プラセボの有害事象

SIDERデータの集計

臨床試験ではプラセボが投与された被験者にも当然のように有害事象が起きます。多くはプラセボの「薬効」ではなく、偶発症だろうと思います。基礎疾患の症状であったり、併用薬剤の副作用であったり、さまざまな偶発症で有害事象が起きます。SIDERデータベースは、添付文書の副作用情報をまとめた物です。(それ以外の情報源も含むようですが) 最新のversion 4.1には1400剤を超える医薬品の「副作用」情報が14万件弱ほど登録されています。その中には、当該医薬品の試験に際してプラセボが投与された被験者のデータを添付文書に掲載しているものがあり、今回はこの中で添付文書由来のデータのプラセボが投与された被験者のデータを集計しました。言うならば、「プラセボ」の有害事象データです。さまざまな疾患に対する様々な医薬品の試験でのプラセボのデータですので、かなり高い頻度で有害事象が発現している場合もあります。

Frequency of Adverse Event in Placebo

Adverse EventFrequencyLowerLimitUpperLimit
Abdominal bloating0.080.0140.08
Abdominal discomfort0.21500.215
Abdominal distension0.100.1
Abdominal distress0.2150.2150.215
Abdominal pain0.4400.440252
Abdominal pain upper0.1700.17
Abdominal tenderness000
Abnormal behaviour0.090.010.09
Abnormal dreams0.1700.17
Abnormal ejaculation0.18100.180894
Abnormal faeces0.040.040.04
Abnormal involuntary movements0.210.210.21
Abnormal labour0.0050.0050.005
Abnormal sleep-related event000
Abnormal vision0.0600.06
Abrasion NOS000
Abscess0.05900.059
Abscess periodontal0.09770.09767440.0976744
Accident0.110.110.11
Accident at home0.0190.0190.019
Accidental injury0.200.2
Accidental overdose000
Accommodation disorder0.011200.0112
Ache0.03200.032
Acid indigestion0.03260.03255810.0325581
Acidosis0.0200.02
Acne0.1900.19
Action tremor0.0290.010.029
Acute appendicitis0.0060.0060.006
Acute bronchitis0.010.010.01
Acute coronary syndrome0.02200.022
Adrenal insufficiency0.010.010.01
Adverse reaction0.0220.0090.022
Affect lability0.0800.08
Ageusia0.0100.01
Aggression0.06900.069
Aggressive reaction0.0400.04
Agitation0.2400.24
Agranulocytosis0.20500.205
Akathisia0.2300.23
Akinesia0.08600.086
Alanine aminotransferase increased0.6600.66
Albumin low0.2100.21
Albumin urine present0.040.040.04
Albuminuria0.057100.0571429
Alopecia0.9800.98
Altered state of consciousness0.030.0030.03
Altered visual depth perception000
Alveolitis0.02940.02940.0294
Amblyopia0.0900.09
Amenorrhoea0.071400.0714286
Amnesia0.100.1
Amylase increased0.170.01234570.17
Anaemia0.4900.49
Anal haemorrhage0.042600.0425532
Anger0.06300.063
Angina pectoris0.1100.11
Angina pectoris aggravated0.020.0110.02
Angina unstable0.0270.0270.027
Angioedema0.0010.0010.001
Angiopathy0.5600.56
Ankle edema0.05610.0209790.0560748
Anogenital warts0.010.010.01
Anorectal discomfort0.08770.050.0877193
Anorectal disorder0.020.020.02
Anorexia0.4700.47
Anorgasmia0.0100.01
Anxiety0.24900.249
Anxiety NEC0.02550.02547770.0254777
Anxiety symptoms NOS0.030.030.03
Apathy0.0100.01
Aphasia0.18300.183333
Aphthous stomatitis000
Apnoea0.260.260.26
Apocrine and eccrine gland disorders0.040.0380.04
Appendicitis0.0060.0060.006
Appetite disorder0.0700.07
Application and instillation site reactions0.190.040.19
Application site dryness0.003420.003424660.00342466
Application site erythema0.0230.003424660.023
Application site irritation000
Application site papules000
Application site paraesthesia0.003420.003424660.00342466
Application site pruritus0.1200.12
Application site rash0.060.00495050.06
Application site reaction0.58600.586207
Application site vesicles000
Arrhythmia0.0800.08
Arterial anomaly0.002930.002929690.00292969
Arthralgia0.37100.3714
Arthritis0.071800.0717703
Arthropathy0.15400.1543
Artificial kidney clotting during dialysis0.0420.0420.042
Ascites0.09430.09433960.0943396
Aspartate aminotransferase increased0.4600.46
Asthenia0.5500.55
Asthenic conditions0.4440.050.444
Asthenopia000
Asthma0.41700.417
Ataxia0.100.1
Atelectasis0.030.010.03
Atrial fibrillation0.05100.051
Atrial flutter0.007940.007936510.00793651
Atrioventricular block0.02700.027
Atrioventricular block complete0.0470.0470.047
Atrioventricular block first degree0.0500.05
Atrioventricular block second degree0.01200.012
Auditory disorder NOS0.0320.010.032
Automatism0.010.010.01
Autonomic neuropathy0.140.050.14
Back pain0.24300.243
Bacteraemia000
Bacterial infection000
Bacteriuria0.0160.0160.016
Bad taste000
Balance disorder0.0500.05
Balanitis000
Benign neoplasm of skin0.0140.010.014
Benign prostatic hyperplasia0.010.010.01
Bilirubin total increased0.100.1
Binge eating000
Bipolar I disorder000
Bizarre dreams000
Bladder and urethral symptoms0.0140.010.014
Bladder pain0.04500.045
Blepharitis0.0100.01
Blindness0.00030.00030.0003
Block heart0.0080.0010.008
