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Drug-induced cirrhosis of liver

Last edited: 4/13/2026

Overview

Drug-induced cirrhosis of the liver results from chronic exposure to hepatotoxic medications, leading to progressive liver damage and fibrosis, potentially culminating in cirrhosis. This condition underscores the importance of recognizing and managing drug-induced liver injury (DILI) early to prevent irreversible liver damage 123456789101112131415161718192021222324252627282930313233343536373839404142434445464748.

Diagnosis

  • Clinical History: Detailed history taking to identify recent drug exposures and exclude other causes of liver injury 717.
  • Laboratory Tests: Elevated liver enzymes (ALT, AST), bilirubin levels, and INR 1234567891011121314151617181920212223242526272829303132333435363738394041424344454647.
  • Imaging: Ultrasound or MRI to assess liver morphology and fibrosis 17.
  • Liver Biopsy: Definitive diagnosis for assessing degree of fibrosis and inflammation 17.
  • Causality Assessment: Use of RUCAM or Naranjo scale to evaluate likelihood of drug causality 3335.

    • Management

  • Discontinue Harmful Drugs: Immediate cessation of the suspected hepatotoxic medication 1234567891011121314151617181920212223242526272829303132333435363738394041424344454647.
  • Supportive Care: Management of symptoms, nutritional support, and monitoring of liver function 17.
  • Liver Transplantation: Consider for end-stage liver disease unresponsive to other treatments 17.
  • Monitoring: Regular follow-up with liver function tests and imaging to monitor progression 17.

    • Special Populations

  • Elderly: Increased susceptibility to DILI due to altered pharmacokinetics and polypharmacy 2024.
  • Comorbidities: Presence of chronic kidney disease may exacerbate hepatotoxicity, as seen with allopurinol and colchicine 3.

    • Key Recommendations

  • Prompt Identification and Withdrawal of Hepatotoxic Drugs: Early recognition and discontinuation of the offending agent is crucial to prevent progression to cirrhosis (Evidence: Strong 1234567891011121314151617181920212223242526272829303132333435363738394041424344454647).
  • Comprehensive Monitoring and Supportive Care: Regular monitoring of liver function tests and provision of supportive care measures are essential for managing DILI (Evidence: Moderate 17).
  • Consider Liver Transplantation for Severe Cases: Evaluate liver transplantation as a definitive treatment option for patients with end-stage liver disease secondary to drug-induced injury (Evidence: Expert opinion 17).

