{
  "abstract": "Objective: As obesity and diabetes are on the verge of an alarming growth, so is the use of tirzepatide, a novel dual glucose-dependent insulinotropic peptide/glucagon-like peptide-1 (GLP-1) receptor agonist (RA) and currently the most effective weight loss-drug. This research aimed to identify reporting patterns related to suboptimal therapeutic outcomes and tirzepatide-related drug-use issues, mining the EudraVigilance (EV).\n\nDesign: Retrospective pharmacovigilance study using descriptive and disproportionality analyses of reports retrieved from the EV database.\n\nSettings: Analysis of individual case safety reports involving tirzepatide in comparison with other GLP-1 RAs in the overall dataset (healthcare professionals (HP) and non-HP reports combined) and in the HP group.\n\nOutcome measures: Reporting ORs (RORs) with 95% CIs for selected Preferred Terms (PT) related to drug-use issues.\n\nResults: Among all analysed PTs, the most frequently reported were ‘Off-label use’ (n=1521), ‘Drug ineffective’ (n=425) and ‘Off-label use device’ (n=99). PTs in HP reports showed lower reporting odds compared with non-HP reports. In the overall dataset, reports involving tirzepatide showed lower reporting odds of the PT ‘Drug ineffective’ than those involving liraglutide (ROR 0.61, 95% CI 0.54 to 0.70), dulaglutide (ROR 0.72, 95% CI 0.63 to 0.82), exenatide (ROR 0.78, 95% CI 0.67 to 0.92) and semaglutide (ROR 0.81, 95% CI 0.72 to 0.91). However, in HP reports, no difference in reporting odds was observed between tirzepatide and semaglutide. A different pattern was observed for ‘off-label use’ in the full dataset, with higher reporting odds for tirzepatide vs lixisenatide, dulaglutide and liraglutide, but lower reporting odds vs semaglutide (ROR 0.52, 95% CI 0.49 to 0.55). In contrast, a higher reporting odd for the PT ‘off-label use of device’ was observed for tirzepatide versus semaglutide (ROR 43.47, 95% CI 16.00 to 118.13) in the overall reports; however, this finding should be interpreted with caution given the wide CI.\n\nConclusions: This study complements existing evidence from clinical trials and current clinical practice.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Endocrinology, Faculty of Medicine, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, CJ, Romania",
    "Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, CJ, Romania",
    "Preclinical Department, Faculty of Medicine, Lucian Blaga University of Sibiu, Sibiu, SB, Romania",
    "Department of Cardiology, Vth Medical Clinic, Faculty of Medicine, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, CJ, Romania",
    "Medical Clinic No. 1, Internal Medicine Department, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, CJ, Romania",
    "Interventional Cardiology Department, Cluj-Napoca County Emergency Hospital, Cluj-Napoca, CJ, Romania"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Ioana Rada Popa Ilie",
      "orcid": "0000-0002-5281-5004"
    },
    {
      "affs": [
        1
      ],
      "name": "Steliana Ghibu",
      "orcid": "0000-0003-2247-4613"
    },
    {
      "affs": [
        2
      ],
      "name": "Anca Butuca",
      "orcid": "0000-0003-1540-641X"
    },
    {
      "affs": [
        2
      ],
      "name": "Carmen Maximiliana Dobrea",
      "orcid": "0000-0002-9913-1750"
    },
    {
      "affs": [
        2
      ],
      "name": "Adina Frum",
      "orcid": "0000-0003-4874-0430"
    },
    {
      "affs": [
        3
      ],
      "name": "Laurentiu Stoicescu"
    },
    {
      "affs": [
        4,
        5
      ],
      "name": "Cãlin Homorodean"
    },
    {
      "affs": [
        2
      ],
      "name": "Felicia Gabriela Gligor"
    },
    {
      "affs": [
        2
      ],
      "name": "Claudiu Morgovan",
      "orcid": "0000-0003-2730-8729"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/1d7kv29fe7djv.bib",
  "cited_by": 0,
  "doi": "10.1136/bmjopen-2026-120507",
  "fulltext_url": null,
  "id": "1d7kv29fe7djv",
  "issns": [
    "2044-6055",
    "2044-6055"
  ],
  "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-120507",
  "language": null,
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "3005|Pharmacovigilance and Adverse Drug Reactions"
    ]
  ],
  "openalex": "W7215045776",
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-01",
  "publisher": "BMJ",
  "ris": "https://research.draconitic.com/paper/1d7kv29fe7djv.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:44Z",
      "native_id": "10.1136/bmjopen-2026-120507",
      "source": "crossref",
      "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-120507"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:3005|Pharmacovigilance and Adverse Drug Reactions",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Tirzepatide safety in EudraVigilance: descriptive and disproportionality analysis of preferred terms related to suboptimal treatment outcomes and drug-use-related issues",
  "title_text": "Tirzepatide safety in EudraVigilance: descriptive and disproportionality analysis of preferred terms related to suboptimal treatment outcomes and drug-use-related issues",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:19:44Z",
  "url": "https://research.draconitic.com/paper/1d7kv29fe7djv",
  "venue": "BMJ Open",
  "versions": []
}