digoxin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
882 20830-75-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • digoxin
  • cardiogoxin
  • digoxine
A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
  • Molecular weight: 780.95
  • Formula: C41H64O14
  • CLOGP: 1.42
  • LIPINSKI: 3
  • HAC: 14
  • HDO: 6
  • TPSA: 203.06
  • ALOGS: -3.79
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.25 mg O
0.25 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.06 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 60 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 4.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.70 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 38 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 24, 1975 FDA EUROHLTH INTL SARL

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
Cardioactive drug level increased 1327.71 11.18 353 87731 1847 63399091
Bradycardia 1090.37 11.18 864 87220 72363 63328575
International normalised ratio increased 958.61 11.18 667 87417 45758 63355180
Atrial fibrillation 673.37 11.18 819 87265 115817 63285121
Cardiac failure congestive 650.75 11.18 719 87365 91714 63309224
Toxicity to various agents 627.36 11.18 1182 86902 246068 63154870
Drug interaction 613.33 11.18 1121 86963 228010 63172928
Cardiac failure 459.91 11.18 592 87492 88550 63312388
Drug ineffective 421.42 11.18 501 87583 1044264 62356674
Hyperkalaemia 392.19 11.18 428 87656 53775 63347163
Acute kidney injury 341.46 11.18 967 87117 262448 63138490
Ventricular tachycardia 269.91 11.18 223 87861 19756 63381182
Pulmonary hypertension 240.81 11.18 277 87807 36846 63364092
Renal failure 231.51 11.18 507 87577 117145 63283793
Synovitis 231.10 11.18 6 88078 186912 63214026
Systemic lupus erythematosus 216.79 11.18 20 88064 208898 63192040
Joint swelling 216.37 11.18 92 87992 327574 63073364
Right ventricular failure 209.85 11.18 181 87903 17007 63383931
Drug intolerance 209.72 11.18 83 88001 308578 63092360
Contraindicated product administered 207.80 11.18 28 88056 217620 63183318
Pain 202.94 11.18 456 87628 740172 62660766
Hand deformity 201.45 11.18 4 88080 159453 63241485
Bradyarrhythmia 197.39 11.18 83 88001 2032 63398906
Off label use 196.58 11.18 401 87683 674061 62726877
Dyspnoea 194.96 11.18 1573 86511 659740 62741198
Torsade de pointes 192.91 11.18 155 87929 13196 63387742
Rheumatoid arthritis 191.85 11.18 57 88027 253762 63147176
Treatment failure 191.46 11.18 25 88059 199018 63201920
Glossodynia 191.39 11.18 15 88069 178861 63222077
Infusion related reaction 191.37 11.18 52 88032 245469 63155469
Therapeutic product effect decreased 188.89 11.18 23 88061 193164 63207774
Arthropathy 186.27 11.18 48 88036 234744 63166194
Arthralgia 183.23 11.18 319 87765 569391 62831547
Pulmonary arterial hypertension 180.38 11.18 188 87896 22389 63378549
Product complaint 179.35 11.18 146 87938 12663 63388275
Melaena 177.73 11.18 215 87869 30150 63370788
Gastrointestinal haemorrhage 177.17 11.18 365 87719 80811 63320127
Rash 169.69 11.18 326 87758 560545 62840393
Hypotension 160.83 11.18 776 87308 271828 63129110
Drug hypersensitivity 159.44 11.18 119 87965 310568 63090370
Atrial tachycardia 155.99 11.18 88 87996 4152 63396786
Myocardial infarction 155.58 11.18 393 87691 99500 63301438
Wound 148.87 11.18 24 88060 163239 63237699
Subarachnoid haemorrhage 138.20 11.18 132 87952 14151 63386787
Alopecia 134.87 11.18 162 87922 337374 63063564
Hypersensitivity 134.24 11.18 125 87959 292560 63108378
Dehydration 132.94 11.18 534 87550 172820 63228118
Syncope 130.82 11.18 409 87675 116976 63283962
Atrioventricular block 130.53 11.18 98 87986 7549 63393389
Musculoskeletal stiffness 126.34 11.18 49 88035 184569 63216369
Sinus bradycardia 124.98 11.18 126 87958 14425 63386513
Product use issue 124.40 11.18 76 88008 220444 63180494
Atrioventricular block first degree 121.47 11.18 92 87992 7181 63393757
Cardioactive drug level above therapeutic 119.54 11.18 30 88054 119 63400819
Sinusitis 118.56 11.18 85 87999 226568 63174370
Hepatic enzyme increased 116.55 11.18 68 88016 202260 63198678
Upper gastrointestinal haemorrhage 116.09 11.18 137 87947 18715 63382223
Discomfort 113.57 11.18 45 88039 167329 63233609
Cardiospasm 111.53 11.18 54 88030 1853 63399085
Swelling 111.20 11.18 131 87953 275247 63125691
Palmoplantar keratoderma 108.91 11.18 54 88030 1953 63398985
Arrhythmia 108.48 11.18 192 87892 37948 63362990
Cardiac arrest 107.31 11.18 327 87757 92218 63308720
Atrioventricular block complete 107.07 11.18 90 87994 8161 63392777
Hypervolaemia 106.46 11.18 162 87922 28251 63372687
Helicobacter infection 104.42 11.18 6 88078 92779 63308159
Duodenal ulcer perforation 103.43 11.18 4 88080 87205 63313733
Subdural haematoma 103.29 11.18 113 87971 14215 63386723
Stomatitis 103.20 11.18 32 88052 138693 63262245
Rheumatoid factor positive 103.19 11.18 3 88081 84403 63316535
Nasopharyngitis 101.52 11.18 122 87962 254135 63146803
Pruritus genital 100.12 11.18 56 88028 2598 63398340
Anaemia 98.77 11.18 721 87363 292709 63108229
Nodal rhythm 97.86 11.18 48 88036 1695 63399243
Oedema peripheral 96.55 11.18 518 87566 188993 63211945
Cerebrovascular accident 96.11 11.18 349 87735 107675 63293263
Sleep terror 94.22 11.18 54 88030 2626 63398312
Psoriatic arthropathy 89.14 11.18 11 88073 91509 63309429
Fibromyalgia 88.10 11.18 6 88078 80414 63320524
Cerebral haemorrhage 86.49 11.18 154 87930 30575 63370363
International normalised ratio abnormal 86.26 11.18 55 88029 3249 63397689
Hypoxia 85.59 11.18 228 87856 59564 63341374
Therapeutic product effect incomplete 84.20 11.18 34 88050 125022 63275916
Lower gastrointestinal haemorrhage 84.18 11.18 77 88007 7813 63393125
Cardioactive drug level decreased 83.99 11.18 20 88064 60 63400878
Asthenia 82.18 11.18 853 87231 382751 63018187
Drug level increased 81.48 11.18 127 87957 22609 63378329
Ventricular fibrillation 81.08 11.18 91 87993 11776 63389162
Nodal arrhythmia 80.52 11.18 37 88047 1126 63399812
Presyncope 80.46 11.18 141 87943 27644 63373294
International normalised ratio decreased 79.76 11.18 59 88025 4442 63396496
Rectal haemorrhage 79.54 11.18 196 87888 48834 63352104
Injection site pain 78.52 11.18 41 88043 129759 63271179
Electrocardiogram ST segment depression 77.88 11.18 49 88035 2828 63398110
Carotid artery occlusion 77.55 11.18 59 88025 4635 63396303
Transient ischaemic attack 75.64 11.18 164 87920 37589 63363349
Orthopnoea 74.53 11.18 65 88019 6196 63394742
Palpitations 74.42 11.18 332 87752 112438 63288500
Irritable bowel syndrome 73.13 11.18 13 88071 82399 63318539
Cardiomegaly 72.55 11.18 105 87979 17509 63383429
Fluid retention 72.09 11.18 214 87870 59472 63341466
Sinus node dysfunction 71.11 11.18 56 88028 4629 63396309
Dizziness 71.00 11.18 909 87175 429016 62971922
Ischaemic stroke 71.00 11.18 105 87979 17852 63383086
Atrioventricular block second degree 70.92 11.18 52 88032 3862 63397076
Hyponatraemia 70.52 11.18 325 87759 111575 63289363
Haemorrhage intracranial 70.46 11.18 90 87994 13329 63387609
Immunisation 70.43 11.18 34 88050 1159 63399779
Overdose 70.15 11.18 331 87753 114747 63286191
Death 69.36 11.18 809 87275 373572 63027366
Infection 69.23 11.18 133 87951 229040 63171898
Atrial flutter 68.59 11.18 76 88008 9696 63391242
Tension headache 68.18 11.18 57 88027 5129 63395809
Maternal exposure during pregnancy 67.98 11.18 126 87958 219936 63181002
Paraesthesia 67.32 11.18 71 88013 156895 63244043
Impaired healing 67.22 11.18 29 88055 102513 63298425
Tachyarrhythmia 67.13 11.18 53 88031 4397 63396541
Blood creatinine increased 66.77 11.18 270 87814 87574 63313364
Prothrombin time prolonged 66.47 11.18 74 88010 9490 63391448
Abdominal discomfort 66.25 11.18 226 87858 320659 63080279
Haematoma 64.95 11.18 147 87937 34673 63366265
Hypoglycaemia 64.76 11.18 207 87877 59858 63341080
Pleural effusion 64.21 11.18 278 87806 92932 63308006
Injection site erythema 62.17 11.18 19 88065 83155 63317783
Mobility decreased 61.28 11.18 47 88037 121112 63279826
Blood urea increased 60.33 11.18 121 87963 26258 63374680
Electrocardiogram QT prolonged 59.55 11.18 200 87884 59330 63341608
Chest pain 59.55 11.18 507 87577 215452 63185486
Pruritus 58.58 11.18 280 87804 361173 63039765
Abdominal wall haematoma 58.57 11.18 42 88042 3013 63397925
Febrile neutropenia 57.34 11.18 48 88036 118401 63282537
Tricuspid valve incompetence 57.09 11.18 85 87999 14536 63386402
Blood cholesterol increased 56.42 11.18 30 88054 94002 63306936
Anosmia 56.36 11.18 58 88026 6802 63394136
Psoriasis 56.35 11.18 25 88059 86932 63314006
Activated partial thromboplastin time prolonged 56.12 11.18 58 88026 6835 63394103
Ventricular extrasystoles 56.10 11.18 75 88009 11612 63389326
Blister 55.34 11.18 59 88025 129755 63271183
Injection site reaction 54.69 11.18 8 88076 58516 63342422
Hallucination 54.69 11.18 184 87900 54633 63346305
Gastrointestinal disorder 54.46 11.18 61 88023 131178 63269760
Ventricular arrhythmia 54.35 11.18 44 88040 3784 63397154
Renal injury 53.86 11.18 66 88018 9373 63391565
Arthritis 52.48 11.18 50 88034 115871 63285067
Mitral valve incompetence 52.34 11.18 96 87988 19498 63381440
Confusional state 52.11 11.18 529 87555 235851 63165087
Dyspnoea exertional 52.06 11.18 193 87891 60109 63340829
Blood potassium increased 51.83 11.18 92 87992 18217 63382721
Epistaxis 51.69 11.18 219 87865 72506 63328432
Supraventricular tachycardia 51.53 11.18 80 88004 14191 63386747
Urticaria 51.12 11.18 95 87989 165707 63235231
Asthma 51.08 11.18 61 88023 127500 63273438
Product use in unapproved indication 50.59 11.18 108 87976 178972 63221966
Pericarditis 50.51 11.18 65 88019 131514 63269424
Respiratory failure 50.17 11.18 276 87808 101582 63299356
Hypoaesthesia 49.73 11.18 99 87985 168294 63232644
Facial pain 49.52 11.18 67 88017 10494 63390444
Ejection fraction decreased 49.36 11.18 101 87983 22231 63378707
Drug abuse 48.34 11.18 20 88064 72498 63328440
Cardiogenic shock 48.07 11.18 88 87996 17844 63383094
Decreased appetite 47.98 11.18 546 87538 250506 63150432
Drug therapeutic incompatibility 47.15 11.18 12 88072 51 63400887
Knee arthroplasty 47.12 11.18 9 88075 54197 63346741
Cardiac failure chronic 46.91 11.18 43 88041 4375 63396563
Multiple organ dysfunction syndrome 46.80 11.18 179 87905 56573 63344365
Alveolitis 46.75 11.18 36 88048 2879 63398059
Bundle branch block right 46.10 11.18 45 88039 4953 63395985
Electrocardiogram ST segment abnormal 45.96 11.18 24 88060 969 63399969
Coagulopathy 45.51 11.18 93 87991 20451 63380487
Injection site pruritus 44.98 11.18 5 88079 45111 63355827
Pulmonary oedema 43.56 11.18 171 87913 54702 63346236
Sleep disorder 43.37 11.18 30 88054 81536 63319402
Completed suicide 42.70 11.18 86 87998 145587 63255351
Embolic stroke 42.54 11.18 38 88046 3738 63397200
Loss of consciousness 42.39 11.18 295 87789 117826 63283112
Ill-defined disorder 42.25 11.18 31 88053 81724 63319214
Multiple sclerosis relapse 42.25 11.18 8 88076 48470 63352468
Metabolic acidosis 42.09 11.18 148 87936 44921 63356017
Suicidal ideation 41.95 11.18 17 88067 62404 63338534
Fall 41.69 11.18 770 87314 391564 63009374
