YAKUGAKU ZASSHI
Online ISSN : 1347-5231
Print ISSN : 0031-6903
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有害事象自発報告データベースを用いたOTC医薬品の解熱鎮痛消炎剤の有害事象発現傾向の調査
長谷川 栞畠平 春奈長沼 美紗島内 あかり笹岡 沙也加元岡 佑美福田 昌穂阿部 純子中尾 智史加藤 大和大森 智史井口 和弘中村 光浩
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2017 年 137 巻 10 号 p. 1301-1311

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 OTC drugs play an important role in self-medication. OTC analgesic and antipyretic drugs are widely used in Japan. The present study aimed to survey the components of OTC drug package inserts for analgesic and antipyretic drugs and to evaluate the adverse event profiles using the Japanese Adverse Drug Event Report database (JADER). The JADER contains 430587 reports from between April 2004 and November 2016; a total of 750 reports of adverse events resulted from the use of OTC analgesic and antipyretic drugs. The safety signals were detected by the reporting odds ratio (ROR). The ROR values for “Skin & subcutaneous tissue disorders”, “Immune system disorders”, and “Hepatobiliary disorders” stratified by system organ class of the Medical Dictionary for Regulatory Activities (MedDRA) were 7.58 (6.56-8.76), 4.25 (3.51-5.14), and 2.35 (1.93-2.85), respectively. OTC analgesic and antipyretic drugs containing allylisopropylacetylurea (AIAU) exhibited a significantly high reporting ratio of “Skin & subcutaneous tissue disorders” compared with the drugs without AIAU. No difference in the reported incidence of “Hepatobiliary disorders” was found between the drugs with or without acetaminophen. Our results suggested that it was important to monitor patients who use OTC analgesic and antipyretic drug containing AIAU; in particular, careful attention should be paid to skin and subcutaneous tissue disorders.

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© 2017 The Pharmaceutical Society of Japan
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