Evidence map›Paper›PMID 41451911›Full record

ArticleSkin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI)2025

Melanosis Secondary to Drugs: A Real-World Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS).

Yilin Zhao, Hanzhang Xie, Zhanshuo Xiao, Yansong Zhao

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Melanosis Secondary to Drugs: A Real-World Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS).Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Yilin ZhaoBeijing University of Chinese Medicine, Beijing, China.
Hanzhang XieBeijing University of Chinese Medicine, Beijing, China.
Zhanshuo XiaoDepartment of Dermatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Yansong ZhaoBeijing University of Chinese Medicine, Beijing, China.

Funding

Escort Project of Guang'anmen Hospital, China Academy of Chinese Medicine Science-Backbone Talent GAMHH9324021High Level Chinese Medical Hospital HLCMHPP2023027High Level Chinese Medical Hospital HLCMHPP2023088Scientific Research Foundation for New recruits, China Academy of Chinese Medical Sciences ZZ16-XRZ-045
6 · The paper itself

Abstract

backgroundMelanosis is an acquired hyperpigmentation disorder that can be associated with the use of medications; timely identification and discontinuation of relevant medications is an important aspect of clinical management.

objectiveThis study investigates the relationship between melanosis and drug exposure based on data from the FDA Adverse Event Reporting System (FAERS) database. We sought to determine the top drugs reported in association with melanosis in the FAERS.

methodsA retrospective analysis of FAERS data from January 2004 to June 2024 was conducted to identify reports related to melanosis, using the Comprehensive Medical Dictionary for Regulatory Activities (MedDRA) terminology. A total of 18 182 912 independent adverse event reports were processed, and signal mining analyses were performed to detect associations between drugs and melanosis. Disproportionality analyses were conducted using four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). The most frequently reported drugs and their associated adverse event reports were analyzed.

resultsHundred and one reports related to melanosis were screened, involving 73 drug names as primary suspect (PS). By combining and organizing the different names of drugs such as trade names and generic names, 66 drugs were obtained. The top five drugs associated with melanosis were talimogene laherparepvec (ROR: 1891.39), followed by ferrous sulfate (ROR: 997.14), minocycline (ROR: 176.05), vemurafenib (ROR: 97.64), and pembrolizumab (ROR: 19.73).

conclusionPatients who experience drug-induced melanosis generally have bad outcomes, underscoring the imperative for heightened clinical surveillance regarding the risk of drug-induced melanosis.

Indexed as

Adverse Drug Reaction Reporting SystemsMelanosisAdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedBayes TheoremBiological ProductsFemaleFerrous CompoundsHerpesvirus 1, HumanHumansMaleMiddle AgedMinocyclineAntibodies, Monoclonal, HumanizedBiological ProductsFerrous Compoundsferrous sulfateMinocyclinepembrolizumabtalimogene laherparepvecVemurafenibadverse eventcutaneous melanosisdrug‐induced cutaneous melanosisFAERSmelanosispharmacovigilance study

Identifiers

PMID41451911
PMCPMC12741942

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.