ArticleJournal of Korean medical science2025
Psychological Adverse Events and Associated Safety Profiles of Doxepin: A Pharmacovigilance Study Using VigiBase.
Article in Journal of Korean medical science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundDoxepin, an antidepressant commonly prescribed for the management of depression and insomnia, has been insufficiently explored regarding its safety. We aimed to determine the overall safety profile of doxepin and evaluate relevant adverse events of special interest (AESIs).
methodsUtilizing the World Health Organization's VigiBase from 1967 to 2022, we conducted a disproportionality analysis for AESIs associated with doxepin compared with other tricyclic antidepressants. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were estimated using multivariable logistic regression analysis. Signals were regarded significant when they met the following criteria: cases ≥ 3, and lower end of the 95% CI of ROR ≥ 1.
resultsOf the 6,827 doxepin-related reports, 3,869 (56.67%) were predominantly reported in women, with a substantial proportion from the middle-aged population. Overall, none of the predefined AESIs met the safety criteria for this analysis. However, among the frequently reported adverse events (AEs) following doxepin administration, safety signal was identified for drug abuse (adjusted ROR, 2.41; 95% CI, 2.06-2.83).
conclusionAlthough no definitive safety signals were detected in our AESI analyses, we identified safety signal for drug abuse. Clinicians should carefully weigh the risks and benefits when prescribing doxepin and emphasize the need for vigilant monitoring of AEs.
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