amlodipine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
calcium channel blockers, nifedipine derivatives 183 88150-42-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amlodipine
  • amlopres
  • racemic amlodipine
  • amlodipine besylate
  • amlodipine besilate
  • amlodipine maleate
  • amlodipine mesylate
  • amlodipine mesilate
A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
  • Molecular weight: 408.88
  • Formula: C20H25ClN2O5
  • CLOGP: 3.43
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 99.88
  • ALOGS: -4.74
  • ROTB: 10

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
5 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.35 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 74 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 17 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 34 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 31, 1992 FDA PFIZER

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 ineffective 976.01 9.79 3129 383758 816204 49402033
Pemphigus 787.06 9.79 30 386857 120136 50098101
Maternal exposure during pregnancy 705.97 9.79 176 386711 159602 50058635
Systemic lupus erythematosus 667.39 9.79 132 386755 140490 50077747
Contraindicated product administered 652.44 9.79 167 386720 148791 50069446
Completed suicide 627.12 9.79 2324 384563 129565 50088672
Hand deformity 580.25 9.79 50 386837 100149 50118088
Glossodynia 577.50 9.79 95 386792 115474 50102763
Synovitis 559.69 9.79 130 386757 123735 50094502
Treatment failure 546.65 9.79 185 386702 137452 50080785
Hypotension 531.38 9.79 3346 383541 232123 49986114
Anti-cyclic citrullinated peptide antibody positive 521.45 9.79 3 386884 70584 50147653
Drug intolerance 498.74 9.79 564 386323 218540 49999697
Infusion related reaction 482.67 9.79 355 386532 169202 50049035
Pericarditis 479.08 9.79 31 386856 78658 50139579
Therapeutic product effect decreased 462.40 9.79 231 386656 135819 50082418
Arthropathy 445.04 9.79 334 386553 157572 50060665
Off label use 444.78 9.79 1992 384895 472434 49745803
Hyponatraemia 422.81 9.79 1653 385234 94486 50123751
Acute kidney injury 422.43 9.79 3087 383800 224971 49993266
Shock 413.97 9.79 640 386247 20010 50198227
Alopecia 408.89 9.79 783 386104 244264 49973973
Blood pressure inadequately controlled 391.37 9.79 300 386587 4080 50214157
Gingival hypertrophy 366.19 9.79 189 386698 1197 50217040
Wound 344.09 9.79 190 386697 105604 50112633
Oedema peripheral 336.32 9.79 2213 384674 155748 50062489
Rheumatoid arthritis 330.99 9.79 655 386232 201895 50016342
Non-cardiogenic pulmonary oedema 326.97 9.79 134 386753 447 50217790
Blood pressure increased 321.90 9.79 1927 384960 131205 50087032
Rheumatoid factor positive 308.40 9.79 18 386869 49841 50168396
Exposure during pregnancy 303.95 9.79 286 386601 120729 50097508
Hepatic enzyme increased 298.02 9.79 367 386520 137013 50081224
Fall 297.46 9.79 3885 383002 331047 49887190
Cerebrovascular accident 286.79 9.79 1457 385430 93223 50125014
Duodenal ulcer perforation 274.56 9.79 19 386868 45592 50172645
Hypersensitivity 272.83 9.79 795 386092 214366 50003871
Discomfort 271.16 9.79 257 386630 108123 50110114
Bradycardia 268.84 9.79 1090 385797 63336 50154901
Pain 268.27 9.79 2984 383903 575919 49642318
Orthostatic hypotension 263.01 9.79 649 386238 28832 50189405
Product use issue 254.88 9.79 471 386416 149004 50069233
Folliculitis 249.37 9.79 12 386875 39213 50179024
Helicobacter infection 230.76 9.79 49 386838 49653 50168584
Abdominal discomfort 225.80 9.79 957 385930 230684 49987553
Sleep disorder due to general medical condition, insomnia type 208.73 9.79 7 386880 31440 50186797
Swelling 205.67 9.79 814 386073 200058 50018179
Dizziness 200.88 9.79 3740 383147 342629 49875608
Renal impairment 200.85 9.79 1123 385764 74538 50143699
Vasoplegia syndrome 198.09 9.79 117 386770 997 50217240
Lactic acidosis 193.17 9.79 628 386259 32727 50185510
Hyperkalaemia 193 9.79 804 386083 47285 50170952
C-reactive protein abnormal 192.77 9.79 4 386883 27805 50190432
Angioedema 192.35 9.79 680 386207 36996 50181241
Muscle injury 188.67 9.79 29 386858 37082 50181155
Lower respiratory tract infection 182.53 9.79 278 386609 94923 50123314
Therapeutic product effect incomplete 177.62 9.79 265 386622 91250 50126987
Arthralgia 176.94 9.79 2329 384558 436373 49781864
Abortion spontaneous 174.89 9.79 51 386836 41721 50176516
Metabolic acidosis 165.20 9.79 661 386226 38164 50180073
Sinusitis 164.64 9.79 707 386180 169851 50048386
Infection 160.85 9.79 727 386160 172227 50046010
Joint swelling 160.68 9.79 1156 385731 244130 49974107
Impaired healing 157.03 9.79 181 386706 69605 50148632
Cardiac failure congestive 155.07 9.79 1141 385746 83241 50134996
Pregnancy 152.92 9.79 22 386865 29555 50188682
Toxicity to various agents 150.30 9.79 2370 384517 210129 50008108
Irritable bowel syndrome 149.73 9.79 105 386782 51336 50166901
Intentional overdose 149.13 9.79 902 385985 61602 50156635
Hypokalaemia 146.69 9.79 1163 385724 86829 50131408
Balance disorder 140.42 9.79 973 385914 69617 50148620
Condition aggravated 139.05 9.79 1526 385361 295532 49922705
Musculoskeletal stiffness 136.97 9.79 512 386375 127969 50090268
Device expulsion 136.72 9.79 27 386860 28795 50189442
Distributive shock 135.84 9.79 83 386804 757 50217480
Depressed level of consciousness 135.77 9.79 768 386119 51185 50167052
Creatinine renal clearance decreased 135.22 9.79 288 386599 11593 50206644
Drug abuse 132.72 9.79 157 386730 59689 50158548
Hypoglycaemia 129.58 9.79 776 386111 52805 50165432
Ill-defined disorder 129.29 9.79 136 386751 54518 50163719
Atrial fibrillation 128.31 9.79 1265 385622 100480 50117757
Injection site reaction 127.00 9.79 117 386770 49915 50168322
Blood creatinine increased 125.50 9.79 1004 385883 75156 50143081
Rash 123.52 9.79 2481 384406 434990 49783247
Myocardial infarction 118.21 9.79 1119 385768 87908 50130329
Sedation complication 115.77 9.79 226 386661 8540 50209697
Injection site erythema 114.90 9.79 251 386636 74685 50143552
Hypertensive crisis 113.53 9.79 286 386601 12868 50205369
Neurologic neglect syndrome 113.33 9.79 92 386795 1366 50216871
Decreased appetite 110.82 9.79 2154 384733 198769 50019468
Swollen tongue 103.59 9.79 464 386423 28166 50190071
Injection site pain 101.17 9.79 470 386417 110554 50107683
Renal failure 101.05 9.79 1253 385634 105380 50112857
Carotid artery thrombosis 100.82 9.79 87 386800 1412 50216825
Live birth 98.26 9.79 7 386880 16401 50201836
Cerebral infarction 95.26 9.79 372 386515 21232 50197005
Syncope 94.04 9.79 1202 385685 101800 50116437
Asthenia 92.62 9.79 3139 383748 315903 49902334
Rhabdomyolysis 91.67 9.79 561 386326 38466 50179771
Product use in unapproved indication 91.00 9.79 516 386371 115303 50102934
Anuria 89.35 9.79 237 386650 11007 50207230
Stomatitis 88.84 9.79 435 386452 100909 50117328
Intentional product use issue 87.61 9.79 298 386589 76620 50141617
Gastrointestinal disorder 86.56 9.79 399 386488 94057 50124180
Atrioventricular block complete 86.21 9.79 179 386708 7076 50211161
Pyrexia 84.99 9.79 2235 384652 377968 49840269
Sinus bradycardia 84.39 9.79 257 386630 12926 50205311
Blood pressure decreased 84.04 9.79 722 386165 55187 50163050
Drug interaction 82.04 9.79 2052 384835 197569 50020668
Hypertensive emergency 80.29 9.79 78 386809 1485 50216752
Dehydration 79.86 9.79 1622 385265 150827 50067410
Hemiplegia 79.51 9.79 175 386712 7206 50211031
Coronary artery disease 79.34 9.79 442 386445 29284 50188953
Blood calcium decreased 77.49 9.79 339 386548 20367 50197870
Hip arthroplasty 77.41 9.79 71 386816 30358 50187879
Adjustment disorder 75.45 9.79 85 386802 1934 50216303
Overdose 74.48 9.79 1123 385764 98604 50119633
Intentional self-injury 74.38 9.79 42 386845 23070 50195167
Blood urea increased 74.17 9.79 367 386520 23218 50195019
Hypertension 73.89 9.79 2126 384761 209077 50009160
Fibromyalgia 73.71 9.79 145 386742 44833 50173404
Sprue-like enteropathy 72.82 9.79 47 386840 476 50217761
Migraine 72.59 9.79 312 386575 74968 50143269
Subacute cutaneous lupus erythematosus 72.32 9.79 87 386800 2128 50216109
Circulatory collapse 72.24 9.79 324 386563 19676 50198561
Cognitive disorder 71.75 9.79 580 386307 43543 50174694
Chronic kidney disease 70.30 9.79 533 386354 39238 50178999
Foetal exposure during pregnancy 69.40 9.79 64 386823 27295 50190942
Cardiac failure 69.23 9.79 887 386000 75153 50143084
Atrioventricular block first degree 69.05 9.79 149 386738 6052 50212185
Angina pectoris 68.97 9.79 388 386499 25800 50192437
Acute myocardial infarction 68.87 9.79 421 386466 28852 50189385
Renin increased 67.40 9.79 30 386857 129 50218108
Injection site swelling 66.46 9.79 137 386750 41636 50176601
Febrile neutropenia 66.41 9.79 455 386432 97212 50121025
Pulmonary oedema 66.36 9.79 618 386269 48320 50169917
Palpitations 64.40 9.79 1048 385839 93458 50124779
Cardiogenic shock 64.28 9.79 263 386624 15336 50202901
Transient ischaemic attack 64.03 9.79 444 386443 31766 50186471
Drug level increased 62.87 9.79 303 386584 18965 50199272
Dyspnoea 61.65 9.79 4921 381966 542687 49675550
Product prescribing error 60.90 9.79 319 386568 20642 50197595
Loss of personal independence in daily activities 59.47 9.79 304 386583 69746 50148491
Psoriatic arthropathy 59.32 9.79 174 386713 46858 50171379
Injection site pruritus 57.38 9.79 141 386746 40270 50177967
Hyperglycaemia 57.28 9.79 475 386412 35930 50182307
Left ventricular hypertrophy 56.93 9.79 119 386768 4726 50213511
Linear IgA disease 55.99 9.79 58 386829 1196 50217041
Hypomagnesaemia 55.73 9.79 335 386552 22821 50195416
Personality disorder 55.31 9.79 110 386777 4214 50214023
Blister 54.63 9.79 405 386482 85013 50133224
Anaemia 53.78 9.79 2402 384485 250054 49968183
Proteinuria 53.43 9.79 260 386627 16337 50201900
Dysarthria 53.08 9.79 477 386410 36926 50181311
Blood pressure systolic increased 52.85 9.79 457 386430 34992 50183245
Rheumatoid nodule 52.48 9.79 16 386871 12719 50205518
Hepatic function abnormal 51.19 9.79 426 386461 32255 50185982
Neutropenia 51.14 9.79 809 386078 147156 50071081
Drug resistance 51.10 9.79 42 386845 18947 50199290
Knee arthroplasty 50.95 9.79 125 386762 35721 50182516
Inappropriate antidiuretic hormone secretion 50.57 9.79 217 386670 12926 50205311
Renal artery stenosis 50.27 9.79 63 386824 1609 50216628
Oliguria 49.65 9.79 157 386730 8059 50210178
Schizoaffective disorder 49.37 9.79 72 386815 2134 50216103
Melaena 49.16 9.79 363 386524 26501 50191736
Blood potassium decreased 48.32 9.79 463 386424 36482 50181755
Blood glucose increased 47.86 9.79 789 386098 70535 50147702
Carotid artery stenosis 46.32 9.79 108 386779 4623 50213614
Vasodilatation 46.17 9.79 71 386816 2208 50216029
Atrioventricular block 45.96 9.79 131 386756 6347 50211890
Tenosynovitis 45.90 9.79 12 386875 10553 50207684
Sedation 45.83 9.79 395 386492 30215 50188022
Infective pulmonary exacerbation of cystic fibrosis 45.61 9.79 4 386883 7905 50210332
Glomerular filtration rate decreased 45.31 9.79 193 386694 11459 50206778
Foot deformity 45.20 9.79 48 386839 19162 50199075
Pemphigoid 44.41 9.79 122 386765 5785 50212452
Haemorrhage subcutaneous 43.68 9.79 76 386811 2625 50215612
Injection site bruising 43.54 9.79 140 386747 36628 50181609
Renal disorder 43.33 9.79 359 386528 27146 50191091
Constipation 43.11 9.79 1783 385104 183925 50034312
Diabetes mellitus inadequate control 43.09 9.79 207 386680 12938 50205299
Weight increased 42.85 9.79 1195 385692 200696 50017541
Suspected suicide 42.65 9.79 113 386774 5244 50212993
Anti-neutrophil cytoplasmic antibody positive vasculitis 42.43 9.79 69 386818 2253 50215984
Malaise 42.09 9.79 3042 383845 332490 49885747
Injection site warmth 42.09 9.79 27 386860 13839 50204398
Nasopharyngitis 41.70 9.79 1139 385748 191788 50026449
Body temperature increased 41.70 9.79 113 386774 31228 50187009
Oedema 41.57 9.79 761 386126 69420 50148817
Fatigue 40.72 9.79 4764 382123 702837 49515400
Eating disorder 40.37 9.79 228 386659 15181 50203056
Loss of consciousness 39.68 9.79 1062 385825 103291 50114946
Premature labour 39.68 9.79 19 386868 11457 50206780
Drug dependence 39.50 9.79 56 386831 19703 50198534
Blood creatine phosphokinase increased 39.34 9.79 340 386547 26027 50192210
Urine output decreased 39.29 9.79 171 386716 10250 50207987
Caesarean section 39.17 9.79 37 386850 15602 50202635
Altered state of consciousness 38.92 9.79 294 386593 21616 50196621
Drug tolerance decreased 38.67 9.79 11 386876 9149 50209088
Wrong technique in product usage process 38.52 9.79 257 386630 55253 50162984
Chest pain 38.07 9.79 1685 385202 175197 50043040
Atrioventricular block second degree 38.04 9.79 85 386802 3536 50214701
Lip swelling 37.98 9.79 321 386566 24415 50193822
Urticaria 37.21 9.79 732 386155 128829 50089408
Glomerulonephritis rapidly progressive 36.78 9.79 38 386849 781 50217456
Multiple sclerosis relapse 36.72 9.79 186 386701 42778 50175459
Muscle spasms 35.97 9.79 1234 385653 124319 50093918
Haematochezia 35.76 9.79 464 386423 39418 50178819
Gingival swelling 35.38 9.79 85 386802 3710 50214527
Allergic reaction to excipient 35.38 9.79 24 386863 266 50217971
Hyperdynamic left ventricle 35.37 9.79 19 386868 132 50218105
Supraventricular extrasystoles 35.35 9.79 87 386800 3857 50214380
Gastrointestinal haemorrhage 34.74 9.79 769 386118 72552 50145685
Premature baby 34.68 9.79 54 386833 18283 50199954
Abortion induced 34.63 9.79 14 386873 9330 50208907
Nodal rhythm 34.37 9.79 51 386836 1536 50216701
Aphasia 34.30 9.79 351 386536 28143 50190094
Lacunar infarction 34.17 9.79 74 386813 3013 50215224
Hepatotoxicity 34.13 9.79 101 386786 27125 50191112
Aortic dissection 33.98 9.79 51 386836 1552 50216685
Ischaemic stroke 33.58 9.79 223 386664 15725 50202512
Red blood cell sedimentation rate increased 33.45 9.79 114 386773 29302 50188935
Device dislocation 33.15 9.79 72 386815 21474 50196763
Plasma cell myeloma 33.13 9.79 376 386511 30946 50187291
Drug withdrawal syndrome 32.94 9.79 91 386796 24990 50193247
Nephrosclerosis 32.87 9.79 38 386849 890 50217347
Hyperaldosteronism 32.19 9.79 21 386866 217 50218020
Therapeutic response decreased 32.11 9.79 220 386667 47011 50171226
Bladder irritation 32.05 9.79 20 386867 190 50218047
Bundle branch block right 32.05 9.79 93 386794 4552 50213685
Gingival bleeding 31.76 9.79 171 386716 11182 50207055
Injury 31.74 9.79 231 386656 48694 50169543
Swelling face 31.38 9.79 571 386316 52024 50166213
Metastases to bone 31.25 9.79 56 386831 17939 50200298
Ear pain 31.23 9.79 111 386776 28172 50190065
Motor dysfunction 31.21 9.79 133 386754 7898 50210339
Affect lability 31.18 9.79 144 386743 8854 50209383
Respiratory failure 31.04 9.79 915 385972 90266 50127971
Leukopenia 30.65 9.79 349 386538 67179 50151058
Pulmonary renal syndrome 30.59 9.79 25 386862 375 50217862
Fear of injection 30.49 9.79 5 386882 6098 50212139
Dyspnoea exertional 30.49 9.79 556 386331 50677 50167560
Intestinal malrotation 29.98 9.79 24 386863 349 50217888
Haematemesis 29.86 9.79 334 386553 27391 50190846
Septic shock 29.82 9.79 286 386601 56889 50161348
Enthesopathy 29.71 9.79 9 386878 7184 50211053
Blood potassium increased 29.67 9.79 221 386666 16177 50202060
Immunodeficiency 29.67 9.79 42 386845 14786 50203451
BRASH syndrome 29.31 9.79 19 386868 194 50218043
Suicide attempt 28.92 9.79 556 386331 51176 50167061
Hyperuricaemia 28.80 9.79 90 386797 4590 50213647
Ear infection 28.62 9.79 102 386785 25868 50192369
Angina unstable 28.37 9.79 114 386773 6592 50211645
Pollakiuria 28.32 9.79 293 386594 23558 50194679
Arrhythmia 28.26 9.79 382 386505 32750 50185487
Injection site urticaria 28.22 9.79 31 386856 12186 50206051
Lung diffusion test abnormal 28.10 9.79 17 386870 152 50218085
Product substitution issue 28.07 9.79 194 386693 13863 50204374
Myocardial ischaemia 27.94 9.79 168 386719 11445 50206792
Sinus arrest 27.75 9.79 48 386839 1650 50216587
Disorientation 27.41 9.79 402 386485 35082 50183155