Renal impairment 41.25 11.18 236 87848 88119 63312819
Hip arthroplasty 41.23 11.18 8 88076 47638 63353300
Neutropenia 41.21 11.18 116 87968 174889 63226049
Cardiomyopathy 40.62 11.18 81 88003 17503 63383435
Pain of skin 40.32 11.18 64 88020 11570 63389368
Fatigue 40.16 11.18 933 87151 887095 62513843
Heart rate irregular 39.98 11.18 93 87991 22328 63378610
Electrocardiogram abnormal 39.68 11.18 56 88028 9123 63391815
Cardiac failure acute 39.55 11.18 57 88027 9466 63391472
Brain natriuretic peptide increased 39.12 11.18 42 88042 5171 63395767
Electrocardiogram QT shortened 38.28 11.18 12 88072 121 63400817
Heart rate decreased 37.81 11.18 144 87940 45416 63355522
Prothrombin time shortened 37.27 11.18 27 88057 1968 63398970
Injection site swelling 37.15 11.18 10 88074 47562 63353376
Neuropathy peripheral 36.95 11.18 63 88021 113604 63287334
Vomiting 36.76 11.18 1026 87058 558591 62842347
Shock haemorrhagic 36.47 11.18 56 88028 9839 63391099
Loss of personal independence in daily activities 36.37 11.18 49 88035 97241 63303697
Transfusion 36.24 11.18 71 88013 15146 63385792
Atrioventricular dissociation 35.74 11.18 13 88071 213 63400725
Disorientation 35.51 11.18 128 87956 39324 63361614
White blood cell count decreased 35.17 11.18 89 87995 139015 63261923
Hypertension 35.10 11.18 235 87849 279068 63121870
Electrocardiogram PR prolongation 34.95 11.18 18 88066 706 63400232
Cardioactive drug level below therapeutic 34.75 11.18 7 88077 6 63400932
Type 2 diabetes mellitus 34.61 11.18 23 88061 63845 63337093
Hyperthyroidism 34.38 11.18 68 88016 14605 63386333
Coronary artery disease 34.36 11.18 111 87973 32266 63368672
Pulmonary arterial pressure increased 34.35 11.18 33 88051 3562 63397376
Cor pulmonale 34.34 11.18 26 88058 2028 63398910
Hypocoagulable state 33.79 11.18 21 88063 1186 63399752
Bundle branch block left 33.42 11.18 45 88039 7014 63393924
Urine output decreased 33.30 11.18 58 88026 11312 63389626
Myocardial ischaemia 33.08 11.18 62 88022 12797 63388141
Xanthopsia 33.08 11.18 12 88072 195 63400743
Heart rate increased 33.01 11.18 234 87850 94004 63306934
Left ventricular failure 32.83 11.18 40 88044 5647 63395291
Calcium deficiency 32.76 11.18 20 88064 1094 63399844
Coagulation time prolonged 32.67 11.18 22 88062 1426 63399512
Extrasystoles 32.60 11.18 38 88046 5122 63395816
Diplopia 32.45 11.18 89 87995 23639 63377299
Intentional product use issue 32.19 11.18 82 88002 127810 63273128
Leukopenia 31.97 11.18 36 88048 77254 63323684
Blood glucose increased 31.72 11.18 212 87872 83544 63317394
Toxic epidermal necrolysis 31.69 11.18 92 87992 25242 63375696
Product dose omission issue 31.55 11.18 193 87891 234120 63166818
Cardiac disorder 31.55 11.18 147 87937 50669 63350269
Weight increased 31.49 11.18 222 87862 260570 63140368
Haemoglobin decreased 31.26 11.18 324 87760 145161 63255777
Haematemesis 31.14 11.18 103 87981 30309 63370629
Musculoskeletal pain 30.12 11.18 51 88033 92226 63308712
Pulse absent 29.73 11.18 37 88047 5337 63395601
Red blood cell sedimentation rate increased 29.52 11.18 12 88072 43970 63356968
Lower respiratory tract infection 29.47 11.18 90 87994 132217 63268721
Erythrodermic psoriasis 29.23 11.18 18 88066 1000 63399938
Lethargy 29.08 11.18 154 87930 55853 63345085
Illness 28.91 11.18 16 88068 49043 63351895
Joint stiffness 28.80 11.18 11 88073 41858 63359080
Acute respiratory failure 28.62 11.18 109 87975 34376 63366562
Unevaluable event 28.56 11.18 144 87940 51242 63349696
Haemorrhage 28.48 11.18 163 87921 60859 63340079
Oropharyngeal pain 28.35 11.18 55 88029 94432 63306506
Osteoarthritis 28.18 11.18 56 88028 95287 63305651
Ischaemic cardiomyopathy 28.05 11.18 25 88059 2452 63398486
Osteoporosis 28.03 11.18 23 88061 57315 63343623
Anuria 28.01 11.18 57 88027 12494 63388444
C-reactive protein increased 27.67 11.18 56 88028 94651 63306287
Accidental overdose 27.59 11.18 83 88001 23226 63377712
Potentiating drug interaction 27.38 11.18 32 88052 4324 63396614
Blindness 27.33 11.18 79 88005 21620 63379318
Therapeutic response decreased 27.30 11.18 27 88057 61498 63339440
Cerebral infarction 27.27 11.18 84 88000 23809 63377129
Sopor 27.26 11.18 80 88004 22084 63378854
Cardiac pacemaker insertion 27.10 11.18 31 88053 4095 63396843
Chromatopsia 27.07 11.18 13 88071 438 63400500
Dyschromatopsia 27.01 11.18 13 88071 440 63400498
Oxygen consumption increased 26.90 11.18 30 88054 3854 63397084
Hypovolaemia 26.89 11.18 51 88033 10622 63390316
Electrocardiogram QRS complex prolonged 26.82 11.18 37 88047 5901 63395037
Blood pressure decreased 26.71 11.18 168 87916 64854 63336084
Inappropriate schedule of product administration 26.67 11.18 66 88018 103899 63297039
Fear 26.59 11.18 64 88020 15702 63385236
Haematuria 26.58 11.18 95 87989 29062 63371876
Hypomagnesaemia 26.51 11.18 94 87990 28643 63372295
Depression 26.37 11.18 162 87922 196330 63204608
Tachycardia 26.27 11.18 265 87819 117891 63283047
Oedema 26.24 11.18 228 87856 97394 63303544
Muscle twitching 26.13 11.18 73 88011 19595 63381343
Obesity 25.98 11.18 5 88079 29947 63370991
Neutrophil count decreased 25.91 11.18 24 88060 56382 63344556
Muscle spasms 25.80 11.18 120 87964 156030 63244908
C-reactive protein abnormal 25.80 11.18 16 88068 46080 63354858
Foot deformity 25.58 11.18 4 88080 27849 63373089
Intentional self-injury 25.22 11.18 3 88081 25684 63375254
Left ventricular dysfunction 25.07 11.18 53 88031 11935 63389003
Lung transplant 24.89 11.18 26 88058 3102 63397836
Oliguria 24.82 11.18 45 88039 9056 63391882
Stupor 24.56 11.18 30 88054 4245 63396693
Mitral valve stenosis 24.46 11.18 17 88067 1160 63399778
Dilatation atrial 24.36 11.18 21 88063 1970 63398968
Catheter management 24.08 11.18 25 88059 2962 63397976
Lactic acidosis 23.95 11.18 111 87973 38176 63362762
Herpes zoster 23.88 11.18 49 88035 82413 63318525
Device related infection 23.75 11.18 79 88005 23313 63377625
Vasculitis 23.62 11.18 67 88017 18142 63382796
Retroperitoneal haemorrhage 23.61 11.18 24 88060 2773 63398165
Left atrial dilatation 23.53 11.18 20 88064 1841 63399097
Headache 23.30 11.18 685 87399 632556 62768382
Pain in extremity 23.23 11.18 322 87762 331164 63069774
Drug monitoring procedure not performed 23.20 11.18 13 88071 605 63400333
Superinfection 23.17 11.18 23 88061 2584 63398354
Occult blood positive 23.14 11.18 27 88057 3643 63397295
Visual impairment 23.09 11.18 198 87886 84248 63316690
Supraventricular extrasystoles 22.87 11.18 30 88054 4559 63396379
Hypochromic anaemia 22.79 11.18 20 88064 1922 63399016
Wheezing 22.76 11.18 63 88021 95532 63305406
Chronic obstructive pulmonary disease 22.74 11.18 157 87927 62529 63338409
Dilatation ventricular 22.53 11.18 22 88062 2423 63398515
Pulmonary congestion 22.51 11.18 64 88020 17354 63383584
Haemoptysis 22.37 11.18 89 87995 28637 63372301
Psychotic symptom 22.28 11.18 18 88066 1543 63399395
Drug level above therapeutic 21.79 11.18 30 88054 4775 63396163
Splenic injury 21.76 11.18 9 88075 211 63400727
Hypokalaemia 21.73 11.18 230 87854 103574 63297364
Anticoagulation drug level above therapeutic 21.45 11.18 17 88067 1418 63399520
Central nervous system injury 21.35 11.18 8 88076 143 63400795
Ventricular hypertrophy 21.20 11.18 25 88059 3411 63397527
Malignant neoplasm progression 21.17 11.18 52 88032 82069 63318869
Congestive hepatopathy 20.85 11.18 23 88061 2919 63398019
Hypochromasia 20.68 11.18 10 88074 342 63400596
Blood bilirubin increased 20.58 11.18 104 87980 37036 63363902
Electrocardiogram repolarisation abnormality 20.55 11.18 16 88068 1301 63399637
Kussmaul respiration 20.52 11.18 9 88075 245 63400693
Sciatica 20.51 11.18 11 88073 34313 63366625
Pyroglutamic acidosis 20.22 11.18 12 88072 623 63400315
Ventricular dysfunction 19.85 11.18 22 88062 2806 63398132
Eye pruritus 19.80 11.18 64 88020 18607 63382331
Transplant evaluation 19.67 11.18 15 88069 1182 63399756
Choroidal haemorrhage 19.65 11.18 6 88078 55 63400883
Respiratory distress 19.47 11.18 96 87988 33855 63367083
Colitis ulcerative 19.42 11.18 6 88078 26085 63374853
Dialysis 19.42 11.18 44 88040 10383 63390555
Aortic valve calcification 19.32 11.18 11 88073 528 63400410
Acute myocardial infarction 19.26 11.18 92 87992 32032 63368906
Haemodialysis 19.22 11.18 40 88044 8907 63392031
Angioedema 19.12 11.18 123 87961 47842 63353096
Ear infection 19.09 11.18 15 88069 38198 63362740
Conduction disorder 19.03 11.18 16 88068 1451 63399487
Iron deficiency anaemia 19.00 11.18 66 88018 19903 63381035
Blood alkaline phosphatase increased 18.90 11.18 113 87971 42854 63358084
Cyanosis 18.83 11.18 59 88025 16876 63384062
Subcutaneous haematoma 18.78 11.18 17 88067 1701 63399237
Blood pressure fluctuation 18.69 11.18 22 88062 46295 63354643
Ecchymosis 18.67 11.18 45 88039 11049 63389889
Anaphylactic reaction 18.53 11.18 40 88044 66060 63334878
Joint range of motion decreased 18.50 11.18 11 88073 32417 63368521
Ascites 18.48 11.18 108 87976 40620 63360318
Cardiac murmur 18.35 11.18 53 88031 14499 63386439
Faeces discoloured 18.34 11.18 62 88022 18447 63382491
Pain in jaw 18.25 11.18 113 87971 43383 63357555
Brain stem haemorrhage 18.15 11.18 12 88072 754 63400184
Blood loss anaemia 17.91 11.18 39 88045 8962 63391976
Peripheral swelling 17.68 11.18 261 87823 265681 63135257
Hypoglycaemic seizure 17.53 11.18 10 88074 482 63400456
Dermatitis exfoliative 17.51 11.18 29 88055 5430 63395508
Pyrexia 17.25 11.18 509 87575 469969 62930969
Medication error 17.25 11.18 128 87956 52156 63348782
Rheumatic heart disease 17.06 11.18 4 88080 11 63400927
Prerenal failure 17.02 11.18 16 88068 1680 63399258
Mitral valve disease 16.91 11.18 19 88065 2461 63398477
Inflammation 16.90 11.18 58 88026 82215 63318723
Anhedonia 16.87 11.18 43 88041 10931 63390007
Electrocardiogram R on T phenomenon 16.80 11.18 4 88080 12 63400926
Cardiopulmonary bypass 16.75 11.18 3 88081 0 63400938
Myelosuppression 16.68 11.18 6 88078 23697 63377241
Cardio-respiratory arrest 16.61 11.18 141 87943 59818 63341120
Right ventricular systolic pressure increased 16.54 11.18 10 88074 537 63400401
Pregnancy 16.53 11.18 16 88068 36820 63364118
Coronary arterial stent insertion 16.49 11.18 20 88064 2809 63398129
Hyponatraemic syndrome 16.41 11.18 10 88074 545 63400393
Blood culture positive 16.34 11.18 26 88058 4709 63396229
Lymphocyte count decreased 16.25 11.18 11 88073 30246 63370692
Hypersensitivity vasculitis 16.19 11.18 24 88060 4088 63396850
Walking distance test abnormal 16.10 11.18 10 88074 564 63400374
Leukocytosis 16.08 11.18 75 88009 25860 63375078
Mental status changes 16.06 11.18 102 87982 39497 63361441
Neuralgia 15.95 11.18 8 88076 25918 63375020
Liver function test abnormal 15.92 11.18 118 87966 48063 63352875
Drug dependence 15.92 11.18 7 88077 24476 63376462
Abdominal tenderness 15.81 11.18 35 88049 8131 63392807
Exposure during pregnancy 15.69 11.18 139 87945 155408 63245530
Chorea 15.69 11.18 15 88069 1609 63399329
Concomitant disease progression 15.67 11.18 17 88067 2117 63398821
Cholecystitis 15.67 11.18 52 88032 15325 63385613
Adams-Stokes syndrome 15.64 11.18 5 88079 54 63400884
Contusion 15.62 11.18 133 87951 149911 63251027
Aortic valve incompetence 15.56 11.18 29 88055 5959 63394979
