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

Stem definitionDrug idCAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic) 475 145040-37-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • candesartan cilexetil
  • TCV-116
  • TCV 116
a nonpeptide angiotensin II receptor antagonist
  • Molecular weight: 610.67
  • Formula: C33H34N6O6
  • CLOGP: 7.08
  • LIPINSKI: 3
  • HAC: 12
  • HDO: 1
  • TPSA: 143.34
  • ALOGS: -5.48
  • ROTB: 13
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
8 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.61 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 0.42 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.405 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 7.015 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 15.066 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 17.865 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.160 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 0.220 % High 1
herg hERG pIC50 4.823 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 118.032 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 242.103 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.340 % High 1
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,MAPKAPK2,PDK1,PDK4,PRKDC 16
kinase-selectivity-class AXL,EIF2AK3,GRK2 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 14.421 High 1
mh-clint Mouse hepatocyte intrinsic clearance 34.119 High 1
mppb Mouse plasma protein binding (% unbound) 0.230 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 48.641 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 0.340 % High 1
rh-clint Rat hepatocyte intrinsic clearance 63.387 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 2 % High 1
rppb Rat plasma protein binding (% unbound) 0.150 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 102.094 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 12, 1999 PMDA Takeda Pharmaceutical Company Limited
June 4, 1998 FDA ASTRAZENECA

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
Blepharospasm 667.33 10.37 699 190876 54746 90382126
Nail disorder 518.45 10.37 632 190943 58435 90378437
Taste disorder 497.69 10.37 632 190943 60914 90375958
Back injury 474.19 10.37 538 191037 46084 90390788
Epilepsy 469.52 10.37 714 190861 81492 90355380
Gastrooesophageal reflux disease 419.11 10.37 1020 190555 165317 90271555
Onychomadesis 404.98 10.37 493 191082 45505 90391367
Breast cancer stage III 380.82 10.37 659 190916 83788 90353084
Product label confusion 375.94 10.37 342 191233 22508 90414364
Drug ineffective 347.48 10.37 1629 189946 1382669 89054203
Liver function test increased 311.61 10.37 606 190969 84249 90352623
Wound infection 305.58 10.37 687 190888 105715 90331157
Adverse reaction 298.92 10.37 341 191234 29371 90407501
Product dose omission issue 291.14 10.37 126 191449 291561 90145311
Bursitis 288.49 10.37 766 190809 130888 90305984
Peripheral venous disease 276.65 10.37 573 191002 83348 90353524
Finger deformity 270.92 10.37 341 191234 32556 90404316
Facet joint syndrome 268.93 10.37 623 190952 97766 90339106
Product quality issue 246.80 10.37 529 191046 78796 90358076
Completed suicide 246.59 10.37 15 191560 145043 90291829
Onychomycosis 245.68 10.37 347 191228 37029 90399843
Muscular weakness 241.36 10.37 970 190605 205696 90231176
Death 235.56 10.37 376 191199 456175 89980697
General physical health deterioration 231.29 10.37 1411 190164 353704 90083168
Hypercholesterolaemia 227.07 10.37 593 190982 100299 90336573
Coeliac disease 222.14 10.37 364 191211 44246 90392626
Arterial occlusive disease 210.06 10.37 189 191386 12257 90424615
Acute kidney injury 209.83 10.37 1275 190300 319112 90117760
Hyponatraemia 195.29 10.37 674 190901 132864 90304008
Infection 194.55 10.37 290 191285 361804 90075068
Neurologic neglect syndrome 189.44 10.37 154 191421 8693 90428179
Obesity 188.20 10.37 570 191005 104937 90331935
Injection site pain 188.14 10.37 66 191509 173633 90263239
Carotid artery thrombosis 185.75 10.37 154 191421 8938 90427934
Gangrene 183.55 10.37 178 191397 12698 90424174
Lip dry 180.62 10.37 546 191029 100409 90336463
Angina pectoris 175.67 10.37 305 191270 38855 90398017
Neck pain 172.58 10.37 582 190993 113381 90323491
C-reactive protein increased 171.51 10.37 799 190776 180590 90256282
Live birth 170.90 10.37 458 191117 78649 90358223
Adjustment disorder 167.83 10.37 149 191426 9493 90427379
Infusion site reaction 159.37 10.37 199 191376 18840 90418032
Cardiospasm 158.85 10.37 96 191479 3350 90433522
Palmoplantar keratoderma 157.30 10.37 96 191479 3411 90433461
Inflammation 156.04 10.37 769 190806 177823 90259049
Intentional product use issue 156.00 10.37 885 190690 216007 90220865
Hemiplegia 155.02 10.37 181 191394 15979 90420893
Personality disorder 153.42 10.37 159 191416 12285 90424587
Pruritus genital 145.98 10.37 101 191474 4457 90432415
Hepatitis 144.27 10.37 401 191174 70338 90366534
Skin haemorrhage 144.22 10.37 201 191374 21179 90415693
Lung disorder 142.97 10.37 662 190913 149221 90287651
Memory impairment 142.60 10.37 806 190769 196438 90240434
Grip strength decreased 140.34 10.37 473 191102 92103 90344769
Night sweats 135.03 10.37 585 190990 128181 90308691
Dry mouth 132.96 10.37 752 190823 183307 90253565
Sleep terror 131.54 10.37 94 191481 4370 90432502
Carotid artery occlusion 128.68 10.37 107 191468 6235 90430637
Injection site erythema 128.21 10.37 26 191549 98476 90338396
Disease progression 127.95 10.37 87 191488 156528 90280344
Musculoskeletal pain 127.90 10.37 706 190869 170545 90266327
Joint range of motion decreased 125.61 10.37 594 190981 135049 90301823
Sputum discoloured 123.31 10.37 182 191393 20209 90416663
Confusional state 120.87 10.37 1298 190277 384907 90051965
Hyperkalaemia 119.62 10.37 355 191220 64609 90372263
Atrial tachycardia 119.34 10.37 100 191475 5890 90430982
Pruritus 118.59 10.37 666 190909 540859 89896013
Sleep disorder due to general medical condition, insomnia type 117.00 10.37 63 191512 128631 90308241
Gait inability 116.27 10.37 614 190961 145842 90291030
Subarachnoid haemorrhage 115.84 10.37 165 191410 17739 90419133
Abdominal distension 112.36 10.37 560 191015 130041 90306831
Motor dysfunction 111.08 10.37 168 191407 19062 90417810
Wheezing 110.38 10.37 871 190704 237209 90199663
Sensory loss 110.27 10.37 162 191413 17913 90418959
Tension headache 109.28 10.37 105 191470 7404 90429468
Folliculitis 108.52 10.37 772 190803 203581 90233291
Immunisation 108.11 10.37 64 191511 2149 90434723
Affect lability 107.47 10.37 160 191415 17903 90418969
Type 2 diabetes mellitus 106.87 10.37 766 190809 202478 90234394
Toxicity to various agents 106.07 10.37 287 191288 287559 90149313
Abdominal pain upper 104.00 10.37 1118 190457 331556 90105316
Neuropathy peripheral 102.94 10.37 83 191492 136887 90299985
Product monitoring error 101.32 10.37 81 191494 4463 90432409
Rheumatoid factor positive 100.58 10.37 129 191446 171521 90265351
Hemiparesis 98.69 10.37 212 191363 31607 90405265
Febrile neutropenia 98.06 10.37 114 191461 158235 90278637
Systemic infection 95.72 10.37 80 191495 4695 90432177
Lung opacity 91.98 10.37 87 191488 6015 90430857
Osteoarthritis 91.76 10.37 718 190857 195012 90241860
Coordination abnormal 91.46 10.37 163 191412 21193 90415679
Palpitations 91.15 10.37 547 191028 136181 90300691
Hypocholesterolaemia 89.76 10.37 88 191487 6361 90430511
Fall 88.81 10.37 1471 190104 480339 89956533
Dyspepsia 88.03 10.37 718 190857 197442 90239430
Neutropenia 87.61 10.37 218 191357 224686 90212186
Sinusitis 87.50 10.37 400 191175 342688 90094184
Muscle spasms 87.48 10.37 865 190710 251018 90185854
Neovascularisation 87.20 10.37 50 191525 1580 90435292
Paraesthesia 84.20 10.37 854 190721 249472 90187400
Oligohydramnios 83.40 10.37 89 191486 7112 90429760
Respiratory tract congestion 83.15 10.37 181 191394 27229 90409643
Blood lactic acid decreased 82.01 10.37 32 191543 410 90436462
Aphasia 81.72 10.37 237 191338 42575 90394297
Bronchopulmonary aspergillosis allergic 81.57 10.37 66 191509 3700 90433172
Anosmia 80.93 10.37 102 191473 9746 90427126
Sinus congestion 80.82 10.37 179 191396 27245 90409627
Vasculitis 80.74 10.37 160 191415 22533 90414339
Hypersensitivity 80.19 10.37 597 190978 454080 89982792
Vitamin B1 decreased 79.28 10.37 33 191542 505 90436367
Sneezing 78.14 10.37 186 191389 29683 90407189
Discomfort 76.57 10.37 309 191266 274026 90162846
Seizure 76.40 10.37 128 191447 152501 90284371
Cardiac output increased 75.99 10.37 32 191543 505 90436367
Injection site swelling 71.50 10.37 19 191556 59820 90377052
Product prescribing error 70.67 10.37 180 191395 29965 90406907
White blood cell count decreased 70.67 10.37 155 191420 166954 90269918
Rash 70.37 10.37 1222 190353 794878 89641994
Blood pressure increased 70.27 10.37 681 190894 196536 90240336
Drug-induced liver injury 69.16 10.37 375 191200 89943 90346929
Total lung capacity decreased 68.76 10.37 60 191515 3735 90433137
Eating disorder 66.20 10.37 168 191407 27905 90408967
Sepsis 64.91 10.37 181 191394 179633 90257239
Accidental exposure to product 64.73 10.37 7 191568 42359 90394513
Urinary tract infection 64.57 10.37 380 191195 305252 90131620
Blood cholesterol increased 64.44 10.37 698 190877 207314 90229558
Mental status changes 64.31 10.37 9 191566 44670 90392202
Therapy interrupted 63.61 10.37 14 191561 50094 90386778
Overlap syndrome 63.16 10.37 84 191491 8464 90428408
Tinnitus 62.47 10.37 217 191358 42885 90393987
Sinus disorder 62.22 10.37 187 191388 34260 90402612
Hypoaesthesia 61.80 10.37 970 190605 313240 90123632
Multiple sclerosis relapse 61.76 10.37 17 191558 52288 90384584
Dizziness 61.35 10.37 1655 189920 587629 89849243
Pain of skin 60.39 10.37 116 191459 15966 90420906
Lactic acidosis 59.72 10.37 238 191337 50225 90386647
Hepatic enzyme 58.31 10.37 64 191511 5280 90431592
Facial pain 58.24 10.37 102 191473 13080 90423792
Pain 56.95 10.37 1638 189937 994703 89442169
Psoriatic arthropathy 56.51 10.37 734 190841 227601 90209271
Therapy non-responder 56.00 10.37 129 191446 136575 90300297
Blood folate decreased 55.83 10.37 38 191537 1632 90435240
Anuria 55.79 10.37 107 191468 14711 90422161
Myelosuppression 55.25 10.37 22 191553 53569 90383303
Asthenia 55.23 10.37 1498 190077 532253 89904619
Flushing 54.45 10.37 64 191511 88427 90348445
Bronchitis 54.41 10.37 155 191420 152772 90284100
Dysarthria 54.40 10.37 244 191331 54238 90382634
Thrombosis 54.27 10.37 45 191530 73206 90363666
Oropharyngeal pain 53.67 10.37 101 191474 115086 90321786
Contusion 52.70 10.37 313 191262 250903 90185969
Electrocardiogram abnormal 52.57 10.37 85 191490 10213 90426659
Muscle injury 52.05 10.37 587 190988 176067 90260805
Irritable bowel syndrome 51.81 10.37 668 190907 206780 90230092
Injection site pruritus 50.93 10.37 25 191550 53809 90383063
Ear infection 50.30 10.37 44 191531 69731 90367141
Suicide attempt 50.30 10.37 51 191524 75348 90361524
Drug abuse 50.20 10.37 60 191515 82287 90354585
Cystitis 49.72 10.37 275 191300 66443 90370429
Inappropriate antidiuretic hormone secretion 49.44 10.37 120 191455 19385 90417487
Ventricular tachycardia 49.31 10.37 139 191436 24569 90412303
Surgery 48.67 10.37 17 191558 44870 90392002
Erythema 48.41 10.37 285 191290 228961 90207911
Eye pruritus 47.27 10.37 152 191423 28875 90407997
Injection site bruising 46.95 10.37 26 191549 52281 90384591
Diplopia 46.43 10.37 150 191425 28564 90408308
Therapeutic drug monitoring analysis not performed 46.24 10.37 31 191544 1298 90435574
Pericarditis 46.11 10.37 815 190760 269336 90167536
Vision blurred 46.04 10.37 103 191472 110190 90326682
Rash erythematous 45.80 10.37 42 191533 65062 90371810
Renal impairment 45.18 10.37 379 191196 105042 90331830
Bradycardia 45.18 10.37 318 191257 83529 90353343
Full blood count decreased 45.12 10.37 5 191570 29684 90407188
Premature delivery 45.02 10.37 13 191562 38749 90398123
Aspiration 44.64 10.37 101 191474 15592 90421280
Obstructive airways disorder 44.45 10.37 138 191437 25731 90411141
Hip arthroplasty 43.87 10.37 58 191517 76150 90360722
Rubber sensitivity 43.82 10.37 41 191534 2796 90434076
Liver injury 43.33 10.37 551 191024 170016 90266856
Muscle spasticity 42.93 10.37 168 191407 35154 90401718
Wrong technique in product usage process 42.72 10.37 53 191522 71518 90365354
Labile hypertension 42.24 10.37 21 191554 494 90436378
Staphylococcal infection 42.16 10.37 25 191550 48414 90388458
Rheumatoid arthritis 41.92 10.37 1033 190542 361581 90075291
Fibromyalgia 41.75 10.37 640 190935 205629 90231243
Unevaluable event 41.49 10.37 33 191542 54815 90382057
Transient ischaemic attack 41.34 10.37 191 191384 42985 90393887
Disturbance in attention 41.19 10.37 203 191372 46906 90389966
Exposure to allergen 40.93 10.37 21 191554 529 90436343
Neutrophil count decreased 40.61 10.37 55 191520 71477 90365395
Vitamin B1 increased 40.50 10.37 15 191560 165 90436707
Therapeutic response decreased 39.79 10.37 81 191494 89648 90347224
Drug resistance 39.69 10.37 8 191567 30441 90406431
Device dislocation 39.55 10.37 9 191566 31473 90405399
Hypertensive crisis 39.43 10.37 104 191471 17680 90419192
Respiratory failure 39.26 10.37 124 191451 118294 90318578
Body temperature increased 39.02 10.37 23 191552 44687 90392185
Dry eye 38.85 10.37 39 191536 57892 90378980
Fatigue 38.79 10.37 2020 189555 1152003 89284869
Sleep disorder 38.01 10.37 609 190966 197421 90239451
Fluid retention 37.81 10.37 81 191494 88010 90348862
Lower respiratory tract infection 37.17 10.37 740 190835 249919 90186953
Injection site rash 36.91 10.37 4 191571 24169 90412703
Incorrect product administration duration 36.90 10.37 107 191468 19215 90417657
Gait disturbance 36.90 10.37 362 191213 260134 90176738
Thrombocytopenia 36.28 10.37 275 191300 208450 90228422
Neoplasm progression 35.93 10.37 25 191550 44461 90392411
Back pain 35.78 10.37 464 191111 316711 90120161
Intentional overdose 35.70 10.37 92 191483 93742 90343130
