amiodarone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antiarrhythmics 176 1951-25-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amiodarone
  • amidorone
  • sedacoron
  • amiodarone hydrochloride
  • amiodarone HCl
An antianginal and class III antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting POTASSIUM CHANNELS and VOLTAGE-GATED SODIUM CHANNELS. There is a resulting decrease in heart rate and in vascular resistance.
  • Molecular weight: 645.32
  • Formula: C25H29I2NO3
  • CLOGP: 8.95
  • LIPINSKI: 2
  • HAC: 4
  • HDO: 0
  • TPSA: 42.68
  • ALOGS: -5.13
  • ROTB: 11
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.72 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 41.37 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.90 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 820 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 46 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.880 Moderate 0.69
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.644 Moderate 0.69
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.026 10^-6 cm/s Moderate 0.69
dh-clint Dog hepatocyte intrinsic clearance 28.642 uL/min/10^6 cells Moderate 0.69
dppb Dog plasma protein binding (% unbound) 0.200 % Moderate 0.69
fcs-ppb Fetal calf serum protein binding (% unbound) 0.210 % Moderate 0.69
herg hERG pIC50 5.100 pIC50 Moderate 0.69
hh-clint Human hepatocyte intrinsic clearance 4.932 uL/min/10^6 cells Moderate 0.69
hlm-clint Human liver microsomal intrinsic clearance 47.643 uL/min/mg protein Moderate 0.69
hppb Human plasma protein binding (% unbound) 0.220 % Moderate 0.69
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK2,CDK4,CDK5,CDK9,CHEK1,CSF1R,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GAK,GRK2,GSK3B,INSR,ITK,JAK1,JAK2,JAK3,KDR,KIT,MAP2K6,MAP3K1,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MAPKAPK5,MARK4,MELK,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM1,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ULK2,ZAP70 75
kinase-selectivity-class ALK,AXL,BRAF,CAMK2D,CDK4,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,MAP2K6,MAPK1,MAPK7,PDK4,PIK3CD,SIK2,STK10,STK33,TEK,TTK 22
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.140 Moderate 0.69
mh-clint Mouse hepatocyte intrinsic clearance 34.435 Moderate 0.69
mppb Mouse plasma protein binding (% unbound) 0.190 Moderate 0.69
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.092 Moderate 0.69
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 0.180 % Moderate 0.69
rh-clint Rat hepatocyte intrinsic clearance 22.336 uL/min/10^6 cells Moderate 0.69
rh-fuinc Rat hepatocyte fraction unbound in incubation 0.080 % Moderate 0.69
rppb Rat plasma protein binding (% unbound) 0.170 % Moderate 0.69
solubility-dd Solubility at pH 7.4 in DMSO 0.221 uM Moderate 0.69

Approvals:

DateAgencyCompanyOrphan
Dec. 24, 1985 FDA WYETH PHARMS INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug interaction 1478.09 13.84 1311 57954 275142 90294040
Bradycardia 1060.05 13.84 668 58597 83179 90486003
Electrocardiogram QT prolonged 991.07 13.84 607 58658 71849 90497333
Hyperthyroidism 905.59 13.84 368 58897 17942 90551240
Torsade de pointes 886.45 13.84 344 58921 14838 90554344
Atrial fibrillation 797.41 13.84 676 58589 132935 90436247
Acute kidney injury 721.72 13.84 964 58301 319423 90249759
Interstitial lung disease 608.10 13.84 458 58807 75947 90493235
Cardiac failure 431.63 13.84 440 58825 109056 90460126
Myxoedema coma 398.68 13.84 84 59181 328 90568854
Ventricular tachycardia 394.70 13.84 229 59036 24479 90544703
Pulmonary toxicity 392.53 13.84 178 59087 11353 90557829
Hypotension 356.78 13.84 707 58558 324690 90244492
Cardiogenic shock 349.54 13.84 211 59054 24257 90544925
Hypothyroidism 341.66 13.84 281 58984 52846 90516336
Hyperkalaemia 337.32 13.84 304 58961 64660 90504522
Hyponatraemia 332.66 13.84 423 58842 133115 90436067
Sinus bradycardia 308.16 13.84 171 59094 16781 90552401
International normalised ratio increased 291.20 13.84 244 59021 47072 90522110
Pain 274.63 13.84 156 59109 996185 89572997
Syncope 273.24 13.84 383 58882 132280 90436902
Gastrointestinal haemorrhage 263.77 13.84 310 58955 89938 90479244
Cardiac arrest 234.19 13.84 315 58950 104620 90464562
Ventricular fibrillation 231.81 13.84 133 59132 13911 90555271
Haematoma 227.20 13.84 195 59070 38853 90530329
Joint swelling 218.68 13.84 34 59231 503266 90065916
Tachyarrhythmia 214.70 13.84 93 59172 5313 90563869
Lactic acidosis 197.22 13.84 202 59063 50261 90518921
Sinus node dysfunction 191.98 13.84 86 59179 5326 90563856
Anaemia 191.09 13.84 585 58680 352217 90216965
Synovitis 188.52 13.84 6 59259 329746 90239436
Systemic lupus erythematosus 186.36 13.84 13 59252 361883 90207299
Shock haemorrhagic 186.31 13.84 110 59155 12135 90557047
Thyroiditis 175.96 13.84 72 59193 3565 90565617
Infusion related reaction 172.49 13.84 32 59233 416748 90152434
Arthropathy 163.00 13.84 23 59242 366219 90202963
Arrhythmia 155.61 13.84 164 59101 42168 90527014
Hypokalaemia 151.92 13.84 292 58973 130824 90438358
Cardiac failure congestive 149.32 13.84 247 59018 98447 90470735
Thyrotoxic crisis 149.05 13.84 48 59217 1183 90567999
Therapeutic product effect decreased 148.79 13.84 8 59257 277563 90291619
Arthralgia 147.10 13.84 176 59089 778346 89790836
Rash 144.11 13.84 186 59079 795914 89773268
Alopecia 144.04 13.84 72 59193 494999 90074183
Headache 143.77 13.84 214 59051 862532 89706650
Wound 142.15 13.84 16 59249 302964 90266218
Swelling 136.03 13.84 52 59213 419006 90150176
Sinusitis 134.32 13.84 30 59235 343058 90226124
Atrial flutter 133.89 13.84 85 59180 10673 90558509
Melaena 133.61 13.84 138 59127 34659 90534523
Mitral valve incompetence 132.06 13.84 113 59152 22411 90546771
Fall 127.38 13.84 637 58628 481173 90088009
Musculoskeletal stiffness 122.13 13.84 23 59242 296509 90272673
Rheumatoid arthritis 121.03 13.84 43 59222 362571 90206611
Hypersensitivity 120.83 13.84 74 59191 454603 90114579
Drug intolerance 120.13 13.84 72 59193 447519 90121663
Ventricular arrhythmia 120.11 13.84 58 59207 4263 90564919
Cardio-respiratory arrest 119.17 13.84 175 59090 62965 90506217
Renal failure 119.06 13.84 264 59001 130743 90438439
Acute hepatic failure 117.85 13.84 106 59159 22455 90546727
Pericarditis 115.51 13.84 19 59246 270132 90299050
Nasopharyngitis 114.23 13.84 62 59203 407042 90162140
Fibromyalgia 113.55 13.84 5 59260 206264 90362918
Psoriatic arthropathy 112.45 13.84 10 59255 228325 90340857
Long QT syndrome 108.64 13.84 53 59212 3984 90565198
Labelled drug-drug interaction medication error 108.35 13.84 84 59181 14498 90554684
Cerebral haemorrhage 104.81 13.84 121 59144 34401 90534781
Urticaria 104.49 13.84 37 59228 312697 90256485
Toxicity to various agents 103.36 13.84 417 58848 287429 90281753
Cholestasis 103.17 13.84 123 59142 36176 90533006
Arterial haemorrhage 102.14 13.84 44 59221 2479 90566703
Cornea verticillata 100.13 13.84 25 59240 233 90568949
Ventricular extrasystoles 99.92 13.84 77 59188 13173 90556009
Lymphatic fistula 99.26 13.84 37 59228 1424 90567758
Abdominal discomfort 98.69 13.84 100 59165 477228 90091954
Femoral hernia incarcerated 98.12 13.84 37 59228 1471 90567711
Haematoma muscle 97.67 13.84 39 59226 1811 90567371
Alveolitis 97.65 13.84 45 59220 2976 90566206
Migraine 97.47 13.84 7 59258 190385 90378797
Irritable bowel syndrome 97.15 13.84 11 59254 207437 90361745
Pericardial haemorrhage 97.15 13.84 39 59226 1837 90567345
Hypoaesthesia 97.02 13.84 42 59223 314168 90255014
Pulmonary hypertension 95.31 13.84 128 59137 42395 90526787
Blood cholesterol increased 95.02 13.84 12 59253 208000 90361182
Ill-defined disorder 94.07 13.84 7 59258 184884 90384298
Rhabdomyolysis 93.75 13.84 140 59125 51116 90518066
Stomatitis 92.61 13.84 32 59233 274666 90294516
Hypoxia 92.24 13.84 168 59097 72231 90496951
Type 2 diabetes mellitus 92.18 13.84 12 59253 203232 90365950
Pancreatic steatosis 91.53 13.84 36 59229 1606 90567576
Multiple organ dysfunction syndrome 91.45 13.84 162 59103 68174 90501008
Cerebral haematoma 91.14 13.84 48 59217 4241 90564941
Left ventricular dysfunction 90.93 13.84 76 59189 14593 90554589
Wound infection pseudomonas 90.93 13.84 38 59227 1985 90567197
Coronary artery disease 90.77 13.84 111 59154 33512 90535670
Atrioventricular block complete 89.65 13.84 64 59201 9747 90559435
Maternal exposure during pregnancy 89.65 13.84 63 59202 360000 90209182
Atrioventricular block 88.70 13.84 61 59204 8754 90560428
Hypersensitivity myocarditis 87.87 13.84 23 59242 263 90568919
Injury 86.33 13.84 13 59252 197336 90371846
Infection 85.44 13.84 67 59198 362027 90207155
Faecaloma 83.90 13.84 63 59202 10368 90558814
Respiratory distress 83.90 13.84 115 59150 38831 90530351
Cardioversion 83.33 13.84 32 59233 1338 90567844
Haemarthrosis 82.89 13.84 44 59221 3950 90565232
Hepatocellular injury 82.09 13.84 98 59167 28860 90540322
Acute respiratory failure 81.04 13.84 119 59146 42799 90526383
Weight increased 79.25 13.84 94 59171 417833 90151349
Urinary retention 79.13 13.84 110 59155 37634 90531548
Discomfort 78.04 13.84 41 59224 274294 90294888
Dyspnoea 76.26 13.84 895 58370 880060 89689122
Respiratory failure 75.10 13.84 208 59057 118210 90450972
Pain in extremity 73.61 13.84 113 59152 450416 90118766
BRASH syndrome 73.55 13.84 32 59233 1847 90567335
Mesenteric haematoma 73.27 13.84 15 59250 49 90569133
Bursitis 73.08 13.84 3 59262 131651 90437531
Seroma 72.95 13.84 37 59228 3023 90566159
Haemorrhage 72.47 13.84 148 59117 69221 90499961
Depression 71.69 13.84 55 59210 300546 90268636
Blister 71.23 13.84 39 59226 254959 90314223
Haematuria 70.53 13.84 100 59165 34837 90534345
Blood loss anaemia 70.13 13.84 56 59209 10084 90559098
Hepatic cyst 69.77 13.84 47 59218 6521 90562661
Keratopathy 67.30 13.84 23 59242 685 90568497
Aortic valve stenosis 66.89 13.84 39 59226 4201 90564981
Therapeutic product effect incomplete 66.35 13.84 22 59243 193874 90375308
Ischaemic stroke 66.12 13.84 77 59188 22089 90547093
Inflammatory marker increased 66.12 13.84 52 59213 9162 90560020
Fatigue 65.70 13.84 464 58801 1153559 89415623
Tricuspid valve incompetence 65.38 13.84 67 59198 16664 90552518
Toxic skin eruption 64.99 13.84 65 59200 15709 90553473
Anuria 64.65 13.84 63 59202 14755 90554427
C-reactive protein abnormal 64.32 13.84 5 59260 127424 90441758
Blood thyroid stimulating hormone increased 64.26 13.84 51 59214 9104 90560078
Myxoedema 64 13.84 16 59249 150 90569032
Hepatic enzyme increased 63.31 13.84 86 59179 360650 90208532
Listless 62.41 13.84 34 59231 3215 90565967
Asthma 62.07 13.84 41 59224 242119 90327063
Encephalopathy 60.71 13.84 109 59156 46335 90522847
Product use issue 60.62 13.84 76 59189 329843 90239339
Muscle spasms 58.89 13.84 47 59218 251836 90317346
Orthopnoea 58.83 13.84 43 59222 6792 90562390
Overdose 58.55 13.84 231 59034 157478 90411704
Contraindicated product administered 58.55 13.84 74 59191 320065 90249117
Drug level increased 58.33 13.84 81 59184 27681 90541501
Pneumonitis 58.17 13.84 104 59161 44066 90525116
Pruritus 57.47 13.84 173 59092 541352 90027830
Myocardial infarction 57.44 13.84 176 59089 105796 90463386
Night sweats 57.42 13.84 8 59257 128758 90440424
Intentional product use issue 56.57 13.84 36 59229 216856 90352326
Infusion site phlebitis 56.13 13.84 13 59252 85 90569097
Hypoglycaemia 55.96 13.84 134 59131 69714 90499468
Diverticulum intestinal 55.91 13.84 47 59218 9095 90560087
Septic shock 55.51 13.84 150 59115 84010 90485172
Sudden death 54.51 13.84 50 59215 10859 90558323
Swollen joint count increased 54.37 13.84 5 59260 111201 90457981
Musculoskeletal pain 52.65 13.84 23 59242 171228 90397954
Aortic arteriosclerosis 52.21 13.84 42 59223 7642 90561540
Insomnia 52.20 13.84 86 59179 333388 90235794
Acute respiratory distress syndrome 51.94 13.84 78 59187 28608 90540574
Iodine overload 51.83 13.84 9 59256 7 90569175
Hypomagnesaemia 51.03 13.84 87 59178 35501 90533681
Cardiac ablation 50.80 13.84 24 59241 1680 90567502
Bradyarrhythmia 50.76 13.84 27 59238 2434 90566748
Arthritis 50.60 13.84 23 59242 167292 90401890
Shock 50.34 13.84 77 59188 28701 90540481
Hepatic cytolysis 50.29 13.84 80 59185 30836 90538346
Reduced facial expression 49.82 13.84 27 59238 2526 90566656
Cardiac disorder 49.82 13.84 113 59152 56759 90512423
Impaired healing 49.55 13.84 48 59217 234151 90335031
Spontaneous haematoma 49.54 13.84 21 59244 1137 90568045
Agranulocytosis 49.44 13.84 85 59180 34917 90534265
Nodal rhythm 49.32 13.84 24 59241 1794 90567388
Mobility decreased 48.99 13.84 55 59210 250679 90318503
Cardioactive drug level increased 48.73 13.84 26 59239 2358 90566824
Wound dehiscence 48.69 13.84 36 59229 5786 90563396
Psoriasis 48.43 13.84 18 59247 147736 90421446
Gastrointestinal disorder 48.32 13.84 58 59207 256629 90312553
Mixed liver injury 48.29 13.84 40 59225 7583 90561599
Abdominal pain upper 48.25 13.84 90 59175 332584 90236598
Injection site pain 47.86 13.84 27 59238 173672 90395510
Ischaemic hepatitis 47.56 13.84 27 59238 2766 90566416
Coagulopathy 47.51 13.84 67 59198 23222 90545960
Cardiac tamponade 47.50 13.84 35 59230 5597 90563585
Cardiovascular disorder 47.32 13.84 51 59214 13441 90555741
Sciatica 45.91 13.84 6 59259 101376 90467806
Paraesthesia 45.61 13.84 58 59207 250268 90318914
Road traffic accident 45.02 13.84 8 59257 107618 90461564
Thrombocytopenia 44.82 13.84 261 59004 208464 90360718
Lower respiratory tract infection 44.72 13.84 59 59206 250600 90318582
Osteoarthritis 43.92 13.84 38 59227 195692 90373490
Obesity 43.79 13.84 8 59257 105499 90463683
Exposure during pregnancy 43.69 13.84 55 59210 238355 90330827
Atrial tachycardia 43.40 13.84 34 59231 5956 90563226
Electrocardiogram QRS complex prolonged 43.34 13.84 37 59228 7311 90561871
Hepatitis acute 43.27 13.84 44 59221 10843 90558339
Acute generalised exanthematous pustulosis 43.22 13.84 49 59216 13654 90555528
Pleural effusion 43.15 13.84 166 59099 111825 90457357
Muscle haemorrhage 43.04 13.84 27 59238 3319 90565863
Extrasystoles 42.92 13.84 33 59232 5624 90563558
Gastrooesophageal reflux disease 42.83 13.84 28 59237 166309 90402873
Pyrexia 42.80 13.84 255 59010 660230 89908952
Pericardial effusion 42.57 13.84 82 59183 36751 90532431
Cerebellar haematoma 41.99 13.84 14 59251 386 90568796
Cerebellar syndrome 41.83 13.84 28 59237 3844 90565338
Head injury 41.79 13.84 74 59191 31114 90538068
