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Cited by 9Pharmacovigilance and Adverse Drug ReactionsPharmaceutical Practices and Patient OutcomesComplementary and Alternative Medicine Studies

Safety assessment of disulfiram: real-world adverse event analysis based on FAERS database

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Luo, Jing, Zeng, Yaqi, Chen, Zhe, Luo, Yaan, Shi, Li, Zhou, Xuhui·2024·Frontiers in Psychiatry
DOI 10.3389/fpsyt.2024.1498204PMC PMC11611860
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Abstract

Objective: Disulfiram, an FDA-approved medication for AUD, has shown significant potential as a repurposed drug in therapeutic areas including oncology and infectious diseases. The purpose of study is to analyze adverse events (AEs) associated with disulfiram by examining the FAERS database, with a focus on understanding its safety profile in both traditional and emerging applications. Methods: AE reports concerning disulfiram in the FAERS database from the fourth quarter of 2002 to the third quarter of 2023 were extracted. Various signal detection methods, including ROR, PRR, BCPNN, and MGPS, were used to detect and categorize adverse events. Results: The study collected 52,159,321 AE reports, with 508 reports primarily suspecting disulfiram, identifying 104 Preferred Terms (PTs) across 25 System Organ Classes (SOCs). Major categories of AEs included off label use, psychiatric symptom, liver transplant, and polyneuropathy, with off label use being notably the most reported issue. Strong and new potential AEs were identified, including neurological and psychiatric issues like hypomania, delirium, and vocal cord paralysis; cardiac issues such as electrocardiogram st segment depression; and off label use-related issues like Jarisch-Herxheimer reaction. Conclusion: Disulfiram poses risks of various adverse reactions while having promise as a “repurposed” agent. In clinical applications, practitioners should closely monitor occurrences of hepatobiliary disorders, psychiatric disorders, and nervous system disorders.

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Authors
Luo, J., Zeng, Y., Chen, Z., Luo, Y., Shi, L., & Zhou, X.
Affiliations
  • Hunan University of Traditional Chinese Medicine (CN)
  • Central South University (CN)
Corresponding author
Zhou, Xuhui
ORCID
Venue
Frontiers in Psychiatry
Publisher
Frontiers Media SA
Published
2024-11-19
Volume
15
Pages
1498204-1498204
ISSN
1664-0640 (ISSN-L)
DOI
10.3389/fpsyt.2024.1498204
PMC
PMC11611860
OpenAlex
W4404509995
Cited by
9
References
40
Citations by year
2026: 4 · 2025: 5
FWCI
2.14
Type
journal article
Language
en
Open access
Licence
Locations
  • Frontiers in Psychiatry (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
  • Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
Keywords
disulfiram, adverse drug reactions, drug safety, alcoholism, drug repurposing, off-label drug use, psychiatric adverse events, hepatobiliary adverse events, polyneuropathy, Jarisch-Herxheimer reaction, signal detection, FDA Adverse Event Reporting System

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