Cholestatic liver injury 35.54 10.37 42 191533 3755 90433117
Angioedema 35.50 10.37 247 191328 64629 90372243
Illness 35.49 10.37 75 191500 81894 90354978
Upper respiratory tract infection 35.48 10.37 145 191430 128173 90308699
Forced expiratory volume decreased 35.34 10.37 52 191523 5756 90431116
Knee arthroplasty 35.28 10.37 77 191498 83105 90353767
Normal newborn 35.06 10.37 119 191456 23243 90413629
Lip swelling 34.92 10.37 168 191407 38442 90398430
Therapy cessation 34.22 10.37 17 191558 36344 90400528
Paradoxical drug reaction 34.19 10.37 51 191524 5715 90431157
C3 glomerulopathy 33.50 10.37 13 191562 164 90436708
Syncope 33.45 10.37 428 191147 132235 90304637
Hospitalisation 33.42 10.37 148 191427 127952 90308920
Disease recurrence 33.39 10.37 19 191556 37634 90399238
Occupational asthma 33.22 10.37 13 191562 168 90436704
Sedation 32.80 10.37 32 191543 48139 90388733
Joint injury 32.72 10.37 14 191561 32650 90404222
Cytomegalovirus infection 32.64 10.37 8 191567 26594 90410278
Muscle twitching 32.63 10.37 119 191456 24083 90412789
Encephalopathy 32.62 10.37 30 191545 46414 90390458
Pyrexia 32.48 10.37 1107 190468 659378 89777494
Fibromuscular dysplasia 32.25 10.37 15 191560 303 90436569
Foot deformity 31.75 10.37 48 191527 59603 90377269
Rales 31.54 10.37 89 191486 15738 90421134
Blood calcium increased 31.44 10.37 75 191500 11983 90424889
Pain in jaw 31.39 10.37 33 191542 47952 90388920
Injection site reaction 31.32 10.37 315 191260 91765 90345107
Respiratory tract infection 31.00 10.37 48 191527 59030 90377842
Arthralgia 30.99 10.37 1338 190237 777184 89659688
Device malfunction 30.72 10.37 4 191571 20973 90415899
Device issue 30.65 10.37 12 191563 29525 90407347
Fungal infection 30.63 10.37 27 191548 42634 90394238
Hepatotoxicity 30.58 10.37 31 191544 45811 90391061
Helicobacter infection 30.44 10.37 660 190915 226190 90210682
Haematochezia 30.41 10.37 255 191320 70658 90366214
Mouth ulceration 30.30 10.37 24 191551 39950 90396922
Red blood cell sedimentation rate abnormal 30.25 10.37 7 191568 24197 90412675
Irritability 30.21 10.37 19 191556 35643 90401229
Labelled drug-drug interaction medication error 30.05 10.37 83 191492 14499 90422373
Macular degeneration 29.80 10.37 22 191553 37948 90398924
Depression 29.71 10.37 839 190736 299762 90137110
Dysphonia 29.66 10.37 55 191520 63029 90373843
Chronic spontaneous urticaria 29.46 10.37 27 191548 1793 90435079
Blood creatinine increased 29.44 10.37 336 191239 101050 90335822
Nasal congestion 29.32 10.37 85 191490 83329 90353543
Gastroenteritis viral 28.86 10.37 14 191561 30341 90406531
Food allergy 28.76 10.37 9 191566 25469 90411403
Oxygen saturation decreased 28.75 10.37 123 191452 107360 90329512
Foetal exposure during pregnancy 28.74 10.37 29 191546 42946 90393926
Intentional self-injury 28.70 10.37 13 191562 29321 90407551
Atelectasis 28.69 10.37 8 191567 24401 90412471
Androgenetic alopecia 28.63 10.37 12 191563 187 90436685
Basilar artery occlusion 28.57 10.37 12 191563 188 90436684
Oral candidiasis 28.53 10.37 20 191555 35435 90401437
Skin fissures 28.12 10.37 5 191570 20804 90416068
Cytokine release syndrome 28.00 10.37 12 191563 27961 90408911
Tenderness 27.74 10.37 11 191564 26857 90410015
Constipation 27.43 10.37 422 191153 279973 90156899
Psychotic disorder 27.35 10.37 16 191559 31214 90405658
Abortion spontaneous 27.35 10.37 45 191530 54011 90382861
Skin discolouration 27.31 10.37 32 191543 44283 90392589
Blindness 27.28 10.37 120 191455 26448 90410424
Treatment noncompliance 27.17 10.37 42 191533 51685 90385187
Injection site haemorrhage 27.01 10.37 13 191562 28305 90408567
Impaired healing 26.98 10.37 667 190908 233532 90203340
Duodenal ulcer perforation 26.93 10.37 635 190940 220653 90216219
Pulmonary hypoplasia 26.92 10.37 14 191561 363 90436509
Oral pain 26.88 10.37 18 191557 32665 90404207
Product use in unapproved indication 26.74 10.37 914 190661 335322 90101550
Anaphylactic reaction 26.71 10.37 95 191480 87429 90349443
Blister 26.68 10.37 717 190858 254281 90182591
Pregnancy 26.67 10.37 57 191518 61990 90374882
Swollen joint count increased 26.35 10.37 133 191442 111073 90325799
Infusion site pain 26.12 10.37 5 191570 19733 90417139
Radiculopathy 26.00 10.37 4 191571 18501 90418371
Blood pressure measurement 25.95 10.37 14 191561 392 90436480
Malignant neoplasm progression 25.79 10.37 127 191448 106743 90330129
Joint dislocation 25.59 10.37 34 191541 44548 90392324
Complication associated with device 25.58 10.37 5 191570 19444 90417428
Joint swelling 25.54 10.37 840 190735 502460 89934412
Cardio-respiratory arrest 25.51 10.37 60 191515 63080 90373792
Herpes zoster 25.50 10.37 108 191467 94536 90342336
Platelet count decreased 25.46 10.37 177 191398 136792 90300080
Metastases to bone 25.43 10.37 11 191564 25494 90411378
Suicidal ideation 25.42 10.37 76 191499 73779 90363093
Dermatitis atopic 25.26 10.37 9 191566 23463 90413409
Product storage error 25.00 10.37 6 191569 20235 90416637
Atrial fibrillation 24.92 10.37 409 191166 133202 90303670
Multiple sclerosis 24.75 10.37 14 191561 27826 90409046
Cataract 24.70 10.37 247 191328 71845 90365027
Injection site mass 24.59 10.37 8 191567 22082 90414790
Spur cell anaemia 24.41 10.37 8 191567 59 90436813
Aggression 24.31 10.37 13 191562 26655 90410217
Therapeutic response shortened 24.23 10.37 9 191566 22870 90414002
Metastases to central nervous system 24.18 10.37 4 191571 17538 90419334
Cellulitis 24.14 10.37 105 191470 91232 90345640
Oedema 24.08 10.37 289 191286 200006 90236866
Musculoskeletal disorder 24.02 10.37 8 191567 21761 90415111
Gastrointestinal tract adenoma 23.90 10.37 13 191562 370 90436502
Bronchiectasis 23.80 10.37 102 191473 22228 90414644
Deep vein thrombosis 23.80 10.37 106 191469 91514 90345358
Orbital swelling 23.74 10.37 8 191567 65 90436807
Paresis 23.73 10.37 29 191546 2685 90434187
Cystostomy 23.63 10.37 8 191567 66 90436806
Drug hypersensitivity 23.46 10.37 774 190801 462835 89974037
Cardiac failure congestive 23.40 10.37 118 191457 98576 90338296
Drug withdrawal syndrome 23.38 10.37 16 191559 28707 90408165
Acute respiratory failure 23.36 10.37 34 191541 42884 90393988
Small intestinal obstruction 23.09 10.37 8 191567 21226 90415646
Lichen planus 23.08 10.37 29 191546 2762 90434110
Drug dependence 23.00 10.37 17 191558 29310 90407562
Procedural pain 22.90 10.37 22 191553 33338 90403534
Dystonia 22.82 10.37 4 191571 16815 90420057
Malaise 22.81 10.37 1483 190092 584503 89852369
Candida infection 22.75 10.37 23 191552 34034 90402838
Eye irritation 22.64 10.37 23 191552 33955 90402917
Diverticulum intestinal haemorrhagic 22.61 10.37 23 191552 1738 90435134
Plasma cell myeloma 22.56 10.37 32 191543 40796 90396076
Thalamus haemorrhage 22.52 10.37 16 191559 737 90436135
Oesophageal dilatation 22.50 10.37 14 191561 515 90436357
Urine protein/creatinine ratio increased 22.48 10.37 18 191557 994 90435878
Transaminases increased 22.39 10.37 145 191430 37047 90399825
Anti-cyclic citrullinated peptide antibody 22.38 10.37 15 191560 27206 90409666
Hyperlactacidaemia 22.29 10.37 35 191540 4101 90432771
Hypomagnesaemia 22.20 10.37 140 191435 35448 90401424
Hypertension 22.19 10.37 1181 190394 456351 89980521
Catarrh 22.19 10.37 22 191553 1612 90435260
Neurotoxicity 21.82 10.37 9 191566 21458 90415414
Vaginal discharge 21.75 10.37 7 191568 19457 90417415
Sciatica 21.41 10.37 126 191449 101256 90335616
Neoplasm malignant 21.38 10.37 24 191551 33856 90403016
Limb injury 21.37 10.37 21 191554 31487 90405385
Cardiac failure 21.09 10.37 337 191238 109159 90327713
Injury 20.95 10.37 556 191019 196793 90240079
Cough 20.92 10.37 967 190608 367995 90068877
Circulatory collapse 20.84 10.37 106 191469 24798 90412074
Dyskinesia 20.83 10.37 28 191547 36506 90400366
Cardiac arrest 20.81 10.37 133 191442 104802 90332070
Blood hyposmosis 20.80 10.37 6 191569 27 90436845
Panniculitis 20.60 10.37 3 191572 14455 90422417
Intentional dose omission 20.58 10.37 6 191569 17777 90419095
Foetal death 20.57 10.37 9 191566 20714 90416158
Congenital anomaly 20.50 10.37 43 191532 6304 90430568
Burns second degree 20.38 10.37 23 191552 1957 90434915
Rheumatic fever 20.37 10.37 445 191130 152676 90284196
Conjunctivitis 20.28 10.37 16 191559 26690 90410182
Foot fracture 20.13 10.37 16 191559 26590 90410282
Device difficult to use 20.13 10.37 6 191569 17519 90419353
Inappropriate schedule of product administration 20.12 10.37 211 191364 149722 90287150
Osteochondrosis 19.98 10.37 22 191553 1821 90435051
Unresponsive to stimuli 19.98 10.37 31 191544 38090 90398782
Ultrasound uterus abnormal 19.95 10.37 7 191568 65 90436807
Vestibular migraine 19.86 10.37 10 191565 242 90436630
Bone pain 19.78 10.37 66 191509 61917 90374955
Chronic sinusitis 19.72 10.37 13 191562 23789 90413083
Lymphadenopathy 19.72 10.37 42 191533 45733 90391139
Barotrauma 19.71 10.37 9 191566 174 90436698
Sinonasal obstruction 19.45 10.37 10 191565 253 90436619
Underdose 19.45 10.37 187 191388 53830 90383042
Chronic obstructive pulmonary disease 19.43 10.37 85 191490 73744 90363128
Urticaria pressure 19.40 10.37 7 191568 71 90436801
Myocardial oedema 19.35 10.37 12 191563 439 90436433
Orthostatic hypotension 19.33 10.37 153 191422 41674 90395198
Vertigo positional 19.01 10.37 29 191546 3315 90433557
Mood swings 19.00 10.37 10 191565 20692 90416180
Drug tolerance decreased 18.96 10.37 24 191551 32106 90404766
Lymphocyte count decreased 18.85 10.37 28 191547 35022 90401850
Rhinitis allergic 18.82 10.37 6 191569 16779 90420093
Oral herpes 18.80 10.37 26 191549 33498 90403374
Anti-cyclic citrullinated peptide antibody positive 18.60 10.37 642 190933 235791 90201081
Cerebrovascular arteriovenous malformation 18.58 10.37 7 191568 81 90436791
Tooth disorder 18.58 10.37 23 191552 31067 90405805
Stab wound 18.50 10.37 7 191568 82 90436790
Clostridium difficile infection 18.49 10.37 30 191545 36215 90400657
Osteoporosis 18.31 10.37 124 191451 96407 90340465
Pemphigoid 18.23 10.37 51 191524 8975 90427897
Skin disorder 18.16 10.37 31 191544 36675 90400197
Lung neoplasm malignant 17.87 10.37 15 191560 24258 90412614
Incorrect dose administered 17.80 10.37 96 191479 78834 90358038
Multiple organ dysfunction syndrome 17.79 10.37 79 191496 68257 90368615
Balance disorder 17.77 10.37 126 191449 96954 90339918
Mood altered 17.73 10.37 7 191568 17137 90419735
Device related infection 17.70 10.37 17 191558 25769 90411103
Brain stem stroke 17.62 10.37 11 191564 407 90436465
Influenza like illness 17.41 10.37 253 191322 80358 90356514
Cardiac disorder 17.17 10.37 62 191513 56810 90380062
Coma 17.13 10.37 87 191488 72545 90364327
Renal impairment neonatal 17.07 10.37 6 191569 56 90436816
Cerebrovascular accident 17.07 10.37 361 191214 123172 90313700
Septic shock 17.03 10.37 106 191469 84054 90352818
Chest pain 17.03 10.37 530 191045 319115 90117757
Paternal exposure during pregnancy 16.91 10.37 10 191565 335 90436537
Vaginal haemorrhage 16.80 10.37 25 191550 31246 90405626
Road traffic accident 16.76 10.37 146 191429 107480 90329392
Potentiating drug interaction 16.73 10.37 37 191538 5625 90431247
Hypotension 16.58 10.37 844 190731 324553 90112319
Acute hepatic failure 16.53 10.37 14 191561 22547 90414325
Metastases to fallopian tube 16.45 10.37 6 191569 63 90436809
Crying 16.37 10.37 18 191557 25627 90411245
Pelvic pain 16.33 10.37 6 191569 15351 90421521
Fibrous dysplasia of jaw 16.27 10.37 4 191571 8 90436864
Extrapyramidal disorder 16.26 10.37 73 191502 16230 90420642
Bone disorder 16.16 10.37 15 191560 23105 90413767
Acute myeloid leukaemia 16.14 10.37 12 191563 20628 90416244
Pulpitis dental 16.05 10.37 15 191560 1021 90435851
Mental status changes postoperative 16.02 10.37 8 191567 190 90436682
Eosinophilic fasciitis 15.98 10.37 8 191567 191 90436681
Purpura senile 15.97 10.37 12 191563 603 90436269
Laboratory test abnormal 15.95 10.37 41 191534 41813 90395059
Hypervolaemia 15.90 10.37 28 191547 32729 90404143
Respiratory tract inflammation 15.88 10.37 12 191563 608 90436264
Body height decreased 15.87 10.37 3 191572 11946 90424926
Diffuse alopecia 15.78 10.37 16 191559 1204 90435668
Stress 15.71 10.37 104 191471 81291 90355581
Caesarean section 15.59 10.37 10 191565 18567 90418305
Lip infection 15.49 10.37 7 191568 132 90436740
Ulcer haemorrhage 15.47 10.37 102 191473 26219 90410653
Haemoptysis 15.46 10.37 122 191453 33198 90403674
Drug reaction with eosinophilia and systemic symptoms 15.45 10.37 43 191532 42715 90394157
Amenorrhoea 15.45 10.37 3 191572 11719 90425153
Product contamination chemical 15.38 10.37 4 191571 11 90436861
Vitamin D deficiency 15.36 10.37 9 191566 17547 90419325
Intestinal obstruction 15.23 10.37 35 191540 37096 90399776
Rash papular 15.23 10.37 84 191491 20271 90416601
Alopecia 15.15 10.37 874 190701 494197 89942675
Ileocolostomy 15.13 10.37 5 191570 38 90436834
Ballismus 15.11 10.37 7 191568 140 90436732
Respiratory depression 15.09 10.37 7 191568 15568 90421304
Chills 14.89 10.37 193 191382 131788 90305084
Intraventricular haemorrhage 14.87 10.37 22 191553 2447 90434425
Product administration interrupted 14.86 10.37 4 191571 12488 90424384
Female sterilisation 14.86 10.37 12 191563 671 90436201
Steroid dependence 14.81 10.37 21 191554 2248 90434624
Sensitivity to weather change 14.80 10.37 47 191528 8867 90428005
Eye allergy 14.78 10.37 16 191559 1299 90435573
Immobile 14.78 10.37 38 191537 6360 90430512
Feeling jittery 14.75 10.37 7 191568 15364 90421508
Toxic epidermal necrolysis 14.73 10.37 29 191546 32499 90404373
Kidney enlargement 14.67 10.37 13 191562 826 90436046
Loss of personal independence in daily activities 14.64 10.37 201 191374 135904 90300968
Cerebellar syndrome 14.62 10.37 28 191547 3844 90433028
Therapy partial responder 14.60 10.37 15 191560 22028 90414844
Rhinorrhoea 14.53 10.37 265 191310 88051 90348821
Flail chest 14.46 10.37 6 191569 91 90436781
Faecal elastase concentration decreased 14.45 10.37 4 191571 15 90436857