Bundle branch block left 41.08 13.84 37 59228 7848 90561334
Glomerular filtration rate decreased 41.08 13.84 53 59212 16879 90552303
Anticoagulation drug level increased 40.93 13.84 13 59252 306 90568876
Oliguria 40.53 13.84 42 59223 10582 90558600
Abdominal wall haematoma 40.50 13.84 26 59239 3326 90565856
Wheezing 40.50 13.84 58 59207 238022 90331160
Injection site reaction 40.40 13.84 6 59259 92074 90477108
Heparin-induced thrombocytopenia 40.33 13.84 31 59234 5281 90563901
Wound infection 40.21 13.84 10 59255 106392 90462790
Live birth 40.21 13.84 3 59262 79104 90490078
Neuromyopathy 39.63 13.84 16 59249 765 90568417
Drug hypersensitivity 39.19 13.84 163 59102 463446 90105736
Lower gastrointestinal haemorrhage 39.16 13.84 38 59227 8854 90560328
Pulmonary alveolar haemorrhage 39.10 13.84 32 59233 5966 90563216
Groin pain 39.08 13.84 44 59221 12169 90557013
Death 38.94 13.84 463 58802 456088 90113094
Device stimulation issue 38.84 13.84 9 59256 59 90569123
Prothrombin time shortened 38.73 13.84 22 59243 2256 90566926
Corneal deposits 38.70 13.84 13 59252 367 90568815
Cardiac failure chronic 38.66 13.84 31 59234 5615 90563567
Lung opacity 38.62 13.84 32 59233 6070 90563112
Inflammation 38.48 13.84 36 59229 178556 90390626
Hip arthroplasty 38.42 13.84 3 59262 76205 90492977
Anticoagulation drug level above therapeutic 38.39 13.84 21 59244 2001 90567181
Respiratory acidosis 38.22 13.84 36 59229 8083 90561099
Eructation 37.93 13.84 41 59224 10841 90558341
Nodal arrhythmia 37.76 13.84 18 59247 1285 90567897
Peripheral swelling 37.61 13.84 141 59124 412965 90156217
Eosinophilic pneumonia acute 37.49 13.84 15 59250 700 90568482
Gait inability 37.24 13.84 25 59240 146431 90422751
Red blood cell sedimentation rate increased 37.13 13.84 5 59260 82590 90486592
Subdural haematoma 37.13 13.84 50 59215 16595 90552587
Arrhythmia supraventricular 36.88 13.84 17 59248 1125 90568057
Cardiac failure acute 36.52 13.84 42 59223 11887 90557295
C-reactive protein increased 36.29 13.84 39 59226 181350 90387832
Lung consolidation 36.21 13.84 28 59237 4812 90564370
Mediastinal haematoma 36.13 13.84 9 59256 83 90569099
Craniocerebral injury 35.99 13.84 24 59241 3274 90565908
Treatment failure 35.98 13.84 92 59173 303836 90265346
Stress cardiomyopathy 35.89 13.84 44 59221 13311 90555871
Presyncope 35.77 13.84 70 59195 31735 90537447
Retroperitoneal haematoma 35.53 13.84 24 59241 3344 90565838
Ecchymosis 35.41 13.84 42 59223 12281 90556901
Hypercholesterolaemia 35.30 13.84 11 59254 100881 90468301
Transaminases increased 34.94 13.84 76 59189 37116 90532066
Atrioventricular block first degree 34.93 13.84 35 59230 8476 90560706
Ear infection 34.48 13.84 3 59262 69772 90499410
Right ventricular failure 34.46 13.84 52 59213 19153 90550029
Escherichia infection 34.32 13.84 47 59218 15848 90553334
Subcutaneous haematoma 34.22 13.84 19 59246 1864 90567318
Drug-induced liver injury 34.07 13.84 133 59132 90185 90478997
Cutaneous vasculitis 34.07 13.84 32 59233 7161 90562021
Injection site erythema 34.00 13.84 11 59254 98491 90470691
Liver function test abnormal 33.90 13.84 91 59174 50754 90518428
Drug level above therapeutic 33.75 13.84 29 59236 5780 90563402
Eosinophilia 33.56 13.84 64 59201 28469 90540713
Peripheral venous disease 33.48 13.84 7 59258 83914 90485268
Dry mouth 33.15 13.84 43 59222 184016 90385166
Hypervolaemia 33.15 13.84 69 59196 32688 90536494
Knee arthroplasty 33.06 13.84 7 59258 83175 90486007
Rectal haemorrhage 32.98 13.84 124 59141 82620 90486562
Ventricular tachyarrhythmia 32.97 13.84 10 59255 201 90568981
Haemorrhagic stroke 32.90 13.84 30 59235 6466 90562716
Blood creatinine increased 32.50 13.84 142 59123 101244 90467938
Potentiating drug interaction 32.36 13.84 28 59237 5634 90563548
Prerenal failure 32.17 13.84 19 59246 2096 90567086
Head discomfort 31.86 13.84 46 59219 16287 90552895
Foreign body 31.77 13.84 20 59245 2474 90566708
Tracheal compression 31.67 13.84 5 59260 0 90569182
Memory impairment 31.65 13.84 50 59215 197194 90371988
Haemorrhagic diathesis 30.93 13.84 27 59238 5497 90563685
Apathy 30.69 13.84 37 59228 11003 90558179
Retroperitoneal haemorrhage 30.25 13.84 21 59244 3059 90566123
Prescribed overdose 30.17 13.84 13 59252 97612 90471570
Upper respiratory tract infection 29.90 13.84 24 59241 128294 90440888
Acute pulmonary oedema 29.78 13.84 34 59231 9546 90559636
Amnesia 29.69 13.84 17 59248 108488 90460694
Oedema peripheral 29.69 13.84 278 58987 257637 90311545
Product quality issue 28.94 13.84 8 59257 79317 90489865
Organising pneumonia 28.92 13.84 30 59235 7567 90561615
Thyroid disorder 28.89 13.84 46 59219 17739 90551443
Colitis ulcerative 28.70 13.84 3 59262 60263 90508919
Anxiety 28.65 13.84 105 59160 309667 90259515
Rales 28.60 13.84 43 59222 15784 90553398
Adverse event 28.58 13.84 21 59244 117397 90451785
Myocardial ischaemia 28.56 13.84 40 59225 13774 90555408
Pelvic fracture 28.44 13.84 42 59223 15177 90554005
Dehydration 28.39 13.84 221 59044 194226 90374956
Pulseless electrical activity 28.27 13.84 32 59233 8900 90560282
Neck pain 28.24 13.84 20 59245 113943 90455239
Product dose omission issue 28.23 13.84 97 59168 291590 90277592
Goitre congenital 28.20 13.84 5 59260 5 90569177
Alveolar proteinosis 28.16 13.84 13 59252 863 90568319
Coronary artery bypass 27.84 13.84 18 59247 2331 90566851
Renal phospholipidosis 27.75 13.84 9 59256 227 90568955
Oesophageal squamous cell carcinoma 27.69 13.84 8 59257 135 90569047
Petechiae 27.36 13.84 42 59223 15699 90553483
Pulmonary oedema 27.25 13.84 96 59169 61984 90507198
Central nervous system injury 27.15 13.84 8 59257 145 90569037
Prescription drug used without a prescription 26.94 13.84 20 59245 3235 90565947
Dyspnoea exertional 26.90 13.84 106 59159 72182 90497000
Aplastic anaemia 26.81 13.84 38 59227 13231 90555951
Device capturing issue 26.49 13.84 6 59259 35 90569147
Sinoatrial block 26.46 13.84 13 59252 992 90568190
Joint stiffness 26.43 13.84 9 59256 78033 90491149
Cholestatic liver injury 26.32 13.84 21 59244 3776 90565406
Rash maculo-papular 26.03 13.84 72 59193 40861 90528321
Dyspnoea at rest 25.99 13.84 23 59242 4768 90564414
Myelodysplastic syndrome 25.97 13.84 48 59217 20855 90548327
Subarachnoid haemorrhage 25.97 13.84 44 59221 17860 90551322
Vertigo 25.68 13.84 102 59163 69709 90499473
Oxygen saturation decreased 25.43 13.84 138 59127 107345 90461837
Device pacing issue 25.18 13.84 7 59258 102 90569080
Pulmonary arterial hypertension 25.15 13.84 54 59211 26133 90543049
Chronic kidney disease 25.01 13.84 81 59184 50110 90519072
Postoperative wound infection 25.01 13.84 37 59228 13389 90555793
Abortion spontaneous 24.96 13.84 3 59262 54053 90515129
Sleep disorder 24.96 13.84 58 59207 197972 90371210
Splenic injury 24.51 13.84 8 59257 206 90568976
Inappropriate antidiuretic hormone secretion 24.50 13.84 45 59220 19460 90549722
Cardiac sarcoidosis 24.46 13.84 7 59258 114 90569068
Splenic haemorrhage 24.44 13.84 8 59257 208 90568974
Pneumonitis chemical 24.40 13.84 9 59256 336 90568846
Hepatic failure 24.39 13.84 69 59196 39659 90529523
Intra-abdominal haematoma 24.36 13.84 16 59249 2128 90567054
Hypochromasia 24.18 13.84 9 59256 345 90568837
Lower limb fracture 23.72 13.84 13 59252 85000 90484182
Hypothermia 23.56 13.84 39 59226 15536 90553646
Metabolic acidosis 23.50 13.84 85 59180 55591 90513591
Hypovolaemic shock 23.46 13.84 26 59239 7068 90562114
Hypocoagulable state 23.37 13.84 14 59251 1585 90567597
Toxic nodular goitre 23.30 13.84 6 59259 64 90569118
Thyroxine free increased 23.27 13.84 12 59253 1015 90568167
Mitral valve disease mixed 23.10 13.84 4 59261 3 90569179
Cardioactive drug level above therapeutic 22.97 13.84 7 59258 143 90569039
Back pain 22.93 13.84 118 59147 317057 90252125
Ear pain 22.64 13.84 5 59260 57697 90511485
Myelosuppression 22.37 13.84 4 59261 53587 90515595
Myalgia 22.30 13.84 51 59214 175074 90394108
Frequent bowel movements 22.20 13.84 5 59260 56930 90512252
Cyanosis 22.10 13.84 43 59222 19412 90549770
Bone erosion 22.04 13.84 4 59261 53017 90516165
Myopathy 22.01 13.84 35 59230 13483 90555699
Kidney malrotation 21.82 13.84 5 59260 31 90569151
Disorientation 21.81 13.84 71 59194 44043 90525139
Tachypnoea 21.70 13.84 45 59220 21264 90547918
Feeling hot 21.66 13.84 12 59253 77996 90491186
Injection site bruising 21.63 13.84 4 59261 52303 90516879
Sopor 21.61 13.84 49 59216 24595 90544587
Brugada syndrome 21.61 13.84 9 59256 466 90568716
Hepatitis fulminant 21.52 13.84 19 59246 3926 90565256
Atrioventricular block second degree 21.46 13.84 20 59245 4432 90564750
Sudden cardiac death 21.41 13.84 15 59250 2217 90566965
Haemodynamic instability 21.36 13.84 32 59233 11707 90557475
Loss of consciousness 21.36 13.84 161 59104 140077 90429105
Hypertensive heart disease 21.35 13.84 16 59249 2624 90566558
Osteoporosis 21.33 13.84 19 59246 96512 90472670
Anti-thyroid antibody positive 21.27 13.84 9 59256 485 90568697
Diarrhoea 21.12 13.84 461 58804 938729 89630453
White blood cell count decreased 21.01 13.84 49 59216 167060 90402122
Goitre 21.01 13.84 24 59241 6743 90562439
Thyroiditis acute 21.01 13.84 6 59259 97 90569085
Palpitations 20.84 13.84 157 59108 136571 90432611
Sepsis 20.77 13.84 194 59071 179620 90389562
Laryngitis 20.73 13.84 4 59261 50749 90518433
Product administered to patient of inappropriate age 20.71 13.84 20 59245 4633 90564549
Cerebrovascular accident 20.64 13.84 145 59120 123388 90445794
Concomitant disease aggravated 20.40 13.84 31 59234 11487 90557695
Suicide attempt 20.36 13.84 12 59253 75387 90493795
Nausea 20.35 13.84 562 58703 1109754 89459428
Haemorrhage intracranial 20.34 13.84 36 59229 15126 90554056
Cardiac amyloidosis 20.34 13.84 11 59254 1025 90568157
Cardiac arrest neonatal 20.20 13.84 6 59259 112 90569070
Hypoglycaemic seizure 20.18 13.84 9 59256 551 90568631
Liver scan abnormal 19.89 13.84 5 59260 48 90569134
Chorea 19.82 13.84 14 59251 2096 90567086
Therapy non-responder 19.78 13.84 37 59228 136667 90432515
Supraventricular tachycardia 19.65 13.84 37 59228 16299 90552883
Ejection fraction decreased 19.57 13.84 49 59216 26204 90542978
Throat irritation 19.55 13.84 4 59261 48691 90520491
Drug reaction with eosinophilia and systemic symptoms 19.52 13.84 67 59198 42691 90526491
Congenital hypothyroidism 19.49 13.84 7 59258 242 90568940
Coeliac disease 19.35 13.84 3 59262 44607 90524575
Altered visual depth perception 19.32 13.84 8 59257 408 90568774
Stress 19.24 13.84 15 59250 81380 90487802
Neovascular age-related macular degeneration 19.01 13.84 8 59257 425 90568757
Renal impairment 18.95 13.84 126 59139 105295 90463887
Haemorrhagic thyroid cyst 18.91 13.84 4 59261 16 90569166
Blood creatine increased 18.80 13.84 23 59242 6944 90562238
Hypoxic-ischaemic encephalopathy 18.80 13.84 19 59246 4649 90564533
Pharyngeal haematoma 18.73 13.84 5 59260 62 90569120
Hyperthermia 18.56 13.84 28 59237 10307 90558875
Hiatus hernia 18.55 13.84 47 59218 25314 90543868
Hepatitis toxic 18.47 13.84 17 59248 3708 90565474
Foot deformity 18.34 13.84 8 59257 59643 90509539
Prostatic specific antigen abnormal 18.31 13.84 5 59260 68 90569114
Respiratory sinus arrhythmia magnitude 18.31 13.84 5 59260 68 90569114
Medication error 18.24 13.84 106 59159 84546 90484636
Activated partial thromboplastin time prolonged 18.21 13.84 24 59241 7801 90561381
Blood phosphorus increased 18.17 13.84 18 59247 4300 90564882
Propionibacterium infection 17.86 13.84 4 59261 22 90569160
Secondary hyperthyroidism 17.86 13.84 4 59261 22 90569160
Compensatory sweating 17.71 13.84 4 59261 23 90569159
Influenza like illness 17.65 13.84 16 59249 80595 90488587
N-terminal prohormone brain natriuretic peptide increased 17.64 13.84 15 59250 2947 90566235
Dyschromatopsia 17.60 13.84 9 59256 748 90568434
Fluid balance positive 17.57 13.84 4 59261 24 90569158
Tubulointerstitial nephritis 17.54 13.84 46 59219 25297 90543885
Echolalia 17.51 13.84 7 59258 326 90568856
Splenic rupture 17.48 13.84 11 59254 1360 90567822
Haemoglobin decreased 17.35 13.84 172 59093 161784 90407398
Renal injury 17.34 13.84 27 59238 10216 90558966
Congestive hepatopathy 17.33 13.84 15 59250 3018 90566164
Sleep disorder due to a general medical condition 17.30 13.84 4 59261 44734 90524448
Epilepsy 17.20 13.84 17 59248 82189 90486993
Embolic stroke 17.18 13.84 17 59248 4055 90565127
Anisocytosis 17.12 13.84 9 59256 792 90568390
Hallucination, visual 17.11 13.84 43 59222 23049 90546133
Circulatory collapse 17.03 13.84 45 59220 24859 90544323
Thyroxine increased 17.00 13.84 9 59256 803 90568379
Infective pericardial effusion 16.79 13.84 4 59261 30 90569152
Electrocardiogram U wave present 16.70 13.84 5 59260 96 90569086
Retinal artery occlusion 16.69 13.84 13 59252 2258 90566924
Ventricular dysfunction 16.53 13.84 16 59249 3715 90565467
Drug clearance decreased 16.47 13.84 12 59253 1886 90567296
Endovenous ablation 16.46 13.84 3 59262 4 90569178
Oesophageal adenocarcinoma recurrent 16.46 13.84 4 59261 33 90569149
Eosinophilic pneumonia 16.43 13.84 14 59251 2759 90566423
Monoclonal gammopathy 16.37 13.84 9 59256 866 90568316
Off label use 16.27 13.84 574 58691 1101678 89467504
Ventricular asystole 16.24 13.84 5 59260 106 90569076
Epistaxis 16.07 13.84 103 59162 85022 90484160
Hypertension 16.01 13.84 207 59058 457325 90111857
Electrocardiogram T wave alternans 15.95 13.84 4 59261 38 90569144
Intestinal ischaemia 15.86 13.84 24 59241 8859 90560323
Low cardiac output syndrome 15.74 13.84 7 59258 426 90568756
Cardiovascular insufficiency 15.71 13.84 11 59254 1624 90567558
Hypothyroidic goitre 15.71 13.84 3 59262 6 90569176
Extradural haematoma 15.55 13.84 12 59253 2056 90567126
Coagulation test abnormal 15.50 13.84 9 59256 962 90568220
Injection site swelling 15.50 13.84 10 59255 59829 90509353
Immobile 15.48 13.84 20 59245 6378 90562804
Central nervous system haemorrhage 15.44 13.84 6 59259 259 90568923
Pulmonary congestion 15.26 13.84 37 59228 19396 90549786
White blood cells urine 15.22 13.84 7 59258 461 90568721
Anaphylactic reaction 15.19 13.84 21 59244 87503 90481679
Osteopenia 15.16 13.84 41 59224 22961 90546221
Pancreatitis 15.12 13.84 14 59251 69812 90499370
Oral mucosa haematoma 15.11 13.84 3 59262 8 90569174
Therapeutic response decreased 15.11 13.84 22 59243 89707 90479475
Cardiac output decreased 15.09 13.84 9 59256 1011 90568171
Anticoagulation drug level below therapeutic 15.02 13.84 8 59257 723 90568459
