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

Stem definitionDrug idCAS RN
antiulcer, benzimidazole derivatives 2054 102625-70-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pantoprazole
  • pantozol
  • pantoprazole sodium
  • controloc control
  • pantoprazole sodium hydrate
  • pantoprazole sodium sesquihydrate
Pantoprazole sodium is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours.
  • Molecular weight: 383.37
  • Formula: C16H15F2N3O4S
  • CLOGP: 2.11
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 86.33
  • ALOGS: -2.89
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
40 mg O
40 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.74 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.17 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.20 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.90 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 2, 2000 FDA WYETH PHARMS INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
General physical health deterioration 749.76 9.93 3156 477469 166854 55644588
Toxicity to various agents 545.57 9.93 669 479956 223895 55587547
Chronic kidney disease 544.81 9.93 1147 479478 40909 55770533
Completed suicide 522.79 9.93 244 480381 133589 55677853
Drug ineffective 399.10 9.93 5497 475128 913492 54897950
Folliculitis 344.97 9.93 1144 479481 53835 55757607
Muscle injury 338.88 9.93 1103 479522 51397 55760045
Irritable bowel syndrome 309.13 9.93 1281 479344 67177 55744265
Exposure during pregnancy 293.64 9.93 443 480182 135899 55675543
Haematochezia 275.41 9.93 911 479714 42807 55768635
Lower respiratory tract infection 241.15 9.93 1743 478882 113051 55698391
Impaired healing 233.68 9.93 1403 479222 85438 55726004
Sleep disorder due to general medical condition, insomnia type 230.52 9.93 854 479771 42484 55768958
Product prescribing error 220.42 9.93 560 480065 22626 55788816
Death 199.89 9.93 1907 478718 339519 55471923
Acute kidney injury 199.86 9.93 3024 477601 237739 55573703
Device expulsion 193.97 9.93 18 480607 30431 55781011
Abdominal pain upper 185.51 9.93 2332 478293 175981 55635461
Injection site pain 183.86 9.93 459 480166 116659 55694783
Injection site erythema 180.24 9.93 238 480387 77210 55734232
Stomatitis 178.33 9.93 1694 478931 119116 55692326
Anaemia 175.69 9.93 3234 477391 264277 55547165
Blister 172.39 9.93 1550 479075 107337 55704105
Gastrointestinal disorder 171.18 9.93 1590 479035 111112 55700330
Off label use 170.68 9.93 3539 477086 552641 55258801
End stage renal disease 169.37 9.93 234 480391 5877 55805565
Peripheral swelling 168.08 9.93 2877 477748 231849 55579593
Renal injury 162.82 9.93 281 480344 8606 55802836
Ill-defined disorder 162.34 9.93 1072 479553 67471 55743971
Abortion spontaneous 161.34 9.93 86 480539 43667 55767775
Intentional overdose 159.86 9.93 208 480417 67909 55743533
Injection site reaction 158.26 9.93 133 480492 53114 55758328
Dyspnoea 153.90 9.93 6350 474275 586227 55225215
Hyponatraemia 152.10 9.93 1435 479190 100704 55710738
Hypomagnesaemia 151.08 9.93 514 480111 24501 55786941
Drug hypersensitivity 140.90 9.93 1586 479039 273619 55537823
Maternal exposure during pregnancy 140.28 9.93 994 479631 188559 55622883
Muscle spasticity 138.46 9.93 430 480195 19530 55791912
Confusional state 136.74 9.93 2517 478108 205638 55605804
Treatment failure 135.31 9.93 875 479750 169517 55641925
Rheumatoid arthritis 126.61 9.93 2403 478222 380201 55431241
Systemic infection 116.93 9.93 142 480483 3127 55808315
Drug abuse 116.50 9.93 252 480373 67358 55744084
Sinusitis 114.76 9.93 2345 478280 195236 55616206
Wrong technique in product usage process 112.12 9.93 203 480422 57965 55753477
Night sweats 109.62 9.93 664 479961 40549 55770893
Ear pain 109.36 9.93 538 480087 30352 55781090
Product dose omission issue 109.10 9.93 1169 479456 203584 55607858
Asthenia 108.25 9.93 3757 476868 339216 55472226
Body temperature increased 107.72 9.93 577 480048 33665 55777777
Injection site swelling 104.38 9.93 131 480494 43447 55767995
Labelled drug-drug interaction medication error 103.09 9.93 273 480352 11313 55800129
Pruritus 100.80 9.93 3472 477153 313151 55498291
Abdominal pain 99.95 9.93 2905 477720 255900 55555542
Product monitoring error 98.20 9.93 134 480491 3325 55808117
Orthostatic intolerance 95.08 9.93 77 480548 1012 55810430
Haematemesis 94.86 9.93 491 480134 28267 55783175
Tubulointerstitial nephritis 94.18 9.93 335 480290 16330 55795112
Injection site pruritus 89.46 9.93 137 480488 41794 55769648
Hepatic function abnormal 83.70 9.93 103 480522 34455 55776987
Therapeutic product effect incomplete 81.34 9.93 550 480075 105481 55705961
Subacute cutaneous lupus erythematosus 80.73 9.93 100 480525 2249 55809193
Hypokalaemia 80.44 9.93 1192 479433 93245 55718197
Melaena 77.27 9.93 459 480166 27831 55783611
Sedation complication 76.81 9.93 6 480619 11666 55799776
Foetal exposure during pregnancy 76.58 9.93 106 480519 33717 55777725
No adverse event 76.49 9.93 120 480505 36254 55775188
Accidental exposure to product 76.43 9.93 59 480566 24588 55786854
Overdose 73.41 9.93 565 480060 105265 55706177
Drug resistance 73.38 9.93 42 480583 20500 55790942
Premature delivery 72.82 9.93 74 480551 26986 55784456
Weight increased 72.54 9.93 2517 478108 227186 55584256
Hypocalcaemia 72.47 9.93 457 480168 28303 55783139
Cardio-respiratory arrest 71.26 9.93 238 480387 55083 55756359
Drug intolerance 70.92 9.93 1720 478905 263098 55548344
Respiratory disorder 69.15 9.93 512 480113 33445 55777997
Agranulocytosis 68.69 9.93 378 480247 22281 55789161
Seizure 68.35 9.93 710 479915 124409 55687033
Pyrexia 65.23 9.93 4277 476348 414496 55396946
Respiratory arrest 64.43 9.93 101 480524 30524 55780918
Neuropathy peripheral 63.34 9.93 567 480058 102326 55709116
Sedation 63.33 9.93 126 480499 34728 55776714
Suicidal ideation 62.93 9.93 266 480359 57476 55753966
Liver injury 62.27 9.93 588 480037 41260 55770182
Infection 62.24 9.93 2190 478435 198016 55613426
Therapeutic response decreased 61.30 9.93 237 480388 52521 55758921
Injection site bruising 61.16 9.93 150 480475 38371 55773071
Disease progression 61.11 9.93 588 480037 104585 55706857
Alopecia 59.49 9.93 1981 478644 291477 55519965
Product use in unapproved indication 59.45 9.93 845 479780 139977 55671465
Gastrointestinal haemorrhage 59.04 9.93 944 479681 75007 55736435
Gastritis 56.93 9.93 498 480127 34204 55777238
Depression 56.75 9.93 1140 479485 178977 55632465
Eosinophilia 55.64 9.93 327 480298 19750 55791692
Foetal death 54.89 9.93 5 480620 8582 55802860
Contusion 52.93 9.93 1454 479171 126976 55684466
Breast cancer 52.57 9.93 226 480399 48607 55762835
Anaphylactic reaction 52.54 9.93 292 480333 58703 55752739
Renal failure 51.64 9.93 1272 479353 109228 55702214
Drug dependence 51.63 9.93 70 480555 22463 55788979
Helicobacter infection 51.56 9.93 896 479729 72372 55739070
Coma 51.12 9.93 299 480326 59356 55752086
Hypoaesthesia 50.62 9.93 876 479749 140615 55670827
Malaise 49.99 9.93 2599 478026 365261 55446181
Faecaloma 49.49 9.93 158 480467 7283 55804159
Gastrooesophageal reflux disease 48.86 9.93 990 479635 82267 55729175
Pallor 48.53 9.93 363 480262 23786 55787656
Suicide attempt 48.44 9.93 292 480333 57544 55753898
Leukopenia 47.95 9.93 862 479763 70078 55741364
Intentional self-injury 47.45 9.93 88 480537 24904 55786538
Caesarean section 46.82 9.93 41 480584 16050 55795392
White blood cell count decreased 46.38 9.93 776 479849 125214 55686228
Hypertensive nephropathy 45.03 9.93 37 480588 497 55810945
Rebound acid hypersecretion 44.96 9.93 30 480595 286 55811156
Blood loss anaemia 44.52 9.93 164 480461 8133 55803309
Feeling abnormal 44.07 9.93 839 479786 132763 55678679
Electrolyte imbalance 43.86 9.93 284 480341 17749 55793693
Myelosuppression 43.35 9.93 51 480574 17404 55794038
Intentional product misuse 43.15 9.93 260 480365 51244 55760198
Vomiting 42.60 9.93 4867 475758 493361 55318081
Irritability 42.57 9.93 121 480504 29467 55781975
Drug reaction with eosinophilia and systemic symptoms 42.23 9.93 420 480205 29884 55781558
Psoriasis 42.06 9.93 548 480077 92144 55719298
Injection site warmth 41.79 9.93 36 480589 14207 55797235
Breast cancer female 41.59 9.93 27 480598 12311 55799131
Lung diffusion test abnormal 41.56 9.93 27 480598 245 55811197
Stillbirth 41.44 9.93 3 480622 6211 55805231
Duodenal ulcer perforation 41.22 9.93 816 479809 67526 55743916
Flushing 41.10 9.93 391 480234 69709 55741733
Dystonia 40.77 9.93 28 480597 12393 55799049
Adverse drug reaction 40.03 9.93 359 480266 64773 55746669
Therapeutic drug monitoring analysis not performed 39.82 9.93 46 480579 959 55810483
Pneumonia viral 39.68 9.93 143 480482 7015 55804427
Genital haemorrhage 38.92 9.93 6 480619 6856 55804586
Nasopharyngitis 38.60 9.93 2280 478345 218679 55592763
Device difficult to use 38.44 9.93 22 480603 10739 55800703