Pancytopenia 14.27 10.37 174 191401 120089 90316783
Confusion postoperative 14.24 10.37 8 191567 243 90436629
Tooth infection 14.20 10.37 13 191562 20157 90416715
Painful respiration 14.18 10.37 24 191551 2994 90433878
Deafness 14.15 10.37 16 191559 22498 90414374
Pneumobilia 14.11 10.37 7 191568 164 90436708
Lung perforation 14.06 10.37 6 191569 98 90436774
Non-cardiogenic pulmonary oedema 13.95 10.37 15 191560 1209 90435663
Hypersomnia 13.87 10.37 15 191560 21516 90415356
Paternal exposure before pregnancy 13.84 10.37 6 191569 102 90436770
Gastrointestinal dysplasia 13.84 10.37 5 191570 51 90436821
Increased tendency to bruise 13.78 10.37 4 191571 11886 90424986
Sleep apnoea syndrome 13.78 10.37 29 191546 31718 90405154
Histamine intolerance 13.75 10.37 5 191570 52 90436820
Pneumococcal infection 13.74 10.37 15 191560 1230 90435642
Eye disorder 13.67 10.37 23 191552 27367 90409505
Impaired gastric emptying 13.63 10.37 5 191570 12804 90424068
Blood alkaline phosphatase 13.48 10.37 7 191568 181 90436691
Haemorrhagic cyst 13.48 10.37 8 191567 270 90436602
Epistaxis 13.47 10.37 115 191460 85010 90351862
Infusion site erythema 13.47 10.37 6 191569 13664 90423208
Eye pain 13.44 10.37 48 191527 44120 90392752
Leukopenia 13.40 10.37 142 191433 100568 90336304
Skin burning sensation 13.38 10.37 13 191562 19598 90417274
Ankle fracture 13.33 10.37 14 191561 20356 90416516
Respiratory arrest 13.18 10.37 32 191543 33279 90403593
Occult blood 13.10 10.37 15 191560 1296 90435576
Liver disorder 13.08 10.37 179 191396 121090 90315782
Incontinence 13.07 10.37 6 191569 13429 90423443
Sedation complication 13.06 10.37 10 191565 16934 90419938
Periorbital inflammation 13.04 10.37 7 191568 194 90436678
Sputum retention 13.02 10.37 11 191564 655 90436217
Cushingoid 13.00 10.37 3 191572 10392 90426480
Myelodysplastic syndrome 12.98 10.37 15 191560 20888 90415984
Paraesthesia oral 12.86 10.37 30 191545 31629 90405243
Vertigo 12.75 10.37 213 191362 69598 90367274
Hypoglycaemia 12.72 10.37 213 191362 69635 90367237
Nephrolithiasis 12.62 10.37 57 191518 49028 90387844
Neutrophil count 12.58 10.37 9 191566 419 90436453
Hyperglycaemic hyperosmolar nonketotic syndrome 12.58 10.37 15 191560 1354 90435518
Putamen haemorrhage 12.54 10.37 7 191568 210 90436662
Immunodeficiency 12.49 10.37 48 191527 43186 90393686
Heavy menstrual bleeding 12.46 10.37 15 191560 20515 90416357
Tubulointerstitial nephritis 12.43 10.37 94 191481 25249 90411623
Bone density decreased 12.42 10.37 11 191564 17334 90419538
Emotional distress 12.42 10.37 38 191537 36624 90400248
Panic attack 12.38 10.37 23 191552 26342 90410530
Intravascular haemolysis 12.36 10.37 9 191566 431 90436441
Tarsal tunnel syndrome 12.26 10.37 10 191565 567 90436305
Therapeutic response unexpected 12.24 10.37 17 191558 21863 90415009
Laryngeal papilloma 12.20 10.37 3 191572 6 90436866
Vascular device infection 12.17 10.37 5 191570 11947 90424925
Lymphangiectasia 12.16 10.37 5 191570 74 90436798
Wrong strength 12.16 10.37 5 191570 74 90436798
Binocular eye movement disorder 12.15 10.37 4 191571 30 90436842
Coagulopathy 12.14 10.37 19 191556 23270 90413602
Spontaneous haemorrhage 12.11 10.37 11 191564 722 90436150
Immune system disorder 12.09 10.37 5 191570 11900 90424972
Hypoosmolar state 12.07 10.37 7 191568 226 90436646
Anger 12.05 10.37 7 191568 13713 90423159
Urinary incontinence 11.98 10.37 40 191535 37526 90399346
Skin laceration 11.97 10.37 23 191552 26012 90410860
Diabetes mellitus 11.97 10.37 84 191491 64791 90372081
Breath sounds abnormal 11.96 10.37 9 191566 15377 90421495
Blood calcium decreased 11.94 10.37 29 191546 30153 90406719
Decubitus ulcer 11.93 10.37 5 191570 11808 90425064
Clostridium difficile colitis 11.93 10.37 24 191551 26682 90410190
Nodule 11.90 10.37 24 191551 26662 90410210
Renal tubular disorder 11.88 10.37 23 191552 3184 90433688
Dermatitis contact 11.85 10.37 7 191568 13588 90423284
Kidney infection 11.82 10.37 23 191552 25893 90410979
Lipoedema 11.81 10.37 8 191567 341 90436531
Aspartate aminotransferase increased 11.81 10.37 150 191425 102787 90334085
Pulmonary hypertension 11.78 10.37 48 191527 42475 90394397
Infusion site swelling 11.77 10.37 5 191570 11715 90425157
Head deformity 11.74 10.37 6 191569 150 90436722
Muscle strain 11.72 10.37 3 191572 9684 90427188
Thoracic operation 11.70 10.37 6 191569 151 90436721
Throat irritation 11.67 10.37 58 191517 48637 90388235
Laryngeal dysplasia 11.60 10.37 3 191572 8 90436864
Blood test abnormal 11.60 10.37 80 191495 20872 90416000
Alanine aminotransferase increased 11.59 10.37 178 191397 118160 90318712
Cerebral infarction 11.59 10.37 96 191479 26500 90410372
Haematotoxicity 11.59 10.37 6 191569 12529 90424343
Cardiorenal syndrome 11.59 10.37 13 191562 1099 90435773
Upper-airway cough syndrome 11.58 10.37 9 191566 15126 90421746
Gamma-glutamyltransferase increased 11.57 10.37 127 191448 37825 90399047
Polyp 11.52 10.37 39 191536 7605 90429267
Multiple fractures 11.49 10.37 3 191572 9559 90427313
Gallbladder disorder 11.47 10.37 15 191560 19788 90417084
Nightmare 11.47 10.37 82 191493 21643 90415229
Mucosal inflammation 11.44 10.37 73 191502 57552 90379320
Tetany 11.42 10.37 20 191555 2564 90434308
Product dose omission in error 11.40 10.37 16 191559 20487 90416385
Sinus arrest 11.35 10.37 18 191557 2128 90434744
Gastrointestinal toxicity 11.32 10.37 3 191572 9464 90427408
Endometrial cancer stage I 11.31 10.37 7 191568 255 90436617
Injection site induration 11.29 10.37 4 191571 10464 90426408
Creatinine renal clearance decreased 11.27 10.37 14 191561 18885 90417987
Thrombotic microangiopathy 11.26 10.37 10 191565 15733 90421139
Peripheral arterial occlusive disease 11.26 10.37 28 191547 4593 90432279
Skin ulcer 11.24 10.37 61 191514 50014 90386858
Productive cough 11.23 10.37 227 191348 76836 90360036
Complication of device insertion 11.23 10.37 4 191571 10432 90426440
Vascular purpura 11.22 10.37 16 191559 1722 90435150
Acute myocardial infarction 11.21 10.37 118 191457 34772 90402100
Urogenital haemorrhage 11.19 10.37 7 191568 260 90436612
Blood magnesium decreased 11.18 10.37 10 191565 15683 90421189
Cardiac murmur functional 11.14 10.37 4 191571 40 90436832
Epstein-Barr virus infection 11.07 10.37 4 191571 10340 90426532
Idiopathic orbital inflammation 11.07 10.37 7 191568 265 90436607
Lethargy 11.05 10.37 83 191492 63056 90373816
Device occlusion 10.99 10.37 3 191572 9279 90427593
Spider naevus 10.96 10.37 6 191569 173 90436699
Lupus endocarditis 10.91 10.37 7 191568 272 90436600
Arrhythmia 10.84 10.37 137 191438 42195 90394677
Haemophagocytic lymphohistiocytosis 10.84 10.37 10 191565 15449 90421423
Spinal operation 10.82 10.37 4 191571 10192 90426680
Toothache 10.79 10.37 19 191556 22211 90414661
Blood potassium decreased 10.79 10.37 58 191517 47669 90389203
Diarrhoea 10.79 10.37 1783 189792 937407 89499465
Nasopharyngitis 10.78 10.37 1000 190575 406104 90030768
Hypoventilation 10.77 10.37 30 191545 5266 90431606
Nerve injury 10.75 10.37 5 191570 11101 90425771
Skin necrosis 10.69 10.37 12 191563 16929 90419943
Nephrotic syndrome 10.68 10.37 37 191538 7302 90429570
Gamma-glutamyltransferase abnormal 10.63 10.37 9 191566 538 90436334
Angiodysplasia 10.61 10.37 10 191565 688 90436184
Retching 10.60 10.37 15 191560 19144 90417728
Diverticulitis intestinal perforated 10.58 10.37 8 191567 406 90436466
Chronic cutaneous lupus erythematosus 10.56 10.37 11 191564 855 90436017
Haemoglobin decreased 10.56 10.37 261 191314 161695 90275177
Hot flush 10.50 10.37 78 191497 59410 90377462
Psoas abscess 10.49 10.37 10 191565 698 90436174
Drug metabolising enzyme decreased 10.49 10.37 3 191572 13 90436859
Drug therapeutic incompatibility 10.49 10.37 4 191571 48 90436824
Device leakage 10.47 10.37 4 191571 9987 90426885
Serum amyloid A protein increased 10.38 10.37 10 191565 707 90436165
Nasal polyps 10.37 10.37 5 191570 10875 90425997

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
Death 260.83 10.89 342 85600 470843 42064550
Vasculitis 219.72 10.89 226 85716 18168 42517225
General physical health deterioration 204.48 10.89 720 85222 150526 42384867
Drug ineffective 202.55 10.89 628 85314 629569 41905824
Pulmonary vasculitis 190.44 10.89 132 85810 6134 42529259
Respiratory symptom 187.04 10.89 165 85777 10941 42524452
Product monitoring error 162.88 10.89 105 85837 4318 42531075
Neuritis 156.88 10.89 117 85825 6103 42529290
Haematochezia 155.78 10.89 356 85586 58080 42477313
Completed suicide 155.03 10.89 10 85932 96455 42438938
Cardiospasm 154.65 10.89 76 85866 1831 42533562
Hyperkalaemia 149.84 10.89 428 85514 80030 42455363
Toxicity to various agents 143.85 10.89 150 85792 228986 42306407
Palmoplantar keratoderma 139.83 10.89 75 85867 2179 42533214
Total lung capacity abnormal 135.96 10.89 94 85848 4349 42531044
Acute kidney injury 131.85 10.89 1222 84720 366115 42169278
Tinnitus 131.81 10.89 221 85721 28717 42506676
Pruritus genital 131.44 10.89 76 85866 2563 42532830
Tension headache 130.56 10.89 83 85859 3331 42532062
Facial pain 130.06 10.89 90 85852 4170 42531223
Product dose omission issue 125.63 10.89 78 85864 154287 42381106
Migraine 125.08 10.89 201 85741 25213 42510180
Eosinophilic granulomatosis with polyangiitis 121.42 10.89 116 85826 8522 42526871
Neurological symptom 119.74 10.89 123 85819 9868 42525525
Carotid artery occlusion 119.64 10.89 85 85857 4109 42531284
Sleep terror 119.08 10.89 74 85868 2852 42532541
Spirometry abnormal 110.54 10.89 88 85854 5058 42530335
Drug abuse 104.86 10.89 40 85902 104731 42430662
Atrial tachycardia 102.45 10.89 77 85865 4063 42531330
Pulmonary fibrosis 102.38 10.89 189 85753 26492 42508901
Immunisation 101.61 10.89 50 85892 1208 42534185
Mycotic allergy 97.36 10.89 80 85862 4811 42530582
Conjunctivitis allergic 95.91 10.89 86 85856 5825 42529568
Hypopnoea 94.39 10.89 97 85845 7785 42527608
Steroid dependence 93.97 10.89 90 85852 6632 42528761
Burns second degree 93.63 10.89 86 85856 6010 42529383
Vertigo 93.43 10.89 211 85731 34136 42501257
Catarrh 93.01 10.89 85 85857 5901 42529492
Pain of skin 92.38 10.89 97 85845 7983 42527410
Obstructive airways disorder 92.01 10.89 173 85769 24586 42510807
Forced expiratory volume decreased 91.55 10.89 94 85848 7536 42527857
Palpitations 91.40 10.89 267 85675 50530 42484863
Mite allergy 91.07 10.89 78 85864 4968 42530425
Pulmonary alveolar haemorrhage 89.63 10.89 129 85813 14687 42520706
Anosmia 89.35 10.89 78 85864 5098 42530295
Disease progression 88.98 10.89 95 85847 143561 42391832
Neutropenia 88.70 10.89 167 85775 199264 42336129
Dust allergy 87.35 10.89 78 85864 5254 42530139
Antineutrophil cytoplasmic antibody positive 81.91 10.89 69 85873 4296 42531097
Hypothyroidism 81.65 10.89 192 85750 31892 42503501
Rhinitis 79.46 10.89 109 85833 11868 42523525
Bradycardia 79.18 10.89 362 85580 85122 42450271
Parosmia 78.57 10.89 87 85855 7604 42527789
Normochromic normocytic anaemia 78.53 10.89 94 85848 8937 42526456
Bronchiectasis 75.97 10.89 133 85809 17886 42517507
Product prescribing error 75.05 10.89 164 85778 25948 42509445
Gingival pain 74.83 10.89 89 85853 8405 42526988
Neuropathy peripheral 74.17 10.89 58 85884 101795 42433598
Nipple swelling 68.80 10.89 27 85915 370 42535023
Systemic lupus erythematosus 68.20 10.89 89 85853 9235 42526158
Off label use 67.85 10.89 895 85047 637440 41897953
Full blood count abnormal 67.72 10.89 171 85771 29705 42505688
Frequent bowel movements 66.77 10.89 139 85803 21268 42514125
Dizziness 65.42 10.89 779 85163 248475 42286918
Loss of personal independence in daily activities 64.44 10.89 234 85708 49582 42485811
Angina pectoris 64.11 10.89 178 85764 32718 42502675
Blood cholesterol 62.46 10.89 22 85920 218 42535175
Sleep disorder due to a general medical condition 62.43 10.89 120 85822 17333 42518060
Arteriosclerosis 62.30 10.89 122 85820 17867 42517526
Lung disorder 61.05 10.89 224 85718 47699 42487694
Cardiac murmur 60.08 10.89 99 85843 12676 42522717
Transient ischaemic attack 59.39 10.89 176 85766 33563 42501830
Pneumonia 58.93 10.89 556 85386 421593 42113800
Sepsis 58.47 10.89 206 85736 199128 42336265
Swollen tongue 58.37 10.89 131 85811 21100 42514293
No adverse event 57.27 10.89 6 85936 39015 42496378
Impaired work ability 57.26 10.89 94 85848 11997 42523396
Capillaritis 56.38 10.89 42 85900 2186 42533207
Pericarditis 56.37 10.89 99 85843 13345 42522048
Muscle twitching 56.36 10.89 92 85850 11688 42523705
Renal artery stenosis 54.92 10.89 42 85900 2275 42533118
Asthma 54.82 10.89 260 85682 62054 42473339
Disturbance in attention 54.68 10.89 158 85784 29708 42505685
Lip swelling 54.00 10.89 119 85823 18934 42516459
Subarachnoid haemorrhage 52.37 10.89 100 85842 14372 42521021
Eyelid function disorder 51.41 10.89 18 85924 175 42535218
Hospitalisation 50.80 10.89 45 85897 74285 42461108
Pulmonary hypoplasia 49.33 10.89 23 85919 491 42534902
Seizure 49.23 10.89 106 85836 120455 42414938
Agitation 48.89 10.89 35 85907 64279 42471114
Renal cyst haemorrhage 48.61 10.89 25 85917 665 42534728
Tubulointerstitial nephritis 48.50 10.89 157 85785 31391 42504002
Adrenal insufficiency 47.87 10.89 113 85829 18811 42516582
Therapy non-responder 47.63 10.89 24 85918 53335 42482058
Hyperthyroidism 46.94 10.89 95 85847 14246 42521147
White blood cell count decreased 46.80 10.89 95 85847 110301 42425092
Labelled drug-drug interaction medication error 46.07 10.89 99 85843 15483 42519910
Large intestine polyp 43.83 10.89 72 85870 9193 42526200
Dyspnoea 43.63 10.89 1184 84758 441437 42093956
Polyp 43.39 10.89 50 85892 4564 42530829
Nipple pain 43.00 10.89 27 85915 1060 42534333
Drug hypersensitivity 42.58 10.89 85 85857 99304 42436089
Systemic infection 41.72 10.89 52 85890 5153 42530240
Urogenital haemorrhage 41.58 10.89 23 85919 711 42534682
Rectal prolapse 41.23 10.89 21 85921 547 42534846
Eczema 40.64 10.89 156 85786 33930 42501463
Diplopia 40.64 10.89 111 85831 20205 42515188
Gastrointestinal angiodysplasia 40.49 10.89 22 85920 656 42534737