Stillbirth 27.35 9.79 6 386881 5946 50212291
Unintended pregnancy 27.21 9.79 3 386884 4943 50213294
Product label on wrong product 27.17 9.79 7 386880 0 50218237
Product monitoring error 26.95 9.79 63 386824 2701 50215536
Premature delivery 26.71 9.79 92 386795 23571 50194666
Feeling abnormal 26.66 9.79 1194 385693 124298 50093939
Parkinsonism 26.64 9.79 136 386751 8711 50209526
Hypocalcaemia 26.62 9.79 318 386569 26498 50191739
Hemiparesis 26.58 9.79 252 386635 19796 50198441
Panniculitis 26.58 9.79 16 386871 8487 50209750
Uterine perforation 26.54 9.79 8 386879 6407 50211830
Hypervolaemia 26.48 9.79 305 386582 25194 50193043
Accidental exposure to product 26.46 9.79 89 386798 22968 50195269
Sensory loss 26.20 9.79 123 386764 7615 50210622
Myocardial depression 26.06 9.79 24 386863 426 50217811
Unintentional medical device removal 25.97 9.79 5 386882 5430 50212807
Haematotoxicity 25.90 9.79 14 386873 7881 50210356
Ischaemia 25.86 9.79 82 386805 4215 50214022
Nocturia 25.80 9.79 111 386776 6619 50211618
Ovarian cyst 25.73 9.79 42 386845 13954 50204283
Ageusia 25.63 9.79 164 386723 11419 50206818
Confusional state 25.59 9.79 1699 385188 184229 50034008
Bone erosion 25.54 9.79 31 386856 11656 50206581
Faeces discoloured 25.15 9.79 210 386677 15914 50202323
Myalgia 25.15 9.79 1177 385710 123142 50095095
Labile hypertension 25.13 9.79 24 386863 447 50217790
Gangrene 25.07 9.79 86 386801 4606 50213631
Listless 24.99 9.79 56 386831 2334 50215903
Arteriosclerosis 24.91 9.79 136 386751 8941 50209296
Generalised oedema 24.81 9.79 185 386702 13546 50204691
Hyperlipidaemia 24.78 9.79 223 386664 17267 50200970
Gastric ulcer haemorrhage 24.68 9.79 83 386804 4401 50213836
Glycosylated haemoglobin increased 24.61 9.79 152 386735 10454 50207783
Type 2 diabetes mellitus 24.43 9.79 158 386729 34217 50184020
Aortic aneurysm 24.38 9.79 67 386820 3178 50215059
Scleral discolouration 24.33 9.79 21 386866 341 50217896
Loose tooth 24.31 9.79 67 386820 3183 50215054
Pathogen resistance 23.71 9.79 7 386880 5682 50212555
Mental status changes 23.50 9.79 399 386488 35873 50182364
Dysphagia 23.49 9.79 767 386120 76751 50141486
Fibromuscular dysplasia 23.24 9.79 16 386871 182 50218055
Blood pressure abnormal 23.18 9.79 172 386715 12575 50205662
Heavy menstrual bleeding 23.02 9.79 53 386834 15484 50202753
C-reactive protein increased 22.76 9.79 364 386523 66110 50152127
Pleural effusion 22.67 9.79 798 386089 80656 50137581
Tubulointerstitial nephritis 22.62 9.79 196 386691 15015 50203222
Neovascularisation 22.58 9.79 33 386854 980 50217257
Hypoglycaemic coma 22.56 9.79 53 386834 2280 50215957
Conjoined twins 22.47 9.79 18 386869 262 50217975
Hepatocellular carcinoma 22.22 9.79 48 386839 1951 50216286
Joint effusion 22.18 9.79 41 386846 12980 50205257
Acute coronary syndrome 22.16 9.79 135 386752 9239 50208998
Foetal death 22.12 9.79 18 386869 8162 50210075
Subdural haematoma 22.03 9.79 172 386715 12775 50205462
Acute motor-sensory axonal neuropathy 22.02 9.79 18 386869 270 50217967
Tongue oedema 21.96 9.79 72 386815 3767 50214470
Psychotic disorder 21.88 9.79 89 386798 21723 50196514
Lymphocyte stimulation test positive 21.87 9.79 23 386864 483 50217754
Device difficult to use 21.84 9.79 26 386861 9860 50208377
Cholecystitis chronic 21.82 9.79 25 386862 9644 50208593
Injection site rash 21.76 9.79 58 386829 16119 50202118
Haemoglobin decreased 21.53 9.79 1184 385703 126032 50092205
Harlequin syndrome 21.53 9.79 9 386878 32 50218205
Prescription drug used without a prescription 21.45 9.79 43 386844 1657 50216580
Haemodialysis 21.43 9.79 123 386764 8239 50209998
Inflammation 21.41 9.79 306 386581 56606 50161631
Lichen nitidus 21.40 9.79 11 386876 69 50218168
Atrioventricular dissociation 21.34 9.79 16 386871 210 50218027
Nephrogenic systemic fibrosis 21.19 9.79 77 386810 4245 50213992
Therapy partial responder 21.17 9.79 12 386875 6579 50211658
Disability 21.08 9.79 41 386846 12734 50205503
Hypoperfusion 20.96 9.79 37 386850 1293 50216944
Tendonitis 20.91 9.79 62 386825 16643 50201594
Diabetic nephropathy 20.78 9.79 37 386850 1302 50216935
Blood aldosterone increased 20.65 9.79 14 386873 155 50218082
Dysgeusia 20.65 9.79 415 386472 38501 50179736
Chronic pigmented purpura 20.65 9.79 11 386876 75 50218162
Diarrhoea 20.63 9.79 4934 381953 583542 49634695
Medication error 20.50 9.79 389 386498 35715 50182522
Hyperkaliuria 20.37 9.79 10 386877 56 50218181
Blood glucose decreased 20.35 9.79 221 386666 17990 50200247
Hypernatraemia 20.33 9.79 99 386788 6222 50212015
Hypertensive heart disease 20.26 9.79 50 386837 2220 50216017
Autoimmune enteropathy 20.25 9.79 6 386881 4 50218233
Electrocardiogram abnormal 20.23 9.79 113 386774 7492 50210745
Anaphylactic reaction 20.21 9.79 291 386596 53764 50164473
Venoocclusive liver disease 20.19 9.79 4 386883 4257 50213980
Dementia 20.19 9.79 199 386688 15798 50202439
Gingival atrophy 20.14 9.79 8 386879 24 50218213
Retinal ischaemia 20.13 9.79 18 386869 307 50217930
Grip strength decreased 19.92 9.79 39 386848 12082 50206155
Gingivitis 19.89 9.79 109 386778 7175 50211062
Device adhesion issue 19.83 9.79 3 386884 3882 50214355
Irritability 19.52 9.79 132 386755 28294 50189943
Gestational diabetes 19.49 9.79 17 386870 7448 50210789
Lymphocele 19.42 9.79 27 386860 765 50217472
Urine albumin/creatinine ratio increased 19.38 9.79 15 386872 207 50218030
Hypoglossal nerve paralysis 19.27 9.79 7 386880 15 50218222
Skin tightness 19.27 9.79 68 386819 3695 50214542
Mucosal inflammation 19.19 9.79 205 386682 39937 50178300
Hypertensive encephalopathy 19.17 9.79 23 386864 561 50217676
Bone marrow failure 19.11 9.79 128 386759 27496 50190741
Ankylosing spondylitis 19.09 9.79 16 386871 7149 50211088
Sinus rhythm 19.06 9.79 24 386863 616 50217621
Acute hepatic failure 19.04 9.79 59 386828 15618 50202619
Hypothermia 19.01 9.79 157 386730 11859 50206378
Upper respiratory tract infection 19.00 9.79 372 386515 65526 50152711
Pseudolymphoma 18.98 9.79 23 386864 567 50217670
Heart rate decreased 18.97 9.79 388 386499 36109 50182128
Periodontitis 18.87 9.79 59 386828 3010 50215227
Gallbladder adenocarcinoma 18.79 9.79 11 386876 92 50218145
Purpura 18.75 9.79 135 386752 9776 50208461
Oral discharge 18.73 9.79 13 386874 150 50218087
Haemodynamic instability 18.62 9.79 115 386772 7909 50210328
Upper gastrointestinal haemorrhage 18.57 9.79 196 386691 15839 50202398
Reduced facial expression 18.55 9.79 39 386848 1555 50216682
Blood uric acid increased 18.54 9.79 68 386819 3766 50214471
Mydriasis 18.52 9.79 33 386854 10594 50207643
Skin candida 18.51 9.79 35 386852 1291 50216946
Device issue 18.50 9.79 84 386803 19888 50198349
Blood lactic acid increased 18.34 9.79 88 386799 5497 50212740
Staphylococcal infection 18.22 9.79 179 386708 35437 50182800
Febrile bone marrow aplasia 18.20 9.79 13 386874 6298 50211939
Sickle cell anaemia with crisis 18.20 9.79 6 386881 4537 50213700
Acute myeloid leukaemia 18.12 9.79 57 386830 15017 50203220
Seizure 18.07 9.79 727 386160 117147 50101090
Rectourethral fistula 18.05 9.79 8 386879 34 50218203
Colitis ulcerative 18.04 9.79 67 386820 16787 50201450
Mood swings 18.02 9.79 62 386825 15892 50202345
Blood cholesterol increased 18.02 9.79 305 386582 54910 50163327
Head discomfort 17.99 9.79 145 386742 10874 50207363
Drug hypersensitivity 17.98 9.79 1663 385224 249347 49968890
Vision blurred 17.97 9.79 754 386133 77893 50140344
Cardiac disorder 17.96 9.79 443 386444 42536 50175701
Rectal ulcer haemorrhage 17.90 9.79 13 386874 162 50218075
Pericardial effusion 17.87 9.79 285 386602 25304 50192933
Blood loss anaemia 17.86 9.79 115 386772 8024 50210213
Protein urine present 17.86 9.79 85 386802 5292 50212945
Adenoma benign 17.64 9.79 26 386861 778 50217459
Blood parathyroid hormone decreased 17.62 9.79 17 386870 7097 50211140
Abnormal loss of weight 17.51 9.79 81 386806 4983 50213254
Restlessness 17.45 9.79 280 386607 24893 50193344
Congenital bladder anomaly 17.32 9.79 13 386874 171 50218066
Body tinea 17.26 9.79 34 386853 1293 50216944
Presyncope 17.09 9.79 270 386617 23928 50194309
Product storage error 17.08 9.79 43 386844 12181 50206056
Cardiac failure chronic 17.06 9.79 63 386824 3500 50214737
Fryns syndrome 17.06 9.79 9 386878 60 50218177
Vitello-intestinal duct remnant 17.02 9.79 8 386879 40 50218197
Putamen haemorrhage 17.01 9.79 13 386874 176 50218061
Urachal abnormality 16.82 9.79 13 386874 179 50218058
Anorexia nervosa 16.82 9.79 13 386874 179 50218058
Lethargy 16.80 9.79 496 386391 48936 50169301
Nephrogenic anaemia 16.78 9.79 39 386848 1666 50216571
Adverse drug reaction 16.76 9.79 309 386578 54913 50163324
Granuloma skin 16.76 9.79 12 386875 5806 50212431
Premature rupture of membranes 16.75 9.79 7 386880 4573 50213664
Lymphocyte count decreased 16.68 9.79 125 386762 26182 50192055
Nodule 16.67 9.79 70 386817 16933 50201304
Bursitis 16.63 9.79 100 386787 22035 50196202
Status epilepticus 16.61 9.79 50 386837 13356 50204881
Gravitational oedema 16.57 9.79 31 386856 1134 50217103
Urinary retention 16.57 9.79 287 386600 25903 50192334
Transcription medication error 16.53 9.79 13 386874 184 50218053
Benign neoplasm of adrenal gland 16.51 9.79 7 386880 26 50218211
Peripheral arterial occlusive disease 16.49 9.79 62 386825 3475 50214762
Gingival pain 16.49 9.79 90 386797 5916 50212321
Albuminuria 16.41 9.79 13 386874 186 50218051
Ventricular failure 16.39 9.79 17 386870 351 50217886
Cytomegalovirus infection 16.37 9.79 76 386811 17886 50200351
Myelosuppression 16.33 9.79 51 386836 13466 50204771
Coordination abnormal 16.31 9.79 147 386740 11387 50206850
Skin discolouration 16.29 9.79 346 386541 32411 50185826
Cardiac arrest 16.28 9.79 789 386098 82862 50135375
Injection site haemorrhage 16.26 9.79 96 386791 21250 50196987
Cerebral haemorrhage 16.24 9.79 294 386593 26758 50191479
Cardiomegaly 16.23 9.79 190 386697 15755 50202482
Organ failure 16.19 9.79 47 386840 2301 50215936
Neurotoxicity 16.17 9.79 58 386829 14682 50203555
Insulin-like growth factor decreased 16.16 9.79 17 386870 357 50217880
Skin induration 16.12 9.79 54 386833 2857 50215380
Osteopenia 16.11 9.79 71 386816 16947 50201290
Blood sodium decreased 16.10 9.79 239 386648 20908 50197329
Skin weeping 16.10 9.79 18 386869 406 50217831
Suspected product quality issue 16.07 9.79 13 386874 192 50218045
Persistent cloaca 16.07 9.79 13 386874 192 50218045
Vertigo 15.99 9.79 514 386373 51318 50166919
Mitral valve incompetence 15.97 9.79 204 386683 17267 50200970
Hypergastrinaemia 15.94 9.79 10 386877 96 50218141
Saliva discolouration 15.93 9.79 7 386880 29 50218208
Cerebral ischaemia 15.86 9.79 88 386799 5820 50212417
Cough 15.86 9.79 2091 384796 239173 49979064
Dialysis 15.85 9.79 125 386762 9313 50208924
Pulse abnormal 15.80 9.79 40 386847 1805 50216432
Gastrointestinal toxicity 15.78 9.79 8 386879 4669 50213568
Generalised tonic-clonic seizure 15.75 9.79 127 386760 26183 50192054
Humerus fracture 15.72 9.79 106 386781 7512 50210725
Congenital acrochordon 15.72 9.79 8 386879 49 50218188
Renal cell carcinoma 15.68 9.79 56 386831 3061 50215176
Haemorrhage intracranial 15.65 9.79 154 386733 12220 50206017
Fluid intake reduced 15.63 9.79 56 386831 3066 50215171
Osteoporosis 15.61 9.79 245 386642 44634 50173603
Substance abuse 15.58 9.79 6 386881 4118 50214119
CD30 expression 15.57 9.79 7 386880 31 50218206
Adverse event 15.53 9.79 238 386649 43525 50174712
Peritoneal effluent leukocyte count increased 15.53 9.79 4 386883 0 50218237
Complication of device insertion 15.48 9.79 14 386873 6027 50212210
Metabolic alkalosis 15.43 9.79 51 386836 2680 50215557
Tachypnoea 15.42 9.79 175 386712 14402 50203835
Blood cholinesterase decreased 15.35 9.79 10 386877 103 50218134
Carotid arteriosclerosis 15.29 9.79 27 386860 944 50217293
Full blood count decreased 15.28 9.79 248 386639 22098 50196139
Maternal drugs affecting foetus 15.25 9.79 10 386877 5067 50213170
Device deployment issue 15.13 9.79 4 386883 3492 50214745
Coeliac disease 15.11 9.79 27 386860 8658 50209579
Infected dermal cyst 15.10 9.79 18 386869 436 50217801
Jaundice 15.09 9.79 285 386602 26144 50192093
Ventricular septal defect 15.06 9.79 6 386881 4035 50214202
Zinc deficiency 15.06 9.79 7 386880 34 50218203
Taste disorder 14.95 9.79 112 386775 8212 50210025
Dermatitis bullous 14.92 9.79 100 386787 7073 50211164
Neurosensory hypoacusis 14.91 9.79 13 386874 214 50218023
Dysphoria 14.90 9.79 9 386878 4765 50213472
Hypertensive angiopathy 14.83 9.79 9 386878 81 50218156
Hyperplastic cholecystopathy 14.83 9.79 9 386878 81 50218156
Joint stiffness 14.80 9.79 154 386733 30154 50188083
Oropharyngeal swelling 14.79 9.79 24 386863 782 50217455
Finger deformity 14.76 9.79 13 386874 5669 50212568
Schizophrenia 14.75 9.79 21 386866 7376 50210861
Apical granuloma 14.74 9.79 7 386880 36 50218201
Inhibitory drug interaction 14.73 9.79 44 386843 2189 50216048
Exercise tolerance decreased 14.73 9.79 75 386812 4799 50213438
Kidney transplant rejection 14.71 9.79 65 386822 3922 50214315
Acute respiratory failure 14.63 9.79 305 386582 28477 50189760
Temperature regulation disorder 14.61 9.79 7 386880 4220 50214017
Forced vital capacity decreased 14.60 9.79 26 386861 915 50217322
Product solubility abnormal 14.59 9.79 23 386864 731 50217506
Sleep disorder 14.57 9.79 330 386557 56953 50161284
Electrocardiogram U wave present 14.56 9.79 9 386878 84 50218153
Joint injury 14.56 9.79 102 386785 21687 50196550
Arterial occlusive disease 14.54 9.79 74 386813 4734 50213503
Soft tissue disorder 14.53 9.79 7 386880 4207 50214030
Post transplant lymphoproliferative disorder 14.47 9.79 7 386880 4197 50214040
Renal transplant 14.39 9.79 30 386857 1189 50217048
Vasculitis 14.37 9.79 167 386720 13824 50204413
Ventricular extrasystoles 14.35 9.79 133 386754 10383 50207854
Oxalosis 14.29 9.79 7 386880 39 50218198
Hyperprolactinaemia 14.28 9.79 4 386883 3361 50214876
Norepinephrine increased 14.28 9.79 8 386879 61 50218176
Chondroma 14.21 9.79 6 386881 22 50218215
Pancreatic toxicity 14.21 9.79 6 386881 22 50218215
Amenorrhoea 14.20 9.79 27 386860 8457 50209780
Kidney fibrosis 14.19 9.79 35 386852 1554 50216683
Thirst 14.18 9.79 134 386753 10516 50207721
Crush syndrome 14.15 9.79 10 386877 119 50218118
Gout 14.14 9.79 142 386745 11328 50206909
Renal tubular necrosis 14.08 9.79 129 386758 10039 50208198
Labelled drug-drug interaction medication error 14.04 9.79 132 386755 10345 50207892
Cytokine release syndrome 14.00 9.79 28 386859 8606 50209631
Congenital nail disorder 13.96 9.79 9 386878 91 50218146
Multiple-drug resistance 13.95 9.79 4 386883 3310 50214927
Intestinal ischaemia 13.93 9.79 94 386793 6663 50211574
Hallucination, gustatory 13.86 9.79 8 386879 65 50218172
Skin necrosis 13.85 9.79 40 386847 10827 50207410
Dermatosis 13.84 9.79 13 386874 237 50218000
Dyslalia 13.78 9.79 17 386870 427 50217810
Genital haemorrhage 13.78 9.79 18 386869 6556 50211681
Prescribed overdose 13.77 9.79 61 386826 14539 50203698
Microalbuminuria 13.71 9.79 15 386872 330 50217907
Dystonia 13.71 9.79 46 386841 11880 50206357
Burn oesophageal 13.68 9.79 11 386876 161 50218076
Platelet aggregation decreased 13.63 9.79 6 386881 25 50218212
Rib deformity 13.62 9.79 11 386876 162 50218075
Cerebrovascular disorder 13.56 9.79 47 386840 2531 50215706
Deformity 13.53 9.79 25 386862 7915 50210322
Electrolyte imbalance 13.45 9.79 195 386692 16974 50201263
Hyperparathyroidism secondary 13.42 9.79 31 386856 1319 50216918
Dermatitis exfoliative 13.41 9.79 76 386811 5066 50213171
Diverticulum intestinal haemorrhagic 13.39 9.79 29 386858 1181 50217056
Hypomania 13.36 9.79 9 386878 4496 50213741
Intestinal villi atrophy 13.30 9.79 11 386876 168 50218069
Suicidal ideation 13.27 9.79 322 386565 55063 50163174
Bradyarrhythmia 13.19 9.79 38 386849 1852 50216385
Device malfunction 13.18 9.79 65 386822 15056 50203181
Essential hypertension 13.16 9.79 68 386819 4376 50213861
Sinus arrhythmia 13.13 9.79 31 386856 1338 50216899