    • References

    1 Tan S, Yang Y, Ma L, Zuo X, Rao J, Pu Y et al.. Ceritinib-ibuprofen synergistic hepatotoxicity: Insights from real-world data and liver organoid models. Toxicology 2026. link 2 Song Y, Li C, Liu X, Gao H. Drug-Induced Liver Injury Associated With Moxifloxacin: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System and a Real-World Retrospective Study. Basic & clinical pharmacology & toxicology 2026. link 3 Looby N, Tessendorf CD, Hagen J, Looby M, Guido J. A Potential Unrecognized Risk for Acute Hepatotoxicity: A Case Report of Fulminant Liver Failure Following Recent Initiation of Allopurinol and Colchicine. South Dakota medicine : the journal of the South Dakota State Medical Association 2025. link 4 Björnsson HK, Björnsson ES. Risk factors and prediction for DILI in clinical practice. Expert opinion on drug metabolism & toxicology 2025. link 5 He Y, Chen XD, Wu SN, Zhou CB, Wang PH, Tang SH et al.. Identifying high-risk drugs and demographic patterns in drug-induced liver injury from FAERS and CVARD analyses. Scientific reports 2025. link 6 Zhou L, Wu B, Bian Y, Lu Y, Zou Y, Lin S et al.. Hepatotoxicity associated with statins: A retrospective pharmacovigilance study based on the FAERS database. PloS one 2025. link 7 Mao Y, Ma S, Liu C, Liu X, Su M, Li D et al.. Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update. Hepatology international 2024. link 8 Segovia-Zafra A, Villanueva-Paz M, Serras AS, Matilla-Cabello G, Bodoque-García A, Di Zeo-Sánchez DE et al.. Control compounds for preclinical drug-induced liver injury assessment: Consensus-driven systematic review by the ProEuroDILI network. Journal of hepatology 2024. link 9 He S, Chen B, Li C. Drug-induced liver injury associated with atypical generation antipsychotics from the FDA Adverse Event Reporting System (FAERS). BMC pharmacology & toxicology 2024. link 10 Gu J, Guo Y, Wu B, He J. Liver injury associated with endothelin receptor antagonists: a pharmacovigilance study based on FDA adverse event reporting system data. International journal of clinical pharmacy 2024. link 11 Lee S, Shin H, Choe S, Kang MG, Kim SH, Kang DY et al.. MetaLAB-HOI: Template standardization of health outcomes enable massive and accurate detection of adverse drug reactions from electronic health records. Pharmacoepidemiology and drug safety 2024. link 12 Sun C, Yang X, Tang L, Chen J. A pharmacovigilance study on drug-induced liver injury associated with antibody-drug conjugates (ADCs) based on the food and drug administration adverse event reporting system. Expert opinion on drug safety 2024. link 13 Shi A, Nguyen H, Kuo CB, Beringer PM. Drug-induced liver injury associated with elexacaftor/tezacaftor/ivacaftor: A pharmacovigilance analysis of the FDA adverse event reporting system (FAERS). Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society 2024. link 14 Liu Y, Li H, Huang L, Wan C, Wang H, Jiao X et al.. Liver injury in children: signal analysis of suspected drugs based on the food and drug administration adverse event reporting system. BMC pediatrics 2023. link 15 Wei C, Liu Y, Jiang A, Wu B. A pharmacovigilance study of the association between tetracyclines and hepatotoxicity based on Food and Drug Administration adverse event reporting system data. International journal of clinical pharmacy 2022. link 16 Ishida T, Kawada K, Jobu K, Kawazoe T, Tamura N, Miyamura M. Analysis of Drug-Induced Liver Injury from Bofutsushosan Administration Using Japanese Adverse Drug Event Report (JADER) Database. Biological & pharmaceutical bulletin 2022. link 17 Chalasani NP, Maddur H, Russo MW, Wong RJ, Reddy KR. ACG Clinical Guideline: Diagnosis and Management of Idiosyncratic Drug-Induced Liver Injury. The American journal of gastroenterology 2021. link 18 Piloiu C, Dumitrascu DL. Albendazole-Induced Liver Injury. American journal of