Alcohol poisoning 40.15 10.89 62 85880 7512 42527881
Nodule 39.80 10.89 82 85860 12452 42522941
Wheezing 39.38 10.89 216 85726 54565 42480828
Drug dependence 39.00 10.89 6 85936 29088 42506305
Colitis ulcerative 38.21 10.89 128 85814 26047 42509346
Abdominal discomfort 37.99 10.89 271 85671 74984 42460409
Presyncope 37.71 10.89 115 85827 22272 42513121
Haemoptysis 37.28 10.89 188 85754 45979 42489414
Nightmare 37.12 10.89 123 85819 24889 42510504
Troponin increased 36.99 10.89 103 85839 18959 42516434
Eye pruritus 36.64 10.89 75 85867 11337 42524056
Lichenoid keratosis 35.80 10.89 42 85900 3908 42531485
Medication error 35.72 10.89 147 85795 33007 42502386
Arteriosclerosis coronary artery 35.34 10.89 100 85842 18577 42516816
Impaired quality of life 35.15 10.89 84 85858 14093 42521300
Vena cava injury 34.91 10.89 16 85926 328 42535065
Mental status changes 34.60 10.89 21 85921 42094 42493299
Respiratory failure 34.54 10.89 137 85805 127995 42407398
Abdominal wall haemorrhage 34.29 10.89 18 85924 500 42534893
Blindness 33.76 10.89 96 85846 17882 42517511
Lymphocyte count 33.59 10.89 14 85928 226 42535167
Cardiac arrest 33.35 10.89 111 85831 109209 42426184
Blood growth hormone increased 33.28 10.89 19 85923 625 42534768
Sinusitis 33.07 10.89 28 85914 47264 42488129
Oedema peripheral 32.89 10.89 419 85523 135657 42399736
Actinic keratosis 32.68 10.89 46 85896 5130 42530263
Spinal osteoarthritis 32.64 10.89 61 85881 8625 42526768
Product use issue 32.56 10.89 66 85876 76685 42458708
SARS-CoV-2 antibody test positive 32.46 10.89 16 85926 388 42535005
Cardiac failure 32.03 10.89 343 85599 106513 42428880
Renin increased 31.94 10.89 13 85929 197 42535196
Lymphocyte count abnormal 31.93 10.89 30 85912 2157 42533236
Ventricular tachycardia 31.92 10.89 133 85809 30027 42505366
Renal artery thrombosis 31.56 10.89 15 85927 335 42535058
Interstitial lung disease 31.53 10.89 268 85674 78194 42457199
Hypertensive crisis 31.51 10.89 66 85876 10140 42525253
Rash papular 31.48 10.89 72 85870 11739 42523654
Neurotoxicity 31.42 10.89 5 85937 23646 42511747
Aortic valve incompetence 31.13 10.89 51 85891 6497 42528896
Pain in extremity 30.78 10.89 450 85492 150154 42385239
Thrombocytopenia 30.73 10.89 241 85701 190038 42345355
Full blood count decreased 30.59 10.89 3 85939 20557 42514836
Post concussion syndrome 30.47 10.89 12 85930 166 42535227
Therapeutic product effect decreased 30.15 10.89 21 85921 39129 42496264
Vascular anastomotic haemorrhage 30.02 10.89 14 85928 299 42535094
Vascular compression 29.87 10.89 15 85927 379 42535014
Anencephaly 29.65 10.89 11 85931 128 42535265
Myalgia 29.54 10.89 310 85632 95770 42439623
Patient dissatisfaction with treatment 29.34 10.89 10 85932 89 42535304
Polyserositis 28.72 10.89 14 85928 331 42535062
Pancytopenia 28.59 10.89 131 85811 117612 42417781
Aortic dilatation 28.50 10.89 25 85917 1644 42533749
Carotid arteriosclerosis 28.46 10.89 29 85913 2303 42533090
Hyperparathyroidism secondary 28.31 10.89 26 85916 1816 42533577
Myelosuppression 28.24 10.89 24 85918 40437 42494956
Treatment failure 28.17 10.89 52 85890 62572 42472821
Respiratory arrest 28.17 10.89 11 85931 28413 42506980
Cytomegalovirus infection 28.13 10.89 15 85927 32291 42503102
Respiratory tract haemorrhage 27.94 10.89 23 85919 1386 42534007
Injection site pain 27.81 10.89 46 85896 57752 42477641
Diverticulum intestinal 27.31 10.89 42 85900 5071 42530322
Therapy partial responder 27.13 10.89 4 85938 20017 42515376
Blood creatinine increased 27.11 10.89 340 85602 109663 42425730
Hyperuricaemia 26.86 10.89 59 85883 9365 42526028
Treatment noncompliance 26.72 10.89 22 85920 37650 42497743
Gastroduodenal ulcer 26.39 10.89 17 85925 698 42534695
Glycosylated haemoglobin increased 26.23 10.89 71 85871 12853 42522540
Loss of control of legs 26.06 10.89 18 85924 831 42534562
Platelet count decreased 25.52 10.89 169 85773 138412 42396981
Coronary artery stenosis 25.19 10.89 61 85881 10318 42525075
Respiratory depression 25.04 10.89 4 85938 18864 42516529
Rectal haemorrhage 24.65 10.89 178 85764 49428 42485965
Phonophobia 24.16 10.89 12 85930 296 42535097
Intraductal papillary mucinous neoplasm 24.08 10.89 14 85928 477 42534916
Unresponsive to stimuli 23.98 10.89 17 85925 31386 42504007
Candida infection 23.78 10.89 7 85935 21603 42513790
Blood pressure inadequately controlled 23.55 10.89 29 85913 2839 42532554
Perineal cyst 23.54 10.89 11 85931 236 42535157
Bronchopulmonary aspergillosis allergic 23.48 10.89 37 85905 4561 42530832
Ejection fraction abnormal 23.33 10.89 20 85922 1275 42534118
Pemphigoid 23.28 10.89 63 85879 11404 42523989
Hypotension 23.27 10.89 682 85260 256949 42278444
Neutrophil count decreased 23.26 10.89 59 85883 63356 42472037
Abdominal pain lower 23.13 10.89 65 85877 12027 42523366
Therapy interrupted 23.08 10.89 8 85934 22242 42513151
Cytokine release syndrome 22.79 10.89 34 85908 44493 42490900
Syncope 22.71 10.89 303 85639 99103 42436290
Alveolitis 22.41 10.89 23 85919 1842 42533551
Respiratory distress 22.32 10.89 31 85911 41789 42493604
Septic shock 22.24 10.89 102 85840 91570 42443823
Intentional product use issue 22.18 10.89 232 85710 71601 42463792
Injection site oedema 21.93 10.89 12 85930 363 42535030
Renal oncocytoma 21.91 10.89 10 85932 203 42535190
Accidental exposure to product 21.73 10.89 7 85935 20386 42515007
Overdose 21.65 10.89 124 85818 105140 42430253
Rash 21.58 10.89 411 85531 276543 42258850
Intermittent claudication 21.57 10.89 26 85916 2489 42532904
Chronic coronary syndrome 21.48 10.89 11 85931 290 42535103
Craniofacial fracture 21.29 10.89 12 85930 385 42535008
Bacteraemia 21.26 10.89 12 85930 25028 42510365
Multiple organ dysfunction syndrome 21.22 10.89 112 85830 96923 42438470
Renal impairment 21.20 10.89 326 85616 109902 42425491
Electrolyte imbalance 20.99 10.89 79 85863 17022 42518371
Angioedema 20.86 10.89 152 85790 42325 42493068
Renal artery angioplasty 20.57 10.89 5 85937 10 42535383
Congenital renal disorder 20.49 10.89 8 85934 108 42535285
Cerebral infarction 20.48 10.89 120 85822 31049 42504344
Stress 20.46 10.89 156 85786 44056 42491337
Blood pressure increased 20.19 10.89 303 85639 101625 42433768
Dysgeusia 20.17 10.89 128 85814 34061 42501332
Blood 25-hydroxycholecalciferol decreased 20.13 10.89 11 85931 332 42535061
Wrong dose 20.06 10.89 17 85925 1067 42534326
Memory impairment 19.88 10.89 171 85771 50051 42485342
Atrioventricular block 19.69 10.89 53 85889 9562 42525831
Cardio-respiratory arrest 19.67 10.89 57 85885 58579 42476814
Renal artery stent placement 19.66 10.89 5 85937 13 42535380
Tender joint count decreased 19.65 10.89 10 85932 260 42535133
Swollen joint count decreased 19.65 10.89 10 85932 260 42535133
Product use in unapproved indication 19.65 10.89 258 85684 184198 42351195
Total cholesterol/HDL ratio increased 19.27 10.89 9 85933 193 42535200
Acute cutaneous lupus erythematosus 19.06 10.89 7 85935 79 42535314
Pallor 18.84 10.89 111 85831 28775 42506618
Appendicitis 18.80 10.89 9 85933 20604 42514789
Hemiataxia 18.74 10.89 6 85936 43 42535350
Drug resistance 18.67 10.89 25 85917 34223 42501170
Neuroleptic malignant syndrome 18.65 10.89 10 85932 21462 42513931
Micturition disorder 18.65 10.89 24 85918 2456 42532937
Bone hypertrophy 18.60 10.89 10 85932 292 42535101
Accidental overdose 18.57 10.89 109 85833 28221 42507172
Plasma cell myeloma 18.45 10.89 43 85899 47535 42487858
Psychotic disorder 18.41 10.89 19 85923 29189 42506204
Orthostatic hypotension 18.37 10.89 115 85827 30455 42504938
Hypervolaemia 18.35 10.89 12 85930 23113 42512280
Nervous system neoplasm 18.11 10.89 8 85934 150 42535243
Hypochromic anaemia 18.09 10.89 16 85926 1064 42534329
Aortic arteriosclerosis 18.06 10.89 35 85907 5085 42530308
Mastication disorder 17.98 10.89 20 85922 1756 42533637
Blood potassium abnormal 17.89 10.89 20 85922 1766 42533627
Heart rate increased 17.88 10.89 175 85767 53080 42482313
Multiple drug therapy 17.48 10.89 16 85926 1113 42534280
Peripheral arterial occlusive disease 17.47 10.89 41 85901 6797 42528596
Endoscopy upper gastrointestinal tract abnormal 17.45 10.89 6 85936 55 42535338
Abdominal pain upper 17.31 10.89 248 85694 82361 42453032
Therapeutic response decreased 17.30 10.89 30 85912 36982 42498411
Constipation 17.28 10.89 227 85715 162064 42373329
Bone marrow failure 17.20 10.89 25 85917 33068 42502325
Surgery 17.16 10.89 7 85935 17609 42517784
Influenza 17.04 10.89 66 85876 62109 42473284
Cerebral haematoma 16.99 10.89 36 85906 5574 42529819
Cytopenia 16.96 10.89 7 85935 17490 42517903
Urinary tract infection 16.83 10.89 124 85818 99160 42436233
Cranial sutures widening 16.80 10.89 7 85935 113 42535280
Visual impairment 16.65 10.89 146 85796 42967 42492426
Atrioventricular block second degree 16.48 10.89 30 85912 4157 42531236
Tonsillar ulcer 16.46 10.89 8 85934 188 42535205
Urticaria 16.44 10.89 85 85857 73951 42461442
Supine hypertension 16.34 10.89 10 85932 375 42535018
Urinary hesitation 16.31 10.89 25 85917 3010 42532383
Basal ganglia haemorrhage 16.27 10.89 15 85927 1053 42534340
Joint contracture 16.23 10.89 21 85921 2160 42533233
Vital functions abnormal 16.15 10.89 10 85932 383 42535010
Lung hernia 16.08 10.89 6 85936 71 42535322
Oral lichen planus 16.08 10.89 8 85934 198 42535195
Muscular weakness 16.06 10.89 247 85695 83251 42452142
IIIrd nerve paresis 16.05 10.89 7 85935 127 42535266
Arthritis 16.01 10.89 142 85800 41923 42493470
Pulmonary embolism 15.98 10.89 334 85608 119278 42416115
Atrial fibrillation 15.88 10.89 381 85561 139212 42396181
Irritability 15.88 10.89 20 85922 28108 42507285
Sedation 15.86 10.89 23 85919 30452 42504941
Infection 15.80 10.89 147 85795 111921 42423472
Benign prostatic hyperplasia 15.79 10.89 84 85858 20968 42514425
Acute right ventricular failure 15.76 10.89 7 85935 133 42535260
Ventricular extrasystoles 15.72 10.89 61 85881 13329 42522064
Injection site reaction 15.72 10.89 6 85936 15715 42519678
Condition aggravated 15.71 10.89 659 85283 260095 42275298
Device lead damage 15.63 10.89 3 85939 0 42535393
Paresis cranial nerve 15.57 10.89 6 85936 78 42535315
Gastrointestinal ischaemia 15.50 10.89 9 85933 306 42535087
Jaundice 15.42 10.89 121 85821 34468 42500925
Wrong technique in product usage process 15.38 10.89 40 85902 42595 42492798
Dry eye 15.37 10.89 6 85936 15500 42519893
SAPHO syndrome 15.34 10.89 10 85932 419 42534974
Sinus rhythm 15.34 10.89 10 85932 419 42534974
Therapeutic product effect incomplete 15.28 10.89 214 85728 70725 42464668
Congenital vas deferens absence 15.25 10.89 5 85937 39 42535354
Congenital muscle absence 15.25 10.89 5 85937 39 42535354
Costovertebral angle tenderness 15.24 10.89 6 85936 83 42535310
Vertebral artery stenosis 15.21 10.89 7 85935 145 42535248
Shock hypoglycaemic 15.17 10.89 6 85936 84 42535309
Fracture 14.95 10.89 43 85899 8060 42527333
Unevaluable event 14.95 10.89 29 85913 34259 42501134
Vasculitic rash 14.84 10.89 14 85928 1012 42534381
Muscle spasms 14.81 10.89 107 85835 85937 42449456
Drug withdrawal syndrome 14.77 10.89 13 85929 21536 42513857
Abnormal behaviour 14.73 10.89 19 85923 26432 42508961
Xanthopsia 14.70 10.89 7 85935 157 42535236
Amnesia 14.68 10.89 103 85839 28334 42507059
Pleurothotonus 14.67 10.89 15 85927 1196 42534197
Hypozincaemia 14.63 10.89 4 85938 15 42535378
Cerebellar infarction 14.52 10.89 20 85922 2185 42533208
Papillary renal cell carcinoma 14.48 10.89 9 85933 347 42535046
Therapy cessation 14.43 10.89 12 85930 20438 42514955
Laboratory test abnormal 14.42 10.89 15 85927 22963 42512430
Blood sodium abnormal 14.41 10.89 11 85931 594 42534799
Acute respiratory failure 14.37 10.89 36 85906 38822 42496571
Arrhythmia 14.28 10.89 134 85808 40183 42495210
Insulin-like growth factor increased 14.22 10.89 17 85925 1614 42533779
Nasopharyngitis 14.19 10.89 105 85837 83891 42451502
Blood iron decreased 14.14 10.89 36 85906 6282 42529111
Injection site bruising 14.10 10.89 3 85939 11522 42523871
Exercise tolerance decreased 14.03 10.89 35 85907 6031 42529362
Pathogen resistance 13.97 10.89 3 85939 11447 42523946
Infusion related reaction 13.96 10.89 69 85873 60737 42474656
Oesophageal ulcer haemorrhage 13.87 10.89 9 85933 374 42535019
Influenza like illness 13.82 10.89 27 85915 31813 42503580
Dysphagia 13.72 10.89 88 85854 72631 42462762
Activated partial thromboplastin time prolonged 13.71 10.89 66 85876 15837 42519556
Anxiety disorder due to a general medical condition 13.71 10.89 4 85938 20 42535373
Generalised tonic-clonic seizure 13.63 10.89 20 85922 26359 42509034
Diabetic nephropathy 13.60 10.89 20 85922 2321 42533072
Food aversion 13.58 10.89 10 85932 511 42534882
Intervertebral disc space narrowing 13.54 10.89 14 85928 1131 42534262
Vascular stent stenosis 13.47 10.89 14 85928 1138 42534255
Desmoplastic melanoma 13.39 10.89 4 85938 22 42535371
Haemorrhoids 13.36 10.89 69 85873 17028 42518365
Basal cell carcinoma 13.34 10.89 85 85857 22648 42512745
Idiopathic pulmonary fibrosis 13.32 10.89 29 85913 4575 42530818
Anti-erythropoietin antibody negative 13.28 10.89 7 85935 196 42535197
Encephalopathy 13.27 10.89 41 85901 41292 42494101
Hypovolaemia 13.23 10.89 52 85890 11433 42523960
Delayed graft function 13.18 10.89 21 85921 2614 42532779
Blood potassium decreased 13.14 10.89 13 85929 20371 42515022
Lipase increased 13.12 10.89 49 85893 10517 42524876
Foetal exposure during pregnancy 13.11 10.89 50 85892 47261 42488132
Cardiac failure congestive 13.07 10.89 110 85832 85492 42449901
pH body fluid increased 13.05 10.89 5 85937 64 42535329
Coronavirus infection 13.04 10.89 31 85911 5183 42530210
Musculoskeletal stiffness 13.00 10.89 66 85876 57699 42477694
Enterobacter pneumonia 12.93 10.89 10 85932 551 42534842
Clostridium difficile infection 12.91 10.89 16 85926 22643 42512750
Cogwheel rigidity 12.87 10.89 17 85925 1784 42533609
Hypogammaglobulinaemia 12.82 10.89 4 85938 11887 42523506
Glomerular filtration rate abnormal 12.81 10.89 14 85928 1206 42534187
