Adverse Drug Reactions Induced by Chinese Patent Medicine:Analysis of 333 Cases

OBJECTIVE:To investigate the characteristic and regularities of the adverse drug reactions(ADR)induced by Chinese patent medicine in Xiamen city during 2013 for reference of strengthening monitoring on the ADR of Chinese patent medicine.METHODS:A total of 333 ADR cases induced by Chinese patent medicine were analyzed statistically with regard to patients' age and gender,route of administration,dosage forms,major ADR-inducing drugs,organs or systems involved,and ADR types. RESULTS:Of the 333 ADR cases,women accounted for 64.56%;a total of 136 Chinese patent drugs were involved,with 35 respectively induced ADR of at least 3 cases,and the total ADR cases induced by the 35 drugs represented 61.26% of the total ADR cases;59.76% of the ADR cases were induced by oral drugs followed by intravenous drugs(26.43%). 77.77% of the ADR cases manifested as lesion of sensory organs and 39.04% by digestive system lesions. CONCLUSIONS:The ADRs of Chinese patent medicine are associated with multiple factors thus their ADR monitoring should be emphasized to promote medication safety of Chinese patent medicine.