schrey, A. K., & Preißner, R. (2018) · Nucleic Acids Research · doi:10.1093/nar/gky318 · Cited by 3,312

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

Drug-induced liver injury: recent advances in diagnosis and risk assessment

Kullak-Ublick, G. A., Andrade, R. J., Merz, M., End, P., Benesic, A., Gerbes, A. L., & Aithal, G. P. (2017) · Gut · doi:10.1136/gutjnl-2016-313369 · Cited by 438

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

DILIrank dataset for QSAR modeling of drug-induced liver injury

Chen, M., Liao, T.-J., Li, D., Ning, B., Hong, H., & Tong, W. (2023) · Elsevier eBooks · doi:10.1016/b978-0-443-15339-6.00014-x

FDA use of the black box warning: time for reevaluation as a safety tool

Liang, B. A. (2002) · Journal of Clinical Anesthesia · doi:10.1016/s0952-8180(02)00444-0 · Cited by 15

DILIrank 2.0: An updated and expanded database for drug-induced liver injury risk based on FDA labeling and a literature review

Olubamiwa, A. O., Qu, Y., Connor, S., Tong, W., Li, D., & Chen, M. (2025) · Drug Discovery Today · doi:10.1016/j.drudis.2025.104485 · Cited by 9

Drug-induced liver injury severity and toxicity (DILIst): binary classification of 1279 drugs by human hepatotoxicity

Thakkar, S., Li, T., Liu, Z., Wu, L., Roberts, R., & Tong, W. (2020) · Drug Discovery Today · doi:10.1016/j.drudis.2019.09.022 · Cited by 140

Drug-Induced Liver Injury (DILI) Classification and Its Application on Human DILI Risk Prediction

Thakkar, S., Chen, M., Hong, H., Liu, Z., Fang, H., & Tong, W. (2018) · Methods in pharmacology and toxicology · doi:10.1007/978-1-4939-7677-5_3 · Cited by 8