Type 2 diabetes mellitus 12.71 10.89 72 85870 18399 42516994
Lymph gland infection 12.70 10.89 7 85935 215 42535178
Congenital hiatus hernia 12.61 10.89 34 85908 6140 42529253
Pterygium 12.58 10.89 6 85936 135 42535258
Mesenteric artery thrombosis 12.55 10.89 11 85931 723 42534670
Lactic acidosis 12.50 10.89 143 85799 45118 42490275
Coronary artery bypass 12.46 10.89 29 85913 4781 42530612
Drug intolerance 12.44 10.89 103 85839 80321 42455072
Hepatic ischaemia 12.40 10.89 9 85933 450 42534943
Metabolic acidosis 12.22 10.89 159 85783 51699 42483694
Rhabdomyolysis 12.15 10.89 223 85719 77796 42457597
Adverse event 12.14 10.89 18 85924 23622 42511771
Adverse drug reaction 12.07 10.89 122 85820 37312 42498081
Faeces soft 12.06 10.89 29 85913 4883 42530510
Renal cyst 12.01 10.89 46 85896 9993 42525400
Pulmonary haemorrhage 11.99 10.89 4 85938 11393 42524000
Pseudarthrosis 11.98 10.89 5 85937 81 42535312
Hepatosplenomegaly 11.97 10.89 28 85914 4632 42530761
Dermatitis atopic 11.96 10.89 5 85937 12399 42522994
Therapeutic response unexpected 11.96 10.89 4 85938 11377 42524016
Basilar artery thrombosis 11.90 10.89 7 85935 244 42535149
Hepatocellular carcinoma 11.89 10.89 40 85902 8154 42527239
Klebsiella infection 11.88 10.89 4 85938 11328 42524065
Anxiety 11.83 10.89 318 85624 118242 42417151
Brain stem infarction 11.82 10.89 14 85928 1316 42534077
Ocular hyperaemia 11.72 10.89 9 85933 15954 42519439
Periorbital discomfort 11.60 10.89 4 85938 37 42535356
Muscle rupture 11.59 10.89 19 85923 2421 42532972
Asthma-chronic obstructive pulmonary disease overlap syndrome 11.59 10.89 15 85927 1544 42533849
Product storage error 11.56 10.89 4 85938 11136 42524257
Retinal artery occlusion 11.56 10.89 18 85924 2197 42533196
Dyskinesia 11.49 10.89 21 85921 25369 42510024
Aortic valve disease mixed 11.45 10.89 5 85937 91 42535302
Mucosal haemorrhage 11.44 10.89 16 85926 1774 42533619
Serum amyloid A protein increased 11.38 10.89 7 85935 265 42535128
Prothrombin time shortened 11.36 10.89 15 85927 1574 42533819
Dysuria 11.34 10.89 104 85838 30992 42504401
Fractured skull depressed 11.32 10.89 4 85938 40 42535353
Hyperbilirubinaemia 11.31 10.89 15 85927 20620 42514773
Thrombotic microangiopathy 11.29 10.89 8 85934 14774 42520619
Radiation proctitis 11.26 10.89 6 85936 172 42535221
Hepatic steatosis 11.26 10.89 78 85864 21370 42514023
Cardiovascular disorder 11.19 10.89 55 85887 13310 42522083
Fungal infection 11.16 10.89 14 85928 19708 42515685
Blood loss anaemia 11.15 10.89 44 85898 9692 42525701
Eosinophilic pneumonia 11.15 10.89 28 85914 4846 42530547
Choroidal detachment 11.10 10.89 9 85933 531 42534862
Clostridium difficile colitis 11.09 10.89 16 85926 21236 42514157
Diverticulum intestinal haemorrhagic 11.09 10.89 21 85921 2998 42532395
Albumin urine present 11.09 10.89 8 85934 396 42534997
Oligohydramnios 11.07 10.89 8 85934 397 42534996
Acute respiratory distress syndrome 11.05 10.89 28 85914 30080 42505313
Myelodysplastic syndrome 11.03 10.89 18 85924 22727 42512666
Rheumatoid arthritis 11.03 10.89 46 85896 42394 42492999
Gamma-glutamyltransferase increased 11.01 10.89 107 85835 32390 42503003
Melaena 10.96 10.89 123 85819 38623 42496770
Febrile neutropenia 10.90 10.89 288 85654 185415 42349978
Macular ischaemia 10.89 10.89 6 85936 184 42535209

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
Blepharospasm 546.55 10.08 658 258024 54193 110276424
Nail disorder 475.60 10.08 631 258051 57304 110273313
Completed suicide 461.39 10.08 26 258656 242355 110088262
General physical health deterioration 429.93 10.08 2051 256631 423244 109907373
Death 427.44 10.08 608 258074 698261 109632356
Back injury 416.68 10.08 534 258148 46865 110283752
Taste disorder 389.98 10.08 612 258070 64775 110265842
Onychomadesis 372.72 10.08 496 258186 45167 110285450
Drug ineffective 354.92 10.08 2099 256583 1518441 108812176
Product label confusion 350.45 10.08 343 258339 22334 110308283
Breast cancer stage III 348.29 10.08 647 258035 78470 110252147
Gastrooesophageal reflux disease 344.32 10.08 1064 257618 178912 110151705
Epilepsy 329.62 10.08 726 257956 99483 110231134
Wound infection 318.57 10.08 700 257982 95765 110234852
Product dose omission issue 297.63 10.08 193 258489 321589 110009028
Toxicity to various agents 295.53 10.08 416 258266 480139 109850478
Adverse reaction 284.96 10.08 349 258333 29245 110301372
Cardiospasm 281.82 10.08 164 258518 4803 110325814
Hypercholesterolaemia 279.62 10.08 641 258041 90196 110240421
Palmoplantar keratoderma 266.92 10.08 163 258519 5224 110325393
Liver function test increased 262.84 10.08 616 258066 87932 110242685
Bursitis 252.06 10.08 772 257910 129146 110201471
Finger deformity 251.14 10.08 347 258335 32745 110297872
Pruritus genital 250.33 10.08 168 258514 6354 110324263
Product monitoring error 241.70 10.08 186 258496 8741 110321876
Muscular weakness 241.11 10.08 1185 257497 247283 110083334
Vasculitis 236.77 10.08 352 258330 35521 110295096
Facet joint syndrome 235.18 10.08 624 258058 96204 110234413
Acute kidney injury 234.08 10.08 2392 256290 633038 109697579
Sleep terror 229.39 10.08 160 258522 6450 110324167
Onychomycosis 226.06 10.08 358 258324 38173 110292444
Peripheral venous disease 224.85 10.08 562 258120 83555 110247062
Neutropenia 223.61 10.08 331 258351 374289 109956328
Product quality issue 219.95 10.08 529 258153 76770 110253847
Carotid artery occlusion 219.82 10.08 181 258501 9384 110321233
Tension headache 210.65 10.08 177 258505 9441 110321176
Coeliac disease 206.31 10.08 366 258316 42821 110287796
Disease progression 202.60 10.08 164 258518 243870 110086747
Hyperkalaemia 201.29 10.08 737 257945 135059 110195558
Atrial tachycardia 201.21 10.08 169 258513 9009 110321608
Angina pectoris 195.46 10.08 443 258239 61852 110268765
Drug abuse 189.17 10.08 89 258593 177322 110153295
Neurologic neglect syndrome 187.10 10.08 163 258519 9135 110321482
Immunisation 185.64 10.08 107 258575 3076 110327541
Arterial occlusive disease 181.62 10.08 201 258481 15107 110315510
Memory impairment 180.21 10.08 924 257758 196020 110134597
Intentional product use issue 180.20 10.08 1093 257589 246813 110083804
Lung disorder 175.51 10.08 860 257822 179187 110151430
Infection 173.64 10.08 367 258315 361833 109968784
Carotid artery thrombosis 172.22 10.08 158 258524 9480 110321137
Pulmonary vasculitis 171.76 10.08 134 258548 6426 110324191
Injection site pain 165.39 10.08 106 258576 177816 110152801
Palpitations 164.22 10.08 773 257909 158439 110172178
Obesity 160.30 10.08 606 258076 112745 110217872
Gangrene 159.41 10.08 194 258488 16147 110314470
Live birth 158.89 10.08 438 258244 69046 110261571
Anosmia 158.84 10.08 170 258512 12302 110318315
Tinnitus 155.02 10.08 398 258284 60142 110270475
Wheezing 153.52 10.08 1073 257609 254157 110076460
Adjustment disorder 153.36 10.08 156 258526 10639 110319978
Type 2 diabetes mellitus 152.82 10.08 818 257864 176414 110154203
Neuropathy peripheral 151.90 10.08 118 258564 179159 110151458
Grip strength decreased 150.43 10.08 471 258211 79703 110250914
Facial pain 149.46 10.08 182 258500 15157 110315460
Folliculitis 148.11 10.08 779 257903 166874 110163743
Subarachnoid haemorrhage 143.52 10.08 253 258429 29449 110301168
Lip dry 143.11 10.08 537 258145 99546 110231071
Personality disorder 142.80 10.08 163 258519 12674 110317943
Pain of skin 141.55 10.08 203 258479 19826 110310791
Sepsis 139.70 10.08 353 258329 326993 110003624
Neck pain 134.49 10.08 608 258074 122522 110208095
Product prescribing error 133.02 10.08 339 258343 50992 110279625
Haematochezia 132.64 10.08 579 258103 114945 110215672
Neuritis 131.63 10.08 121 258561 7278 110323339
Respiratory symptom 130.72 10.08 168 258514 14777 110315840
Hemiplegia 129.95 10.08 209 258473 22573 110308044
Infusion site reaction 126.11 10.08 180 258502 17502 110313115
Total lung capacity abnormal 123 10.08 95 258587 4488 110326129
Skin haemorrhage 121.93 10.08 213 258469 24614 110306003
Systemic infection 120.08 10.08 131 258551 9688 110320929
Dizziness 119.47 10.08 2294 256388 695899 109634718
Gait inability 118.60 10.08 631 258051 135745 110194872
Seizure 118.21 10.08 210 258472 220975 110109642
White blood cell count decreased 117.96 10.08 223 258459 229167 110101450
Injection site erythema 117.35 10.08 37 258645 94139 110236478
Joint range of motion decreased 116.59 10.08 579 258103 121253 110209364
Pericarditis 115.63 10.08 893 257789 218221 110112396
Inflammation 115.34 10.08 811 257871 192427 110138190
Abdominal pain upper 114.59 10.08 1285 257397 347826 109982791
C-reactive protein increased 113.81 10.08 886 257796 217033 110113584
Obstructive airways disorder 111.61 10.08 297 258385 45852 110284765
Musculoskeletal pain 110.92 10.08 771 257911 182252 110148365
Forced expiratory volume decreased 110.39 10.08 145 258537 13031 110317586
Febrile neutropenia 109.48 10.08 377 258305 316390 110014227
Night sweats 108.48 10.08 608 258074 133375 110197242
Myelosuppression 104.18 10.08 45 258637 94295 110236322
Affect lability 103.62 10.08 169 258513 18468 110312149
Mental status changes 100.17 10.08 27 258655 76095 110254522
Confusional state 99.05 10.08 1593 257089 467087 109863530
Hyponatraemia 98.12 10.08 856 257826 216797 110113820
Spirometry abnormal 97.99 10.08 90 258592 5407 110325210
Sensory loss 97.56 10.08 178 258504 21279 110309338
Thrombocytopenia 97.28 10.08 452 258230 348433 109982184
Catarrh 96.99 10.08 102 258580 7233 110323384
Eosinophilic granulomatosis with polyangiitis 96.42 10.08 122 258560 10564 110320053
Burns second degree 96.01 10.08 104 258578 7629 110322988
Osteoarthritis 95.62 10.08 743 257939 181880 110148737
Therapy non-responder 93.75 10.08 139 258543 157168 110173449
Bronchopulmonary aspergillosis allergic 93.74 10.08 107 258575 8319 110322298
Respiratory failure 93.54 10.08 230 258452 215102 110115515
Steroid dependence 93.30 10.08 107 258575 8362 110322255
Pruritus 92.75 10.08 891 257791 580669 109749948
Transient ischaemic attack 92.03 10.08 344 258338 63638 110266979
Sleep disorder due to general medical condition, insomnia type 91.43 10.08 68 258614 105575 110225042
Hepatitis 89.02 10.08 432 258250 89622 110240995
Urinary tract infection 87.87 10.08 428 258254 325854 110004763
Conjunctivitis allergic 87.43 10.08 94 258588 6837 110323780
Dyspepsia 87.09 10.08 753 257929 190212 110140405
Bronchiectasis 86.37 10.08 233 258449 36260 110294357
Cardiac arrest 86.37 10.08 209 258473 196544 110134073
Disturbance in attention 85.61 10.08 329 258353 61666 110268951
Eye pruritus 85.48 10.08 217 258465 32558 110298059
Dry mouth 84.28 10.08 775 257907 199173 110131444
Hemiparesis 84.26 10.08 260 258422 43643 110286974
Motor dysfunction 83.82 10.08 180 258502 24226 110306391
Hypocholesterolaemia 82.61 10.08 88 258594 6333 110324284
Accidental exposure to product 82.40 10.08 10 258672 49998 110280619
Muscle injury 82.28 10.08 588 258094 140219 110190398
Irritable bowel syndrome 80.97 10.08 659 258023 163556 110167061
Rheumatoid factor positive 80.72 10.08 114 258568 131526 110199091
Sputum discoloured 80.27 10.08 192 258490 27753 110302864
Bradycardia 79.90 10.08 630 258052 154887 110175730
Neovascularisation 79.57 10.08 50 258632 1687 110328930
Platelet count decreased 79.09 10.08 275 258407 230168 110100449
Muscle twitching 78.91 10.08 199 258483 29736 110300881
Fall 78.71 10.08 1907 256775 601575 109729042
Hypopnoea 78.45 10.08 114 258568 11266 110319351
Neutrophil count decreased 77.93 10.08 101 258581 120840 110209777
Coordination abnormal 76.46 10.08 177 258505 25051 110305566
Mycotic allergy 75.55 10.08 81 258601 5873 110324744
Psoriatic arthropathy 74.21 10.08 745 257937 196016 110134601
Mite allergy 73.73 10.08 79 258603 5724 110324893
Lip swelling 73.36 10.08 273 258409 50394 110280223
Blood lactic acid decreased 73.24 10.08 33 258649 555 110330062
Neurological symptom 72.90 10.08 131 258551 15477 110315140
Diplopia 72.11 10.08 239 258443 41655 110288962
Dust allergy 71.54 10.08 79 258603 5922 110324695
Rheumatoid arthritis 70.37 10.08 1037 257645 298576 110032041
Erythema 69.69 10.08 398 258284 291049 110039568
Sinusitis 69.42 10.08 408 258274 296280 110034337
Cardiac output increased 68.91 10.08 32 258650 579 110330038
Blood cholesterol increased 68.89 10.08 698 257984 184087 110146530
Cytomegalovirus infection 68.52 10.08 21 258661 54423 110276194
Blood pressure increased 68.21 10.08 913 257769 257460 110073157
Antineutrophil cytoplasmic antibody positive 67.86 10.08 71 258611 5005 110325612
Therapy interrupted 66.83 10.08 17 258665 49805 110280812
Sneezing 65.69 10.08 194 258488 31790 110298827
Vertigo 64.94 10.08 386 258296 86484 110244133
Nipple swelling 64.92 10.08 27 258655 370 110330247
Injection site swelling 64.31 10.08 32 258650 61758 110268859
Eating disorder 64.17 10.08 188 258494 30670 110299947
Fibromyalgia 63.91 10.08 646 258036 170263 110160354
Drug dependence 63.48 10.08 19 258663 50001 110280616
Helicobacter infection 63.07 10.08 677 258005 181200 110149417
Flushing 62.93 10.08 92 258590 104644 110225973
Sinus congestion 62.80 10.08 185 258497 30274 110300343
Respiratory tract congestion 62.27 10.08 186 258496 30671 110299946
Sinus disorder 62.05 10.08 193 258489 32535 110298082
Cardio-respiratory arrest 61.84 10.08 110 258572 115726 110214891
Off label use 61.48 10.08 2877 255805 1497308 108833309
Neurotoxicity 61.45 10.08 12 258670 42195 110288422
Labelled drug-drug interaction medication error 61.40 10.08 179 258503 29123 110301494
Vitamin B1 decreased 61.34 10.08 34 258648 905 110329712
Multiple organ dysfunction syndrome 61.31 10.08 168 258514 151542 110179075
Cytokine release syndrome 59.88 10.08 46 258636 70260 110260357
Liver injury 59.38 10.08 575 258107 149838 110180779
Ventricular tachycardia 59.18 10.08 253 258429 49756 110280861
Drug resistance 58.97 10.08 29 258653 56345 110274272
Abdominal distension 58.96 10.08 648 258034 174455 110156162