Blood pressure increased 15.41 11.18 147 87937 161915 63239023
Head injury 15.38 11.18 77 88007 27319 63373619
Aspartate aminotransferase increased 15.30 11.18 192 87892 90085 63310853
Constipation 15.21 11.18 220 87864 224723 63176215
Neoplasm progression 15.02 11.18 17 88067 36411 63364527
Basal ganglia haemorrhage 14.91 11.18 10 88074 644 63400294
Dyspepsia 14.90 11.18 82 88002 102114 63298824
Cardioversion 14.83 11.18 13 88071 1247 63399691
Tremor 14.78 11.18 115 87969 132124 63268814
Exercise tolerance decreased 14.76 11.18 27 88057 5470 63395468
Circulatory collapse 14.76 11.18 65 88019 21873 63379065
Dry eye 14.76 11.18 21 88063 40740 63360198
Hypoglycaemic coma 14.68 11.18 18 88066 2557 63398381
Azotaemia 14.68 11.18 24 88060 4447 63396491
Electrocardiogram change 14.63 11.18 10 88074 664 63400274
Cellulitis 14.62 11.18 176 87908 81782 63319156
Suicide attempt 14.61 11.18 40 88044 60878 63340060
Joint dislocation 14.59 11.18 4 88080 18796 63382142
Haematocrit decreased 14.54 11.18 99 87985 39241 63361697
Immunodeficiency 14.47 11.18 5 88079 20249 63380689
Cardiorenal syndrome 14.46 11.18 11 88073 864 63400074
Angina unstable 14.41 11.18 31 88053 7064 63393874
Fungal infection 14.36 11.18 18 88066 36856 63364082
Pneumocystis jirovecii pneumonia 14.30 11.18 3 88081 16911 63384027
Atrial thrombosis 14.27 11.18 15 88069 1803 63399135
Right ventricular hypertrophy 14.25 11.18 10 88074 693 63400245
Cardiac valve disease 14.20 11.18 23 88061 4229 63396709
Depressed level of consciousness 14.16 11.18 140 87944 61938 63339000
Lower limb fracture 14.13 11.18 8 88076 24213 63376725
Catheter site erythema 14.10 11.18 23 88061 4253 63396685
Disability 14.06 11.18 4 88080 18343 63382595
Rhythm idioventricular 13.97 11.18 7 88077 259 63400679
Aortic stenosis 13.92 11.18 25 88059 4995 63395943
Chills 13.92 11.18 96 87988 113282 63287656
Mouth swelling 13.65 11.18 24 88060 4716 63396222
Cytomegalovirus infection 13.60 11.18 6 88078 20946 63379992
Dizziness postural 13.59 11.18 31 88053 7345 63393593
Liver injury 13.59 11.18 41 88043 60479 63340459
Venous pressure jugular increased 13.58 11.18 9 88075 568 63400370
Grip strength decreased 13.53 11.18 7 88077 22280 63378658
Paracentesis 13.46 11.18 11 88073 959 63399979
Paralysis 13.40 11.18 37 88047 9863 63391075
No adverse event 13.40 11.18 23 88061 41382 63359556
Catheter site rash 13.40 11.18 10 88074 763 63400175
Respiratory acidosis 13.25 11.18 29 88055 6686 63394252
Haemarthrosis 13.24 11.18 19 88065 3142 63397796
Lip swelling 13.22 11.18 81 88003 30982 63369956
Blood pressure immeasurable 13.10 11.18 12 88072 1220 63399718
Sepsis 13.04 11.18 291 87793 152832 63248106
Irritability 12.84 11.18 15 88069 31679 63369259
Intentional overdose 12.83 11.18 56 88028 74096 63326842
Multi-organ disorder 12.81 11.18 13 88071 1499 63399439
Oxygen saturation decreased 12.78 11.18 183 87901 88402 63312536
Hemiparesis 12.76 11.18 65 88019 23217 63377721
Therapy non-responder 12.73 11.18 58 88026 75843 63325095
Insomnia 12.70 11.18 216 87868 215036 63185902
Injection site mass 12.67 11.18 5 88079 18651 63382287
Protein total 12.62 11.18 4 88080 42 63400896
Bursitis 12.52 11.18 20 88064 37021 63363917
Ventricular asystole 12.51 11.18 5 88079 107 63400831
Rash papular 12.51 11.18 49 88035 15653 63385285
Blood creatinine 12.47 11.18 5 88079 108 63400830
Heart sounds abnormal 12.44 11.18 9 88075 655 63400283
Catheter site pruritus 12.38 11.18 15 88069 2105 63398833
Intervertebral disc protrusion 12.23 11.18 9 88075 23700 63377238
Coma scale abnormal 12.22 11.18 24 88060 5129 63395809
Orthostatic hypotension 12.20 11.18 89 87995 36071 63364867
Sedation 12.16 11.18 22 88062 38787 63362151
Panic attack 12.15 11.18 8 88076 22323 63378615
N-terminal prohormone brain natriuretic peptide increased 12.15 11.18 15 88069 2146 63398792
Leg amputation 12.13 11.18 15 88069 2149 63398789
Spontaneous haematoma 12.12 11.18 10 88074 883 63400055
Blood sodium decreased 12.12 11.18 66 88018 24186 63376752
Pulseless electrical activity 12.12 11.18 30 88054 7491 63393447
Rales 12.11 11.18 42 88042 12655 63388283
Duodenal ulcer haemorrhage 12.10 11.18 16 88068 2451 63398487
Microcytic anaemia 12.07 11.18 19 88065 3410 63397528
Delirium 12.03 11.18 115 87969 50426 63350512
Eosinophilic granulomatosis with polyangiitis 11.98 11.18 15 88069 2177 63398761
Acne 11.81 11.18 9 88075 23284 63377654
Anisocytosis 11.81 11.18 9 88075 709 63400229
Catheter site infection 11.79 11.18 23 88061 4891 63396047
Night sweats 11.74 11.18 32 88052 48782 63352156
Muscle haemorrhage 11.73 11.18 18 88066 3161 63397777
Body temperature increased 11.73 11.18 21 88063 37171 63363767
Adverse event 11.70 11.18 51 88033 67508 63333430
Chronic kidney disease 11.66 11.18 105 87979 45293 63355645
Diabetic ketoacidosis 11.64 11.18 7 88077 20498 63380440
Staphylococcal sepsis 11.63 11.18 31 88053 8097 63392841
Tinnitus 11.62 11.18 87 87997 35541 63365397
Basal cell carcinoma 11.61 11.18 13 88071 27978 63372960
Muscle spasticity 11.60 11.18 8 88076 21786 63379152
Bone pain 11.57 11.18 38 88046 54603 63346335
Flat anterior chamber of eye 11.57 11.18 4 88080 56 63400882
Ventricular failure 11.56 11.18 7 88077 377 63400561
Acute pulmonary oedema 11.56 11.18 31 88053 8127 63392811
Palmar-plantar erythrodysaesthesia syndrome 11.54 11.18 9 88075 23006 63377932
Wrong technique in product usage process 11.46 11.18 46 88038 62294 63338644
Congestive cardiomyopathy 11.41 11.18 26 88058 6156 63394782
Delusion of replacement 11.39 11.18 3 88081 15 63400923
Cardiac output decreased 11.39 11.18 10 88074 962 63399976
Cerebellar haematoma 11.38 11.18 7 88077 388 63400550
Serratia infection 11.38 11.18 10 88074 963 63399975
Procedural pain 11.37 11.18 8 88076 21561 63379377
Pneumonia 11.37 11.18 757 87327 456010 62944928
Pericardial effusion 11.32 11.18 76 88008 29982 63370956
Hyperchloraemia 11.32 11.18 9 88075 754 63400184
Injection site rash 11.28 11.18 6 88078 18803 63382135
Unresponsive to stimuli 11.27 11.18 83 88001 33733 63367205
Pharyngitis 11.26 11.18 7 88077 20136 63380802
Sudden death 11.25 11.18 36 88048 10413 63390525

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
Cardioactive drug level increased 828.52 11.14 256 76348 1461 34878866
Bradycardia 637.48 11.14 805 75799 74613 34805714
Cardiac failure congestive 609.47 11.14 828 75776 82442 34797885
International normalised ratio increased 578.00 11.14 611 75993 46716 34833611
Atrial fibrillation 409.04 11.14 857 75747 121536 34758791
Ventricular tachycardia 352.74 11.14 359 76245 26220 34854107
Off label use 245.36 11.14 338 76266 419186 34461141
Cardiac failure 219.58 11.14 562 76042 90686 34789641
Hyperkalaemia 203.00 11.14 461 76143 68928 34811399
Drug ineffective 190.77 11.14 453 76151 456298 34424029
Product complaint 160.55 11.14 120 76484 5770 34874557
Toxicity to various agents 157.04 11.14 858 75746 199504 34680823
Atrial tachycardia 153.23 11.14 97 76507 3548 34876779
Drug abuse 152.13 11.14 19 76585 99077 34781250
Myocardial infarction 144.30 11.14 586 76018 120499 34759828
Gastrointestinal haemorrhage 132.64 11.14 461 76143 88016 34792311
Cardiospasm 131.72 11.14 66 76538 1522 34878805
Palmoplantar keratoderma 116.14 11.14 65 76539 1888 34878439
Venous pressure jugular increased 115.90 11.14 49 76555 752 34879575
Drug interaction 110.26 11.14 859 75745 225087 34655240
Pruritus genital 108.83 11.14 65 76539 2139 34878188
Sleep terror 105.80 11.14 65 76539 2253 34878074
Dyspnoea 105.12 11.14 1273 75331 375509 34504818
Hypotension 104.47 11.14 836 75768 220813 34659514
Melaena 96.70 11.14 229 76375 35151 34845176
Cardiac arrest 95.01 11.14 440 76164 95719 34784608
Carotid artery occlusion 92.73 11.14 72 76532 3665 34876662
Acute kidney injury 92.72 11.14 1048 75556 303940 34576387
Febrile neutropenia 92.55 11.14 98 76506 136751 34743576
Tension headache 92.00 11.14 66 76538 2976 34877351
Immunisation 90.03 11.14 45 76559 1032 34879295
Neutropenia 89.49 11.14 128 76476 156650 34723677
Product use in unapproved indication 88.96 11.14 76 76528 117423 34762904
Cardiac murmur 86.43 11.14 96 76508 7741 34872586
Cardioactive drug level above therapeutic 83.37 11.14 21 76583 46 34880281
Facial pain 82.56 11.14 67 76537 3637 34876690
Dizziness 82.48 11.14 785 75819 217736 34662591
Atrial flutter 82.10 11.14 133 76471 15441 34864886
Right ventricular failure 80.79 11.14 98 76506 8686 34871641
Anosmia 79.75 11.14 68 76536 3956 34876371
Product dose omission issue 79.51 11.14 87 76517 119624 34760703
Ischaemic cardiomyopathy 75.21 11.14 81 76523 6308 34874019
Subarachnoid haemorrhage 75.07 11.14 114 76490 12521 34867806
Nodal rhythm 72.40 11.14 43 76561 1400 34878927
Transient ischaemic attack 71.44 11.14 175 76429 27438 34852889
Ventricular extrasystoles 70.86 11.14 108 76496 11900 34868427
Arrhythmia 70.44 11.14 205 76399 35603 34844724
Palpitations 63.92 11.14 213 76391 39773 34840554
Pulmonary hypertension 61.07 11.14 139 76465 20785 34859542
Cardioactive drug level decreased 60.94 11.14 17 76587 63 34880264
Bradyarrhythmia 60.51 11.14 45 76559 2146 34878181
Prothrombin time prolonged 57.49 11.14 86 76518 9320 34871007
Pain of skin 55.92 11.14 68 76536 6041 34874286
Pulmonary arterial hypertension 54.99 11.14 81 76523 8658 34871669
Rash 53.36 11.14 279 76325 222473 34657854
Congestive cardiomyopathy 52.23 11.14 73 76531 7437 34872890
Muscle twitching 51.65 11.14 86 76518 10212 34870115
Ventricular fibrillation 51.63 11.14 138 76466 22816 34857511
Drug hypersensitivity 50.76 11.14 61 76543 80468 34799859
Mitral valve incompetence 50.12 11.14 105 76499 14838 34865489
Torsade de pointes 50.02 11.14 70 76534 7139 34873188
Xanthopsia 49.86 11.14 17 76587 138 34880189
Coronary artery disease 49.85 11.14 224 76380 48081 34832246
Atrioventricular block 49.68 11.14 74 76530 7989 34872338
Renal failure 49.63 11.14 470 76134 130087 34750240
Tricuspid valve incompetence 49.61 11.14 82 76522 9678 34870649
International normalised ratio decreased 48.74 11.14 55 76549 4512 34875815
Cardiomegaly 46.66 11.14 104 76500 15334 34864993
Cerebrovascular accident 46.03 11.14 331 76273 84480 34795847
Atrioventricular block complete 45.64 11.14 77 76527 9242 34871085
Left ventricular dysfunction 45.49 11.14 80 76524 9927 34870400
Eye pruritus 45.09 11.14 68 76536 7421 34872906
Cardiomyopathy 45.05 11.14 108 76496 16700 34863627
Confusional state 43.88 11.14 496 76108 143664 34736663
Heart rate irregular 42.83 11.14 102 76502 15705 34864622
Neuropathy peripheral 42.67 11.14 73 76531 83190 34797137
Left ventricular failure 41.88 11.14 54 76550 5090 34875237
Blood urea increased 41.82 11.14 154 76450 30210 34850117
Subdural haematoma 41.20 11.14 118 76486 20303 34860024
Injection site pain 41.05 11.14 17 76587 38988 34841339
Product use issue 40.78 11.14 47 76557 63169 34817158
Heart rate increased 40.62 11.14 205 76399 46138 34834189
Conduction disorder 40.47 11.14 35 76569 2075 34878252
Pericarditis 40.43 11.14 83 76521 11562 34868765
Syncope 40.26 11.14 340 76264 91111 34789216
Sinus node dysfunction 40.04 11.14 48 76556 4201 34876126