Blood albumin decreased0.2100.21
Blood alkaline phosphatase increased0.6600.66
Blood amylase increased0.01230.01234570.0123457
Blood and lymphatic system disorders0.07330.0060.0732759
Blood bilirubin increased0.1400.14
Blood calcium decreased0.1200.12
Blood cortisol decreased0.0038800.00387597
Blood creatine phosphokinase increased0.5200.52
Blood creatinine increased0.3800.38
Blood glucose decreased0.0300.03
Blood glucose increased0.3500.35
Blood in stool0.0340.0340.034
Blood insulin increased0.010.010.01
Blood lactate dehydrogenase increased0.035700.0357143
Blood magnesium decreased0.1400.14
Blood phosphorus decreased0.1400.14
Blood potassium decreased0.0500.05
Blood potassium increased0.1100.11
Blood pressure diastolic decreased000
Blood pressure increased0.01900.019
Blood prolactin increased0.0030.0030.003
Blood triglycerides increased0.5300.53
Blood urea increased0.07600.076
Blood uric acid increased0.020.0070.02
Body odor000
Body temperature increased0.43500.435
Bone disorder0.0250.0070.025
Bone pain0.75400.754
Bradycardia0.10600.105708
Bradykinesia0.08600.086
Bradyphrenia0.0310.0140.031
Brain abscess0.040.040.04
Brain oedema0.1920.010.191667
Breast cancer0.0100.01
Breast disorder0.4700.47
Breast enlargement0.034500.0344828
Breast neoplasm0.0690.06896550.0689655
Breast pain0.09600.096
Breast pain female000
Breast tenderness0.0600.06
Breath odour0.003010.003012050.00301205
Bronchial obstruction0.0100.01
Bronchitis0.1500.15
Bronchopneumonia0.01290.0129310.012931
Bronchospasm0.0200.02
Bronchospasm paradoxical0.0190.0190.019
Bruxism0.0060.0050.006
Buffalo hump0.018700.0186916
Bullous eruption0.010.003039510.01
Bundle branch block0.0200.02
Burning feeling vagina0.0220.0220.022
Burning sensation0.013900.0138889
Bursitis0.00600.006
Calcium low0.1200.12
Calculus of kidney000
Candida infection0.08300.083
Carcinoma0.0310.0310.031
Carcinoma breast0.0100.01
Cardiac arrest0.0270.003906250.027
Cardiac disorder0.11600.116379
Cardiac failure0.31500.315
Cardiac failure congestive0.05500.055
Cardiac fibrillation000
Cardiac murmur000
Cardiac pain0.04600.046
Cardiac tamponade0.01060.007903140.0106458
Cardiac valve disease0.02350.004784690.0235097
Cardioactive drug level above therapeutic0.007940.007936510.00793651
Cardioactive drug level increased0.040.010.04
Cardiogenic shock0.0200.02
Cardiovascular disorder0.0600.06
Carpal tunnel syndrome0.00300.003
Cataplexy0.010.010.01
Cataract0.05700.057
Cataract unilateral000
Cauda equina syndrome0.0450.0380.045
Cellulitis0.0600.06
Cerebellar syndrome000
Cerebral haemorrhage0.0400.04
Cerebral ischaemia0.0050.0050.005
Cerebration impaired0.1400.14
Cerebrovascular accident0.03200.032
Cervical polyp0.01910.01913880.0191388
Chest discomfort0.062500.0625
Chest pain0.29800.298
Chest pressure0.0100.01
Chest tightness0.0100.01
Chills0.3900.39
Cholecystitis0.0440.0440.0440252
Cholelithiasis000
Chromaturia0.0600.06
Chronic obstructive pulmonary disease0.130.130.13
Circumoral paresthesia0.00400.004
Claudication0.0300.03
Coagulopathy0.0100.01
Cognitive disorder0.210.2050.21
Cogwheel rigidity000
Cold hands & feet000
Cold sweat0.0110.0110.011
Cold symptoms0.050.0170.05
Colitis0.2700.27
Coma0.050.050.05
Common cold0.21400.213953
Confusional state0.20800.208333
Congenital arterial malformation0.002930.002929690.00292969
Congenital eye disorder0.010.010.01
Congenital genitourinary abnormality000
Conjunctival oedema0.06670.06666670.0666667
Conjunctivitis0.03600.036
Connective tissue disorder0.3500.35
Consciousness abnormal0.030.0290.03
Constipation0.38600.386
Constipation aggravated0.008470.005110730.00847458
Contusion0.14600.146
Convulsion0.37500.375
Coordination abnormal0.1800.18
COPD exacerbation0.130.130.13
Corneal lesion000
Corneal staining0.0130.0130.013
Coronary artery disease0.0009770.0009765620.000976562
Coronary artery occlusion0.001950.001953120.00195312
Cough0.51200.5125
Cough increased0.47300.473
Cramp muscle0.21100.211429
Cramps of lower extremities0.1300.13
Creatine phosphokinase increased0.5200.52
Creatinine increased0.3800.38
Creatinine renal clearance decreased0.02400.024
Crying000
Cushingoid0.049200.0491803
Cushing's syndrome0.2420.050.242424
Cyst0.03450.03448280.0344828
Cystitis0.04500.045
Cystitis noninfective0.04500.045