Polyuria 15.00 13.84 25 59240 10015 90559167
Hypocalcaemia 14.86 13.84 61 59204 42307 90526875
Swelling face 14.65 13.84 19 59246 81333 90487849
Metabolic encephalopathy 14.63 13.84 20 59245 6732 90562450
Jugular vein distension 14.51 13.84 9 59256 1084 90568098
Acute myocardial infarction 14.49 13.84 53 59212 34837 90534345
Orthostatic hypotension 14.49 13.84 60 59205 41767 90527415
Cardiac pacemaker insertion 14.31 13.84 16 59249 4391 90564791
Acidosis 14.28 13.84 28 59237 12708 90556474
Asthenia 14.23 13.84 453 58812 533298 90035884
Retinal vein thrombosis 14.23 13.84 7 59258 536 90568646
Bradyphrenia 14.21 13.84 21 59244 7591 90561591
Upper gastrointestinal haemorrhage 14.20 13.84 40 59225 22936 90546246
Pseudopapilloedema 14.18 13.84 3 59262 12 90569170
Irritability 14.17 13.84 3 59262 35659 90533523
Ventricular enlargement 14.16 13.84 4 59261 62 90569120
Paroxysmal arrhythmia 14.10 13.84 4 59261 63 90569119
Drug ineffective for unapproved indication 14.07 13.84 83 59182 66561 90502621
Abdominal wall haemorrhage 14.06 13.84 5 59260 168 90569014
Adverse drug reaction 14.05 13.84 35 59230 116666 90452516
Pancytopenia 14.01 13.84 130 59135 120133 90449049
General physical condition abnormal 14.00 13.84 17 59248 5094 90564088
Muscle spasticity 13.98 13.84 3 59262 35319 90533863
Sedation 13.98 13.84 7 59258 48164 90521018
Muscle necrosis 13.94 13.84 8 59257 836 90568346
Subdural haemorrhage 13.91 13.84 14 59251 3409 90565773
Haemothorax 13.90 13.84 12 59253 2406 90566776
Distributive shock 13.90 13.84 14 59251 3410 90565772
Optic atrophy 13.84 13.84 10 59255 1551 90567631

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hyperthyroidism 2427.38 11.74 963 86786 13378 42520208
Interstitial lung disease 692.54 11.74 830 86919 77632 42455954
Pulmonary toxicity 680.96 11.74 340 87409 8315 42525271
Cardiac failure 579.26 11.74 892 86857 105964 42427622
Drug interaction 549.55 11.74 1489 86260 265510 42268076
Bradycardia 548.94 11.74 773 86976 84711 42448875
Ventricular tachycardia 540.31 11.74 468 87281 29692 42503894
Cardiogenic shock 458.62 11.74 460 87289 35180 42498406
Thyrotoxic crisis 456.05 11.74 135 87614 699 42532887
Electrocardiogram QT prolonged 445.45 11.74 521 87228 47424 42486162
Thyroiditis 400.51 11.74 174 87575 3062 42530524
Atrial fibrillation 358.75 11.74 848 86901 138745 42394841
Torsade de pointes 329.91 11.74 211 87538 8383 42525203
Hypothyroidism 313.58 11.74 358 87391 31726 42501860
Ventricular fibrillation 259.31 11.74 315 87434 29808 42503778
Appendicolith 247.33 11.74 212 87537 13244 42520342
Cornea verticillata 213.40 11.74 49 87700 64 42533522
Ejection fraction decreased 211.63 11.74 244 87505 21843 42511743
Appendicitis 199.66 11.74 229 87520 20384 42513202
Hypotension 196.94 11.74 1047 86702 256584 42277002
Acute kidney injury 193.51 11.74 1355 86394 365982 42167604
Cardiac failure congestive 182.76 11.74 485 87264 85117 42448469
Multiple organ dysfunction syndrome 180.70 11.74 523 87226 96512 42437074
Pulmonary fibrosis 171.98 11.74 242 87507 26439 42507147
Pyrexia 156.68 11.74 364 87385 393678 42139908
Febrile neutropenia 140.78 11.74 106 87643 185597 42347989
Blood thyroid stimulating hormone increased 134.85 11.74 101 87648 5191 42528395
Cardiac failure acute 134.62 11.74 153 87596 13480 42520106
Ventricular arrhythmia 134.24 11.74 108 87641 6171 42527415
Thyroid disorder 129.74 11.74 88 87661 3862 42529724
Cardiac failure chronic 129.08 11.74 127 87622 9474 42524112
Arthralgia 128.35 11.74 140 87609 205098 42328488
Atrioventricular block 123.38 11.74 124 87625 9491 42524095
Sinus bradycardia 120.80 11.74 151 87598 14702 42518884
International normalised ratio increased 120.56 11.74 290 87459 47878 42485708
Hyponatraemia 120.41 11.74 470 87279 100992 42432594
Blood phosphorus increased 119.34 11.74 138 87611 12387 42521199
Atrial flutter 117.94 11.74 161 87588 17090 42516496
Acute respiratory distress syndrome 113.28 11.74 214 87535 29894 42503692
Pulmonary alveolar haemorrhage 103.91 11.74 140 87609 14676 42518910
Diarrhoea 102.58 11.74 545 87204 460304 42073282
Ascites 99.22 11.74 299 87450 56379 42477207
Analgesic therapy 98.49 11.74 92 87657 6432 42527154
Lung disorder 97.63 11.74 267 87482 47656 42485930
Myasthenia gravis 97.56 11.74 142 87607 15995 42517591
Cardiac arrest 96.36 11.74 463 87286 108857 42424729
Syncope 94.95 11.74 431 87318 98975 42434611
Myxoedema coma 94.90 11.74 31 87718 233 42533353
Pain 93.26 11.74 231 87518 244617 42288969
Seizure 87.28 11.74 72 87677 120489 42413097
Keratopathy 84.63 11.74 37 87712 661 42532925
N-terminal prohormone brain natriuretic peptide increased 83.77 11.74 64 87685 3389 42530197
Sleep disorder therapy 81.36 11.74 85 87664 6809 42526777
Cerebral haematoma 80.65 11.74 77 87672 5533 42528053
Neutropenia 80.00 11.74 183 87566 199248 42334338
Stress 79.98 11.74 236 87513 43976 42489610
Rash 79.91 11.74 297 87452 276657 42256929
Drug ineffective 78.78 11.74 1771 85978 628426 41905160
Arrhythmia 78.53 11.74 221 87528 40096 42493490
Hyperphosphataemia 77.98 11.74 114 87635 12890 42520696
Headache 77.65 11.74 244 87505 239125 42294461
Pain in extremity 77.31 11.74 119 87630 150485 42383101
Tachycardia induced cardiomyopathy 75.86 11.74 23 87726 131 42533455
Organising pneumonia 75.15 11.74 85 87664 7447 42526139
Hyperkalaemia 74.69 11.74 346 87403 80112 42453474
Completed suicide 74.40 11.74 54 87695 96411 42437175
Nasopharyngitis 73.02 11.74 41 87708 83955 42449631
Malignant neoplasm progression 72.15 11.74 70 87679 108330 42425256
Drug abuse 70.49 11.74 67 87682 104704 42428882
Infusion site phlebitis 70.26 11.74 17 87732 32 42533554
Activated partial thromboplastin time prolonged 69.95 11.74 121 87628 15782 42517804
Pericardial haemorrhage 69.19 11.74 58 87691 3511 42530075
Thyroxine free increased 68.91 11.74 26 87723 311 42533275
Atrioventricular block complete 68.69 11.74 100 87649 11264 42522322
Anticoagulation drug level increased 66.84 11.74 30 87719 572 42533014
Troponin increased 66.20 11.74 131 87618 18931 42514655
Disease progression 65.02 11.74 123 87626 143533 42390053
Blood uric acid increased 64.13 11.74 115 87634 15432 42518154
Labelled drug-drug interaction medication error 63.94 11.74 115 87634 15467 42518119
Muscle spasms 62.74 11.74 51 87698 85993 42447593
Sinus node dysfunction 61.62 11.74 62 87687 4750 42528836
Fatigue 60.76 11.74 589 87160 435052 42098534
Iron deficiency 60.66 11.74 93 87656 10968 42522618
Atrial tachycardia 59.85 11.74 57 87692 4083 42529503
Neutrophil count decreased 59.51 11.74 28 87721 63387 42470199
Myelosuppression 59.00 11.74 7 87742 40454 42493132
Secondary hyperthyroidism 58.20 11.74 16 87733 60 42533526
Therapeutic product effect incomplete 56.95 11.74 38 87711 70901 42462685
Abdominal distension 56.91 11.74 295 87454 71440 42462146
Dyspnoea 56.69 11.74 1249 86500 441372 42092214
Injection site pain 56.62 11.74 24 87725 57774 42475812
End stage renal disease 56.54 11.74 113 87636 16445 42517141
Gastrointestinal haemorrhage 56.16 11.74 369 87380 97357 42436229
Shock haemorrhagic 55.65 11.74 111 87638 16131 42517455
Dyspnoea exertional 55.17 11.74 227 87522 49921 42483665
Device inappropriate shock delivery 55.16 11.74 14 87735 35 42533551
Pulmonary ossification 53.80 11.74 15 87734 60 42533526
BRASH syndrome 53.69 11.74 38 87711 1787 42531799
Acute respiratory failure 53.55 11.74 189 87560 38669 42494917
Depression 53.37 11.74 92 87657 111271 42422315
Anticoagulation drug level above therapeutic 52.10 11.74 43 87706 2547 42531039
Product dose omission issue 50.95 11.74 156 87593 154209 42379377
Ventricular extrasystoles 50.13 11.74 95 87654 13295 42520291
Antacid therapy 50.10 11.74 55 87694 4662 42528924
Neuropathy peripheral 48.94 11.74 84 87665 101769 42431817
Anticoagulant therapy 48.37 11.74 53 87696 4482 42529104
Hypophosphataemia 48.04 11.74 122 87627 20823 42512763
Platelet count decreased 47.93 11.74 137 87612 138444 42395142
Deep vein thrombosis 47.46 11.74 53 87696 76904 42456682
Suicidal ideation 47.17 11.74 20 87729 48141 42485445
Melaena 47.13 11.74 181 87568 38565 42495021
Presyncope 46.84 11.74 126 87623 22261 42511325
Potentiating drug interaction 46.70 11.74 62 87687 6406 42527180
Pseudopapilloedema 46.69 11.74 9 87740 0 42533586
Atrioventricular block first degree 46.52 11.74 62 87687 6429 42527157
Haematoma 46.37 11.74 145 87604 27878 42505708
White blood cell count decreased 46.10 11.74 99 87650 110297 42423289
Pruritus 45.94 11.74 216 87533 188555 42345031
Back pain 45.57 11.74 145 87604 141631 42391955
Jugular vein distension 45.47 11.74 24 87725 660 42532926
Loss of personal independence in daily activities 45.21 11.74 23 87726 49793 42483793
Incorrect route of product administration 45.15 11.74 131 87618 24174 42509412
General physical health deterioration 44.64 11.74 492 87257 150754 42382832
Goitre 44.57 11.74 34 87715 1796 42531790
Hypoaesthesia 44.31 11.74 49 87700 71414 42462172
Anxiety 44.16 11.74 113 87636 118447 42415139
Coronary artery bypass 44.15 11.74 52 87697 4758 42528828
Myxoedema 43.86 11.74 12 87737 44 42533542
Eosinophilic pneumonia 43.60 11.74 52 87697 4822 42528764
Aortic stenosis 43.07 11.74 70 87679 8675 42524911
Blood cholesterol increased 42.99 11.74 137 87612 26604 42506982
Neuralgia 42.70 11.74 133 87616 25514 42508072
Haematuria 42.63 11.74 233 87516 57566 42476020
Drug dependence 42.50 11.74 5 87744 29089 42504497
Lung opacity 42.21 11.74 56 87693 5781 42527805
Bundle branch block left 42.10 11.74 59 87690 6417 42527169
Exercise tolerance decreased 42.04 11.74 57 87692 6009 42527577
Nodal arrhythmia 41.93 11.74 25 87724 874 42532712
Dry skin 41.42 11.74 24 87725 48314 42485272
COVID-19 41.29 11.74 113 87636 115835 42417751
Sinusitis 41.21 11.74 23 87726 47269 42486317
Drug-induced liver injury 41.11 11.74 172 87577 38101 42495485
Migraine 40.76 11.74 3 87746 25411 42508175
Aggression 40.67 11.74 20 87729 44143 42489443
Chills 40.41 11.74 83 87666 93983 42439603
Myalgia 40.25 11.74 86 87663 95994 42437592
Hypersensitivity 40.24 11.74 54 87695 72316 42461270
Electrocardiogram PR prolongation 39.30 11.74 25 87724 983 42532603
Orthopnoea 39.22 11.74 52 87697 5365 42528221
Pneumonitis 39.12 11.74 180 87569 41538 42492048
Palpitations 38.97 11.74 207 87542 50590 42482996
Mucosal inflammation 38.89 11.74 27 87722 49347 42484239
Therapeutic product effect decreased 38.76 11.74 16 87733 39134 42494452
Left atrial enlargement 38.69 11.74 25 87724 1010 42532576
Tachyarrhythmia 38.59 11.74 44 87705 3888 42529698
Intentional product use issue 38.54 11.74 55 87694 71778 42461808
Sedation 38.28 11.74 8 87741 30467 42503119
Hepatocellular injury 37.78 11.74 121 87628 23557 42510029
Myoclonus 37.69 11.74 98 87651 16967 42516619
Venous pressure jugular increased 37.40 11.74 22 87727 750 42532836
Bacterial infection 37.04 11.74 134 87615 27745 42505841
Toxic goitre 37.04 11.74 8 87741 6 42533580
Cardioversion 36.98 11.74 24 87725 977 42532609
Blood calcium increased 36.75 11.74 64 87685 8390 42525196
Subdural haematoma 36.70 11.74 118 87631 23020 42510566
Stomatitis 36.46 11.74 30 87719 50299 42483287
Electrocardiogram QRS complex prolonged 36.30 11.74 52 87697 5771 42527815
Abdominal discomfort 36.20 11.74 62 87687 75193 42458393
Insomnia 35.88 11.74 124 87625 118129 42415457
Thyroxine increased 35.45 11.74 12 87737 102 42533484
Spontaneous haematoma 35.15 11.74 21 87728 737 42532849
Renal failure 35.11 11.74 451 87298 143275 42390311
Left ventricular failure 34.90 11.74 52 87697 5979 42527607
Rales 34.46 11.74 74 87675 11326 42522260
Pericardial effusion 34.17 11.74 135 87614 29140 42504446
Cytomegalovirus infection 33.98 11.74 12 87737 32294 42501292
Gravitational oedema 33.84 11.74 20 87729 688 42532898
Long QT syndrome 33.76 11.74 37 87712 3130 42530456
Rectal haemorrhage 33.30 11.74 195 87554 49411 42484175
Cardioactive drug level increased 33.20 11.74 28 87721 1709 42531877
Infusion related reaction 33.17 11.74 46 87703 60760 42472826
Infection 33.01 11.74 119 87630 111949 42421637
Respiratory failure 32.97 11.74 406 87343 127726 42405860
Blood pressure increased 32.91 11.74 104 87645 101824 42431762
Nodal rhythm 32.85 11.74 27 87722 1590 42531996
Mitral valve incompetence 32.70 11.74 91 87658 16398 42517188
Colitis ulcerative 32.62 11.74 7 87742 26168 42507418
Pacemaker generated rhythm 32.54 11.74 10 87739 60 42533526
Rhabdomyolysis 32.50 11.74 273 87476 77746 42455840
Chronic obstructive pulmonary disease 32.48 11.74 232 87517 62882 42470704
Rheumatoid arthritis 32.39 11.74 24 87725 42416 42491170
Pleural effusion 31.88 11.74 323 87426 96843 42436743
Acute interstitial pneumonitis 31.80 11.74 18 87731 570 42533016
Optic neuropathy 31.50 11.74 32 87717 2480 42531106
Mitochondrial aspartate aminotransferase increased 31.48 11.74 7 87742 7 42533579
Bone marrow granuloma 31.13 11.74 6 87743 0 42533586
Pancreatitis 31.09 11.74 26 87723 43242 42490344
Dry mouth 30.24 11.74 162 87587 39717 42493869
Coagulopathy 29.85 11.74 107 87642 22055 42511531
Left ventricular dysfunction 29.57 11.74 70 87679 11431 42522155
Blood glucose increased 29.20 11.74 68 87681 73631 42459955
Hypertransaminasaemia 29.17 11.74 61 87688 9166 42524420
Intraocular haematoma 28.65 11.74 7 87742 14 42533572
Haemodynamic instability 28.64 11.74 73 87676 12484 42521102
Total lung capacity decreased 28.55 11.74 36 87713 3534 42530052
Herpes zoster 28.38 11.74 23 87726 38854 42494732
Urinary tract infection 28.20 11.74 107 87642 99177 42434409
Decreased appetite 28.14 11.74 258 87491 192879 42340707
Nephrolithiasis 27.88 11.74 21 87728 36809 42496777
Platelet distribution width increased 27.86 11.74 11 87738 150 42533436
Cardiac ventricular disorder 27.78 11.74 13 87736 274 42533312
Vascular purpura 27.69 11.74 28 87721 2158 42531428
Oropharyngeal pain 27.63 11.74 28 87721 42482 42491104
Alopecia 27.35 11.74 13 87736 29263 42504323
Prostate cancer 27.24 11.74 31 87718 44612 42488974
Bronchopulmonary aspergillosis allergic 27.12 11.74 40 87709 4558 42529028
Xyphoid retraction 27.09 11.74 11 87738 162 42533424
Acute hepatic failure 27.01 11.74 87 87662 16986 42516600
Gout 27.01 11.74 122 87627 27933 42505653
Influenza like illness 27.00 11.74 16 87733 31824 42501762
Anastomotic infection 26.94 11.74 10 87739 114 42533472
Corneal deposits 26.77 11.74 12 87737 228 42533358
Off label use 26.72 11.74 1060 86689 637275 41896311