Cardiac failure chronic 39.78 11.14 66 76538 7813 34872514
Therapeutic product effect incomplete 39.07 11.14 32 76572 50509 34829818
Asthenia 39.04 11.14 754 75850 244497 34635830
Mucosal inflammation 38.80 11.14 18 76586 38604 34841723
Vasculitis 38.62 11.14 80 76524 11216 34869111
Leukopenia 38.15 11.14 49 76555 62807 34817520
Nasopharyngitis 38.04 11.14 59 76545 69909 34810418
Atrioventricular block first degree 37.66 11.14 56 76548 6036 34874291
Blood creatinine increased 37.61 11.14 345 76259 94631 34785696
Blood potassium increased 36.92 11.14 99 76505 16396 34863931
Blood lactic acid 36.63 11.14 17 76587 329 34879998
Neutrophil count decreased 36.32 11.14 35 76569 51069 34829258
Nodal arrhythmia 35.99 11.14 23 76581 855 34879472
Chronic obstructive pulmonary disease 35.82 11.14 206 76398 48712 34831615
Electrocardiogram ST segment depression 35.77 11.14 35 76569 2433 34877894
Completed suicide 35.62 11.14 104 76500 98064 34782263
White blood cell count decreased 35.44 11.14 100 76504 95345 34784982
Rheumatoid arthritis 35.17 11.14 20 76584 38218 34842109
Malignant neoplasm progression 35.15 11.14 89 76515 87957 34792370
Visual impairment 34.69 11.14 163 76441 35639 34844688
Inappropriate schedule of product administration 33.42 11.14 53 76551 62243 34818084
Ejection fraction decreased 33.28 11.14 105 76499 19049 34861278
Suicidal ideation 33.21 11.14 24 76580 40364 34839963
Electrocardiogram QRS complex prolonged 33.18 11.14 47 76557 4847 34875480
Haematuria 32.93 11.14 205 76399 49861 34830466
Bundle branch block left 32.79 11.14 52 76552 5927 34874400
Stomatitis 32.75 11.14 27 76577 42487 34837840
Diplopia 32.70 11.14 96 76508 16747 34863580
Supraventricular tachycardia 32.60 11.14 74 76530 11043 34869284
Blindness 32.59 11.14 89 76515 14897 34865430
Treatment failure 32.02 11.14 33 76571 46664 34833663
Ventricular arrhythmia 31.60 11.14 49 76555 5479 34874848
Dehydration 31.27 11.14 428 76176 129541 34750786
Aortic stenosis 31.26 11.14 43 76561 4315 34876012
Orthostatic hypotension 31.22 11.14 126 76478 25793 34854534
N-terminal prohormone brain natriuretic peptide increased 31.22 11.14 34 76570 2681 34877646
Depression 30.94 11.14 109 76495 96989 34783338
Intentional overdose 30.93 11.14 30 76574 43644 34836683
Cardioactive drug level below therapeutic 30.75 11.14 6 76598 0 34880327
Infusion related reaction 30.53 11.14 43 76561 53014 34827313
Coagulopathy 30.36 11.14 104 76500 19685 34860642
Electrocardiogram ST segment abnormal 30.25 11.14 19 76585 685 34879642
Drug dependence 29.95 11.14 8 76596 24209 34856118
Pyrexia 29.87 11.14 532 76072 332481 34547846
Cardiorenal syndrome 29.79 11.14 19 76585 704 34879623
Ischaemic stroke 28.96 11.14 97 76507 18153 34862174
Drug intolerance 28.91 11.14 54 76550 59516 34820811
Hypersensitivity 28.17 11.14 57 76547 60978 34819349
Cytomegalovirus infection 28.14 11.14 11 76593 26124 34854203
Drug reaction with eosinophilia and systemic symptoms 27.96 11.14 19 76585 32993 34847334
Psoriatic arthropathy 27.59 11.14 5 76599 19793 34860534
Haematoma 27.36 11.14 120 76484 25485 34854842
Blood pressure increased 27.34 11.14 100 76504 88002 34792325
Myasthenic syndrome 27.10 11.14 16 76588 515 34879812
Epistaxis 26.92 11.14 219 76385 58032 34822295
Cardiac disorder 26.76 11.14 174 76430 42952 34837375
Oedema peripheral 26.58 11.14 389 76215 119423 34760904
Arthralgia 26.28 11.14 242 76362 169799 34710528
Jugular vein distension 26.20 11.14 17 76587 649 34879678
Anuria 25.99 11.14 65 76539 10320 34870007
Oedema 25.66 11.14 180 76424 45561 34834766
International normalised ratio abnormal 25.58 11.14 34 76570 3301 34877026
Sinusitis 25.40 11.14 32 76572 41370 34838957
Rash papular 25.37 11.14 64 76540 10214 34870113
Hyperthyroidism 25.26 11.14 65 76539 10501 34869826
Lip swelling 25.10 11.14 85 76519 15995 34864332
Orthopnoea 24.77 11.14 42 76562 5061 34875266
Muscle spasms 24.69 11.14 83 76521 74918 34805409
Drug resistance 24.66 11.14 13 76591 25914 34854413
Lymphadenopathy 24.62 11.14 16 76588 28447 34851880
Lethargy 24.35 11.14 164 76440 40958 34839369
Dilatation atrial 24.30 11.14 26 76578 2009 34878318
Diabetic ketoacidosis 24.19 11.14 5 76599 18027 34862300
Hallucination 24.00 11.14 194 76410 51304 34829023
Chest pain 23.73 11.14 400 76204 126362 34753965
Pleural effusion 23.62 11.14 278 76326 81268 34799059
Somnolence 23.40 11.14 145 76459 110971 34769356
Suicide attempt 23.21 11.14 31 76573 39085 34841242
Dissociation 23.08 11.14 23 76581 1635 34878692
Prostate cancer 22.94 11.14 32 76572 39617 34840710
Tachycardia 22.81 11.14 285 76319 84487 34795840
Faeces discoloured 22.66 11.14 78 76526 14800 34865527
Appendicitis 22.31 11.14 3 76601 14804 34865523
Creatinine renal clearance decreased 22.23 11.14 32 76572 3349 34876978
Dilatation ventricular 21.98 11.14 28 76576 2608 34877719
Psoriasis 21.79 11.14 32 76572 38780 34841547
Pancytopenia 21.72 11.14 121 76483 95036 34785291
Cardiac output decreased 21.59 11.14 17 76587 883 34879444
Benign gastrointestinal neoplasm 21.41 11.14 9 76595 136 34880191
Concomitant disease progression 21.39 11.14 27 76577 2491 34877836
Blood glucose increased 21.37 11.14 232 76372 66486 34813841
Drug-induced liver injury 21.37 11.14 19 76585 28813 34851514
Peripheral embolism 21.36 11.14 18 76586 1030 34879297
Ventricular hypertrophy 21.16 11.14 37 76567 4570 34875757
Sleep disorder 21.04 11.14 23 76581 31665 34848662
Lip discolouration 21.00 11.14 9 76595 143 34880184
Myelosuppression 20.92 11.14 8 76596 19257 34861070
Cardiac death 20.85 11.14 18 76586 1065 34879262
Synovitis 20.84 11.14 3 76601 14063 34866264
Arthropathy 20.83 11.14 17 76587 26890 34853437
Polymerase chain reaction 20.77 11.14 8 76596 95 34880232
Neuralgia 20.67 11.14 4 76600 15109 34865218
Urticaria 20.55 11.14 69 76535 62308 34818019
Brain natriuretic peptide increased 20.43 11.14 41 76563 5618 34874709
Upper gastrointestinal haemorrhage 20.36 11.14 110 76494 25408 34854919
Activated partial thromboplastin time prolonged 20.28 11.14 53 76551 8642 34871685
Intentional self-injury 20.26 11.14 3 76601 13768 34866559
Heart rate decreased 20.25 11.14 129 76475 31616 34848711
Fluid retention 20.18 11.14 114 76490 26773 34853554
Constipation 19.86 11.14 198 76406 136784 34743543
Illness 19.78 11.14 3 76601 13526 34866801
Eosinophilia 19.77 11.14 17 76587 26205 34854122
Acute myocardial infarction 19.68 11.14 192 76412 53527 34826800
Drug ineffective for unapproved indication 19.62 11.14 14 76590 23701 34856626
Haemorrhage intracranial 19.59 11.14 78 76526 15868 34864459
Anhedonia 19.53 11.14 48 76556 7537 34872790
Coronary artery bypass 19.51 11.14 37 76567 4865 34875462
Fall 19.45 11.14 582 76022 202303 34678024
Injury 19.17 11.14 93 76511 20594 34859733
Congestive hepatopathy 18.97 11.14 22 76582 1859 34878468
Drug withdrawal syndrome 18.78 11.14 10 76594 19824 34860503
Cardiogenic shock 18.77 11.14 111 76493 26507 34853820
Prohormone brain natriuretic peptide increased 18.73 11.14 7 76597 76 34880251
Cyanosis 18.64 11.14 66 76538 12698 34867629
Joint swelling 18.56 11.14 68 76536 59822 34820505
Supraventricular extrasystoles 18.54 11.14 30 76574 3478 34876849
Colitis 18.51 11.14 34 76570 37716 34842611
Influenza 18.45 11.14 52 76552 49614 34830713
Infection 18.44 11.14 120 76484 90795 34789532
Cardiac failure acute 18.41 11.14 58 76546 10512 34869815
International normalised ratio fluctuation 18.34 11.14 18 76586 1256 34879071
Procalcitonin abnormal 18.17 11.14 11 76593 371 34879956
Musculoskeletal stiffness 17.99 11.14 48 76556 46632 34833695
Chills 17.98 11.14 104 76500 80939 34799388
Extrasystoles 17.94 11.14 31 76573 3792 34876535
Oesophageal achalasia 17.75 11.14 11 76593 387 34879940
Peripheral coldness 17.74 11.14 45 76559 7206 34873121
Colitis ulcerative 17.71 11.14 7 76597 16513 34863814
Abnormal loss of weight 17.69 11.14 32 76572 4058 34876269
Ventricular dysfunction 17.46 11.14 31 76573 3874 34876453
Aspergillus infection 17.28 11.14 3 76601 12251 34868076
Renal impairment 17.22 11.14 297 76307 94216 34786111
Headache 17.16 11.14 323 76281 200312 34680015
Pneumocystis jirovecii pneumonia 17.15 11.14 11 76593 19699 34860628
Blood pressure fluctuation 17.13 11.14 18 76586 25231 34855096
Enzyme induction 16.86 11.14 6 76598 56 34880271
Herpes zoster 16.85 11.14 31 76573 34368 34845959
Burning feet syndrome 16.82 11.14 7 76597 103 34880224
Pruritus 16.73 11.14 215 76389 141766 34738561
Brain natriuretic peptide 16.72 11.14 5 76599 25 34880302
Erythema 16.60 11.14 120 76484 88660 34791667
Palmar-plantar erythrodysaesthesia syndrome 16.60 11.14 8 76596 16787 34863540
Migraine 16.51 11.14 79 76525 17399 34862928
Haemothorax 16.49 11.14 30 76574 3822 34876505
Subdural haemorrhage 16.47 11.14 27 76577 3164 34877163
Irritability 16.30 11.14 18 76586 24672 34855655
Pain in extremity 16.27 11.14 188 76416 126325 34754002
Ischaemic hepatitis 16.17 11.14 20 76584 1808 34878519
Electrocardiogram T wave amplitude decreased 16.14 11.14 10 76594 352 34879975
Dyspnoea exertional 16.00 11.14 155 76449 43124 34837203
Tricuspid valve sclerosis 15.96 11.14 5 76599 30 34880297
Cerebral infarction 15.96 11.14 109 76495 27346 34852981
Angina unstable 15.95 11.14 59 76545 11594 34868733
Anaphylactic reaction 15.92 11.14 29 76575 32272 34848055
Amnesia 15.76 11.14 106 76498 26457 34853870
Withdrawal syndrome 15.62 11.14 4 76600 12451 34867876
Atrioventricular block second degree 15.58 11.14 29 76575 3759 34876568
Electrocardiogram PR prolongation 15.48 11.14 14 76590 881 34879446
Foetal tachyarrhythmia 15.38 11.14 3 76601 0 34880327
Mitral valve sclerosis 15.30 11.14 7 76597 131 34880196
Loss of personal independence in daily activities 15.29 11.14 31 76573 33148 34847179
Tremor 15.26 11.14 112 76492 82475 34797852
Diverticulum intestinal haemorrhagic 15.19 11.14 23 76581 2519 34877808
Toxic epidermal necrolysis 15.17 11.14 15 76589 21631 34858696
Tracheal injury 14.98 11.14 4 76600 12 34880315
Cognitive disorder 14.98 11.14 111 76493 28582 34851745
Cerebral haematoma 14.98 11.14 32 76572 4583 34875744
Adrenal insufficiency 14.98 11.14 6 76598 14041 34866286
Pulmonary arterial pressure increased 14.82 11.14 16 76588 1249 34879078
Haemorrhage 14.81 11.14 175 76429 51195 34829132
Pulmonary embolism 14.60 11.14 126 76478 89620 34790707
Embolic stroke 14.59 11.14 31 76573 4423 34875904
Dystonia 14.56 11.14 3 76601 10842 34869485
Rash maculo-papular 14.51 11.14 25 76579 28426 34851901
Cardio-respiratory arrest 14.51 11.14 185 76419 55088 34825239
Paraneoplastic syndrome 14.48 11.14 11 76593 542 34879785
Chromatopsia 14.47 11.14 9 76595 319 34880008
COVID-19 14.41 11.14 105 76499 77445 34802882
Infective exacerbation of chronic obstructive airways disease 14.40 11.14 19 76585 1832 34878495
Lymphopenia 14.38 11.14 9 76595 16326 34864001
Right atrial dilatation 14.32 11.14 9 76595 325 34880002
Haematocrit decreased 14.27 11.14 120 76484 32096 34848231
Normochromic normocytic anaemia 14.23 11.14 30 76574 4257 34876070
Intentional product use issue 14.23 11.14 75 76529 59741 34820586
Transaminases increased 14.21 11.14 23 76581 26800 34853527
Tumour lysis syndrome 14.20 11.14 10 76594 17049 34863278
