Signal mining and analysis of adverse events associated with Isotretinoin: A 20-Year real-world pharmacovigilance study based on FAERS and EudraVigilance databases

Qian Chen; JinYue Li; Mao Zhang; XueDong Kang; LiZhu Han; Yuan Bian; HongLi Luo

doi:10.1371/journal.pone.0329161

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Open Access

Peer-reviewed

Research Article

Signal mining and analysis of adverse events associated with Isotretinoin: A 20-Year real-world pharmacovigilance study based on FAERS and EudraVigilance databases

Qian Chen,

Roles Conceptualization, Methodology, Writing â original draft

Affiliation Department of Pharmacy, Affiliated Hospital of Southwest Medical University, Luzhou city, Sichuan Province, China
⨯
JinYue Li,

Roles Data curation

Affiliation Department of Pharmacy, Affiliated Hospital of Southwest Medical University, Luzhou city, Sichuan Province, China
⨯
Mao Zhang,

Roles Methodology

Affiliation Department of Pharmacy, the First People’s Hospital of Yibin, YinBin city, Sichuan Province, China
⨯
XueDong Kang,

Roles Conceptualization

Affiliation Department of Pharmacy, the First People’s Hospital of Yibin, YinBin city, Sichuan Province, China
⨯
LiZhu Han,

Roles Data curation

Affiliation Personalized Drug Therapy Key Laboratory of Sichuan Province, Department of Pharmacy, Sichuan Academy of Medical Sciences, Sichuan Provincial People’s Hospital, Affiliated Hospital of University of Electronic Science and Technology of China, Chengdu city, Sichuan Province, China
⨯
Yuan Bian ,

Roles Writing â review & editing

* E-mail: bianyuan567@126.com (YB); lyfylhl@163.com (HLL)

Affiliation Personalized Drug Therapy Key Laboratory of Sichuan Province, Department of Pharmacy, Sichuan Academy of Medical Sciences, Sichuan Provincial People’s Hospital, Affiliated Hospital of University of Electronic Science and Technology of China, Chengdu city, Sichuan Province, China

https://orcid.org/0000-0003-2365-9177

⨯
HongLi Luo

Roles Conceptualization, Formal analysis, Methodology, Project administration, Resources, Supervision

* E-mail: bianyuan567@126.com (YB); lyfylhl@163.com (HLL)

Affiliation Department of Pharmacy, Affiliated Hospital of Southwest Medical University, Luzhou city, Sichuan Province, China

https://orcid.org/0000-0002-2973-5612

⨯

Signal mining and analysis of adverse events associated with Isotretinoin: A 20-Year real-world pharmacovigilance study based on FAERS and EudraVigilance databases

Qian Chen,
JinYue Li,
Mao Zhang,
XueDong Kang,
LiZhu Han,
Yuan Bian,
HongLi Luo

Published: July 16, 2026
https://doi.org/10.1371/journal.pone.0329161

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