Cerebral haemorrhage 26.68 11.74 154 87595 38812 42494774
Eosinophilia 26.56 11.74 136 87613 32763 42500823
Cardiac tamponade 26.49 11.74 48 87701 6492 42527094
Joint swelling 25.96 11.74 64 87685 67958 42465628
Thyroid dermatopathy 25.94 11.74 5 87744 0 42533586
Accessory cardiac pathway 25.94 11.74 5 87744 0 42533586
Abnormal behaviour 25.87 11.74 11 87738 26440 42507146
Depressed mood 25.79 11.74 8 87741 23376 42510210
Pulseless electrical activity 25.77 11.74 55 87694 8382 42525204
Urticaria 25.72 11.74 73 87676 73963 42459623
Death 25.59 11.74 757 86992 470428 42063158
Atrial thrombosis 25.10 11.74 28 87721 2416 42531170
Phlebitis 25.05 11.74 37 87712 4221 42529365
Cardiorenal syndrome 24.91 11.74 18 87731 875 42532711
Serotonin syndrome 24.88 11.74 11 87738 25834 42507752
Blood loss anaemia 24.75 11.74 59 87690 9677 42523909
Gastrooesophageal reflux disease 24.61 11.74 34 87715 44989 42488597
Congenital hiatus hernia 24.61 11.74 45 87704 6129 42527457
Pemphigoid 24.45 11.74 65 87684 11402 42522184
Ulcer 24.42 11.74 82 87667 16359 42517227
Conduction disorder 24.41 11.74 28 87721 2490 42531096
Angioedema 24.32 11.74 31 87718 42446 42491140
Diaphragmatic paralysis 24.18 11.74 15 87734 564 42533022
Helicobacter test false negative 24.06 11.74 8 87741 64 42533522
Cell death 23.92 11.74 30 87719 2929 42530657
Prothrombin time prolonged 23.66 11.74 57 87692 9412 42524174
Glomerular filtration rate 23.61 11.74 9 87740 111 42533475
Lymphocyte count decreased 23.55 11.74 14 87735 27795 42505791
Arteriosclerotic gangrene 23.33 11.74 8 87741 71 42533515
Puncture site haematoma 23.27 11.74 10 87739 171 42533415
Anuria 23.22 11.74 64 87685 11468 42522118
Cholestasis 23.21 11.74 131 87618 32748 42500838
Blood creatinine increased 23.09 11.74 336 87413 109667 42423919
Urine iodine increased 23.01 11.74 5 87744 4 42533582
Respiratory distress 22.85 11.74 156 87593 41664 42491922
Toxic nodular goitre 22.85 11.74 6 87743 18 42533568
Blood thyroid stimulating hormone decreased 22.81 11.74 26 87723 2297 42531289
Electrocardiogram P wave abnormal 22.80 11.74 10 87739 180 42533406
Arthritis 22.76 11.74 32 87717 42033 42491553
Colitis 22.73 11.74 38 87711 46534 42487052
Atrioventricular block second degree 22.67 11.74 35 87714 4152 42529434
Neoplasm progression 22.65 11.74 16 87733 28984 42504602
Neonatal pneumonia 22.58 11.74 9 87740 126 42533460
Neuroleptic malignant syndrome 22.54 11.74 8 87741 21464 42512122
Periorbital haemorrhage 22.51 11.74 9 87740 127 42533459
Low cardiac output syndrome 22.51 11.74 15 87734 639 42532947
Iodine uptake abnormal 22.48 11.74 5 87744 5 42533581
Lupus-like syndrome 22.41 11.74 30 87719 3124 42530462
Body temperature increased 22.39 11.74 7 87742 20351 42513235
Cardiac amyloidosis 22.38 11.74 24 87725 1981 42531605
Dyspnoea at rest 22.28 11.74 35 87714 4214 42529372
Injection site reaction 22.24 11.74 3 87746 15718 42517868
Bacteroides infection 22.16 11.74 27 87722 2560 42531026
Cardiac dysfunction 22.14 11.74 31 87718 3368 42530218
Injection site erythema 22.11 11.74 7 87742 20188 42513398
Cardiac output decreased 22.09 11.74 18 87731 1047 42532539
Gastrointestinal angiodysplasia 22.02 11.74 15 87734 663 42532923
Asthma 21.97 11.74 61 87688 62253 42471333
Ecchymosis 21.93 11.74 49 87700 7703 42525883
Angiodysplasia 21.90 11.74 16 87733 791 42532795
Foetal exposure during pregnancy 21.82 11.74 40 87709 47271 42486315
No adverse event 21.80 11.74 29 87720 38992 42494594
Rhinorrhoea 21.76 11.74 20 87729 31774 42501812
Thyroid function test abnormal 21.66 11.74 15 87734 681 42532905
Lymphadenopathy 21.66 11.74 22 87727 33343 42500243
Leukopenia 21.58 11.74 80 87669 74666 42458920
Orthostatic hypertension 21.44 11.74 13 87736 469 42533117
Supine hypertension 21.40 11.74 12 87737 373 42533213
Hepatitis acute 21.33 11.74 53 87696 8922 42524664
Antiacetylcholine receptor antibody positive 21.33 11.74 8 87741 94 42533492
Ventricular pre-excitation 21.32 11.74 6 87743 25 42533561
Heparin-induced thrombocytopenia 21.31 11.74 44 87705 6553 42527033
Sleep disorder due to a general medical condition 21.08 11.74 5 87744 17448 42516138
Mesenteric artery thrombosis 20.94 11.74 15 87734 719 42532867
Chronotropic incompetence 20.78 11.74 6 87743 28 42533558
Accidental exposure to product 20.73 11.74 8 87741 20385 42513201
Electrocardiogram T wave alternans 20.67 11.74 8 87741 103 42533483
Lupus pneumonitis 20.63 11.74 7 87742 60 42533526
Thrombocytopenia 20.60 11.74 272 87477 190007 42343579
Oedema peripheral 20.59 11.74 394 87355 135682 42397904
Porphyria acute 20.54 11.74 12 87737 404 42533182
Withdrawal syndrome 20.47 11.74 3 87746 14772 42518814
Sinoatrial block 20.42 11.74 13 87736 512 42533074
Cutaneous mucormycosis 20.31 11.74 14 87735 631 42532955
Coronary artery disease 20.29 11.74 184 87565 53536 42480050
Skin exfoliation 20.19 11.74 34 87715 41519 42492067
Therapeutic response decreased 20.18 11.74 28 87721 36984 42496602
Osteonecrosis of jaw 20.16 11.74 7 87742 19042 42514544
Treatment noncompliance 20.04 11.74 29 87720 37643 42495943
Pulmonary oedema 19.88 11.74 182 87567 53090 42480496
Dysphagia 19.61 11.74 80 87669 72639 42460947
Subarachnoid haemorrhage 19.60 11.74 70 87679 14402 42519184
Blood pressure fluctuation 19.54 11.74 16 87733 26892 42506694
Acute pulmonary oedema 19.43 11.74 50 87699 8601 42524985
Haemothorax 19.41 11.74 37 87712 5199 42528387
Ventricular internal diameter abnormal 19.26 11.74 9 87740 189 42533397
Aerophagia 19.25 11.74 6 87743 38 42533548
Hyperglycaemia 19.23 11.74 41 87708 45818 42487768
Lactic acidosis 19.17 11.74 159 87590 45102 42488484
Cardiac ablation 19.10 11.74 18 87731 1272 42532314
Dyspepsia 19.04 11.74 35 87714 41317 42492269
Ill-defined disorder 19.04 11.74 5 87744 16291 42517295
Hypersensitivity pneumonitis 18.95 11.74 22 87727 1982 42531604
Tinnitus 18.87 11.74 19 87730 28919 42504667
Proteinuria 18.86 11.74 12 87737 22971 42510615
Coma uraemic 18.86 11.74 6 87743 41 42533545
Blood test abnormal 18.84 11.74 64 87685 12842 42520744
Halo vision 18.84 11.74 9 87740 199 42533387
Neonatal hypotension 18.84 11.74 9 87740 199 42533387
Cardio-respiratory arrest 18.78 11.74 194 87555 58442 42475144
Bone pain 18.75 11.74 13 87736 23779 42509807
Inappropriate schedule of product administration 18.74 11.74 118 87631 95784 42437802
Renal impairment 18.72 11.74 325 87424 109903 42423683
Traumatic lung injury 18.61 11.74 18 87731 1314 42532272
Iodine overload 18.52 11.74 4 87745 3 42533583
Bladder cancer 18.50 11.74 6 87743 17041 42516545
Agitation 18.46 11.74 69 87680 64245 42469341
Diffuse vasculitis 18.46 11.74 7 87742 85 42533501
Haemoptysis 18.40 11.74 160 87589 46007 42487579
Flushing 18.27 11.74 30 87719 36998 42496588
Thyroxine free decreased 18.16 11.74 10 87739 300 42533286
Hydrops foetalis 18.15 11.74 15 87734 890 42532696
Drug withdrawal syndrome 18.03 11.74 11 87738 21538 42512048
Ischaemic stroke 18.01 11.74 92 87657 22141 42511445
Fall 17.97 11.74 620 87129 233900 42299686
Glomerular filtration rate decreased 17.96 11.74 74 87675 16277 42517309
Illness 17.88 11.74 15 87734 24915 42508671
Nausea 17.83 11.74 653 87096 396146 42137440
Frequent bowel movements 17.81 11.74 11 87738 21396 42512190
Irritability 17.74 11.74 19 87730 28109 42505477
Tumour lysis syndrome 17.71 11.74 12 87737 22219 42511367
Optic ischaemic neuropathy 17.62 11.74 25 87724 2750 42530836
Drug resistance 17.60 11.74 27 87722 34221 42499365
Arteriosclerotic retinopathy 17.55 11.74 5 87744 22 42533564
Left ventricular false tendon 17.42 11.74 6 87743 54 42533532
Pseudolymphoma 17.29 11.74 13 87736 672 42532914
Amyloidosis 17.17 11.74 23 87726 2396 42531190
Cellulitis 17.08 11.74 67 87682 61518 42472068
Therapy partial responder 17.06 11.74 10 87739 20011 42513575
Oesophageal infection 17.00 11.74 10 87739 341 42533245
Optic nerve infarction 16.87 11.74 5 87744 26 42533560
Inferior vena cava syndrome 16.77 11.74 6 87743 61 42533525
Normocytic anaemia 16.76 11.74 28 87721 3549 42530037
Mouth ulceration 16.72 11.74 5 87744 14958 42518628
Lung diffusion test abnormal 16.69 11.74 6 87743 62 42533524
Tri-iodothyronine free decreased 16.69 11.74 6 87743 62 42533524
Kounis syndrome 16.64 11.74 27 87722 3341 42530245
Osteoporosis 16.62 11.74 5 87744 14901 42518685
Fungal infection 16.60 11.74 10 87739 19712 42513874
Drug therapy 16.58 11.74 39 87710 6341 42527245
Femoral artery aneurysm 16.50 11.74 8 87741 183 42533403
Linear IgA disease 16.49 11.74 21 87728 2082 42531504
Generalised tonic-clonic seizure 16.44 11.74 18 87731 26361 42507225
Nasal congestion 16.40 11.74 22 87727 29479 42504107
Subarachnoid haematoma 16.40 11.74 9 87740 268 42533318
Influenza 16.39 11.74 69 87680 62106 42471480
Product use issue 16.28 11.74 92 87657 76659 42456927
Swollen tongue 16.20 11.74 12 87737 21219 42512367
Product use in unapproved indication 16.02 11.74 495 87254 183961 42349625
Ischaemic cardiomyopathy 16.02 11.74 39 87710 6483 42527103
Cardiac pacemaker insertion 16.00 11.74 26 87723 3222 42530364
Acute lung injury 15.97 11.74 18 87731 1571 42532015
Hepatitis fulminant 15.93 11.74 33 87716 4926 42528660
Basal cell carcinoma 15.91 11.74 14 87735 22719 42510867
Acidosis 15.89 11.74 3 87746 12276 42521310
Memory impairment 15.67 11.74 52 87697 50170 42483416
Nightmare 15.66 11.74 17 87732 24995 42508591
Cerebellar syndrome 15.64 11.74 24 87725 2831 42530755
Weight decreased 15.63 11.74 318 87431 207630 42325956
Anaemia macrocytic 15.57 11.74 27 87722 3528 42530058
Systemic-pulmonary artery shunt 15.56 11.74 3 87746 0 42533586
Hereditary ataxia 15.56 11.74 3 87746 0 42533586
Viral infection 15.55 11.74 14 87735 22469 42511117
Impaired work ability 15.55 11.74 3 87746 12088 42521498
Musculoskeletal pain 15.54 11.74 28 87721 33312 42500274
Cardiac arrest neonatal 15.49 11.74 5 87744 36 42533550
Lung assist device therapy 15.49 11.74 5 87744 36 42533550
Hepatitis cholestatic 15.48 11.74 50 87699 9774 42523812
Cardiomegaly 15.46 11.74 72 87677 16694 42516892
Heart rate abnormal 15.46 11.74 21 87728 2218 42531368
Impaired quality of life 15.37 11.74 5 87744 14172 42519414
Rhinitis 15.34 11.74 3 87746 11974 42521612
Ejection fraction abnormal 15.34 11.74 16 87733 1279 42532307
Pseudarthrosis 15.32 11.74 6 87743 80 42533506
Obstructive airways disorder 15.31 11.74 17 87732 24742 42508844
Hypophonesis 15.23 11.74 4 87745 12 42533574
Asthenia 15.17 11.74 715 87034 280078 42253508
Injection site swelling 15.15 11.74 8 87741 16965 42516621
Product quality issue 15.14 11.74 9 87740 17873 42515713
Hepatotoxicity 15.03 11.74 96 87653 25071 42508515
Intentional product misuse 14.99 11.74 194 87555 61706 42471880
Blood creatine increased 14.99 11.74 35 87714 5665 42527921
Renal phospholipidosis 14.89 11.74 7 87742 149 42533437
Osteonecrosis 14.88 11.74 7 87742 15858 42517728
Dysgeusia 14.81 11.74 30 87719 34159 42499427
Electrocardiogram QRS complex shortened 14.80 11.74 8 87741 231 42533355
Myelodysplastic syndrome 14.76 11.74 15 87734 22730 42510856
Oesophageal achalasia 14.64 11.74 10 87739 444 42533142
Ilium fracture 14.56 11.74 7 87742 157 42533429
Progressive multifocal leukoencephalopathy 14.55 11.74 3 87746 11533 42522053
White blood cell count increased 14.54 11.74 46 87703 45041 42488545
Haemorrhage intracranial 14.53 11.74 72 87677 17120 42516466
Psoriatic arthropathy 14.52 11.74 18 87731 24949 42508637
Ventricular dysfunction 14.50 11.74 30 87719 4473 42529113
Papilloedema 14.44 11.74 25 87724 3261 42530325
Pathogen resistance 14.39 11.74 3 87746 11447 42522139
Anticoagulation drug level abnormal 14.32 11.74 7 87742 163 42533423
Therapeutic response shortened 14.31 11.74 5 87744 13549 42520037
Device issue 14.24 11.74 5 87744 13504 42520082
Neck pain 14.18 11.74 25 87724 29989 42503597
Psychotic disorder 14.10 11.74 24 87725 29184 42504402
Amnesia 14.06 11.74 23 87726 28414 42505172
Mental disorder 14.01 11.74 10 87739 18019 42515567
Abdominal pain upper 13.98 11.74 106 87643 82503 42451083
Bradyarrhythmia 13.98 11.74 22 87727 2653 42530933
Pleuritic pain 13.97 11.74 39 87710 7038 42526548
Lymphoma 13.94 11.74 6 87743 14315 42519271
Sopor 13.91 11.74 59 87690 13143 42520443
Skin disorder 13.70 11.74 9 87740 16935 42516651
Thyroiditis acute 13.68 11.74 6 87743 108 42533478
Plasma cell myeloma 13.68 11.74 51 87698 47527 42486059
Hypervolaemia 13.68 11.74 88 87661 23037 42510549
Arthropathy 13.67 11.74 25 87724 29572 42504014
Mobility decreased 13.64 11.74 33 87716 35273 42498313
Non-compaction cardiomyopathy 13.63 11.74 5 87744 55 42533531
Adrenal haematoma 13.63 11.74 5 87744 55 42533531
Alveolitis necrotising 13.63 11.74 4 87745 20 42533566
Haematotoxicity 13.56 11.74 3 87746 10982 42522604
Suicide attempt 13.53 11.74 49 87700 46051 42487535
Hirsutism 13.51 11.74 8 87741 276 42533310
Cholestatic liver injury 13.49 11.74 26 87723 3683 42529903
Skin lesion 13.42 11.74 22 87727 27152 42506434
Nephroangiosclerosis 13.38 11.74 7 87742 189 42533397
Fascial rupture 13.31 11.74 4 87745 22 42533564
Failure to suspend medication 13.31 11.74 9 87740 393 42533193
Eosinophilic pneumonia acute 13.26 11.74 12 87737 805 42532781
Hyponatraemic syndrome 13.21 11.74 7 87742 194 42533392
Cardiomyopathy 13.20 11.74 76 87673 19134 42514452
Conjunctival haemorrhage 13.14 11.74 25 87724 3508 42530078
Diabetic ketoacidosis 13.14 11.74 16 87733 22351 42511235
Device pacing issue 13.09 11.74 5 87744 62 42533524
Electrocardiogram low voltage 13.02 11.74 4 87745 24 42533562
Scrotal haematocoele 13.02 11.74 4 87745 24 42533562
Subdural haematoma evacuation 13.02 11.74 4 87745 24 42533562
Systemic inflammatory response syndrome 12.93 11.74 39 87710 7351 42526235
Bundle branch block 12.91 11.74 13 87736 997 42532589
Pulmonary vascular resistance abnormality 12.88 11.74 5 87744 65 42533521
Amaurosis 12.87 11.74 12 87737 837 42532749
Sinus rhythm 12.78 11.74 9 87740 420 42533166
Anti factor V antibody 12.75 11.74 8 87741 307 42533279
Transplant rejection 12.74 11.74 6 87743 13582 42520004
Nodule 12.60 11.74 5 87744 12529 42521057
Feeling hot 12.57 11.74 18 87731 23464 42510122
Feeling abnormal 12.55 11.74 88 87661 69698 42463888
Unevaluable event 12.51 11.74 33 87716 34255 42499331
Erectile dysfunction 12.46 11.74 20 87729 24893 42508693
Spinal cord haemorrhage 12.43 11.74 8 87741 321 42533265
Oxygen saturation decreased 12.42 11.74 80 87669 64607 42468979
Therapeutic drug monitoring analysis not performed 12.42 11.74 10 87739 572 42533014