therapeutics 2021. link 19 Lee BT, Odin JA, Grewal P. An Approach to Drug-Induced Liver Injury from the Geriatric Perspective. Current gastroenterology reports 2021. link 20 Weersink RA, Alvarez-Alvarez I, Medina-Cáliz I, Sanabria-Cabrera J, Robles-Díaz M, Ortega-Alonso A et al.. Clinical Characteristics and Outcome of Drug-Induced Liver Injury in the Older Patients: From the Young-Old to the Oldest-Old. Clinical pharmacology and therapeutics 2021. link 21 Akimoto H, Nagashima T, Minagawa K, Hayakawa T, Takahashi Y, Asai S. Signal Detection of Potential Hepatotoxic Drugs: Case-Control Study Using Both a Spontaneous Reporting System and Electronic Medical Records. Biological & pharmaceutical bulletin 2021. link 22 Fang L, Wang S, Cao L, Yao K. Early intervention of acute liver injury related to venlafaxine: A case report. Medicine 2021. link 23 Ortland I, Mirjalili M, Kullak-Ublick GA, Peymani P. Drug-induced liver injury in Switzerland: an analysis of drug-related hepatic disorders in the WHO pharmacovigilance database VigiBase from 2010 to 2020. Swiss medical weekly 2021. link 24 Lucena MI, Sanabria J, García-Cortes M, Stephens C, Andrade RJ. Drug-induced liver injury in older people. The lancet. Gastroenterology & hepatology 2020. link30006-6) 25 . EASL Clinical Practice Guidelines: Drug-induced liver injury. Journal of hepatology 2019. link 26 Ye JH, Ho YF, On AW, Chen WW, Huang YM, Huang WI et al.. Trends in reporting drug-associated liver injuries in Taiwan: a focus on amiodarone. International journal of clinical pharmacy 2018. link 27 Teschke R. Top-ranking drugs out of 3312 drug-induced liver injury cases evaluated by the Roussel Uclaf Causality Assessment Method. Expert opinion on drug metabolism & toxicology 2018. link 28 Chalasani N, Reddy KRK, Fontana RJ, Barnhart H, Gu J, Hayashi PH et al.. Idiosyncratic Drug Induced Liver Injury in African-Americans Is Associated With Greater Morbidity and Mortality Compared to Caucasians. The American journal of gastroenterology 2017. link 29 Friedrich ME, Akimova E, Huf W, Konstantinidis A, Papageorgiou K, Winkler D et al.. Drug-Induced Liver Injury during Antidepressant Treatment: Results of AMSP, a Drug Surveillance Program. The international journal of neuropsychopharmacology 2016. link 30 Suzuki A, Yuen NA, Ilic K, Miller RT, Reese MJ, Brown HR et al.. Comedications alter drug-induced liver injury reporting frequency: Data mining in the WHO VigiBase™. Regulatory toxicology and pharmacology : RTP 2015. link 31 Hanatani T, Sai K, Tohkin M, Segawa K, Kimura M, Hori K et al.. A detection algorithm for drug-induced liver injury in medical information databases using the Japanese diagnostic scale and its comparison with the Council for International Organizations of Medical Sciences/the Roussel Uclaf Causality Assessment Method scale. Pharmacoepidemiology and drug safety 2014. link 32 Hunt CM, Yuen NA, Stirnadel-Farrant HA, Suzuki A. Age-related differences in reporting of drug-associated liver injury: data-mining of WHO Safety Report Database. Regulatory toxicology and pharmacology : RTP 2014. link 33 Stine JG, Sateesh P, Lewis JH. Drug-induced liver injury in the elderly. Current gastroenterology reports 2013. link 34 Petronijevic M, Ilic K. Associations of gender and age with the reporting of drug-induced hepatic failure: data from the VigiBase™. Journal of clinical pharmacology 2013. link 35 M'Kada H, Perazzo H, Munteanu M, Ngo Y, Ramanujam N, Fautrel B et al.. Real time identification of drug-induced liver injury (DILI) through daily screening of ALT results: a prospective pilot cohort study. PloS one 2012. link 36 Björnsson E, Jacobsen EI, Kalaitzakis E. Hepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing. Journal of hepatology 2012. link 37 Suzuki A, Andrade RJ, Bjornsson E, Lucena MI, Lee WM, Yuen NA et al.. Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: unified list based on international collaborative work. Drug safety 2010. link 38 Assis DN, Navarro VJ. Human drug hepatotoxicity: a contemporary clinical perspective. Expert opinion on drug metabolism & toxicology 2009. link 39 Papay JI, Clines D, Rafi R, Yuen N, Britt SD, Walsh JS et al.. Drug-induced liver injury following positive drug rechallenge. Regulatory toxicology and pharmacology : RTP 2009. link 40 Ursem CJ, Kruhlak NL, Contrera JF, MacLaughlin PM, Benz RD, Matthews EJ. 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. Regulatory toxicology and pharmacology : RTP 2009. link 41 Matthews EJ, Ursem CJ, Kruhlak NL, Benz RD, Sabaté DA, Yang C et al.. Identification of structure-activity relationships for adverse effects of pharmaceuticals in humans: Part B. Use of (Q)SAR systems for early detection of drug-induced hepatobiliary and urinary tract toxicities. Regulatory toxicology and pharmacology : RTP 2009. link 42 Daly AK, Day CP. Genetic association studies in drug-induced liver injury. Seminars in liver disease 2009. link 43 Hayashi PH. Causality assessment in drug-induced liver injury. Seminars in liver disease 2009. link 44 Subramanian K, Raghavan S, Rajan Bhat A, Das S, Bajpai Dikshit J, Kumar R et al.. A systems biology based integrative framework to enhance the predictivity of in vitro methods for drug-induced liver injury. Expert opinion on drug safety 2008. link 45 García-Cortés M, Lucena MI, Pachkoria K, Borraz Y, Hidalgo R, Andrade RJ. Evaluation of naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury. Alimentary pharmacology & therapeutics 2008. link 46 Reuben A. Needles in haystacks. The American journal of gastroenterology 2007. link 47 Motola D, Vargiu A, Leone R, Cocci A, Salvo F, Ros B et al.. Hepatic adverse drug reactions: a case/non-case study in Italy. European journal of clinical pharmacology 2007. link 48 Njoku DB, Mellerson JL, Talor MV, Kerr DR, Faraday NR, Outschoorn I et al.. Role of CYP2E1 immunoglobulin G4 subclass antibodies and complement in pathogenesis of idiosyncratic drug-induced hepatitis. Clinical and vaccine immunology : CVI 2006. link 49 Björnsson E, Nordlinder H, Olsson R. Clinical characteristics and prognostic markers in disulfiram-induced liver injury. Journal of hepatology 2006. link 50 Goldkind L, Laine L. A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: lessons learned from the bromfenac experience. Pharmacoepidemiology and drug safety 2006. link 51 Ruiz Montero A, Durán Quintana JA, Jiménez Sáenz M, Abadín Delgado JA. A strategy to improve the detection of drug-induced hepatotoxicity. Revista espanola de enfermedades digestivas 2005. link 52 Björnsson E, Jerlstad P, Bergqvist A, Olsson R. Fulminant drug-induced hepatic failure leading to death or liver transplantation in Sweden. Scandinavian journal of gastroenterology 2005. link 53 Abe M, Furukawa S, Takayama S, Michitaka K, Minami H, Yamamoto K et al.. Drug-induced hepatitis with autoimmune features during minocycline therapy. Internal medicine (Tokyo, Japan) 2003. link 54 Valois M, Cooper MA, Shear NH. Clinical pharmacology consultations: consultation requests may be misleading -- an organized approach to drug-induced hepatitis. The Canadian journal of clinical pharmacology = Journal canadien de pharmacologie clinique 2003. link 55 Bagheri H, Michel F, Lapeyre-Mestre M, Lagier E, Cambus JP, Valdiguié P et al.. Detection and incidence of drug-induced liver injuries in hospital: a prospective analysis from laboratory signals. British journal of clinical pharmacology 2000. link 56 Golstein PE, Deviere J, Cremer M. Acute hepatitis and drug-related lupus induced by minocycline treatment. The American journal of gastroenterology 1997. link 57 Pillans PI. Drug associated hepatic reactions in New Zealand: 21 years experience. The New Zealand medical journal 1996. link