Stomatitis haemorrhagic 13.09 9.79 6 386881 28 50218209
Lichen planus 13.06 9.79 39 386848 1940 50216297
Macular degeneration 13.04 9.79 61 386826 14327 50203910
Capillary disorder 13.00 9.79 8 386879 74 50218163
Skin haemorrhage 12.95 9.79 94 386793 6824 50211413
Cystic fibrosis 12.93 9.79 3 386884 2861 50215376
Ischaemic cardiomyopathy 12.90 9.79 43 386844 2269 50215968
Toxic epidermal necrolysis 12.90 9.79 229 386658 20763 50197474
Retroperitoneal haematoma 12.88 9.79 47 386840 2596 50215641
Interstitial lung disease 12.88 9.79 513 386374 52663 50165574
Cell marker increased 12.87 9.79 13 386874 260 50217977
Pigmentation disorder 12.87 9.79 60 386827 3704 50214533
Atrial pressure increased 12.84 9.79 5 386882 14 50218223
No adverse event 12.82 9.79 180 386707 33398 50184839
Blood sodium increased 12.81 9.79 44 386843 2358 50215879
Diabetes mellitus 12.81 9.79 477 386410 48556 50169681
Venous aneurysm 12.78 9.79 4 386883 4 50218233
Jaundice hepatocellular 12.77 9.79 6 386881 30 50218207
Sinus node dysfunction 12.76 9.79 62 386825 3893 50214344
Heat illness 12.74 9.79 10 386877 141 50218096
Metastatic renal cell carcinoma 12.68 9.79 22 386865 758 50217479
Cerebral atrophy 12.67 9.79 69 386818 4532 50213705
Pulmonary hypertension 12.66 9.79 340 386547 33077 50185160
Bowel movement irregularity 12.66 9.79 62 386825 3906 50214331
Diffuse large B-cell lymphoma refractory 12.65 9.79 26 386861 1020 50217217
Duodenal ulcer 12.65 9.79 92 386795 6683 50211554
Multiple drug therapy 12.62 9.79 38 386849 1899 50216338
Nephropathy 12.61 9.79 76 386811 5182 50213055
Renal aneurysm 12.59 9.79 5 386882 15 50218222
Psychogenic visual disorder 12.59 9.79 5 386882 15 50218222
Hepatorenal failure 12.52 9.79 19 386868 584 50217653
Maternal exposure timing unspecified 12.50 9.79 6 386881 3614 50214623
Dislocation of vertebra 12.50 9.79 4 386883 3083 50215154
Femoral neck fracture 12.47 9.79 99 386788 7391 50210846
Eye oedema 12.43 9.79 30 386857 1313 50216924
Duodenal ulcer repair 12.43 9.79 7 386880 54 50218183
Small cell carcinoma 12.40 9.79 10 386877 147 50218090
Gingival disorder 12.39 9.79 53 386834 3152 50215085
Normal newborn 12.37 9.79 20 386867 6671 50211566
Blood cholinesterase increased 12.35 9.79 5 386882 16 50218221
Thalamus haemorrhage 12.35 9.79 19 386868 591 50217646
Ocular icterus 12.33 9.79 56 386831 3419 50214818
Hospice care 12.33 9.79 81 386806 5691 50212546
Bromhidrosis 12.32 9.79 4 386883 5 50218232
Lymphadenopathy 12.29 9.79 181 386706 33318 50184919
Gastrointestinal stromal tumour 12.29 9.79 24 386863 907 50217330
Concomitant disease progression 12.28 9.79 39 386848 2006 50216231
Hypoacusis 12.26 9.79 224 386663 20423 50197814
Retinopathy hypertensive 12.24 9.79 12 386875 231 50218006
Biopsy kidney 12.20 9.79 9 386878 115 50218122
Sensorimotor disorder 12.20 9.79 16 386871 428 50217809
Sudden hearing loss 12.16 9.79 26 386861 1049 50217188
Injection site induration 12.15 9.79 29 386858 8368 50209869
Enterochromaffin cell hyperplasia 12.11 9.79 7 386880 57 50218180
Acute pulmonary oedema 12.07 9.79 96 386791 7171 50211066
Rales 12.05 9.79 123 386764 9855 50208382
Ventricular internal diameter abnormal 12.03 9.79 6 386881 35 50218202
Anti-erythropoietin antibody positive 12.00 9.79 15 386872 382 50217855
Hand dermatitis 12.00 9.79 8 386879 86 50218151
Bladder sphincter atony 11.97 9.79 10 386877 155 50218082
Muscular weakness 11.96 9.79 862 386025 94151 50124086
Hypophagia 11.94 9.79 287 386600 27441 50190796
Faeces hard 11.93 9.79 33 386854 1571 50216666
Hypoxia 11.87 9.79 491 386396 50632 50167605
Breast cancer stage III 11.87 9.79 5 386882 3251 50214986
Bifascicular block 11.82 9.79 9 386878 121 50218116
Blood phosphorus increased 11.82 9.79 45 386842 2537 50215700
Agitation 11.81 9.79 314 386573 53070 50165167
Dry skin 11.73 9.79 422 386465 42769 50175468
Renal function test abnormal 11.71 9.79 48 386839 2801 50215436
Cytotoxic oedema 11.70 9.79 9 386878 123 50218114
Gamma-glutamyltransferase increased 11.69 9.79 303 386584 29320 50188917
Immune reconstitution inflammatory syndrome 11.67 9.79 15 386872 5501 50212736
Glucose tolerance impaired 11.65 9.79 73 386814 5045 50213192
Adrenal gland cancer metastatic 11.64 9.79 3 386884 0 50218237
Blood pressure difference of extremities 11.64 9.79 3 386884 0 50218237
Mixed dementia 11.64 9.79 3 386884 0 50218237
Typical aura without headache 11.64 9.79 3 386884 0 50218237
Tongue abscess 11.64 9.79 3 386884 0 50218237
Peripheral nerve paresis 11.64 9.79 3 386884 0 50218237
Carbohydrate metabolism disorder 11.64 9.79 3 386884 0 50218237
Cardiac index increased 11.64 9.79 3 386884 0 50218237
Azotaemia 11.64 9.79 61 386826 3947 50214290
Skin exfoliation 11.62 9.79 338 386549 33274 50184963
Congenital diaphragmatic hernia 11.60 9.79 11 386876 203 50218034
Urinary incontinence 11.56 9.79 290 386597 27918 50190319
Yellow skin 11.56 9.79 38 386849 1991 50216246
Leukaemic infiltration renal 11.51 9.79 5 386882 20 50218217
Retroperitoneal oedema 11.51 9.79 5 386882 20 50218217
Pernicious anaemia 11.50 9.79 19 386868 629 50217608
Vaginal haemorrhage 11.49 9.79 126 386761 24425 50193812
Head banging 11.48 9.79 15 386872 400 50217837
Device use error 11.47 9.79 14 386873 5252 50212985
Cerebellar haemorrhage 11.47 9.79 28 386859 1235 50217002
Brain stem infarction 11.46 9.79 21 386866 756 50217481
Tonsillar inflammation 11.41 9.79 8 386879 94 50218143
Internal haemorrhage 11.34 9.79 65 386822 4352 50213885
Blood lactic acid 11.34 9.79 8 386879 95 50218142
Liver injury 11.33 9.79 128 386759 24678 50193559
Congenital syphilitic osteochondritis 11.32 9.79 5 386882 21 50218216
Hallucination, visual 11.32 9.79 184 386703 16398 50201839
Cardiac hypertrophy 11.28 9.79 24 386863 965 50217272
Aggression 11.28 9.79 105 386782 21011 50197226
Hypereosinophilic syndrome 11.22 9.79 12 386875 257 50217980
Pulmonary arterial hypertension 11.22 9.79 218 386669 20101 50198136
Synovial cyst 11.20 9.79 29 386858 8137 50210100
Rheumatoid factor negative 11.20 9.79 18 386869 582 50217655
Hypertonic bladder 11.13 9.79 49 386838 2951 50215286
Oesophageal food impaction 11.11 9.79 10 386877 172 50218065
Drug tolerance 11.09 9.79 13 386874 4963 50213274
Malignant hypertension 11.05 9.79 25 386862 1049 50217188
Dilatation ventricular 11.04 9.79 41 386846 2284 50215953
Myoglobin blood increased 11.04 9.79 28 386859 1265 50216972
Colitis ischaemic 11.02 9.79 116 386771 9367 50208870
Gastric pH increased 11.02 9.79 6 386881 43 50218194
Gastric cancer 10.98 9.79 49 386838 2969 50215268
Porphyrins urine increased 10.97 9.79 5 386882 23 50218214
Acquired porphyria 10.97 9.79 5 386882 23 50218214
Cardiac valve sclerosis 10.97 9.79 5 386882 23 50218214
Flatulence 10.96 9.79 299 386588 29159 50189078
Peritonitis bacterial 10.94 9.79 67 386820 4594 50213643
Gastric cyst 10.93 9.79 8 386879 101 50218136
Graft versus host disease in skin 10.92 9.79 3 386884 2553 50215684
Renal neoplasm 10.89 9.79 25 386862 1059 50217178
Fibrosis 10.87 9.79 57 386830 3690 50214547
Menstruation irregular 10.86 9.79 19 386868 6143 50212094
Therapeutic product effect increased 10.84 9.79 24 386863 992 50217245
Nephrotic syndrome 10.84 9.79 68 386819 4702 50213535
Base excess decreased 10.84 9.79 7 386880 71 50218166
Pulmonary alveolar haemorrhage 10.82 9.79 60 386827 3967 50214270
Joint range of motion decreased 10.79 9.79 90 386797 18422 50199815
End stage renal disease 10.77 9.79 78 386809 5659 50212578
Chromaturia 10.76 9.79 164 386723 14426 50203811
Haemorrhagic erosive gastritis 10.76 9.79 12 386875 270 50217967
Osteoarthritis 10.76 9.79 422 386465 68184 50150053
Hypertensive urgency 10.75 9.79 10 386877 180 50218057
Urine flow decreased 10.73 9.79 11 386876 224 50218013
Disease recurrence 10.66 9.79 100 386787 19981 50198256
Dry eye 10.57 9.79 177 386710 31918 50186319
Glomerulonephritis 10.55 9.79 31 386856 1528 50216709
Peritoneal dialysis complication 10.53 9.79 26 386861 1155 50217082
Hyperparathyroidism primary 10.50 9.79 13 386874 328 50217909
Pulmonary hypoplasia 10.48 9.79 12 386875 278 50217959
Orthopnoea 10.48 9.79 77 386810 5612 50212625
Bacteriuria 10.41 9.79 19 386868 682 50217555
Small for dates baby 10.40 9.79 7 386880 3498 50214739
Neurofibrosarcoma 10.38 9.79 9 386878 147 50218090
Pneumonia viral 10.38 9.79 23 386864 6811 50211426
Mouth haemorrhage 10.37 9.79 82 386805 6114 50212123
Subarachnoid haemorrhage 10.35 9.79 127 386760 10649 50207588
Acute graft versus host disease 10.35 9.79 9 386878 3949 50214288
Therapeutic drug monitoring analysis not performed 10.33 9.79 19 386868 686 50217551
Renal cyst infection 10.30 9.79 8 386879 111 50218126
Sinoatrial block 10.26 9.79 20 386867 755 50217482
Oesophageal carcinoma recurrent 10.19 9.79 5 386882 28 50218209
Iliac artery occlusion 10.19 9.79 9 386878 151 50218086
Skin toxicity 10.11 9.79 9 386878 3904 50214333
Oesophageal atresia 10.09 9.79 16 386871 511 50217726
Periarticular disorder 10.07 9.79 6 386881 52 50218185
Oculomucocutaneous syndrome 10.07 9.79 8 386879 115 50218122
Haemorrhagic diathesis 10.07 9.79 58 386829 3890 50214347
Haematoma 10.06 9.79 305 386582 30205 50188032
Pneumothorax traumatic 10.04 9.79 9 386878 154 50218083
Oesophageal achalasia 10.01 9.79 14 386873 399 50217838
Carcinoid tumour of the stomach 9.99 9.79 9 386878 155 50218082
Cardiovascular disorder 9.95 9.79 123 386764 10331 50207906
Tracheo-oesophageal fistula 9.94 9.79 16 386871 518 50217719
Cerebrovascular insufficiency 9.93 9.79 7 386880 83 50218154
Psychomotor retardation 9.91 9.79 52 386835 3366 50214871
Femoral artery dissection 9.91 9.79 5 386882 30 50218207
Interstitial granulomatous dermatitis 9.91 9.79 5 386882 30 50218207
Porphyrins stool increased 9.91 9.79 5 386882 30 50218207
Congenital uterine anomaly 9.90 9.79 8 386879 118 50218119
Carcinoid tumour 9.90 9.79 12 386875 296 50217941
Contusion 9.87 9.79 731 386156 111452 50106785
Blood sodium abnormal 9.86 9.79 18 386869 646 50217591
Urate nephropathy 9.84 9.79 8 386879 119 50218118
Traumatic haemorrhage 9.84 9.79 15 386872 463 50217774
Vascular pseudoaneurysm 9.83 9.79 28 386859 1356 50216881
Drug screen positive 9.82 9.79 7 386880 3395 50214842
Change of bowel habit 9.80 9.79 33 386854 1751 50216486

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
Completed suicide 600.81 11.01 2198 308502 88048 29175779
Gingival hypertrophy 390.47 11.01 234 310466 1431 29262396
Drug abuse 389.02 11.01 176 310524 79707 29184120
Off label use 337.69 11.01 1822 308878 298978 28964849
Drug ineffective 324.15 11.01 2362 308338 360808 28903019
Blood pressure inadequately controlled 261.49 11.01 210 310490 2176 29261651
Shock 214.94 11.01 601 310099 20803 29243024
Hypertensive crisis 181.77 11.01 309 310391 7539 29256288
Neutropenia 176.25 11.01 748 309952 130963 29132864
Foetal exposure during pregnancy 175.40 11.01 68 310632 33799 29230028
Product use in unapproved indication 173.40 11.01 412 310288 86463 29177364
Intentional overdose 168.95 11.01 827 309873 37701 29226126
Hypotension 165.88 11.01 2915 307785 191439 29072388
Febrile neutropenia 165 11.01 614 310086 111626 29152201
Oedema peripheral 158.72 11.01 1725 308975 101832 29161995
Treatment failure 148.58 11.01 103 310597 36836 29226991
Bradycardia 142.31 11.01 1177 309523 64452 29199375
Angioedema 139.15 11.01 684 310016 31231 29232596
Non-cardiogenic pulmonary oedema 138.99 11.01 85 310615 542 29263285
Acute kidney injury 136.88 11.01 3700 307000 261567 29002260
Death 133.96 11.01 2663 308037 339421 28924406
Distributive shock 121.57 11.01 93 310607 892 29262935
Blood pressure increased 116.07 11.01 1236 309464 72567 29191260
Syncope 109.12 11.01 1321 309379 80050 29183777
Cerebral infarction 103.42 11.01 523 310177 24152 29239675
Angina pectoris 93.66 11.01 556 310144 27294 29236533
Blood creatinine increased 90.22 11.01 1324 309376 83778 29180049
Thrombocytopenia 89.74 11.01 944 309756 133879 29129948
Drug resistance 82.78 11.01 63 310637 21477 29242350
Swollen tongue 82.42 11.01 300 310400 11966 29251861
Lip swelling 77.12 11.01 296 310404 12114 29251713
Premature baby 76.64 11.01 43 310657 17237 29246590
Hyperkalaemia 75.98 11.01 982 309718 60410 29203417
Hypokalaemia 75.28 11.01 833 309867 49370 29214457
Drug dependence 73.67 11.01 67 310633 20914 29242913
Renal impairment 71.69 11.01 1227 309473 80106 29183721
Blood pressure systolic increased 69.15 11.01 355 310345 16490 29247337
Cerebrovascular accident 69.13 11.01 1164 309536 75747 29188080
Chronic kidney disease 68.42 11.01 633 310067 35783 29228044
Rhabdomyolysis 66.37 11.01 951 309749 59857 29203970
Immune reconstitution inflammatory syndrome 65.90 11.01 4 310696 7798 29256029
Pancytopenia 65.23 11.01 559 310141 82609 29181218
Metabolic acidosis 63.54 11.01 640 310060 37022 29226805
Aggression 60.66 11.01 182 310518 35359 29228468
Sepsis 59.75 11.01 1097 309603 141585 29122242
Pyrexia 59.44 11.01 2445 308255 285177 28978650
Product use issue 58.79 11.01 309 310391 51135 29212692
Infusion related reaction 58.73 11.01 249 310451 43637 29220190
Dizziness 58.29 11.01 2492 308208 187192 29076635
Pathogen resistance 56.04 11.01 9 310691 8107 29255720
Suspected suicide 53.97 11.01 126 310574 3894 29259933
Exposure during pregnancy 51.74 11.01 13 310687 8541 29255286
Leukopenia 49.81 11.01 357 310343 54846 29208981
Rheumatoid arthritis 49.74 11.01 172 310528 31980 29231847
Septic shock 47.04 11.01 425 310275 62135 29201692
Mucosal inflammation 46.89 11.01 172 310528 31423 29232404
Progressive multifocal leukoencephalopathy 45.98 11.01 17 310683 8702 29255125
Vasoplegia syndrome 45.46 11.01 67 310633 1441 29262386
Nephrotic syndrome 45.27 11.01 158 310542 6170 29257657
Multiple organ dysfunction syndrome 45.21 11.01 434 310266 62682 29201145
Myalgia 44.28 11.01 1054 309646 72965 29190862
Myocardial depression 44.16 11.01 18 310682 38 29263789
Suicide attempt 44.04 11.01 550 310150 33560 29230267
Glycosylated haemoglobin increased 43.94 11.01 206 310494 9220 29254607
Proteinuria 43.54 11.01 300 310400 15504 29248323
Chronic pigmented purpura 43.42 11.01 22 310678 91 29263736
Gingival swelling 42.47 11.01 56 310644 1081 29262746
Lactic acidosis 42.22 11.01 495 310205 29752 29234075
Agitation 41.94 11.01 341 310359 50963 29212864
Pemphigoid 41.64 11.01 174 310526 7407 29256420
Renal cell carcinoma 41.49 11.01 126 310574 4570 29259257
Acute graft versus host disease 41.26 11.01 6 310694 5818 29258009
Palmar-plantar erythrodysaesthesia syndrome 41.16 11.01 281 310419 14478 29249349
Seizure 41.15 11.01 709 309991 92414 29171413
Renal artery stenosis 39.96 11.01 73 310627 1888 29261939
Pulmonary oedema 39.92 11.01 651 310049 42084 29221743
Myelosuppression 39.51 11.01 42 310658 12185 29251642
Cardiac failure congestive 39.47 11.01 1069 309631 75512 29188315
Drug ineffective for unapproved indication 39.41 11.01 55 310645 14159 29249668
Synovitis 39.16 11.01 34 310666 10856 29252971
Infective pulmonary exacerbation of cystic fibrosis 38.65 11.01 9 310691 6227 29257600
Tachycardia 38.55 11.01 532 310168 71878 29191949
Cytokine release syndrome 38.16 11.01 49 310651 13070 29250757
Atrioventricular block complete 38.02 11.01 176 310524 7835 29255992
Orthostatic hypotension 37.89 11.01 384 310316 22245 29241582
Suicidal ideation 37.74 11.01 212 310488 34504 29229323
Depression 37.71 11.01 648 310052 84499 29179328
Contraindicated product administered 37.70 11.01 85 310615 18181 29245646
C-reactive protein abnormal 37.53 11.01 11 310689 6525 29257302
Hypomagnesaemia 37.12 11.01 312 310388 17156 29246671
Sedation 36.74 11.01 80 310620 17325 29246502
Intentional product use issue 36.34 11.01 279 310421 42219 29221608
Haemophagocytic lymphohistiocytosis 36.33 11.01 34 310666 10470 29253357
Gastrointestinal tract mucosal pigmentation 36.32 11.01 31 310669 352 29263475
Bronchopulmonary aspergillosis 36.02 11.01 46 310654 12298 29251529
5-hydroxyindolacetic acid in urine increased 35.64 11.01 25 310675 207 29263620