Product quality issue 37.23 9.93 142 480483 31594 55779848
Pre-eclampsia 37.12 9.93 13 480612 8473 55802969
Balance disorder 37.11 9.93 446 480179 76074 55735368
Neutropenic sepsis 37.04 9.93 45 480580 15140 55796302
Premature baby 37.02 9.93 67 480558 19138 55792304
Platelet count decreased 36.97 9.93 662 479963 105721 55705721
Cellulitis 36.67 9.93 436 480189 74513 55736929
Injection site haemorrhage 36.39 9.93 85 480540 22116 55789326
Musculoskeletal stiffness 35.73 9.93 1036 479589 154971 55656471
Cholestasis 35.58 9.93 369 480256 26544 55784898
Clostridium test positive 35.58 9.93 71 480554 2434 55809008
Neutrophil count decreased 35.47 9.93 264 480361 49558 55761884
Joint injury 35.39 9.93 107 480518 25547 55785895
Angina pectoris 35.31 9.93 380 480245 27596 55783846
Polyneuropathy 35.16 9.93 211 480414 12839 55798603
Injection site rash 34.66 9.93 57 480568 16901 55794541
Device issue 34.44 9.93 81 480544 21025 55790417
Hyperkinesia 34.28 9.93 55 480570 1584 55809858
Cardiac arrest 33.62 9.93 526 480099 85788 55725654
Dyspepsia 33.53 9.93 942 479683 82529 55728913
Joint stiffness 33.39 9.93 172 480453 35253 55776189
Loss of personal independence in daily activities 33.36 9.93 491 480134 80878 55730564
Mycotic allergy 33.05 9.93 38 480587 788 55810654
Haematoma 32.47 9.93 417 480208 31602 55779840
Hypoparathyroidism secondary 32.35 9.93 13 480612 35 55811407
Sleep disorder 32.23 9.93 781 479844 66882 55744560
Haemoglobin decreased 32.20 9.93 1427 479198 132710 55678732
Drug ineffective for unapproved indication 32.09 9.93 112 480513 25581 55785861
Cachexia 32.02 9.93 104 480521 4838 55806604
Eructation 31.90 9.93 139 480486 7449 55803993
Musculoskeletal disorder 31.63 9.93 73 480552 19074 55792368
Product storage error 31.35 9.93 40 480585 13173 55798269
Bursitis 31.34 9.93 367 480258 27215 55784227
Gestational diabetes 31.00 9.93 15 480610 8049 55803393
Gastroenteritis clostridial 30.59 9.93 31 480594 554 55810888
Somnolence 30.55 9.93 1114 479511 162299 55649143
Breath sounds abnormal 30.55 9.93 155 480470 8852 55802590
Anxiety 30.49 9.93 1343 479282 191829 55619613
Device use error 30.43 9.93 5 480620 5451 55805991
Soft tissue disorder 30.39 9.93 93 480532 4189 55807253
Restlessness 30.32 9.93 354 480271 26232 55785210
Device dislocation 29.98 9.93 96 480529 22510 55788932
Vision blurred 29.82 9.93 513 480112 82430 55729012
Product used for unknown indication 29.70 9.93 35 480590 746 55810696
Painful respiration 29.60 9.93 66 480559 2448 55808994
Enthesopathy 29.50 9.93 16 480609 8047 55803395
Blood pressure systolic increased 29.30 9.93 501 480124 40335 55771107
Abnormal behaviour 29.09 9.93 83 480542 20189 55791253
Dehydration 28.89 9.93 1645 478980 157180 55654262
Depressed level of consciousness 28.88 9.93 325 480300 56108 55755334
Drug withdrawal syndrome 28.86 9.93 118 480507 25739 55785703
Diabetic nephropathy 28.84 9.93 46 480579 1318 55810124
Pain in jaw 28.57 9.93 212 480413 39824 55771618
Therapy non-responder 28.47 9.93 361 480264 60994 55750448
Uterine perforation 28.40 9.93 10 480615 6495 55804947
Red blood cell sedimentation rate increased 28.05 9.93 190 480435 36433 55775009
Injection site urticaria 28.01 9.93 41 480584 12742 55798700
Drug eruption 27.87 9.93 119 480506 25644 55785798
Abortion induced 27.55 9.93 25 480600 9620 55801822
Dyspnoea exertional 27.49 9.93 636 479989 54053 55757389
Hypochromic anaemia 27.20 9.93 53 480572 1785 55809657
Renal impairment 27.08 9.93 891 479734 79822 55731620
Abdominal pain lower 27.01 9.93 309 480316 22783 55788659
Oesophagitis 26.96 9.93 209 480416 13848 55797594
Mydriasis 26.80 9.93 33 480592 11038 55800404
Fear of injection 26.80 9.93 11 480614 6504 55804938
Treatment noncompliance 26.64 9.93 166 480459 32457 55778985
Trimethylaminuria 26.60 9.93 16 480609 125 55811317
Hepatitis cholestatic 26.59 9.93 117 480508 6297 55805145
Temperature regulation disorder 26.27 9.93 91 480534 4377 55807065
Acute abdomen 26.16 9.93 46 480579 1430 55810012
Glomerulonephropathy 26.15 9.93 14 480611 85 55811357
Febrile infection 25.80 9.93 44 480581 1334 55810108
Substance abuse 25.57 9.93 4 480621 4521 55806921
Headache 25.35 9.93 4292 476333 554752 55256690
Premature rupture of membranes 25.20 9.93 5 480620 4760 55806682
Gastric ulcer 25.10 9.93 299 480326 22264 55789178
Product use issue 24.90 9.93 1316 479309 184725 55626717
Blood parathyroid hormone decreased 24.71 9.93 21 480604 8343 55803099
Hiatus hernia 24.37 9.93 266 480359 19386 55792056
Heavy menstrual bleeding 24.28 9.93 65 480560 16144 55795298
Food allergy 23.98 9.93 143 480482 8681 55802761
Duodenitis 23.83 9.93 74 480551 3360 55808082
Dysphoria 23.76 9.93 6 480619 4836 55806606
Poisoning deliberate 23.75 9.93 30 480595 9923 55801519
Disseminated intravascular coagulation 23.68 9.93 76 480549 17809 55793633
Nephrogenic anaemia 23.57 9.93 51 480574 1853 55809589
Clostridium difficile colitis 23.41 9.93 254 480371 18484 55792958
Hypertensive crisis 23.31 9.93 202 480423 13834 55797608
Device malfunction 23.20 9.93 66 480559 16070 55795372
Complication of device insertion 23.14 9.93 13 480612 6411 55805031
Serotonin syndrome 23.10 9.93 132 480493 26358 55785084
Granuloma skin 23.00 9.93 16 480609 7035 55804407
Brain contusion 22.92 9.93 26 480599 531 55810911
Wheelchair user 22.86 9.93 9 480616 5457 55805985
Gastrointestinal toxicity 22.84 9.93 12 480613 6144 55805298
Joint swelling 22.70 9.93 2816 477809 286984 55524458
Body temperature decreased 22.41 9.93 245 480380 17863 55793579
Atrial fibrillation 22.41 9.93 1141 479484 107756 55703686
Pancreatic steatosis 22.35 9.93 34 480591 934 55810508
Neuroleptic malignant syndrome 22.16 9.93 40 480585 11438 55800004
Colitis erosive 22.13 9.93 12 480613 75 55811367
Gamma-glutamyltransferase increased 22.10 9.93 380 480245 30625 55780817
Coagulation test abnormal 22.07 9.93 29 480596 693 55810749
Low birth weight baby 22.06 9.93 13 480612 6245 55805197
Multiple sclerosis relapse 22.04 9.93 261 480364 44642 55766800
Urosepsis 22.01 9.93 229 480396 16487 55794955
Spinal pain 21.86 9.93 175 480450 11709 55799733
Hyperkalaemia 21.83 9.93 579 480046 50286 55761156
Device breakage 21.79 9.93 33 480592 10114 55801328
Normal newborn 21.77 9.93 19 480606 7451 55803991
Cerebral ischaemia 21.68 9.93 107 480518 6043 55805399
Pulmonary embolism 21.34 9.93 1119 479506 106005 55705437
Therapeutic drug monitoring analysis incorrectly performed 21.30 9.93 16 480609 187 55811255
Wheezing 21.16 9.93 812 479813 74214 55737228
Panniculitis 21.14 9.93 32 480593 9810 55801632
Folate deficiency 21.12 9.93 53 480572 2124 55809318
Oesophageal dilatation 21.11 9.93 20 480605 328 55811114
Cholecystitis chronic 21.00 9.93 149 480476 9599 55801843
Haematocrit decreased 20.96 9.93 436 480189 36393 55775049
Nasal obstruction 20.91 9.93 38 480587 1213 55810229
Total lung capacity decreased 20.91 9.93 42 480583 1447 55809995
Skin disorder 20.90 9.93 135 480490 26174 55785268
Shock 20.76 9.93 105 480520 21623 55789819
Synovial fluid analysis 20.74 9.93 49 480576 1889 55809553
Injection site discolouration 20.52 9.93 19 480606 7240 55804202
Neck pain 20.45 9.93 386 480239 61169 55750273
Abdominal wall wound 20.38 9.93 11 480614 68 55811374
Gastritis erosive 20.35 9.93 98 480527 5479 55805963
Knee arthroplasty 20.31 9.93 261 480364 43998 55767444
Status epilepticus 20.28 9.93 64 480561 15077 55796365
Poisoning 20.25 9.93 50 480575 12763 55798679
Breast cancer stage II 20.24 9.93 12 480613 5746 55805696
Hepatitis acute 19.95 9.93 131 480494 8226 55803216
Dysuria 19.92 9.93 371 480254 30358 55781084
Deafness 19.87 9.93 73 480552 16421 55795021
Internal haemorrhage 19.82 9.93 87 480538 4677 55806765
Nephritis allergic 19.79 9.93 14 480611 148 55811294
Peripheral arterial occlusive disease 19.74 9.93 75 480550 3775 55807667
Iron deficiency anaemia 19.73 9.93 237 480388 17682 55793760
Medication error 19.66 9.93 487 480138 41848 55769594
Urinary tract obstruction 19.63 9.93 47 480578 1828 55809614
Spontaneous haemorrhage 19.61 9.93 18 480607 283 55811159
Surgery 19.55 9.93 180 480445 32306 55779136
Amenorrhoea 19.51 9.93 29 480596 8957 55802485
Pregnancy 19.46 9.93 184 480441 32849 55778593
Bacteriuria 19.31 9.93 31 480594 893 55810549
Adenovirus infection 19.28 9.93 3 480622 3405 55808037
Chronic gastritis 19.25 9.93 57 480568 2521 55808921
Basal cell carcinoma 19.24 9.93 131 480494 25090 55786352
Pancytopenia 19.17 9.93 934 479691 87781 55723661
Rapid eye movement sleep behaviour disorder 19.17 9.93 15 480610 187 55811255
Complication associated with device 19.11 9.93 67 480558 15283 55796159
Hepatotoxicity 19.01 9.93 172 480453 30981 55780461
Neuropathy vitamin B12 deficiency 18.86 9.93 5 480620 0 55811442
Haemorrhagic erosive gastritis 18.81 9.93 18 480607 299 55811143
Blood pressure diastolic abnormal 18.79 9.93 166 480459 11432 55800010
