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U.S. Department of Health and Human Services

Science & Research

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LTKB Benchmark Dataset

NCTR scientists have developed a benchmark dataset (LTKB-BD) containing drugs whose potential to cause DILI (Drug-Induced Liver Injury) in humans has been established using the FDA-approved prescription drug labels. The first set of drugs examined are these that have been available for ten or more years and are available commercially from one of three large chemical supply companies.

After reviewing the labels of 287 prescription drugs the following was found:

  • 137 most-DILI-concern drugs which are either withdrawn/discontinued from the markets or have a "Boxed Warning" label due to hepatotoxicity, or come from the "Warnings and Precautions" section with severe DILI content
  • 85 less-DILI-concern drugs whose DILI events are highlighted in the "Adverse Reactions" section or "Warnings and Precautions" section with mild DILI content
  • 65 no-DILI-concern drugs whose labels did not contain any DILI indication


Register for LTKB

The LTKB Benchmark Dataset will be continually updated with new drugs or new label information for a drug. Please complete the following information to be informed of any updates.








Launch the LTKB Benchmark Dataset


Chen, M., Vijay, V., Shi, Q., Liu, Z., Fang, H., Tong, W. "FDA-Approved Drug Labeling for the Study of Drug-Induced Liver Injury," Drug Discovery Today, 16(15-16):697-703, 2011  Abstract


LTKB Contact Information

Questions or Suggestions: 
Weida Tong, Ph.D., NCTR  at 870-543-7142 or weida.tong@fda.hhs.gov

Technical Problems:  






Contact FDA

National Center for Toxicological Research

Food and Drug Administration

3900 NCTR Road

Jefferson, AR 72079