Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (7): 683-685.
DOI: 10.19803/j.1672-8629.2021.07.18

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Risks of Shuanghuanglian Oral Preparation

YU Hongli1, YU Dongmei2, PANG Yu1, SHAO Bo1, SONG Haibo1,*   

  1. 1Center for Drug Reevaluation, NMPA, Beijing 100022, China;
    2Center for Food Evaluation, State Administration for Market Regulation, Beijing 100070, China
  • Received:2020-01-22 Online:2021-07-15 Published:2021-07-23

Abstract: Objective To analyze the risk of Shuanghuanglian oral preparation in order to provide reference for rational clinical use. Methods Cases of adverse reactions related to Shuanghuanglian oral preparation that were retrieved from China adverse drug reaction database and domestic literature were analyzed. Results The adverse drug reaction/adverse event (ADR/AE) reports from the national ADR monitoring system and literature showed that the ADR of Shuanghuanglian oral preparation involved multiple systems and organs, and that the clinical manifestations included rash, pruritus, nausea and vomiting, etc. Conclusion Shuanghuanglian oral preparation should be used with caution and related adverse reactions deserve attention.

Key words: Shuanghuanglian, oral preparation, adverse reaction

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