    Original source

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      Ceritinib-ibuprofen synergistic hepatotoxicity: Insights from real-world data and liver organoid models. — Tan S, Yang Y, Ma L, Zuo X, Rao J, Pu Y et al. Toxicology (2026)
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      Drug-Induced Liver Injury Associated With Moxifloxacin: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System and a Real-World Retrospective Study. — Song Y, Li C, Liu X, Gao H Basic & clinical pharmacology & toxicology (2026)
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      Identifying high-risk drugs and demographic patterns in drug-induced liver injury from FAERS and CVARD analyses. — He Y, Chen XD, Wu SN, Zhou CB, Wang PH, Tang SH et al. Scientific reports (2025)
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      Hepatotoxicity associated with statins: A retrospective pharmacovigilance study based on the FAERS database. — Zhou L, Wu B, Bian Y, Lu Y, Zou Y, Lin S et al. PloS one (2025)
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      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 et al. Hepatology international (2024)
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      Control compounds for preclinical drug-induced liver injury assessment: Consensus-driven systematic review by the ProEuroDILI network. — Segovia-Zafra A, Villanueva-Paz M, Serras AS, Matilla-Cabello G, Bodoque-García A, Di Zeo-Sánchez DE et al. Journal of hepatology (2024)
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      Drug-induced liver injury associated with atypical generation antipsychotics from the FDA Adverse Event Reporting System (FAERS). — He S, Chen B, Li C BMC pharmacology & toxicology (2024)
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      MetaLAB-HOI: Template standardization of health outcomes enable massive and accurate detection of adverse drug reactions from electronic health records. — Lee S, Shin H, Choe S, Kang MG, Kim SH, Kang DY et al. Pharmacoepidemiology and drug safety (2024)
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      Drug-induced liver injury associated with elexacaftor/tezacaftor/ivacaftor: A pharmacovigilance analysis of the FDA adverse event reporting system (FAERS). — Shi A, Nguyen H, Kuo CB, Beringer PM Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society (2024)
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      A pharmacovigilance study of the association between tetracyclines and hepatotoxicity based on Food and Drug Administration adverse event reporting system data. — Wei C, Liu Y, Jiang A, Wu B International journal of clinical pharmacy (2022)
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      Analysis of Drug-Induced Liver Injury from Bofutsushosan Administration Using Japanese Adverse Drug Event Report (JADER) Database. — Ishida T, Kawada K, Jobu K, Kawazoe T, Tamura N, Miyamura M Biological & pharmaceutical bulletin (2022)
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      Albendazole-Induced Liver Injury. — Piloiu C, Dumitrascu DL American journal of therapeutics (2021)
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      An Approach to Drug-Induced Liver Injury from the Geriatric Perspective. — Lee BT, Odin JA, Grewal P Current gastroenterology reports (2021)
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      Clinical Characteristics and Outcome of Drug-Induced Liver Injury in the Older Patients: From the Young-Old to the Oldest-Old. — Weersink RA, Alvarez-Alvarez I, Medina-Cáliz I, Sanabria-Cabrera J, Robles-Díaz M, Ortega-Alonso A et al. Clinical pharmacology and therapeutics (2021)
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      Signal Detection of Potential Hepatotoxic Drugs: Case-Control Study Using Both a Spontaneous Reporting System and Electronic Medical Records. — Akimoto H, Nagashima T, Minagawa K, Hayakawa T, Takahashi Y, Asai S Biological & pharmaceutical bulletin (2021)
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      Early intervention of acute liver injury related to venlafaxine: A case report. — Fang L, Wang S, Cao L, Yao K Medicine (2021)
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      Drug-induced liver injury in Switzerland: an analysis of drug-related hepatic disorders in the WHO pharmacovigilance database VigiBase from 2010 to 2020. — Ortland I, Mirjalili M, Kullak-Ublick GA, Peymani P Swiss medical weekly (2021)
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      EASL Clinical Practice Guidelines: Drug-induced liver injury. Journal of hepatology (2019)
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      Trends in reporting drug-associated liver injuries in Taiwan: a focus on amiodarone. — Ye JH, Ho YF, On AW, Chen WW, Huang YM, Huang WI et al. International journal of clinical pharmacy (2018)
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      Top-ranking drugs out of 3312 drug-induced liver injury cases evaluated by the Roussel Uclaf Causality Assessment Method. — Teschke R Expert opinion on drug metabolism & toxicology (2018)
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      Idiosyncratic Drug Induced Liver Injury in African-Americans Is Associated With Greater Morbidity and Mortality Compared to Caucasians. — Chalasani N, Reddy KRK, Fontana RJ, Barnhart H, Gu J, Hayashi PH et al. The American journal of gastroenterology (2017)
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      Real time identification of drug-induced liver injury (DILI) through daily screening of ALT results: a prospective pilot cohort study. — M'Kada H, Perazzo H, Munteanu M, Ngo Y, Ramanujam N, Fautrel B et al. PloS one (2012)
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      Detection and incidence of drug-induced liver injuries in hospital: a prospective analysis from laboratory signals. — Bagheri H, Michel F, Lapeyre-Mestre M, Lagier E, Cambus JP, Valdiguié P et al. British journal of clinical pharmacology (2000)
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      Drug associated hepatic reactions in New Zealand: 21 years experience. — Pillans PI The New Zealand medical journal (1996)
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