Dermatomyositis 35.17 11.01 49 310651 999 29262828
Thalamus haemorrhage 34.96 11.01 46 310654 886 29262941
Interstitial lung disease 34.85 11.01 823 309877 56895 29206932
Hypertension 34.62 11.01 1527 309173 115087 29148740
Aspergillus infection 34.58 11.01 36 310664 10545 29253282
Hypoglycaemia 34.14 11.01 705 309995 47641 29216186
Post transplant lymphoproliferative disorder 33.90 11.01 8 310692 5485 29258342
Injection site pain 33.73 11.01 201 310499 32245 29231582
Nocturia 33.47 11.01 175 310525 8187 29255640
Infection 33.37 11.01 586 310114 76165 29187662
Bone marrow failure 32.98 11.01 162 310538 27287 29236540
Abnormal behaviour 32.32 11.01 129 310571 22998 29240829
Haematotoxicity 32.20 11.01 15 310685 6684 29257143
Cytomegalovirus infection 32.12 11.01 130 310570 23085 29240742
Renal failure 31.75 11.01 1537 309163 117062 29146765
Diastolic dysfunction 31.64 11.01 121 310579 4943 29258884
Gingival bleeding 31.54 11.01 143 310557 6310 29257517
Product monitoring error 31.34 11.01 79 310621 2566 29261261
Respiratory depression 31.23 11.01 59 310641 13464 29250363
Wrong technique in product usage process 30.95 11.01 198 310502 31230 29232597
Carotid artery stenosis 30.61 11.01 110 310590 4359 29259468
Multiple-drug resistance 30.13 11.01 3 310697 3897 29259930
Graft versus host disease 30.09 11.01 34 310666 9594 29254233
Irritability 30.05 11.01 125 310575 22027 29241800
Peripheral swelling 29.57 11.01 878 309822 62861 29200966
Plasmapheresis 29.07 11.01 25 310675 287 29263540
Polymyositis 29.06 11.01 51 310649 1277 29262550
Sinus bradycardia 28.92 11.01 215 310485 11388 29252439
Chronic graft versus host disease 28.89 11.01 4 310696 4025 29259802
Febrile bone marrow aplasia 28.89 11.01 21 310679 7330 29256497
Substance abuse 28.53 11.01 18 310682 6769 29257058
Primary hyperaldosteronism 28.37 11.01 14 310686 54 29263773
Therapeutic product effect decreased 28.27 11.01 187 310513 29264 29234563
Disease progression 27.68 11.01 652 310048 81264 29182563
Psychotic disorder 27.52 11.01 115 310585 20239 29243588
Mucormycosis 27.29 11.01 10 310690 5148 29258679
Cardiogenic shock 27.20 11.01 315 310385 18875 29244952
Electrocardiogram QRS complex prolonged 27.17 11.01 100 310600 4010 29259817
Vertebral osteophyte 26.97 11.01 13 310687 47 29263780
Myocardial infarction 26.96 11.01 1417 309283 108879 29154948
Palpitations 26.94 11.01 487 310213 32117 29231710
Sinusitis 26.85 11.01 231 310469 34119 29229708
Breath sounds abnormal 26.72 11.01 121 310579 5336 29258491
Macroglossia 26.65 11.01 26 310674 355 29263472
Transient ischaemic attack 26.60 11.01 367 310333 22903 29240924
Myelodysplastic syndrome 26.31 11.01 97 310603 17697 29246130
Eczema 26.29 11.01 241 310459 13585 29250242
Accelerated hypertension 26.27 11.01 21 310679 216 29263611
Pseudolymphoma 26.23 11.01 30 310670 497 29263330
Pelvic mass 26.13 11.01 20 310680 192 29263635
Neutrophil count decreased 25.79 11.01 313 310387 43254 29220573
Hyperplasia 25.77 11.01 30 310670 507 29263320
Periodontitis 25.55 11.01 58 310642 1759 29262068
Akathisia 25.54 11.01 20 310680 6722 29257105
Coma 25.47 11.01 278 310422 39172 29224655
Stenosis 25.45 11.01 42 310658 999 29262828
Staphylococcal infection 25.45 11.01 191 310509 29049 29234778
Loss of consciousness 25.44 11.01 985 309715 73071 29190756
Candida infection 25.23 11.01 79 310621 15146 29248681
Hypertensive heart disease 25.03 11.01 63 310637 2044 29261783
Metastatic renal cell carcinoma 24.87 11.01 59 310641 1843 29261984
Hyponatraemia 24.78 11.01 906 309794 66727 29197100
Orbital myositis 24.74 11.01 16 310684 114 29263713
Drug withdrawal syndrome 24.69 11.01 101 310599 17883 29245944
Atrioventricular block first degree 24.61 11.01 116 310584 5203 29258624
Blood mercury abnormal 24.36 11.01 19 310681 188 29263639
Acute hepatic failure 24.35 11.01 56 310644 11896 29251931
Diabetes mellitus inadequate control 24.35 11.01 214 310486 11920 29251907
Coronary artery disease 24.24 11.01 622 310078 43568 29220259
Condition aggravated 24.20 11.01 1273 309427 145022 29118805
Aortic dissection 23.98 11.01 67 310633 2317 29261510
Lymphadenopathy 23.56 11.01 160 310540 24889 29238938
Clear cell renal cell carcinoma 23.55 11.01 40 310660 975 29262852
Disease recurrence 23.37 11.01 87 310613 15827 29248000
Acute myocardial infarction 22.94 11.01 669 310031 47769 29216058
Adenovirus infection 22.90 11.01 9 310691 4438 29259389
Diabetic nephropathy 22.87 11.01 57 310643 1838 29261989
Erectile dysfunction 22.65 11.01 289 310411 17720 29246107
Carotid sinus syndrome 22.61 11.01 10 310690 28 29263799
Overdose 22.31 11.01 1039 309661 78780 29185047
Dystonia 22.11 11.01 43 310657 9706 29254121
Ventricular septal defect 22.06 11.01 5 310695 3524 29260303
Alcohol abuse 21.94 11.01 9 310691 4324 29259503
Tongue oedema 21.88 11.01 68 310632 2498 29261329
Hepatojugular reflux 21.78 11.01 26 310674 452 29263375
Hospitalisation 21.65 11.01 346 310354 45642 29218185
Maternal drugs affecting foetus 21.54 11.01 7 310693 3886 29259941
Dyskinesia 21.53 11.01 123 310577 19938 29243889
Drug intolerance 21.46 11.01 368 310332 48011 29215816
Cytomegalovirus chorioretinitis 21.46 11.01 4 310696 3234 29260593
Asthma 21.45 11.01 486 310214 33363 29230464
Carotid arteriosclerosis 21.45 11.01 47 310653 1391 29262436
Obstructive airways disorder 21.45 11.01 193 310507 10823 29253004
Hypoinsulinaemia 21.40 11.01 6 310694 0 29263827
Leukaemoid reaction 21.24 11.01 13 310687 83 29263744
Drug use disorder 21.09 11.01 5 310695 3417 29260410
Device issue 20.68 11.01 31 310669 7749 29256078
Gout 20.68 11.01 270 310430 16641 29247186
Pulmonary embolism 20.66 11.01 629 310071 75905 29187922
Hyperdynamic left ventricle 20.65 11.01 14 310686 109 29263718
Cytomegalovirus infection reactivation 20.56 11.01 5 310695 3359 29260468
Lung diffusion test decreased 20.53 11.01 28 310672 559 29263268
Psoriatic arthropathy 20.49 11.01 82 310618 14609 29249218
Therapeutic product effect incomplete 20.47 11.01 290 310410 39015 29224812
Renal disorder 20.28 11.01 342 310358 22253 29241574
Therapy partial responder 20.24 11.01 15 310685 5184 29258643
Lipodystrophy acquired 20.13 11.01 4 310696 3090 29260737
Arthropathy 20.11 11.01 138 310562 21416 29242411
Status epilepticus 20.09 11.01 53 310647 10741 29253086
Product dose omission issue 20.08 11.01 818 309882 95565 29168262
Blood creatine phosphokinase increased 19.98 11.01 564 310136 40080 29223747
Apparent death 19.93 11.01 6 310694 3498 29260329
Ear infection 19.91 11.01 34 310666 8066 29255761
Fall 19.87 11.01 2139 308561 175039 29088788
Lacunar infarction 19.83 11.01 70 310630 2749 29261078
Pseudomonas infection 19.66 11.01 54 310646 10798 29253029
Neurotoxicity 19.48 11.01 83 310617 14530 29249297
No adverse event 19.39 11.01 106 310594 17372 29246455
Pneumonia 19.37 11.01 3011 307689 317161 28946666
Electrocardiogram Q wave abnormal 19.29 11.01 20 310680 295 29263532
Lymphocele 19.27 11.01 43 310657 1289 29262538
Brain stem infarction 19.26 11.01 39 310661 1091 29262736
Blood glucose increased 19.20 11.01 780 309920 58204 29205623
Bone erosion 19.19 11.01 3 310697 2757 29261070
Microalbuminuria 19.17 11.01 29 310671 639 29263188
Dyspnoea 19.02 11.01 3798 306902 322934 28940893
Venoocclusive liver disease 18.94 11.01 27 310673 6890 29256937
Atrioventricular block 18.91 11.01 132 310568 6850 29256977
Small for dates baby 18.83 11.01 7 310693 3572 29260255
Graft versus host disease in skin 18.83 11.01 6 310694 3373 29260454
Haemorrhage subcutaneous 18.76 11.01 57 310643 2068 29261759
Maternal exposure during pregnancy 18.66 11.01 10 310690 4113 29259714
Mouth swelling 18.60 11.01 47 310653 1529 29262298
Blood pressure diastolic decreased 18.58 11.01 132 310568 6890 29256937
Congenital hiatus hernia 18.45 11.01 23 310677 419 29263408
Zoonotic bacterial infection 18.43 11.01 10 310690 49 29263778
Chills 18.27 11.01 590 310110 70710 29193117
Atheroembolism 18.15 11.01 17 310683 220 29263607
Heart rate decreased 18.15 11.01 365 310335 24547 29239280
Paranoia 18.00 11.01 49 310651 9828 29253999
Acute myeloid leukaemia 17.85 11.01 101 310599 16412 29247415
Nipple inflammation 17.82 11.01 10 310690 53 29263774
Left ventricular hypertrophy 17.73 11.01 126 310574 6577 29257250
Intentional self-injury 17.73 11.01 69 310631 12392 29251435
Diffuse large B-cell lymphoma recurrent 17.66 11.01 3 310697 2594 29261233
Melaena 17.44 11.01 440 310260 30736 29233091
Mydriasis 17.42 11.01 23 310677 6062 29257765
Bundle branch block 17.31 11.01 31 310669 789 29263038
Hepatic failure 17.30 11.01 230 310470 31282 29232545
Skin toxicity 17.28 11.01 9 310691 3762 29260065
Hyperlipidaemia 17.10 11.01 205 310495 12385 29251442
Angina unstable 17.06 11.01 182 310518 10683 29253144
Dysmorphism 17.06 11.01 5 310695 2966 29260861
Haemodynamic instability 17.05 11.01 144 310556 7929 29255898
Multiple sclerosis relapse 17.05 11.01 62 310638 11357 29252470
Product substitution issue 17.00 11.01 159 310541 9013 29254814
Liver carcinoma ruptured 16.98 11.01 14 310686 151 29263676
Tenosynovitis 16.97 11.01 9 310691 3724 29260103
Milk-alkali syndrome 16.91 11.01 24 310676 498 29263329
Fungal infection 16.88 11.01 80 310620 13605 29250222
Hypertensive emergency 16.88 11.01 31 310669 805 29263022
Peripheral arterial occlusive disease 16.84 11.01 101 310599 4975 29258852
Obsessive-compulsive disorder 16.80 11.01 14 310686 4562 29259265
Myopathy 16.80 11.01 177 310523 10356 29253471
Hyperuricaemia 16.80 11.01 127 310573 6762 29257065
Vomiting 16.77 11.01 1963 308737 210297 29053530
Diabetic neuropathy 16.75 11.01 81 310619 3672 29260155
Dyspnoea exertional 16.74 11.01 502 310198 35988 29227839
Deep vein thrombosis 16.67 11.01 467 310233 56932 29206895
Pollakiuria 16.66 11.01 260 310440 16656 29247171
Cognitive disorder 16.64 11.01 162 310538 23337 29240490
Fibrillary glomerulonephritis 16.60 11.01 9 310691 44 29263783
Stomatitis 16.56 11.01 282 310418 36831 29226996
Pharyngeal oedema 16.48 11.01 110 310590 5624 29258203
Swelling face 16.47 11.01 303 310397 20047 29243780
Acidosis 16.39 11.01 165 310535 9540 29254287
Neuroleptic malignant syndrome 16.28 11.01 101 310599 16047 29247780
Epiglottic oedema 16.26 11.01 14 310686 161 29263666
Haemodialysis 16.22 11.01 168 310532 9786 29254041
Nasal crusting 16.18 11.01 20 310680 361 29263466
Pericardial disease 16.14 11.01 20 310680 362 29263465
Epstein-Barr virus infection 16.13 11.01 28 310672 6601 29257226
Duodenal ulcer haemorrhage 16.08 11.01 91 310609 4388 29259439
Cardiomegaly 16.04 11.01 218 310482 13558 29250269
Cytomegalovirus viraemia 16.02 11.01 26 310674 6294 29257533
Drug eruption 15.99 11.01 256 310444 16485 29247342
Chest pain 15.97 11.01 1375 309325 110598 29153229
Serotonin syndrome 15.91 11.01 113 310587 17399 29246428
Dermatitis infected 15.89 11.01 11 310689 89 29263738
Pericardial haemorrhage 15.88 11.01 67 310633 2864 29260963
Eyelid oedema 15.86 11.01 93 310607 4543 29259284
Tricuspid valve incompetence 15.80 11.01 146 310554 8248 29255579
Hypersensitivity vasculitis 15.78 11.01 72 310628 3185 29260642
Presyncope 15.73 11.01 247 310453 15842 29247985
Kidney small 15.70 11.01 9 310691 50 29263777
Ventricular hypertrophy 15.55 11.01 87 310613 4177 29259650
Osteonecrosis 15.55 11.01 81 310619 13438 29250389
Hyperglycaemia 15.54 11.01 471 310229 33816 29230011
Prescription drug used without a prescription 15.50 11.01 39 310661 1265 29262562
Embolic stroke 15.50 11.01 77 310623 3529 29260298
Neuropathy peripheral 15.39 11.01 600 310100 70427 29193400
White blood cell count decreased 15.39 11.01 717 309983 82645 29181182
Tremor 15.34 11.01 624 310076 72914 29190913
Musculoskeletal stiffness 15.32 11.01 289 310411 37169 29226658
Viral infection 15.26 11.01 92 310608 14718 29249109
Pain 15.17 11.01 1573 309127 169859 29093968
Hepatic neoplasm 15.05 11.01 48 310652 1788 29262039
Hydronephrosis 15.02 11.01 149 310551 8581 29255246
Intervertebral disc displacement 14.97 11.01 12 310688 124 29263703
Tricuspid valve calcification 14.94 11.01 5 310695 4 29263823
Lymphoma 14.91 11.01 53 310647 9775 29254052
Cerebral haemorrhage 14.87 11.01 434 310266 30992 29232835
Low density lipoprotein decreased 14.84 11.01 33 310667 987 29262840
Putamen haemorrhage 14.80 11.01 15 310685 215 29263612
Dyspnoea at rest 14.80 11.01 70 310630 3144 29260683
Malignant neoplasm progression 14.71 11.01 630 310070 73229 29190598
Band neutrophil percentage decreased 14.62 11.01 6 310694 13 29263814
Graft versus host disease in gastrointestinal tract 14.60 11.01 8 310692 3250 29260577
High density lipoprotein decreased 14.54 11.01 66 310634 2913 29260914
Atrial septal defect 14.50 11.01 31 310669 6758 29257069
Blood uric acid increased 14.44 11.01 107 310593 5661 29258166
Bundle branch block left 14.43 11.01 100 310600 5177 29258650
Cachexia 14.40 11.01 28 310672 6321 29257506
Product administered to patient of inappropriate age 14.30 11.01 5 310695 2650 29261177
Blood pressure abnormal 14.28 11.01 121 310579 6669 29257158
Mucosal membrane hyperplasia 14.27 11.01 4 310696 0 29263827
Ventricular compliance decreased 14.27 11.01 4 310696 0 29263827
Left ventricular enlargement 14.22 11.01 25 310675 627 29263200
Discomfort 14.19 11.01 226 310474 14537 29249290
Blood cholinesterase decreased 14.17 11.01 11 310689 108 29263719
Muscle rigidity 14.11 11.01 51 310649 9360 29254467
Hepatic enzyme increased 14.06 11.01 260 310440 33539 29230288
Euphoric mood 14.06 11.01 18 310682 4807 29259020
Hypospadias 14.00 11.01 7 310693 2995 29260832
Polypectomy 13.98 11.01 22 310678 502 29263325
Device leakage 13.91 11.01 16 310684 4479 29259348
Herpes zoster 13.84 11.01 227 310473 29825 29234002
Gastric cancer 13.80 11.01 92 310608 4702 29259125
Lacrimal disorder 13.79 11.01 17 310683 306 29263521
Body temperature decreased 13.78 11.01 172 310528 10492 29253335
Blood aldosterone increased 13.77 11.01 6 310694 16 29263811
Prostate cancer recurrent 13.76 11.01 30 310670 885 29262942
Encephalitis toxic 13.72 11.01 16 310684 271 29263556
Giant cell arteritis 13.63 11.01 27 310673 743 29263084
Crying 13.58 11.01 22 310678 5329 29258498
Neonatal respiratory distress syndrome 13.57 11.01 12 310688 3798 29260029
Hepatocellular carcinoma 13.54 11.01 123 310577 6915 29256912
Thromboangiitis obliterans 13.51 11.01 6 310694 17 29263810
Unintentional medical device removal 13.51 11.01 4 310696 2357 29261470
Hypocalcaemia 13.50 11.01 298 310402 20367 29243460
Post-traumatic amnestic disorder 13.47 11.01 8 310692 48 29263779
Suspected suicide attempt 13.46 11.01 11 310689 117 29263710
Cutaneous lupus erythematosus 13.46 11.01 26 310674 702 29263125
Migraine 13.45 11.01 76 310624 12354 29251473
Intentional product misuse 13.39 11.01 270 310430 34391 29229436
Histology abnormal 13.36 11.01 16 310684 279 29263548
Mitral valve incompetence 13.35 11.01 205 310495 13088 29250739
Nausea 13.33 11.01 2760 307940 286495 28977332
Oedema 13.32 11.01 536 310164 39947 29223880
Allergy to animal 13.28 11.01 15 310685 245 29263582
Device use error 13.28 11.01 3 310697 2119 29261708
Product solubility abnormal 13.27 11.01 20 310680 439 29263388
Toxic nodular goitre 13.27 11.01 6 310694 18 29263809
Osteoporosis 13.26 11.01 63 310637 10706 29253121
Dysphagia 13.24 11.01 458 310242 54468 29209359
Pulmonary valve disease 13.23 11.01 16 310684 282 29263545
Lipoma 13.21 11.01 39 310661 1392 29262435
Nodal rhythm 13.18 11.01 37 310663 1283 29262544
Lymphocyte count decreased 13.16 11.01 134 310566 19137 29244690
Atrioventricular block second degree 13.16 11.01 67 310633 3101 29260726
Sex hormone binding globulin increased 13.14 11.01 5 310695 8 29263819
Generalised oedema 13.13 11.01 177 310523 10988 29252839
Acute coronary syndrome 13.13 11.01 192 310508 12133 29251694
Pruritus 13.12 11.01 1411 309289 115438 29148389
Pelvic cyst 13.11 11.01 7 310693 33 29263794
Hair colour changes 13.10 11.01 42 310658 1569 29262258
Bacteraemia 13.10 11.01 109 310591 16214 29247613
Malaise 13.10 11.01 1890 308810 157712 29106115
Retinopathy hypertensive 13.05 11.01 15 310685 250 29263577
Multiple sclerosis 13.03 11.01 24 310676 5530 29258297
Hepatic function abnormal 12.96 11.01 520 310180 38739 29225088
Respiratory arrest 12.96 11.01 192 310508 25641 29238186
Hyperthermia 12.92 11.01 53 310647 9377 29254450
Injection site reaction 12.88 11.01 67 310633 11121 29252706
Thrombotic stroke 12.86 11.01 15 310685 254 29263573
Hyperammonaemia 12.82 11.01 25 310675 5638 29258189
Nephrogenic systemic fibrosis 12.80 11.01 78 310622 3864 29259963
Thirst 12.78 11.01 114 310586 6377 29257450
Guillain-Barre syndrome 12.76 11.01 94 310606 4964 29258863
Hypertensive encephalopathy 12.74 11.01 17 310683 332 29263495
Blood urea increased 12.69 11.01 386 310314 27726 29236101
Low birth weight baby 12.64 11.01 32 310668 6576 29257251
Aortic aneurysm 12.64 11.01 110 310590 6110 29257717
Therapy non-responder 12.48 11.01 239 310461 30672 29233155
Macrophages increased 12.35 11.01 12 310688 163 29263664
Drug screen positive 12.34 11.01 13 310687 3788 29260039
Hyperbilirubinaemia 12.31 11.01 99 310601 14835 29248992
Blood potassium decreased 12.29 11.01 233 310467 15501 29248326
Urogenital haemorrhage 12.29 11.01 20 310680 470 29263357
Enterococcal infection 12.27 11.01 45 310655 8223 29255604
Incorrect route of product administration 12.26 11.01 65 310635 10736 29253091
Fracture displacement 12.26 11.01 8 310692 58 29263769
Sinonasal obstruction 12.19 11.01 6 310694 23 29263804
Thrombotic cerebral infarction 12.17 11.01 16 310684 308 29263519
Herbal interaction 12.17 11.01 16 310684 308 29263519
Drug level decreased 12.15 11.01 30 310670 6217 29257610
Brain contusion 12.09 11.01 25 310675 710 29263117
Dialysis 12.07 11.01 162 310538 10046 29253781
Generalised bullous fixed drug eruption 12.06 11.01 4 310696 3 29263824
Ventricular hyperkinesia 12.01 11.01 13 310687 202 29263625
Uveitis 12.01 11.01 28 310672 5919 29257908
Primary hypoparathyroidism 11.99 11.01 6 310694 24 29263803
Flour sensitivity 11.99 11.01 6 310694 24 29263803
Lung hernia 11.93 11.01 8 310692 61 29263766
Body temperature increased 11.88 11.01 96 310604 14369 29249458
Respiratory failure 11.87 11.01 869 309831 96262 29167565
Peripheral artery stenosis 11.87 11.01 27 310673 820 29263007
Helicobacter gastritis 11.84 11.01 31 310669 1031 29262796
Antipsychotic drug level increased 11.81 11.01 10 310690 3233 29260594
Peripheral artery occlusion 11.78 11.01 38 310662 1424 29262403
Renal artery thrombosis 11.75 11.01 15 310685 280 29263547
Pneumocystis jirovecii pneumonia 11.74 11.01 116 310584 16663 29247164
Left atrial enlargement 11.68 11.01 25 310675 728 29263099
Lymphomatoid papulosis 11.63 11.01 12 310688 176 29263651
Full blood count abnormal 11.62 11.01 222 310478 14791 29249036
Noninfective gingivitis 11.61 11.01 14 310686 246 29263581
Therapeutic response decreased 11.60 11.01 186 310514 24525 29239302
Sinus node dysfunction 11.57 11.01 73 310627 3661 29260166
Pericarditis uraemic 11.56 11.01 5 310695 13 29263814
Arterial stenosis 11.55 11.01 32 310668 1101 29262726
Anxiety 11.55 11.01 757 309943 84608 29179219
Diffuse large B-cell lymphoma 11.54 11.01 31 310669 6245 29257582
Forced vital capacity decreased 11.49 11.01 23 310677 638 29263189
Hepatotoxicity 11.49 11.01 126 310574 17741 29246086
Drug abuser 11.44 11.01 14 310686 3813 29260014
Pneumonia cytomegaloviral 11.43 11.01 7 310693 2675 29261152
Intercepted product preparation error 11.43 11.01 5 310695 2312 29261515
Lung operation 11.43 11.01 8 310692 66 29263761
Arteriosclerosis 11.41 11.01 161 310539 10095 29253732
Prerenal failure 11.40 11.01 43 310657 1745 29262082
Strongyloidiasis 11.39 11.01 5 310695 2307 29261520
Gingivitis 11.38 11.01 61 310639 2881 29260946
Ultrafiltration failure 11.35 11.01 11 310689 149 29263678
Hypertensive nephropathy 11.34 11.01 18 310682 414 29263413
Occult blood 11.34 11.01 21 310679 549 29263278
Red blood cell sedimentation rate abnormal 11.31 11.01 5 310695 2298 29261529
Yellow skin 11.31 11.01 45 310655 1873 29261954
Hepatitis 11.30 11.01 152 310548 20631 29243196
Retinal vascular thrombosis 11.24 11.01 8 310692 68 29263759
Renal transplant 11.23 11.01 40 310660 1578 29262249
Brain abscess 11.22 11.01 7 310693 2648 29261179
Decreased appetite 11.19 11.01 1715 308985 143627 29120200
Intestinal stenosis 11.17 11.01 3 310697 1885 29261942
Large intestine polyp 11.16 11.01 111 310589 6398 29257429
Cytomegalovirus colitis 11.16 11.01 6 310694 2463 29261364
Osmolar gap abnormal 11.12 11.01 6 310694 29 29263798
Oliguria 11.10 11.01 123 310577 7289 29256538
Gastric ulcer haemorrhage 11.10 11.01 89 310611 4825 29259002
Stasis dermatitis 11.07 11.01 24 310676 705 29263122
Mean platelet volume increased 11.06 11.01 18 310682 423 29263404
Mycobacterium avium complex infection 11.03 11.01 5 310695 2264 29261563
Palatal oedema 11.03 11.01 24 310676 707 29263120

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
Completed suicide 1173.37 10.37 4577 580316 219837 63694002
Drug ineffective 882.41 10.37 4277 580616 835970 63077869
Hypotension 672.34 10.37 5815 579078 375159 63538680
Off label use 650.08 10.37 3243 581650 629563 63284276
Shock 638.33 10.37 1201 583692 37039 63876800
Gingival hypertrophy 631.85 10.37 362 584531 2385 63911454
Synovitis 562.29 10.37 108 584785 98982 63814857
Acute kidney injury 515.05 10.37 6278 578615 442962 63470877
Maternal exposure during pregnancy 476.11 10.37 139 584754 95745 63818094
Drug abuse 455.36 10.37 322 584571 132052 63781787
Treatment failure 453.26 10.37 247 584646 116569 63797270
Contraindicated product administered 439.18 10.37 214 584679 107615 63806224
Anti-cyclic citrullinated peptide antibody positive 431.59 10.37 3 584890 49559 63864280
Non-cardiogenic pulmonary oedema 425.63 10.37 217 584676 1091 63912748
Drug intolerance 425.13 10.37 654 584239 187338 63726501
Infusion related reaction 417.00 10.37 527 584366 163940 63749899
Bradycardia 410.89 10.37 2138 582755 116081 63797758
Blood pressure inadequately controlled 408.15 10.37 360 584533 5024 63908815
Hand deformity 397.84 10.37 50 584843 62721 63851118
Oedema peripheral 391.05 10.37 3250 581643 207067 63706772
Pemphigus 385.57 10.37 48 584845 60653 63853186
Systemic lupus erythematosus 368.29 10.37 122 584771 77490 63836349
Intentional overdose 364.81 10.37 1700 583193 88244 63825595
Therapeutic product effect decreased 348.65 10.37 319 584574 115032 63798807
Arthropathy 345.33 10.37 352 584541 120615 63793224
Hyponatraemia 316.09 10.37 2366 582527 145973 63767866
Pericarditis 311.47 10.37 90 584803 62426 63851413
Angioedema 300.61 10.37 1234 583659 60587 63853252
Rheumatoid arthritis 298.83 10.37 653 584240 163641 63750198
Cerebrovascular accident 279.96 10.37 2171 582722 135412 63778427
Glossodynia 265.52 10.37 127 584766 64569 63849270
Orthostatic hypotension 263.03 10.37 977 583916 45761 63868078
Blood pressure increased 261.90 10.37 2552 582341 170000 63743839
Distributive shock 254.69 10.37 177 584716 1698 63912141
Hypertensive crisis 245.58 10.37 524 584369 17724 63896115
Rheumatoid factor positive 244.44 10.37 19 584874 34919 63878920
Hyperkalaemia 241.38 10.37 1658 583235 99471 63814368
Hepatic enzyme increased 240.80 10.37 511 584382 129432 63784407
Renal impairment 240.41 10.37 2067 582826 132950 63780889
Alopecia 240.34 10.37 738 584155 164952 63748887
Product use in unapproved indication 237.23 10.37 814 584079 175804 63738035
Fall 233.21 10.37 5178 579715 411648 63502191
Vasoplegia syndrome 227.91 10.37 194 584699 2573 63911266
Metabolic acidosis 221.83 10.37 1247 583646 69711 63844128
Product use issue 217.72 10.37 679 584214 151036 63762803
Exposure during pregnancy 216.03 10.37 231 584662 77444 63836395
C-reactive protein abnormal 214.40 10.37 12 584881 29035 63884804
Hypersensitivity 212.17 10.37 987 583906 195465 63718374
Sleep disorder due to general medical condition, insomnia type 203.12 10.37 8 584885 26262 63887577
Lactic acidosis 201.84 10.37 1094 583799 60316 63853523
Pain 200.88 10.37 3673 581220 549838 63364001
Syncope 197.08 10.37 2242 582651 155393 63758446
Neutropenia 196.13 10.37 1319 583574 238305 63675534
Hypokalaemia 191.81 10.37 1817 583076 120086 63793753
Helicobacter infection 189.67 10.37 56 584837 38306 63875533
Febrile neutropenia 185.82 10.37 972 583921 186685 63727154
Sinusitis 185.64 10.37 688 584205 145240 63768599
Duodenal ulcer perforation 185.56 10.37 43 584850 34582 63879257
Wound 181.56 10.37 257 584636 76220 63837619
Cerebral infarction 175.40 10.37 788 584105 40256 63873583
Folliculitis 172.23 10.37 32 584861 30045 63883794
Blood creatinine increased 170.50 10.37 1933 582960 133849 63779990
Cardiac failure congestive 167.62 10.37 1867 583026 128713 63785126
Hypoglycaemia 162.99 10.37 1382 583511 88510 63825329
Dizziness 162.97 10.37 5077 579816 425086 63488753
Rhabdomyolysis 156.30 10.37 1391 583502 90335 63823504
Arthralgia 155.50 10.37 2950 581943 439310 63474529
Infection 146.09 10.37 1028 583865 183852 63729987
Angina pectoris 142.69 10.37 795 584098 44286 63869553
Injection site pain 139.87 10.37 528 584365 110880 63802959
Muscle injury 139.37 10.37 34 584859 26403 63887436
Therapeutic product effect incomplete 138.14 10.37 478 584415 103004 63810835
Abortion spontaneous 137.19 10.37 30 584863 25113 63888726
Swollen tongue 136.03 10.37 653 584240 34301 63879538
Condition aggravated 134.30 10.37 2473 582420 369953 63543886
Injection site erythema 131.46 10.37 278 584615 70522 63843317
Pregnancy 128.89 10.37 18 584875 20847 63892992
Myocardial infarction 128.56 10.37 2166 582727 163655 63750184
Musculoskeletal stiffness 127.68 10.37 628 584265 122578 63791261
Pyrexia 126.51 10.37 3981 580912 554663 63359176
Red blood cell sedimentation rate abnormal 125.95 10.37 5 584888 16301 63897538
Irritable bowel syndrome 123.11 10.37 95 584798 37274 63876565
Chronic kidney disease 116.61 10.37 912 583981 57007 63856832
Device expulsion 115.77 10.37 25 584868 21111 63892728
Renal failure 114.89 10.37 2299 582594 179389 63734450
Atrioventricular block complete 114.76 10.37 339 584554 14079 63899760
Drug resistance 114.67 10.37 90 584803 35012 63878827
Injection site reaction 113.56 10.37 154 584739 46510 63867329
Overdose 113.18 10.37 2055 582838 157511 63756328
Impaired healing 108.50 10.37 242 584651 60231 63853608
Discomfort 106.99 10.37 375 584518 80503 63833336
Lower respiratory tract infection 104.64 10.37 471 584422 94143 63819696
Coronary artery disease 104.24 10.37 919 583974 59514 63854325
Suicide attempt 104.08 10.37 1043 583850 69964 63843875
Intentional product use issue 102.34 10.37 480 584413 94884 63818955
Creatinine renal clearance decreased 98.95 10.37 322 584571 14099 63899740
Cardiogenic shock 98.75 10.37 566 584327 31861 63881978
Sinus bradycardia 98.16 10.37 440 584453 22453 63891386
Abdominal discomfort 97.77 10.37 1119 583774 181203 63732636
Atrial fibrillation 97.75 10.37 2133 582760 168956 63744883
Pulmonary oedema 97.34 10.37 1117 583776 77557 63836282
Neurologic neglect syndrome 97.13 10.37 95 584798 1523 63912316
Toxicity to various agents 94.48 10.37 4114 580779 359399 63554440
Stomatitis 94.28 10.37 594 584299 109011 63804828
Hypomagnesaemia 92.82 10.37 619 584274 36757 63877082
Swelling 91.61 10.37 969 583924 159249 63754590
Drug dependence 91.57 10.37 100 584793 33212 63880627
Atrioventricular block first degree 89.88 10.37 257 584636 10477 63903362
Suspected suicide 89.44 10.37 224 584669 8430 63905409
Blood pressure systolic increased 87.35 10.37 756 584137 48697 63865142
Depressed level of consciousness 87.17 10.37 1125 583768 80311 63833528
Proteinuria 87.12 10.37 488 584405 27235 63886604
Fibromyalgia 86.86 10.37 118 584775 35613 63878226
Joint swelling 84.93 10.37 1407 583486 213975 63699864
Sedation complication 83.89 10.37 245 584648 10109 63903730
Carotid artery thrombosis 81.90 10.37 91 584802 1704 63912135
Hypertensive emergency 81.62 10.37 102 584791 2174 63911665
Acute myocardial infarction 81.43 10.37 979 583914 68739 63845100
Psoriatic arthropathy 81.13 10.37 169 584724 43112 63870727
Lip swelling 79.58 10.37 529 584364 31378 63882461
Balance disorder 79.01 10.37 1133 583760 82793 63831046
Wrong technique in product usage process 78.91 10.37 312 584581 64662 63849177
Pemphigoid 78.58 10.37 278 584615 12708 63901131
Decreased appetite 76.74 10.37 3200 581693 278089 63635750
Migraine 76.74 10.37 300 584593 62377 63851462
Anuria 76.49 10.37 358 584535 18606 63895233
Live birth 75.88 10.37 7 584886 11197 63902642
Renin increased 75.33 10.37 38 584855 186 63913653
Ill-defined disorder 75.23 10.37 181 584712 43871 63869968
Rash 74.87 10.37 3397 581496 455152 63458687
Pathogen resistance 72.56 10.37 13 584880 12530 63901309
Intentional self-injury 71.53 10.37 95 584798 28949 63884890
Renal artery stenosis 70.35 10.37 109 584784 2860 63910979
Transient ischaemic attack 70.14 10.37 660 584233 43522 63870317
Injection site pruritus 69.81 10.37 149 584744 37677 63876162
Infective pulmonary exacerbation of cystic fibrosis 68.73 10.37 12 584881 11784 63902055
Hypertension 68.13 10.37 2938 581955 256323 63657516
Hyperglycaemia 68.11 10.37 849 584044 60119 63853720
Injection site swelling 67.43 10.37 174 584719 41179 63872660
Septic shock 66.37 10.37 623 584270 104814 63809025
Weight increased 65.87 10.37 1453 583440 211895 63701944
Diabetes mellitus inadequate control 65.47 10.37 373 584520 20948 63892891
Rheumatoid nodule 65.27 10.37 17 584876 12634 63901205
Sprue-like enteropathy 64.75 10.37 62 584831 967 63912872
Drug interaction 64.24 10.37 3952 580941 358131 63555708
Chronic pigmented purpura 64.03 10.37 32 584861 153 63913686
Immune reconstitution inflammatory syndrome 63.88 10.37 17 584876 12453 63901386
Gastrointestinal disorder 63.59 10.37 514 584379 89195 63824644
Cytomegalovirus infection 62.61 10.37 154 584739 37045 63876794
Asthenia 61.80 10.37 4592 580301 423452 63490387
Gingival swelling 61.55 10.37 120 584773 3800 63910039
Thrombocytopenia 61.38 10.37 1552 583341 222249 63691590
Injection site bruising 60.89 10.37 151 584742 36222 63877617
Carotid artery stenosis 59.70 10.37 183 584710 7758 63906081
Loss of consciousness 59.40 10.37 1764 583129 146601 63767238
Glycosylated haemoglobin increased 59.27 10.37 295 584598 15724 63898115
Dyspnoea 59.24 10.37 7410 577483 711264 63202575
Tenosynovitis 58.99 10.37 17 584876 11816 63902023
Leukopenia 58.37 10.37 611 584282 100631 63813208
Hemiplegia 58.23 10.37 250 584643 12518 63901321
Gingival bleeding 58.15 10.37 278 584615 14576 63899263
Mucosal inflammation 57.57 10.37 332 584561 62252 63851587
Product monitoring error 57.23 10.37 142 584751 5312 63908527
Bone marrow failure 57.12 10.37 232 584661 47720 63866119
Aortic dissection 57.06 10.37 108 584785 3344 63910495
Atrioventricular block 56.93 10.37 238 584655 11777 63902062
Myocardial depression 55.81 10.37 42 584851 461 63913378
Left ventricular hypertrophy 55.38 10.37 201 584692 9305 63904534
Blood calcium decreased 55.13 10.37 409 584484 25145 63888694
Melaena 54.89 10.37 734 584159 52814 63861025
Nasopharyngitis 54.76 10.37 1356 583537 194717 63719122
Blood pressure decreased 54.51 10.37 1091 583802 85108 63828731
Blood creatine phosphokinase increased 54.10 10.37 788 584105 57770 63856069
Myelosuppression 53.69 10.37 83 584810 23747 63890092
Product prescribing error 53.58 10.37 522 584371 34747 63879092
Palpitations 53.50 10.37 1283 583610 103205 63810634
Haematotoxicity 53.38 10.37 25 584868 12871 63900968
Body temperature increased 52.61 10.37 164 584729 36502 63877337
Circulatory collapse 52.60 10.37 502 584391 33230 63880609
Acute graft versus host disease 49.23 10.37 11 584882 9073 63904766
Angina unstable 49.09 10.37 273 584620 15194 63898645
Myalgia 48.93 10.37 1829 583064 156788 63757051
Bone erosion 48.74 10.37 22 584871 11573 63902266
Injection site warmth 48.59 10.37 31 584862 13431 63900408