Cytomegalovirus infection0.0540.0080.054
Dandruff000
Deafness0.0310.0050.031
Decreased appetite0.4700.47
Decubitus ulcer0.0110.0110.011
Deep vein thrombosis0.04290.0020.0428571
Defaecation urgency0.09210.09210530.0921053
Defect conduction intraventricular0.0400.04
Dehydration0.042900.0428571
Delusion0.013900.0138889
Depersonalisation0.01900.019
Depressed level of consciousness0.00300.003
Depressed mood0.02600.026
Depression0.3700.37
Depression aggravated0.010.010.01
Depressive disorder0.030.0290.03
Derealisation0.0380.010.038
Dermatitis0.3700.37
Dermatitis acneiform0.0700.07
Dermatitis atopic0.030.030.03
Dermatitis bullous0.0100.01
Dermatitis contact0.018100.0180723
Dermatitis exfoliative000
Device capturing issue0.0100.01
Device malfunction0.0420.0420.042
Diabetes mellitus0.1600.16
Diabetes mellitus exacerbated0.0810.0810.081
Diabetic neuropathy0.030.030.03
Diabetic vascular disorder0.090.090.09
Diarrhoea0.5500.55
Digoxin level increased0.040.010.04
Diplopia0.0900.09
Discomfort0.5500.55
Disinhibition0.0200.02
Disorder sight0.01470.010.0146699
Disorientation0.0200.02
Disseminated intravascular coagulation000
Distention0.0050.0040.005
Distress0.020.020.02
Disturbance in attention0.1400.14
Disturbance in sexual arousal0.0800.08
Dizziness0.36900.369
Dizziness postural0.1400.14
Dreaming excessive0.170.170.17
Drooling0.0500.05
Drowsiness0.42700.427
Drug dependence0.0200.02
Drug intolerance000
Drug level increased0.0370.0020.037
Drug withdrawal syndrome0.11900.119403
Dry eye0.0300.03
Dry mouth0.3500.35
Dry skin0.068600.0686
Dry throat0.0100.01
Duodenal ulcer haemorrhage0.04110.04113110.0411311
Dysaesthesia0.0330.0290.033
Dysarthria0.06300.063
Dyschezia0.053200.0531915
Dysentery0.0440.0440.044
Dysgeusia0.097100.0971429
Dyskinesia0.3100.31
Dyslipidaemia0.03400.034
Dysmenorrhoea0.1400.14
Dysmetria000
Dyspepsia0.3400.34
Dyspeptic signs and symptoms0.0380.010.038
Dysphagia0.100.1
Dysphasia000
Dysphonia0.0900.09
Dysphoria0.0100.01
Dyspnoea0.38500.385
Dyspnoea exacerbated0.06060.030.0606061
Dyspnoea exertional0.0700.07
Dysthymic disorder0.030.0290.03
Dystonia000
Dystonic reaction000
Dysuria0.0900.09
Ear and labyrinth disorders0.1100.11
Ear disorder0.0600.06
Ear infection0.0400.04
Ear pain0.08800.088
Ecchymosis0.0300.03
Eczema0.0300.03
Edema cerebral0.190.010.19
Edema of lower extremities0.03330.0070.0333333
Ejaculation delayed0.0100.01
Ejaculation disorder0.18100.180894
Ejaculation failure0.0200.02
Electrocardiogram abnormal0.03400.034
Electrocardiogram abnormal specific0.010.010.01
Electrocardiogram change000
Electrocardiogram QT corrected interval prolonged0.030.010.03
Electrocardiogram QT prolonged0.030.010.03
Electrocardiogram ST segment depression000
Electrocardiogram T wave abnormal0.0100.01
Electrocardiogram T wave inversion0.010.010.01
Electroencephalogram abnormal000
Emotional disorder0.010.010.01
Emotional distress0.020.020.02
Endocrine disorder0.2290.0360.228571
Endometrial disorder0.08210.0140.0820896
Endometrial hyperplasia000
Endophthalmitis0.00900.009
Enlargement abdomen0.100.1
Enuresis0.100.1
Enzyme abnormality0.0320.0320.032
Eosinophilia0.2500.25
Epigastric discomfort0.0280.0280.028
Epigastric pain0.0170.0170.017
Epistaxis0.1300.13
Erectile dysfunction0.12200.122
Eructation0.1500.15
Eruption0.02010.02014590.0201459
Erythema0.0500.05
Euphoric mood0.0100.01
Exacerbation of asthma0.0850.0850.085
Excitement0.0570.010.057
Excoriation000
Exfoliative rash0.0900.09
Exposure to poisonous plant000
Exposure to toxic agent000
Expressive language disorder0.0160.010.016
Extrapyramidal disorder0.2600.26
Extrapyramidal symptoms0.1600.16
Extrasystoles0.0100.01
Extravasation0.020.010.02
Eye disorder0.1400.14
Eye haemorrhage0.00030.00030.0003
Eye infection0.010.010.01
Eye irritation0.0060.0060.006
Eye oedema000
Eye pain0.0200.02
Eye redness000
Face oedema0.0500.05
Facial paralysis0.04170.04166670.0416667
Faecal incontinence0.027800.0277778
Fall0.0400.04
Fasting0.030.0030.03
Fasting hyperglycaemia0.0800.08
Fatigue0.5500.55
Fear0.010.010.01
Febrile neutropenia000
Feeling abnormal0.5500.55
Feeling cold0.0400.04
Feeling drunk0.0100.01
Feeling hot0.0800.08
Feeling jittery0.0400.04
Feeling strange000
Flank pain000
Flat affect0.0100.01
Flatulence0.300.3
