Evidence map›Paper›PMID 35024312›Full record

ArticleActa pharmaceutica Sinica. B2021

Hepatotoxicity reports in the FDA adverse event reporting system database: A comparison of drugs that cause injury

Payal Rana, Michael D Aleo, Xuerong Wen, Stephen Kogut

Open access · diamondAbstract read
In one paragraph

Article in Acta pharmaceutica Sinica. B, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.9field-weighted citation impact, top 5% 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

19 citing papers in PubMed, 45 citations in OpenAlex.

  1. Article
  2. Development and hepatotoxicity of rifamycin derivatives.Expert opinion on drug metabolism & toxicology · 2025
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  18. Hepatotoxicity Induced by Azole Antifungal Agents: A Review Study.Iranian journal of pharmaceutical research : IJPR
    Review
  19. Article
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

4 authors at 2 institutions in 1 country.

Payal RanaDrug Safety Research & Development, Pfizer, Groton, CT 06340, USA.
Michael D AleoDrug Safety Research & Development, Pfizer, Groton, CT 06340, USA.
Xuerong WenUniversity of Rhode Island, College of Pharmacy, Kingston, RI 02881, USA.
Stephen KogutUniversity of Rhode Island, College of Pharmacy, Kingston, RI 02881, USA.
Pfizer (United States) · USUniversity of Rhode Island · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Drug-induced liver injury (DILI) is a leading reason for preclinical safety attrition and post-market drug withdrawals. Drug-induced mitochondrial toxicity has been shown to play an essential role in various forms of DILI, especially in idiosyncratic liver injury. This study examined liver injury reports submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) for drugs associated with hepatotoxicity

Indexed as

Adverse event reportingAE, adverse eventCI, confidence intervalCNS, center nervous systemDILI, drug-induced liver injuryDNA, deoxyribonucleic acidDrug-induced liver injuryFAERS databaseFAERS, FDA's Adverse Event Reporting SystemFDA, US Food and Drug AdministrationHepatotoxicityMedDRA, Medical Dictionary for Regulatory ActivitiesMitochondrial toxicityNCTR-LTKB, National Center for Toxicological Research-Liver Toxicity Knowledge BaseNSAID, nonsteroidal anti-inflammatory drugsROR, Reporting Odds Ratio

Identifiers

PMID35024312
PMCPMC8727782
OpenAlexW3168407294

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.