Tenosynovitis stenosans 18.77 9.93 57 480568 2557 55808885
Cardiac failure 18.74 9.93 869 479756 81224 55730218
Flatulence 18.66 9.93 373 480252 30915 55780527
Pharyngeal dystonia 18.52 9.93 6 480619 6 55811436
Thrombocytopenia 18.44 9.93 1376 479249 134848 55676594
Discontinued product administered 18.36 9.93 9 480616 44 55811398
Blood calcium decreased 18.36 9.93 123 480502 23646 55787796
Epstein-Barr virus infection 18.33 9.93 22 480603 7441 55804001
Somatic symptom disorder 18.27 9.93 49 480576 2046 55809396
Sopor 18.16 9.93 265 480360 20657 55790785
Multiple sclerosis 18.08 9.93 151 480474 27651 55783791
Hepatic cyst 18.06 9.93 85 480540 4708 55806734
Fall 18.03 9.93 3389 477236 354121 55457321
Rib deformity 17.98 9.93 15 480610 206 55811236
Injection site mass 17.90 9.93 78 480547 16715 55794727
Complication of device removal 17.90 9.93 8 480617 4496 55806946
Gastric haemorrhage 17.86 9.93 99 480526 5851 55805591
Jaundice 17.85 9.93 330 480295 26964 55784478
Throat clearing 17.83 9.93 40 480585 1490 55809952
Cardiorenal syndrome 17.81 9.93 28 480597 792 55810650
Pathogen resistance 17.81 9.93 15 480610 5985 55805457
Troponin abnormal 17.77 9.93 8 480617 31 55811411
Akathisia 17.76 9.93 29 480596 8623 55802819
Condition aggravated 17.56 9.93 2630 477995 342268 55469174
Abnormal faeces 17.56 9.93 84 480541 4684 55806758
Obstructive airways disorder 17.49 9.93 225 480400 17057 55794385
Drug use disorder 17.47 9.93 9 480616 4660 55806782
Solar urticaria 17.45 9.93 9 480616 50 55811392
Patent ductus arteriosus 17.37 9.93 6 480619 3945 55807497
Maternal drugs affecting foetus 17.37 9.93 11 480614 5082 55806360
Paresis 17.34 9.93 51 480574 2247 55809195
Tetany 17.27 9.93 42 480583 1650 55809792
Lethargy 17.27 9.93 322 480303 51119 55760323
Acute graft versus host disease 17.25 9.93 7 480618 4168 55807274
Exposure to toxic agent 17.22 9.93 5 480620 3673 55807769
Occupational asthma 17.03 9.93 12 480613 126 55811316
Therapy partial responder 17.02 9.93 25 480600 7760 55803682
Macular degeneration 17.01 9.93 241 480384 18667 55792775
Urinary tract infection enterococcal 16.99 9.93 55 480570 2554 55808888
Pseudarthrosis 16.95 9.93 20 480605 427 55811015
Mobility decreased 16.91 9.93 682 479943 98309 55713133
Systemic lupus erythematosus 16.84 9.93 1316 479309 178762 55632680
Hepatitis B 16.83 9.93 5 480620 3619 55807823
Device deployment issue 16.83 9.93 5 480620 3619 55807823
Cystostomy 16.76 9.93 9 480616 55 55811387
Tachyarrhythmia 16.75 9.93 76 480549 4145 55807297
Tuberculosis 16.69 9.93 44 480581 10985 55800457
Reactive gastropathy 16.60 9.93 19 480606 392 55811050
Renal cyst 16.54 9.93 136 480489 9173 55802269
Creatinine renal clearance decreased 16.53 9.93 66 480559 14493 55796949
Sensory level abnormal 16.50 9.93 12 480613 133 55811309
Musculoskeletal pain 16.42 9.93 849 479776 80303 55731139
Underdose 16.38 9.93 127 480498 23630 55787812
Agitation 16.35 9.93 359 480266 55677 55755765
Product complaint 16.26 9.93 49 480576 11711 55799731
Arterial occlusive disease 16.23 9.93 90 480535 5320 55806122
Pulmonary tuberculosis 16.20 9.93 9 480616 4467 55806975
Haemarthrosis 16.19 9.93 60 480565 2984 55808458
Therapeutic product effect decreased 16.16 9.93 1668 478957 167784 55643658
Vaginal haemorrhage 15.99 9.93 141 480484 25532 55785910
Prerenal failure 15.97 9.93 39 480586 1536 55809906
Arterial stenosis 15.88 9.93 22 480603 554 55810888
Demyelination 15.87 9.93 18 480607 6244 55805198
Hip arthroplasty 15.84 9.93 233 480392 38390 55773052
Hepatocellular injury 15.78 9.93 316 480309 26198 55785244
Bicytopenia 15.77 9.93 47 480578 2086 55809356
Mixed liver injury 15.64 9.93 71 480554 3873 55807569
Subileus 15.63 9.93 58 480567 2886 55808556
Salpingo-oophorectomy unilateral 15.55 9.93 24 480601 668 55810774
Colorectal cancer 15.44 9.93 5 480620 3424 55808018
Cytomegalovirus infection 15.33 9.93 99 480526 19197 55792245
Faeces hard 15.33 9.93 42 480583 1776 55809666
Megacolon 15.31 9.93 41 480584 1710 55809732
Incorrect dose administered 15.23 9.93 337 480288 52210 55759232
Tongue disorder 15.22 9.93 40 480585 9996 55801446
Post procedural pulmonary embolism 15.21 9.93 15 480610 259 55811183
Carcinoid tumour of the stomach 15.18 9.93 12 480613 152 55811290
Fracture 15.16 9.93 227 480398 17791 55793651
Aortic valve stenosis 15.07 9.93 60 480565 3087 55808355
Prothrombin time shortened 14.99 9.93 41 480584 1732 55809710
Neutrophil function disorder 14.97 9.93 6 480619 16 55811426
Intermenstrual bleeding 14.95 9.93 23 480602 7004 55804438
Red blood cell count decreased 14.91 9.93 414 480211 36203 55775239
Biliary dyskinesia 14.89 9.93 52 480573 2511 55808931
Live birth 14.87 9.93 102 480523 19503 55791939
Hypomania 14.86 9.93 12 480613 4890 55806552
Diverticulum intestinal 14.80 9.93 100 480525 6340 55805102
Lipoedema 14.76 9.93 15 480610 269 55811173
Drug-induced liver injury 14.70 9.93 392 480233 34070 55777372
Suspected suicide 14.65 9.93 15 480610 5451 55805991
Polycystic ovaries 14.63 9.93 5 480620 3309 55808133
Colitis ulcerative 14.62 9.93 291 480334 24100 55787342
Osteomyelitis 14.60 9.93 135 480490 24211 55787231
Smear cervix abnormal 14.54 9.93 3 480622 2778 55808664
Stoma site discharge 14.52 9.93 35 480590 1367 55810075
Clostridium difficile infection 14.51 9.93 319 480306 26879 55784563
Hepatic vein dilatation 14.47 9.93 6 480619 18 55811424
Feeling jittery 14.46 9.93 162 480463 11884 55799558
Neutropenia 14.45 9.93 1158 479467 157009 55654433
Pseudomembranous colitis 14.43 9.93 56 480569 2847 55808595
Gastrointestinal inflammation 14.39 9.93 82 480543 4896 55806546
Lymphoproliferative disorder 14.39 9.93 4 480621 3024 55808418
Multiple-drug resistance 14.37 9.93 8 480617 3966 55807476
Dysphagia 14.36 9.93 846 479779 81101 55730341
Respiratory depression 14.35 9.93 56 480569 12379 55799063
Tooth disorder 14.35 9.93 144 480481 25409 55786033
Unevaluable event 14.35 9.93 304 480321 47383 55764059
Epigastric discomfort 14.35 9.93 97 480528 6151 55805291
Schizophrenia 14.33 9.93 44 480581 10455 55800987
Erysipelas 14.25 9.93 108 480517 7105 55804337
Thrombosis prophylaxis 14.23 9.93 6 480619 19 55811423
Cholecystitis 14.22 9.93 187 480438 14248 55797194
Pneumonia aspiration 14.19 9.93 193 480432 32218 55779224
COVID-19 14.16 9.93 511 480114 74547 55736895
Injection site induration 14.11 9.93 33 480592 8582 55802860
Toothache 14.07 9.93 92 480533 17788 55793654
Eosinophils urine present 14.00 9.93 6 480619 20 55811422
Oedema peripheral 13.90 9.93 1668 478957 169586 55641856
Hypochloraemia 13.89 9.93 39 480586 1673 55809769
Haematotoxicity 13.82 9.93 32 480593 8351 55803091
Strangury 13.79 9.93 5 480620 9 55811433
Peripheral venous disease 13.71 9.93 139 480486 9940 55801502
Vocal cord dysfunction 13.70 9.93 17 480608 383 55811059
Hypersensitivity 13.69 9.93 2438 478187 253970 55557472
Upper gastrointestinal haemorrhage 13.63 9.93 213 480412 16841 55794601
Glomerular filtration rate decreased 13.54 9.93 163 480462 12166 55799276
Intraocular pressure increased 13.53 9.93 18 480607 5823 55805619
Laboratory test abnormal 13.52 9.93 140 480485 24555 55786887
Abnormal dreams 13.49 9.93 40 480585 9609 55801833
Gastrointestinal complication associated with device 13.45 9.93 5 480620 10 55811432
Infusion site pain 13.44 9.93 66 480559 13696 55797746
Nephropathy 13.43 9.93 88 480537 5521 55805921
Skin necrosis 13.43 9.93 57 480568 12304 55799138
Drug tolerance 13.35 9.93 19 480606 5975 55805467
Pemphigus 13.31 9.93 1158 479467 156054 55655388
Pharyngitis 13.30 9.93 98 480527 18440 55793002
Monoparesis 13.17 9.93 36 480589 1520 55809922
Product administered to patient of inappropriate age 13.10 9.93 4 480621 2844 55808598
Neurotoxicity 13.09 9.93 80 480545 15715 55795727
Abdominal discomfort 13.03 9.93 2124 478501 275150 55536292
Presyncope 13.01 9.93 298 480327 25284 55786158
Clostridium colitis 12.97 9.93 39 480586 1740 55809702
Ischaemic stroke 12.95 9.93 209 480416 16633 55794809
Facet joint syndrome 12.95 9.93 100 480525 6617 55804825
Hyperplastic cholecystopathy 12.89 9.93 9 480616 93 55811349
Foot operation 12.87 9.93 21 480604 6246 55805196
Incorrect dosage administered 12.81 9.93 39 480586 1752 55809690
Poor venous access 12.79 9.93 161 480464 12145 55799297
Mood swings 12.77 9.93 87 480538 16660 55794782
Psychotic disorder 12.72 9.93 134 480491 23424 55788018
Injection site irritation 12.67 9.93 12 480613 4524 55806918
Foot deformity 12.67 9.93 136 480489 23689 55787753
Adverse event 12.60 9.93 368 480257 55008 55756434
Iron deficiency 12.55 9.93 94 480531 6162 55805280
Alanine aminotransferase abnormal 12.55 9.93 11 480614 4304 55807138
Stress 12.53 9.93 395 480230 58515 55752927
Type I hypersensitivity 12.48 9.93 48 480577 2430 55809012
Atelectasis 12.47 9.93 233 480392 19075 55792367
Hypergastrinaemia 12.43 9.93 9 480616 99 55811343
