J Pharmacoepidemiol Risk Manage.  2020 Sep;12(2):79-84.

Characteristics of Adverse Drug Reactions of Central Muscle Relaxants Including Eperisone: Analysis of KAERS Data

• Park G
• Sohn JE
• Moon M
• Lee JY
• Kang HR
• Kang DY

Abstract

Objective
Eperisone is the most widely prescribed muscle relaxant in Korea. However, few studies have investigated the adverse drug reactions (ADRs) of eperisone in the Korean population. A study is needed to analyze the ADR characteristics of eperisone in Koreans, especially the risk of anaphylaxis compared to other spasmolytic agents.
Methods
The individual safety case report (ISCR) of 1989 to 2015 from the Korea Institute of Drug Safety and Risk Management (KIDS) have been analyzed. Frequent ADRs of eperisone were listed by using World Health Organization Adverse Reaction Terminology classification. The proportional reporting ratio (PRR) has been calculated to estimate the risk of anaphylaxis caused by eperisone compared to other central muscle relaxants.
Results
9,036 cases (1.1%) were related to central muscle relaxants among a total of 860,224 ISCRs from 1989 to 2015. Eperisone was the first place as 3,030 cases (33.5%). The symptoms of eperisone-induced ADRs were mostly similar with those of other central muscle relaxants. However, the anaphylaxis, which is a serious ADR that could be life-threatening, was significantly more reported in ADRs related to eperisone than those related to other central muscle relaxants (PRR = 4.80, 95% confidence interval: 2.73-8.41, p ＜ 0.001).
Conclusion
Eperisone is highly related to drug-induced anaphylaxis compared to other central muscle relaxants.

Keyword

Central muscle relaxants; Drug-related side effects and adverse reactions; Drug hypersensitivity; Anaphylaxis