■アレセンサⓇ カプセル　副作用名別件数一覧表【集計期間　2014/09/05-2015/4/23 】調査が終了していない情報も含まれており、今後の調査により副作用名、重篤度、関連性等が変更となる場合がありますので、ご了承下さい。 [English] ■Table of ADRs(Adverse Drug Reactions) for Alecensa Capsule 【Summary Period:　2014/09/05-2015/4/23 】 Surveillance has not been completed for some information, and details including ADR term, seriousness, and causality may change based on further surveillance. 1頁／ 8頁表1-1　重篤副作用の集積状況副作用器官別大分類感染症および寄生虫症血液およびリンパ系障害代謝および栄養障害神経系障害心臓障害血管障害呼吸器、胸郭および縦隔障害胃腸障害肝胆道系障害皮膚および皮下組織障害一般・全身障害および投与部位の状態臨床検査副作用肺炎敗血症播種性血管内凝固低カリウム血症食欲減退頚髄神経根障害脳神経障害完全房室ブロック心不全プリンツメタル狭心症高血圧出血性ショック深部静脈血栓症塞栓症四肢静脈血栓症好酸球性肺炎間質性肺疾患肺障害肺臓炎肺水腫肺瘻便秘下痢腸炎イレウス大腸穿孔悪心膵炎直腸穿孔嘔吐肝機能異常薬疹多形紅斑そう痒症皮膚障害突然死血中ビリルビン増加血中クレアチンホスホキナーゼ増加血中クレアチニン増加好中球数減少白血球数減少重篤注2) 2 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1 14 1 1 1 1 1 1 1 2 1 2 1 2 2 1 1 1 1 1 1 1 2 1 6 1 66 総計注1:MedDRA(国際医学用語集の一つ)Ver17.1の基本語(PT)を使用。注2:「重篤」は本集計期間中に規制当局（独立行政法人医薬品医療機器総合機構）へ報告したアレセンサとの因果関係が否定できない重篤な副作用の件数を記載しております。 2頁／ 8頁表1-2　非重篤の副作用収集状況副作用非重篤器官別大分類感染症および寄生虫症結膜炎ヘルペスウイルス感染鼻咽頭炎爪囲炎副鼻腔炎上気道感染尿路感染ウイルス性上気道感染細菌性肺炎肺感染良性、悪性および詳細不明の新生物（嚢脂漏性角化症胞およびポリープを含む）血液およびリンパ系障害貧血好中球減少症血小板減少症代謝および栄養障害脱水高カリウム血症低アルブミン血症低ナトリウム血症食欲減退高クレアチニン血症過小食精神障害うつ病不眠症神経系障害浮動性めまい体位性めまい味覚異常頭痛感覚鈍麻末梢性ニューロパチー傾眠眼障害眼精疲労眼瞼浮腫羞明霧視視力障害硝子体浮遊物耳および迷路障害回転性めまい心臓障害不整脈洞性徐脈心室性期外収縮血管障害塞栓症呼吸器、胸郭および縦隔障害呼吸困難喀血しゃっくり胸水肺臓炎気胸湿性咳嗽肺線維症鼻漏上気道の炎症胃腸障害腹部不快感腹部膨満腹痛 1 1 3 1 1 2 1 1 1 1 1 6 2 1 2 1 2 1 8 1 1 1 1 1 1 30 2 7 1 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 3 1 1 2 3頁／ 8頁表1-2　非重篤の副作用収集状況副作用非重篤器官別大分類肝胆道系障害皮膚および皮下組織障害筋骨格系および結合組織障害腎および尿路障害生殖系および乳房障害一般・全身障害および投与部位の状態臨床検査上腹部痛便秘齲歯下痢胃食道逆流性疾患口唇腫脹悪心口内炎変色歯嘔吐痔出血肝機能異常胆汁うっ滞性黄疸肝障害胆管狭窄脱毛症ざ瘡様皮膚炎薬疹皮膚乾燥湿疹紅斑扁平苔癬皮膚疼痛そう痒症発疹斑状丘疹状皮疹皮膚萎縮皮膚剥脱蕁麻疹色素沈着障害関節痛背部痛筋力低下筋肉痛筋骨格硬直血尿夜間頻尿蛋白尿腎障害尿閉腎機能障害月経過多月経障害胸痛顔面浮腫異常感倦怠感浮腫末梢性浮腫疼痛発熱粘膜出血アラニンアミノトランスフェラーゼ増加アスパラギン酸アミノトランスフェラーゼ 1 28 1 7 1 1 9 5 1 9 2 16 1 3 1 1 2 1 4 1 2 1 1 2 14 5 1 1 1 2 3 1 1 18 1 1 1 1 2 1 4 1 1 1 1 1 10 4 4 1 8 1 15 1 4頁／ 8頁表1-2　非重篤の副作用収集状況副作用非重篤器官別大分類アスパラギン酸アミノトランスフェラーゼ増加血中ビリルビン増加血中非抱合ビリルビン増加血中クレアチンホスホキナーゼ増加血中クレアチニン増加血中乳酸脱水素酵素増加血中尿素増加Ｃ－反応性蛋白増加心電図ＱＴ延長好酸球数増加眼底検査異常ヘモグロビン減少肝機能検査異常リンパ球数減少好中球数減少血小板数減少プロトロンビン時間比増加体重増加白血球数減少白血球数増加血小板数増加血中アルカリホスファターゼ増加肝酵素上昇転倒傷害、中毒および処置合併症総計注1:MedDRA(国際医学用語集の一つ)Ver17.1の基本語(PT)を使用。 16 15 1 30 31 1 1 1 1 1 1 2 4 2 15 1 1 2 12 1 1 7 1 1 469 5頁／ 8頁 1-1)Table of ADRs ADRs SOC Infections and infestations Blood and lymphatic system disorders Metabolism and nutrition disorders Nervous system disorders Cardiac disorders Vascular disorders Respiratory, thoracic and mediastinal disorders PT seriousnote2 Pneumonia Sepsis Disseminated intravascular coagulation Hypokalaemia Decreased appetite Cervical radiculopathy Cranial nerve disorder Atrioventricular block complete Cardiac failure Prinzmetal angina Hypertension Shock haemorrhagic Deep vein thrombosis Embolism Venous thrombosis limb 2 1 Eosinophilic pneumonia 1 1 1 1 1 1 1 1 1 1 2 1 1 1 14 Interstitial lung disease Lung disorder 1 Pneumonitis 1 Pulmonary oedema 1 Pulmonary fistula 1 Gastrointestinal disorders Constipation 1 Diarrhoea 1 Enterocolitis 1 Ileus 2 Large intestine perforation 1 Nausea 2 Pancreatitis 1 Rectal perforation 2 Vomiting 2 Hepatobiliary disorders Hepatic function abnormal 1 Skin and subcutaneous tissue disorders Drug eruption 1 Erythema multiforme 1 Pruritus 1 Skin disorder 1 General disorders and administration Sudden death 1 site conditions Investigations Blood bilirubin increased 1 Blood creatine phosphokinase 2 increased Blood creatinine increased 1 Neutrophil count decreased 6 White blood cell count decreased 1 Total 66 note1: mapped to Preferred Term (PT) of MedDRA ver 17.1 note2: These are serious ADRs cases reported to PMDA during the following period. 