Pancreatitis 12.26 9.93 486 480139 44594 55766848
Inappropriate antidiuretic hormone secretion 12.24 9.93 175 480450 13581 55797861
Myocardial infarction 12.21 9.93 658 479967 92212 55719230
Retroperitoneal haematoma 12.21 9.93 51 480574 2682 55808760
Arterial haemorrhage 12.20 9.93 36 480589 1589 55809853
Premature labour 12.18 9.93 56 480569 11826 55799616
Rhabdomyolysis 12.17 9.93 443 480182 40215 55771227
Productive cough 12.14 9.93 592 480033 55640 55755802
Renal haemangioma 12.14 9.93 6 480619 30 55811412
Graft versus host disease in skin 12.10 9.93 4 480621 2703 55808739
Non-economic loss 12.06 9.93 5 480620 15 55811427
Nightmare 12.05 9.93 89 480536 16737 55794705
Orthostatic hypotension 12.03 9.93 205 480420 32994 55778448
Loss of consciousness 12.02 9.93 788 479837 108561 55702881
Shock haemorrhagic 12.01 9.93 124 480501 8909 55802533
Sexual dysfunction 12.00 9.93 7 480618 3381 55808061
Diarrhoea 11.99 9.93 5815 474810 632692 55178750
Acute generalised exanthematous pustulosis 11.97 9.93 133 480492 9736 55801706
Waist circumference increased 11.96 9.93 23 480602 767 55810675
Skin test positive 11.94 9.93 21 480604 653 55810789
Blood iron abnormal 11.92 9.93 7 480618 3370 55808072
Swelling face 11.92 9.93 376 480249 55693 55755749
Pulmonary renal syndrome 11.91 9.93 16 480609 391 55811051
Flank pain 11.87 9.93 180 480445 14145 55797297
Bradycardia 11.84 9.93 697 479928 66807 55744635
Spigelian hernia 11.83 9.93 6 480619 32 55811410
Neurosensory hypoacusis 11.82 9.93 12 480613 215 55811227
Syncope 11.77 9.93 1075 479550 107124 55704318
Metabolic surgery 11.77 9.93 29 480596 1149 55810293
Femoral hernia incarcerated 11.74 9.93 23 480602 778 55810664
White blood cell count abnormal 11.73 9.93 20 480605 5847 55805595
Lip dry 11.69 9.93 131 480494 9609 55801833
Tachypnoea 11.69 9.93 191 480434 15239 55796203
Cytomegalovirus viraemia 11.63 9.93 16 480609 5104 55806338
Cushingoid 11.61 9.93 105 480520 7279 55804163
Renal atrophy 11.57 9.93 32 480593 1361 55810081
Natural killer cell count decreased 11.54 9.93 6 480619 34 55811408
Rectal haemorrhage 11.50 9.93 448 480177 41019 55770423
Glomerulonephritis chronic 11.49 9.93 10 480615 146 55811296
Coeliac disease 11.49 9.93 137 480488 10202 55801240
Carotid arteriosclerosis 11.49 9.93 26 480599 974 55810468
Tardive dyskinesia 11.44 9.93 33 480592 7998 55803444
Administration site discomfort 11.43 9.93 8 480617 83 55811359
Gastroenteritis salmonella 11.41 9.93 20 480605 620 55810822
Enterochromaffin cell hyperplasia 11.40 9.93 7 480618 57 55811385
Hyperchlorhydria 11.39 9.93 35 480590 1580 55809862
Lipase increased 11.35 9.93 122 480503 8857 55802585
Rheumatoid factor positive 11.32 9.93 478 480147 68582 55742860
Low density lipoprotein 11.32 9.93 3 480622 0 55811442
Adenocarcinoma of appendix 11.32 9.93 3 480622 0 55811442
Vascular access site complication 11.32 9.93 3 480622 0 55811442
Automatism epileptic 11.32 9.93 3 480622 0 55811442
Blood pressure ambulatory abnormal 11.32 9.93 3 480622 0 55811442
Speech rehabilitation 11.32 9.93 3 480622 0 55811442
Anaesthesia oral 11.32 9.93 3 480622 0 55811442
Faeces discoloured 11.29 9.93 206 480419 16790 55794652
Cerebellar ataxia 11.26 9.93 24 480601 863 55810579
Dissociation 11.24 9.93 4 480621 2581 55808861
Duodenal polyp 11.19 9.93 9 480616 117 55811325
Deep vein thrombosis 11.17 9.93 782 479843 76195 55735247
Bone lesion 11.12 9.93 82 480543 5348 55806094
Interstitial lung disease 11.11 9.93 387 480238 56676 55754766
Cholangitis acute 11.10 9.93 17 480608 470 55810972
Blood pressure diastolic decreased 11.07 9.93 229 480396 19094 55792348
Blood pressure systolic abnormal 11.07 9.93 130 480495 9647 55801795
Sacroiliitis 11.06 9.93 50 480575 2722 55808720
Carcinoid tumour 11.06 9.93 15 480610 370 55811072
Hyperprolactinaemia 11.05 9.93 9 480616 3652 55807790
Nephritis 11.04 9.93 44 480581 2265 55809177
Vaccination site reaction 11.01 9.93 9 480616 120 55811322
Heart rate 10.91 9.93 7 480618 62 55811380
Gait deviation 10.91 9.93 7 480618 62 55811380
Mucormycosis 10.91 9.93 5 480620 2769 55808673
Rapid correction of hyponatraemia 10.89 9.93 9 480616 122 55811320
Paralysis 10.86 9.93 40 480585 8992 55802450
Alkalosis 10.83 9.93 14 480611 329 55811113
Lymphatic fistula 10.83 9.93 22 480603 764 55810678
Bacterial test 10.80 9.93 28 480597 1145 55810297
Paradoxical drug reaction 10.79 9.93 10 480615 3810 55807632
Myeloblast percentage decreased 10.63 9.93 6 480619 41 55811401
Gastrointestinal vascular malformation haemorrhagic 10.62 9.93 11 480614 202 55811240
Wound infection fungal 10.59 9.93 9 480616 127 55811315
Emphysema 10.57 9.93 131 480494 9845 55801597
Hepatic steatosis 10.56 9.93 296 480329 25918 55785524
Pain in extremity 10.56 9.93 2312 478313 295119 55516323
Total lung capacity abnormal 10.55 9.93 7 480618 66 55811376
Petit mal epilepsy 10.55 9.93 9 480616 3569 55807873
Extrapyramidal disorder 10.54 9.93 62 480563 12294 55799148
Hospitalisation 10.50 9.93 528 480097 74472 55736970
Vitamin B12 decreased 10.49 9.93 53 480572 3022 55808420
Dermatitis atopic 10.48 9.93 36 480589 8263 55803179
Gastritis fungal 10.47 9.93 8 480617 96 55811346
Dermatitis acneiform 10.46 9.93 13 480612 4331 55807111
Stenosis 10.45 9.93 30 480595 1304 55810138
Hepatic enzyme increased 10.41 9.93 1641 478984 169743 55641699
Gastrointestinal wall thickening 10.41 9.93 28 480597 1171 55810271
Squamous cell carcinoma of the oral cavity 10.41 9.93 13 480612 295 55811147
Incorrect product administration duration 10.38 9.93 49 480576 10277 55801165
N-terminal prohormone brain natriuretic peptide increased 10.38 9.93 37 480588 1805 55809637
Pneumocystis jirovecii pneumonia 10.33 9.93 85 480540 15616 55795826
Crepitations 10.32 9.93 98 480527 6886 55804556
Dysentery 10.32 9.93 22 480603 791 55810651
Anuria 10.22 9.93 149 480476 11611 55799831
Uterine cancer 10.17 9.93 14 480611 4465 55806977
Wound treatment 10.17 9.93 10 480615 172 55811270
Ear infection 10.16 9.93 197 480428 31098 55780344
Blood glucose increased 10.15 9.93 531 480094 74620 55736822
Labelled drug-food interaction medication error 10.15 9.93 9 480616 135 55811307
Fear 10.14 9.93 80 480545 14828 55796614
Palmar-plantar erythrodysaesthesia syndrome 10.12 9.93 123 480502 20942 55790500
Thrombosis 10.12 9.93 612 480013 58815 55752627
Toxic nodular goitre 10.11 9.93 5 480620 25 55811417
Limb deformity 10.09 9.93 11 480614 3884 55807558
Psoriatic arthropathy 10.08 9.93 748 479877 73260 55738182
Spontaneous haematoma 10.08 9.93 22 480603 804 55810638
Stoma site inflammation 10.08 9.93 15 480610 404 55811038
Pericarditis 10.07 9.93 1070 479555 107853 55703589
Anal polyp 10.07 9.93 6 480619 46 55811396
Influenza like illness 10.02 9.93 422 480203 60566 55750876
Vascular stent stenosis 9.98 9.93 17 480608 515 55810927
Acquired diaphragmatic eventration 9.97 9.93 15 480610 408 55811034

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
General physical health deterioration 928.95 10.98 2635 275758 110800 31308151
Toxicity to various agents 501.49 10.98 513 277880 180974 31237977
Drug ineffective 468.29 10.98 1842 276551 393731 31025220
Completed suicide 411.21 10.98 145 278248 91369 31327582
Chronic kidney disease 324.53 10.98 897 277496 37078 31381873
Drug abuse 284.39 10.98 213 278180 87545 31331406
Hypomagnesaemia 255.45 10.98 536 277857 18522 31400429
Product prescribing error 220.98 10.98 515 277878 19127 31399824
Haematochezia 201.62 10.98 796 277597 39668 31379283
Anaemia 200.02 10.98 2802 275591 210720 31208231
Systemic infection 196.59 10.98 194 278199 3255 31415696
Hypocalcaemia 144.10 10.98 473 277920 21505 31397446
Death 143.50 10.98 2267 276126 358302 31060649
End stage renal disease 120.42 10.98 238 278155 7871 31411080
Foetal exposure during pregnancy 107.61 10.98 120 278273 40756 31378195
Hepatic function abnormal 105.28 10.98 124 278269 41098 31377853
Dyspnoea 104.80 10.98 3841 274552 339638 31079313
Product monitoring error 103.58 10.98 136 278257 3154 31415797
Electrolyte imbalance 94.98 10.98 278 278115 11870 31407081
Intentional overdose 94.88 10.98 135 278258 41254 31377697
Acute kidney injury 92.63 10.98 3158 275235 276556 31142395
Off label use 92.46 10.98 2334 276059 344940 31074011
Cholestasis 91.17 10.98 449 277944 24626 31394325
Renal injury 91.11 10.98 252 278141 10413 31408538
Overdose 87.93 10.98 413 277980 84251 31334700
Intentional product misuse 79.12 10.98 132 278261 37819 31381132
Abdominal pain upper 77.63 10.98 882 277511 63120 31355831
Drug resistance 77.09 10.98 56 278337 23397 31395554
Treatment failure 76.88 10.98 151 278242 40641 31378310
Melaena 76.32 10.98 520 277873 32134 31386817
Hypokalaemia 76.03 10.98 762 277631 52812 31366139
Haematemesis 73.95 10.98 431 277962 25222 31393729
Gastrooesophageal reflux disease 73.09 10.98 529 277864 33342 31385609
