Hepatotoxicity epidemiology and demographics

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]

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Drug-related hepatotoxicity is generally considered as an uncommon complication for many drugs, with an incidence between 1 in 10,000 and 1 in 100,000.[1] The true incidence of drug-induced liver injury is hard to determine, partly because of difficulties in detection as well as lack of unified criteria for diagnosis.

Epidemiology and Demographics

Drug-induced liver injury (DILI) has an approximate annual incidence between 10 and 15 per 10,000 to 100,000 persons. One study from France reported a crude annual incidence of 13.9 ± 2.4 per 100,000 inhabitants, which is 16 times greater than the number noted by spontaneous reporting to French regulatory authorities.[2] The true incidence of hepatic adverse events in the general population remains unknown and is often underestimated.

More than a thousand drugs have been associated with DILI, the most common among them are antimicrobial agents, central venous system medications, and herbal supplements. Women were found to be more prone to developing DILI than men.[3]

It has been suggested that for every 10 cases of elevations in alanine aminotransferase (ALT) in a clinical trial, there will be at least one case of severe DILI that develops once the drug becomes widely available.[4][5]


  1. Navarro, VJ.; Senior, JR. (2006). "Drug-related hepatotoxicity". N Engl J Med. 354 (7): 731–9. doi:10.1056/NEJMra052270. PMID 16481640. Unknown parameter |month= ignored (help)
  2. Sgro, C.; Clinard, F.; Ouazir, K.; Chanay, H.; Allard, C.; Guilleminet, C.; Lenoir, C.; Lemoine, A.; Hillon, P. (2002). "Incidence of drug-induced hepatic injuries: a French population-based study". Hepatology. 36 (2): 451–5. doi:10.1053/jhep.2002.34857. PMID 12143055. Unknown parameter |month= ignored (help)
  3. Chalasani, N.; Fontana, RJ.; Bonkovsky, HL.; Watkins, PB.; Davern, T.; Serrano, J.; Yang, H.; Rochon, J.; Chalasani, N. (2008). "Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States". Gastroenterology. 135 (6): 1924–34, 1934.e1–4. doi:10.1053/j.gastro.2008.09.011. PMID 18955056. Unknown parameter |month= ignored (help)
  4. Maddur, H.; Chalasani, N. (2011). "Idiosyncratic drug-induced liver injury: a clinical update". Curr Gastroenterol Rep. 13 (1): 65–71. doi:10.1007/s11894-010-0154-8. PMID 21049293. Unknown parameter |month= ignored (help)
  5. Lewis, JH. (2006). "'Hy's law,' the 'Rezulin Rule,' and other predictors of severe drug-induced hepatotoxicity: putting risk-benefit into perspective". Pharmacoepidemiol Drug Saf. 15 (4): 221–9. doi:10.1002/pds.1209. PMID 16444771. Unknown parameter |month= ignored (help)

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