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資料４－４ 研究報告の報告状況［714KB］ (14 ページ)
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| 出典情報 | 薬事審議会 医薬品等安全対策部会（令和8年度第1回 6／18）《厚生労働省》 |
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研究報告の報告状況
（2025年12月1日～2026年3月31日）
133 クロピドグレル硫酸塩
Alhalalmeh, Y. et al. Impact of concomitant clopidogrel and
proton pump inhibitor use on cardiovascular outcomes in
acute coronary syndrome and post-revascularization
patients: A matched cohort study. Am. J. Gastroenterol.
2025, 120(10), Suppl.2, S687
134 アセトアミノフェン
Cho J, Jo H, Park L, et al.：TOP10-SCAR: A Global
Pharmacovigilance Study on Medications Most Frequently
Related to Severe Cutaneous Adverse Reactions. Allergy
2025;80(11):3181-3184.
135 シルデナフィルクエン酸塩
Chen, Xiao-Dong; Xiao, Kun-Hong; Wu, Shi-Nan; Wei,
Ming-Yan; Yu, Chao-Feng; Feng, Ke; Cai, Pei-Xin; Wang,
Yu-Ru; Miao, Yan-Liang; Li, Li; Wang, Bo-Zhao; Li, ShiYing; Chen, Qian. Drug-related retinal detachment
pharmacovigilance signals in the real world: evidence from
the FDA Adverse Event Reporting System. Eye
(Basingstoke). 2025; 39(18): 3284-3293.
136 アバコパン
Ilay Berke, Felix Keller, Clemens Untersulzner, Jae Il Shin,
Peong Gang Park, Sarah Soyeon Oh, Jasper Callemeyn,
Andreas Kronbichler. Systematic Review of Efficacy and
Safety of Avacopan in Real-World Clinical Practice. Kidney
International Reports. 2025.
137
フェンタニルクエン酸塩
フェンタニル
138 エスゾピクロン
Inker, L.A, et al. A drug-wide association study on
medications associated with cystatin C-estimated GFR. Am.
J. Kidney Dis. 2025;86(6):860-864.
Xu Y, et al.. Suicide adverse events associated with
zopiclone and eszopiclone: A pharmacovigilance analysis
based on FAERS, JADER and CVARD.. PloS one. 2026;
21(1): e0340357-.
クアゼパム
クロチアゼパム
フルタゾラム
139 ジアゼパム
トフィソパム
ロフラゼプ酸エチル
ロラゼパム
Benzodiazepine Use in Pregnancy and the Risk of Pregnancy
Outcomes
140 プロカルバジン塩酸塩
Owens, C.A. et al. .Colorectal-specific radiation dose and
chemotherapy risk for subsequent colorectal malignancies in
childhood cancer survivors: A Childhood Cancer Survivor
Study (CCSS) report.J. Clin. Oncol. 2025;43(31):3403-3421.
141 レボフロキサシン水和物
Goyal, K. et al. Identification of novel signal of DRESS
associated with antibiotics: a disproportionality analysis of
the FDA Adverse Event Reporting System (FAERS)
database. Europ. J. Clin. Pharmacol. 2026;82(2):36.
142 アトルバスタチンカルシウム水和物
Zimmerman, M. et al. Statin treatment is associated with a
higher risk of carpal tunnel syndrome, but not of ulnar nerve
entrapment, in type 2 diabetes - A nationwide register
study.Clin. Ther. 47(12),1097-1103,2025
143
アセトアミノフェン
レボフロキサシン水和物
Karkra R, Mohsen M, Fletcher D, et al. Drug-Induced
Vanishing Bile Duct Syndrome: A Disproportionality Analysis
Using the FDA Adverse Event Reporting System (FAERS)
Database. Am. J. Gastroenterol. 2025
Oct;120(10),Suppl.2:S521-S522.
14/30
（2025年12月1日～2026年3月31日）
133 クロピドグレル硫酸塩
Alhalalmeh, Y. et al. Impact of concomitant clopidogrel and
proton pump inhibitor use on cardiovascular outcomes in
acute coronary syndrome and post-revascularization
patients: A matched cohort study. Am. J. Gastroenterol.
2025, 120(10), Suppl.2, S687
134 アセトアミノフェン
Cho J, Jo H, Park L, et al.：TOP10-SCAR: A Global
Pharmacovigilance Study on Medications Most Frequently
Related to Severe Cutaneous Adverse Reactions. Allergy
2025;80(11):3181-3184.
135 シルデナフィルクエン酸塩
Chen, Xiao-Dong; Xiao, Kun-Hong; Wu, Shi-Nan; Wei,
Ming-Yan; Yu, Chao-Feng; Feng, Ke; Cai, Pei-Xin; Wang,
Yu-Ru; Miao, Yan-Liang; Li, Li; Wang, Bo-Zhao; Li, ShiYing; Chen, Qian. Drug-related retinal detachment
pharmacovigilance signals in the real world: evidence from
the FDA Adverse Event Reporting System. Eye
(Basingstoke). 2025; 39(18): 3284-3293.
136 アバコパン
Ilay Berke, Felix Keller, Clemens Untersulzner, Jae Il Shin,
Peong Gang Park, Sarah Soyeon Oh, Jasper Callemeyn,
Andreas Kronbichler. Systematic Review of Efficacy and
Safety of Avacopan in Real-World Clinical Practice. Kidney
International Reports. 2025.
137
フェンタニルクエン酸塩
フェンタニル
138 エスゾピクロン
Inker, L.A, et al. A drug-wide association study on
medications associated with cystatin C-estimated GFR. Am.
J. Kidney Dis. 2025;86(6):860-864.
Xu Y, et al.. Suicide adverse events associated with
zopiclone and eszopiclone: A pharmacovigilance analysis
based on FAERS, JADER and CVARD.. PloS one. 2026;
21(1): e0340357-.
クアゼパム
クロチアゼパム
フルタゾラム
139 ジアゼパム
トフィソパム
ロフラゼプ酸エチル
ロラゼパム
Benzodiazepine Use in Pregnancy and the Risk of Pregnancy
Outcomes
140 プロカルバジン塩酸塩
Owens, C.A. et al. .Colorectal-specific radiation dose and
chemotherapy risk for subsequent colorectal malignancies in
childhood cancer survivors: A Childhood Cancer Survivor
Study (CCSS) report.J. Clin. Oncol. 2025;43(31):3403-3421.
141 レボフロキサシン水和物
Goyal, K. et al. Identification of novel signal of DRESS
associated with antibiotics: a disproportionality analysis of
the FDA Adverse Event Reporting System (FAERS)
database. Europ. J. Clin. Pharmacol. 2026;82(2):36.
142 アトルバスタチンカルシウム水和物
Zimmerman, M. et al. Statin treatment is associated with a
higher risk of carpal tunnel syndrome, but not of ulnar nerve
entrapment, in type 2 diabetes - A nationwide register
study.Clin. Ther. 47(12),1097-1103,2025
143
アセトアミノフェン
レボフロキサシン水和物
Karkra R, Mohsen M, Fletcher D, et al. Drug-Induced
Vanishing Bile Duct Syndrome: A Disproportionality Analysis
Using the FDA Adverse Event Reporting System (FAERS)
Database. Am. J. Gastroenterol. 2025
Oct;120(10),Suppl.2:S521-S522.
14/30