Abdominal pain lower 72.25 10.98 212 278181 9064 31409887
Syncope 70.46 10.98 1095 277298 84087 31334864
Abdominal pain 66.43 10.98 1715 276678 144237 31274714
Oedema peripheral 66.28 10.98 1343 277050 108496 31310455
Neuropathy peripheral 63.10 10.98 397 277996 75252 31343699
Respiratory arrest 62.83 10.98 83 278310 26174 31392777
Product dose omission issue 60.77 10.98 613 277780 104973 31313978
Blood loss anaemia 57.82 10.98 174 278219 7545 31411406
Agranulocytosis 57.41 10.98 351 278042 20896 31398055
Cardiac arrest 57.26 10.98 503 277890 88559 31330392
Dyspnoea at rest 55.30 10.98 106 278287 3425 31415526
Hypoparathyroidism 55.09 10.98 43 278350 518 31418433
Product use in unapproved indication 54.91 10.98 581 277812 98590 31320361
Premature baby 54.51 10.98 47 278346 18019 31400932
Irritability 54.11 10.98 73 278320 22816 31396135
Atrial fibrillation 53.80 10.98 1344 277049 112439 31306512
Erysipelas 53.69 10.98 121 278272 4392 31414559
Diastolic dysfunction 52.62 10.98 133 278260 5202 31413749
Normocytic anaemia 51.49 10.98 76 278317 1973 31416978
Abnormal behaviour 50.48 10.98 82 278311 23746 31395205
Pallor 49.98 10.98 353 278040 22071 31396880
Febrile infection 48.28 10.98 74 278319 1988 31416963
Acute abdomen 46.99 10.98 68 278325 1733 31417218
Gastrointestinal haemorrhage 46.71 10.98 1000 277393 81549 31337402
Hepatitis cholestatic 46.11 10.98 153 278240 6993 31411958
Prostate cancer 46.09 10.98 172 278221 37429 31381522
Lower respiratory tract infection 45.43 10.98 114 278279 28123 31390828
Psychotic disorder 45.12 10.98 79 278314 22214 31396737
Musculoskeletal pain 45.11 10.98 430 277963 29398 31389553
Shock haemorrhagic 44.20 10.98 192 278201 9985 31408966
Type I hypersensitivity 44.13 10.98 52 278341 1076 31417875
Cardio-respiratory arrest 43.87 10.98 270 278123 51456 31367495
Cytomegalovirus infection 43.55 10.98 95 278298 24612 31394339
Suicide attempt 43.33 10.98 174 278219 37074 31381877
Drug ineffective for unapproved indication 42.80 10.98 56 278337 17734 31401217
Labelled drug-drug interaction medication error 42.47 10.98 228 278165 12935 31406016
Infective exacerbation of chronic obstructive airways disease 42.41 10.98 63 278330 1645 31417306
Sedation 42.33 10.98 63 278330 18902 31400049
Asthenia 41.94 10.98 2393 276000 222362 31196589
Feeling abnormal 41.64 10.98 311 278082 56691 31362260
Neutrophil count decreased 41.55 10.98 238 278155 46156 31372795
Therapeutic drug monitoring analysis not performed 41.44 10.98 35 278358 475 31418476
Occult blood 41.40 10.98 39 278354 616 31418335
Right atrial hypertrophy 40.91 10.98 38 278355 589 31418362
Hypoparathyroidism secondary 40.40 10.98 21 278372 115 31418836
Agitation 40.31 10.98 294 278099 53875 31365076
Immune reconstitution inflammatory syndrome 40.19 10.98 11 278382 8167 31410784
Seizure 39.50 10.98 627 277766 99141 31319810
Synovitis 39.50 10.98 30 278363 12253 31406698
Benign prostatic hyperplasia 38.79 10.98 222 278171 12903 31406048
Dyspnoea exertional 38.74 10.98 516 277877 38321 31380630
Suicidal ideation 38.71 10.98 176 278217 36230 31382721
Pathogen resistance 38.67 10.98 14 278379 8687 31410264
Aggression 38.63 10.98 182 278211 37109 31381842
Rectal haemorrhage 38.59 10.98 488 277905 35816 31383135
Disease progression 37.69 10.98 563 277830 89901 31329050
Insomnia 37.55 10.98 596 277797 94240 31324711
Platelet count decreased 37.02 10.98 715 277678 109720 31309231
Gastrointestinal bacterial overgrowth 36.74 10.98 18 278375 85 31418866
Aortic valve stenosis 36.57 10.98 72 278321 2374 31416577
Helicobacter gastritis 36.52 10.98 49 278344 1161 31417790
Injection site pain 36.48 10.98 168 278225 34466 31384485
Bronchial wall thickening 35.98 10.98 48 278345 1131 31417820
Leukopenia 35.81 10.98 710 277683 57118 31361833
Rash maculo-papular 35.59 10.98 364 278029 25355 31393596
Psoriasis 35.52 10.98 252 278141 46467 31372484
Mucosal haemorrhage 35.25 10.98 55 278338 1501 31417450
Tricuspid valve incompetence 34.91 10.98 162 278231 8667 31410284
C-reactive protein increased 34.87 10.98 611 277782 48039 31370912
Drug reaction with eosinophilia and systemic symptoms 34.72 10.98 410 277983 29608 31389343
Exposure during pregnancy 34.69 10.98 16 278377 8582 31410369
Malaise 34.48 10.98 1173 277220 167338 31251613
Rash 34.26 10.98 1434 276959 200052 31218899
Hypertensive nephropathy 34.13 10.98 30 278363 431 31418520
Haematoma 34.06 10.98 343 278050 23796 31395155
Bronchial secretion retention 33.80 10.98 49 278344 1251 31417700
Gastritis 33.44 10.98 298 278095 19994 31398957
Visual acuity reduced 33.25 10.98 52 278341 15291 31403660
Dizziness 33.10 10.98 2099 276294 197048 31221903
Adjustment disorder 32.40 10.98 45 278348 1103 31417848
Stomatitis 32.33 10.98 208 278185 39230 31379721
Drug withdrawal syndrome 32.31 10.98 73 278320 18677 31400274
Therapy partial responder 31.93 10.98 9 278384 6553 31412398
Cardiac failure 31.79 10.98 984 277409 84969 31333982
Serotonin syndrome 31.61 10.98 74 278319 18699 31400252
Low birth weight baby 31.34 10.98 11 278382 6959 31411992
Interstitial lung disease 31.09 10.98 367 278026 61036 31357915
Acute graft versus host disease 30.76 10.98 8 278385 6145 31412806
Drug hypersensitivity 29.83 10.98 453 277940 72146 31346805
Urogenital haemorrhage 29.68 10.98 31 278362 558 31418393
Therapy non-responder 29.44 10.98 175 278218 33636 31385315
Upper gastrointestinal haemorrhage 29.22 10.98 322 278071 22861 31396090
Nephrogenic anaemia 29.16 10.98 60 278333 2043 31416908
Tachyarrhythmia 29.13 10.98 78 278315 3161 31415790
Intentional self-injury 28.98 10.98 45 278348 13270 31405681
Rheumatoid arthritis 28.97 10.98 274 278119 47535 31371416
Solar lentigo 28.60 10.98 28 278365 465 31418486
Cerebral infarction 28.57 10.98 124 278269 25853 31393098
Hyperlipasaemia 28.08 10.98 28 278365 476 31418475
Chronic graft versus host disease 27.92 10.98 3 278390 4389 31414562
Wrong technique in product usage process 27.77 10.98 175 278218 33168 31385783
Therapeutic response decreased 27.67 10.98 129 278264 26380 31392571
Angina pectoris 27.59 10.98 389 278004 29252 31389699
Bladder cancer 27.31 10.98 55 278338 14670 31404281
Dysplastic naevus 27.21 10.98 27 278366 456 31418495
Bronchiectasis 27.02 10.98 135 278258 7445 31411506
Injection site haemorrhage 26.97 10.98 24 278369 9061 31409890
Pulmonary function test abnormal 26.93 10.98 60 278333 2161 31416790
Fracture 26.90 10.98 118 278275 6162 31412789
Subileus 26.88 10.98 72 278321 2918 31416033
Accidental exposure to product 26.83 10.98 37 278356 11458 31407493
Post transplant lymphoproliferative disorder 26.62 10.98 10 278383 6066 31412885
Vertigo 26.56 10.98 315 278078 22770 31396181
Haematoma muscle 26.43 10.98 42 278351 1165 31417786
Joint swelling 26.42 10.98 321 278072 53110 31365841
Eosinophilia 26.19 10.98 316 278077 22937 31396014
Right ventricular hypertrophy 26.15 10.98 43 278350 1228 31417723
Serum ferritin decreased 26.00 10.98 29 278364 564 31418387
Photodermatosis 25.94 10.98 27 278366 484 31418467
Diverticulum intestinal 25.85 10.98 80 278313 3523 31415428
Troponin increased 25.62 10.98 163 278230 9839 31409112
Rhinitis perennial 25.61 10.98 22 278371 306 31418645
Arrhythmia 25.36 10.98 420 277973 32657 31386294
Aortic valve incompetence 25.19 10.98 106 278287 5435 31413516
Injection site erythema 25.16 10.98 56 278337 14406 31404545
Accidental overdose 25.15 10.98 80 278313 18270 31400681
Tetanus 25.12 10.98 12 278381 53 31418898
Full blood count abnormal 24.88 10.98 236 278157 16111 31402840
Product use issue 24.76 10.98 350 278043 56409 31362542
Blood pressure fluctuation 24.75 10.98 307 278086 22429 31396522
Mitral valve incompetence 24.64 10.98 209 278184 13824 31405127
Congenital hiatus hernia 24.58 10.98 28 278365 558 31418393
Thrombocytopenia 24.50 10.98 1509 276884 141238 31277713
Lower gastrointestinal haemorrhage 24.40 10.98 145 278248 8544 31410407
Hepatocellular injury 24.36 10.98 293 278100 21251 31397700
Hypersensitivity 24.22 10.98 344 278049 55399 31363552
Carotid arteriosclerosis 24.21 10.98 50 278343 1707 31417244
Vitamin B12 deficiency 24.20 10.98 77 278316 3442 31415509
Hydrocholecystis 23.99 10.98 21 278372 300 31418651
Body temperature decreased 23.77 10.98 181 278212 11589 31407362
Liver disorder 23.68 10.98 158 278235 29549 31389402
Extrapyramidal disorder 23.59 10.98 42 278351 11736 31407215
Urinary hesitation 23.51 10.98 60 278333 2361 31416590
Presyncope 23.38 10.98 244 278149 17084 31401867
Renal cyst 23.34 10.98 140 278253 8276 31410675
Withdrawal syndrome 23.28 10.98 42 278351 11675 31407276
Psoriatic arthropathy 23.05 10.98 93 278300 19790 31399161
Myelosuppression 22.65 10.98 62 278331 14858 31404093
Glomerular filtration rate decreased 22.60 10.98 180 278213 11685 31407266
Ventricular arrhythmia 22.57 10.98 94 278299 4797 31414154
