Chinese Journal of Pharmacovigilance ›› 2018, Vol. 15 ›› Issue (12): 728-732.

Previous Articles     Next Articles

Analysis of 4217 Cases of Adverse Drug Reactions Induced by Progesterone Oral Agents

HU Tingxia1, LV Xiaoqin1, LI Lan2, TAO Qiaofeng1   

  1. 1Zhejiang Center for Drug & Cosmetic Evaluation, Zhejiang Hangzhou 310012, China;
    2Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2019-01-18 Revised:2019-01-18 Online:2018-12-20 Published:2019-01-18

Abstract: Objective To study the features of adverse drug reactions(ADRs) induced by progesterone oral agents, so as to provide rational use of drugs in clinic. Methods 4 217 cases of ADRs report caused by progesterone oral agents consisted of feedback data of related drug manufacturers and data reported by provincial ADRs monitorting system were collected from 2009 to 2017 and performed the statistical analysis by the Excel 2010 electronic form. Results Most cases of ADRs report caused by progesterone oral agents happened on the day of medication. Adverse reactions mainly included central and peripheral nervous system damage, followed by gastrointestinal system damage and systemic damage. As the extension of the duration of drug application, cases involved in hepatobiliary system damage were reported. Conclusion Hospital staff and patients should pay attention to ADRs induced by progesterone oral agents,especially for the influence of psychiatric and neurological system such as dizziness, vertigo, somnolence, syncope et al. Production enterprises should promptly revise and improve the safety information of drug instructions, so as to ensure the safety of drug use for patients.

Key words: progesterone oral agents, adverse reaction, analysis

CLC Number: