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已发表论文
药物所致皮肤色素沉着（色素沉着过度和色素沉着不足）调查
Authors Tang J, Lv B, Liu L, Hu Y , Li K, Xu L, Zheng J, Liu G, Jiao L, Li Q
Received 2 August 2025
Accepted for publication 13 November 2025
Published 17 November 2025 Volume 2025:18 Pages 3061—3074
DOI https://doi.org/10.2147/CCID.S557919
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Monica K. Li
Jia Tang,1 Bing Lv,2 Linli Liu,1 Yuan Hu,1 Kehan Li,1 Liuli Xu,1 Ji Zheng,1 Guanglin Liu,3 Liang Jiao,1 Qianying Li1
1Department of Dermatology, Suining Central Hospital, Suining, Sichuan, People’s Republic of China; 2Department of Emergency, The First Hospital of Jilin University, Changchun, Jilin, People’s Republic of China; 3Department of Cardiology, the People’s Hospital of Kaijiang, Dazhou, Sichuan, People’s Republic of China
Correspondence: Qianying Li, Email 1208719173@qq.com
Background: Drug-induced skin pigmentary changes are an underrecognized yet clinically significant type of adverse event (AE). Despite growing awareness, labeling for many implicated drugs remains incomplete.
Objective: To conduct a comprehensive pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database (2010– 2024) to identify drugs associated with skin hyperpigmentation, hypopigmentation, or both, and to explore their clinical implications and repurposing potential.
Methods: The study analyzed case reports from the FAERS database using the OpenVigil 2.1 platform. Pigmentary AEs were identified based on the MedDRA Preferred Terms “skin hyperpigmentation” and “skin hypopigmentation.” To ensure consistency, all drug names were standardized to their generic forms using the DrugBank database before inclusion in the analysis. Disproportionality analysis was performed using the Reporting Odds Ratio (ROR) to detect significant associations between drugs and pigmentary AEs.
Results: A spectrum of agents demonstrated strong associations with pigmentary changes. Minocycline (ROR 115.66) and setmelanotide (ROR 1506.82) showed high RORs for hyperpigmentation, while triamcinolone (ROR 37.20) and ribociclib (ROR 60.20) were strongly linked to hypopigmentation. Several drugs, including dupilumab, tretinoin, and clobetasol, exhibited bidirectional pigmentary modulation. Notably, a substantial proportion of implicated drugs lacked labeling for these effects.
Conclusion: This study identifies notable pigmentary AE signals associated with several commonly prescribed drugs. These findings emphasize the importance of early recognition and dermatologic monitoring during prolonged therapy. Considering the odds ratio and analysis results, the drugs found to be associated with hyperpigmentation or hypopigmentation warrant further investigation.
Keywords: drug-induced pigmentation, hyperpigmentation, hypopigmentation, pharmacovigilance, drug repurposing
1Department of Dermatology, Suining Central Hospital, Suining, Sichuan, People’s Republic of China; 2Department of Emergency, The First Hospital of Jilin University, Changchun, Jilin, People’s Republic of China; 3Department of Cardiology, the People’s Hospital of Kaijiang, Dazhou, Sichuan, People’s Republic of China
Correspondence: Qianying Li, Email 1208719173@qq.com
Background: Drug-induced skin pigmentary changes are an underrecognized yet clinically significant type of adverse event (AE). Despite growing awareness, labeling for many implicated drugs remains incomplete.
Objective: To conduct a comprehensive pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database (2010– 2024) to identify drugs associated with skin hyperpigmentation, hypopigmentation, or both, and to explore their clinical implications and repurposing potential.
Methods: The study analyzed case reports from the FAERS database using the OpenVigil 2.1 platform. Pigmentary AEs were identified based on the MedDRA Preferred Terms “skin hyperpigmentation” and “skin hypopigmentation.” To ensure consistency, all drug names were standardized to their generic forms using the DrugBank database before inclusion in the analysis. Disproportionality analysis was performed using the Reporting Odds Ratio (ROR) to detect significant associations between drugs and pigmentary AEs.
Results: A spectrum of agents demonstrated strong associations with pigmentary changes. Minocycline (ROR 115.66) and setmelanotide (ROR 1506.82) showed high RORs for hyperpigmentation, while triamcinolone (ROR 37.20) and ribociclib (ROR 60.20) were strongly linked to hypopigmentation. Several drugs, including dupilumab, tretinoin, and clobetasol, exhibited bidirectional pigmentary modulation. Notably, a substantial proportion of implicated drugs lacked labeling for these effects.
Conclusion: This study identifies notable pigmentary AE signals associated with several commonly prescribed drugs. These findings emphasize the importance of early recognition and dermatologic monitoring during prolonged therapy. Considering the odds ratio and analysis results, the drugs found to be associated with hyperpigmentation or hypopigmentation warrant further investigation.
Keywords: drug-induced pigmentation, hyperpigmentation, hypopigmentation, pharmacovigilance, drug repurposing