Enthesopathy 22.56 10.98 5 278388 4282 31414669
Fluid intake reduced 22.52 10.98 71 278322 3158 31415793
Occupational dermatitis 22.48 10.98 12 278381 70 31418881
Respiratory tract haemorrhage 22.43 10.98 38 278355 1113 31417838
Drug use disorder 22.31 10.98 4 278389 3979 31414972
Therapeutic product effect incomplete 22.18 10.98 261 278132 43435 31375516
Gastrointestinal angiodysplasia 22.17 10.98 27 278366 579 31418372
Anaphylactic reaction 22.17 10.98 160 278233 29393 31389558
Anger 22.14 10.98 40 278353 11113 31407838
Rebound acid hypersecretion 22.09 10.98 13 278380 94 31418857
Injection site swelling 22.04 10.98 34 278359 10053 31408898
Electrocardiogram Q wave abnormal 22.01 10.98 22 278371 375 31418576
Systolic dysfunction 22.00 10.98 58 278335 2328 31416623
Depression 22.00 10.98 618 277775 90197 31328754
Urticaria 21.91 10.98 364 278029 57153 31361798
Oesophageal carcinoma 21.78 10.98 23 278370 8010 31410941
Degenerative mitral valve disease 21.63 10.98 17 278376 207 31418744
Tetany 21.50 10.98 28 278365 644 31418307
Lactic acidosis 21.43 10.98 397 277996 31540 31387411
Flushing 21.23 10.98 166 278227 29962 31388989
Bronchopulmonary aspergillosis 21.19 10.98 56 278337 13578 31405373
Biliary cirrhosis 21.12 10.98 13 278380 103 31418848
Fear of disease 20.85 10.98 19 278374 287 31418664
Hyponatraemia 20.81 10.98 819 277574 72980 31345971
Osteochondrosis 20.79 10.98 32 278361 863 31418088
No adverse event 20.78 10.98 95 278298 19530 31399421
Product storage error 20.57 10.98 19 278374 7047 31411904
Gastritis erosive 20.51 10.98 101 278292 5538 31413413
Gamma-glutamyltransferase increased 20.48 10.98 351 278042 27474 31391477
Mood swings 20.41 10.98 21 278372 7403 31411548
Victim of child abuse 20.33 10.98 32 278361 880 31418071
Neuroleptic malignant syndrome 20.12 10.98 78 278315 16791 31402160
Poisoning 19.97 10.98 38 278355 10353 31408598
Thrombotic microangiopathy 19.97 10.98 32 278361 9319 31409632
Obstruction 19.84 10.98 52 278341 2080 31416871
Colitis microscopic 19.71 10.98 50 278343 1960 31416991
Cytomegalovirus viraemia 19.68 10.98 18 278375 6707 31412244
Syringe issue 19.65 10.98 9 278384 4847 31414104
Weight decreased 19.55 10.98 1645 276748 158307 31260644
Cardiac failure congestive 19.54 10.98 539 277854 78848 31340103
Acute graft versus host disease in skin 19.48 10.98 9 278384 4823 31414128
Nicotine dependence 19.48 10.98 23 278370 477 31418474
Flatulence 19.41 10.98 253 278140 18695 31400256
Apparent death 19.39 10.98 4 278389 3601 31415350
Chest X-ray abnormal 19.37 10.98 79 278314 3994 31414957
Discontinued product administered 19.32 10.98 7 278386 12 31418939
Cardiotoxicity 19.30 10.98 10 278383 5017 31413934
Injection site bruising 19.29 10.98 25 278368 7950 31411001
Memory impairment 19.25 10.98 228 278165 37902 31381049
Therapeutic product effect decreased 19.25 10.98 181 278212 31441 31387510
Mean cell haemoglobin decreased 19.17 10.98 41 278352 1435 31417516
Fall 19.14 10.98 1890 276503 184199 31234752
Chest injury 19.06 10.98 41 278352 1441 31417510
Pancreatic enzyme abnormality 19.06 10.98 10 278383 56 31418895
Foetal malformation 19.06 10.98 13 278380 125 31418826
Mania 19.04 10.98 32 278361 9145 31409806
N-terminal prohormone brain natriuretic peptide increased 19.04 10.98 52 278341 2132 31416819
Device leakage 19.02 10.98 12 278381 5401 31413550
Serum ferritin abnormal 19.01 10.98 16 278377 216 31418735
Iron deficiency anaemia 18.94 10.98 144 278249 9215 31409736
Hiatus hernia 18.91 10.98 115 278278 6832 31412119
Altered state of consciousness 18.84 10.98 108 278285 20943 31398008
Hepatojugular reflux 18.83 10.98 24 278369 540 31418411
Cold sweat 18.81 10.98 142 278251 9067 31409884
Blood pressure diastolic abnormal 18.78 10.98 77 278316 3902 31415049
Haematotoxicity 18.72 10.98 21 278372 7116 31411835
Drug dependence 18.55 10.98 119 278274 22460 31396491
Autoimmune colitis 18.39 10.98 32 278361 958 31417993
Polyneuropathy 18.35 10.98 185 278208 12837 31406114
Gastrointestinal pain 18.20 10.98 60 278333 2733 31416218
White blood cell count decreased 18.16 10.98 607 277786 86791 31332160
Pulmonary valve disease 18.14 10.98 18 278375 304 31418647
Erectile dysfunction 18.13 10.98 97 278296 19138 31399813
Pericardial disease 18.05 10.98 20 278373 386 31418565
Hyperkinesia 17.87 10.98 43 278350 1630 31417321
Status epilepticus 17.86 10.98 51 278342 12055 31406896
Graft versus host disease 17.73 10.98 41 278352 10406 31408545
Miosis 17.68 10.98 30 278363 8540 31410411
Peripheral arterial occlusive disease 17.63 10.98 93 278300 5240 31413711
Tendonitis 17.61 10.98 30 278363 8528 31410423
Dermatitis infected 17.58 10.98 11 278382 90 31418861
Drug screen false positive 17.56 10.98 26 278367 677 31418274
Cerebellar ischaemia 17.54 10.98 12 278381 116 31418835
Disseminated intravascular coagulation 17.51 10.98 107 278286 20430 31398521
Jaundice 17.46 10.98 368 278025 29919 31389032
Sexual dysfunction 17.43 10.98 16 278377 5952 31412999
SARS-CoV-2 antibody test positive 17.42 10.98 19 278374 360 31418591
Treatment noncompliance 17.41 10.98 143 278250 25541 31393410
Microcytic anaemia 17.40 10.98 49 278344 2046 31416905
Lethargy 17.30 10.98 237 278156 38404 31380547
Left ventricular hypertrophy 17.26 10.98 117 278276 7215 31411736
Phalangeal hypoplasia 17.26 10.98 10 278383 70 31418881
Sleep disorder due to a general medical condition 17.24 10.98 74 278319 3828 31415123
Bronchial obstruction 17.21 10.98 39 278354 1421 31417530
Pruritus allergic 17.09 10.98 15 278378 215 31418736
Paresis 17.02 10.98 47 278346 1940 31417011
Drug eruption 16.98 10.98 92 278301 18095 31400856
Chronic kidney disease-mineral and bone disorder 16.82 10.98 19 278374 375 31418576
Urosepsis 16.75 10.98 167 278226 11553 31407398
Gravitational oedema 16.66 10.98 24 278369 609 31418342
Dysuria 16.65 10.98 303 278090 23991 31394960
Alanine aminotransferase abnormal 16.61 10.98 7 278386 3960 31414991
Abdominal wall haemorrhage 16.56 10.98 20 278373 425 31418526
Underdose 16.56 10.98 56 278337 12551 31406400
Mean cell haemoglobin concentration 16.46 10.98 8 278385 37 31418914
Hyperreflexia 16.44 10.98 3 278390 2946 31416005
Cardiac aneurysm 16.41 10.98 28 278365 825 31418126
Somnolence 16.39 10.98 710 277683 98735 31320216
Abnormal faeces 16.37 10.98 60 278333 2884 31416067
Saliva altered 16.36 10.98 13 278380 161 31418790
Jugular vein distension 16.26 10.98 24 278369 623 31418328
Rectal prolapse 16.24 10.98 20 278373 434 31418517
Subacute cutaneous lupus erythematosus 16.05 10.98 29 278364 895 31418056
Drug abuser 16 10.98 7 278386 3873 31415078
Cachexia 15.98 10.98 107 278286 6572 31412379
Device dependence 15.97 10.98 8 278385 40 31418911
Nightmare 15.88 10.98 54 278339 12083 31406868
Perihepatic abscess 15.77 10.98 10 278383 84 31418867
Base excess decreased 15.77 10.98 14 278379 204 31418747
Productive cough 15.76 10.98 396 277997 33144 31385807
Substance abuse 15.76 10.98 24 278369 7134 31411817
Hallucination 15.67 10.98 300 278093 46110 31372841
Procalcitonin abnormal 15.59 10.98 18 278375 364 31418587
COVID-19 pneumonia 15.59 10.98 175 278218 12480 31406471
Dysentery 15.57 10.98 15 278378 244 31418707
Bicytopenia 15.56 10.98 47 278346 2042 31416909
Alveolar lung disease 15.56 10.98 18 278375 365 31418586
Bradyarrhythmia 15.53 10.98 47 278346 2044 31416907
Aortic dilatation 15.51 10.98 34 278359 1211 31417740
Abnormal dreams 15.49 10.98 24 278369 7084 31411867
Hyperparathyroidism secondary 15.41 10.98 38 278355 1463 31417488
Immature granulocyte count increased 15.37 10.98 11 278382 115 31418836
Intraductal papillary mucinous neoplasm 15.29 10.98 21 278372 509 31418442
Electrocardiogram QT prolonged 15.14 10.98 439 277954 37548 31381403
Injection site reaction 15.13 10.98 52 278341 11599 31407352
Thrombophlebitis 15.13 10.98 59 278334 2921 31416030
Activated partial thromboplastin time shortened 15.13 10.98 20 278373 467 31418484
Stenosis 15.11 10.98 33 278360 1172 31417779
Mucormycosis 15.04 10.98 16 278377 5554 31413397
Duodenogastric reflux 14.98 10.98 4 278389 0 31418951
Uveitis 14.87 10.98 23 278370 6793 31412158
Hypercholesterolaemia 14.85 10.98 121 278272 7909 31411042
Reversible airways obstruction 14.80 10.98 17 278376 342 31418609
Vision blurred 14.76 10.98 269 278124 41646 31377305
Tuberculosis 14.76 10.98 32 278361 8309 31410642
Procalcitonin increased 14.75 10.98 40 278353 1633 31417318
Drug intolerance 14.75 10.98 346 278047 51687 31367264
Faeces pale 14.75 10.98 34 278359 1253 31417698
Eosinophilic pneumonia 14.67 10.98 60 278333 3037 31415914
Impaired work ability 14.66 10.98 18 278375 5859 31413092
Hypertrophy 14.62 10.98 19 278374 436 31418515
Burns second degree 14.61 10.98 17 278376 347 31418604
Incorrect route of product administration 14.56 10.98 53 278340 11620 31407331
Dehydration 14.55 10.98 1225 277168 117886 31301065