Flu symptoms0.1860.020.186047
Fluid overload0.1700.17
Fluid retention0.300.3
Flushing0.43300.432958
Foetal distress syndrome0.038500.0384615
Foetor hepaticus0.0030.0030.003
Folliculitis0.020.0190.02
Foot edema0.01900.019
Forced expiratory volume decreased0.2870.2869570.286957
Fracture0.0080.0080.008
Frequent bowel movements000
Fullness abdominal0.020.020.02
Fungal infection0.011500.0114943
Fungal skin infection0.0200.02
Gait disturbance0.0700.07
Galactorrhoea000
Gamma-glutamyltransferase increased0.0300.03
Gastric atony0.050.050.05
Gastric disorder0.0440.0420.044
Gastritis0.2400.24
Gastroenteritis0.0600.06
Gastrointestinal candidiasis000
Gastrointestinal discomfort0.030.0080.03
Gastrointestinal disorder0.64200.642241
Gastrointestinal haemorrhage0.0800.08
Gastrointestinal infection0.010.010.01
Gastrointestinal pain0.4400.440252
Gastrointestinal symptom NOS000
Gastrooesophageal reflux disease0.0400.04
Generalised oedema0.0500.05
Genital candidiasis0.02130.02127660.0212766
Genital disorder female0.062100.0621469
Genital disorder male000
Genital infection fungal0.0320.0030.032
Gingival bleeding0.003630.003631960.00363196
Gingival disorder0.0290.0150.029
Gingival hyperplasia0.02300.023
Gingival pain0.02790.0279070.027907
Gingivitis0.0100.01
Glossitis000
Glossodynia0.0400.04
Glucose decreased0.0300.03
Glucose increased0.3500.35
Glycosuria0.030.0070.03
Gout0.06200.062
Grand mal convulsion0.041700.0416667
Gravitational oedema0.0300.03
Gynaecomastia0.071400.0714286
Haematemesis0.0039100.00390625
Haematochezia0.0340.0340.034
Haematoma0.10900.109091
Haematuria0.100.1
Haemoglobin0.18700.187
Haemoglobin decreased0.7900.79
Haemoglobin increased000
Haemoptysis0.2370.020.237
Haemorrhage0.18700.187
Haemorrhage intracranial0.00300.003
Haemorrhagic stroke0.0010.0010.001
Haemorrhoids0.0300.03
Hair colour changes0.0300.03
Hallucination0.0500.05
Hand swelling0.090.090.09
Hangover0.020.0110.02
Head injury0.0100.01
Headache0.5300.53
Headache aggravated000
Hearing impaired0.0320.0050.032
Heartburn0.0800.08
Hemiplegia0.4420.4416670.441667
Hepatic enzyme abnormal0.10.020.1
Hepatic enzyme increased0.04100.041
Hepatic function abnormal0.0800.08
Hepatic steatosis0.020.020.02
Hepatobiliary disease0.0500.05
Hepatocellular injury0.0030.0030.003
Hernia0.010.010.01
Herpes simplex0.080.030.08
Herpes virus infection0.080.0380.08
Herpes zoster0.03100.031
Hiccups0.03700.037
Hirsutism0.0800.08
Hoarseness0.0100.01
Hormone level abnormal000
Hostility0.140.0060.14
Hot flush0.4800.48
Hydrocephalus0.020.020.02
Hyperacusis0.0100.01
Hyperaemia0.0140.0090.014
Hyperaesthesia0.0100.01
Hyperbilirubinaemia0.170.00360360.17
Hypercalcaemia0.0300.03
Hypercholesterolaemia0.4600.46
Hyperglycaemia0.50900.509
Hyperhidrosis0.3100.31
Hyperkalaemia0.270.0010.27
Hyperkeratosis0.0100.01
Hyperkinesia0.08900.089
Hyperlipidaemia0.2300.23
Hypermagnesaemia0.0200.02
Hypernatraemia0.2500.25
Hyperpyrexia0.030.030.03
Hyperreflexia0.030.010.03
Hypersensitivity0.0600.06
Hypersomnia0.00900.009
Hypertension0.4800.48
Hypertensive crisis0.0500.05
Hypertonia0.0600.06
Hypertrichosis0.030.010.03
Hypertriglyceridaemia0.5300.53
Hyperuricaemia0.020.0070.02
Hyperventilation0.1450.0270.145
Hypoaesthesia0.071400.0714286
Hypoaesthesia oral0.0100.01
Hypoalbuminaemia0.4700.47
Hypocalcaemia0.2700.27
Hypocholesterolaemia0.0250.0250.025
Hypoglycaemia0.300.3
Hypokalaemia0.19800.198
Hypokinesia0.13900.139
Hypomagnesaemia0.0400.04
Hyponatraemia0.2400.24
Hypophosphataemia0.1900.19
Hypoproteinaemia0.07140.07142860.0714286
Hyporeflexia0.0100.01
Hypotension0.300.3
Hypothyroidism0.0100.01
Hypoventilation0.04260.04255320.0425532
Hypovolaemia0.020.0020.02
Hypoxia0.06590.020.0659134
Ill-defined disorder0.5500.55
Immune system disorder0.230.0040.23
Immunoglobulins increased000
Impaired gastric emptying0.050.050.05
Impaired healing0.11700.116667
Incontinence0.010.0060.01
Increased appetite0.2300.23
Increased bronchial secretion0.3970.0120.397
Infection0.59500.594828
Infestation0.59500.594828
Infestation NOS0.59500.594828
Inflammation0.0300.03
Inflicted injury0.06940.004424780.0694444
Influenza0.400.4
Influenza like illness0.8100.81
Influenza viral infections0.10.09808610.1
Influenza-like symptoms0.200.2
Infusion site erythema000
Infusion site pain0.270.01449280.27
