{
  "abstract": "Background: Metformin-associated diarrhea is well recognized, but spontaneous-report analyses remain sensitive to outcome definition, reporting background, and incomplete event-date data. This study evaluated whether the reporting imbalance persisted across prespecified definitions, comparator sets, and calendar periods.\n\nMethods: U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) reports from the first quarter of 2020 through the first quarter of 2026 were deduplicated and analyzed with metformin coded as a primary or secondary suspect drug. The primary outcome was the Medical Dictionary for Regulatory Activities preferred term DIARRHOEA. Sensitivity analyses used a broad loose-stool phenotype, a clean gastrointestinal event composite, alternative exposure roles, active comparators, co-medication exclusions, and stratification. Exact-date report-level event-date intervals among reports containing the strict-diarrhea preferred term were summarized descriptively. A separately processed dataset covering the first quarter of 2004 through the first quarter of 2026 assessed temporal consistency.\n\nResults: Among 9,112,609 reports, 60,452 involved metformin as a primary or secondary suspect drug and 4,868 included strict diarrhea. The primary reporting odds ratio (ROR) was 2.72 (95% confidence interval, 2.64–2.80). Restriction to non-metformin antidiabetic reports attenuated the ROR to 1.95 (1.89–2.01), showing sensitivity to the reporting background. Only 595 reports (12.2%) yielded a valid report-level event-date interval; the median interval was 14 days (interquartile range, 1–363). The long-term ROR was 2.76 (2.71–2.81), with marked annual variation.\n\nConclusion: Metformin showed a persistent but context-dependent diarrhea reporting imbalance in FAERS. Active-comparator attenuation limits causal and clinical-risk interpretation. The selected interval subset supports descriptive reporting only and cannot define diarrhea-specific onset or a clinical monitoring window.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Endocrinology, The Second People’s Hospital of Bengbu City , , ,",
    "Department of Infectious Diseases, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College , , ,"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 2,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Shida Chen"
    },
    {
      "affs": [
        1
      ],
      "name": "Chengan Xu"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/5edpdt5yexram.bib",
  "cited_by": 0,
  "doi": "10.3389/fphar.2026.1902348",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13690660/?tool=EBI",
  "id": "5edpdt5yexram",
  "issns": [
    "1663-9812"
  ],
  "landing_url": "https://europepmc.org/article/PMC/PMC13690660",
  "language": "eng",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "3005|Pharmacovigilance and Adverse Drug Reactions"
    ]
  ],
  "openalex": "W7221143615",
  "pdf_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13690660/pdf/?tool=EBI",
  "pmcid": "PMC13690660",
  "pmid": null,
  "published": "2026-10-09",
  "publisher": "Frontiers Media SA",
  "ris": "https://research.draconitic.com/paper/5edpdt5yexram.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:59Z",
      "native_id": "PMC:PMC13690660",
      "source": "europepmc",
      "url": "https://europepmc.org/article/PMC/PMC13690660"
    },
    {
      "first_seen": "2026-10-30T12:20:06Z",
      "native_id": "10.3389/fphar.2026.1902348",
      "source": "crossref",
      "url": "https://www.frontiersin.org/articles/10.3389/fphar.2026.1902348/full"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:3005|Pharmacovigilance and Adverse Drug Reactions",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Metformin-associated diarrhea in FAERS: a structured pharmacovigilance study with long-term temporal consistency assessment",
  "title_text": "Metformin-associated diarrhea in FAERS: a structured pharmacovigilance study with long-term temporal consistency assessment",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:06Z",
  "url": "https://research.draconitic.com/paper/5edpdt5yexram",
  "venue": "Frontiers in pharmacology",
  "versions": []
}