Aplastic anaemia 12.35 11.74 5 87744 12379 42521207
Joint stiffness 12.25 11.74 5 87744 12317 42521269
Left ventricular dilatation 12.20 11.74 12 87737 894 42532692
Pericarditis fungal 12.19 11.74 7 87742 228 42533358
Hypertension 12.17 11.74 257 87492 166947 42366639
Depressed level of consciousness 12.17 11.74 54 87695 47916 42485670
Pancytopenia 12.12 11.74 170 87579 117573 42416013
Confusional state 12.09 11.74 258 87491 167339 42366247
Myoglobin urine present 12.07 11.74 6 87743 145 42533441
Hepatitis C 12.05 11.74 3 87746 10130 42523456
Ileus 11.99 11.74 13 87736 19126 42514460
Paranoia 11.96 11.74 7 87742 14019 42519567
Anaemia 11.96 11.74 698 87051 279580 42254006
Thyroidectomy 11.88 11.74 5 87744 81 42533505
Toxic epidermal necrolysis 11.88 11.74 95 87654 26655 42506931
Hallucination, auditory 11.87 11.74 8 87741 14856 42518730
Flatulence 11.84 11.74 21 87728 25131 42508455
Condition aggravated 11.83 11.74 653 87096 260101 42273485
Hospitalisation 11.82 11.74 97 87652 74233 42459353
Adrenal insufficiency 11.80 11.74 73 87676 18851 42514735
Erythema multiforme 11.77 11.74 3 87746 9974 42523612
Diffuse alveolar damage 11.76 11.74 20 87729 2572 42531014
Acute motor-sensory axonal neuropathy 11.74 11.74 6 87743 154 42533432

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hyperthyroidism 3331.53 11.80 1281 135297 27980 110424741
Drug interaction 1890.87 11.80 2683 133895 497500 109955221
Bradycardia 1574.40 11.80 1398 135180 154119 110298602
Interstitial lung disease 1383.19 11.80 1239 135339 138095 110314626
Electrocardiogram QT prolonged 1300.86 11.80 1077 135501 107883 110344838
Torsade de pointes 1088.65 11.80 540 136038 22060 110430661
Pulmonary toxicity 1067.69 11.80 494 136084 17252 110435469
Cardiac failure 1040.16 11.80 1219 135359 186407 110266314
Atrial fibrillation 1037.88 11.80 1346 135232 228296 110224425
Ventricular tachycardia 971.34 11.80 662 135916 49347 110403374
Acute kidney injury 916.90 11.80 2254 134324 633176 109819545
Cardiogenic shock 880.87 11.80 658 135920 56680 110396041
Hypothyroidism 619.57 11.80 595 135983 72304 110380417
Thyrotoxic crisis 599.60 11.80 182 136396 1858 110450863
Thyroiditis 581.10 11.80 240 136338 6333 110446388
Ventricular fibrillation 546.66 11.80 434 136144 40879 110411842
Hypotension 522.09 11.80 1625 134953 522224 109930497
Myxoedema coma 443.11 11.80 114 136464 588 110452133
Hyponatraemia 437.38 11.80 883 135695 216770 110235951
Pain 406.73 11.80 350 136228 954605 109498116
International normalised ratio increased 402.80 11.80 516 136062 86256 110366465
Sinus bradycardia 382.06 11.80 306 136272 29177 110423544
Multiple organ dysfunction syndrome 377.08 11.80 674 135904 151036 110301685
Appendicolith 348.31 11.80 218 136360 14037 110438684
Syncope 346.91 11.80 770 135808 201766 110250955
Hyperkalaemia 343.49 11.80 608 135970 135188 110317533
Arthralgia 339.98 11.80 279 136299 779353 109673368
Cardiac arrest 332.46 11.80 744 135834 196009 110256712
Joint swelling 308.21 11.80 83 136495 442762 110009959
Cornea verticillata 303.18 11.80 72 136506 248 110452473
Cardiac failure congestive 292.96 11.80 604 135974 150396 110302325
Headache 289.59 11.80 401 136177 881976 109570745
Alopecia 282.50 11.80 54 136524 364699 110088022
Gastrointestinal haemorrhage 279.69 11.80 626 135952 164892 110287829
Synovitis 271.03 11.80 17 136561 274075 110178646
Infusion related reaction 260.40 11.80 74 136504 381088 110071633
Nasopharyngitis 259.55 11.80 82 136496 394279 110058442
Systemic lupus erythematosus 256.89 11.80 14 136564 254324 110198397
Ventricular arrhythmia 255.90 11.80 158 136420 9929 110442792
Atrial flutter 250.70 11.80 221 136357 24041 110428680
Appendicitis 246.77 11.80 235 136343 28229 110424492
Hand deformity 245.17 11.80 5 136573 218501 110234220
Pemphigus 240.39 11.80 5 136573 214565 110238156
Glossodynia 238.16 11.80 8 136570 221996 110230725
Sinus node dysfunction 237.91 11.80 145 136433 8902 110443819
Haematoma 231.79 11.80 322 136256 58154 110394567
Arthropathy 230.31 11.80 39 136539 287483 110165238
Hypersensitivity 227.76 11.80 107 136471 403891 110048830
Therapeutic product effect decreased 227.75 11.80 20 136558 244296 110208425
Atrioventricular block 222.56 11.80 177 136401 16700 110436021
Rash 218.91 11.80 427 136151 820537 109632184
Sinusitis 217.19 11.80 50 136528 296638 110156083
Tachyarrhythmia 216.20 11.80 132 136446 8129 110444592
Arrhythmia 212.45 11.80 339 136239 69236 110383485
Shock haemorrhagic 208.29 11.80 210 136368 27037 110425684
Cardiac failure acute 203.44 11.80 196 136382 23882 110428839
Acute respiratory distress syndrome 197.62 11.80 284 136294 52914 110399807
Rheumatoid arthritis 195.83 11.80 63 136515 299550 110153171
Stomatitis 192.97 11.80 48 136530 270194 110182527
Fibromyalgia 191.37 11.80 4 136574 170905 110281816
Hypoaesthesia 190.15 11.80 75 136503 314148 110138573
Melaena 187.00 11.80 318 136260 68439 110384282
Anaemia 186.69 11.80 1235 135343 545851 109906870
Blood phosphorus increased 185.34 11.80 157 136421 16183 110436538
Pain in extremity 185.27 11.80 197 136381 486921 109965800
Migraine 184.76 11.80 6 136572 171646 110281075
Folliculitis 183.58 11.80 5 136573 167648 110285073
Maternal exposure during pregnancy 182.51 11.80 45 136533 254838 110197883
Pulmonary alveolar haemorrhage 181.62 11.80 170 136408 19980 110432741
Labelled drug-drug interaction medication error 179.92 11.80 201 136377 29101 110423620
Pericardial haemorrhage 175.23 11.80 98 136480 5119 110447602
Renal failure 173.95 11.80 645 135933 225929 110226792
Cerebral haematoma 173.94 11.80 122 136456 9510 110443211
Abdominal discomfort 168.79 11.80 143 136435 393715 110059006
Psoriatic arthropathy 165.95 11.80 23 136555 196738 110255983
Atrioventricular block complete 165.02 11.80 161 136417 19921 110432800
Ill-defined disorder 163.60 11.80 7 136571 156846 110295875
Lactic acidosis 163.42 11.80 357 136221 92454 110360267
Wound 162.85 11.80 44 136534 234393 110218328
Cardiac failure chronic 161.39 11.80 135 136443 13676 110439045
Urticaria 158.42 11.80 99 136479 318758 110133963
Irritable bowel syndrome 157.01 11.80 12 136566 164203 110288518
Fatigue 156.64 11.80 873 135705 1215085 109237636
Haematuria 156.18 11.80 328 136250 82677 110370044
Pyrexia 152.31 11.80 583 135995 897682 109555039
Keratopathy 148.59 11.80 58 136520 1315 110451406
Myasthenia gravis 148.56 11.80 157 136421 21354 110431367
Analgesic therapy 147.46 11.80 99 136479 7185 110445536
Blood thyroid stimulating hormone increased 147.39 11.80 122 136456 12179 110440542
Bursitis 145.60 11.80 3 136575 129915 110322806
Rhabdomyolysis 144.75 11.80 400 136178 120001 110332720
Ventricular extrasystoles 140.19 11.80 156 136422 22485 110430236
Ascites 140.17 11.80 336 136242 92472 110360249
Acute respiratory failure 139.97 11.80 296 136282 74964 110377757
Type 2 diabetes mellitus 139.78 11.80 25 136553 177207 110275514
Muscle spasms 138.67 11.80 86 136492 278071 110174650
Pericarditis 134.67 11.80 51 136527 219063 110233658
Depression 132.54 11.80 118 136460 317217 110135504
Respiratory failure 132.37 11.80 572 136006 214760 110237961
Coronary artery disease 131.05 11.80 280 136298 71410 110381311
Ejection fraction decreased 130.05 11.80 203 136375 40677 110412044
Therapeutic product effect incomplete 129.59 11.80 57 136521 223748 110228973
Sleep disorder therapy 128.82 11.80 92 136486 7379 110445342
C-reactive protein abnormal 128.28 11.80 8 136570 129687 110323034
Cerebral haemorrhage 127.22 11.80 261 136317 64707 110388014
Wheezing 127.10 11.80 79 136499 255151 110197570
BRASH syndrome 125.22 11.80 70 136508 3653 110449068
Intentional product use issue 124.46 11.80 76 136502 247830 110204891
Long QT syndrome 123.53 11.80 88 136490 7030 110445691
Activated partial thromboplastin time prolonged 123.09 11.80 145 136433 22223 110430498
Mitral valve incompetence 120.95 11.80 176 136402 33153 110419568
Discomfort 120.70 11.80 57 136521 214650 110238071
Dyspnoea 120.08 11.80 1975 134603 1104897 109347824
Respiratory distress 119.05 11.80 263 136315 68611 110384110
Cholestasis 117.95 11.80 252 136326 64266 110388455
Pruritus 117.85 11.80 349 136229 581211 109871510
Hyperphosphataemia 117.48 11.80 122 136456 16259 110436462
Blister 115.13 11.80 69 136509 227307 110225414
Infection 115.08 11.80 168 136410 362032 110090689
Musculoskeletal stiffness 114.52 11.80 106 136472 279716 110173005
Injury 114.50 11.80 38 136540 177227 110275494
Acute hepatic failure 113.10 11.80 179 136399 36289 110416432
Organising pneumonia 112.95 11.80 112 136466 14131 110438590
Cardio-respiratory arrest 112.70 11.80 357 136221 115479 110337242
Hepatocellular injury 111.87 11.80 214 136364 50428 110402293
Pneumonitis 110.15 11.80 272 136306 76259 110376462
Insomnia 109.98 11.80 172 136406 360418 110092303
Orthopnoea 107.13 11.80 97 136481 10924 110441797
Musculoskeletal pain 106.92 11.80 46 136532 182977 110269744
Mobility decreased 106.90 11.80 82 136496 237340 110215381
Infusion site phlebitis 106.65 11.80 27 136551 129 110452592
Hypokalaemia 106.30 11.80 477 136101 181971 110270750
Injection site pain 105.09 11.80 44 136534 177878 110274843
Left ventricular dysfunction 104.71 11.80 137 136441 23356 110429365
Asthma 104.58 11.80 93 136485 250198 110202523
Anticoagulation drug level above therapeutic 103.62 11.80 67 136511 4563 110448158
Impaired healing 103.44 11.80 57 136521 196660 110256061
Troponin increased 103.42 11.80 154 136424 29612 110423109
Thyroid disorder 101.77 11.80 115 136463 16854 110435867
Abdominal pain upper 101.34 11.80 172 136406 348939 110103782
Night sweats 101.20 11.80 21 136557 133962 110318759
Joint range of motion decreased 100.95 11.80 15 136563 121817 110330904
Diarrhoea 100.15 11.80 913 135665 1138592 109314129
Pleural effusion 100.09 11.80 460 136118 177249 110275472
Cardioversion 98.65 11.80 51 136527 2272 110450449
Febrile neutropenia 98.60 11.80 149 136429 316618 110136103
Product use issue 97.61 11.80 146 136432 311549 110141172
Presyncope 96.42 11.80 197 136381 48690 110404031
End stage renal disease 95.36 11.80 125 136453 21348 110431373
Anticoagulation drug level increased 94.00 11.80 38 136540 947 110451774
Myxoedema 93.09 11.80 27 136551 232 110452489
Anxiety 92.12 11.80 179 136399 344899 110107822
Gastrooesophageal reflux disease 91.97 11.80 54 136524 179922 110272799
Coronary artery bypass 91.95 11.80 69 136509 5973 110446748
Arthritis 91.88 11.80 46 136532 167540 110285181
Osteoarthritis 91.63 11.80 56 136522 182567 110270154
Tachycardia induced cardiomyopathy 91.50 11.80 26 136552 206 110452515
N-terminal prohormone brain natriuretic peptide increased 91.15 11.80 69 136509 6052 110446669
Subdural haematoma 90.51 11.80 162 136416 36292 110416429
Blood uric acid increased 90.50 11.80 122 136456 21407 110431314
Fall 89.94 11.80 1139 135439 602343 109850378
Atrioventricular block first degree 88.04 11.80 98 136480 14127 110438594
Drug ineffective 87.83 11.80 2476 134102 1518064 108934657
Potentiating drug interaction 87.63 11.80 89 136489 11554 110441167
Obesity 87.20 11.80 17 136561 113334 110339387
Exposure during pregnancy 85.88 11.80 50 136528 167374 110285347
Hypoxia 85.73 11.80 352 136226 129163 110323558
Arterial haemorrhage 84.82 11.80 55 136523 3764 110448957
Anuria 84.66 11.80 126 136452 24215 110428506
Nodal arrhythmia 84.35 11.80 45 136533 2139 110450582
Lung opacity 83.95 11.80 87 136491 11565 110441156
Drug intolerance 83.69 11.80 242 136336 406270 110046451
Blood loss anaemia 83.28 11.80 107 136471 17918 110434803
Swollen joint count increased 83.22 11.80 5 136573 83656 110369065
Pulmonary fibrosis 82.03 11.80 295 136283 101747 110350974
Cardioactive drug level increased 81.57 11.80 54 136524 3828 110448893
Injection site reaction 81.07 11.80 8 136570 89062 110363659
Cardiac tamponade 80.71 11.80 84 136494 11223 110441498
Hypophosphataemia 80.52 11.80 146 136432 33036 110419685
Dyspnoea exertional 80.41 11.80 297 136281 103763 110348958
Antacid therapy 79.86 11.80 61 136517 5423 110447298
Weight increased 79.85 11.80 259 136319 419385 110033336
Thyroxine free increased 79.71 11.80 38 136540 1419 110451302
Myelosuppression 79.59 11.80 11 136567 94329 110358392
Grip strength decreased 79.12 11.80 5 136573 80169 110372552
Swelling 79.01 11.80 200 136378 350841 110101880
Ischaemic stroke 78.69 11.80 164 136414 41099 110411622
Eosinophilia 78.22 11.80 201 136377 57735 110394986
Inflammation 78.10 11.80 74 136504 193164 110259557
Atrial tachycardia 78.07 11.80 75 136503 9103 110443618
Coagulopathy 77.32 11.80 162 136416 40749 110411972
Lower respiratory tract infection 76.94 11.80 113 136465 242993 110209728
Anticoagulant therapy 76.68 11.80 59 136519 5302 110447419
Haemarthrosis 76.18 11.80 67 136511 7262 110445459
Lymphatic fistula 75.77 11.80 37 136541 1458 110451263
Femoral hernia incarcerated 75.44 11.80 37 136541 1472 110451249
Peripheral swelling 75.06 11.80 252 136326 403782 110048939
Spontaneous haematoma 74.60 11.80 40 136538 1921 110450800
Sciatica 72.91 11.80 13 136565 92386 110360335
Blood creatinine increased 72.87 11.80 430 136148 182459 110270262
Alveolitis 72.74 11.80 53 136525 4386 110448335
Paraesthesia 72.44 11.80 145 136433 276376 110176345
Memory impairment 72.17 11.80 82 136496 196862 110255859
Iron deficiency 72.09 11.80 101 136477 18375 110434346
Haematoma muscle 71.98 11.80 51 136527 4039 110448682
Hepatic enzyme increased 71.30 11.80 184 136394 320708 110132013
Back pain 71.25 11.80 228 136350 370768 110081953
Wound infection 71.05 11.80 16 136562 96449 110356272
Eosinophilic pneumonia 71.02 11.80 64 136514 7163 110445558
Nodal rhythm 70.44 11.80 47 136531 3376 110449345
Bundle branch block left 70.01 11.80 83 136495 12805 110439916
Pericardial effusion 69.64 11.80 191 136387 57026 110395695
Rales 69.34 11.80 116 136462 24623 110428098
Aortic stenosis 69.12 11.80 83 136495 12976 110439745
Pancreatic steatosis 68.85 11.80 37 136541 1785 110450936
Red blood cell sedimentation rate increased 68.79 11.80 8 136570 78294 110374427
Secondary hyperthyroidism 68.69 11.80 18 136560 101 110452620
Hypersensitivity myocarditis 68.65 11.80 23 136555 330 110452391
Pulmonary hypertension 67.87 11.80 185 136393 55035 110397686
Toxicity to various agents 66.91 11.80 896 135682 479659 109973062
Iodine overload 66.12 11.80 13 136565 11 110452710