Infusion site phlebitis0.01450.01449280.0144928
Infusion site reaction0.2700.27
Inguinal hernia000
Initial insomnia0.02800.028
Injection site dermatitis000
Injection site erythema0.02700.027
Injection site haemorrhage0.0040.0040.004
Injection site inflammation0.490.080.49
Injection site irritation0.040.0110.04
Injection site mass0.2700.27
Injection site pain0.7300.73
Injection site pruritus0.40.0080.4
Injection site reaction0.5900.59
Injection site swelling0.0040.0040.004
Injection site urticaria0.0500.05
Injury0.200.2
Insomnia0.41800.418
Insomnia exacerbated0.020.020.02
Insulin C-peptide increased0.010.010.01
Intentional injury000
Intermittent claudication0.0600.06
International normalised ratio increased0.170.02580650.17
Intracranial pressure increased0.020.01666670.02
Intraventricular haemorrhage0.240.10.24
Irritability0.30100.301
Jaundice0.010.010.01
Joint related signs and symptoms0.030.0190.03
Joint sprain0.010.010.01
Joint stiffness0.0200.02
Joint swelling0.056100.0560748
Keratitis000
Keratoconjunctivitis sicca0.0300.03
Kidney function abnormal0.0230.0020.023
Knee pain0.040.040.04
Laboratory test abnormal0.0400.04
Labyrinthitis000
Laceration0.020.010.02
Lacrimal disorder0.0200.02
Lacrimal structural disorder000
Lacrimation0.080.010.08
Lacrimation abnormal NOS0.0200.02
Lacrimation increased0.0800.08
Lactation female000
Lactic dehydrogenase activity increased0.035700.0357143
Laryngeal pain0.14200.141667
Laryngitis0.01400.014
Leg edema0.010.0020.01
Leg pain0.0400.04
Lenticular opacities0.0040.0040.004
Lethargy0.08800.088
Leukocytosis0.04100.041
Leukoderma0.0100.01
Leukopenia0.2100.21
Leukorrhea0.073500.0735294
Libido decreased0.0800.08
Libido increased0.0410.040.041
Ligament sprain0.010.010.01
Lightheadedness0.36900.369
Limb injury0.0100.01
Lipase increased0.190.050.19
Lipodystrophy0.0050.0050.005
Lipodystrophy acquired0.0050.0050.005
Lipohypertrophy0.018700.0186916
Liver disorder0.0030.0030.003
Liver function test abnormal0.100.1
Local reaction0.340.340.34
Local swelling0.0900.09
Local throat irritation0.0040.0020.004
Logorrhoea0.010.010.01
Loose stools0.1500.15
Loss of consciousness0.0900.09
Low back pain000
Lower respiratory tract infection0.09400.094
Lung disorder0.31300.313
Lung infection0.0480.0130.048
Lymphadenopathy0.1200.12
Lymphocele0.060.060.06
Lymphocyte count decreased0.2800.28
Lymphoma000
Lymphopenia0.5300.53
Lymphoproliferative disorder0.03200.032
Macule000
Malaise0.5500.55
Malignant hypertension0.050.010.05
Malignant melanoma0.03100.031
Malignant neoplasm progression0.20.20.2
Malnutrition0.38400.383621
Mania0.060.02689490.06
Manic psychosis0.060.02689490.06
Mediastinal disorder0.500.5
Melaena0.0300.03
Melanoma skin0.0310.0310.031
Memory impairment0.22100.221
Menopausal symptoms0.4800.48
Menorrhagia0.0500.05
Menstrual disorder0.2600.26
Menstruation delayed0.010.010.01
Menstruation irregular0.1900.19
Mental deficiency000
Mental disability0.1400.14
Mental disorder0.41800.418103
Mental impairment disorders0.01800.018
Mental retardation0.05700.057
Metabolic disorder0.2090.01243680.208706
Metastasis0.2440.030.244
Metrorrhagia0.044600.044586
Mg reduced0.1400.14
Micturition burning0.040.040.04
Micturition disorder0.020.010.02
Micturition urgency0.013900.0138889
Middle insomnia0.080.0090.08
Migraine0.22200.222
Miosis000
Mood alteration NOS0.02470.02472530.0247253
Mood swings0.0800.08
Motion sickness000
Motor dysfunction000
Mouth ulceration0.2300.23
Movement disorder000
Mucosal inflammation0.0500.05
Multiple congenital abnormalities000
Multiple fractures0.0080.0080.008
Multiple sclerosis0.008330.008333330.00833333
Multiple sclerosis relapse0.030.030.03
Muscle atrophy0.0050.0050.005
Muscle contractions involuntary0.0100.01
Muscle injury0.010.010.01
Muscle rigidity0.05300.053
Muscle spasms0.21100.211429
Muscle stiffness0.0330.0330.033
Muscle strain0.0100.01
Muscle tightness000
Muscle twitching0.11800.118
Muscular weakness0.088900.0888889
Musculoskeletal chest pain0.040.0030.04
Musculoskeletal discomfort0.5700.57
Musculoskeletal disorder0.3250.0040.324913
Musculoskeletal pain0.3200.32
Musculoskeletal stiffness0.03300.033
Myalgia0.5700.57
Myasthenia0.088900.0888889
Mydriasis0.00400.004
Myocardial infarction0.02200.022
Myocardial ischaemia0.008620.008620690.00862069
