Evidence map›Paper›PMID 21356330›Full record

ArticleClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2011

Clinical and histopathologic features of fluoroquinolone-induced liver injury.

Eric S Orman, Hari S Conjeevaram, Raj Vuppalanchi, James W Freston, James Rochon, David E Kleiner, Paul H Hayashi, DILIN Research Group

Open access · greenAbstract read
In one paragraph

Article in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed
10.9field-weighted citation impact, top 2% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 130 citations in OpenAlex.

  1. Article
  2. HLA-B*44 Alleles and HLA-DQA1*03:01 as Genetic Risk Factors for Drug-Induced Liver Injury due to Fluoroquinolones.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Antibacterial Mechanisms and Clinical Impact of Sitafloxacin.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
  8. Article
  9. Safety of fluoroquinolones.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2024
    Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Liver Damage and microRNAs: An Update.Current issues in molecular biology · 2022
    Review
  15. Article
  16. Oral Fluoroquinolone Use and the Risk of Acute Liver Injury: A Nationwide Cohort Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  17. Article
  18. Article
  19. Article
  20. Article

3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Eric S OrmanDivision of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, USA.
Hari S Conjeevaram
Raj Vuppalanchi
James W Freston
James Rochon
David E Kleiner
Paul H Hayashi
DILIN Research Group
University of North Carolina at Chapel Hill · USDuke University · USIndiana University School of MedicineNational Institutes of Health · USUniversity of Michigan–Ann Arbor · US

Funding

INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR024134 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2006 to 2011
$70.4M
MAYO CLINIC CENTER FOR TRANSLATIONAL SCIENCE ACTIVITIESUL1RR024150 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 2006 to 2011
$66.4M
MICHIGAN INSTITUTE FOR CLINICAL AND HEALTH RESEARCH (MICHR) (UL1): (BPCA)UL1RR024986 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SHANLEY, THOMAS P. · 2007 to 2011
$51.2M
UNC CLINICAL AND TRANSLATIONAL SCIENCE AWARD: BPCAUL1RR025747 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUNGE, MARSCHALL S. · 2008 to 2011
$44.6M
Histology Core LaboratoryZICBC010687 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CHINQUEE, JOSEPH · 2009 to 2025
$35.1M
NORTH AND CENTRAL TEXAS CTSA FOR PEDIATRIC RESEARCHUL1RR024982 · NCRR · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2007 to 2011
$27.9M
Drug Induced Liver Injury Network Data Coordinating CenterU01DK065176 · NIDDK · DUKE UNIVERSITY · PI Huiman X Barnhart · 2003 to 2026
$25.5M
INDIANA CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE (UL1): BPCAUL1RR025761 · NCRR · INDIANA UNIVERSITY INDIANAPOLIS · PI SHEKHAR, ANANTHA · 2008 to 2011
$21.0M
IU Clinical Center: Drug Induced Liver Injury NetworkU01DK065211 · NIDDK · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI NAGA P CHALASANI · 2003 to 2026
$7.5M
University of North Carolina Clinical Center for DILINU01DK065201 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI PAUL B WATKINS · 2003 to 2026
$7.3M
Michigan Hepatotoxicity Clinical Research Network Renewal 2018U01DK065184 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ROBERT J FONTANA · 2003 to 2026
$7.0M
The Drug Induced Liver Injury Network (DILIN): Focus on Herbal and DietarySupplementsU01DK083027 · NIDDK · THOMAS JEFFERSON UNIVERSITY · PI Dina Halegoua-DeMarzio · 2008 to 2026
$7.0M
Intramural NIH HHSNCRR NIH HHS UL1 RR024134NCRR NIH HHS UL1 RR024150NCRR NIH HHS UL1 RR024982NCRR NIH HHS UL1 RR024986NCRR NIH HHS UL1 RR025747NCRR NIH HHS UL1 RR025761NIDDK NIH HHS 1U01-DK082992-01NIDDK NIH HHS 1U01-DK083020-01NIDDK NIH HHS 1U01-DK083023-01NIDDK NIH HHS 1U01-DK083027-01NIDDK NIH HHS 2U01-DK065176-06NIDDK NIH HHS 2U01-DK065184-06NIDDK NIH HHS 2U01-DK065201-06NIDDK NIH HHS 2U01-DK065211-06NIDDK NIH HHS 5U01DK065193-04NIDDK NIH HHS 5U01-DK065238-08NIDDK NIH HHS U01 DK065176NIDDK NIH HHS U01 DK065184NIDDK NIH HHS U01 DK065193NIDDK NIH HHS U01 DK065201NIDDK NIH HHS U01 DK065211NIDDK NIH HHS U01 DK065238NIDDK NIH HHS U01 DK082992NIDDK NIH HHS U01 DK083020NIDDK NIH HHS U01 DK083023NIDDK NIH HHS U01 DK083027
6 · The paper itself

Abstract

BACKGROUND &

aimsFluoroquinolone-induced liver injury is rare; no prospective studies of well-characterized case series have been published. We studied patients with fluoroquinolone-induced hepatotoxicity from the Drug-Induced Liver Injury Network (DILIN) to characterize injury patterns, outcomes, and associated features.

methodsWe identified subjects with fluoroquinolone hepatotoxicity enrolled in the DILIN from September 2004 to January 2010. Demographic, clinical, and laboratory data were analyzed by descriptive statistical methods.

resultsOf the 679 registrants in the DILIN prospective study, 12 had fluoroquinolone hepatotoxicity (6 ciprofloxacin, 4 moxifloxacin, 1 levofloxacin, and 1 gatifloxacin). Seven were women; median age was 57 years (range, 23-80 years), and median time from fluoroquinolone start to symptoms was only 4 days (range, 1-39 days). Nine patients developed symptoms on medication; 3 did so 2, 8, and 32 days after stopping the medication. Cases were equally distributed among hepatocellular injury (predominantly increased levels of alanine aminotransferase), cholestatic injury (predominantly increased levels of alkaline phosphatase), and both. Seven patients had immunoallergic features. Patients with mixed hepatocellular and cholestatic injury had mild disease without jaundice; all recovered. In contrast, 2 of 4 patients with hepatocellular injury and jaundice died, 1 of acute liver failure. One patient with cholestatic injury developed vanishing bile duct syndrome and required liver transplantation; another had a persistently increased serum level of alkaline phosphatase.

conclusionsFluoroquinolone liver injury is rapid in onset and often has immunoallergic features, indicating a hypersensitivity reaction. The pattern of injury can be hepatocellular, cholestatic, or mixed; mixed cases are the least severe. Acute and chronic liver failure can occur.

Indexed as

AdultAgedAged, 80 and overAlanine TransaminaseAlkaline PhosphataseAnti-Bacterial AgentsAspartate AminotransferasesChemical and Drug Induced Liver InjuryFemaleFluoroquinolonesHistocytochemistryHumansHypersensitivityLiverLiver Function TestsMaleAlanine TransaminaseAlkaline PhosphataseAnti-Bacterial AgentsAspartate AminotransferasesFluoroquinolones

Identifiers

PMID21356330
PMCPMC3718017
OpenAlexW1978351154

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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.