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<p>Medications for alcohol use disorder (AUD) are associated with various adverse events, raising safety concerns in clinical practice. Therefore, this study aimed to investigate the adverse event profiles of AUD medications using a Japanese pharmacovigilance database.&#xa0;We used data from the Japanese Adverse Drug Event Report database from April 2004 to July 2025. We focused on reports involving acamprosate, cyanamide, disulfiram and nalmefene, the four medications approved for AUD treatment in Japan.&#xa0;In total, 562 reports were analyzed, including 96 for acamprosate, 270 for cyanamide, 103 for disulfiram and 93 for nalmefene. Disproportionality signals were identified for completed suicide, cerebral infarction and acute eosinophilic pneumonia with acamprosate, Stevens–Johnson syndrome, toxic epidermal necrolysis and hematologic disorders with cyanamide, liver disorders, metabolic and neurological events with disulfiram, and cutaneous reactions with nalmefene.&#xa0;This study comprehensively investigated the adverse events associated with the approved AUD medications in Japan. Our findings should be regarded as preliminary and hypothesis-generating rather than conclusive evidence of risk. Further studies are needed. In addition, continued pharmacovigilance and cautious clinical monitoring are required for patients receiving AUD medications.</p>

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Analysis of the Adverse Event Profiles of Medications for Alcohol Use Disorder: Insights from a Japanese Pharmacovigilance Database

  • 期刊论文

  • 发表日期：

    2026年2月9日

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  • Kazumasa Kotake,
  • Masaki Fujiwara,
  • Tadashi Shimizu

摘要

Medications for alcohol use disorder (AUD) are associated with various adverse events, raising safety concerns in clinical practice. Therefore, this study aimed to investigate the adverse event profiles of AUD medications using a Japanese pharmacovigilance database. We used data from the Japanese Adverse Drug Event Report database from April 2004 to July 2025. We focused on reports involving acamprosate, cyanamide, disulfiram and nalmefene, the four medications approved for AUD treatment in Japan. In total, 562 reports were analyzed, including 96 for acamprosate, 270 for cyanamide, 103 for disulfiram and 93 for nalmefene. Disproportionality signals were identified for completed suicide, cerebral infarction and acute eosinophilic pneumonia with acamprosate, Stevens–Johnson syndrome, toxic epidermal necrolysis and hematologic disorders with cyanamide, liver disorders, metabolic and neurological events with disulfiram, and cutaneous reactions with nalmefene. This study comprehensively investigated the adverse events associated with the approved AUD medications in Japan. Our findings should be regarded as preliminary and hypothesis-generating rather than conclusive evidence of risk. Further studies are needed. In addition, continued pharmacovigilance and cautious clinical monitoring are required for patients receiving AUD medications.