Cutaneous toxicity induced by antidepressants and second-generation antipsychotics in the United States food and drug administration adverse event reporting system.

BACKGROUND: Adverse cutaneous drug reactions have been reported with most drugs, including antidepressants (ADs) and second-generation antipsychotics (SGAs). The lack of extensive research on the relationship between ADs and SGAs, and cutaneous toxicity remains troubling. Our study aimed to assess the cutaneous toxicity of ADs and SGAs and provide valuable insights for clinical applications and scientific investigations.

RESEARCH DESIGN AND METHODS: We conduct a pharmacovigilance study based of the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analysis the relationship of ADs and SGAs and cutaneous adverse events. Reporting odds ratios (ROR) and information components (IC) were presented using statistical shrinkage transformation.

RESULTS: Comparing ACDRs to other ADRs, each AD (fluoxetine (ROR025 = 1.49), fluvoxamine (ROR025 = 1.14), paroxetine (ROR025 = 1.49), escitalopram (ROR025 = 1.79), sertraline (ROR025 = 1.44), venlafaxine (ROR025 = 1.46) and duloxetine (ROR025 = 1.69)) showed significantly more cases. There was no association between SGA and cutaneous toxicity. The spectrum displayed strong signals in duloxetine-induced genital ulceration (IC025 = 2.75) and amisulpride-induced conjunctivitis (IC025 = 2.56).

DISCUSSION: This study provides a valuable foundation for clinical practice and medication monitoring by thoroughly analyzing, methodically evaluating, and quantifying the potential dermal toxicity of ADs and SGAs.