Pulpitis dental 14.53 10.98 18 278375 393 31418558
Injection site phlebitis 14.46 10.98 7 278386 32 31418919
Disinhibition 14.46 10.98 3 278390 2690 31416261
Generalised tonic-clonic seizure 14.42 10.98 109 278284 19822 31399129
Appendicitis 14.34 10.98 52 278341 11413 31407538
Adverse event 14.26 10.98 87 278306 16618 31402333
Product quality issue 14.23 10.98 83 278310 16028 31402923
Hypertransaminasaemia 14.19 10.98 75 278318 4229 31414722
Mastitis 14.14 10.98 12 278381 164 31418787
Dependence on oxygen therapy 14.13 10.98 13 278380 199 31418752
Lichenoid keratosis 14.03 10.98 49 278344 2299 31416652
Benign gastrointestinal neoplasm 13.99 10.98 11 278382 134 31418817
Poisoning deliberate 13.99 10.98 27 278366 7317 31411634
Intestinal angioedema 13.97 10.98 13 278380 202 31418749
Anxiety 13.97 10.98 655 277738 90378 31328573
Headache 13.97 10.98 1406 276987 182246 31236705
Peripheral venous disease 13.84 10.98 50 278343 2386 31416565
Physical examination abnormal 13.77 10.98 15 278378 284 31418667
Cellulitis 13.69 10.98 319 278074 47699 31371252
Activated partial thromboplastin time prolonged 13.66 10.98 121 278272 8104 31410847
Osteonecrosis 13.66 10.98 69 278324 13815 31405136
Renal cyst haemorrhage 13.65 10.98 21 278372 566 31418385
Shock 13.62 10.98 130 278263 22515 31396436
Dermatosis 13.60 10.98 15 278378 288 31418663
Periarthritis calcarea 13.59 10.98 9 278384 82 31418869
Internal fixation of fracture 13.59 10.98 9 278384 82 31418869
Pancreatitis acute 13.47 10.98 307 278086 25293 31393658
Stress 13.43 10.98 147 278246 24794 31394157
Upper motor neurone lesion 13.33 10.98 10 278383 113 31418838
Articular calcification 13.33 10.98 9 278384 85 31418866
Puncture site haematoma 13.22 10.98 11 278382 146 31418805
Actinic keratosis 13.22 10.98 72 278321 4107 31414844
Bone marrow failure 13.19 10.98 170 278223 27838 31391113
Blindness 13.14 10.98 61 278332 12490 31406461
Renal cancer 13.14 10.98 30 278363 7649 31411302
Fatigue 13.14 10.98 3225 275168 331981 31086970
Unintentional medical device removal 13.14 10.98 3 278390 2517 31416434
Paranoia 13.11 10.98 48 278345 10507 31408444
Device issue 13.07 10.98 35 278358 8449 31410502
Urinary straining 13 10.98 5 278388 11 31418940
Myelocyte count increased 13.00 10.98 16 278377 347 31418604
Hallucination, auditory 12.95 10.98 47 278346 10313 31408638
Stoma site discharge 12.91 10.98 27 278366 930 31418021
Epidural lipomatosis 12.85 10.98 24 278369 760 31418191
Phlebitis infective 12.84 10.98 10 278383 120 31418831
Haematuria 12.82 10.98 513 277880 45801 31373150
Vasculitis 12.79 10.98 123 278270 8427 31410524
Fibrin D dimer increased 12.73 10.98 62 278331 3384 31415567
Granulomatous dermatitis 12.67 10.98 13 278380 229 31418722
Left ventricular enlargement 12.66 10.98 22 278371 658 31418293
Taste disorder 12.62 10.98 89 278304 5561 31413390
Paranasal sinus discomfort 12.61 10.98 23 278370 715 31418236
Exercise tolerance decreased 12.61 10.98 77 278316 4581 31414370
Nasal oedema 12.59 10.98 15 278378 314 31418637
Blood pressure increased 12.58 10.98 836 277557 78797 31340154
Vitamin D decreased 12.57 10.98 57 278336 3020 31415931
Symmetrical drug-related intertriginous and flexural exanthema 12.56 10.98 14 278379 272 31418679
Rhythm idioventricular 12.56 10.98 14 278379 272 31418679
Neoplasm malignant 12.56 10.98 106 278287 18825 31400126
Cough 12.53 10.98 1360 277033 133454 31285497
Obstructive airways disorder 12.52 10.98 168 278225 12496 31406455
Blood iron decreased 12.36 10.98 77 278316 4613 31414338
Rales 12.30 10.98 123 278270 8516 31410435
Alanine aminotransferase increased 12.30 10.98 533 277860 74123 31344828
Xyphoid retraction 12.30 10.98 11 278382 162 31418789
Hypovolaemic shock 12.29 10.98 98 278295 6364 31412587
Pneumonia aspiration 12.27 10.98 253 278140 38473 31380478
Acute generalised exanthematous pustulosis 12.26 10.98 93 278300 5947 31413004
Arteriosclerotic gangrene 12.25 10.98 8 278385 71 31418880
Confabulation 12.25 10.98 10 278383 129 31418822
Electrocardiogram abnormal 12.22 10.98 116 278277 7920 31411031
Myocardial infarction 12.18 10.98 845 277548 112609 31306342
Sinusitis 12.15 10.98 238 278155 36458 31382493
Leptospirosis 12.14 10.98 6 278387 29 31418922
Soft tissue haemorrhage 12.13 10.98 10 278383 131 31418820
Painful respiration 12.05 10.98 30 278363 1162 31417789
Anaemia macrocytic 12.05 10.98 54 278339 2846 31416105
Forced expiratory volume decreased 12.05 10.98 55 278338 2922 31416029
Blood pressure systolic increased 12.03 10.98 239 278154 19231 31399720
Nasal polyps 12.02 10.98 42 278351 1971 31416980
Nocardiosis 12.02 10.98 8 278385 3499 31415452
Prolonged expiration 11.97 10.98 11 278382 168 31418783
Dysmorphism 11.96 10.98 6 278387 3066 31415885
Nuchal rigidity 11.95 10.98 18 278375 476 31418475
Vena cava injury 11.94 10.98 14 278379 288 31418663
Pneumonia cytomegaloviral 11.94 10.98 5 278388 2839 31416112
Leptotrichia infection 11.89 10.98 8 278385 75 31418876
Haemoglobin decreased 11.80 10.98 1146 277247 111529 31307422
Blood pressure systolic abnormal 11.73 10.98 56 278337 3031 31415920
Anaemia of malignant disease 11.73 10.98 17 278376 434 31418517
Haemorrhoids 11.72 10.98 163 278230 12219 31406732
Vascular compression 11.72 10.98 15 278378 339 31418612
Mood altered 11.71 10.98 36 278357 8310 31410641
Splenic thrombosis 11.68 10.98 5 278388 16 31418935
Peripheral paralysis 11.67 10.98 6 278387 32 31418919
Clostridium difficile infection 11.66 10.98 215 278178 17064 31401887
Occupational exposure to air contaminants 11.65 10.98 10 278383 139 31418812
Vascular access site occlusion 11.63 10.98 7 278386 53 31418898
Device malfunction 11.60 10.98 42 278351 9224 31409727
Arteriovenous fistula 11.57 10.98 27 278366 1003 31417948
Pancreatic duct stenosis 11.56 10.98 11 278382 176 31418775
Tobacco abuse 11.56 10.98 16 278377 391 31418560
Vascular anastomotic haemorrhage 11.53 10.98 13 278380 256 31418695
Cytomegalovirus chorioretinitis 11.51 10.98 8 278385 3420 31415531
Lymph node calcification 11.47 10.98 10 278383 142 31418809
Varicose vein 11.44 10.98 29 278364 1136 31417815
Angioedema 11.44 10.98 217 278176 33401 31385550
Foetal growth restriction 11.42 10.98 10 278383 3805 31415146
Carotid artery stenosis 11.41 10.98 75 278318 4577 31414374
Hypochromic anaemia 11.38 10.98 23 278370 773 31418178
Graft versus host disease in skin 11.29 10.98 9 278384 3588 31415363
Hospitalisation 11.28 10.98 342 278051 49465 31369486
Wound haemorrhage 11.27 10.98 39 278354 1821 31417130
Hypergammaglobulinaemia 11.27 10.98 12 278381 221 31418730
Organic brain syndrome 11.26 10.98 13 278380 263 31418688
Portal fibrosis 11.26 10.98 14 278379 307 31418644
Hypogammaglobulinaemia 11.25 10.98 26 278367 6601 31412350
Cardiovascular somatic symptom disorder 11.24 10.98 6 278387 35 31418916
Achlorhydria 11.23 10.98 3 278390 0 31418951
Spinal cord herniation 11.23 10.98 3 278390 0 31418951
Band neutrophil count decreased 11.23 10.98 3 278390 0 31418951
Bladder diverticulitis 11.23 10.98 3 278390 0 31418951
Fibrin D dimer 11.23 10.98 3 278390 0 31418951
Multiple sclerosis relapse 11.22 10.98 61 278332 11986 31406965
Arthritis 11.19 10.98 171 278222 27214 31391737
Acute coronary syndrome 11.17 10.98 166 278227 12623 31406328
Lung neoplasm malignant 11.16 10.98 90 278303 16140 31402811
Pulmonary tuberculosis 11.16 10.98 15 278378 4696 31414255
Schizophrenia 11.13 10.98 53 278340 10777 31408174
Granulocytopenia 11.12 10.98 23 278370 6076 31412875
Akathisia 11.11 10.98 30 278363 7223 31411728
Brain stem ischaemia 11.10 10.98 9 278384 115 31418836
Pulmonary valve incompetence 11.08 10.98 23 278370 788 31418163
Meralgia paraesthetica 11.08 10.98 10 278383 149 31418802
Pulmonary interstitial emphysema syndrome 11.08 10.98 17 278376 457 31418494
Hypertensive crisis 11.07 10.98 116 278277 8131 31410820
Bile duct stone 11.06 10.98 46 278347 2346 31416605
Polypectomy 11.05 10.98 18 278375 510 31418441
Hyperalbuminaemia 11.04 10.98 5 278388 19 31418932
Macrocytosis 11.03 10.98 25 278368 911 31418040
Myoglobin blood increased 10.98 10.98 4 278389 2473 31416478

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
General physical health deterioration 1644.18 10.15 5205 622432 230826 70069981
Toxicity to various agents 1096.36 10.15 1060 626577 381112 69919695
Completed suicide 1009.12 10.15 374 627263 226761 70074046
Drug ineffective 630.27 10.15 5312 622325 934440 69366367
Haematochezia 501.40 10.15 1605 626032 71476 70229331
Product prescribing error 458.03 10.15 1044 626593 37908 70262899
Drug abuse 387.03 10.15 439 627198 146817 70153990
Hypomagnesaemia 385.82 10.15 1005 626632 39759 70261048
Anaemia 380.77 10.15 5335 622302 398088 69902719
Chronic kidney disease 352.73 10.15 1266 626371 59791 70241016
Systemic infection 306.26 10.15 335 627302 6322 70294485
Intentional overdose 276.97 10.15 277 627360 98158 70202649
