Analysis of licorice-induced pseudoaldosteronism in the Japanese Adverse Drug Event Report database

Aim We analyzed the association of age, sex, and dosage with licorice-associated pseudoaldosteronism using spontaneous adverse event reports. Methods Pseudoaldosteronism incidence data from 2004 to 2013 were obtained from the Japanese Adverse Drug Event Report (JADER) database. These reports were analyzed using a reporting odds ratio (ROR). Medical Dictionary for Regulatory Activities-preferred terms were used to identify pseudoaldosteronism. Results Pseudoaldosteronism was reported frequently in female patients aged >50 years. ROR of pseudoaldosteronism were calculated and stratified by licorice dosage. ROR (95%CI) for doses <2.5, 2.5–4.9, and ≥5.0 g were 20.9 (15.1–28.8), 26.1 (15.1–45.0), and 147.3 (150.3–206.0), respectively. Conclusion Despite the limitations of spontaneous reporting, licorice dosage may be associated with pseudoaldosteronism. Considering the causality restraint of the current analysis, further epidemiological studies are recommended.