Multiple sclerosis relapse 58.67 10.08 22 258660 50218 110280399
Aphasia 58.29 10.08 283 258399 58714 110271903
Parosmia 58.24 10.08 108 258574 13072 110317545
Septic shock 58.17 10.08 182 258500 157346 110173271
Paraesthesia 58.00 10.08 939 257743 275582 110055035
Normochromic normocytic anaemia 57.70 10.08 107 258575 12950 110317667
Hypersensitivity 57.34 10.08 636 258046 403362 109927255
Injection site bruising 57.32 10.08 24 258658 51239 110279378
Pulmonary fibrosis 56.66 10.08 421 258261 101621 110228996
Hepatic enzyme 56.48 10.08 65 258617 5098 110325519
Encephalopathy 56.12 10.08 64 258618 80991 110249626
Blindness 56.09 10.08 200 258482 36159 110294458
Oligohydramnios 55.43 10.08 57 258625 3937 110326680
Overlap syndrome 54.27 10.08 85 258597 8974 110321643
Full blood count decreased 53.93 10.08 6 258676 32093 110298524
Pulmonary alveolar haemorrhage 53.16 10.08 134 258548 20016 110310601
Oropharyngeal pain 53.03 10.08 152 258530 135124 110195493
Muscle spasms 53.01 10.08 930 257752 277227 110053390
Systemic lupus erythematosus 52.71 10.08 862 257820 253476 110077141
Treatment noncompliance 52.33 10.08 56 258626 72934 110257683
Premature delivery 50.78 10.08 6 258676 30626 110299991
Pancytopenia 50.77 10.08 285 258397 209328 110121289
Psychotic disorder 50.62 10.08 28 258654 50909 110279708
Agitation 50.46 10.08 119 258563 112932 110217685
Rhinitis 50.42 10.08 141 258541 22404 110308213
Therapeutic response decreased 50.29 10.08 93 258589 96406 110234211
Urogenital haemorrhage 49.90 10.08 30 258652 934 110329683
Polyp 49.50 10.08 86 258596 9894 110320723
Neoplasm progression 49.23 10.08 47 258635 64548 110266069
Duodenal ulcer perforation 48.99 10.08 633 258049 177067 110153550
Wrong technique in product usage process 48.40 10.08 81 258601 87267 110243350
Dystonia 48.36 10.08 3 258679 25802 110304815
Gingival pain 48.34 10.08 111 258571 15625 110314992
Intentional overdose 48.27 10.08 154 258528 132347 110198270
Sedation 48.27 10.08 55 258627 69628 110260989
Hypoaesthesia 48.09 10.08 1016 257666 313207 110017410
Capillaritis 47.55 10.08 42 258640 2397 110328220
Blood folate decreased 47.11 10.08 41 258641 2294 110328323
Impaired healing 46.99 10.08 683 257999 196034 110134583
Arteriosclerosis 46.90 10.08 146 258536 24621 110305996
Candida infection 46.83 10.08 27 258655 47982 110282635
Unresponsive to stimuli 46.79 10.08 48 258634 63742 110266875
Pemphigus 46.62 10.08 733 257949 213837 110116780
Rubber sensitivity 45.87 10.08 41 258641 2377 110328240
Dry eye 45.64 10.08 38 258644 55755 110274862
Therapy cessation 45.53 10.08 24 258658 44833 110285784
Anti-cyclic citrullinated peptide antibody positive 45.53 10.08 637 258045 181347 110149270
Renal cyst haemorrhage 45.50 10.08 26 258656 735 110329882
Surgery 45.09 10.08 20 258662 41263 110289354
Respiratory arrest 44.92 10.08 42 258640 58257 110272360
Electrocardiogram abnormal 44.82 10.08 120 258562 18589 110312028
Respiratory depression 44.73 10.08 10 258672 31991 110298626
Hypertension 44.59 10.08 1533 257149 508551 109822066
Acute respiratory failure 44.34 10.08 67 258615 75193 110255424
Hospitalisation 44.33 10.08 177 258505 142316 110188301
Renal artery stenosis 44.33 10.08 49 258633 3677 110326940
Sleep disorder 43.69 10.08 680 258002 197964 110132653
Suicide attempt 43.66 10.08 112 258570 103282 110227335
Fungal infection 43.57 10.08 33 258649 50773 110279844
Rash erythematous 43.42 10.08 78 258604 81754 110248863
Rash 43.20 10.08 1529 257153 819435 109511182
Depression 43.17 10.08 1009 257673 316326 110014291
Injection site rash 43.07 10.08 3 258679 23416 110307201
Injection site pruritus 43.06 10.08 34 258648 51224 110279393
Lactic acidosis 42.82 10.08 367 258315 92444 110238173
Oxygen saturation decreased 42.76 10.08 205 258477 156777 110173840
Tubulointerstitial nephritis 41.72 10.08 243 258439 54041 110276576
Ear infection 40.81 10.08 52 258630 62680 110267937
Constipation 40.77 10.08 590 258092 357196 109973421
Cardiac failure congestive 40.65 10.08 198 258484 150802 110179815
Device issue 40.53 10.08 15 258667 34520 110296097
Muscle spasticity 40.43 10.08 179 258503 35736 110294881
Therapy partial responder 40.40 10.08 18 258664 37043 110293574
Total lung capacity decreased 40.21 10.08 65 258617 7049 110323568
Nipple pain 40.15 10.08 28 258654 1128 110329489
Irritability 39.80 10.08 32 258650 47777 110282840
Unevaluable event 39.68 10.08 48 258634 59179 110271438
Lower respiratory tract infection 39.13 10.08 792 257890 242314 110088303
Vitamin B1 increased 39.02 10.08 15 258667 165 110330452
Bronchitis 38.84 10.08 212 258470 156820 110173797
Hepatotoxicity 38.76 10.08 55 258627 63345 110267272
Staphylococcal infection 38.63 10.08 65 258617 69879 110260738
Exposure to allergen 38.40 10.08 21 258661 544 110330073
Hypertensive crisis 38.40 10.08 135 258547 24237 110306380
Mouth ulceration 37.90 10.08 34 258648 48104 110282513
Lung opacity 37.81 10.08 84 258598 11568 110319049
Hypervolaemia 37.68 10.08 36 258646 49424 110281193
Haemoptysis 37.15 10.08 290 258392 71064 110259553
Therapeutic drug monitoring analysis not performed 37.15 10.08 33 258649 1898 110328719
Glossodynia 36.98 10.08 727 257955 221277 110109340
Blood cholesterol 36.47 10.08 24 258658 878 110329739
Drug withdrawal syndrome 36.27 10.08 22 258660 38032 110292585
Drug-induced liver injury 36.22 10.08 435 258247 119632 110210985
Lichenoid keratosis 36.19 10.08 58 258624 6244 110324373
Angioedema 36.18 10.08 371 258311 98129 110232488
Contusion 36.07 10.08 360 258322 233001 110097616
Rash papular 35.98 10.08 144 258538 27495 110303122
Pyrexia 35.96 10.08 1726 256956 896539 109434078
Renal impairment 35.86 10.08 630 258052 187815 110142802
Red blood cell sedimentation rate abnormal 35.61 10.08 7 258675 24502 110306115
Malignant neoplasm progression 35.24 10.08 251 258431 174316 110156301
Coma 35.05 10.08 149 258533 117720 110212897
Body temperature increased 34.93 10.08 46 258636 54667 110275950
Rheumatic fever 34.77 10.08 439 258243 122140 110208477
Blood calcium increased 34.77 10.08 107 258575 17933 110312684
Aspartate aminotransferase increased 34.75 10.08 225 258457 159711 110170906
Blister 34.71 10.08 735 257947 226641 110103976
Lymphocyte count decreased 34.66 10.08 50 258632 57193 110273424
Cellulitis 34.64 10.08 164 258518 125852 110204765
Labile hypertension 34.57 10.08 20 258662 579 110330038
Small intestinal obstruction 34.56 10.08 16 258666 32197 110298420
Disease recurrence 34.02 10.08 56 258626 60728 110269889
Atelectasis 33.92 10.08 22 258660 36690 110293927
Nightmare 33.89 10.08 180 258502 38683 110291934
Alcohol poisoning 33.86 10.08 69 258613 8951 110321666
Dysphonia 33.82 10.08 80 258602 75849 110254768
Device malfunction 33.75 10.08 9 258673 25549 110305068
Eyelid function disorder 33.67 10.08 19 258663 524 110330093
Device dislocation 33.63 10.08 16 258666 31688 110298929
Klebsiella infection 32.97 10.08 4 258678 20005 110310612
Pemphigoid 32.65 10.08 111 258571 19596 110311021
Syncope 32.64 10.08 660 258022 201876 110128741
Cardiac murmur 32.61 10.08 129 258553 24499 110306118
Vision blurred 32.56 10.08 173 258509 128849 110201768
Nasal congestion 32.56 10.08 119 258563 98163 110232454
Drug reaction with eosinophilia and systemic symptoms 32.35 10.08 92 258590 82003 110248614
Vena cava injury 32.30 10.08 16 258666 336 110330281
Respiratory tract infection 32.27 10.08 75 258607 71542 110259075
Bacteraemia 32.12 10.08 31 258651 42359 110288258
Clostridium difficile infection 32.09 10.08 45 258637 52084 110278533
Alanine aminotransferase increased 32.07 10.08 275 258407 183498 110147119
Fluid retention 32.03 10.08 113 258569 94194 110236423
Cystitis 31.99 10.08 264 258418 65772 110264845
Dermatitis atopic 31.87 10.08 10 258672 25531 110305086
Pain in jaw 31.68 10.08 44 258638 51133 110279484
Wound 31.43 10.08 744 257938 233693 110096924
Cataract 31.42 10.08 304 258378 79181 110251436
Aspiration 31.27 10.08 148 258534 30385 110300232
Chronic sinusitis 30.99 10.08 10 258672 25074 110305543
Carotid arteriosclerosis 30.97 10.08 37 258645 3020 110327597
Normal newborn 30.88 10.08 117 258565 21779 110308838
Anaphylactic reaction 30.69 10.08 150 258532 114150 110216467
Fibromuscular dysplasia 30.49 10.08 15 258667 310 110330307
Pathogen resistance 30.47 10.08 3 258679 17669 110312948
Schizophrenia 30.15 10.08 7 258675 21819 110308798
Dyskinesia 30.11 10.08 46 258636 51400 110279217
Musculoskeletal disorder 29.89 10.08 8 258674 22656 110307961
SARS-CoV-2 antibody test positive 29.81 10.08 16 258666 399 110330218
Tenderness 29.51 10.08 16 258666 29421 110301196
Toxic epidermal necrolysis 29.27 10.08 55 258627 56672 110273945
Plasma cell myeloma 29.09 10.08 65 258617 62871 110267746
Thrombotic microangiopathy 29.00 10.08 16 258666 29133 110301484
Mucosal inflammation 28.91 10.08 121 258561 96020 110234597
Injection site haemorrhage 28.91 10.08 21 258661 33007 110297610
Myelodysplastic syndrome 28.89 10.08 27 258655 37457 110293160
Clostridium difficile colitis 28.78 10.08 36 258646 43742 110286875
Respiratory distress 28.78 10.08 75 258607 68799 110261818
Lymphadenopathy 28.64 10.08 67 258615 63768 110266849
Complication associated with device 28.61 10.08 6 258676 20067 110310550
Orthostatic hypotension 28.50 10.08 258 258424 65991 110264626
Incorrect product administration duration 28.47 10.08 109 258573 20389 110310228
Cholestatic liver injury 28.37 10.08 57 258625 7319 110323298
Skin fissures 28.08 10.08 11 258671 24447 110306170
Vascular anastomotic haemorrhage 28.04 10.08 14 258668 299 110330318
Product storage error 28.04 10.08 8 258674 21720 110308897
Hip arthroplasty 28.02 10.08 55 258627 55758 110274859
Abdominal discomfort 27.98 10.08 1157 257525 392701 109937916
Sciatica 27.97 10.08 116 258566 92283 110238334
Abdominal wall haemorrhage 27.95 10.08 19 258663 734 110329883
Bone pain 27.93 10.08 70 258612 65063 110265554
Cytopenia 27.89 10.08 18 258664 30098 110300519
Conjunctivitis 27.66 10.08 23 258659 33769 110296848
Coagulopathy 27.57 10.08 33 258649 40878 110289739
Gastrointestinal angiodysplasia 27.56 10.08 23 258659 1215 110329402
Poisoning 27.50 10.08 17 258665 29088 110301529
Hypothyroidism 27.45 10.08 276 258406 72623 110257994
Discomfort 27.35 10.08 346 258336 214361 110116256
Immune reconstitution inflammatory syndrome 27.34 10.08 3 258679 16223 110314394
Blood creatinine increased 27.20 10.08 589 258093 182300 110148317
Injection site urticaria 27.03 10.08 4 258678 17211 110313406
Paresis 27.03 10.08 44 258638 4800 110325817
Injection site reaction 26.99 10.08 323 258359 88747 110241870
Foetal death 26.95 10.08 3 258679 16042 110314575
Illness 26.88 10.08 100 258582 82071 110248546
Drug hypersensitivity 26.82 10.08 833 257849 453257 109877360
Haematotoxicity 26.77 10.08 8 258674 21074 110309543
Sinus rhythm 26.65 10.08 21 258661 1022 110329595
Oral pain 26.54 10.08 29 258653 37415 110293202
Chills 26.23 10.08 302 258380 190278 110140339
Device difficult to use 26.04 10.08 6 258676 18799 110311818
Renin increased 25.98 10.08 14 258668 352 110330265
Epstein-Barr virus infection 25.90 10.08 6 258676 18732 110311885
Back pain 25.88 10.08 665 258017 370331 109960286
Neuroleptic malignant syndrome 25.70 10.08 25 258657 34034 110296583
Intraductal papillary mucinous neoplasm 25.70 10.08 19 258663 840 110329777
Chronic obstructive pulmonary disease 25.57 10.08 150 258532 109008 110221609
Knee arthroplasty 25.43 10.08 73 258609 64875 110265742
Asthenia 25.38 10.08 1905 256777 687094 109643523
Enterococcal infection 25.37 10.08 8 258674 20358 110310259
Ultrasound uterus abnormal 25.29 10.08 7 258675 23 110330594
Injection site warmth 25.23 10.08 5 258677 17400 110313217
Pneumonia aspiration 25.20 10.08 101 258581 81132 110249485
Chronic spontaneous urticaria 25.09 10.08 27 258655 1966 110328651
Respiratory tract haemorrhage 24.85 10.08 27 258655 1987 110328630
Overdose 24.74 10.08 391 258291 233403 110097214
Maternal exposure during pregnancy 24.53 10.08 775 257907 254108 110076509
Arteriosclerosis coronary artery 24.46 10.08 120 258562 24998 110305619
Device related infection 24.44 10.08 34 258648 39485 110291132
Malaise 24.16 10.08 1854 256828 669965 109660652
Foot deformity 24.14 10.08 48 258634 48432 110282185
Androgenetic alopecia 24.01 10.08 12 258670 257 110330360
Haemophagocytic lymphohistiocytosis 24.00 10.08 23 258659 31536 110299081
Dysarthria 23.74 10.08 301 258381 83820 110246797
Transplant rejection 23.70 10.08 14 258668 24553 110306064
Ascites 23.66 10.08 124 258558 92684 110237933
Gastroduodenal ulcer 23.63 10.08 19 258663 952 110329665
Eye irritation 23.61 10.08 26 258656 33426 110297191
Endoscopy upper gastrointestinal tract abnormal 23.50 10.08 8 258674 60 110330557
Pregnancy 23.39 10.08 53 258629 51014 110279603
Pulmonary haemorrhage 23.29 10.08 5 258677 16451 110314166
Rales 23.24 10.08 117 258565 24622 110305995
Large intestine polyp 23.18 10.08 83 258599 15034 110315583
Intentional dose omission 23.10 10.08 9 258673 20071 110310546
Renal artery thrombosis 23.00 10.08 15 258667 540 110330077
Food allergy 22.85 10.08 9 258673 19939 110310678
Basilar artery occlusion 22.77 10.08 12 258670 288 110330329
Vascular compression 22.75 10.08 17 258665 764 110329853
Oral candidiasis 22.56 10.08 44 258638 44716 110285901
Appendicitis 22.53 10.08 20 258662 28444 110302173
Bronchopulmonary aspergillosis 22.44 10.08 22 258660 29841 110300776
Cerebrovascular accident 22.40 10.08 569 258113 180715 110149902
Vaginal discharge 22.37 10.08 7 258675 17901 110312716
Mood altered 22.35 10.08 11 258671 21364 110309253
Epistaxis 22.34 10.08 196 258486 130176 110200441
Gastroenteritis viral 22.34 10.08 24 258658 31202 110299415
Cardiac failure 22.33 10.08 586 258096 187040 110143577
Perineal cyst 22.12 10.08 11 258671 233 110330384
Injury 22.08 10.08 557 258125 176708 110153909
Metastases to central nervous system 22.02 10.08 13 258669 22804 110307813
Incorrect dose administered 21.91 10.08 147 258535 103494 110227123