Peripheral venous disease 66.02 11.80 12 136566 84105 110368616
Road traffic accident 65.96 11.80 25 136553 107373 110345348
Colitis ulcerative 65.31 11.80 9 136569 77354 110375367
Rectal haemorrhage 65.10 11.80 307 136271 119526 110333195
Heparin-induced thrombocytopenia 64.43 11.80 75 136503 11349 110441372
Wound infection pseudomonas 64.31 11.80 39 136539 2372 110450349
Completed suicide 63.56 11.80 127 136451 242254 110210467
Nausea 63.36 11.80 1110 135468 1234580 109218141
Gastrointestinal disorder 63.26 11.80 127 136451 241825 110210896
Injection site erythema 62.92 11.80 19 136559 94157 110358564
Toxic skin eruption 62.90 11.80 118 136460 27397 110425324
Drug-induced liver injury 62.62 11.80 304 136274 119763 110332958
Hepatitis acute 62.22 11.80 95 136483 18671 110434050
Pulmonary ossification 61.40 11.80 15 136563 60 110452661
Myocardial infarction 59.58 11.80 424 136154 191659 110261062
Contraindicated product administered 59.35 11.80 137 136441 248130 110204591
Tricuspid valve incompetence 59.14 11.80 106 136472 23767 110428954
Myalgia 58.76 11.80 116 136462 222265 110230456
White blood cell count decreased 58.61 11.80 122 136456 229268 110223453
Product quality issue 58.60 11.80 12 136566 77287 110375434
Shock 58.50 11.80 172 136406 53416 110399305
Renal impairment 58.47 11.80 416 136162 188029 110264692
Mesenteric haematoma 58.20 11.80 15 136563 78 110452643
Septic shock 58.06 11.80 363 136215 157165 110295556
Cardiac ablation 58.04 11.80 38 136540 2644 110450077
Neck pain 57.37 11.80 41 136537 123089 110329632
Goitre 57.17 11.80 53 136525 6151 110446570
Bradyarrhythmia 57.17 11.80 48 136530 4886 110447835
Sepsis 57.10 11.80 637 135941 326709 110126012
Corneal deposits 56.90 11.80 23 136555 573 110452148
Gait inability 56.55 11.80 51 136527 136325 110316396
Adverse event 56.50 11.80 32 136546 108777 110343944
COVID-19 56.38 11.80 138 136440 244922 110207799
Jugular vein distension 56.03 11.80 31 136547 1585 110451136
C-reactive protein increased 55.59 11.80 116 136462 217803 110234918
Haemorrhage 54.82 11.80 269 136309 106423 110346298
Taste disorder 54.28 11.80 8 136570 65379 110387342
Product dose omission issue 54.23 11.80 209 136369 321573 110131148
Neutrophil count decreased 54.12 11.80 42 136536 120899 110331822
Cardiovascular disorder 53.77 11.80 99 136479 22661 110430060
Ear infection 53.66 11.80 7 136571 62725 110389996
Ecchymosis 53.62 11.80 85 136493 17253 110435468
Hip arthroplasty 53.56 11.80 4 136574 55809 110396912
Ischaemic hepatitis 53.41 11.80 45 136533 4603 110448118
Pulmonary oedema 53.30 11.80 256 136322 100403 110352318
Pseudopapilloedema 52.82 11.80 12 136566 32 110452689
Device inappropriate shock delivery 52.63 11.80 13 136565 55 110452666
Oedema peripheral 52.60 11.80 629 135949 328031 110124690
Electrocardiogram PR prolongation 52.24 11.80 31 136547 1812 110450909
Drug level increased 51.93 11.80 153 136425 47566 110405155
Amnesia 51.92 11.80 33 136545 105375 110347346
Chronic obstructive pulmonary disease 51.71 11.80 269 136309 108889 110343832
Left ventricular failure 51.66 11.80 67 136511 11322 110441399
Hypoglycaemia 50.84 11.80 280 136298 115824 110336897
Cerebellar syndrome 50.79 11.80 50 136528 6252 110446469
Osteoporosis 50.73 11.80 22 136556 87130 110365591
Glomerular filtration rate decreased 50.51 11.80 111 136467 28845 110423876
Subarachnoid haemorrhage 49.72 11.80 112 136466 29590 110423131
Haemodynamic instability 49.66 11.80 96 136482 22792 110429929
Knee arthroplasty 49.41 11.80 10 136568 64938 110387783
Influenza like illness 48.86 11.80 24 136554 88388 110364333
Seroma 48.69 11.80 37 136541 3264 110449457
Sedation 48.51 11.80 13 136565 69670 110383051
Injection site pruritus 48.27 11.80 4 136574 51254 110401467
Joint stiffness 47.85 11.80 12 136566 67231 110385490
Oropharyngeal pain 47.75 11.80 58 136520 135218 110317503
Electrocardiogram QRS complex prolonged 47.59 11.80 69 136509 12952 110439769
Muscle haemorrhage 47.19 11.80 50 136528 6819 110445902
Treatment failure 46.75 11.80 180 136398 277054 110175667
Frequent bowel movements 46.62 11.80 15 136563 71375 110381346
Psoriasis 46.34 11.80 63 136515 139930 110312791
Gravitational oedema 46.29 11.80 29 136549 1869 110450852
Neuralgia 45.84 11.80 148 136430 48330 110404391
Bacterial infection 45.78 11.80 143 136435 45893 110406828
Dyspnoea at rest 45.75 11.80 54 136524 8292 110444429
Palpitations 45.68 11.80 345 136233 158867 110293854
Feeling hot 45.60 11.80 28 136550 91078 110361643
Gout 45.43 11.80 123 136455 36443 110416278
Acute interstitial pneumonitis 45.42 11.80 26 136552 1420 110451301
Toxic nodular goitre 45.11 11.80 12 136566 72 110452649
Off label use 45.02 11.80 1462 135116 1498723 108953998
Haemorrhage intracranial 44.93 11.80 106 136472 28863 110423858
Pulseless electrical activity 44.88 11.80 77 136501 16680 110436041
Onychomadesis 44.60 11.80 3 136575 45660 110407061
Eosinophilic pneumonia acute 44.58 11.80 27 136551 1638 110451083
Exercise tolerance decreased 44.18 11.80 64 136514 12003 110440718
Lung disorder 43.96 11.80 376 136202 179671 110273050
Lower limb fracture 43.89 11.80 19 136559 75329 110377392
Congenital hiatus hernia 43.78 11.80 46 136532 6213 110446508
Loss of personal independence in daily activities 43.41 11.80 74 136504 149946 110302775
Haemoptysis 43.37 11.80 189 136389 71165 110381556
Prothrombin time shortened 43.34 11.80 36 136542 3610 110449111
General physical health deterioration 43.31 11.80 752 135826 424543 110028178
Atrioventricular block second degree 43.31 11.80 52 136526 8129 110444592
Hypervolaemia 43.21 11.80 147 136431 49313 110403408
Contusion 42.99 11.80 146 136432 233215 110219506
Bone erosion 42.63 11.80 4 136574 46367 110406354
Drug dependence 41.80 11.80 6 136572 50014 110402707
Acute pulmonary oedema 41.51 11.80 75 136503 16921 110435800
Stress 41.49 11.80 247 136331 105101 110347620
Aortic valve stenosis 41.47 11.80 45 136533 6305 110446416
Back injury 41.25 11.80 5 136573 47394 110405327
Herpes zoster 40.93 11.80 44 136534 108335 110344386
Ear pain 40.90 11.80 8 136570 53218 110399503
Neuromyopathy 40.44 11.80 26 136552 1753 110450968
Blood pressure increased 40.26 11.80 173 136405 258200 110194521
Renal phospholipidosis 40.22 11.80 16 136562 382 110452339
Cardiac amyloidosis 40.09 11.80 31 136547 2806 110449915
Thyroxine increased 40.06 11.80 21 136557 963 110451758
Acute generalised exanthematous pustulosis 40.02 11.80 85 136493 21579 110431142
Myoclonus 40.00 11.80 110 136468 32888 110419833
Toxic goitre 39.99 11.80 10 136568 45 110452676
Sinoatrial block 39.85 11.80 24 136554 1441 110451280
Hepatitis fulminant 39.83 11.80 51 136527 8509 110444212
Seizure 39.65 11.80 140 136438 221045 110231676
Rhinorrhoea 39.53 11.80 41 136537 102625 110350096
Cholestatic liver injury 39.23 11.80 47 136531 7329 110445392
Venous pressure jugular increased 39.00 11.80 23 136555 1329 110451392
Malignant neoplasm progression 38.82 11.80 100 136478 174467 110278254
Craniocerebral injury 38.66 11.80 42 136536 5892 110446829
Prescribed overdose 38.45 11.80 31 136547 87550 110365171
Dyspepsia 38.30 11.80 115 136463 190850 110261871
Abdominal wall haematoma 38.26 11.80 41 136537 5664 110447057
Vascular purpura 38.25 11.80 34 136544 3737 110448984
Laryngitis 38.10 11.80 4 136574 42407 110410314
Electrocardiogram T wave alternans 38.00 11.80 12 136566 141 110452580
Low cardiac output syndrome 37.75 11.80 21 136557 1085 110451636
Oliguria 37.75 11.80 76 136502 18581 110434140
Cell death 37.75 11.80 41 136537 5750 110446971
Haemothorax 37.73 11.80 45 136533 6986 110445735
Sleep disorder due to a general medical condition 37.66 11.80 9 136569 52103 110400618
Pancreatitis 37.57 11.80 36 136542 93497 110359224
Cardiac disorder 37.53 11.80 190 136388 76090 110376631
Dry skin 37.11 11.80 47 136531 107606 110345115
Transaminases increased 37.08 11.80 166 136412 63224 110389497
Pacemaker generated rhythm 37.04 11.80 10 136568 64 110452657
Device pacing issue 37.04 11.80 12 136566 154 110452567
Disease progression 36.45 11.80 166 136412 243868 110208853
Left atrial enlargement 36.18 11.80 24 136554 1707 110451014
Pemphigoid 36.03 11.80 77 136501 19630 110433091
Atrial thrombosis 36.00 11.80 35 136543 4311 110448410
Hepatic cytolysis 35.92 11.80 149 136429 54904 110397817
Rash maculo-papular 35.91 11.80 184 136394 74038 110378683
Suicidal ideation 35.62 11.80 38 136540 93899 110358822
Hypertension 35.52 11.80 431 136147 509653 109943068
Injection site swelling 35.33 11.80 16 136562 61774 110390947
Abdominal distension 35.32 11.80 351 136227 174752 110277969
Haemorrhagic stroke 35.15 11.80 62 136516 13727 110438994
Head injury 35.10 11.80 125 136453 42892 110409829
Mitochondrial aspartate aminotransferase increased 35.04 11.80 7 136571 7 110452714
Blood creatine increased 34.96 11.80 56 136522 11465 110441256
Blood calcium increased 34.75 11.80 72 136506 17968 110434753
Cardiac output decreased 34.58 11.80 25 136553 2044 110450677
Prothrombin time prolonged 34.55 11.80 70 136508 17191 110435530
Mixed liver injury 34.33 11.80 57 136521 12022 110440699
Epilepsy 34.28 11.80 44 136534 100165 110352556
Cardiomegaly 34.21 11.80 96 136482 29034 110423687
Optic neuropathy 33.96 11.80 35 136543 4623 110448098
Cardiorenal syndrome 33.95 11.80 24 136554 1894 110450827
Cutaneous vasculitis 33.45 11.80 58 136520 12671 110440050
Agranulocytosis 33.36 11.80 158 136420 61602 110391119
Drug abuse 33.35 11.80 110 136468 177301 110275420
Sudden death 33.30 11.80 85 136493 24310 110428411
Muscle spasticity 33.28 11.80 3 136575 35912 110416809
Platelet distribution width increased 33.28 11.80 11 136567 151 110452570
Extrasystoles 33.24 11.80 46 136532 8272 110444449
Ischaemic cardiomyopathy 33.06 11.80 45 136533 7966 110444755
Listless 33.05 11.80 34 136544 4481 110448240
Bacteroides infection 33.00 11.80 28 136550 2891 110449830
Neutropenia 32.79 11.80 300 136278 374320 110078401
Mediastinal haematoma 32.66 11.80 12 136566 229 110452492
Xyphoid retraction 32.57 11.80 11 136567 162 110452559
Incorrect route of product administration 32.53 11.80 161 136417 63900 110388821
Hepatic failure 32.28 11.80 169 136409 68570 110384151
Blood pressure fluctuation 32.20 11.80 27 136551 74797 110377924
Epistaxis 32.20 11.80 273 136305 130099 110322622
Cardiovascular insufficiency 32.08 11.80 29 136549 3259 110449462
Subcutaneous haematoma 32.05 11.80 28 136550 3008 110449713
Throat irritation 32.00 11.80 13 136565 53539 110399182
Lung infiltration 31.76 11.80 84 136494 24544 110428177
Phlebitis 31.47 11.80 49 136529 9792 110442929
Abortion spontaneous 31.40 11.80 3 136575 34279 110418442
Myocardial ischaemia 31.40 11.80 88 136490 26596 110426125
Hepatitis cholestatic 31.39 11.80 68 136510 17498 110435223
Chills 31.31 11.80 125 136453 190455 110262266
Glomerular filtration rate 31.28 11.80 11 136567 184 110452537
Bone pain 31.25 11.80 21 136557 65112 110387609
Swelling face 31.10 11.80 41 136537 92280 110360441
Cyanosis 31.07 11.80 94 136484 29647 110423074
Malaise 31.01 11.80 614 135964 671205 109781516
Total lung capacity decreased 30.95 11.80 41 136537 7073 110445648
Oral herpes 30.92 11.80 4 136574 36076 110416645
Fungal infection 30.91 11.80 12 136566 50794 110401927
Haemorrhagic diathesis 30.72 11.80 42 136536 7466 110445255
Sopor 30.51 11.80 107 136471 36439 110416282
Gastrointestinal angiodysplasia 30.41 11.80 19 136559 1219 110451502
Blood thyroid stimulating hormone decreased 30.39 11.80 41 136537 7198 110445523
Therapeutic response decreased 30.37 11.80 45 136533 96454 110356267
Procedural pain 30.34 11.80 4 136574 35561 110417160
Anastomotic infection 30.34 11.80 10 136568 136 110452585
Chronic kidney disease 30.12 11.80 179 136399 76112 110376609
Cerebellar haematoma 30.07 11.80 15 136563 619 110452102
Cardiac pacemaker insertion 30.05 11.80 38 136540 6263 110446458
Body temperature increased 30.00 11.80 15 136563 54698 110398023
Acute coronary syndrome 29.98 11.80 79 136499 23033 110429688
Mouth ulceration 29.90 11.80 11 136567 48127 110404594
Nasal congestion 29.81 11.80 47 136531 98235 110354486
Injection site bruising 29.74 11.80 13 136565 51250 110401471
Intraocular haematoma 29.73 11.80 7 136571 23 110452698
Hepatic cyst 29.55 11.80 42 136536 7741 110444980
Ventricular tachyarrhythmia 29.46 11.80 14 136564 519 110452202
Feeling abnormal 29.39 11.80 119 136459 180592 110272129
Faecaloma 29.30 11.80 60 136518 14848 110437873
Lung consolidation 29.19 11.80 49 136529 10427 110442294
Neuropathy peripheral 29.19 11.80 118 136460 179159 110273562
Lower gastrointestinal haemorrhage 29.05 11.80 68 136510 18418 110434303
Diverticulum intestinal 28.98 11.80 52 136526 11667 110441054
Deep vein thrombosis 28.95 11.80 83 136495 139804 110312917
Hypercholesterolaemia 28.94 11.80 42 136536 90795 110361926
Respiratory acidosis 28.79 11.80 57 136521 13769 110438952
Conduction disorder 28.72 11.80 30 136548 4025 110448696
Drug therapy 28.66 11.80 40 136538 7251 110445470
Anaemia macrocytic 28.60 11.80 40 136538 7263 110445458
Orthostatic hypotension 28.48 11.80 159 136419 66090 110386631
Inappropriate schedule of product administration 28.37 11.80 142 136436 203495 110249226
Paraesthesia oral 28.22 11.80 4 136574 33667 110419054
Optic ischaemic neuropathy 28.16 11.80 30 136548 4117 110448604
Helicobacter test false negative 28.09 11.80 8 136570 64 110452657
Jaundice 28.06 11.80 146 136432 59090 110393631
Skin disorder 28.05 11.80 9 136569 42904 110409817
Hypovolaemic shock 27.85 11.80 58 136520 14525 110438196
Drug reaction with eosinophilia and systemic symptoms 27.67 11.80 185 136393 81910 110370811
Intraventricular haemorrhage 27.52 11.80 34 136544 5473 110447248
Wound dehiscence 27.38 11.80 41 136537 7921 110444800
Therapy non-responder 27.24 11.80 101 136477 157206 110295515
Illness 27.17 11.80 37 136541 82134 110370587
Arteriosclerotic gangrene 27.15 11.80 8 136570 73 110452648
Drug hypersensitivity 27.11 11.80 396 136182 453694 109999027
Right ventricular failure 27.09 11.80 82 136496 25872 110426849
Ilium fracture 27.07 11.80 11 136567 278 110452443
Angiodysplasia 27.06 11.80 19 136559 1483 110451238
Foot deformity 27.03 11.80 13 136565 48467 110404254
Bronchopulmonary aspergillosis allergic 27.01 11.80 42 136536 8384 110444337
Inflammatory marker increased 26.99 11.80 57 136521 14412 110438309
Swollen tongue 26.95 11.80 21 136557 60341 110392380