Myoclonus000
Myopia000
Nail abnormality NOS000
Nail disorder0.0200.02
Nasal burning0.0260.0120.026
Nasal congestion0.16500.165
Nasal discomfort0.048400.0484429
Nasal dryness0.0049800.00497512
Nasal inflammation0.020.020.02
Nasal irritation0.03600.036036
Nasal passage irritation0.0360.0220.036
Nasal septum ulceration0.002580.002583980.00258398
Nasal ulcer0.01200.012
Nasopharyngitis0.25400.253731
Nausea0.51800.518
Neck injury000
Neck pain0.0800.08
Neck stiffness0.0100.01
Neck tightness000
Necrotising colitis0.02560.0256410.025641
Necrotising enterocolitis neonatal0.02560.0256410.025641
Necrotizing enterocolitis0.02560.0256410.025641
Neoplasm0.0100.01
Neoplasm malignant0.03100.031
Neoplasm malignant aggravated0.20.20.2
Neoplasm skin000
Nephrolithiasis000
Nephropathy0.03890.002331910.0388651
Nerve root lesion0.0190.0190.019
Nervous system disorder0.59500.594828
Nervousness0.18500.185
Neuralgia0.01900.019
Neuropathy0.100.1
Neuropathy peripheral0.24200.242054
Neurosis000
Neurotoxicity0.130.050.13
Neutropenia0.4100.41
Neutrophil count decreased0.0610.002777780.061
Night sweats0.170.0040.17
Nightmare0.05700.057
Nipple pain000
Nocturia0.00800.008
Non-cardiac chest pain0.0300.03
Non-Hodgkin's lymphoma000
NPN increased0.050.0020.05
Nuchal rigidity0.0100.01
Numbness0.020.0040.02
Nystagmus0.09300.093
Ocular hyperaemia000
Oculogyration000
Oculogyric crisis0.0100.01
Oedema0.5400.54
Oedema peripheral0.4800.48
Oesophageal ulcer0.01500.015
Oesophagitis0.070.0060.07
Oliguria0.100.1
Oral candidiasis0.0700.07
Oral fungal infection000
Oral herpes0.020.01666670.02
Oral pain0.060.060.06
Orgasm abnormal0.0100.01
Oropharyngeal candidiasis000
Oropharyngeal discomfort0.0900.09
Oropharyngeal pain0.18300.182692
Orthostatic hypotension0.4800.48
Osteoarthritis0.15400.1543
Otitis0.0370.0250.037
Otitis externa000
Otitis media0.5800.58
Otitis media acute000
Pain0.4900.49
Pain in arm0.01400.014
Pain in extremity0.100.1
Pain in jaw0.0500.05
Pain localised0.090.0150.09
Pain of lower extremities0.020.020.02
Pallor0.0600.06
Palpitations0.15600.156
Pancreatitis000
Pancytopenia000
Panic attack0.0030.0030.003
Panic reaction000
Panophthalmitis0.0090.0090.009
Paraesthesia0.11400.114286
Paraesthesia oral0.00500.005
Paranoia000
Paranoid reaction000
Parathyroid disorder0.020.020.02
Paresis000
Parkinsonism0.1500.15
Parkinsonism aggravated0.1480.1480.148
Parkinson's disease0.010.010.01
Parosmia0.0100.01
Pelvic pain0.0600.06
Penis disorder000
Pericardial effusion0.002930.002929690.00292969
Pericardial haemorrhage000
Pericarditis000
Perineal pain000
Periodontitis0.0070.0070.007
Periorbital oedema0.14500.145
Peripheral coldness0.0500.05
Peripheral ischaemia000
Peripheral sensory neuropathy0.051700.0517241
Peripheral swelling0.0030.0030.003
Peripheral vascular disorder0.0240.0240.024
Peritonitis000
Personality disorder0.0900.09
Pharyngitis0.39300.393
Pharyngitis streptococcal0.0300.03
Pharyngolaryngeal pain0.14200.141667
Phlebitis0.050.0030.05
Phlebitis superficial000
Phonological disorder0.010.010.01
Phosphatase alkaline increased0.6600.66
Phosphate low0.1400.14
Phosphorus low0.1100.11
Photosensitivity000
Photosensitivity reaction000
Pica0.0610.0610.061
Piloerection000
Pitting edema0.0030.0030.003
Platelet count decreased0.1100.11
Pleural effusion0.0910.010.091
Pleuritic pain000
Pneumocystis jirovecii pneumonia000
Pneumonia0.1700.17
Pneumonia aspiration0.0050.0050.005
Pneumonia bacterial000
Pneumothorax0.030.010.03
Pollakiuria0.0700.07
Polyuria0.031800.0318182
Post procedural diarrhoea000
Post procedural haemorrhage0.060.0060.06
Post procedural oedema0.320.320.32
Post procedural pain0.0180.01796410.0179641
Post procedural swelling0.0100.01
Postictal state0.010.010.01
Postoperative hemorrhage0.006080.0060.00607903
Post-traumatic pain0.005560.005555560.00555556
Posture abnormal0.0080.0080.008
Potassium increased0.1100.11
Potassium low0.0500.05
Prehypertension0.540.540.54
Premature ejaculation000
Premenstrual syndrome0.0060.0060.006
Presyncope0.050.020.05
Proarrhythmia0.01900.019
Procedural pain0.01800.0179641
Procedural site reaction0.0240.0240.024
Proctalgia0.087700.0877193
Productive cough0.1300.13
Prostatic disorder0.00600.006
Prostatic specific antigen increased000
Prostatitis000
