Chinese Journal of Pharmacovigilance ›› 2020, Vol. 17 ›› Issue (5): 300-304.
DOI: 10.19803/j.1672-8629.2020.05.09

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128 Cases of Adverse Drug Reactions Induced by Amisulpride Tablets

YANG Xue   

  1. Food and Drug Reevaluation Center of Henan, Zhengzhou Henan 450018, China
  • Received:2019-07-08 Revised:2020-06-22 Online:2020-05-15 Published:2020-05-13

Abstract: ObjectiveTo analyze the characteristics and patterns of adverse drug reactions (ADRs) induced by amisulpride and promote clinically rational use of this drug. Methods The clinical data on 128 cases of ADRs caused by amisulpride tablets was retrospectively analyzed. These cases were collected by Henan ADR monitoring system between January 2011 and May 2019. The patients' gender, age, medical history, medication and adverse drug reactions were analyzed. Results ADRs caused by amisulpride mostly occurred in patients aged 15 to 44 (75.78%). Most of the ADRs were neurologcial disorders , endocrine disorders, gastrointestinal disorders and cardiovascular disorders. Clinical manifestations included extrapyramidal disorders, hyperprolactinaemia, sinus bradycardia, constipation and leucopenia. Conclusion We should be alert to the occurrence of adverse reactions, strengthen the monitoring and risk management of drug use, and ensure the safety of drug use.

Key words: amisulpride, adverse drug reactions, analysis

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