Post-marketing safety assessment of tetrandrine based on the WHO-VigiAccess database

Tetrandrine, a bisbenzylisoquinoline alkaloid extracted from Stephania tetrandra S. Moore, is clinically used in the treatment of silicosis and rheumatoid arthritis. Despite its demonstrated efficacy, systematic safety evaluations remain limited. This study represents the first effort to identify adverse event (AE) signals associated with tetrandrine meglumine using the World Health Organization VigiAccess database. Global AE reports for tetrandrine were extracted up to July 6, 2025. The collected data included demographic variables such as age group and gender, as well as regional distribution. Additionally, data on adverse drug reaction-related disease systems and symptoms were compiled from adverse drug reaction annual reports and reports submitted to the World Health Organization. Disproportionality analyses were conducted using the reporting odds ratio (ROR) and the Bayesian confidence propagation neural network. A total of 265 reports were included, documenting 448 AEs. The most commonly affected systems were gastrointestinal disorders (38.39%), skin and subcutaneous tissue disorders (16.96%), and nervous system disorders (16.07%). Frequently reported adverse reactions included nausea, dizziness, pruritus, vomiting, rash, abdominal pain, diarrhea, and abnormal hepatic function. Strong association signals were observed for oral anesthesia (ROR 241.19, 95% confidence interval [CI] 79.74-729.58), abnormal hepatic function (ROR 20.31, 95% CI 12.27-33.63), hypoaesthesia (ROR 10.47, 95% CI 4.66-23.54), pollakiuria (ROR 9.53, 95% CI 3.04-29.83), and abdominal pain (ROR 8.94, 95% CI 5.96-13.41). Additionally, potential adverse reactions not listed in the product labeling, including pruritus, rash, abnormal hepatic function, chest pain, palpitations, hypoaesthesia, edema, pyrexia, insomnia, pollakiuria, and dyspnea, were identified. This study comprehensively characterized the AE profile of tetrandrine and identified novel adverse effects. These findings underscore the importance of ongoing drug safety monitoring and patient management, and highlight the need for clinicians to use this medication more appropriately, tailoring treatment regimens based on the identified adverse effect profiles.