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Drug-induced liver injury

Drug-induced Liver Injury (DILI) is the most important cause for acute liver failure and a major risk in Drug development. In contrast to dose-dependent hepatotoxicity (e.g. acetaminophen [Paracetamol]), idiosyncratic DILI (iDILI) affects only susceptible patients (e.g. 1 in 10.000) after a latency from weeks to months without clear dose-dependence.

The diagnosis of iDILI relies on exclusion of other causes for liver injury (e.g. viral hepatitis, autoimmune diseases and metabolic liver diseases). Thus, iDILI is one of the most challenging diagnoses in hepatology and identification of the causative agent (causality assessment) may be impossible in polymedicated patients1,2.

The current gold standard for iDILI diagnosis and causality assessment is expert opinion supported by diagnostic scales such as CIOMS/RUCAM (see also:

Expert opinion causality assessment is based on

  1. Exclusion of other causes
  2. Time course of liver injury in relation to drug therapy
  3. Drug “signature” (i.e. typical pattern of injury, if known)
  4. Response to re-challenge (Deliberate re-challenge is not recommended, typically this occurs inadvertently)


  1. Chalasani NP et al. Am J Gastroenterol. 2014; 109(7):950-66
  2. Teschke R et al. Ann Hepatol. 2014 Mar-Apr;13(2):248-55.