Evaluation of the association of pseudoaldosteronism with licorice-containing herbal medicine using the Japanese adverse drug event report (JADER) database

Clinical Snapshot

Key Findings

• P Value: Not reported in abstract

• Effect Size: RORs >1 for all top 20 licorice-containing herbal medicines

• Primary Outcome: 537 cases of pseudoaldosteronism identified from 961,171 reports

• Nnt Or Sensitivity: ROC analysis: AUC 0.71, sensitivity 84.93%, specificity 44.70%, cutoff 1.125 g/day licorice

• Confidence Interval: Not reported in abstract

Clinical Application

Practical threshold of 1.125 g/day licorice provides actionable clinical guidance for monitoring and dose adjustment Relevant to Australian practice where herbal medicines are TGA-regulated. Findings support need for patient education and monitoring protocols for licorice-containing preparations available through pharmacies and practitioners Patients using Kampo or licorice-containing herbal medicines, particularly relevant for complementary medicine practitioners and general practitioners

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE: Herbal medicine in Japan is known as Kampo preparation, a traditional medicine that combines multiple medicinal herbs and is widely used in medical practice. Pseudoaldosteronism is an issue associated with herbal medicines that contain licorice. However, the relationship between licorice intake and pseudoaldosteronism is not fully understood and is debatable. AIM OF THE STUDY: This study evaluates the association between herbal medicine preparations containing licorice and pseudoaldosteronism using data from the Japanese Adverse Drug Reaction Reporting System (JADER) database. MATERIALS AND METHODS: The JADER database contained 961,171 reports published between April 2004 and December 2024. The association between herbal medicines and pseudoaldosteronism was evaluated using the pharmacovigilance index as the reporting odds ratio (ROR) and logistic regression models. RESULTS: There were 537 cases of pseudoaldosteronism (PT code: 10037113). The reporting ratio of pseudoaldosteronism was higher in the licorice-containing herbal medicines group than in the overall herbal medicines group. The RORs of the top 20 herbal medicines with the highest number of pseudoaldosteronism reports, all of which contained licorice, exceeded one, and a signal was detected. The risk of pseudoaldosteronism increased with increasing licorice intake. According to the receiver operating characteristic (ROC) curve for pseudoaldosteronism (area under the curve (AUC) = 0.71, sensitivity = 0.8493, 1-specificity = 0.5530), the cutoff value was 1.125 g/day. CONCLUSIONS: This study is the first to clarify the association between licorice intake from herbal medicines and pseudoaldosteronism using Japan's spontaneous adverse event-reporting database. These findings will be useful and informative for medical professionals considering treatments with herbal medicines.

References

1. 1.Nakao, S., Liao, J., Ino, Y., Oura, K., Ito, S., Kageyama, K., Sato, M., Murakami, Y., Ishida, S., Hirota, T., Endo, S., Uchida, M., Iguchi, K., & Nakamura, M. (2026). Evaluation of the association of pseudoaldosteronism with licorice-containing herbal medicine using the Japanese adverse drug event report (JADER) database. Journal of Ethnopharmacology, 121202. https://doi.org/10.1016/j.jep.2026.121202