Mesenteric artery thrombosis 26.93 11.80 16 136562 937 110451784
Concomitant disease aggravated 26.60 11.80 61 136517 16303 110436418
Neonatal hypotension 26.32 11.80 7 136571 42 110452679
Ventricular dysfunction 26.29 11.80 39 136539 7472 110445249
Myopathy 26.18 11.80 79 136499 24881 110427840
Tracheal compression 26.14 11.80 5 136573 3 110452718
Femoral artery aneurysm 26.11 11.80 10 136568 215 110452506
Nephrolithiasis 25.99 11.80 26 136552 66186 110386535
Metabolic acidosis 25.77 11.80 211 136367 99533 110353188
Encephalopathy 25.74 11.80 180 136398 80875 110371846
Upper respiratory tract infection 25.68 11.80 80 136498 131248 110321473
Traumatic lung injury 25.67 11.80 23 136555 2554 110450167
Periorbital haemorrhage 25.66 11.80 11 136567 319 110452402
Loss of consciousness 25.62 11.80 362 136216 195944 110256777
Lymphocyte count decreased 25.45 11.80 20 136558 57223 110395498
Supine hypertension 25.40 11.80 12 136566 439 110452282
Cutaneous mucormycosis 25.30 11.80 14 136564 716 110452005
Amyloidosis 25.20 11.80 25 136553 3156 110449565
Emotional distress 25.04 11.80 12 136566 44835 110407886
Urine iodine increased 25.03 11.80 5 136573 5 110452716
Iodine uptake abnormal 25.03 11.80 5 136573 5 110452716
Arrhythmia supraventricular 24.70 11.80 22 136556 2424 110450297
Sinus congestion 24.66 11.80 4 136574 30455 110422266
Retroperitoneal haematoma 24.64 11.80 34 136544 6097 110446624
Neoplasm progression 24.64 11.80 26 136552 64569 110388152
Disability 24.40 11.80 4 136574 30219 110422502
Ventricular pre-excitation 24.37 11.80 6 136572 25 110452696
Puncture site haematoma 24.20 11.80 10 136568 264 110452457
Impaired quality of life 24.17 11.80 4 136574 30013 110422708
Accidental exposure to product 24.16 11.80 16 136562 49992 110402729
Bone marrow granuloma 23.99 11.80 6 136572 27 110452694
Inappropriate antidiuretic hormone secretion 23.98 11.80 94 136484 33757 110418964
Aortic arteriosclerosis 23.88 11.80 46 136532 10892 110441829
Adverse drug reaction 23.82 11.80 60 136518 105499 110347222
Depressed mood 23.73 11.80 24 136554 60785 110391936
Electrocardiogram P wave abnormal 23.58 11.80 11 136567 391 110452330
Erythema 23.54 11.80 238 136340 291209 110161512
Upper gastrointestinal haemorrhage 23.40 11.80 123 136455 49973 110402748
Intra-abdominal haematoma 23.37 11.80 25 136553 3447 110449274
Finger deformity 23.36 11.80 6 136572 33086 110419635
Hepatotoxicity 23.28 11.80 146 136432 63254 110389467
Neonatal pneumonia 23.15 11.80 6 136572 32 110452689
Cytomegalovirus infection 23.00 11.80 20 136558 54424 110398297
Thyroiditis acute 22.98 11.80 9 136569 206 110452515
Cardiomyopathy 22.87 11.80 92 136486 33433 110419288
Protein bound iodine increased 22.79 11.80 4 136574 0 110452721
Argyria 22.79 11.80 4 136574 0 110452721
Mitral valve disease mixed 22.79 11.80 4 136574 0 110452721
Device capturing issue 22.56 11.80 6 136572 36 110452685
Aortic valve incompetence 22.54 11.80 45 136533 10936 110441785
Vomiting 22.53 11.80 908 135670 909767 109542954
Sinus arrest 22.51 11.80 27 136551 4215 110448506
Osteonecrosis of jaw 22.35 11.80 16 136562 48001 110404720
Reduced facial expression 22.33 11.80 25 136553 3626 110449095
Toxic epidermal necrolysis 22.33 11.80 133 136445 56594 110396127
Osteonecrosis 22.19 11.80 7 136571 33734 110418987
Platelet count decreased 22.18 11.80 180 136398 230263 110222458
Drug level above therapeutic 22.02 11.80 46 136532 11542 110441179
Retroperitoneal haemorrhage 21.96 11.80 32 136546 6033 110446688
Hypothermia 21.95 11.80 77 136501 26225 110426496
Normocytic anaemia 21.81 11.80 33 136545 6434 110446287
Ventricular internal diameter abnormal 21.77 11.80 9 136569 238 110452483
Coma uraemic 21.76 11.80 6 136572 42 110452679
Cardiac sarcoidosis 21.71 11.80 10 136568 345 110452376
Blood glucose increased 21.70 11.80 87 136491 132409 110320312
Central nervous system injury 21.57 11.80 8 136570 157 110452564
Mucosal inflammation 21.42 11.80 55 136523 96086 110356635
Cataract 21.38 11.80 41 136537 79444 110373277
Cardiac dysfunction 21.33 11.80 32 136546 6191 110446530
Pulmonary arterial hypertension 21.13 11.80 88 136490 32480 110420241
Hypertransaminasaemia 21.10 11.80 72 136506 24183 110428538
Burning sensation 21.08 11.80 33 136545 69179 110383542
Left ventricular false tendon 21.06 11.80 6 136572 48 110452673
Acute myocardial infarction 20.99 11.80 176 136402 83601 110369120
Suicide attempt 20.91 11.80 62 136516 103332 110349389
Hypophonesis 20.88 11.80 5 136573 18 110452703
Blood pressure systolic abnormal 20.72 11.80 3 136575 24847 110427874
Drug ineffective for unapproved indication 20.66 11.80 206 136372 102632 110350089
Cystitis 20.58 11.80 31 136547 66005 110386716
Thrombosis 20.56 11.80 215 136363 108447 110344274
Injection site mass 20.45 11.80 3 136575 24610 110428111
Eye pain 20.45 11.80 19 136559 50080 110402641
Skin fissures 20.28 11.80 3 136575 24455 110428266
Acne 20.25 11.80 8 136570 33512 110419209
Colitis 20.24 11.80 62 136516 102261 110350460
Diaphragmatic paralysis 20.19 11.80 15 136563 1279 110451442
Liver function test abnormal 20.10 11.80 150 136428 68800 110383921
Weight decreased 20.02 11.80 433 136145 467624 109985097
No adverse event 19.94 11.80 38 136540 73801 110378920
Basal cell carcinoma 19.90 11.80 16 136562 45254 110407467
Diffuse vasculitis 19.86 11.80 7 136571 118 110452603
Respiratory disorder neonatal 19.70 11.80 6 136572 62 110452659
Hypocoagulable state 19.70 11.80 20 136558 2595 110450126
Irritability 19.67 11.80 18 136560 47791 110404930
Kounis syndrome 19.65 11.80 30 136548 5895 110446826
Flushing 19.64 11.80 65 136513 104671 110348050
Gastroenteritis viral 19.62 11.80 7 136571 31219 110421502
Subarachnoid haematoma 19.58 11.80 9 136569 309 110452412
Stress cardiomyopathy 19.46 11.80 53 136525 15753 110436968
Anaphylactic reaction 19.39 11.80 74 136504 114226 110338495
Lupus pneumonitis 19.33 11.80 7 136571 128 110452593
Vascular graft 19.29 11.80 18 136560 2107 110450614
Hyperthermia 19.26 11.80 64 136514 21208 110431513
Injection site rash 19.13 11.80 3 136575 23416 110429305
Pelvic fracture 18.99 11.80 49 136529 14105 110438616
Product prescribing error 18.72 11.80 118 136460 51213 110401508
Thyroxine free decreased 18.72 11.80 14 136564 1206 110451515
Influenza 18.70 11.80 127 136451 168974 110283747
Palmar-plantar erythrodysaesthesia syndrome 18.66 11.80 14 136564 41011 110411710
Aerophagia 18.66 11.80 6 136572 75 110452646
Cellulitis 18.64 11.80 86 136492 125930 110326791
Pseudolymphoma 18.56 11.80 14 136564 1221 110451500
Papilloedema 18.48 11.80 33 136545 7376 110445345
Ventricular hypokinesia 18.45 11.80 42 136536 11172 110441549
Orthostatic hypertension 18.43 11.80 13 136565 1022 110451699
Ocular hyperaemia 18.40 11.80 13 136565 39273 110413448
Cardioactive drug level above therapeutic 18.38 11.80 8 136570 241 110452480
Halo vision 18.36 11.80 11 136567 654 110452067
Prerenal failure 18.33 11.80 25 136553 4434 110448287
Groin pain 18.27 11.80 51 136527 15377 110437344
Thyroid dermatopathy 18.26 11.80 5 136573 34 110452687
Tri-iodothyronine increased 18.21 11.80 9 136569 364 110452357
Vascular stent thrombosis 18.13 11.80 24 136554 4137 110448584
Hyperlipidaemia 18.13 11.80 90 136488 35758 110416963
Pneumonitis chemical 18.02 11.80 11 136567 677 110452044
Vascular pseudoaneurysm 18.00 11.80 24 136554 4166 110448555
Adverse reaction 17.98 11.80 7 136571 29587 110423134
Eosinophilic pleural effusion 17.95 11.80 10 136568 518 110452203
Hypersensitivity pneumonitis 17.94 11.80 27 136551 5238 110447483
Arteriosclerotic retinopathy 17.89 11.80 5 136573 37 110452684
Angioedema 17.87 11.80 62 136516 98438 110354283
Hot flush 17.82 11.80 34 136544 66002 110386719
Intentional product misuse 17.70 11.80 246 136332 132658 110320063
Supraventricular extrasystoles 17.68 11.80 34 136544 8039 110444682
Decreased appetite 17.63 11.80 450 136128 475396 109977325
Drug tolerance decreased 17.61 11.80 6 136572 27534 110425187
Splenic injury 17.56 11.80 8 136570 269 110452452
Petechiae 17.54 11.80 66 136512 23251 110429470
Viral infection 17.49 11.80 24 136554 53115 110399606
Brugada syndrome 17.48 11.80 15 136563 1573 110451148
Antiacetylcholine receptor antibody positive 17.48 11.80 8 136570 272 110452449
Blood pressure decreased 17.40 11.80 218 136360 114873 110337848
Leukopenia 17.33 11.80 110 136468 148681 110304040
Tachypnoea 17.23 11.80 95 136483 39300 110413421
Dysgeusia 17.21 11.80 38 136540 69947 110382774
Eructation 17.17 11.80 47 136531 14010 110438711
Conjunctival haemorrhage 17.14 11.80 30 136548 6603 110446118
Diabetes mellitus 17.12 11.80 193 136385 99188 110353533
Diffuse alveolar damage 17.11 11.80 23 136555 4024 110448697
Endovenous ablation 17.09 11.80 3 136575 0 110452721
Oral candidiasis 17.09 11.80 18 136560 44742 110407979
Sinus arrhythmia 17.09 11.80 17 136561 2153 110450568
Thyroid haemorrhage 17.03 11.80 6 136572 101 110452620
Blood cholesterol increased 17.02 11.80 146 136432 184639 110268082
Accessory cardiac pathway 17.02 11.80 4 136574 13 110452708
Visual impairment 16.91 11.80 97 136481 134331 110318390
Mental disorder 16.69 11.80 14 136564 38777 110413944
Benign prostatic hyperplasia 16.64 11.80 55 136523 18179 110434542
Acute lung injury 16.63 11.80 20 136558 3131 110449590
Asthenia 16.63 11.80 1024 135554 687975 109764746
Ventricular flutter 16.60 11.80 6 136572 109 110452612
Pericarditis fungal 16.60 11.80 8 136570 306 110452415
Haematotoxicity 16.56 11.80 3 136575 21079 110431642
Hyperglycaemia 16.51 11.80 52 136526 85038 110367683
Impaired work ability 16.47 11.80 6 136572 26413 110426308
Anticoagulation drug level abnormal 16.46 11.80 8 136570 312 110452409
Anti factor V antibody 16.41 11.80 8 136570 314 110452407
Haemorrhagic thyroid cyst 16.37 11.80 4 136574 16 110452705
Nodule 16.37 11.80 10 136568 32621 110420100
Inferior vena cava syndrome 16.26 11.80 6 136572 116 110452605
Klebsiella infection 16.20 11.80 58 136520 19951 110432770
Conjunctivitis 16.07 11.80 11 136567 33781 110418940
Drug withdrawal syndrome 16.05 11.80 14 136564 38040 110414681
Chronotropic incompetence 16.02 11.80 6 136572 121 110452600
Failure to suspend medication 15.97 11.80 9 136569 477 110452244
Intentional overdose 15.93 11.80 97 136481 132404 110320317
Alveolar proteinosis 15.88 11.80 14 136564 1522 110451199
Intestinal ischaemia 15.85 11.80 50 136528 16129 110436592
Non-compaction cardiomyopathy 15.82 11.80 5 136573 59 110452662
Foreign body 15.79 11.80 19 136559 2976 110449745
Sneezing 15.77 11.80 10 136568 31974 110420747
Dry eye 15.70 11.80 28 136550 55765 110396956
Linear IgA disease 15.66 11.80 23 136555 4366 110448355
Optic nerve infarction 15.66 11.80 5 136573 61 110452660
Electrocardiogram RR interval prolonged 15.65 11.80 4 136574 20 110452701
Alveolitis necrotising 15.65 11.80 4 136574 20 110452701
Death 15.65 11.80 1032 135546 697837 109754884
Thyroid function test abnormal 15.57 11.80 20 136558 3347 110449374
Oral pain 15.52 11.80 14 136564 37430 110415291
Amaurosis 15.47 11.80 14 136564 1575 110451146
International normalised ratio abnormal 15.46 11.80 28 136550 6329 110446392
Lymphadenopathy 15.42 11.80 35 136543 63800 110388921
Normal newborn 15.40 11.80 4 136574 21892 110430829
Skin exfoliation 15.35 11.80 56 136522 87595 110365126
Fascial rupture 15.33 11.80 4 136574 22 110452699
Systemic inflammatory response syndrome 15.33 11.80 43 136535 13000 110439721
Drug clearance decreased 15.29 11.80 22 136556 4100 110448621
Brain natriuretic peptide increased 15.24 11.80 39 136539 11170 110441551
Ventricular remodelling 15.21 11.80 6 136572 140 110452581
Uveitis 15.20 11.80 4 136574 21706 110431015
Therapy partial responder 15.19 11.80 14 136564 37047 110415674
Respiratory sinus arrhythmia magnitude 15.17 11.80 5 136573 68 110452653
Pharyngitis 15.15 11.80 6 136572 25092 110427629
Chronic sinusitis 15.13 11.80 6 136572 25078 110427643
Walking aid user 15.12 11.80 6 136572 25069 110427652
Liver scan abnormal 15.10 11.80 5 136573 69 110452652
Rash pruritic 15.06 11.80 66 136512 98003 110354718
Muscular weakness 15.05 11.80 216 136362 248252 110204469
Hypothyroidic goitre 15.02 11.80 3 136575 3 110452718
Chest pain 15.01 11.80 352 136226 376023 110076698
Therapeutic drug monitoring analysis not performed 14.97 11.80 15 136563 1916 110450805
Hypokinesia 14.97 11.80 60 136518 21766 110430955
Bundle branch block right 14.92 11.80 41 136537 12250 110440471
Hepatojugular reflux 14.90 11.80 10 136568 725 110451996
Adrenal haematoma 14.86 11.80 6 136572 149 110452572
Scrotal oedema 14.80 11.80 14 136564 1667 110451054
Hypernatraemia 14.70 11.80 52 136526 17781 110434940
Chorea 14.62 11.80 19 136559 3216 110449505
Transplant rejection 14.62 11.80 6 136572 24561 110428160
Hypoglycaemic seizure 14.57 11.80 11 136567 961 110451760
Atrio-oesophageal fistula 14.56 11.80 3 136575 4 110452717
Overdose 14.55 11.80 385 136193 233409 110219312
Tendonitis 14.53 11.80 7 136571 26076 110426645
Acute left ventricular failure 14.49 11.80 16 136562 2285 110450436
Anti-thyroid antibody positive 14.48 11.80 9 136569 572 110452149
Gastrointestinal vascular malformation haemorrhagic 14.47 11.80 11 136567 971 110451750
Traumatic haemothorax 14.46 11.80 10 136568 762 110451959
Anticoagulation drug level below therapeutic 14.43 11.80 14 136564 1720 110451001
Iron deficiency anaemia 14.41 11.80 77 136501 31482 110421239
Oesophageal infection 14.39 11.80 10 136568 768 110451953
White blood cell count increased 14.37 11.80 66 136512 96776 110355945
Panic attack 14.33 11.80 9 136569 28931 110423790
Supraventricular tachycardia 14.31 11.80 64 136514 24358 110428363
Rhinitis 14.26 11.80 5 136573 22540 110430181
Abdominal pain lower 14.23 11.80 15 136563 37268 110415453
Device issue 14.21 11.80 13 136565 34522 110418199
Eye swelling 14.13 11.80 12 136566 33036 110419685
Injection site haemorrhage 14.11 11.80 12 136566 33016 110419705
Crying 14.09 11.80 7 136571 25621 110427100
Graft versus host disease 14.09 11.80 3 136575 18803 110433918
Colonic haematoma 14.04 11.80 5 136573 87 110452634
Extradural haematoma 14.02 11.80 19 136559 3350 110449371
Congestive hepatopathy 14.00 11.80 24 136554 5196 110447525
Bundle branch block 13.97 11.80 14 136564 1789 110450932
Circulatory collapse 13.96 11.80 96 136482 42897 110409824
Electrocardiogram QRS complex shortened 13.91 11.80 10 136568 810 110451911
Splenic haemorrhage 13.91 11.80 10 136568 810 110451911