Electrocardiogram ST-T change 14.20 11.14 11 76593 558 34879769
Polypectomy 14.18 11.14 11 76593 559 34879768
Thrombotic microangiopathy 14.15 11.14 3 76601 10627 34869700
Electrocardiogram repolarisation abnormality 14.11 11.14 14 76590 990 34879337
Graft versus host disease 14.03 11.14 3 76601 10566 34869761
Encephalomalacia 14.02 11.14 13 76591 845 34879482
Gastric mucosal lesion 13.93 11.14 11 76593 574 34879753
Encephalopathy 13.85 11.14 36 76568 35283 34845044
Cardiovascular disorder 13.84 11.14 51 76553 10005 34870322
Limited symptom panic attack 13.84 11.14 5 76599 49 34880278
Haematemesis 13.79 11.14 106 76498 27605 34852722
Emotional distress 13.53 11.14 67 76537 14959 34865368
PO2 decreased 13.51 11.14 17 76587 1564 34878763
Acute hepatic failure 13.47 11.14 7 76597 14067 34866260
Multiple sclerosis relapse 13.38 11.14 6 76598 13127 34867200
Carotid artery disease 13.33 11.14 13 76591 900 34879427
Atrial thrombosis 13.18 11.14 20 76584 2194 34878133
Hospitalisation 13.17 11.14 72 76532 56830 34823497
Hepatic enzyme increased 13.03 11.14 43 76561 39037 34841290
Therapeutic response decreased 13.00 11.14 28 76576 29285 34851042
Mitral valve replacement 12.93 11.14 7 76597 190 34880137
Posterior reversible encephalopathy syndrome 12.86 11.14 3 76601 9951 34870376
Hypovolaemia 12.85 11.14 47 76557 9187 34871140
Electrocardiogram abnormal 12.81 11.14 47 76557 9200 34871127
COVID-19 pneumonia 12.79 11.14 11 76593 16956 34863371
Prothrombin level decreased 12.75 11.14 14 76590 1114 34879213
Hepatic cytolysis 12.74 11.14 8 76596 14488 34865839
Cytokine release syndrome 12.70 11.14 19 76585 22858 34857469
Hallucination, olfactory 12.64 11.14 7 76597 199 34880128
Dyspnoea paroxysmal nocturnal 12.62 11.14 16 76588 1483 34878844
Erectile dysfunction 12.61 11.14 16 76588 20621 34859706
Sinus bradycardia 12.54 11.14 59 76545 12904 34867423
Presyncope 12.50 11.14 78 76526 18981 34861346
Fungal infection 12.42 11.14 10 76594 15925 34864402
Neoplasm progression 12.32 11.14 20 76584 23280 34857047
Disturbance in attention 12.22 11.14 98 76506 25847 34854480
Nephrogenic systemic fibrosis 12.12 11.14 27 76577 3978 34876349
Morning glory syndrome 12.09 11.14 3 76601 6 34880321
Glomerular filtration rate abnormal 12.06 11.14 12 76592 851 34879476
Mania 12.03 11.14 3 76601 9508 34870819
Cerebral haemorrhage 11.89 11.14 123 76481 34814 34845513
Pain 11.78 11.14 350 76254 204325 34676002
Hypoalbuminaemia 11.73 11.14 6 76598 12168 34868159
Bundle branch block 11.71 11.14 12 76592 882 34879445
Bronchopulmonary aspergillosis 11.68 11.14 9 76595 14650 34865677
Transplant rejection 11.67 11.14 4 76600 10307 34870020
Asthma 11.59 11.14 51 76553 42605 34837722
Skin exfoliation 11.51 11.14 27 76577 27405 34852922
Acne 11.36 11.14 5 76599 11061 34869266
Blood pressure decreased 11.30 11.14 167 76437 51348 34828979
Weight increased 11.28 11.14 140 76464 92893 34787434
Bundle branch block bilateral 11.27 11.14 4 76600 37 34880290
Seizure 11.19 11.14 162 76442 104695 34775632
Haemodynamic test abnormal 11.18 11.14 4 76600 38 34880289

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
Cardioactive drug level increased 1877.91 10.68 547 141101 3162 79599578
Bradycardia 1599.99 10.68 1559 140089 133998 79468742
International normalised ratio increased 1346.79 10.68 1152 140496 83569 79519171
Cardiac failure congestive 1079.93 10.68 1297 140351 141105 79461635
Atrial fibrillation 905.55 10.68 1411 140237 196475 79406265
Drug interaction 616.69 10.68 1875 139773 413308 79189432
Ventricular tachycardia 593.09 10.68 534 141114 41401 79561339
Toxicity to various agents 590.17 10.68 1865 139783 419675 79183065
Hyperkalaemia 548.25 10.68 834 140814 113564 79489176
Cardiac failure 539.47 10.68 978 140670 153864 79448876
Drug ineffective 462.34 10.68 758 140890 1080155 78522585
Off label use 377.36 10.68 647 141001 906568 78696172
Acute kidney injury 352.31 10.68 1835 139813 517569 79085171
Product complaint 327.87 10.68 235 141413 13114 79589626
Myocardial infarction 311.23 10.68 872 140776 183257 79419483
Atrial tachycardia 278.99 10.68 168 141480 6965 79595775
Gastrointestinal haemorrhage 267.89 10.68 718 140930 147001 79455739
Right ventricular failure 250.23 10.68 256 141392 23241 79579499
Dyspnoea 249.99 10.68 2468 139180 854557 78748183
Melaena 243.50 10.68 409 141239 60481 79542259
Cardiospasm 233.17 10.68 115 141533 3186 79599554
Synovitis 231.90 10.68 8 141640 150726 79452014
Hypotension 231.30 10.68 1454 140194 438863 79163877
Pulmonary hypertension 227.93 10.68 349 141299 47731 79555009
Renal failure 221.35 10.68 822 140826 200146 79402594
Bradyarrhythmia 219.52 10.68 119 141529 4027 79598713
Drug intolerance 218.17 10.68 98 141550 264021 79338719
Palmoplantar keratoderma 217.43 10.68 114 141534 3602 79599138
Torsade de pointes 215.87 10.68 216 141432 19096 79583644
Drug hypersensitivity 206.21 10.68 139 141509 298777 79303963
Pruritus genital 202.67 10.68 116 141532 4370 79598370
Subarachnoid haemorrhage 198.50 10.68 231 141417 24234 79578506
Sleep terror 197.99 10.68 114 141534 4344 79598396
Rheumatoid arthritis 197.83 10.68 62 141586 208408 79394332
Pulmonary arterial hypertension 197.77 10.68 248 141400 28118 79574622
Infusion related reaction 192.38 10.68 84 141564 230153 79372587
Joint swelling 191.48 10.68 140 141508 288506 79314234
Arthralgia 190.83 10.68 462 141186 571341 79031399
Drug abuse 178.23 10.68 36 141612 162655 79440085
Arrhythmia 176.13 10.68 357 141291 60915 79541825
Cardioactive drug level above therapeutic 176.11 10.68 48 141600 208 79602532
Rash 174.86 10.68 491 141157 577867 79024873
Hand deformity 169.35 10.68 3 141645 103916 79498824
Treatment failure 168.50 10.68 47 141601 170439 79432301
Carotid artery occlusion 168.29 10.68 126 141522 7521 79595219
Nodal rhythm 163.26 10.68 89 141559 3046 79599694
Arthropathy 162.18 10.68 56 141592 177055 79425685
Pain 160.32 10.68 675 140973 703127 78899613
Syncope 159.80 10.68 687 140961 178762 79423978
Pemphigus 157.83 10.68 4 141644 99578 79503162
Nasopharyngitis 154.70 10.68 134 141514 253747 79348993
Cardiac arrest 153.34 10.68 659 140989 171437 79431303
Therapeutic product effect decreased 153.20 10.68 50 141598 163813 79438927
Tension headache 152.45 10.68 116 141532 7095 79595645
Immunisation 151.59 10.68 75 141573 2092 79600648
Atrioventricular block 149.53 10.68 153 141495 13888 79588852
Hypersensitivity 147.33 10.68 149 141499 262090 79340650
Atrioventricular block complete 143.46 10.68 162 141486 16448 79586292
Dehydration 141.67 10.68 838 140810 247349 79355391
Systemic lupus erythematosus 140.90 10.68 23 141625 121126 79481614
Transient ischaemic attack 140.85 10.68 298 141350 52397 79550343
Anosmia 137.71 10.68 119 141529 8725 79594015
Stomatitis 136.80 10.68 45 141603 146712 79456028
Atrial flutter 134.97 10.68 179 141469 21446 79581294
Febrile neutropenia 133.49 10.68 128 141520 230871 79371869
Product use issue 132.42 10.68 107 141541 209715 79393025
Cerebrovascular accident 129.47 10.68 583 141065 154709 79448031
Dizziness 128.37 10.68 1464 140184 524977 79077763
Sinusitis 128.06 10.68 96 141552 195405 79407335
Glossodynia 126.21 10.68 17 141631 103320 79499420
Contraindicated product administered 126.08 10.68 61 141587 157477 79445263
Ventricular extrasystoles 125.91 10.68 165 141483 19539 79583201
Neutropenia 125.66 10.68 198 141450 287512 79315228
Musculoskeletal stiffness 123.83 10.68 79 141569 174929 79427811
Venous pressure jugular increased 123.25 10.68 56 141592 1284 79601456
Injection site pain 120.68 10.68 40 141608 129798 79472942
Facial pain 119.75 10.68 128 141520 12222 79590518
Hepatic enzyme increased 117.90 10.68 91 141557 182519 79420221
Product use in unapproved indication 117.39 10.68 164 141484 250195 79352545
Psoriatic arthropathy 117.00 10.68 5 141643 77994 79524746
Cardioactive drug level decreased 116.90 10.68 33 141615 167 79602573
Electrocardiogram ST segment depression 115.50 10.68 84 141564 4794 79597946
International normalised ratio decreased 114.48 10.68 103 141545 7967 79594773
Subdural haematoma 113.65 10.68 202 141446 31232 79571508
Ventricular fibrillation 112.66 10.68 203 141445 31723 79571017
Therapeutic product effect incomplete 107.16 10.68 59 141589 141586 79461154
Sinus node dysfunction 104.76 10.68 96 141552 7605 79595135
Asthenia 104.30 10.68 1376 140272 510313 79092427
Wound 104.17 10.68 38 141610 116141 79486599
Palpitations 103.03 10.68 472 141176 126138 79476602
Upper gastrointestinal haemorrhage 102.56 10.68 227 141421 41153 79561587
Cardiac murmur 101.87 10.68 133 141515 15691 79587049
Tricuspid valve incompetence 100.40 10.68 148 141500 19564 79583176
Cardiomegaly 98.71 10.68 172 141476 26180 79576560
Blood creatinine increased 98.56 10.68 539 141109 154518 79448222
Pain of skin 97.48 10.68 125 141523 14488 79588252
Nodal arrhythmia 97.07 10.68 54 141594 1924 79600816
Prothrombin time prolonged 96.53 10.68 134 141514 16765 79585975
Blood urea increased 95.32 10.68 244 141404 48546 79554194
Coronary artery disease 95.07 10.68 294 141354 65180 79537560
Atrioventricular block first degree 94.80 10.68 114 141534 12377 79590363
Ischaemic cardiomyopathy 93.31 10.68 90 141558 7605 79595135
Oedema peripheral 93.14 10.68 766 140882 251522 79351218
International normalised ratio abnormal 92.63 10.68 79 141569 5689 79597051
Mitral valve incompetence 92.46 10.68 175 141473 28390 79574350
Fibromyalgia 90.65 10.68 6 141642 64334 79538406
Sinus bradycardia 87.13 10.68 159 141489 25088 79577652
Orthopnoea 86.57 10.68 98 141550 9975 79592765
Rheumatoid factor positive 86.04 10.68 5 141643 59834 79542906
Ischaemic stroke 85.80 10.68 185 141463 32946 79569794
Infection 85.47 10.68 189 141459 241523 79361217
Swelling 84.65 10.68 160 141488 216551 79386189
Confusional state 84.50 10.68 900 140748 317097 79285643
Discomfort 83.11 10.68 61 141587 125556 79477184
Xanthopsia 82.66 10.68 29 141619 326 79602414
Fluid retention 82.19 10.68 292 141356 69517 79533223
Duodenal ulcer perforation 80.59 10.68 11 141637 66200 79536540
Maternal exposure during pregnancy 79.61 10.68 75 141573 136463 79466277
Hallucination 79.13 10.68 332 141316 85413 79517327
Cardiac failure chronic 78.64 10.68 98 141550 11037 79591703
Haematoma 78.22 10.68 237 141411 51958 79550782
Drug level increased 78.19 10.68 199 141449 39452 79563288
Helicobacter infection 75.12 10.68 16 141632 69688 79533052
Completed suicide 74.53 10.68 208 141440 245559 79357181
White blood cell count decreased 73.54 10.68 139 141509 188149 79414591
Asthma 73.29 10.68 79 141569 135016 79467724
Product dose omission issue 73.23 10.68 212 141436 247325 79355415
Muscle injury 73.21 10.68 3 141645 48558 79554182
Chest pain 73.12 10.68 795 140853 281509 79321231
Blood potassium increased 73.00 10.68 161 141487 29114 79573626
Ventricular arrhythmia 72.59 10.68 84 141564 8756 79593984
Irritable bowel syndrome 71.94 10.68 12 141636 62229 79540511
Ejection fraction decreased 71.81 10.68 177 141471 34400 79568340
Epistaxis 71.75 10.68 389 141259 111126 79491614
Urticaria 71.22 10.68 138 141510 185063 79417677