6頁／ 8頁 1-2)Table of ADRs ADRs SOC Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps) Blood and lymphatic system disorders Metabolism and nutrition disorders Psychiatric disorders Nervous system disorders Eye disorders Ear and labyrinth disorders Cardiac disorders Vascular disorders Respiratory, thoracic and mediastinal disorders PT Nonserious Conjunctivitis Herpes virus infection Nasopharyngitis Paronychia Sinusitis Upper respiratory tract infection Urinary tract infection Viral upper respiratory tract infection Pneumonia bacterial Lung infection 1 1 3 1 1 2 1 Seborrhoeic keratosis 1 Anaemia Neutropenia Thrombocytopenia Dehydration Hyperkalaemia Hypoalbuminaemia Hyponatraemia Decreased appetite Hypercreatininaemia Hypophagia Depression Insomnia Dizziness Dizziness postural Dysgeusia Headache Hypoaesthesia Neuropathy peripheral Somnolence Asthenopia Eyelid oedema Photophobia Vision blurred Visual impairment Vitreous floaters Vertigo Arrhythmia Sinus bradycardia Ventricular extrasystoles Embolism 6 2 1 2 1 2 1 8 1 1 1 1 1 1 30 2 7 1 1 1 1 1 1 1 1 1 1 1 1 1 Dyspnoea 2 Haemoptysis Hiccups Pleural effusion Pneumonitis Pneumothorax Productive cough Pulmonary fibrosis Rhinorrhoea 1 1 1 1 1 1 1 1 1 1 1 7頁／ 8頁 1-2)Table of ADRs ADRs SOC PT Upper respiratory tract inflammation Gastrointestinal disorders Abdominal discomfort Abdominal distension Abdominal pain Abdominal pain upper Constipation Dental caries Diarrhoea Gastrooesophageal reflux disease Lip swelling Nausea Stomatitis Tooth discolouration Vomiting Haemorrhoidal haemorrhage Hepatobiliary disorders Hepatic function abnormal Jaundice cholestatic Liver disorder Bile duct stenosis Skin and subcutaneous tissue disorders Alopecia Dermatitis acneiform Drug eruption Dry skin Eczema Erythema Lichen planus Pain of skin Pruritus Rash Rash maculo-papular Skin atrophy Skin exfoliation Urticaria Pigmentation disorder Musculoskeletal and connective tissue Arthralgia disorders Back pain Muscular weakness Myalgia Musculoskeletal stiffness Renal and urinary disorders Haematuria Nocturia Proteinuria Renal disorder Urinary retention Renal impairment Reproductive system and breast Menorrhagia Menstrual disorder General disorders and administration Chest pain site conditions Face oedema Feeling abnormal Malaise Oedema Nonserious 3 1 1 2 1 28 1 7 1 1 9 5 1 9 2 16 1 3 1 1 2 1 4 1 2 1 1 2 14 5 1 1 1 2 3 1 1 18 1 1 1 1 2 1 4 1 1 1 1 1 10 4 8頁／ 8頁 1-2)Table of ADRs ADRs SOC Investigations PT Oedema peripheral Pain Pyrexia Mucosal haemorrhage Alanine aminotransferase increased Aspartate aminotransferase Aspartate aminotransferase increased Blood bilirubin increased Blood bilirubin unconjugated increased Blood creatine phosphokinase increased Blood creatinine increased Blood lactate dehydrogenase increased Blood urea increased C-reactive protein increased Electrocardiogram QT prolonged Eosinophil count increased Fundoscopy abnormal Haemoglobin decreased Liver function test abnormal Lymphocyte count decreased Neutrophil count decreased Platelet count decreased Prothrombin time ratio increased Weight increased White blood cell count decreased White blood cell count increased Platelet count increased Blood alkaline phosphatase increased Hepatic enzyme increased Injury, poisoning and procedural Fall complications Total note1: mapped to Preferred Term (PT) of MedDRA ver 17.1 Nonserious 4 1 8 1 15 1 16 15 1 30 31 1 1 1 1 1 1 2 4 2 15 1 1 2 12 1 1 7 1 1 469