Immunodeficiency 48.20 10.37 45 584848 16079 63897760
Nocturia 48.17 10.37 215 584678 10950 63902889
Hyperdynamic left ventricle 48.01 10.37 31 584862 260 63913579
Interstitial lung disease 47.62 10.37 1192 583701 96540 63817299
Hypertensive heart disease 47.50 10.37 106 584787 3698 63910141
Oliguria 47.41 10.37 259 584634 14317 63899522
Multiple sclerosis relapse 47.15 10.37 202 584691 40933 63872906
Renal cell carcinoma 47.14 10.37 142 584751 5962 63907877
Blood urea increased 46.83 10.37 609 584284 43544 63870295
Adjustment disorder 46.76 10.37 87 584806 2658 63911181
Pseudolymphoma 46.66 10.37 52 584841 977 63912862
Hip arthroplasty 46.56 10.37 76 584817 21275 63892564
Hepatic function abnormal 46.51 10.37 831 584062 63482 63850357
Nephrotic syndrome 46.50 10.37 191 584702 9376 63904463
Aggression 45.96 10.37 239 584654 45993 63867846
Lacunar infarction 45.88 10.37 132 584761 5400 63908439
Subacute cutaneous lupus erythematosus 45.56 10.37 91 584802 2934 63910905
Post transplant lymphoproliferative disorder 45.26 10.37 15 584878 9529 63904310
Aspergillus infection 45.20 10.37 49 584844 16330 63897509
Foot deformity 44.85 10.37 50 584843 16454 63897385
Therapeutic response decreased 44.77 10.37 283 584610 51905 63861934
Hyperlipidaemia 44.70 10.37 359 584534 22617 63891222
Cytokine release syndrome 44.62 10.37 75 584818 20754 63893085
Renal disorder 44.57 10.37 504 584389 34861 63878978
Ear infection 44.19 10.37 91 584802 23313 63890526
Haemorrhage subcutaneous 44.15 10.37 112 584781 4249 63909590
Haematochezia 43.96 10.37 846 584047 65527 63848312
Nodal rhythm 43.94 10.37 87 584806 2787 63911052
Loss of personal independence in daily activities 43.94 10.37 432 584461 72022 63841817
Hepatotoxicity 43.53 10.37 200 584693 39762 63874077
Dehydration 42.98 10.37 2390 582503 214373 63699466
Haemophagocytic lymphohistiocytosis 42.95 10.37 58 584835 17551 63896288
Blood glucose increased 42.82 10.37 1179 583714 96894 63816945
Personality disorder 42.60 10.37 116 584777 4595 63909244
Cardiac failure 42.18 10.37 1532 583361 130841 63782998
Mydriasis 42.04 10.37 46 584847 15266 63898573
Device issue 41.97 10.37 89 584804 22559 63891280
Dysarthria 41.69 10.37 764 584129 58642 63855197
Anti-neutrophil cytoplasmic antibody positive vasculitis 41.46 10.37 86 584807 2850 63910989
Blood potassium decreased 41.09 10.37 553 584340 39846 63873993
Acute hepatic failure 40.95 10.37 112 584781 26000 63887839
Eating disorder 40.93 10.37 277 584616 16528 63897311
Graft versus host disease 40.76 10.37 39 584854 13774 63900065
Hypocalcaemia 40.62 10.37 567 584326 41186 63872653
Haemodynamic instability 40.10 10.37 252 584641 14660 63899179
Disability 40.02 10.37 31 584862 12141 63901698
Agitation 40 10.37 562 584331 87805 63826034
Chronic graft versus host disease 39.75 10.37 5 584888 6271 63907568
Erectile dysfunction 39.49 10.37 222 584671 12405 63901434
Caesarean section 39.29 10.37 27 584866 11247 63902592
Neurotoxicity 39.02 10.37 123 584770 27281 63886558
Haemodialysis 38.95 10.37 277 584616 16800 63897039
5-hydroxyindolacetic acid in urine increased 38.79 10.37 25 584868 209 63913630
Progressive multifocal leukoencephalopathy 38.73 10.37 66 584827 18166 63895673
BRASH syndrome 38.58 10.37 30 584863 347 63913492
Atrioventricular block second degree 38.05 10.37 137 584756 6317 63907522
Urticaria 37.88 10.37 1031 583862 146286 63767553
Therapy partial responder 37.82 10.37 23 584870 10225 63903614
Periodontitis 37.20 10.37 102 584791 4057 63909782
Hypoinsulinaemia 37.12 10.37 10 584883 0 63913839
Multiple-drug resistance 37.05 10.37 7 584886 6495 63907344
Product substitution issue 36.91 10.37 283 584610 17578 63896261
Inappropriate antidiuretic hormone secretion 36.91 10.37 336 584557 21953 63891886
Carotid arteriosclerosis 36.81 10.37 67 584826 2012 63911827
Unintentional medical device removal 36.81 10.37 8 584885 6726 63907113
Faeces discoloured 36.76 10.37 376 584517 25353 63888486
Diabetic nephropathy 36.62 10.37 77 584816 2577 63911262
Prescription drug used without a prescription 36.53 10.37 76 584817 2524 63911315
Thalamus haemorrhage 36.37 10.37 58 584835 1561 63912278
Chest pain 36.27 10.37 2545 582348 233435 63680404
Osteoporosis 36.19 10.37 228 584665 41852 63871987
Glomerulonephritis rapidly progressive 36.11 10.37 52 584841 1276 63912563
Irritability 35.94 10.37 191 584702 36555 63877284
Device adhesion issue 35.77 10.37 3 584890 5183 63908656
Hyperuricaemia 35.13 10.37 184 584709 10007 63903832
Seizure 35.05 10.37 1200 583693 165692 63748147
Hepatocellular carcinoma 34.90 10.37 160 584733 8243 63905596
Hemiparesis 34.88 10.37 419 584474 29408 63884431
Arteriosclerosis 34.75 10.37 255 584638 15622 63898217
Anaemia 34.70 10.37 3932 580961 374748 63539091
Metastatic renal cell carcinoma 34.21 10.37 67 584826 2129 63911710
Substance abuse 34.09 10.37 21 584872 9271 63904568
Status epilepticus 33.91 10.37 93 584800 21570 63892269
Acute myeloid leukaemia 33.90 10.37 131 584762 27332 63886507
Ovarian cyst 33.83 10.37 30 584863 10988 63902851
Hyperaldosteronism 33.72 10.37 28 584865 358 63913481
Glomerular filtration rate decreased 33.41 10.37 297 584596 19275 63894564
Staphylococcal infection 33.37 10.37 296 584597 50382 63863457
Cardiomegaly 33.30 10.37 345 584548 23339 63890500
Oedema 33.30 10.37 1080 583813 90855 63822984
Drug withdrawal syndrome 33.26 10.37 158 584735 31133 63882706
Diastolic dysfunction 33.23 10.37 164 584729 8711 63905128
Linear IgA disease 33.19 10.37 76 584817 2698 63911141
Drug tolerance decreased 33.19 10.37 11 584882 6987 63906852
Febrile bone marrow aplasia 32.95 10.37 32 584861 11223 63902616
Urine output decreased 32.80 10.37 259 584634 16233 63897606
Tongue oedema 32.67 10.37 124 584769 5866 63907973
Pancytopenia 32.56 10.37 1020 583873 142289 63771550
Allergic reaction to excipient 32.39 10.37 23 584870 229 63913610
Malaise 32.29 10.37 4084 580809 392163 63521676
Lymphocyte count decreased 32.25 10.37 226 584667 40473 63873366
Nephrosclerosis 32.20 10.37 54 584839 1517 63912322
Psychotic disorder 32.03 10.37 183 584710 34395 63879444
Cerebral haemorrhage 31.74 10.37 645 584248 50445 63863394
Uterine perforation 31.64 10.37 7 584886 5813 63908026
Presyncope 31.55 10.37 470 584423 34619 63879220
Dyspnoea exertional 31.51 10.37 884 584009 72846 63840993
Ischaemic stroke 31.43 10.37 402 584491 28633 63885206
Primary hyperaldosteronism 31.36 10.37 18 584875 119 63913720
Peripheral arterial occlusive disease 31.24 10.37 136 584757 6851 63906988
Palmar-plantar erythrodysaesthesia syndrome 31.19 10.37 399 584494 28420 63885419
Vasodilatation 31.06 10.37 78 584815 2940 63910899
Dystonia 31.04 10.37 79 584814 18786 63895053
Drug ineffective for unapproved indication 30.91 10.37 161 584732 30972 63882867
Generalised oedema 30.88 10.37 307 584586 20546 63893293
Gastric ulcer haemorrhage 30.86 10.37 151 584742 7992 63905847
Lymphadenopathy 30.60 10.37 273 584620 46413 63867426
Pollakiuria 30.60 10.37 428 584465 31102 63882737
Bronchopulmonary aspergillosis 30.58 10.37 81 584812 19004 63894835
Bundle branch block right 30.45 10.37 178 584715 10091 63903748
Altered state of consciousness 30.02 10.37 497 584396 37405 63876434
Venoocclusive liver disease 29.88 10.37 28 584865 9987 63903852
Injection site haemorrhage 29.84 10.37 116 584777 24162 63889677
Swelling face 29.82 10.37 725 584168 58441 63855398
Premature labour 29.70 10.37 16 584877 7604 63906235
Mitral valve incompetence 29.54 10.37 358 584535 25180 63888659
Acute coronary syndrome 29.43 10.37 286 584607 19024 63894815
Gastrointestinal tract mucosal pigmentation 29.26 10.37 39 584854 888 63912951
Fatigue 29.22 10.37 6173 578720 742557 63171282
Injection site urticaria 29.17 10.37 35 584858 11146 63902693
Haematemesis 29.08 10.37 593 584300 46406 63867433
Ischaemia 29.06 10.37 137 584756 7141 63906698
Diabetic neuropathy 28.96 10.37 114 584779 5487 63908352
Gout 28.74 10.37 309 584584 21104 63892735
Panniculitis 28.70 10.37 23 584870 8856 63904983
Tubulointerstitial nephritis 28.57 10.37 416 584477 30493 63883346
Knee arthroplasty 28.30 10.37 137 584756 26862 63886977
Gingivitis 28.30 10.37 141 584752 7518 63906321
Blood aldosterone increased 28.26 10.37 20 584873 198 63913641
Disease recurrence 28.00 10.37 169 584724 31341 63882498
Cytomegalovirus infection reactivation 27.38 10.37 9 584884 5747 63908092
Heavy menstrual bleeding 27.27 10.37 42 584851 12035 63901804
Bladder irritation 27.22 10.37 20 584873 211 63913628
Adenovirus infection 27.17 10.37 16 584877 7239 63906600
Myelodysplastic syndrome 27.17 10.37 143 584750 27436 63886403
Herpes zoster 27.15 10.37 530 584363 78657 63835182
Blood mercury abnormal 26.86 10.37 19 584874 188 63913651
Metastases to bone 26.84 10.37 95 584798 20340 63893499
Hypervolaemia 26.73 10.37 492 584401 37793 63876046
Aphasia 26.61 10.37 520 584373 40386 63873453
Blood parathyroid hormone decreased 26.54 10.37 17 584876 7349 63906490
Blood uric acid increased 26.52 10.37 145 584748 8018 63905821
Gastric cancer 26.50 10.37 123 584770 6370 63907469
Myocardial ischaemia 26.48 10.37 325 584568 22926 63890913
Blood lactic acid increased 26.27 10.37 173 584720 10228 63903611
Carotid sinus syndrome 26.26 10.37 12 584881 45 63913794
Accelerated hypertension 26.09 10.37 30 584863 584 63913255
Device use error 26.09 10.37 13 584880 6458 63907381
Graft versus host disease in skin 26.08 10.37 8 584885 5339 63908500
Thirst 25.95 10.37 218 584675 13919 63899920
Venoocclusive disease 25.67 10.37 3 584890 3982 63909857
Upper respiratory tract infection 25.61 10.37 485 584408 72300 63841539
Skin toxicity 25.53 10.37 14 584879 6588 63907251
Eczema 25.52 10.37 395 584498 29325 63884514
Prostatic specific antigen increased 25.43 10.37 151 584742 8609 63905230
Premature delivery 25.38 10.37 85 584808 18504 63895335
Drug hypersensitivity 25.35 10.37 1835 583058 235980 63677859
Sepsis 25.26 10.37 1773 583120 228568 63685271
Mucormycosis 25.03 10.37 18 584875 7323 63906516
Sinus arrest 24.92 10.37 73 584820 3017 63910822
Accidental exposure to product 24.70 10.37 139 584754 26225 63887614
Nodule 24.54 10.37 82 584811 17865 63895974
Hypoperfusion 24.53 10.37 61 584832 2285 63911554
Red blood cell sedimentation rate increased 24.47 10.37 174 584719 31061 63882778
Putamen haemorrhage 24.35 10.37 25 584868 426 63913413
Enthesopathy 24.27 10.37 31 584862 9607 63904232
Sickle cell anaemia with crisis 24.22 10.37 9 584884 5323 63908516
Brain stem infarction 24.12 10.37 52 584841 1771 63912068
Hypertensive encephalopathy 24.12 10.37 35 584858 865 63912974
Pulmonary renal syndrome 24.12 10.37 28 584865 551 63913288
Abortion induced 24.05 10.37 14 584879 6374 63907465
Dialysis 24.04 10.37 247 584646 16673 63897166
Anaphylactic reaction 24.02 10.37 458 584435 68206 63845633
Fibromuscular dysplasia 23.96 10.37 18 584875 197 63913642
Orbital myositis 23.95 10.37 16 584877 143 63913696
Serotonin syndrome 23.90 10.37 234 584659 39048 63874791
Foetal death 23.78 10.37 12 584881 5918 63907921
Lung diffusion test abnormal 23.77 10.37 16 584877 145 63913694
Candida infection 23.67 10.37 177 584716 31242 63882597
Device dislocation 23.66 10.37 105 584788 21073 63892766
Fear of injection 23.65 10.37 12 584881 5900 63907939
Adverse drug reaction 23.57 10.37 281 584612 45183 63868656
Respiratory depression 23.40 10.37 121 584772 23322 63890517
Supraventricular extrasystoles 23.37 10.37 111 584782 5804 63908035
Granuloma skin 23.31 10.37 13 584880 6061 63907778
Plasmapheresis 23.31 10.37 28 584865 572 63913267
Ageusia 23.26 10.37 209 584684 13604 63900235
Arrhythmia 23.25 10.37 637 584256 52307 63861532
Drug use disorder 23.17 10.37 13 584880 6041 63907798
Device difficult to use 23.17 10.37 33 584860 9765 63904074
Lymphocele 23.10 10.37 48 584845 1593 63912246
Medication error 23.03 10.37 605 584288 49361 63864478
Yellow skin 22.91 10.37 71 584822 3028 63910811
Hepatojugular reflux 22.82 10.37 26 584867 501 63913338
Myopathy 22.75 10.37 253 584640 17427 63896412
Flushing 22.73 10.37 541 584352 78107 63835732
Blood cholinesterase decreased 22.68 10.37 18 584875 215 63913624
Ischaemic cardiomyopathy 22.58 10.37 122 584771 6716 63907123
Epstein-Barr virus infection 22.37 10.37 50 584843 12438 63901401
Alcohol abuse 22.36 10.37 8 584885 4844 63908995
Heart rate decreased 22.36 10.37 656 584237 54411 63859428
Duodenal ulcer haemorrhage 22.36 10.37 115 584778 6210 63907629
Injection site rash 22.17 10.37 71 584822 15671 63898168
Fungal infection 22.13 10.37 201 584692 34050 63879789
Cognitive disorder 22.03 10.37 655 584238 54432 63859407
Ventricular hypertrophy 22.02 10.37 117 584776 6399 63907440
Hypovolaemic shock 21.96 10.37 164 584729 10102 63903737
Pericardial effusion 21.94 10.37 488 584405 38766 63875073
Affect lability 21.78 10.37 148 584745 8842 63904997
Disease progression 21.75 10.37 1056 583837 140624 63773215
Joint effusion 21.72 10.37 57 584836 13416 63900423
Multiple sclerosis 21.71 10.37 93 584800 18848 63894991
Large intestine polyp 21.45 10.37 170 584723 10667 63903172
Hyperplasia 21.38 10.37 37 584856 1067 63912772
Lymphocyte stimulation test positive 21.33 10.37 37 584856 1069 63912770
Osteopenia 21.25 10.37 71 584822 15469 63898370
Tendonitis 21.21 10.37 103 584790 20179 63893660
Red blood cell sedimentation rate 21.16 10.37 4 584889 3710 63910129
Suicidal ideation 21.13 10.37 451 584442 66091 63847748
Coma 21.02 10.37 619 584274 86996 63826843
Scleral discolouration 20.96 10.37 25 584868 507 63913332
Human herpesvirus 6 infection 20.90 10.37 8 584885 4646 63909193
Blood glucose decreased 20.89 10.37 310 584583 22813 63891026
Labile hypertension 20.88 10.37 25 584868 509 63913330
Joint destruction 20.54 10.37 4 584889 3632 63910207
Liver carcinoma ruptured 20.51 10.37 15 584878 157 63913682
Varicella zoster virus infection 20.49 10.37 5 584888 3883 63909956
Blister 20.45 10.37 568 584325 80399 63833440
Low density lipoprotein decreased 20.42 10.37 36 584857 1054 63912785
Cardiovascular disorder 20.31 10.37 227 584666 15654 63898185
Congenital hiatus hernia 20.31 10.37 22 584871 400 63913439
Bundle branch block left 20.19 10.37 158 584735 9876 63903963
Urine albumin/creatinine ratio increased 20.09 10.37 20 584873 328 63913511
Gestational diabetes 20.00 10.37 13 584880 5577 63908262
Blood potassium increased 19.96 10.37 339 584554 25641 63888198
Hypergastrinaemia 19.90 10.37 15 584878 165 63913674
Diabetes mellitus 19.88 10.37 764 584129 65710 63848129
Diverticulum intestinal haemorrhagic 19.79 10.37 70 584823 3199 63910640
Forced vital capacity decreased 19.78 10.37 43 584850 1473 63912366
Ear pain 19.71 10.37 140 584753 24996 63888843
Lipodystrophy acquired 19.68 10.37 6 584887 4021 63909818
Viral infection 19.66 10.37 221 584672 35919 63877920
Nipple inflammation 19.66 10.37 10 584883 50 63913789
Ocular icterus 19.66 10.37 95 584798 5003 63908836
Rales 19.63 10.37 218 584675 15011 63898828
Cytomegalovirus chorioretinitis 19.61 10.37 10 584883 4902 63908937
Hepatic neoplasm 19.59 10.37 67 584826 3010 63910829
Product dose omission issue 19.58 10.37 1510 583383 193237 63720602
Polypectomy 19.53 10.37 33 584860 933 63912906
Inflammation 19.47 10.37 447 584446 64853 63848986
Sinus node dysfunction 19.38 10.37 117 584776 6711 63907128
Mycobacterium marinum infection 19.37 10.37 21 584872 382 63913457
Temperature regulation disorder 19.31 10.37 7 584886 4204 63909635
Lichen nitidus 19.26 10.37 11 584882 72 63913767
Diabetic retinopathy 19.13 10.37 63 584830 2776 63911063
Gravitational oedema 19.12 10.37 45 584848 1627 63912212
Polymyositis 19.03 10.37 61 584832 2649 63911190
Headache 19.02 10.37 4382 580511 525085 63388754
Renal transplant 18.99 10.37 54 584839 2194 63911645
Bundle branch block 18.97 10.37 41 584852 1399 63912440
Peripheral artery stenosis 18.97 10.37 37 584856 1172 63912667
Gastrointestinal haemorrhage 18.94 10.37 1419 583474 130893 63782946
Left ventricular enlargement 18.92 10.37 27 584866 657 63913182
