メトリジン錠2mg、メトリジンD錠2mg
項目別副作用発現頻度及び臨床検査値異常一覧
総症例9,156例中、121例(1.32%)154件に副作用が認められた。その主なものは、頭痛14件、悪心13件、腹痛12件であった。〔メトリジン錠2mg再審査終了時〕
承認時迄の調査 | 製造販売後調査* | 総 計 | |||||
調査症例数 | 784 | 8372 | 9156 | ||||
副作用発現症例数(%) | 45 | (5.74) | 76 | (0.91) | 121 | (1.32) | |
副作用発現件数(%) | 51 | (6.51) | 103 | (1.23) | 154 | (1.68) | |
副作用の種類 | 副作用発現件数(%) | ||||||
皮膚・皮膚付属器障害 | 11 | (1.40) | 10 | (0.12) | 21 | (0.23) | |
発疹 | 4 | (0.51) | 4 | (0.05) | 8 | (0.09) | |
蕁麻疹 | 1 | (0.13) | 1 | (0.01) | 2 | (0.02) | |
そう痒感 | 2 | (0.26) | 1 | (0.01) | 3 | (0.03) | |
皮膚炎 | 1 | (0.01) | 1 | (0.01) | |||
立毛感 | 3 | (0.38) | 3 | (0.04) | 6 | (0.07) | |
発赤 | 1 | (0.13) | 1 | (0.01) | |||
中枢・末梢神経系障害 | 12 | (1.53) | 18 | (0.22) | 30 | (0.33) | |
肩こり | 1 | (0.13) | 1 | (0.01) | 2 | (0.02) | |
筋強剛 | 1 | (0.13) | 1 | (0.01) | |||
痙攣 | 1 | (0.13) | 1 | (0.01) | |||
もうろう状態 | 1 | (0.01) | 1 | (0.01) | |||
手指冷感 | 1 | (0.01) | 1 | (0.01) | |||
頭痛(頭重を含む) | 9 | (1.15) | 5 | (0.06) | 14 | (0.15) | |
下肢しびれ(感) | 2 | (0.02) | 2 | (0.02) | |||
めまい | 7 | (0.08) | 7 | (0.08) | |||
末梢神経障害 | 1 | (0.01) | 1 | (0.01) | |||
自律神経系障害 | 2 | (0.26) | 5 | (0.06) | 7 | (0.08) | |
高血圧(血圧上昇を含む) | 5 | (0.06) | 5 | (0.05) | |||
発汗亢進 | 2 | (0.26) | 2 | (0.02) | |||
精神障害 | 4 | (0.51) | 8 | (0.10) | 12 | (0.13) | |
眠気 | 1 | (0.13) | 4 | (0.05) | 5 | (0.05) | |
幻覚 | 1 | (0.13) | 1 | (0.01) | 2 | (0.02) | |
いらいら感 | 1 | (0.13) | 1 | (0.01) | |||
不穏 | 1 | (0.01) | 1 | (0.01) | |||
不眠(症) | 2 | (0.02) | 2 | (0.02) | |||
妄想 | 1 | (0.13) | 1 | (0.01) | |||
消化管障害 | 15 | (1.91) | 26 | (0.31) | 41 | (0.45) | |
悪心 | 6 | (0.77) | 7 | (0.08) | 13 | (0.14) | |
嘔吐 | 1 | (0.13) | 3 | (0.04) | 4 | (0.04) | |
下痢 | 2 | (0.02) | 2 | (0.02) | |||
口内炎 | 2 | (0.26) | 2 | (0.02) | |||
胃もたれ感 | 1 | (0.13) | 1 | (0.01) | |||
胸やけ | 1 | (0.01) | 1 | (0.01) | |||
食欲減退 | 1 | (0.01) | 1 | (0.01) | |||
腹痛 | 2 | (0.26) | 10 | (0.12) | 12 | (0.13) | |
便秘 | 1 | (0.13) | 1 | (0.01) | 2 | (0.02) | |
腹部膨満感 | 2 | (0.26) | 2 | (0.02) | |||
排便回数増加 | 1 | (0.01) | 1 | (0.01) | |||
心拍数・心リズム障害 | 1 | (0.13) | 4 | (0.05) | 5 | (0.05) | |
心室性期外収縮 | 1 | (0.13) | 1 | (0.01) | |||
動悸 | 4 | (0.05) | 4 | (0.04) | |||
肝臓 | 2 | (0.26) | 10 | (0.12) | 12 | (0.13) | |
肝機能障害 | 6 | (0.07) | 6 | (0.07) | |||
ALT上昇 | 1 | (0.13) | 2 | (0.02) | 3 | (0.03) | |
AST上昇 | 2 | (0.02) | 2 | (0.02) | |||
Al-P上昇 | 1 | (0.13) | 1 | (0.01) | |||
血液 | 0 | (0.00) | 4 | (0.05) | 4 | (0.04) | |
赤血球減少 | 1 | (0.01) | 1 | (0.01) | |||
ヘマトクリット値減少 | 1 | (0.01) | 1 | (0.01) | |||
白血球減少(症) | 1 | (0.01) | 1 | (0.01) | |||
血小板減少(症) | 1 | (0.01) | 1 | (0.01) | |||
泌尿器系障害 | 1 | (0.13) | 1 | (0.01) | 2 | (0.02) | |
頻尿 | 1 | (0.13) | 1 | (0.01) | 2 | (0.02) | |
その他 | 3 | (0.38) | 17 | (0.20) | 20 | (0.22) | |
悪寒 | 3 | (0.04) | 3 | (0.03) | |||
顔面浮腫 | 1 | (0.01) | 1 | (0.01) | |||
倦怠感 | 3 | (0.04) | 3 | (0.03) | |||
浮腫 | 1 | (0.01) | 1 | (0.01) | |||
ほてり感 | 3 | (0.38) | 6 | (0.07) | 9 | (0.10) | |
脱力(感) | 1 | (0.01) | 1 | (0.01) | |||
BUN上昇 | 1 | (0.01) | 1 | (0.01) | |||
耳閉感 | 1 | (0.01) | 1 | (0.01) |
*製造販売後調査〔使用成績調査報告(H1.3.31~H7.3.30)、特別調査(H5.9.1~H6.8.31)〕