ReviewDrug safety2018
Drug-Induced Liver Injury: Why is the Roussel Uclaf Causality Assessment Method (RUCAM) Still Used 25 Years After Its Launch?
Review in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
51 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Potential Hepatotoxins Found in Herbal Medicinal Products: A Systematic Review.International journal of molecular sciences · 2020Pooled it
- Metabolic heterogeneity, networks, and biomarkers of drug-induced liver injury.Journal of pharmaceutical analysis · 2026Article
- Article
- Drug metabolizing enzymes and transporters, and their roles for the development of drug-induced liver injury.Expert opinion on drug metabolism & toxicology · 2025Review
- Evaluation of glutamate dehydrogenase (GLDH) as a diagnostic and prognostic marker in drug-induced liver injury.Przeglad gastroenterologiczny · 2025Article
- Real-world data of Azvudine-induced hepatotoxicity among hospitalized COVID-19 patients in China: a retrospective case-control study.Frontiers in pharmacology · 2025Article
- Pharmacist-Led Assessment of Drug-Induced Liver Injury in Hospitalized Patients.The Canadian journal of hospital pharmacy · 2025Article
- Hepatotoxicity associated with anti-neoplastic agents: a pharmacovigilance analysis of the Food and Drug Administration Adverse Event Reporting System database.Frontiers in immunology · 2025Article
- Selective androgen receptor modulator use and related adverse events including drug-induced liver injury: Analysis of suspected cases.European journal of clinical pharmacology · 2024Review
- Drug-Induced Liver Injury with Commonly Used Antibiotics in the All of Us Research Program.Clinical pharmacology and therapeutics · 2023Article
- Advances in Idiosyncratic Drug-Induced Liver Injury Issues: New Clinical and Mechanistic Analysis Due to Roussel Uclaf Causality Assessment Method Use.International journal of molecular sciences · 2023Review
- Metformin-Induced Acute Hepatitis.Cureus · 2023Article
- [Significance of histological assessment in drug-induced liver injury].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2023Article
- Article
- Treatment of Drug-Induced Liver Injury.Biomedicines · 2022Review
- Drug-Induced Liver Injury during Consolidation Therapy in Childhood Acute Lymphoblastic Leukemia as Assessed for Causality Using the Updated RUCAM.Canadian journal of gastroenterology & hepatology · 2022Article
- The LiverTox Paradox-Gaps between Promised Data and Reality Check.Diagnostics (Basel, Switzerland) · 2021Article
- Using an Automated Algorithm to Identify Potential Drug-Induced Liver Injury Cases in a Pharmacovigilance Database.Advances in therapy · 2021Article
- The Diagnosis of Drug-induced Liver Injury: Current Diagnostic Ability and Future Challenges of the Digestive Disease Week-Japan 2004 Scale 15 Years after Its Proposal.Internal medicine (Tokyo, Japan) · 2021Article
- Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials.Drug safety · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Launched in 1993 and partially based on the results of an international consensus meeting organized under the auspices of the Council of International Organizations of Medical Sciences (CIOMS), the Roussel Uclaf Causality Assessment Method (RUCAM) is the most used causality assessment tool worldwide for the diagnosis of drug-induced liver injury (DILI) and herb-induced liver injury (HILI) in a large number of epidemiological studies, case reports, and case series. The 25-year experience of RUCAM use confirmed that the success was due to its objective, standardized, and liver-injury-specific approach structured with defined key elements derived from a series of DILI cases with positive rechallenge. Using this series, the validation procedure avoided arbitrary definitions and confirmed scores to key items. The algorithm provides a quantitative causality grading of highly probable, probable, possible, unlikely, or excluded relationship between the liver injury and the suspected product(s). Despite challenges, prospective use of RUCAM fosters case data completeness and transparent causality adjudication in real time, as opposed to subjective opinion resulting from several rounds by experts lacking defined key elements and scores. In 2016, RUCAM was updated with specification of alcohol use and Hepatitis E Virus (HEV) biomarkers and simplified item handling to further reduce inter-observer variability. RUCAM-based probable and highly probable DILI and HILI cases are essential for the detection of new hepatotoxins, confirmation of new biomarkers, description of clinical features and risk factors, and determination of incidence in pharmacoepidemiological studies. This article is intended to encourage systematic use of sophisticated causality assessment methods such as RUCAM to improve DILI and HILI case evaluation and to increase confidence in published cases.
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.