Peripheral arterial occlusive disease 21.70 10.08 59 258623 9221 110321396
Cystostomy 21.67 10.08 8 258674 78 110330539
Hyperuricaemia 21.62 10.08 79 258603 14452 110316165
Procedural pain 21.60 10.08 31 258651 35534 110295083
No adverse event 21.54 10.08 94 258588 73745 110256872
Crying 21.53 10.08 17 258665 25611 110305006
Coronary artery stenosis 21.50 10.08 76 258606 13682 110316935
Acute myeloid leukaemia 21.43 10.08 35 258647 38075 110292542
Viral infection 21.34 10.08 59 258623 53080 110277537
Blood pressure measurement 21.18 10.08 14 258668 516 110330101
Diverticulum intestinal haemorrhagic 21.01 10.08 39 258643 4724 110325893
Sleep disorder due to a general medical condition 20.94 10.08 200 258482 51912 110278705
Abnormal behaviour 20.90 10.08 37 258645 39002 110291615
Hand deformity 20.66 10.08 663 258019 217843 110112774
Cardiogenic shock 20.63 10.08 67 258615 57271 110273346
Atrial fibrillation 20.48 10.08 692 257990 228950 110101667
Intentional self-injury 20.47 10.08 35 258647 37394 110293223
Metastases to bone 20.41 10.08 26 258656 31346 110299271
Leukopenia 20.38 10.08 236 258446 148555 110182062
Orbital swelling 20.34 10.08 8 258674 94 110330523
Presyncope 20.33 10.08 189 258493 48698 110281919
Swollen joint count decreased 20.33 10.08 12 258670 361 110330256
Radiculopathy 20.14 10.08 10 258672 19326 110311291
Inappropriate antidiuretic hormone secretion 20.13 10.08 142 258540 33709 110296908
Tender joint count decreased 20.08 10.08 11 258671 286 110330331
Aggression 20.07 10.08 71 258611 59139 110271478
Cough 20.05 10.08 1294 257388 460347 109870270
Blood growth hormone increased 20.05 10.08 18 258664 1050 110329567
Road traffic accident 19.97 10.08 158 258524 107240 110223377
Rebound effect 19.96 10.08 5 258677 14801 110315816
Serum amyloid A protein increased 19.94 10.08 17 258665 925 110329692
Paternal exposure during pregnancy 19.89 10.08 10 258672 217 110330400
Paranoia 19.88 10.08 14 258668 22360 110308257
Upper respiratory tract infection 19.71 10.08 204 258478 131124 110199493
Hyperlactacidaemia 19.70 10.08 53 258629 8233 110322384
Vascular device infection 19.67 10.08 7 258675 16505 110314112
Throat irritation 19.67 10.08 62 258620 53490 110277127
Sedation complication 19.60 10.08 11 258671 19844 110310773
Hypersomnia 19.59 10.08 22 258660 28039 110302578
Malnutrition 19.47 10.08 21 258661 27258 110303359
Hypotension 19.37 10.08 1449 257233 522400 109808217
Skin discolouration 19.30 10.08 55 258627 48991 110281626
Hypertransaminasaemia 19.25 10.08 17 258665 24238 110306379
Product dose omission in error 19.25 10.08 16 258666 23496 110307121
Pulmonary oedema 19.22 10.08 147 258535 100512 110230105
Bone marrow failure 19.19 10.08 70 258612 57778 110272839
Urinary hesitation 19.13 10.08 37 258645 4621 110325996
Blood test abnormal 18.90 10.08 123 258559 28431 110302186
Impaired gastric emptying 18.86 10.08 4 258678 13271 110317346
Emotional distress 18.61 10.08 49 258633 44798 110285819
Intestinal obstruction 18.60 10.08 63 258619 53164 110277453
Oral herpes 18.59 10.08 35 258647 36045 110294572
Therapeutic response unexpected 18.58 10.08 17 258665 23826 110306791
Urticaria pressure 18.54 10.08 7 258675 73 110330544
Herpes zoster 18.54 10.08 163 258519 108216 110222401
Aortic arteriosclerosis 18.47 10.08 62 258620 10876 110319741
Hyperbilirubinaemia 18.36 10.08 27 258655 30644 110299973
Blood potassium decreased 18.27 10.08 65 258617 54049 110276568
Spur cell anaemia 18.23 10.08 8 258674 126 110330491
Pulmonary arterial hypertension 18.23 10.08 30 258652 32538 110298079
Impaired work ability 18.23 10.08 115 258567 26304 110304313
Pulmonary hypertension 18.19 10.08 67 258615 55153 110275464
Barotrauma 18.17 10.08 9 258673 189 110330428
Movement disorder 18.16 10.08 36 258646 36368 110294249
Hyperthyroidism 18.14 10.08 124 258558 29137 110301480
Anuria 18.08 10.08 108 258574 24233 110306384
Device lead damage 18.01 10.08 4 258678 3 110330614
Ankylosing spondylitis 17.96 10.08 7 258675 15605 110315012
Rhinovirus infection 17.92 10.08 3 258679 11786 110318831
Alveolitis 17.92 10.08 35 258647 4404 110326213
Panniculitis 17.90 10.08 7 258675 15575 110315042
Mental impairment 17.81 10.08 16 258666 22623 110307994
Therapeutic response shortened 17.75 10.08 26 258656 29557 110301060
Ileocolostomy 17.74 10.08 6 258676 44 110330573
Adrenal insufficiency 17.69 10.08 164 258518 42226 110288391
Skin burning sensation 17.68 10.08 15 258667 21810 110308807
Gastrointestinal disorder 17.68 10.08 713 257969 241239 110089378
Blood glucose decreased 17.61 10.08 26 258656 29462 110301155
Tardive dyskinesia 17.52 10.08 5 258677 13574 110317043
Feeling hot 17.42 10.08 133 258549 90973 110239644
Joint effusion 17.39 10.08 14 258668 20891 110309726
Blood pressure inadequately controlled 17.33 10.08 48 258634 7585 110323032
Substance abuse 17.21 10.08 4 258678 12459 110318158
Pseudomonas infection 17.19 10.08 24 258658 27829 110302788
Device leakage 17.17 10.08 8 258674 16040 110314577
Vaginal haemorrhage 17.14 10.08 20 258662 25054 110305563
Product contamination chemical 17.11 10.08 5 258677 21 110330596
Flatulence 17.09 10.08 192 258490 51957 110278660
Thalamus haemorrhage 17.05 10.08 22 258660 1942 110328675
Swollen joint count increased 17.02 10.08 120 258562 83541 110247076
Myoclonus 17.02 10.08 32 258650 32966 110297651
Pelvic pain 16.98 10.08 8 258674 15934 110314683
Abdominal pain lower 16.97 10.08 147 258535 37136 110293481
Pneumonitis 16.96 10.08 107 258575 76424 110254193
Catatonia 16.91 10.08 3 258679 11297 110319320
Aspergillus infection 16.90 10.08 21 258661 25595 110305022
Joint dislocation 16.90 10.08 34 258648 34156 110296461
Kidney infection 16.88 10.08 21 258661 25578 110305039
Electrolyte imbalance 16.86 10.08 146 258536 36882 110293735
Foot fracture 16.80 10.08 21 258661 25525 110305092
Nasal polyps 16.78 10.08 5 258677 13195 110317422
Arrhythmia 16.77 10.08 242 258440 69333 110261284
Decubitus ulcer 16.75 10.08 11 258671 18225 110312392
Pancreatitis 16.75 10.08 139 258543 93394 110237223
Muscle strain 16.70 10.08 3 258679 11199 110319418
BK virus infection 16.59 10.08 5 258677 13101 110317516
Generalised oedema 16.53 10.08 29 258653 30675 110299942
Mass 16.52 10.08 13 258669 19617 110311000
Tetany 16.51 10.08 30 258652 3574 110327043
Lung neoplasm malignant 16.43 10.08 34 258648 33808 110296809
Graft versus host disease 16.40 10.08 12 258670 18794 110311823
Post transplant lymphoproliferative disorder 16.38 10.08 8 258674 15605 110315012
Lethargy 16.33 10.08 140 258542 93436 110237181
Acute cutaneous lupus erythematosus 16.32 10.08 11 258671 419 110330198
Feeling jittery 16.29 10.08 7 258675 14715 110315902
Renal oncocytoma 16.26 10.08 9 258673 239 110330378
Renal artery angioplasty 16.24 10.08 5 258677 26 110330591
Caesarean section 16.22 10.08 6 258676 13811 110316806
Aortic dilatation 16.22 10.08 23 258659 2223 110328394
Laboratory test abnormal 16.21 10.08 51 258631 44028 110286589
Blood hyposmosis 16.08 10.08 5 258677 27 110330590
Cerebrovascular arteriovenous malformation 16.02 10.08 7 258675 109 110330508
Full blood count abnormal 16.00 10.08 201 258481 55851 110274766
Pericardial effusion 16.00 10.08 74 258608 57143 110273474
Atrioventricular block 15.98 10.08 80 258602 16797 110313820
Drug level decreased 15.97 10.08 12 258670 18536 110312081
Metastases to fallopian tube 15.94 10.08 6 258676 62 110330555
Blood bilirubin increased 15.93 10.08 108 258574 75864 110254753
Fibrous dysplasia of jaw 15.87 10.08 4 258678 8 110330609
Neoplasm malignant 15.86 10.08 40 258642 37103 110293514
Supine hypertension 15.84 10.08 11 258671 440 110330177
Actinic keratosis 15.82 10.08 44 258638 6969 110323648
Deep vein thrombosis 15.80 10.08 231 258451 139656 110190961
Ventricular fibrillation 15.76 10.08 47 258635 41266 110289351
Cerebral infarction 15.71 10.08 188 258494 51650 110278967
Immunodeficiency 15.69 10.08 43 258639 38795 110291822
Phonophobia 15.69 10.08 13 258669 680 110329937
Pleuritic pain 15.64 10.08 77 258605 16063 110314554
Posterior reversible encephalopathy syndrome 15.63 10.08 35 258647 33826 110296791
Troponin increased 15.50 10.08 121 258561 29645 110300972
Injection site mass 15.40 10.08 21 258661 24592 110306025
Osteoporosis 15.38 10.08 130 258552 87022 110243595
Paraesthesia oral 15.38 10.08 35 258647 33636 110296981
Oesophageal carcinoma 15.33 10.08 4 258678 11520 110319097
Blood 25-hydroxycholecalciferol decreased 15.31 10.08 11 258671 465 110330152
Brain oedema 15.31 10.08 31 258651 31067 110299550
Haemoglobin decreased 15.23 10.08 454 258228 248273 110082344
Uveitis 15.18 10.08 17 258665 21693 110308924
Faecal elastase concentration decreased 15.18 10.08 3 258679 0 110330617
Osteomyelitis 15.18 10.08 40 258642 36560 110294057
Bacterial sepsis 15.10 10.08 3 258679 10423 110320194
Haemorrhage 15.09 10.08 168 258514 106524 110224093
Patient dissatisfaction with treatment 15.07 10.08 10 258672 371 110330246
Hallucination, auditory 15.07 10.08 24 258658 26373 110304244
Lung hernia 15.07 10.08 6 258676 73 110330544
Prothrombin time shortened 15.02 10.08 29 258653 3617 110327000
Oedema 15.00 10.08 375 258307 209601 110121016
Hypogammaglobulinaemia 14.84 10.08 15 258667 20061 110310556
Drug tolerance decreased 14.83 10.08 26 258656 27514 110303103
Balance disorder 14.78 10.08 188 258494 116372 110214245
Hyperaesthesia 14.77 10.08 8 258674 14719 110315898
Chronic coronary syndrome 14.75 10.08 9 258673 288 110330329
Hypozincaemia 14.71 10.08 6 258676 78 110330539
Anti-cyclic citrullinated peptide antibody 14.67 10.08 15 258667 19949 110310668
Cytomegalovirus viraemia 14.65 10.08 12 258670 17752 110312865
Craniofacial fracture 14.62 10.08 14 258668 887 110329730
Eczema 14.58 10.08 244 258438 72049 110258568
Generalised tonic-clonic seizure 14.54 10.08 72 258610 54608 110276009
Eye allergy 14.49 10.08 15 258667 1044 110329573
Eye pain 14.48 10.08 64 258618 50035 110280582
Pulpitis dental 14.48 10.08 18 258664 1531 110329086
Cytomegalovirus infection reactivation 14.37 10.08 13 258669 18320 110312297
Paradoxical drug reaction 14.29 10.08 53 258629 9764 110320853
Product prescribing issue 14.25 10.08 6 258676 12766 110317851
Total cholesterol/HDL ratio increased 14.19 10.08 10 258672 410 110330207
Respiratory rate increased 14.14 10.08 23 258659 25060 110305557
Product preparation error 14.05 10.08 4 258678 10875 110319742
Sleep apnoea syndrome 14.04 10.08 48 258634 40399 110290218
Cerebral haematoma 14.02 10.08 52 258630 9580 110321037
Spinal osteoarthritis 14.01 10.08 88 258594 20095 110310522
Hemiataxia 13.99 10.08 5 258677 44 110330573
Lichen planus 13.90 10.08 27 258655 3383 110327234
Hypochromic anaemia 13.85 10.08 26 258656 3175 110327442
Abscess 13.85 10.08 27 258655 27442 110303175
Cardiac disorder 13.82 10.08 113 258569 76167 110254450
Heart rate increased 13.74 10.08 437 258245 143397 110187220
Sopor 13.64 10.08 42 258640 36504 110294113
Paresis cranial nerve 13.61 10.08 5 258677 48 110330569
Akathisia 13.57 10.08 12 258670 17101 110313516
Vitamin D deficiency 13.56 10.08 14 258668 18538 110312079
Acute hepatic failure 13.55 10.08 42 258640 36426 110294191
Lipoedema 13.54 10.08 8 258674 241 110330376
Gait disturbance 13.49 10.08 523 258159 277685 110052932
Ventricular extrasystoles 13.48 10.08 95 258587 22546 110308071
Immune effector cell-associated neurotoxicity syndrome 13.47 10.08 9 258673 14773 110315844
Flail chest 13.42 10.08 6 258676 99 110330518
Swollen tongue 13.40 10.08 207 258475 60155 110270462
Ocular hyperaemia 13.39 10.08 47 258635 39239 110291378
Cerebellar infarction 13.38 10.08 30 258652 4157 110326460
Lip infection 13.36 10.08 7 258675 166 110330451
Post concussion syndrome 13.35 10.08 12 258670 701 110329916
Hot flush 13.29 10.08 95 258587 65941 110264676
Pneumonia 13.24 10.08 1823 256859 874891 109455726
Pulmonary thrombosis 13.23 10.08 8 258674 13855 110316762
Neutropenic sepsis 13.21 10.08 33 258649 30713 110299904
Malignant melanoma 13.21 10.08 12 258670 16879 110313738
Accidental overdose 13.18 10.08 182 258500 51652 110278965
Abdominal pain 13.17 10.08 1027 257655 511962 109818655
Oedema peripheral 13.14 10.08 915 257767 327745 110002872
Basal ganglia haemorrhage 13.14 10.08 19 258663 1869 110328748
SAPHO syndrome 13.13 10.08 11 258671 584 110330033
Leukocytosis 13.12 10.08 73 258609 53755 110276862
Diffuse alopecia 13.12 10.08 16 258666 1334 110329283
Gallbladder disorder 13.10 10.08 18 258664 21011 110309606
Product administration interrupted 13.09 10.08 5 258677 11287 110319330
Glomerular filtration rate decreased 13.09 10.08 114 258568 28842 110301775
Skin ulcer 13.09 10.08 91 258591 63554 110267063
Abortion spontaneous 13.08 10.08 39 258643 34243 110296374
Aplastic anaemia 13.05 10.08 23 258659 24285 110306332
Bone density decreased 13.03 10.08 11 258671 16031 110314586
Psychomotor hyperactivity 12.99 10.08 17 258665 20260 110310357
Atrioventricular block complete 12.99 10.08 86 258596 19996 110310621
Blood sodium abnormal 12.93 10.08 16 258666 1354 110329263
Encephalitis 12.90 10.08 15 258667 18824 110311793
Infusion site pain 12.90 10.08 13 258669 17406 110313211
Tooth infection 12.87 10.08 20 258662 22196 110308421
Joint injury 12.87 10.08 49 258633 39945 110290672
Suicidal ideation 12.86 10.08 149 258533 93788 110236829
Hypercapnia 12.84 10.08 5 258677 11154 110319463
Purpura senile 12.82 10.08 11 258671 604 110330013
Migraine 12.80 10.08 507 258175 171145 110159472
Diffuse large B-cell lymphoma 12.79 10.08 11 258671 15887 110314730
Loss of control of legs 12.77 10.08 20 258662 2112 110328505
Amnesia 12.76 10.08 330 258352 105078 110225539
Amenorrhoea 12.67 10.08 3 258679 9228 110321389
Mobility decreased 12.67 10.08 678 258004 236744 110093873
Anxiety disorder due to a general medical condition 12.66 10.08 4 258678 23 110330594
Endometrial cancer stage I 12.64 10.08 7 258675 186 110330431
Rectal prolapse 12.60 10.08 22 258660 2541 110328076
