{
  "abstract": "Background: Excipients play a crucial role in pharmaceutical formulations, however, their safety profile in pediatric populations remains inadequately characterized.\n\nMethods: This retrospective multicenter study was conducted in two phases. Phase one reviewed package inserts of pediatric medications used at seven Fujian hospitals (July 2019–June 2024) to assess excipient labeling. Phase two analyzed associations between potentially harmful excipients (PHEs) exposure and adverse drug reactions using the reporting odds ratio (ROR) method at a single children's hospital.\n\nResults: The rates of excipient labeling exhibited significant variation based on hospital type, drug source, and drug category. In total, 41.3% of pediatric cases and 43.2% of prescriptions included at least one PHE. Benzyl alcohol was associated with application site pain (ROR = 393.20, P < 0.05) and erythema (ROR = 85.84, P < 0.05); thimerosal was linked to application site irritation (ROR = 278.35, P < 0.05) and pruritus (ROR = 115.20, P < 0.05); and sodium citrate was associated with bradycardia (ROR = 157.59, P < 0.05).\n\nConclusion: The labeling of excipients in pediatric pharmaceutical products is insufficient in the institutions examined, potentially hindering the identification of excipient exposure in clinical practice. The safety signals identified in this study necessitate further systematic investigation and careful consideration within both regulatory and clinical contexts.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Pharmacy, Children’s Hospital of Fudan University (Xiamen Branch), Xiamen Children’s Hospital",
    "Department of Pharmacy, Quanzhou Women’s and Children’s Hospital",
    "Department of Pharmacy, Women and Children’s Hospital Affiliated to Xiamen University",
    "Department of Pharmacy, Zhongshan Hospital Affiliated to Xiamen University",
    "Department of Pharmacy, Longyan First Affiliated Hospital of Fujian Medical University",
    "Department of Pharmacy, Nanping First Hospital Affiliated to Fujian Medical University",
    "Department of Pharmacy, Fuzhou Children’s Hospital of Fujian Province",
    "Fujian Key Laboratory of Neonatal Diseases, Xiamen Key Laboratory of Neonatal Diseases, Xiamen Children’s Hospital (Children’s Hospital of Fudan University at Xiamen)"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Su-ping Li"
    },
    {
      "affs": [
        0
      ],
      "name": "Xia-yang Wu"
    },
    {
      "affs": [
        1
      ],
      "name": "Jun-kai Ning"
    },
    {
      "affs": [
        2
      ],
      "name": "Xiao-qing Huang"
    },
    {
      "affs": [
        3
      ],
      "name": "Yi-juan Shen"
    },
    {
      "affs": [
        4
      ],
      "name": "Yu-ying Chen"
    },
    {
      "affs": [
        5
      ],
      "name": "Kai-jun Liao"
    },
    {
      "affs": [
        6
      ],
      "name": "Feng Weng"
    },
    {
      "affs": [
        0,
        7
      ],
      "name": "You-hong Wang"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/bn1sk4p7ny04b.bib",
  "cited_by": 0,
  "doi": "10.3389/fphar.2026.1949057",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13710364/",
  "id": "bn1sk4p7ny04b",
  "issns": [
    "1663-9812"
  ],
  "landing_url": "https://www.frontiersin.org/articles/10.3389/fphar.2026.1949057/full",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Research"
    ],
    [
      "openalex",
      "2735|Pharmaceutical studies and practices"
    ]
  ],
  "openalex": "W7221717106",
  "pdf_url": "https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2026.1949057/pdf",
  "pmcid": "PMC13710364",
  "pmid": "42947935",
  "published": "2026-10-13",
  "publisher": "Frontiers Media SA",
  "ris": "https://research.draconitic.com/paper/bn1sk4p7ny04b.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:06Z",
      "native_id": "10.3389/fphar.2026.1949057",
      "source": "crossref",
      "url": "https://www.frontiersin.org/articles/10.3389/fphar.2026.1949057/full"
    },
    {
      "first_seen": "2026-10-31T12:21:21Z",
      "native_id": "PMC13710364",
      "source": "pmc",
      "url": "https://doi.org/10.3389/fphar.2026.1949057"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2735|Pharmaceutical studies and practices",
      "subfield": "reproductive-child"
    }
  ],
  "title": "Potentially harmful excipients in drugs: an analysis of labeling practices and adverse drug reactions",
  "title_text": "Potentially harmful excipients in drugs: an analysis of labeling practices and adverse drug reactions",
  "type": "peer-reviewed",
  "updated_at": "2026-10-31T12:21:21Z",
  "url": "https://research.draconitic.com/paper/bn1sk4p7ny04b",
  "venue": "Frontiers in Pharmacology",
  "versions": []
}