Protein urine present0.3400.34
Proteinuria0.3400.34
Prothrombin level decreased0.0110.0110.011
Prothrombin level increased000
Prurigo000
Pruritus0.3600.36
Pruritus generalised0.1300.13
Pruritus genital000
Pseudohyperkalaemia0.071400.0714286
Pseudoparkinsonism0.0160.0160.016
Psychomotor retardation000
Psychotic disorder000
Pulmonary congestion0.010.0030.01
Pulmonary embolism0.08330.0020.0833333
Pulmonary function test decreased0.320.0940.32
Pulmonary hypertension0.20.05303030.2
Pulmonary oedema0.04100.041
Purpura0.07400.074
Pyelonephritis0.2150.030.215
Pyuria0.010.0090.01
Radiculopathy0.0190.0190.019
Rales0.15700.156522
Rash0.3700.37
Rash both legs0.020.020.02
Rash erythematous000
Rash maculo-papular0.05710.05714290.0571429
Rash pustular0.0100.01
Rash vesicular0.001660.001655630.00165563
Reaction aggravation0.0220.0090.022
Reaction gastrointestinal0.2380.2380.238
Rectal discharge0.031900.0319149
Rectal disorder0.020.020.02
Rectal haemorrhage0.0500.05
Rectal tenesmus0.08770.050.0877193
Red blood cell abnormality0.0060.0060.006
Red blood cell disorders000
Red blood cell sedimentation rate increased0.05220.01736110.0521739
Redness0.0140.0140.014
Regurgitation0.04300.043
Renal failure0.0500.05
Renal failure acute0.0050.0050.005
Renal failure chronic000
Renal impairment0.040.0020.04
Reproductive tract disorder0.083300.0833333
Respiration abnormal0.020.0190.02
Respiratory depression0.320.0940.32
Respiratory disorder0.020.0190.02
Respiratory distress000
Respiratory failure0.04260.040.0425532
Respiratory rate decreased0.040.040.04
Respiratory tract congestion0.010.0030.01
Respiratory tract infection0.3600.36
Restless legs syndrome0.0100.01
Retinopathy of prematurity000
Retrograde ejaculation0.008750.008752740.00875274
Retroperitoneal haemorrhage0.0009770.0009765620.000976562
Rheumatic disorder0.0100.01
Rheumatism0.0100.01
Rheumatoid arthritis0.0230.0230.023
Rhinalgia0.0100.01
Rhinitis0.3600.36
Rhinitis allergic0.130.0060.13
Rhinitis seasonal0.0200.02
Rhinorrhoea0.1300.13
Right ventricular failure0.1210.1212120.121212
Rigors0.3900.39
Road traffic accident000
Salivary hypersecretion0.34200.342
Salivation0.3420.3420.342
Scab000
Schizophrenia0.02540.010.0253759
Sciatica0.01110.010.0111111
Scotoma0.06670.06666670.0666667
Seasonal allergy0.0200.02
Seborrhoeic dermatitis000
Sensation of heat0.0800.08
Sensation of pressure0.0200.02
Sensation of warmth0.020.020.02
Sensory disturbance0.0320.020.032
Sensory loss0.0200.02
Sepsis0.1400.14
Serum ferritin decreased0.010.010.01
Sexual dysfunction0.0400.04
Shivering0.07130.02114160.071298
Shock0.0900.09
Shoulder pain0.05600.056
Sinoatrial block0.0100.01
Sinus arrhythmia000
Sinus bradycardia0.00400.004
Sinus congestion0.0600.06
Sinus disorder0.0130.0130.013
Sinus headache0.0510.0040.0509554
Sinus tachycardia0.040.010.04
Sinusitis0.18400.183908
Skin breakdown000
Skin discolouration0.0100.01
Skin disorder0.5300.53
Skin exfoliation0.1600.16
Skin laceration0.020.010.02
Skin lesion0.060.060.06
Skin mass0.0400.04
Skin nodule0.0400.04
Skin odour abnormal000
Skin striae0.018700.0186916
Skin ulcer0.0200.02
Skin wrinkling000
Sleep attacks0.0100.01
Sleep disorder0.1800.18
Sleep disturbance0.0240.0090.024
Sleep paralysis0.010.010.01
Sleep terror000
Sluggishness0.0100.01
Sneezing0.072100.0720721
Sodium decreased0.2400.24
Somnambulism000
Somnolence0.5400.54
Speech disorder0.083300.0833333
Speech impairment NOS0.020.020.02
Spinal cord compression0.05560.0380.0555556
Spinal disorder0.0150.01502150.0150215
Spondyloarthropathy0.0150.01502150.0150215
Spontaneous penile erection000
Spots before eyes0.010.010.01
Sprain0.010.010.01
Sputum increased0.3970.0120.397
Status epilepticus000
Sticky skin0.0110.0110.011
Stiffness0.0100.01
Stomach ache0.010.010.01
Stomatitis0.4100.41
Strangury0.0900.09
Stress0.011900.0119048
Stress symptoms000
Stupor000
Sudden death0.0610.0110.061
Sudden onset of sleep0.010.010.01
Suicidal ideation0.010.010.01
Suicide attempt0.0300.03
Supraventricular tachycardia000
Surgery0.030.0070.03
Surgical intervention0.030.0070.03
Surgical site reaction0.0240.0240.024
Sweating0.3100.31
Sweating increased0.22400.224252
Swelling0.02300.023
Swollen tongue000
Syncope0.0900.09
Synovitis0.0200.02
Tachycardia0.26800.268
Talkativeness0.010.010.01