Psoriasis 71.18 10.68 35 141613 89552 79513188
Hypervolaemia 70.82 10.68 201 141447 42489 79560251
Leukopenia 70.30 10.68 62 141586 116451 79486289
Electrocardiogram ST segment abnormal 69.92 10.68 40 141608 1505 79601235
Pruritus 69.26 10.68 414 141234 394234 79208506
Presyncope 68.80 10.68 194 141454 40860 79561880
Neuropathy peripheral 68.78 10.68 90 141558 141215 79461525
Blindness 68.42 10.68 154 141494 28229 79574511
Haematuria 67.83 10.68 272 141376 68564 79534176
Pleural effusion 67.64 10.68 466 141182 144796 79457944
Left ventricular failure 67.14 10.68 84 141564 9497 79593243
Impaired healing 65.58 10.68 37 141611 87618 79515122
Cardiomyopathy 64.81 10.68 152 141496 28622 79574118
Blood cholesterol increased 64.59 10.68 34 141614 83686 79519054
Coagulopathy 64.15 10.68 174 141474 35832 79566908
Haemorrhage intracranial 64.12 10.68 143 141505 26050 79576690
Eye pruritus 64.08 10.68 124 141524 20446 79582294
Rectal haemorrhage 63.94 10.68 287 141361 76013 79526727
Muscle twitching 63.80 10.68 138 141510 24626 79578114
Cerebral haemorrhage 63.45 10.68 236 141412 57437 79545303
Injection site erythema 62.97 10.68 30 141618 78167 79524573
Diplopia 61.91 10.68 164 141484 33302 79569438
Hypoaesthesia 61.14 10.68 143 141505 179209 79423531
Dyspnoea exertional 60.30 10.68 310 141338 86763 79515977
Vasculitis 60.28 10.68 136 141512 24966 79577774
Injection site pruritus 59.39 10.68 4 141644 42279 79560461
Atrioventricular block second degree 59.23 10.68 69 141579 7243 79595497
Arthritis 59.23 10.68 70 141578 114810 79487930
Sleep disorder 58.78 10.68 40 141608 85637 79517103
Inappropriate schedule of product administration 58.24 10.68 92 141556 133536 79469204
Injection site reaction 58.17 10.68 13 141635 54772 79547968
Cardioactive drug level below therapeutic 57.91 10.68 12 141636 8 79602732
Heart rate increased 57.82 10.68 390 141258 120334 79482406
Visual impairment 56.99 10.68 318 141330 91813 79510927
Neutrophil count decreased 56.68 10.68 50 141598 93909 79508831
Bundle branch block left 56.56 10.68 85 141563 11428 79591312
Alopecia 56.16 10.68 216 141432 231139 79371601
Left ventricular dysfunction 55.84 10.68 113 141535 19248 79583492
Congestive cardiomyopathy 55.09 10.68 85 141563 11695 79591045
Suicidal ideation 54.60 10.68 34 141614 76306 79526434
Embolic stroke 53.86 10.68 68 141580 7758 79594982
Activated partial thromboplastin time prolonged 53.46 10.68 93 141555 14135 79588605
Mobility decreased 52.41 10.68 85 141563 122090 79480650
Heart rate irregular 52.40 10.68 152 141496 32527 79570213
Hyponatraemia 52.25 10.68 514 141134 177334 79425406
Pain in extremity 51.74 10.68 407 141241 364131 79238609
Brain natriuretic peptide increased 51.47 10.68 71 141577 8829 79593911
Renal impairment 51.32 10.68 466 141182 157317 79445423
Musculoskeletal pain 50 10.68 65 141583 102289 79500451
Lower gastrointestinal haemorrhage 49.98 10.68 97 141551 16028 79586712
Blood glucose increased 49.53 10.68 362 141286 114613 79488127
Muscle spasms 49.24 10.68 153 141495 174577 79428163
Loss of personal independence in daily activities 49.24 10.68 66 141582 102514 79500226
Renal injury 49.06 10.68 99 141549 16828 79585912
Cardiogenic shock 49.05 10.68 175 141473 41739 79561001
Paraesthesia 48.56 10.68 156 141492 176167 79426573
Lethargy 47.91 10.68 277 141371 81015 79521725
Conduction disorder 47.68 10.68 43 141605 3336 79599404
Multiple sclerosis relapse 47.52 10.68 12 141636 46521 79556219
Electrocardiogram abnormal 47.46 10.68 97 141551 16640 79586100
Tachyarrhythmia 47.14 10.68 60 141588 6902 79595838
Gastrointestinal disorder 47.01 10.68 91 141557 122114 79480626
Malignant neoplasm progression 46.68 10.68 108 141540 135882 79466858
Tachycardia 46.62 10.68 502 141146 177266 79425474
Knee arthroplasty 46.45 10.68 10 141638 43238 79559502
Hyperthyroidism 46.44 10.68 114 141534 22095 79580645
Illness 45.59 10.68 13 141635 46498 79556242
Cytomegalovirus infection 45.52 10.68 10 141638 42634 79560106
Depression 45.46 10.68 214 141434 216576 79386164
Blood pressure increased 45.29 10.68 207 141441 211153 79391587
Cardiac failure acute 44.84 10.68 102 141546 18827 79583913
Osteoporosis 44.74 10.68 20 141628 54092 79548648
Weight increased 44.50 10.68 299 141349 277087 79325653
Anuria 44.26 10.68 108 141540 20855 79581885
Cardiac disorder 44.06 10.68 232 141416 65525 79537215
Pyrexia 44.01 10.68 896 140752 677813 78924927
Blood pressure fluctuation 43.89 10.68 33 141615 67112 79535628
N-terminal prohormone brain natriuretic peptide increased 43.85 10.68 48 141600 4707 79598033
Electrocardiogram PR prolongation 43.84 10.68 30 141618 1553 79601187
Ill-defined disorder 43.55 10.68 32 141616 65843 79536897
Therapeutic response decreased 43.52 10.68 33 141615 66820 79535920
Oropharyngeal pain 43.32 10.68 80 141568 109273 79493467
Supraventricular tachycardia 43.23 10.68 108 141540 21162 79581578
Oedema 42.95 10.68 361 141287 119219 79483521
Chronic obstructive pulmonary disease 42.73 10.68 279 141369 85140 79517600
Extrasystoles 42.63 10.68 59 141589 7360 79595380
Haematemesis 42.60 10.68 195 141453 52069 79550671
Blister 42.54 10.68 93 141555 119383 79483357
Dilatation atrial 42.44 10.68 42 141606 3662 79599078
Herpes zoster 41.59 10.68 63 141585 93020 79509720
C-reactive protein abnormal 41.39 10.68 17 141631 48350 79554390
Injection site swelling 41.26 10.68 16 141632 47116 79555624
Red blood cell sedimentation rate increased 41.21 10.68 15 141633 45927 79556813
Abdominal wall haematoma 41.18 10.68 47 141601 4826 79597914
Loss of consciousness 40.72 10.68 467 141181 167476 79435264
Haemorrhage 40.46 10.68 289 141359 90829 79511911
Intentional self-injury 40.38 10.68 5 141643 32414 79570326
Bundle branch block right 40.28 10.68 72 141576 11179 79591561
Dilatation ventricular 40.26 10.68 43 141605 4101 79598639
Hypoxia 39.94 10.68 317 141331 102926 79499814
Cerebral infarction 39.92 10.68 174 141474 45502 79557238
Ventricular hypertrophy 39.60 10.68 55 141593 6883 79595857
Acute myocardial infarction 39.38 10.68 253 141395 76783 79525957
Headache 39.18 10.68 874 140774 652898 78949842
Rash papular 39.13 10.68 106 141542 21810 79580930
Heart rate decreased 39.11 10.68 236 141412 70080 79532660
Cardiorenal syndrome 39.07 10.68 28 141620 1561 79601179
Hip arthroplasty 38.95 10.68 8 141640 35748 79566992
Drug dependence 38.86 10.68 12 141636 40757 79561983
Faeces discoloured 38.80 10.68 127 141521 29000 79573740
Intentional product use issue 38.20 10.68 140 141508 151972 79450768
Myelosuppression 38.16 10.68 12 141636 40284 79562456
Myocardial ischaemia 37.41 10.68 115 141533 25404 79577336
Oral herpes 37.41 10.68 3 141645 27451 79575289
Fall 36.88 10.68 1130 140518 486499 79116241
Aortic stenosis 36.34 10.68 55 141593 7440 79595300
Hypoglycaemia 36.11 10.68 306 141342 101288 79501452
Electrocardiogram QT shortened 36.07 10.68 14 141634 213 79602527
Obesity 35.98 10.68 9 141639 35116 79567624
Mucosal inflammation 35.89 10.68 49 141599 75531 79527209
Prothrombin time shortened 35.87 10.68 36 141612 3192 79599548
Anaemia 35.74 10.68 1039 140609 443976 79158764
Hypocoagulable state 35.55 10.68 30 141618 2129 79600611
Congestive hepatopathy 35.33 10.68 42 141606 4505 79598235
Blood lactic acid 35.31 10.68 17 141631 446 79602294
Pulmonary arterial pressure increased 35.27 10.68 42 141606 4513 79598227
Electrocardiogram QT prolonged 35.23 10.68 278 141370 90108 79512632
Lip swelling 35.11 10.68 155 141493 40756 79561984
Anhedonia 34.98 10.68 80 141568 14818 79587922
Angina unstable 34.73 10.68 85 141563 16442 79586298
Pulmonary oedema 34.70 10.68 272 141376 87982 79514758
Electrocardiogram QRS complex prolonged 34.60 10.68 66 141582 10767 79591973
Decreased appetite 34.58 10.68 824 140824 341594 79261146
Osteoarthritis 34.47 10.68 64 141584 87245 79515495
Neoplasm progression 34.30 10.68 25 141623 51657 79551083
Unevaluable event 33.79 10.68 191 141457 55394 79547346
Neuralgia 33.34 10.68 9 141639 33375 79569365
Ventricular dysfunction 33.27 10.68 47 141601 5976 79596764
Respiratory failure 33.24 10.68 478 141170 180433 79422307
Hypertension 33.23 10.68 402 141246 330590 79272150
Alveolitis 33.12 10.68 39 141609 4141 79598599
Hypovolaemia 33.03 10.68 87 141561 17604 79585136
Orthostatic hypotension 32.84 10.68 191 141457 55973 79546767
Constipation 32.68 10.68 333 141315 282717 79320023
Intentional overdose 32.59 10.68 89 141559 105871 79496869
Fear 32.16 10.68 99 141549 21887 79580853
Supraventricular extrasystoles 32.09 10.68 50 141598 6937 79595803
Jugular vein distension 31.85 10.68 24 141624 1446 79601294
Colitis ulcerative 31.75 10.68 11 141637 34731 79568009
Peripheral embolism 31.72 10.68 27 141621 1939 79600801
Wheezing 31.57 10.68 104 141544 116560 79486180
Chills 31.38 10.68 162 141486 160072 79442668
Irritability 31.30 10.68 17 141631 41127 79561613
Drug-induced liver injury 31.26 10.68 43 141605 66074 79536666
Hypochromic anaemia 31.16 10.68 31 141617 2720 79600020
Transfusion 31.15 10.68 96 141552 21234 79581506
Shock haemorrhagic 30.91 10.68 92 141556 19968 79582772
Diabetic ketoacidosis 30.85 10.68 11 141637 34111 79568629
Disturbance in attention 30.51 10.68 174 141474 50627 79552113
C-reactive protein increased 30.31 10.68 122 141526 128905 79473835
Pneumocystis jirovecii pneumonia 30.22 10.68 10 141638 32498 79570242
Lymphocyte count decreased 29.95 10.68 24 141624 47265 79555475
Vomiting 29.66 10.68 1456 140192 664372 78938368
Calcium deficiency 29.65 10.68 19 141629 880 79601860
Foot deformity 29.29 10.68 4 141644 24070 79578670
Drug reaction with eosinophilia and systemic symptoms 29.17 10.68 43 141605 64201 79538539
Anaphylactic reaction 29.14 10.68 66 141582 83677 79519063
Chromatopsia 29.09 10.68 17 141631 666 79602074
Drug therapeutic incompatibility 28.85 10.68 11 141637 159 79602581
Concomitant disease progression 28.51 10.68 33 141615 3440 79599300
Tremor 28.44 10.68 181 141467 169902 79432838
Joint stiffness 28.09 10.68 19 141629 40811 79561929
Influenza 27.71 10.68 127 141521 129479 79473261
Suicide attempt 27.55 10.68 67 141581 82865 79519875
Occult blood positive 27.18 10.68 46 141602 6837 79595903
Inflammation 27.18 10.68 81 141567 93672 79509068
Overdose 27.13 10.68 469 141179 183737 79419003
Cyanosis 26.82 10.68 102 141546 25080 79577660
Mitral valve stenosis 26.76 10.68 20 141628 1190 79601550
Coagulation time prolonged 26.22 10.68 27 141621 2468 79600272
Cardiac death 26.18 10.68 22 141626 1552 79601188
Colitis 26.14 10.68 57 141591 73250 79529490
Progressive multifocal leukoencephalopathy 26.09 10.68 3 141645 20597 79582143
Acne 25.92 10.68 8 141640 27182 79575558
Haemoptysis 25.66 10.68 179 141469 55820 79546920
Immunodeficiency 25.60 10.68 4 141644 21764 79580976
Medication error 25.59 10.68 209 141439 68433 79534307
Drug ineffective for unapproved indication 25.58 10.68 32 141616 51206 79551534
Aortic valve incompetence 25.57 10.68 54 141594 9476 79593264
Atrial thrombosis 25.53 10.68 32 141616 3624 79599116
Feeling hot 25.20 10.68 42 141606 59692 79543048
Amnesia 25.15 10.68 195 141453 62862 79539878
Potentiating drug interaction 24.87 10.68 51 141597 8768 79593972