Withdrawal syndrome 13.90 11.80 11 136567 31369 110421352
Diabetic ketoacidosis 13.84 11.80 19 136559 42039 110410682
Serotonin syndrome 13.84 11.80 33 136545 59120 110393601
Traumatic haematoma 13.83 11.80 16 136562 2405 110450316
Diastolic dysfunction 13.71 11.80 40 136538 12364 110440357
Oedema genital 13.66 11.80 9 136569 633 110452088
Orchitis 13.59 11.80 14 136564 1848 110450873
Therapeutic response shortened 13.58 11.80 10 136568 29573 110423148
Coagulation test abnormal 13.56 11.80 13 136565 1573 110451148
Myopathy toxic 13.55 11.80 12 136566 1313 110451408
Tenderness 13.45 11.80 10 136568 29427 110423294
Infective pericardial effusion 13.43 11.80 4 136574 38 110452683
Microcytic anaemia 13.39 11.80 26 136552 6192 110446529
Vertigo 13.32 11.80 165 136413 86705 110366016
Throat tightness 13.32 11.80 13 136565 33476 110419245
Hypoxic-ischaemic encephalopathy 13.31 11.80 32 136546 8815 110443906
Eye irritation 13.29 11.80 13 136565 33439 110419282
Blood test abnormal 13.26 11.80 70 136508 28484 110424237
Urinary retention 13.24 11.80 138 136440 69545 110383176
Thyrotoxic periodic paralysis 13.22 11.80 6 136572 200 110452521
Bronchitis 13.19 11.80 127 136451 156905 110295816
Gait disturbance 13.19 11.80 253 136325 277955 110174766
Apathy 13.09 11.80 47 136531 16192 110436529
Demyelinating polyneuropathy 13.08 11.80 15 136563 2234 110450487
Red blood cell sedimentation rate abnormal 13.02 11.80 7 136571 24502 110428219
Electrocardiogram low voltage 12.99 11.80 4 136574 43 110452678
Device dislocation 12.97 11.80 12 136566 31692 110421029
Altered visual depth perception 12.94 11.80 8 136570 504 110452217
Atrial enlargement 12.93 11.80 11 136567 1140 110451581
Thrombin time prolonged 12.93 11.80 7 136571 343 110452378
Limb discomfort 12.90 11.80 19 136559 40835 110411886
Oesophageal adenocarcinoma recurrent 12.83 11.80 4 136574 45 110452676
Hypochromasia 12.81 11.80 9 136569 703 110452018
Adrenal insufficiency 12.80 11.80 93 136485 42297 110410424
Photosensitivity reaction 12.77 11.80 64 136514 25525 110427196
Oesophageal squamous cell carcinoma 12.76 11.80 8 136570 516 110452205
Musculoskeletal disorder 12.75 11.80 6 136572 22658 110430063
Pulmonary haemorrhage 12.73 11.80 47 136531 16409 110436312
Right ventricular dysfunction 12.72 11.80 18 136560 3305 110449416
Eye pruritus 12.72 11.80 13 136565 32762 110419959
Ventricular enlargement 12.68 11.80 9 136569 715 110452006
Blood cyanide increased 12.67 11.80 4 136574 47 110452674
Neuroleptic malignant syndrome 12.66 11.80 14 136564 34045 110418676
Resting tremor 12.66 11.80 13 136565 1710 110451011
Enterovesical fistula 12.60 11.80 12 136566 1441 110451280
Electrocardiogram ST segment elevation 12.59 11.80 32 136546 9128 110443593
Labelled drug-drug interaction issue 12.53 11.80 20 136558 4081 110448640
Heparin-induced thrombocytopenia test 12.51 11.80 6 136572 227 110452494
Paranoia 12.47 11.80 6 136572 22368 110430353
Pulmonary congestion 12.44 11.80 73 136505 30893 110421828
Sarcopenia 12.42 11.80 11 136567 1203 110451518
Pleuritic pain 12.40 11.80 46 136532 16094 110436627
Echolalia 12.40 11.80 8 136570 543 110452178
Arterial insufficiency 12.34 11.80 7 136571 376 110452345
Immunodeficiency 12.33 11.80 18 136560 38820 110413901
Electrocardiogram T wave biphasic 12.32 11.80 6 136572 235 110452486
Tooth infection 12.32 11.80 6 136572 22210 110430511
Akathisia 12.28 11.80 3 136575 17110 110435611
Eating disorder 12.25 11.80 12 136566 30846 110421875
Respiratory tract congestion 12.25 11.80 12 136566 30845 110421876
Intentional self-injury 12.22 11.80 17 136561 37412 110415309
Middle insomnia 12.21 11.80 5 136573 20497 110432224
Atrioventricular dissociation 12.15 11.80 7 136571 387 110452334
Blood pressure systolic increased 12.06 11.80 57 136521 82934 110369787
Scar 12.03 11.80 3 136575 16878 110435843
General physical condition abnormal 12.02 11.80 28 136550 7562 110445159
Oesophageal achalasia 11.97 11.80 10 136568 1011 110451710
Electrocardiogram U wave present 11.96 11.80 5 136573 136 110452585
Skin burning sensation 11.94 11.80 6 136572 21819 110430902
Neovascular age-related macular degeneration 11.93 11.80 8 136570 579 110452142
Clostridium test positive 11.92 11.80 35 136543 10858 110441863
Endocarditis 11.90 11.80 40 136538 13331 110439390
Product storage error 11.85 11.80 6 136572 21722 110430999
Hepatitis toxic 11.84 11.80 24 136554 5897 110446824
Dyschromatopsia 11.82 11.80 11 136567 1283 110451438

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Treatment failure 78.85 53.08 23 156 166 113608

Pharmacologic Action:

SourceCodeDescription
ATC C01BD01 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
ANTIARRHYTHMICS, CLASS I AND III
Antiarrhythmics, class III
FDA EPC N0000175426 Antiarrhythmic
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:38070 anti-arrhythmia drug
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D014665 Vasodilator Agents
MeSH PA D026902 Potassium Channel Blockers
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D065609 Cytochrome P-450 CYP1A2 Inhibitors
MeSH PA D065688 Cytochrome P-450 CYP2C9 Inhibitors
MeSH PA D065690 Cytochrome P-450 CYP2D6 Inhibitors
MeSH PA D065692 Cytochrome P-450 CYP3A Inhibitors
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000182138 Cytochrome P450 1A2 Inhibitors
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors

Related Drugs by ATC class:

C01BD Antiarrhythmics, class III 6 drugs
bretyliumbunaftinedofetilidedronedaroneibutilidetedisamil

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Ventricular fibrillation indication 71908006
Prevention of Ventricular Fibrillation indication
Life-Threatening Ventricular Tachycardia indication
Atrial fibrillation off-label use 49436004 DOID:0060224
Cardioversion of Atrial Fibrillation off-label use
Prevention of Post Cardio-Thoracic Surgery Atrial Fibrillation off-label use
Complete atrioventricular block contraindication 27885002
Torsades de pointes contraindication 31722008
Hyperthyroidism contraindication 34486009 DOID:7998
Extrinsic allergic alveolitis contraindication 37471005 DOID:841
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Refractive keratoplasty by laser surgery contraindication 58076004
Sinus node dysfunction contraindication 60423000
Interstitial pneumonia contraindication 64667001
Optic neuritis contraindication 66760008 DOID:1210
Corneal deposit contraindication 74460005 DOID:11547
Disorder of optic nerve contraindication 77157004 DOID:1891
Pulmonary hemorrhage contraindication 78144005
Cardiogenic shock contraindication 89138009
Thyrotoxicosis contraindication 90739004 DOID:7997
Prolonged QT interval contraindication 111975006
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Second degree atrioventricular block contraindication 195042002
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Pregnancy, function contraindication 289908002
Peripheral nerve disease contraindication 302226006
Eosinophilic asthma contraindication 367542003 DOID:9498
Surgical procedure contraindication 387713003
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Congenital long QT syndrome contraindication 442917000
Syncope due to Bradycardia contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.72 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Potassium voltage-gated channel subfamily H member 2 Ion channel BLOCKER IC50 5 WOMBAT-PK CHEMBL
Melanocortin receptor 4 GPCR Ki 4.88 DRUG MATRIX
Beta-1 adrenergic receptor GPCR IC50 4.70 WOMBAT-PK
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 7.10 WOMBAT-PK
Mu-type opioid receptor GPCR Ki 5.11 DRUG MATRIX
D(1A) dopamine receptor GPCR Ki 5.34 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 5.18 DRUG MATRIX
Alpha-2A adrenergic receptor GPCR IC50 6.30 WOMBAT-PK
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7 WOMBAT-PK
Thyroid hormone receptor alpha Nuclear hormone receptor IC50 5.64 WOMBAT-PK
Thyroid hormone receptor beta Nuclear hormone receptor IC50 6.22 WOMBAT-PK
Cytochrome P450 3A4 Enzyme Ki 6.22 WOMBAT-PK
3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase Enzyme Ki 7.60 WOMBAT-PK
Multidrug resistance protein 1 Transporter Ki 5.30 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 5.91 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.65 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 5.99 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 6.23 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 6.67 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 5.05 DRUG MATRIX
Alpha-2B adrenergic receptor GPCR Ki 5.23 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 6.39 DRUG MATRIX
Histamine H2 receptor GPCR Ki 4.98 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 6.20 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 5.74 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 6.17 DRUG MATRIX
Muscarinic acetylcholine receptor M4 GPCR Ki 6.30 DRUG MATRIX
Muscarinic acetylcholine receptor M5 GPCR Ki 5.97 DRUG MATRIX
Beta-3 adrenergic receptor GPCR Ki 4.50 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.70 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 5.00 DRUG MATRIX
D(4) dopamine receptor GPCR Ki 5.21 DRUG MATRIX
Kappa-type opioid receptor GPCR Ki 5.18 DRUG MATRIX
Delta-type opioid receptor GPCR Ki 5.55 DRUG MATRIX
Cytochrome P450 2C9 Enzyme EC50 7.40 WOMBAT-PK
Voltage-dependent T-type calcium channel subunit alpha-1H Ion channel Ki 5.28 WOMBAT-PK
Endothelin-1 receptor GPCR Ki 4.79 DRUG MATRIX
Squalene monooxygenase Enzyme IC50 4.92 CHEMBL
Tyrosine-protein kinase Fyn Kinase IC50 6.09 DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2 Kinase IC50 5.04 DRUG MATRIX
Squalene synthase Enzyme IC50 5.10 CHEMBL
C-C chemokine receptor type 2 GPCR Ki 5.37 DRUG MATRIX
Substance-K receptor GPCR Ki 5.19 DRUG MATRIX
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 Ion channel IC50 5.35 WOMBAT-PK
Potassium voltage-gated channel subfamily A member 7 Ion channel IC50 6 WOMBAT-PK
Melanocortin receptor 5 GPCR Ki 5.05 DRUG MATRIX
Melanocortin receptor 3 GPCR Ki 4.97 DRUG MATRIX
C-C chemokine receptor type 4 GPCR Ki 4.94 DRUG MATRIX
THAP domain-containing protein 1 Transcription factor IC50 6.19 WOMBAT-PK
NAD-dependent deacetylase sirtuin 3 Enzyme EC50 5.49 CHEMBL
Lysine-specific demethylase PHF2 Enzyme IC50 4.08 CHEMBL
Lysine-specific demethylase 5A Enzyme IC50 4 CHEMBL
B2 bradykinin receptor GPCR Ki 5.12 DRUG MATRIX
Lysine-specific demethylase 7A Enzyme IC50 4.10 CHEMBL
Androgen receptor Transcription factor Ki 4.55 DRUG MATRIX
Lethal factor Enzyme IC50 5.46 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 4.41 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor IC50 6.93 DRUG MATRIX
C-8 sterol isomerase Enzyme Ki 7.21 CHEMBL
Cruzipain Enzyme IC50 5.40 CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 5.70 IUPHAR

External reference:

IDSource
4019606 VUID
N0000147701 NUI
D00636 KEGG_DRUG
19774-82-4 SECONDARY_CAS_RN
203114 RXNORM
C0002598 UMLSCUI
CHEBI:2663 CHEBI
BBI PDB_CHEM_ID
CHEMBL633 ChEMBL_ID
CHEMBL1083993 ChEMBL_ID
D000638 MESH_DESCRIPTOR_UI
DB01118 DRUGBANK_ID
2566 IUPHAR_LIGAND_ID
2012 INN_ID
N3RQ532IUT UNII
2157 PUBCHEM_CID
13960 MMSL
4177 MMSL
d00002 MMSL
4018065 VANDF
4019606 VANDF
000629 NDDF
004484 NDDF
372821002 SNOMEDCT_US
52574003 SNOMEDCT_US
69236009 SNOMEDCT_US
N3RQ532IUT INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9875 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 26 sections
Pacerone HUMAN PRESCRIPTION DRUG LABEL 1 0245-0144 TABLET 100 mg ORAL ANDA 30 sections
Pacerone HUMAN PRESCRIPTION DRUG LABEL 1 0245-0147 TABLET 200 mg ORAL ANDA 30 sections
Pacerone HUMAN PRESCRIPTION DRUG LABEL 1 0245-1645 TABLET 400 mg ORAL ANDA 30 sections
AMIODARONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9772 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 16 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8258 TABLET 200 mg ORAL ANDA 27 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8538 TABLET 100 mg ORAL ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8607 TABLET 100 mg ORAL ANDA 27 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6993 TABLET 200 mg ORAL ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7576 TABLET 200 mg ORAL ANDA 27 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 14335-430 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 14335-431 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 14335-432 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 28 sections
Amiodarone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-796 TABLET 200 mg ORAL ANDA 25 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-359 TABLET 200 mg ORAL ANDA 19 sections
Nexterone HUMAN PRESCRIPTION DRUG LABEL 1 43066-150 INJECTION, SOLUTION 1.50 mg INTRAVENOUS NDA 25 sections
Nexterone HUMAN PRESCRIPTION DRUG LABEL 1 43066-360 INJECTION, SOLUTION 1.80 mg INTRAVENOUS NDA 25 sections
amiodarone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 48433-154 TABLET 200 mg ORAL ANDA 25 sections
Amiodarone Hydrochloride Human Prescription Drug Label 1 50090-3015 TABLET 200 mg ORAL ANDA 27 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-3496 TABLET 200 mg ORAL ANDA 27 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-5766 TABLET 200 mg ORAL ANDA 19 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50268-097 TABLET 100 mg ORAL ANDA 28 sections
AMIODARONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 51662-1205 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 18 sections
AMIODARONE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 51662-1358 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 18 sections
AMIODARONE HCI HUMAN PRESCRIPTION DRUG LABEL 1 51662-1363 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 12 sections
NEXTERONE (AMIODARONE HCI) HUMAN PRESCRIPTION DRUG LABEL 1 51662-1480 INJECTION, SOLUTION 1.50 mg INTRAVENOUS NDA 18 sections
NEXTERONE (AMIODARONE HCI) HUMAN PRESCRIPTION DRUG LABEL 1 51662-1481 INJECTION, SOLUTION 1.80 mg INTRAVENOUS NDA 18 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51672-4025 TABLET 200 mg ORAL ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51672-4055 TABLET 100 mg ORAL ANDA 28 sections
Amiodarone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51672-4056 TABLET 300 mg ORAL ANDA 28 sections