Immune system disorder 12.60 10.08 8 258674 13493 110317124
Herpes simplex 12.57 10.08 11 258671 15753 110314864
Aortic valve incompetence 12.56 10.08 55 258627 10926 110319691
Sinonasal obstruction 12.54 10.08 9 258673 380 110330237
Anaphylactic shock 12.52 10.08 70 258612 51476 110279141
Dyspnoea 12.47 10.08 2846 255836 1104026 109226591
Tooth disorder 12.43 10.08 32 258650 29477 110301140
Splenomegaly 12.42 10.08 24 258658 24474 110306143
Brain stem stroke 12.42 10.08 12 258670 769 110329848
Drug effective for unapproved indication 12.41 10.08 9 258673 14158 110316459
Heart rate irregular 12.36 10.08 40 258642 34234 110296383
Blood phosphorus increased 12.32 10.08 12 258670 16328 110314289
Bradyphrenia 12.31 10.08 6 258676 11722 110318895
Vertigo positional 12.29 10.08 28 258654 3920 110326697
Lung perforation 12.24 10.08 6 258676 123 110330494
Pharyngitis streptococcal 12.21 10.08 8 258674 13269 110317348
Neutrophil count 12.19 10.08 9 258673 397 110330220
Aortic dissection 12.18 10.08 32 258650 4901 110325716
Breast cancer female 12.18 10.08 7 258675 12461 110318156
Acne 12.17 10.08 39 258643 33481 110297136
Nasopharyngitis 12.17 10.08 1076 257606 393285 109937332
Graft versus host disease in gastrointestinal tract 12.14 10.08 3 258679 8965 110321652
Pneumonia fungal 12.13 10.08 10 258672 14744 110315873
Mental status changes postoperative 12.12 10.08 7 258675 202 110330415
Dyspnoea at rest 12.10 10.08 45 258637 8301 110322316
Multiple fractures 12.09 10.08 3 258679 8937 110321680
Acute graft versus host disease in skin 12.05 10.08 5 258677 10735 110319882
Deafness 12.01 10.08 28 258654 26681 110303936
Nerve injury 12.00 10.08 5 258677 10708 110319909
Retinal artery occlusion 11.99 10.08 29 258653 4220 110326397
Impaired quality of life 11.96 10.08 115 258567 29902 110300715
Frequent bowel movements 11.95 10.08 234 258448 71156 110259461
Gastrointestinal ischaemia 11.94 10.08 10 258672 531 110330086
Rotator cuff syndrome 11.91 10.08 13 258669 16781 110313836
Gerstmann's syndrome 11.90 10.08 3 258679 6 110330611
Idiopathic pulmonary fibrosis 11.89 10.08 32 258650 4972 110325645
Intraventricular haemorrhage 11.88 10.08 34 258648 5473 110325144
Tarsal tunnel syndrome 11.81 10.08 10 258672 539 110330078
Renal cancer 11.79 10.08 8 258674 13026 110317591
Atrioventricular block second degree 11.77 10.08 44 258638 8137 110322480
Skin laceration 11.76 10.08 40 258642 33713 110296904
pH body fluid increased 11.74 10.08 5 258677 73 110330544
Transaminases increased 11.72 10.08 211 258471 63179 110267438
Cystitis haemorrhagic 11.72 10.08 7 258675 12202 110318415
Skin disorder 11.70 10.08 56 258626 42857 110287760
Radiation proctitis 11.70 10.08 7 258675 216 110330401
Diabetes mellitus 11.61 10.08 163 258519 99218 110231399
Anal incontinence 11.59 10.08 21 258661 21943 110308674
Hypercalcaemia 11.52 10.08 63 258619 46594 110284023
Pneumobilia 11.48 10.08 8 258674 322 110330295
IIIrd nerve paresis 11.47 10.08 7 258675 224 110330393
Sputum retention 11.45 10.08 15 258667 1344 110329273
Productive cough 11.37 10.08 349 258333 113956 110216661
Hip fracture 11.35 10.08 43 258639 35108 110295509
Refusal of treatment by patient 11.35 10.08 4 258678 9490 110321127
Ulcer haemorrhage 11.34 10.08 91 258591 22480 110308137
Ankle fracture 11.33 10.08 18 258664 19801 110310816
Desmoplastic melanoma 11.32 10.08 4 258678 34 110330583
Wrong strength 11.31 10.08 7 258675 230 110330387
Polyserositis 11.28 10.08 13 258669 1021 110329596
Sexual dysfunction 11.27 10.08 3 258679 8527 110322090
Localised infection 11.26 10.08 57 258625 42991 110287626
Speech disorder 11.25 10.08 91 258591 61478 110269139
Emphysema 11.24 10.08 18 258664 19738 110310879
Heavy menstrual bleeding 11.24 10.08 13 258669 16352 110314265
Underdose 11.21 10.08 210 258472 63344 110267273
Respiratory tract inflammation 11.19 10.08 13 258669 1030 110329587
Vasoplegia syndrome 11.18 10.08 33 258649 5406 110325211
Blood alkaline phosphatase increased 11.13 10.08 109 258573 70826 110259791
Vertebral artery stenosis 11.12 10.08 7 258675 237 110330380
Shock hypoglycaemic 11.09 10.08 7 258675 238 110330379
Hypomania 11.07 10.08 5 258677 10205 110320412
Right ventricular failure 11.04 10.08 28 258654 25926 110304691
Mood swings 11.01 10.08 23 258659 22789 110307828
Prostatomegaly 10.97 10.08 28 258654 4214 110326403
Spider naevus 10.95 10.08 6 258676 156 110330461
Cerebral ventricular rupture 10.94 10.08 9 258673 466 110330151
Hepatocellular carcinoma 10.94 10.08 49 258633 9831 110320786
Limb injury 10.93 10.08 48 258634 37588 110293029
Hyperparathyroidism secondary 10.92 10.08 24 258658 3280 110327337
Costovertebral angle tenderness 10.91 10.08 7 258675 245 110330372
Potentiating drug interaction 10.89 10.08 55 258627 11588 110319029
Bone hypertrophy 10.86 10.08 11 258671 746 110329871
Blood calcium decreased 10.84 10.08 45 258637 35800 110294817
Cardiac murmur functional 10.83 10.08 4 258678 39 110330578
Proctalgia 10.82 10.08 9 258673 13213 110317404
Dermatitis contact 10.81 10.08 10 258672 13943 110316674
Pneumococcal infection 10.80 10.08 17 258665 1802 110328815
Renal artery stent placement 10.79 10.08 5 258677 90 110330527
Pain 10.76 10.08 2019 256663 952936 109377681
Periorbital discomfort 10.74 10.08 4 258678 40 110330577
Fractured skull depressed 10.74 10.08 4 258678 40 110330577
Jaundice cholestatic 10.70 10.08 11 258671 14597 110316020
Oral lichen planus 10.70 10.08 12 258670 915 110329702
Staphylococcal bacteraemia 10.68 10.08 14 258668 16674 110313943
Papillary renal cell carcinoma 10.68 10.08 8 258674 361 110330256
Therapy change 10.67 10.08 5 258677 9992 110320625
Renovascular hypertension 10.64 10.08 5 258677 93 110330524
Systemic candida 10.63 10.08 5 258677 9969 110320648
Endophthalmitis 10.59 10.08 3 258679 8184 110322433
Toxic encephalopathy 10.54 10.08 12 258670 15202 110315415
Device occlusion 10.50 10.08 12 258670 15173 110315444
Thinking abnormal 10.43 10.08 12 258670 15128 110315489
Mesenteric artery thrombosis 10.43 10.08 12 258670 941 110329676
Blood alkaline phosphatase 10.42 10.08 7 258675 265 110330352
Skull fracture 10.41 10.08 18 258664 2062 110328555
Vestibular migraine 10.39 10.08 6 258676 173 110330444
Bacterial infection 10.39 10.08 64 258618 45972 110284645
Skin swelling 10.38 10.08 3 258679 8077 110322540
Macular degeneration 10.31 10.08 22 258660 21637 110308980
Postoperative wound infection 10.31 10.08 13 258669 15740 110314877
Product administered to patient of inappropriate age 10.29 10.08 3 258679 8033 110322584
Nephrolithiasis 10.28 10.08 102 258580 66110 110264507
Intervertebral disc space narrowing 10.28 10.08 17 258665 1879 110328738
Rash macular 10.25 10.08 51 258631 38635 110291982
Eye disorder 10.24 10.08 34 258648 28872 110301745
White blood cell count increased 10.22 10.08 162 258520 96680 110233937
Thermal burn 10.20 10.08 3 258679 7985 110322632
Anger 10.19 10.08 18 258664 18989 110311628
Stevens-Johnson syndrome 10.17 10.08 66 258616 46835 110283782
Periorbital inflammation 10.17 10.08 7 258675 276 110330341
Intermittent claudication 10.17 10.08 25 258657 3676 110326941
Peritonitis bacterial 10.16 10.08 6 258676 10527 110320090
Eosinophilic fasciitis 10.16 10.08 8 258674 389 110330228
Pulse absent 10.12 10.08 7 258675 11285 110319332
Complication of device insertion 10.10 10.08 4 258678 8834 110321783

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C09CA06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
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 C09DX06 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX09 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C10BX19 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA MoA N0000000070 Angiotensin 2 Receptor Antagonists
FDA EPC N0000175561 Angiotensin 2 Receptor Blocker
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:61016 angiotensin receptor antagonist
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:76595 nephroprotective agent
CHEBI has role CHEBI:145947 antiatherosclerotic agent
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D047228 Angiotensin II Type 1 Receptor Blockers
MeSH PA D057911 Angiotensin Receptor Antagonists

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C09DA Angiotensin II receptor blockers (ARBs) and diuretics 8 drugs
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Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
Atrial fibrillation off-label use 49436004 DOID:0060224
Diabetic renal disease off-label use 127013003
Diastolic heart failure off-label use 418304008 DOID:9775
Nondiabetic Proteinuric Nephropathy off-label use
Anuria contraindication 2472002 DOID:2983
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
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
Oliguria contraindication 83128009
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Surgical procedure contraindication 387713003
Azotemia contraindication 445009001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.25 acidic
pKa2 3.2 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Type-1 angiotensin II receptor GPCR ANTAGONIST IC50 9.16 CHEMBL CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 5.52 CHEMBL
Alpha-2B adrenergic receptor GPCR Ki 5.76 CHEMBL
Beta-3 adrenergic receptor GPCR Ki 5.49 CHEMBL
Adenosine receptor A3 GPCR Ki 6.16 CHEMBL
ATP-binding cassette sub-family G member 2 Transporter IC50 5.30 CHEMBL
Cytochrome P450 2C9 Enzyme IC50 5.52 CHEMBL
Epidermal growth factor receptor Kinase IC50 5.48 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor EC50 5.38 CHEMBL
Receptor tyrosine-protein kinase erbB-2 Kinase IC50 5.23 CHEMBL
Thromboxane-A synthase Enzyme IC50 5.51 CHEMBL
DNA polymerase kappa Enzyme IC50 5.25 CHEMBL
DNA polymerase iota Enzyme IC50 5.21 CHEMBL
DNA polymerase eta Enzyme IC50 4.95 CHEMBL
Cytochrome P450 3A4 Enzyme IC50 5.05 CHEMBL
NEDD8-activating enzyme E1 regulatory subunit Enzyme IC50 4.78 CHEMBL
Type-1 angiotensin II receptor GPCR IC50 6.96 CHEMBL
Cruzipain Enzyme IC50 4.38 CHEMBL
Type-1 angiotensin II receptor GPCR Ki 9.19 CHEMBL

External reference:

IDSource
4021148 VUID
N0000179517 NUI
D00522 KEGG_DRUG
135481 RXNORM
C0527379 UMLSCUI
CHEBI:3348 CHEBI
CHEMBL1014 ChEMBL_ID
DB00796 DRUGBANK_ID
C077793 MESH_SUPPLEMENTAL_RECORD_UI
8352 IUPHAR_LIGAND_ID
R85M2X0D68 UNII
2540 PUBCHEM_CID
DB13919 DRUGBANK_ID
188909 MMSL
7490 MMSL
d04322 MMSL
108587008 SNOMEDCT_US
372512008 SNOMEDCT_US
386878000 SNOMEDCT_US
C0717550 UMLSCUI
CHEMBL1016 ChEMBL_ID
139481-59-7 SECONDARY_CAS_RN
2541 PUBCHEM_CID
587 IUPHAR_LIGAND_ID
7239 INN_ID
4021148 VANDF
4021151 VANDF
C081643 MESH_SUPPLEMENTAL_RECORD_UI
S8Q36MD2XX UNII
007275 NDDF
007276 NDDF
CHEBI:149509 CHEBI
R85M2X0D68 INXIGHT DRUGS
S8Q36MD2XX INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Candesartan Cilexetil and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0378-3001 TABLET 16 mg ORAL ANDA 21 sections
Candesartan Cilexetil and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0378-3002 TABLET 32 mg ORAL ANDA 21 sections
Candesartan Cilexetil and Hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 0378-3003 TABLET 32 mg ORAL ANDA 21 sections
candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-3224 TABLET 4 mg ORAL ANDA 27 sections
candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-3225 TABLET 8 mg ORAL ANDA 27 sections
candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-3231 TABLET 16 mg ORAL ANDA 27 sections
candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 0378-3232 TABLET 32 mg ORAL ANDA 27 sections
Candesartan Human Prescription Drug Label 1 33342-114 TABLET 4 mg ORAL ANDA 26 sections
Candesartan Human Prescription Drug Label 1 33342-115 TABLET 8 mg ORAL ANDA 26 sections
Candesartan Human Prescription Drug Label 1 33342-116 TABLET 16 mg ORAL ANDA 26 sections
Candesartan Human Prescription Drug Label 1 33342-117 TABLET 32 mg ORAL ANDA 26 sections
Candesartan Cilexetil and Hydrochlorothiazide Human Prescription Drug Label 2 33342-131 TABLET 16 mg ORAL ANDA 19 sections
Candesartan Cilexetil and Hydrochlorothiazide Human Prescription Drug Label 2 33342-132 TABLET 32 mg ORAL ANDA 19 sections
Candesartan Cilexetil and Hydrochlorothiazide Human Prescription Drug Label 2 33342-133 TABLET 32 mg ORAL ANDA 19 sections
candesartan cilexetil and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 43547-459 TABLET 16 mg ORAL ANDA 22 sections
candesartan cilexetil and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 43547-460 TABLET 32 mg ORAL ANDA 22 sections
candesartan cilexetil and hydrochlorothiazide HUMAN PRESCRIPTION DRUG LABEL 2 43547-461 TABLET 32 mg ORAL ANDA 22 sections
CANDESARTAN CILEXETIL Human Prescription Drug Label 1 46708-060 TABLET 32 mg ORAL ANDA 27 sections
CANDESARTAN CILEXETIL Human Prescription Drug Label 1 46708-341 TABLET 4 mg ORAL ANDA 28 sections
CANDESARTAN CILEXETIL Human Prescription Drug Label 1 46708-342 TABLET 8 mg ORAL ANDA 28 sections
CANDESARTAN CILEXETIL Human Prescription Drug Label 1 46708-343 TABLET 16 mg ORAL ANDA 28 sections
Candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 51407-882 TABLET 4 mg ORAL NDA authorized generic 26 sections
Candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 51407-883 TABLET 8 mg ORAL NDA authorized generic 26 sections
Candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 51407-884 TABLET 16 mg ORAL NDA authorized generic 26 sections
Candesartan cilexetil HUMAN PRESCRIPTION DRUG LABEL 1 51407-885 TABLET 32 mg ORAL NDA authorized generic 26 sections
ATACAND HUMAN PRESCRIPTION DRUG LABEL 1 54868-4413 TABLET 16 mg ORAL NDA 27 sections
ATACAND HUMAN PRESCRIPTION DRUG LABEL 1 54868-4612 TABLET 32 mg ORAL NDA 27 sections
ATACAND HCT HUMAN PRESCRIPTION DRUG LABEL 2 54868-4729 TABLET 16 mg ORAL NDA 22 sections
ATACAND HCT HUMAN PRESCRIPTION DRUG LABEL 2 54868-4869 TABLET 32 mg ORAL NDA 22 sections
ATACAND HUMAN PRESCRIPTION DRUG LABEL 1 54868-5489 TABLET 8 mg ORAL NDA 27 sections