Cytomegalovirus viraemia 18.87 10.37 44 584849 10784 63903055
Uveitis 18.83 10.37 56 584837 12652 63901187
Skin tightness 18.81 10.37 92 584801 4869 63908970
Epiglottic oedema 18.77 10.37 17 584876 246 63913593
Kidney transplant rejection 18.71 10.37 149 584744 9362 63904477
Subdural haematoma 18.71 10.37 358 584535 27696 63886143
Unintended pregnancy 18.68 10.37 3 584890 3131 63910708
Prerenal failure 18.66 10.37 68 584825 3154 63910685
Tricuspid valve incompetence 18.65 10.37 236 584657 16767 63897072
Hypersensitivity vasculitis 18.65 10.37 115 584778 6646 63907193
Prostate cancer recurrent 18.57 10.37 28 584865 717 63913122
Mucosal membrane hyperplasia 18.52 10.37 9 584884 40 63913799
Coeliac disease 18.50 10.37 24 584869 7388 63906451
Injection site discolouration 18.50 10.37 21 584872 6854 63906985
Zoonotic bacterial infection 18.48 10.37 10 584883 58 63913781
Dry eye 18.45 10.37 171 584722 28848 63884991
Blood loss anaemia 18.43 10.37 200 584693 13692 63900147
Bladder sphincter atony 18.36 10.37 12 584881 103 63913736
CD30 expression 18.35 10.37 9 584884 41 63913798
Coordination abnormal 18.29 10.37 212 584681 14752 63899087
Ventricular hyperkinesia 18.23 10.37 17 584876 256 63913583
Enterochromaffin cell hyperplasia 18.20 10.37 11 584882 81 63913758
Chondroma 18.17 10.37 6 584887 6 63913833
Vaginal haemorrhage 18.12 10.37 102 584791 19242 63894597
Pulse abnormal 17.93 10.37 59 584834 2598 63911241
Breath sounds abnormal 17.86 10.37 173 584720 11496 63902343
Fibrillary glomerulonephritis 17.85 10.37 9 584884 44 63913795
Generalised tonic-clonic seizure 17.85 10.37 254 584639 39603 63874236
Portal hypertension 17.84 10.37 18 584875 6201 63907638
Dermatomyositis 17.78 10.37 61 584832 2745 63911094
Dyslalia 17.77 10.37 32 584861 953 63912886
C-reactive protein increased 17.75 10.37 692 584201 94217 63819622
Sensory loss 17.71 10.37 155 584738 10014 63903825
Dyskinesia 17.64 10.37 251 584642 39137 63874702
Cholecystitis chronic 17.62 10.37 36 584857 9251 63904588
Drug abuser 17.61 10.37 16 584877 5792 63908047
Neovascularisation 17.60 10.37 34 584859 1069 63912770
Graft versus host disease in gastrointestinal tract 17.57 10.37 15 584878 5597 63908242
Carcinoid tumour 17.56 10.37 21 584872 427 63913412
Premature rupture of membranes 17.55 10.37 6 584887 3738 63910101
Cardiac disorder 17.52 10.37 645 584248 55171 63858668
Atrioventricular dissociation 17.52 10.37 18 584875 307 63913532
Atheroembolism 17.48 10.37 16 584877 235 63913604
Nephrogenic systemic fibrosis 17.39 10.37 102 584791 5790 63908049
Electrocardiogram Q wave abnormal 17.37 10.37 20 584873 390 63913449
Chromaturia 17.36 10.37 295 584598 22316 63891523
Cerebellar haemorrhage 17.30 10.37 58 584835 2579 63911260
Chronic obstructive pulmonary disease 17.27 10.37 799 584094 70249 63843590
Embolic stroke 17.18 10.37 112 584781 6599 63907240
Arterial occlusive disease 17.17 10.37 116 584777 6917 63906922
Lethargy 17.13 10.37 814 584079 71780 63842059
Clear cell renal cell carcinoma 17.12 10.37 51 584842 2128 63911711
Traumatic haemorrhage 17.11 10.37 34 584859 1092 63912747
Ulcer 17.09 10.37 130 584763 22860 63890979
Dilatation ventricular 17.05 10.37 75 584818 3795 63910044
Drug tolerance 17.02 10.37 18 584875 6067 63907772
Pulmonary hypoplasia 16.94 10.37 9 584884 50 63913789
Gastrointestinal toxicity 16.94 10.37 14 584879 5308 63908531
Pulmonary valve disease 16.84 10.37 16 584877 247 63913592
Breast cancer stage III 16.83 10.37 3 584890 2902 63910937
Urinary retention 16.79 10.37 574 584319 48627 63865212
Retinopathy hypertensive 16.75 10.37 21 584872 449 63913390
Gingival pain 16.75 10.37 107 584786 6260 63907579
Fine motor skill dysfunction 16.72 10.37 11 584882 4688 63909151
Schizophrenia 16.70 10.37 49 584844 11119 63902720
Left atrial enlargement 16.70 10.37 32 584861 1000 63912839
Cardiac dysfunction 16.70 10.37 64 584829 3042 63910797
Bradyarrhythmia 16.69 10.37 73 584820 3685 63910154
Herpes simplex 16.66 10.37 45 584848 10491 63903348
Intestinal ischaemia 16.60 10.37 169 584724 11380 63902459
Paranoia 16.55 10.37 84 584809 16268 63897571
Dislocation of vertebra 16.50 10.37 4 584889 3120 63910719
Sensitivity to weather change 16.49 10.37 22 584871 6692 63907147
Hypoglossal nerve paralysis 16.47 10.37 7 584886 21 63913818
Normal newborn 16.41 10.37 16 584877 5601 63908238
Harlequin syndrome 16.39 10.37 9 584884 54 63913785
End stage renal disease 16.38 10.37 156 584737 10319 63903520
Type I hypersensitivity 16.29 10.37 6 584887 3568 63910271
Sinoatrial block 16.29 10.37 34 584859 1132 63912707
Tuberculosis 16.21 10.37 62 584831 12976 63900863
Aortic aneurysm 16.21 10.37 121 584772 7453 63906386
Obsessive-compulsive disorder 16.19 10.37 12 584881 4806 63909033
Gangrene 16.14 10.37 118 584775 7220 63906619
Pleural effusion 16.10 10.37 1345 583548 125214 63788625
Finger deformity 16.07 10.37 14 584879 5172 63908667
Product administered to patient of inappropriate age 16.06 10.37 11 584882 4590 63909249
Suspected suicide attempt 16.04 10.37 16 584877 263 63913576
Device related infection 15.99 10.37 189 584704 30437 63883402
Drug screen positive 15.96 10.37 17 584876 5712 63908127
Hyperparathyroidism secondary 15.96 10.37 52 584841 2278 63911561
Abnormal behaviour 15.87 10.37 212 584681 33410 63880429
Protein urine present 15.85 10.37 137 584756 8819 63905020
Pseudomonas infection 15.84 10.37 96 584797 17787 63896052
Dyspnoea at rest 15.82 10.37 105 584788 6224 63907615
Gallbladder adenocarcinoma 15.79 10.37 11 584882 106 63913733
Grip strength decreased 15.74 10.37 54 584839 11670 63902169
Joint stiffness 15.73 10.37 188 584705 30216 63883623
Femoral neck fracture 15.73 10.37 134 584759 8590 63905249
Stenosis 15.73 10.37 44 584849 1771 63912068
Device leakage 15.72 10.37 32 584861 8234 63905605
Neoplasm progression 15.66 10.37 269 584624 40695 63873144
Tricuspid valve calcification 15.66 10.37 5 584888 4 63913835
Azotaemia 15.57 10.37 119 584774 7383 63906456
Rectal ulcer haemorrhage 15.56 10.37 15 584878 236 63913603
Nasal crusting 15.55 10.37 22 584871 531 63913308
Deafness neurosensory 15.54 10.37 21 584872 6353 63907486
Alanine aminotransferase abnormal 15.51 10.37 24 584869 6864 63906975
Band neutrophil percentage decreased 15.47 10.37 6 584887 13 63913826
Dermatitis infected 15.44 10.37 14 584879 203 63913636
Incorrect route of product administration 15.37 10.37 136 584757 23162 63890677
Galactorrhoea 15.37 10.37 5 584888 3214 63910625
Intestinal villi atrophy 15.28 10.37 18 584875 360 63913479
Cystic fibrosis 15.26 10.37 6 584887 3428 63910411
Duodenal ulcer 15.26 10.37 199 584694 14236 63899603
Blood pressure abnormal 15.26 10.37 199 584694 14236 63899603
Mitochondrial toxicity 15.23 10.37 3 584890 2703 63911136
Renal injury 15.20 10.37 210 584683 15219 63898620
Pericardial haemorrhage 15.18 10.37 76 584817 4060 63909779
Neuroleptic malignant syndrome 15.16 10.37 149 584744 24847 63888992
Purpura 15.11 10.37 230 584663 17016 63896823
Transplant rejection 15.11 10.37 94 584799 17307 63896532
Diffuse large B-cell lymphoma 15.11 10.37 46 584847 10315 63903524
Micturition urgency 15.09 10.37 152 584741 10207 63903632
Nephrogenic anaemia 15.08 10.37 65 584828 3260 63910579
Adenoma benign 15.07 10.37 31 584862 1021 63912818
Constipation 15.01 10.37 2334 582559 227003 63686836
Body tinea 15.00 10.37 35 584858 1258 63912581
Metabolic alkalosis 15.00 10.37 73 584820 3855 63909984
Glucose tolerance impaired 14.98 10.37 105 584788 6338 63907501
Intestinal angioedema 14.97 10.37 27 584866 805 63913034
Complication of device insertion 14.97 10.37 14 584879 4998 63908841
Peripheral artery occlusion 14.90 10.37 48 584845 2090 63911749
Hypothermia 14.86 10.37 258 584635 19598 63894241
Ventricular compliance decreased 14.85 10.37 4 584889 0 63913839
Sinonasal obstruction 14.82 10.37 13 584880 180 63913659
Idiopathic pulmonary fibrosis 14.79 10.37 71 584822 3729 63910110
Mean arterial pressure decreased 14.74 10.37 17 584876 332 63913507
Hepatosplenomegaly 14.73 10.37 16 584877 5327 63908512
Hepatic failure 14.66 10.37 386 584507 55008 63858831
Benign neoplasm of adrenal gland 14.60 10.37 7 584886 30 63913809
Death 14.60 10.37 4026 580867 478679 63435160
Glucose urine present 14.57 10.37 40 584853 1592 63912247
Hyperthermia 14.56 10.37 82 584811 15468 63898371
Synovial cyst 14.52 10.37 30 584863 7677 63906162
Amenorrhoea 14.52 10.37 23 584870 6516 63907323
Osteonecrosis 14.43 10.37 175 584718 28054 63885785
Gastric pH increased 14.43 10.37 8 584885 49 63913790
Upper gastrointestinal haemorrhage 14.41 10.37 420 584473 34800 63879039
Acute graft versus host disease in skin 14.39 10.37 25 584868 6830 63907009
Product label on wrong product 14.36 10.37 6 584887 17 63913822
Immune-mediated myositis 14.25 10.37 55 584838 2623 63911216
Sex hormone binding globulin increased 14.25 10.37 5 584888 7 63913832
Device deployment issue 14.20 10.37 4 584889 2822 63911017
Neuropathy peripheral 14.15 10.37 897 583996 116628 63797211
Klebsiella infection 14.15 10.37 67 584826 13214 63900625
Device breakage 14.15 10.37 37 584856 8718 63905121
Sexual dysfunction 14.14 10.37 23 584870 6448 63907391
Hypertonic bladder 14.13 10.37 65 584828 3353 63910486
Gingival disorder 14.13 10.37 64 584829 3280 63910559
Dysgeusia 14.13 10.37 541 584352 46506 63867333
Pericardial disease 14.09 10.37 20 584873 484 63913355
Immunosuppression 14.09 10.37 50 584843 10696 63903143
Muscle necrosis 14.08 10.37 33 584860 1190 63912649
Pelvi-ureteric obstruction 14.05 10.37 8 584885 52 63913787
Glomerulonephritis acute 14.04 10.37 12 584881 160 63913679
Dermatosis 14.03 10.37 20 584873 486 63913353
Blood parathyroid hormone increased 14.01 10.37 61 584832 3073 63910766
Base excess decreased 13.98 10.37 17 584876 352 63913487
Foetal exposure during pregnancy 13.97 10.37 12 584881 4464 63909375
Vasculitis 13.86 10.37 236 584657 17859 63895980
Hyperprolactinaemia 13.82 10.37 10 584883 4055 63909784
Toxic nodular goitre 13.76 10.37 7 584886 35 63913804
Pulmonary embolism 13.75 10.37 1141 583752 145215 63768624
Wrong patient received product 13.72 10.37 69 584824 3693 63910146
Product storage error 13.72 10.37 68 584825 13250 63900589
Encephalitis toxic 13.70 10.37 15 584878 276 63913563
Drug level below therapeutic 13.69 10.37 29 584864 7355 63906484
Zinc deficiency 13.69 10.37 8 584885 55 63913784
Faecal calprotectin increased 13.67 10.37 8 584885 3632 63910207
Genital haemorrhage 13.66 10.37 18 584875 5504 63908335
Colon cancer 13.63 10.37 176 584717 12563 63901276
Guillain-Barre syndrome 13.62 10.37 117 584776 7518 63906321
Osteoarthritis 13.61 10.37 454 584439 62882 63850957
Cellulitis of male external genital organ 13.60 10.37 7 584886 36 63913803
Autoimmune enteropathy 13.60 10.37 7 584886 36 63913803
Enterococcal infection 13.60 10.37 72 584821 13794 63900045
Arthritis 13.59 10.37 621 584272 83193 63830646
Essential hypertension 13.49 10.37 87 584806 5107 63908732
Nipple disorder 13.46 10.37 12 584881 170 63913669
Femoral artery dissection 13.45 10.37 7 584886 37 63913802
Tongue disorder 13.43 10.37 60 584833 12020 63901819
Neuroendocrine tumour 13.36 10.37 31 584862 1110 63912729
Angiopathy 13.36 10.37 100 584793 6165 63907674
Hypertensive urgency 13.35 10.37 16 584877 326 63913513
Haemoglobin decreased 13.32 10.37 1990 582903 193073 63720766
Blood sodium decreased 13.31 10.37 356 584537 29126 63884713
Eyelid oedema 13.28 10.37 170 584723 12109 63901730
Aortic stenosis 13.23 10.37 101 584792 6264 63907575
Cross sensitivity reaction 13.22 10.37 7 584886 3360 63910479
Listless 13.19 10.37 62 584831 3228 63910611
Skin necrosis 13.18 10.37 76 584817 14253 63899586
Renovascular hypertension 13.16 10.37 7 584886 39 63913800
Therapy non-responder 13.09 10.37 477 584416 65422 63848417
Cell marker increased 13.07 10.37 22 584871 620 63913219
Myositis 13.06 10.37 215 584678 16162 63897677
Hyperplastic cholecystopathy 13.05 10.37 10 584883 113 63913726
Lung hernia 13.01 10.37 8 584885 61 63913778
Hypertensive cardiomyopathy 13.01 10.37 15 584878 293 63913546
Microalbuminuria 13.00 10.37 26 584867 839 63913000
Motor dysfunction 12.96 10.37 159 584734 11214 63902625
Breast cancer 12.96 10.37 186 584707 28962 63884877
Cardiac myxoma 12.91 10.37 10 584883 115 63913724
Coronary artery surgery 12.91 10.37 12 584881 180 63913659
Continuous haemodiafiltration 12.89 10.37 43 584850 1907 63911932
Acute pulmonary oedema 12.88 10.37 175 584718 12634 63901205
Accidental death 12.88 10.37 9 584884 3716 63910123
White blood cell count decreased 12.86 10.37 1244 583649 156593 63757246
Colitis ulcerative 12.85 10.37 140 584753 22888 63890951
Carcinoid tumour of the stomach 12.80 10.37 12 584881 182 63913657
Chills 12.76 10.37 1071 583822 136193 63777646
Multiple organ dysfunction syndrome 12.74 10.37 771 584122 100642 63813197
Coronary artery stenosis 12.71 10.37 157 584736 11091 63902748
Drug level increased 12.71 10.37 403 584490 33793 63880046
Disturbance in social behaviour 12.65 10.37 10 584883 3877 63909962
Blood cholinesterase increased 12.65 10.37 6 584887 25 63913814
Taste disorder 12.60 10.37 136 584757 9297 63904542
Injury 12.59 10.37 399 584494 55593 63858246
Multiple drug therapy 12.58 10.37 47 584846 2207 63911632
Pericarditis uraemic 12.55 10.37 5 584888 12 63913827
Acidosis 12.53 10.37 229 584664 17566 63896273
Hallucination, gustatory 12.50 10.37 8 584885 66 63913773
Acute motor-sensory axonal neuropathy 12.49 10.37 17 584876 395 63913444
Toxic skin eruption 12.49 10.37 245 584648 19039 63894800
Stent placement 12.49 10.37 90 584803 5481 63908358
Pleuritic pain 12.49 10.37 35 584858 8061 63905778
Abnormal loss of weight 12.48 10.37 112 584781 7288 63906551
Leukaemoid reaction 12.47 10.37 15 584878 307 63913532
Leukaemia recurrent 12.44 10.37 4 584889 2590 63911249
Rhinovirus infection 12.43 10.37 23 584870 6133 63907706
Inappropriate schedule of product administration 12.42 10.37 697 584196 91589 63822250
Urine flow decreased 12.32 10.37 28 584865 989 63912850
Tachycardia 12.31 10.37 1178 583715 148401 63765438
Hypertensive nephropathy 12.31 10.37 25 584868 816 63913023
Primary hypoparathyroidism 12.29 10.37 6 584887 27 63913812
Fulminant type 1 diabetes mellitus 12.28 10.37 29 584864 1051 63912788
Venous oxygen saturation decreased 12.27 10.37 5 584888 13 63913826
Gynaecomastia 12.25 10.37 95 584798 5921 63907918
Macrophages increased 12.24 10.37 12 584881 193 63913646
Renal artery occlusion 12.23 10.37 10 584883 125 63913714
Coronary arterial stent insertion 12.22 10.37 91 584802 5601 63908238
Blood urea abnormal 12.20 10.37 31 584862 1177 63912662
Nephropathy 12.19 10.37 123 584770 8263 63905576
Beta 2 microglobulin urine increased 12.16 10.37 10 584883 126 63913713
Adverse event 12.15 10.37 269 584624 39220 63874619
Periarticular disorder 12.12 10.37 6 584887 28 63913811
Cerebral ischaemia 12.11 10.37 141 584752 9821 63904018
Pleural mass 12.11 10.37 8 584885 70 63913769
Venous aneurysm 12.11 10.37 4 584889 4 63913835
Vagus nerve disorder 12.11 10.37 7 584886 47 63913792
Exposure via ingestion 12.06 10.37 81 584812 4821 63909018
Hypertensive angiopathy 12.02 10.37 9 584884 98 63913741
Transaminases increased 12.00 10.37 310 584583 44284 63869555
Depression 11.96 10.37 1467 583426 181824 63732015
Optic nerve injury 11.95 10.37 20 584873 561 63913278
Norepinephrine increased 11.93 10.37 8 584885 72 63913767
Phaeochromocytoma malignant 11.93 10.37 8 584885 72 63913767
Gingival atrophy 11.93 10.37 8 584885 72 63913767
Thrombotic cerebral infarction 11.85 10.37 18 584875 464 63913375
Peripheral coldness 11.84 10.37 181 584712 13403 63900436
Bursitis 11.84 10.37 131 584762 21354 63892485
Tardive dyskinesia 11.83 10.37 43 584850 9135 63904704
Carbohydrate metabolism disorder 11.79 10.37 6 584887 30 63913809
Fistula 11.77 10.37 47 584846 9714 63904125
Psychogenic visual disorder 11.77 10.37 5 584888 15 63913824
Cytomegalovirus colitis 11.70 10.37 11 584882 3917 63909922
