Abstract: Objective To investigate the characteristics and risk factors of liver injury induced by Gukang capsule, provide technical support for safe and rational use of drugs in clinic. Methods References and reports of liver injury caused by Gukang capsules were summarized and adverse drug reaction monitoring data was collected, and relevant cases were reviewed. The characteristics and causes were also analyzed through studying the potential risk of psoraleae fructus or drugs in the same class in Gukang capsule. Results Liver injury, being the main serious adverse reaction of Gukang capsule, was related to psoraleae fructus. The risk factors may include long-term usage, aged patients, previous history of hepatitis etc. Conclusion The risk of liver injury should be paid attention to. Reference is provided to the clinical usage of Gukang capsule. The drug manufacturers should strengthen pharmacovigilance and risk management to ensure drug safety.

Key words: Gukang capsule, psoraleae fructus, liver injury