Acute respiratory failure 24.79 10.68 186 141462 59355 79543385
Electrocardiogram repolarisation abnormality 24.68 10.68 25 141623 2242 79600498
Coronary artery bypass 24.59 10.68 41 141607 6021 79596719
Angioedema 24.42 10.68 224 141424 75811 79526929
Oliguria 24.38 10.68 74 141574 16235 79586505
Left atrial dilatation 24.29 10.68 29 141619 3124 79599616
Fungal infection 24.24 10.68 23 141625 41725 79561015
Transplant rejection 24.20 10.68 3 141645 19434 79583306
Tinnitus 24.15 10.68 148 141500 44185 79558555
Dry mouth 24.13 10.68 78 141570 87941 79514799
Aspergillus infection 23.75 10.68 3 141645 19158 79583582
Exposure during pregnancy 23.51 10.68 96 141552 101036 79501704
Myasthenic syndrome 23.42 10.68 16 141632 826 79601914
Cataract 23.25 10.68 47 141601 62073 79540667
Haematocrit decreased 23.02 10.68 187 141461 61125 79541615
Benign gastrointestinal neoplasm 23.00 10.68 9 141639 140 79602600
Lymphadenopathy 22.87 10.68 37 141611 53210 79549530
Blood loss anaemia 22.86 10.68 70 141578 15428 79587312
Cor pulmonale 22.86 10.68 24 141624 2244 79600496
Haemoglobin decreased 22.85 10.68 536 141112 221583 79381157
Lymphopenia 22.71 10.68 13 141635 30544 79572196
Cardioversion 22.59 10.68 23 141625 2075 79600665
Ear infection 22.40 10.68 17 141631 34415 79568325
Basal cell carcinoma 22.40 10.68 20 141628 37355 79565385
Disorientation 22.26 10.68 189 141459 62587 79540153
International normalised ratio fluctuation 22.18 10.68 29 141619 3425 79599315
Cardio-respiratory arrest 22.07 10.68 292 141356 108218 79494522
Pyroglutamic acidosis 22.07 10.68 17 141631 1059 79601681
Palmar-plantar erythrodysaesthesia syndrome 22.02 10.68 16 141632 33118 79569622
Lactic acidosis 21.95 10.68 206 141442 70153 79532587
Lower limb fracture 21.83 10.68 7 141641 23208 79579532
Electrocardiogram ST-T change 21.77 10.68 20 141628 1589 79601151
Urine output decreased 21.73 10.68 76 141572 17946 79584794
Exercise tolerance decreased 21.62 10.68 49 141599 9022 79593718
Osteonecrosis of jaw 21.57 10.68 27 141621 43199 79559541
Atrioventricular dissociation 21.35 10.68 11 141637 335 79602405
Pulse absent 21.27 10.68 52 141596 10051 79592689
Pulmonary congestion 21.26 10.68 100 141548 27000 79575740
Injection site mass 21.01 10.68 5 141643 20179 79582561
Dystonia 20.94 10.68 6 141642 21393 79581347
Therapy partial responder 20.91 10.68 3 141645 17394 79585346
Catheter management 20.85 10.68 29 141619 3634 79599106
Haemothorax 20.83 10.68 36 141612 5442 79597298
Drug monitoring procedure not performed 20.79 10.68 16 141632 995 79601745
Blood pressure decreased 20.79 10.68 269 141379 99197 79503543
Dry eye 20.69 10.68 21 141627 36910 79565830
Dialysis 20.68 10.68 76 141572 18386 79584354
Polymerase chain reaction 20.53 10.68 8 141640 123 79602617
Head injury 20.51 10.68 125 141523 37244 79565496
Sopor 20.44 10.68 114 141534 32896 79569844
Erythrodermic psoriasis 20.26 10.68 20 141628 1738 79601002
Procalcitonin abnormal 20.11 10.68 11 141637 379 79602361
Uveitis 20 10.68 3 141645 16827 79585913
Frequent bowel movements 19.98 10.68 14 141634 29525 79573215
Erythema 19.88 10.68 278 141370 223012 79379728
Night sweats 19.85 10.68 39 141609 52056 79550684
Sedation 19.64 10.68 39 141609 51856 79550884
Right atrial dilatation 19.59 10.68 14 141634 777 79601963
Cardiac output decreased 19.52 10.68 20 141628 1818 79600922
Circulatory collapse 19.42 10.68 124 141524 37544 79565196
Bursitis 19.38 10.68 21 141627 35823 79566917
Central nervous system injury 18.84 10.68 8 141640 155 79602585
Neurotoxicity 18.78 10.68 18 141630 32500 79570240
Adrenal insufficiency 18.62 10.68 14 141634 28473 79574267
Fatigue 18.47 10.68 1412 140236 928315 78674425
Drug resistance 18.44 10.68 29 141619 42184 79560556
Impaired work ability 18.39 10.68 6 141642 19675 79583065
Posterior reversible encephalopathy syndrome 18.39 10.68 12 141636 26269 79576471
Procedural pain 18.36 10.68 9 141639 23075 79579665
Gastric ulcer 18.35 10.68 113 141535 33792 79568948
Abdominal discomfort 18.34 10.68 324 141324 250403 79352337
Appendicitis 18.30 10.68 7 141641 20787 79581953
Burning sensation 18.21 10.68 49 141599 58583 79544157
Grip strength decreased 18.21 10.68 8 141640 21861 79580879
Acute hepatic failure 18.18 10.68 16 141632 30097 79572643
Haemophagocytic lymphohistiocytosis 18.16 10.68 8 141640 21829 79580911
Sinus arrest 18.16 10.68 27 141621 3595 79599145
Sedation complication 18.15 10.68 3 141645 15666 79587074
Haemarthrosis 18.06 10.68 35 141613 5777 79596963
Cystitis 17.99 10.68 42 141606 52690 79550050
Cerebral haematoma 17.93 10.68 42 141606 7900 79594840
Skin exfoliation 17.92 10.68 45 141603 55055 79547685
Gastrooesophageal reflux disease 17.90 10.68 110 141538 104136 79498604
Splenic injury 17.81 10.68 9 141639 263 79602477
Pregnancy 17.80 10.68 13 141635 26838 79575902
Schizophrenia 17.79 10.68 3 141645 15437 79587303
Prothrombin level decreased 17.66 10.68 18 141630 1626 79601114
Bundle branch block bilateral 17.64 10.68 6 141642 61 79602679
Cognitive disorder 17.63 10.68 196 141452 69730 79533010
Type 2 diabetes mellitus 17.55 10.68 48 141600 57074 79545666
Dyspepsia 17.48 10.68 117 141531 108570 79494170
Joint range of motion decreased 17.45 10.68 20 141628 33262 79569478
Blood culture positive 17.34 10.68 43 141605 8386 79594354
Haemodialysis 17.26 10.68 71 141577 18097 79584643
Sensory disturbance 17.22 10.68 3 141645 15074 79587666
Hypersensitivity vasculitis 17.10 10.68 38 141610 6905 79595835
Bone pain 17.00 10.68 47 141601 55695 79547045
Tricuspid valve sclerosis 17.00 10.68 5 141643 30 79602710
Drug withdrawal syndrome 17.00 10.68 22 141626 34696 79568044
Sudden cardiac death 16.89 10.68 32 141616 5193 79597547
Device issue 16.86 10.68 14 141634 27094 79575646
Rhinitis 16.79 10.68 3 141645 14804 79587936
COVID-19 16.77 10.68 189 141459 157485 79445255
Contusion 16.76 10.68 176 141472 148600 79454140
Oxygen consumption increased 16.73 10.68 31 141617 4948 79597792
Death 16.64 10.68 1194 140454 565320 79037420
Blood pressure systolic abnormal 16.57 10.68 5 141643 17242 79585498
Prescribed overdose 16.57 10.68 26 141622 37857 79564883
Kussmaul respiration 16.55 10.68 10 141638 417 79602323
Ischaemic hepatitis 16.52 10.68 26 141622 3638 79599102
Hypochromasia 16.51 10.68 12 141636 684 79602056
Heparin-induced thrombocytopenia 16.46 10.68 46 141602 9636 79593104
Cor pulmonale chronic 16.45 10.68 9 141639 310 79602430
Dyschromatopsia 16.40 10.68 13 141635 844 79601896
Disability 16.39 10.68 5 141643 17115 79585625
Dyspnoea paroxysmal nocturnal 16.36 10.68 20 141628 2208 79600532
Sciatica 16.32 10.68 21 141627 33201 79569539
Pulmonary embolism 16.26 10.68 211 141437 171443 79431297
Therapy interrupted 16.25 10.68 19 141629 31322 79571418
Intervertebral disc protrusion 16.23 10.68 11 141637 23610 79579130
Muscle spasticity 16.15 10.68 9 141639 21466 79581274
Neutrophil count increased 16.14 10.68 17 141631 29379 79573361
Catheter placement 16.12 10.68 23 141625 2951 79599789
Lung transplant 16.09 10.68 29 141619 4532 79598208
Adverse event 16.06 10.68 54 141594 60160 79542580
Rhinorrhoea 15.99 10.68 75 141573 75999 79526741
Encephalomalacia 15.97 10.68 15 141633 1226 79601514
Heart sounds abnormal 15.96 10.68 16 141632 1417 79601323
Bronchopulmonary aspergillosis 15.84 10.68 10 141638 22284 79580456
Drug eruption 15.80 10.68 34 141614 43901 79558839
Panic attack 15.70 10.68 12 141636 24204 79578536
COVID-19 pneumonia 15.49 10.68 17 141631 28832 79573908
Hepatic steatosis 15.49 10.68 27 141621 37711 79565029
Anticoagulation drug level above therapeutic 15.38 10.68 25 141623 3595 79599145
Retroperitoneal haematoma 15.37 10.68 31 141617 5266 79597474
Lower respiratory tract infection 15.32 10.68 151 141497 129069 79473671
Right ventricular dilatation 15.31 10.68 18 141630 1908 79600832
Hypophagia 15.25 10.68 135 141513 45232 79557508
Peripheral ischaemia 15.17 10.68 44 141604 9413 79593327
Subdural haemorrhage 15.15 10.68 33 141615 5915 79596825
Metabolic acidosis 15.12 10.68 218 141430 82311 79520429
Graft versus host disease 15.10 10.68 4 141644 15022 79587718
Accidental overdose 15.01 10.68 121 141527 39460 79563280
Ecchymosis 14.90 10.68 60 141588 15146 79587594
Limited symptom panic attack 14.86 10.68 5 141643 49 79602691
Multiple organ dysfunction syndrome 14.86 10.68 298 141350 119948 79482792
Rash pruritic 14.83 10.68 71 141577 71558 79531182
Coronary arterial stent insertion 14.79 10.68 33 141615 6011 79596729
Pulseless electrical activity 14.79 10.68 57 141591 14103 79588637
Diverticulum intestinal haemorrhagic 14.78 10.68 26 141622 3985 79598755
Encephalitis 14.70 10.68 4 141644 14756 79587984
Multiple sclerosis 14.50 10.68 11 141637 22271 79580469
Normochromic normocytic anaemia 14.43 10.68 38 141610 7689 79595051
Thrombotic microangiopathy 14.40 10.68 9 141639 20160 79582580
Drug level above therapeutic 14.39 10.68 41 141607 8682 79594058
Rales 14.39 10.68 72 141576 19929 79582811
Polyneuropathy 14.38 10.68 13 141635 24138 79578602
Aphthous ulcer 14.35 10.68 6 141642 16883 79585857
Neck pain 14.33 10.68 77 141571 75340 79527400
Chronic kidney disease 14.28 10.68 180 141468 65974 79536766
Injection site rash 14.28 10.68 7 141641 17947 79584793
Enzyme induction 14.19 10.68 6 141642 115 79602625
Skin disorder 14.19 10.68 24 141624 33919 79568821
Tachycardia induced cardiomyopathy 14.19 10.68 7 141641 194 79602546
Respiratory acidosis 14.17 10.68 48 141600 11152 79591588
Liver function test increased 14.12 10.68 31 141617 39742 79562998
Cough 14.11 10.68 521 141127 366268 79236472
Burning feet syndrome 14.09 10.68 7 141641 197 79602543
Stupor 14.08 10.68 35 141613 6837 79595903
Deep vein thrombosis 14.04 10.68 142 141506 120777 79481963
Haematotoxicity 14.03 10.68 5 141643 15514 79587226
Hypoglycaemic coma 13.99 10.68 28 141620 4732 79598008
Conjunctivitis 13.98 10.68 15 141633 25700 79577040
Basal ganglia haemorrhage 13.92 10.68 16 141632 1655 79601085
Pulse pressure decreased 13.91 10.68 9 141639 424 79602316
Lip dry 13.89 10.68 5 141643 15413 79587327
Glaucoma 13.85 10.68 9 141639 19752 79582988
Spinal pain 13.85 10.68 5 141643 15387 79587353
Azotaemia 13.75 10.68 39 141609 8237 79594503
Posthaemorrhagic hydrocephalus 13.74 10.68 4 141644 23 79602717
Liver function test abnormal 13.74 10.68 175 141473 64300 79538440
Transplant evaluation 13.72 10.68 16 141632 1681 79601059
Therapeutic response increased 13.71 10.68 10 141638 573 79602167
Walking distance test abnormal 13.71 10.68 11 141637 727 79602013
Injection site urticaria 13.70 10.68 3 141645 12823 79589917
Cytomegalovirus viraemia 13.69 10.68 3 141645 12818 79589922
Haemorrhagic stroke 13.68 10.68 47 141601 10999 79591741
Intracardiac thrombus 13.52 10.68 26 141622 4267 79598473
Pancytopenia 13.48 10.68 210 141438 165535 79437205
Mitral valve disease 13.48 10.68 22 141626 3175 79599565
Sudden death 13.45 10.68 77 141571 22434 79580306
Musculoskeletal disorder 13.44 10.68 11 141637 21437 79581303
Superinfection 13.41 10.68 28 141620 4874 79597866
Product storage error 13.41 10.68 6 141642 16220 79586520
Blood bilirubin increased 13.37 10.68 178 141470 66054 79536686