Intraventricular haemorrhage 11.68 10.37 71 584822 4082 63909757
Physical examination abnormal 11.68 10.37 13 584880 244 63913595
Intentional product misuse 11.65 10.37 536 584357 71759 63842080
Cardiac valve sclerosis 11.65 10.37 9 584884 103 63913736
Bromhidrosis 11.65 10.37 4 584889 5 63913834
Lichenification 11.65 10.37 22 584871 680 63913159
Pelvic cyst 11.65 10.37 7 584886 51 63913788
Post-traumatic amnestic disorder 11.65 10.37 7 584886 51 63913788
Brain oedema 11.61 10.37 136 584757 21939 63891900
Device malfunction 11.60 10.37 103 584790 17530 63896309
Pharyngitis streptococcal 11.58 10.37 40 584853 8628 63905211
Aphthous ulcer 11.58 10.37 69 584824 12837 63901002
Psychomotor hyperactivity 11.57 10.37 80 584813 14371 63899468
Oral discharge 11.55 10.37 13 584880 247 63913592
Loose tooth 11.55 10.37 55 584838 2879 63910960
Surfactant protein increased 11.53 10.37 5 584888 16 63913823
Muscle spasms 11.51 10.37 1454 583439 139569 63774270
Henoch-Schonlein purpura 11.49 10.37 45 584848 2161 63911678
Pulmonary alveolar haemorrhage 11.47 10.37 137 584756 9601 63904238
Anorexia nervosa 11.47 10.37 11 584882 172 63913667
Jaundice 11.45 10.37 544 584349 47968 63865871
Oropharyngeal pain 11.45 10.37 674 584219 88193 63825646
Interstitial granulomatous dermatitis 11.44 10.37 12 584881 210 63913629
Intermenstrual bleeding 11.40 10.37 18 584875 5107 63908732
Flatulence 11.40 10.37 413 584480 35253 63878586
Lung diffusion test decreased 11.37 10.37 30 584863 1166 63912673
Benign gastrointestinal neoplasm 11.37 10.37 10 584883 139 63913700
Dysphonia 11.35 10.37 522 584371 45860 63867979
Myasthenia gravis 11.35 10.37 90 584803 5648 63908191
Neurosensory hypoacusis 11.35 10.37 12 584881 212 63913627
Poor venous access 11.35 10.37 66 584827 12351 63901488
Macroglossia 11.34 10.37 28 584865 1044 63912795
Thromboangiitis obliterans 11.34 10.37 6 584887 33 63913806
Tumour lysis syndrome 11.33 10.37 117 584776 19323 63894516
Muscular weakness 11.32 10.37 1320 583573 126018 63787821
Ureteric cancer 11.31 10.37 13 584880 253 63913586
Ventricular drainage 11.31 10.37 5 584888 17 63913822
Retinal ischaemia 11.25 10.37 22 584871 698 63913141
Renal artery thrombosis 11.25 10.37 17 584876 436 63913403
Peritoneal dialysis complication 11.24 10.37 45 584848 2183 63911656
Gingival hypoplasia 11.24 10.37 4 584889 6 63913833
Pleuroperitoneal communication 11.24 10.37 4 584889 6 63913833
Hepatitis E 11.22 10.37 4 584889 2427 63911412
Vaginal infection 11.21 10.37 17 584876 4903 63908936
Giant cell arteritis 11.21 10.37 46 584847 2257 63911582
Bone pain 11.18 10.37 337 584556 47235 63866604
Product solubility abnormal 11.18 10.37 24 584869 815 63913024
Metastases to central nervous system 11.14 10.37 77 584816 13835 63900004
Glucose tolerance increased 11.14 10.37 3 584890 0 63913839
Diabetic enteropathy 11.14 10.37 3 584890 0 63913839
Craniectomy 11.14 10.37 3 584890 0 63913839
Tear discolouration 11.14 10.37 3 584890 0 63913839
Crush syndrome 11.12 10.37 11 584882 179 63913660
Cogwheel rigidity 11.10 10.37 6 584887 2847 63910992
Hydronephrosis 11.10 10.37 185 584708 13940 63899899
Homicidal ideation 11.09 10.37 8 584885 3249 63910590
Streptococcal infection 11.05 10.37 33 584860 7446 63906393
Ventricular failure 11.01 10.37 18 584875 495 63913344
Tenderness 11.01 10.37 119 584774 19483 63894356
Brain abscess 11 10.37 13 584880 4168 63909671
Cold sweat 10.98 10.37 210 584683 16245 63897594
Electrocardiogram U wave present 10.97 10.37 9 584884 113 63913726
Infected dermal cyst 10.95 10.37 23 584870 769 63913070
Clostridium difficile infection 10.93 10.37 247 584646 35916 63877923
Omphalitis 10.92 10.37 6 584887 36 63913803
Appendicitis 10.92 10.37 75 584818 13494 63900345
Respiratory arrest 10.87 10.37 382 584511 52603 63861236
Inhibitory drug interaction 10.84 10.37 63 584830 3564 63910275
Pneumothorax traumatic 10.83 10.37 12 584881 224 63913615
Peripheral ischaemia 10.83 10.37 120 584773 8258 63905581
Faeces hard 10.82 10.37 43 584850 2079 63911760
Intestinal stenosis 10.80 10.37 8 584885 3206 63910633
Osteoporotic fracture 10.80 10.37 10 584883 3588 63910251
Skin candida 10.77 10.37 37 584856 1666 63912173
Helicobacter gastritis 10.75 10.37 44 584849 2156 63911683
IgA nephropathy 10.74 10.37 33 584860 1401 63912438
Underdose 10.74 10.37 167 584726 25662 63888177
Nystagmus 10.72 10.37 44 584849 9024 63904815
Herbal interaction 10.72 10.37 16 584877 406 63913433
Cardiac failure acute 10.71 10.37 208 584685 16136 63897703
Brain contusion 10.70 10.37 30 584863 1209 63912630
Kidney fibrosis 10.70 10.37 56 584837 3045 63910794
Flour sensitivity 10.69 10.37 5 584888 20 63913819
Retroperitoneal oedema 10.69 10.37 5 584888 20 63913819
Malignant neoplasm of renal pelvis 10.66 10.37 9 584884 118 63913721
Deformity 10.65 10.37 26 584867 6271 63907568
Metabolic disorder 10.64 10.37 35 584858 7662 63906177
Mycobacterium avium complex infection 10.64 10.37 12 584881 3928 63909911
Rib deformity 10.59 10.37 9 584884 119 63913720
Subarachnoid haemorrhage 10.55 10.37 230 584663 18208 63895631
Splenic rupture 10.55 10.37 44 584849 2175 63911664
Malignant hypertension 10.54 10.37 33 584860 1415 63912424
Attention deficit hyperactivity disorder 10.53 10.37 6 584887 2764 63911075
Generalised bullous fixed drug eruption 10.53 10.37 4 584889 8 63913831
Splenomegaly 10.51 10.37 108 584785 17853 63895986
Adrenal mass 10.51 10.37 26 584867 971 63912868
Incorrect dose administered by device 10.50 10.37 13 584880 4084 63909755
JC virus infection 10.46 10.37 9 584884 3346 63910493
Stent malfunction 10.44 10.37 7 584886 63 63913776
Menstruation irregular 10.42 10.37 15 584878 4420 63909419
Heat illness 10.42 10.37 15 584878 368 63913471
Basal ganglia stroke 10.41 10.37 9 584884 122 63913717
Hypogammaglobulinaemia 10.37 10.37 53 584840 10246 63903593

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C07FB07 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents and calcium channel blockers
ATC C07FB12 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents and calcium channel blockers
ATC C07FB13 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents and calcium channel blockers
ATC C08CA01 CARDIOVASCULAR SYSTEM
CALCIUM CHANNEL BLOCKERS
SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
Dihydropyridine derivatives
ATC C08CA51 CARDIOVASCULAR SYSTEM
CALCIUM CHANNEL BLOCKERS
SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
Dihydropyridine derivatives
ATC C08GA02 CARDIOVASCULAR SYSTEM
CALCIUM CHANNEL BLOCKERS
CALCIUM CHANNEL BLOCKERS AND DIURETICS
Calcium channel blockers and diuretics
ATC C09BB03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C09BB04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C09BB07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors and calcium channel blockers
ATC C09BX01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09BX03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09BX04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09DB01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB05 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB09 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DX01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09XA53 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
ATC C09XA54 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Renin-inhibitors
ATC C10BX03 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX07 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX09 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX11 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX14 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
ATC C10BX18 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA CS M0006414 Dihydropyridines
FDA MoA N0000000069 Calcium Channel Antagonists
FDA EPC N0000175421 Dihydropyridine Calcium Channel Blocker
FDA EPC N0000175566 Calcium Channel Blocker
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:38215 calcium channel blockers
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002121 Calcium Channel Blockers
MeSH PA D000077264 Calcium-Regulating Hormones and Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D014665 Vasodilator Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Prinzmetal angina indication 87343002
Angina pectoris indication 194828000
Cerebrovascular accident indication 230690007
Primary Prevention of Coronary Heart Disease indication
Myocardial Infarction Prevention indication
Anuria contraindication 2472002 DOID:2983
Alcoholism contraindication 7200002
Hyperkalemia contraindication 14140009
Jaundice contraindication 18165001
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Obstruction of bile duct contraindication 30144000
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Hypothyroidism contraindication 40930008 DOID:1459
Angioedema contraindication 41291007 DOID:1558
Hypokalemia contraindication 43339004
Diabetes mellitus type 2 contraindication 44054006 DOID:9352
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic idiopathic constipation contraindication 82934008
Hereditary angioneurotic edema contraindication 82966003 DOID:14735
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Disorder of connective tissue contraindication 105969002 DOID:65
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Hemorrhagic cerebral infarction contraindication 230706003
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Surgical procedure contraindication 387713003
Breastfeeding (mother) contraindication 413712001
Traumatic injury contraindication 417746004
Azotemia contraindication 445009001
Head and Neck Angioedema contraindication
Hemodialysis with High-Flux Membrane contraindication
Severe Aortic Valve Stenosis contraindication
Intestinal Angioedema contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.0 Basic
pKa2 1.55 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10MG BASE;14MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
EQ 2.5MG BASE;3.5MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
EQ 5MG BASE;7MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 6696481 April 15, 2023 TREATMENT OF HYPERTENSION
EQ 10MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9662315 May 22, 2029 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 2.5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9662315 May 22, 2029 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9662315 May 22, 2029 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 10MG BASE;14MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 2.5MG BASE;3.5MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 5MG BASE;7MG PRESTALIA ADHERA N205003 Jan. 21, 2015 RX TABLET ORAL 7846961 Oct. 5, 2029 TREATMENT OF HYPERTENSION
EQ 10MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9408837 Feb. 28, 2030 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 2.5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9408837 Feb. 28, 2030 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 9408837 Feb. 28, 2030 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 10MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 10925835 June 14, 2038 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 2.5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 10925835 June 14, 2038 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 5MG BASE;200MG CONSENSI PURPLE BIOTECH N210045 May 31, 2018 DISCN TABLET ORAL 10925835 June 14, 2038 TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
EQ 1MG BASE/ML NORLIQVA CMP DEV LLC N214439 Feb. 24, 2022 RX SOLUTION ORAL 11253474 Feb. 24, 2041 NORLIQVA IS INDICATED FOR THE SYMPTOMATIC TREATMENT OF CHRONIC STABLE ANGINA
EQ 1MG BASE/ML NORLIQVA CMP DEV LLC N214439 Feb. 24, 2022 RX SOLUTION ORAL 11253474 Feb. 24, 2041 NORLIQVA IS INDICATED FOR THE TREATMENT OF CONFIRMED OR SUSPECTED VASOSPASTIC ANGINA
EQ 1MG BASE/ML NORLIQVA CMP DEV LLC N214439 Feb. 24, 2022 RX SOLUTION ORAL 11253474 Feb. 24, 2041 NORLIQVA IS INDICATED FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Voltage-dependent L-type calcium channel subunit alpha-1C Ion channel BLOCKER WOMBAT-PK CHEMBL
Voltage-dependent L-type calcium channel subunit alpha-1D Ion channel BLOCKER Ki 7 WOMBAT-PK CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 5.63 CHEMBL
Aldehyde oxidase Enzyme IC50 5.26 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 6.58 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.36 DRUG MATRIX
Alpha-1D adrenergic receptor GPCR Ki 5.27 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 5.10 CHEMBL
Voltage-dependent calcium channel gamma-1 subunit Ion channel Ki 7.20 WOMBAT-PK
Carbonic anhydrase 1 Enzyme WOMBAT-PK
Voltage-dependent calcium channel subunit alpha-2/delta-1 Ion channel Ki 7.20 WOMBAT-PK
Voltage-dependent T-type calcium channel subunit alpha-1H Ion channel Ki 4.51 WOMBAT-PK
Potassium channel subfamily K member 2 Ion channel IC50 6.40 CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 6.65 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 5.87 DRUG MATRIX
Voltage-dependent L-type calcium channel subunit alpha-1C Ion channel Ki 8.70 CHEMBL
Potassium channel subfamily K member 2 Ion channel IC50 6.37 CHEMBL

External reference:

IDSource
4020813 VUID
N0000148333 NUI
D00615 KEGG_DRUG
111470-99-6 SECONDARY_CAS_RN
88150-47-4 SECONDARY_CAS_RN
104416 RXNORM
C0051696 UMLSCUI
CHEBI:2669 CHEBI
06X PDB_CHEM_ID
CHEMBL1491 ChEMBL_ID
CHEMBL1200402 ChEMBL_ID
D017311 MESH_DESCRIPTOR_UI
DB00381 DRUGBANK_ID
2162 PUBCHEM_CID
6981 IUPHAR_LIGAND_ID
5729 INN_ID
246852-12-0 SECONDARY_CAS_RN
1J444QC288 UNII
108736 MMSL
173594 MMSL
23944 MMSL
27341 MMSL
4180 MMSL
d00689 MMSL
003672 NDDF
003673 NDDF
008599 NDDF
015579 NDDF
4020586 VANDF
4020813 VANDF
CHEMBL1200984 ChEMBL_ID
108537001 SNOMEDCT_US
1193663008 SNOMEDCT_US
384976003 SNOMEDCT_US
386864001 SNOMEDCT_US
421048000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Norvasc HUMAN PRESCRIPTION DRUG LABEL 1 0069-1520 TABLET 2.50 mg ORAL NDA 26 sections
Norvasc HUMAN PRESCRIPTION DRUG LABEL 1 0069-1520 TABLET 2.50 mg ORAL NDA 26 sections
Norvasc HUMAN PRESCRIPTION DRUG LABEL 1 0069-1530 TABLET 5 mg ORAL NDA 26 sections
Norvasc HUMAN PRESCRIPTION DRUG LABEL 1 0069-1530 TABLET 5 mg ORAL NDA 26 sections
Norvasc HUMAN PRESCRIPTION DRUG LABEL 1 0069-1540 TABLET 10 mg ORAL NDA 26 sections
Norvasc HUMAN PRESCRIPTION DRUG LABEL 1 0069-1540 TABLET 10 mg ORAL NDA 26 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2150 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2150 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2160 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2160 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2170 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2170 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2180 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2180 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2190 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2190 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2250 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2250 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2260 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2260 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2270 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2270 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2960 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2970 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-2980 TABLET, FILM COATED 2.50 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-6180 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-6323 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-6565 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-6747 TABLET, FILM COATED 5 mg ORAL NDA 32 sections
Caduet HUMAN PRESCRIPTION DRUG LABEL 2 0069-7232 TABLET, FILM COATED 10 mg ORAL NDA 32 sections