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KMID : 1011320180100020077
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Journal of Pharmacoepidemiology and Risk Management
2018 Volume.10 No. 2 p.77 ~ p.83
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Analysis of Tramadol Induced Adverse Drug Reaction on a Spontaneous Reporting System in a Single Hospital
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Kim Byung-Uk
Park Ji-Yea
Kang Ri-Hyeon
Kim You-Young
Kim Gunn-Hee
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Abstract
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Objective: The purpose of the present study is to highlight the seriousness of tramadol-induced adverse events as well as the possibility of drug abuse or misuse to the healthcare providers and patients, thereby emphasize the need for a more stringent drug management system in Korea in line with the worldwide trend.
Methods: We analyzed 421 reported cases with 634 symptoms that were voluntarily reported to the Drug Safety Monitoring
Center of National Medical Center between January 2013 and August 2017 and deemed significant adverse event on drug-related adverse events causality evaluation by the Drug adverse reaction monitoring center.
Results: Of the 421 reported cases, 290 cases were female and 131 cases were male. Patients in their 70s showed the highest frequency of reported cases at 233 cases. Analysis of frequency by drug formulation showed the highest frequency at 171 cases with Ultracet ER tablet, a tramadol/acetaminophen combination, and with Sinpoong Tramadol HCl injection, an injectable tramadol monotherapy, at 136 cases. The most frequently reported drug-related adverse events were chills (285 cases, 45%), vomiting (152 cases, 24%), dizziness (92 cases, 15%).
Conclusion: Tramadol is not well managed in Korea, as it is categorized under antipyretic/analgesic/anti-inflammatory drugs and is easy to prescribe with relatively few limitations. There is also a possibility of various drug-related adverse
events. Therefore, stricter patient monitoring and drug management as well as general investigation on the misuse or abuse of tramadol are necessary.
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KEYWORD
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Tramadol, Drug-related side effects and adverse reactions
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