Blood sodium decreased 13.35 10.68 103 141545 33152 79569588
Aortic valve calcification 13.30 10.68 11 141637 759 79601981
Blood alkaline phosphatase increased 13.23 10.68 172 141476 63492 79539248
Withdrawal syndrome 13.16 10.68 17 141631 26837 79575903
Metastases to lung 13.11 10.68 8 141640 18155 79584585
Right ventricular systolic pressure increased 13.10 10.68 12 141636 950 79601790
Back pain 13.09 10.68 426 141222 303754 79298986
Oesophageal achalasia 13.01 10.68 11 141637 783 79601957
Vascular graft 12.96 10.68 17 141631 2014 79600726
Subcutaneous haematoma 12.93 10.68 20 141628 2757 79599983
Joint effusion 12.91 10.68 8 141640 18006 79584734
Infective exacerbation of chronic obstructive airways disease 12.89 10.68 20 141628 2764 79599976
Ventricular hypokinesia 12.85 10.68 41 141607 9238 79593502
Bundle branch block 12.80 10.68 15 141633 1585 79601155
Exostosis 12.77 10.68 7 141641 16851 79585889
Mouth ulceration 12.76 10.68 31 141617 38363 79564377
Hemiparesis 12.72 10.68 103 141545 33630 79569110
Morning glory syndrome 12.72 10.68 3 141645 6 79602734
Ocular hyperaemia 12.68 10.68 19 141629 28187 79574553
Catheterisation cardiac 12.62 10.68 30 141618 5698 79597042
Blood pressure immeasurable 12.49 10.68 17 141631 2087 79600653
Hepatocellular injury 12.48 10.68 43 141605 47550 79555190
Body temperature increased 12.43 10.68 39 141609 44381 79558359
Brain stem haemorrhage 12.42 10.68 15 141633 1635 79601105
Blood pressure systolic increased 12.40 10.68 69 141579 66917 79535823
Second primary malignancy 12.35 10.68 5 141643 14345 79588395
Mesenteric artery embolism 12.32 10.68 5 141643 86 79602654
Mental status changes 12.32 10.68 177 141471 66782 79535958
Cardiac pacemaker insertion 12.29 10.68 30 141618 5792 79596948
Vision blurred 12.28 10.68 260 141388 105638 79497102
Cardiopulmonary failure 12.24 10.68 33 141615 6768 79595972
Sleep disorder due to a general medical condition 12.24 10.68 5 141643 14272 79588468
Nail disorder 12.21 10.68 3 141645 11849 79590891
Ear pain 12.18 10.68 25 141623 32844 79569896
Mitral valve sclerosis 12.15 10.68 7 141641 267 79602473
Hereditary haemorrhagic telangiectasia 12.10 10.68 4 141644 37 79602703
Choroidal haemorrhage 12.07 10.68 6 141642 169 79602571
Microcytic anaemia 12.03 10.68 28 141620 5246 79597494
Arteriosclerosis coronary artery 12.03 10.68 63 141585 17753 79584987
Cytokine release syndrome 12.02 10.68 29 141619 35969 79566771
Systolic dysfunction 11.97 10.68 23 141625 3772 79598968
Wound infection 11.96 10.68 15 141633 23976 79578764
Gait disturbance 11.92 10.68 279 141369 207227 79395513
Prohormone brain natriuretic peptide increased 11.92 10.68 7 141641 277 79602463
Intestinal obstruction 11.87 10.68 38 141610 42982 79559758
Bullous haemorrhagic dermatosis 11.87 10.68 5 141643 95 79602645
Labelled drug-drug interaction medication error 11.86 10.68 87 141561 27563 79575177
Blood pressure diastolic abnormal 11.84 10.68 10 141638 19192 79583548
Abscess 11.81 10.68 14 141634 22937 79579803
Refusal of treatment by patient 11.79 10.68 39 141609 8952 79593788
Poor venous access 11.76 10.68 9 141639 18140 79584600
Protein total 11.73 10.68 4 141644 41 79602699
Iron deficiency anaemia 11.72 10.68 82 141566 25590 79577150
Middle insomnia 11.71 10.68 7 141641 16062 79586678
Gastric ulcer haemorrhage 11.70 10.68 39 141609 8988 79593752
Peripheral artery stenosis 11.68 10.68 13 141635 1298 79601442
Cardiovascular disorder 11.66 10.68 63 141585 17962 79584778
Dizziness postural 11.66 10.68 46 141602 11503 79591237
Arteriovenous malformation 11.64 10.68 15 141633 1746 79600994
Breast cancer female 11.61 10.68 3 141645 11458 79591282
Colour blindness 11.56 10.68 8 141640 422 79602318
Cerebral atrophy 11.47 10.68 36 141612 8039 79594701
Emotional distress 11.47 10.68 115 141533 39854 79562886
Paracentesis 11.41 10.68 13 141635 1332 79601408
Electrocardiogram R on T phenomenon 11.40 10.68 3 141645 11 79602729
Feeling cold 11.39 10.68 21 141627 28708 79574032
Retroperitoneal haemorrhage 11.35 10.68 28 141620 5442 79597298
Limb discomfort 11.34 10.68 26 141622 32824 79569916
Eczema 11.30 10.68 36 141612 40782 79561958
Depressed mood 11.28 10.68 46 141602 48434 79554306
Live birth 11.27 10.68 10 141638 18734 79584006
Lacrimation increased 11.26 10.68 14 141634 22463 79580277
Adverse drug reaction 11.23 10.68 173 141475 66219 79536521
Eye pain 11.23 10.68 32 141616 37546 79565194
Blood chloride decreased 11.20 10.68 36 141612 8141 79594599
Electrocardiogram ST-T segment depression 11.20 10.68 3 141645 12 79602728
Prothrombin level increased 11.18 10.68 8 141640 445 79602295
Panniculitis 11.16 10.68 4 141644 12367 79590373
Hepatotoxicity 11.16 10.68 50 141598 51302 79551438
Hyponatraemic syndrome 11.15 10.68 10 141638 770 79601970
Heart disease congenital 11.11 10.68 9 141639 603 79602137
Seizure 11.10 10.68 253 141395 188581 79414159
Catheter site erythema 11.06 10.68 27 141621 5213 79597527
Haematoma evacuation 11.06 10.68 7 141641 317 79602423
Halo vision 11.05 10.68 9 141639 608 79602132
Respiratory distress 11.04 10.68 155 141493 58184 79544556
Dissociation 11.04 10.68 23 141625 3998 79598742
Acute myeloid leukaemia 11.02 10.68 24 141624 30861 79571879
Rhythm idioventricular 10.96 10.68 9 141639 615 79602125
Central nervous system lesion 10.96 10.68 5 141643 13363 79589377
Device related sepsis 10.96 10.68 30 141618 6210 79596530
Prostate cancer 10.95 10.68 27 141621 33241 79569499
Balloon atrial septostomy 10.91 10.68 5 141643 117 79602623
Arrhythmia supraventricular 10.87 10.68 16 141632 2111 79600629
Polypectomy 10.84 10.68 12 141636 1192 79601548
Haemodynamic instability 10.74 10.68 60 141588 17322 79585418
Feeling abnormal 10.71 10.68 364 141284 158835 79443905

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C01AA05 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
CARDIAC GLYCOSIDES
Digitalis glycosides
FDA CS M0003451 Cardiac Glycosides
FDA EPC N0000175568 Cardiac Glycoside
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:38147 cardiotonic drugs
CHEBI has role CHEBI:53000 epitope role
CHEBI has role CHEBI:63510 sodium-potassium adenosine triphosphatase inhibitors
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D002316 Cardiotonic Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D020011 Protective Agents

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

DiseaseRelationSNOMED_IDDOID
Poisoning by digitalis glycoside indication 12876009
Chronic heart failure indication 48447003
Atrial fibrillation indication 49436004 DOID:0060224
Senile cardiac amyloidosis contraindication 16573007
Myocardial infarction contraindication 22298006 DOID:5844
Sick sinus syndrome contraindication 36083008 DOID:13884
Myxedema contraindication 43153006 DOID:11634
Hypokalemia contraindication 43339004
Sinus bradycardia contraindication 49710005
Myocarditis contraindication 50920009 DOID:820
Acute nephropathy contraindication 58574008
Hypercalcemia contraindication 66931009 DOID:12678
Ventricular fibrillation contraindication 71908006
Wolff-Parkinson-White pattern contraindication 74390002 DOID:384
Cor pulmonale contraindication 83291003 DOID:8515
Constrictive pericarditis contraindication 85598007 DOID:11481
Kidney disease contraindication 90708001 DOID:557
Hypomagnesemia contraindication 190855004
Atrioventricular block contraindication 233917008 DOID:0050820
Idiopathic hypertrophic subaortic stenosis contraindication 360465008
Restrictive cardiomyopathy contraindication 415295002 DOID:397




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

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
Sodium/potassium-transporting ATPase Transporter INHIBITOR IC50 6.40 CHEMBL CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 4.14 WOMBAT-PK
Nuclear receptor ROR-gamma Nuclear hormone receptor IC50 5.70 CHEMBL
Signal transducer and activator of transcription 3 Transcription factor IC50 5.73 CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-2 Ion channel IC50 5.78 DRUG MATRIX
Nuclear receptor ROR-gamma Nuclear hormone receptor IC50 5.70 CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-1 Transporter IC50 6.30 CHEMBL

External reference:

IDSource
4018047 VUID
N0000146388 NUI
D00298 KEGG_DRUG
3407 RXNORM
4018047 VANDF
C0012265 UMLSCUI
CHEBI:4551 CHEBI
DGX PDB_CHEM_ID
CHEMBL1751 ChEMBL_ID
D004077 MESH_DESCRIPTOR_UI
DB00390 DRUGBANK_ID
4726 IUPHAR_LIGAND_ID
389 INN_ID
73K4184T59 UNII
2724385 PUBCHEM_CID
1413 MMSL
4597 MMSL
d00210 MMSL
000593 NDDF
387461009 SNOMEDCT_US
796001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0054-0057 SOLUTION 0.05 mg ORAL NDA 27 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0115-9811 TABLET 125 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0115-9811 TABLET 125 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0115-9822 TABLET 250 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0115-9822 TABLET 250 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0143-1240 TABLET 125 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0143-1240 TABLET 125 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0143-1241 TABLET 250 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0143-1241 TABLET 250 ug ORAL ANDA 26 sections
DIGITEK HUMAN PRESCRIPTION DRUG LABEL 1 0378-6155 TABLET 0.13 mg ORAL ANDA 26 sections
DIGITEK HUMAN PRESCRIPTION DRUG LABEL 1 0378-6156 TABLET 0.25 mg ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0404-9850 INJECTION 0.25 mg INTRAVENOUS ANDA 16 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0404-9850 INJECTION 0.25 mg INTRAVENOUS ANDA 16 sections
DIGOX HUMAN PRESCRIPTION DRUG LABEL 1 0527-1324 TABLET 125 ug ORAL ANDA 22 sections
DIGOX HUMAN PRESCRIPTION DRUG LABEL 1 0527-1325 TABLET 250 ug ORAL ANDA 22 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0615-0547 TABLET 0.13 mg ORAL ANDA 12 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8202 TABLET 125 ug ORAL ANDA 27 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8202 TABLET 125 ug ORAL ANDA 27 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8202 TABLET 125 ug ORAL ANDA 27 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0641-1410 INJECTION 0.25 mg INTRAMUSCULAR ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0641-1410 INJECTION 0.25 mg INTRAMUSCULAR ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0641-6184 INJECTION 0.25 mg INTRAMUSCULAR ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0641-6184 INJECTION 0.25 mg INTRAMUSCULAR ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0781-3059 INJECTION, SOLUTION 250 ug INTRAMUSCULAR ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0781-3059 INJECTION, SOLUTION 250 ug INTRAMUSCULAR ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0781-3059 INJECTION, SOLUTION 250 ug INTRAMUSCULAR ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0904-5921 TABLET 125 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0904-5921 TABLET 125 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0904-5922 TABLET 250 ug ORAL ANDA 26 sections
Digoxin HUMAN PRESCRIPTION DRUG LABEL 1 0904-5922 TABLET 250 ug ORAL ANDA 26 sections