Taste bitter0.0240.002450980.024
Taste disorders000
Tearfulness000
Tenderness0.0300.03
Tendon disorder0.0310.0310.031
Tendonitis0.0190.0050.019
Tenosynovitis0.0500.05
Tension0.18500.185
Tension headache0.010.0030.01
Terminal insomnia000
Testicular pain0.0100.01
Therapeutic response unexpected0.0100.01
Thinking abnormal0.083300.0833333
Thirst0.0500.05
Throat irritation0.14200.141667
Throat sore0.0900.09
Throat tightness0.010.0020.01
Thrombocytopenia0.30500.305
Thrombocytosis000
Thrombophlebitis0.09170.0009765620.0916667
Thrombosis0.070.0210.07
Thrombosis in device0.0420.0420.042
Tinea infection0.010.010.01
Tinea pedis0.002780.002777780.00277778
Tingling sensation0.0300.03
Tinnitus0.21400.214
Tongue disorder0.010.0020.01
Tongue oedema0.010.0020.01
Tongue paralysis000
Tonsillitis0.00700.007
Tooth abscess0.097700.0976744
Tooth disorder0.088400.0883721
Tooth infection0.0055600.00555556
Toothache0.41400.414
Torsade de pointes000
Tracheitis0.040.040.04
Tracheobronchitis0.0310.0070.031
Transaminases increased0.01230.01234570.0123457
Transient ischaemic attack0.0060.0060.006
Transplant rejection0.150.150.15
Trauma0.0900.09
Tremor0.1900.19
Trismus0.090.030.09
Tuberculosis000
Tumour pain0.210.020.21
Tympanic membrane disorder0.060.0120.06
Ulcer0.0140.003875970.014
Ulcerative stomatitis0.0050.0050.005
Unspecified disorder of autonomic nervous system0.140.050.14
Unspecified disorder of skin and subcutaneous tissue0.5300.53
Unspecified visual loss0.00030.00030.0003
Upper respiratory tract infection0.5200.52
Upset stomach0.0200.02
Urethral disorder0.4400.44
Urinary hesitation0.0100.01
Urinary incontinence0.200.2
Urinary retention0.06600.066
Urinary tract disorder0.4400.44
Urinary tract infection0.37300.373
Urinary tract signs and symptoms0.0140.010.014
Urination impaired0.0100.01
Urine abnormality0.0600.06
Urine analysis abnormal0.0600.06
Urine color abnormal0.0600.06
Urine output0.010.010.01
Urine output increased0.031800.0318182
Urticaria0.1100.11
Uterine disorder0.0230.0230.023
Uterine haemorrhage0.0400.04
Uterine hypertonus0.01200.012
Uterine neoplasm000
Uterine pain0.009260.009259260.00925926
Vaginal discharge0.3500.35
Vaginal dryness0.10.10.1
Vaginal haemorrhage0.2200.22
Vaginal infection0.06900.0689655
Vaginal inflammation0.06900.0689655
Vaginal irritation0.0370.0370370.037037
Vaginal moniliasis0.07100.071
Vaginal mycosis0.0320.0320.032
Varicose vein0.0150.0150.015
Vascular hypertensive disorders0.020.0140.02
Vascular occlusion0.0210.0210.021
Vascular purpura0.07400.074
Vasodilation0.1800.18
Vasodilation procedure0.1800.18
Ventricular arrhythmia0.13600.136
Ventricular extrasystoles0.0100.01
Ventricular fibrillation0.0310.0010.031
Ventricular tachycardia0.11300.113
Vertigo0.1600.16
Vesiculobullous rash0.0100.01
Vestibular disorder0.020.020.02
VIIth nerve paralysis0.04170.04166670.0416667
Viral diarrhoea0.0200.02
Viral infection0.25800.258
Viral upper respiratory tract infection0.035700.0357143
Vision blurred0.21400.214
Visual disturbance0.0200.02
Visual impairment0.0600.06
Vital dye staining cornea present0.0130.0130.013
Vivid dreams0.05700.057
Vomiting0.4900.49
Vulvovaginal burning sensation0.0220.0220.022
Vulvovaginal candidiasis0.07100.071
Vulvovaginal discomfort0.0370.0370370.037037
Vulvovaginal disorder0.07100.071
Vulvovaginal dryness0.100.1
Vulvovaginal mycotic infection0.07100.071
Vulvovaginal pruritus0.019400.0194175
Vulvovaginitis0.06480.010.0648148
Weight decreased0.23200.232
Weight increased0.22700.227
Welts0.110.020.11
Wheezing0.100.1
White blood cell count decreased0.1300.13
White blood cells urine positive0.020.020.02
Withdrawal syndrome0.37400.373832
Worry0.040.040.04
Worsening of diabetes0.007940.007936510.00793651
Wound0.3050.050.305085
Wound discharge increased000
Wound haematoma000
Wound haemorrhage0.01390.01393730.0139373
Wound infection0.0690.0690.069
Wound secretion000
Xeroderma0.0600.06
Xerophthalmia000
X-linked lymphoproliferative syndrome0.03200.032
Yawning0.0100.01
SIDER データベース中の1430の医薬品添付文書に記載された臨床成績のなかで、プラセボが使用されて有害事象が報告された被験者の割合。

ちなみに、98%の被験者にalopecia(禿げ)が報告された試験はdexrazoxaneの試験です。図は実薬の副作用の頻度です。実薬は抗がん薬の臓器障害から組織を保護する様な作用があるという事でPlaceboより有害事象の頻度が低くなることが期待されます。Placeboは結構危険かもしれません~

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