Hypocalcaemia 231.42 10.15 897 626740 43962 70256845
Exposure during pregnancy 230.95 10.15 261 627376 87456 70213351
Death 219.55 10.15 3185 624452 506876 69793931
Dyspnoea 219.40 10.15 8604 619033 761456 69539351
Abdominal pain upper 217.23 10.15 2644 624993 190958 70109849
Off label use 194.84 10.15 5048 622589 738012 69562795
Product monitoring error 193.27 10.15 268 627369 6508 70294299
Injection site pain 174.46 10.15 500 627137 117119 70183688
Injection site erythema 173.05 10.15 235 627402 72689 70228118
Hepatic function abnormal 170.76 10.15 210 627427 67786 70233021
Abdominal pain 169.03 10.15 4091 623546 338036 69962771
Acute kidney injury 165.19 10.15 5427 622210 469197 69831610
Haematemesis 162.40 10.15 857 626780 47940 70252867
Drug resistance 156.22 10.15 71 627566 38119 70262688
Overdose 156.18 10.15 872 626765 168873 70131934
Asthenia 155.63 10.15 5219 622418 452447 69848360
Folliculitis 154.48 10.15 766 626871 41804 70259003
Muscle injury 152.95 10.15 711 626926 37783 70263024
Melaena 152.19 10.15 936 626701 55419 70245388
Irritable bowel syndrome 151.74 10.15 867 626770 49983 70250824
Device expulsion 143.26 10.15 15 627622 22231 70278576
Injection site reaction 141.68 10.15 139 627498 49713 70251094
Respiratory arrest 138.15 10.15 164 627473 53769 70247038
Cardio-respiratory arrest 136.45 10.15 446 627191 100231 70200576
Hyponatraemia 135.90 10.15 2080 625557 158007 70142800
Electrolyte imbalance 134.38 10.15 532 627105 26329 70274478
Hypokalaemia 132.32 10.15 1757 625880 129431 70171376
Labelled drug-drug interaction medication error 131.47 10.15 491 627146 23636 70277171
Sleep disorder due to general medical condition, insomnia type 127.56 10.15 640 626997 35092 70265715
Agranulocytosis 127.48 10.15 698 626939 39600 70261207
Drug hypersensitivity 126.31 10.15 1601 626036 260858 70039949
Cholestasis 121.72 10.15 783 626854 47089 70253718
Impaired healing 119.23 10.15 1092 626545 73282 70227525
End stage renal disease 118.43 10.15 287 627350 10846 70289961
Product dose omission issue 118.34 10.15 1291 626346 216177 70084630
Neuropathy peripheral 117.72 10.15 650 626987 126246 70174561
Wrong technique in product usage process 116.44 10.15 273 627364 68425 70232382
Injection site swelling 116.23 10.15 126 627511 43031 70257776
Sedation 114.54 10.15 147 627490 46584 70254223
Intentional product misuse 113.92 10.15 344 627293 79251 70221556
Treatment failure 110.13 10.15 784 626853 143358 70157449
Suicide attempt 104.47 10.15 357 627280 79153 70221654
Product use in unapproved indication 104.17 10.15 1254 626383 206224 70094583
Pallor 99.80 10.15 663 626974 40311 70260496
Blood loss anaemia 95.21 10.15 313 627324 14128 70286679
Cardiac arrest 95.06 10.15 929 626708 158905 70141902
Neutrophil count decreased 91.90 10.15 403 627234 83153 70217654
Subacute cutaneous lupus erythematosus 91.52 10.15 127 627510 3086 70297721
Gastrointestinal haemorrhage 88.88 10.15 1709 625928 135699 70165108
Suicidal ideation 88.40 10.15 317 627320 69279 70231528
Gastrooesophageal reflux disease 86.40 10.15 1204 626433 89635 70211172
Accidental exposure to product 85.90 10.15 73 627564 27978 70272829
Abdominal pain lower 85.43 10.15 483 627154 27733 70273074
Abortion spontaneous 83.45 10.15 67 627570 26412 70274395
Injection site pruritus 82.69 10.15 137 627500 39073 70261734
Oedema peripheral 81.14 10.15 2616 625021 225475 70075332
Eosinophilia 81.12 10.15 623 627014 39696 70261111
Leukopenia 78.25 10.15 1352 626285 105208 70195599
Seizure 78.13 10.15 1106 626531 176856 70123951
Myelosuppression 76.84 10.15 92 627545 30053 70270754
Therapeutic drug monitoring analysis not performed 76.83 10.15 81 627556 1463 70299344
Orthostatic intolerance 76.25 10.15 86 627551 1681 70299126
Syncope 74.99 10.15 1959 625678 163750 70137057
Therapeutic response decreased 74.40 10.15 266 627371 58187 70242620
Drug reaction with eosinophilia and systemic symptoms 74.22 10.15 813 626824 57200 70243607
Maternal exposure during pregnancy 73.91 10.15 658 626979 114687 70186120
Therapeutic product effect incomplete 73.30 10.15 692 626945 119190 70181617
Rheumatoid arthritis 73.02 10.15 1994 625643 289811 70010996
Night sweats 71.83 10.15 645 626992 43039 70257768
Musculoskeletal pain 71.44 10.15 1160 626477 89167 70211640
Injection site bruising 71.18 10.15 143 627494 37889 70262918
Hepatitis cholestatic 71.07 10.15 260 627377 12390 70288417
Anaphylactic reaction 68.99 10.15 385 627252 74589 70226218
Acute abdomen 68.77 10.15 105 627532 2789 70298018
Abnormal behaviour 68.01 10.15 127 627510 34582 70266225
Hypoparathyroidism secondary 67.62 10.15 34 627603 170 70300637
Malaise 67.22 10.15 3138 624499 429794 69871013
Drug ineffective for unapproved indication 67.03 10.15 151 627486 38387 70262420
Renal injury 66.69 10.15 301 627336 15793 70285014
Atrial fibrillation 65.97 10.15 2116 625521 182232 70118575
Drug intolerance 65.95 10.15 1507 626130 224180 70076627
White blood cell count decreased 65.93 10.15 1083 626554 169058 70131749
Febrile infection 65.85 10.15 107 627530 3002 70297805
Platelet count decreased 65.63 10.15 1145 626492 177077 70123730
Helicobacter infection 64.02 10.15 764 626873 54892 70245915
Disease progression 63.80 10.15 988 626649 155684 70145123
Gastritis 62.72 10.15 637 627000 43954 70256853
Intentional self-injury 61.84 10.15 116 627521 31534 70269273
Irritability 61.54 10.15 156 627481 38069 70262738
Enthesopathy 59.21 10.15 12 627625 10857 70289950
Post transplant lymphoproliferative disorder 58.80 10.15 11 627626 10534 70290273
Sedation complication 57.93 10.15 23 627614 13387 70287420
Injection site haemorrhage 57.82 10.15 85 627552 25442 70275365
Angina pectoris 57.79 10.15 669 626968 47714 70253093
Premature delivery 57.58 10.15 62 627575 21242 70279565
Cytomegalovirus infection 57.47 10.15 171 627466 39587 70261220
Hypoparathyroidism 57.36 10.15 57 627580 957 70299850
Feeling abnormal 56.09 10.15 903 626734 141416 70159391
Cellulitis 55.08 10.15 584 627053 98344 70202463
Haematoma 54.53 10.15 662 626975 47756 70253051
Drug dependence 54.32 10.15 160 627477 37161 70263646
Flushing 54.30 10.15 465 627172 81707 70219100
Ill-defined disorder 54.26 10.15 731 626906 54010 70246797
Depression 53.88 10.15 1344 626293 197630 70103177
Gastrointestinal disorder 53.52 10.15 1266 626371 104161 70196646
Tubulointerstitial nephritis 53.17 10.15 486 627151 32590 70268217
Diastolic dysfunction 53.09 10.15 194 627443 9239 70291568
Muscle spasticity 52.50 10.15 326 627311 19363 70281444
Serotonin syndrome 51.39 10.15 195 627442 41919 70258888
Acute graft versus host disease 51.18 10.15 11 627626 9551 70291256
Pathogen resistance 50.80 10.15 27 627610 13252 70287555
Blister 50.68 10.15 1206 626431 99320 70201487
Fracture 50.56 10.15 326 627311 19618 70281189
Duodenal ulcer perforation 50.44 10.15 682 626955 50430 70250377
Shock haemorrhagic 50.31 10.15 303 627334 17803 70283004
Prostate cancer 49.54 10.15 128 627509 31035 70269772
Dehydration 49.38 10.15 2461 625176 223681 70077126
Peripheral swelling 49.12 10.15 2562 625075 234001 70066806
Unintentional medical device removal 48.01 10.15 4 627633 7120 70293687
Dyspnoea exertional 47.17 10.15 965 626672 77465 70223342
Drug eruption 46.83 10.15 185 627452 39311 70261496
Confusional state 46.40 10.15 3014 624623 281384 70019423
Rectal haemorrhage 46.08 10.15 829 626808 65002 70235805
Mydriasis 45.94 10.15 45 627592 16108 70284699
Product use issue 45.89 10.15 1226 626411 178711 70122096
Psoriasis 45.59 10.15 605 627032 97828 70202979
Poisoning 45.01 10.15 82 627555 22540 70278267
Aortic valve stenosis 44.61 10.15 120 627517 4839 70295968
Drug use disorder 44.40 10.15 9 627628 8142 70292665
Haemoglobin decreased 44.23 10.15 2230 625407 202929 70097878
Therapy partial responder 43.98 10.15 28 627609 12446 70288361
Hypoaesthesia 43.93 10.15 1030 626607 152709 70148098
Therapy non-responder 43.65 10.15 452 627185 76463 70224344
Coma 43.46 10.15 562 627075 91282 70209525
Lower respiratory tract infection 43.31 10.15 1297 626340 110616 70190191
Ear pain 43.09 10.15 403 627234 27196 70273611
Cachexia 42.41 10.15 187 627450 9713 70291094
Injection site warmth 42.31 10.15 36 627601 13789 70287018
Fall 42.12 10.15 4517 623120 439579 69861228
Hypertensive nephropathy 41.98 10.15 45 627592 829 70299978
Product storage error 41.94 10.15 40 627597 14501 70286306
Device use error 41.89 10.15 5 627632 6691 70294116
Helicobacter gastritis 41.52 10.15 75 627562 2296 70298511
Body temperature decreased 41.48 10.15 412 627225 28260 70272547
Polyneuropathy 40.92 10.15 327 627310 21088 70279719
Adverse drug reaction 40.78 10.15 290 627347 53054 70247753
Dyspnoea at rest 40.73 10.15 143 627494 6676 70294131
Breast cancer female 40.59 10.15 21 627616 10465 70290342
Right atrial hypertrophy 40.51 10.15 38 627599 592 70300215
No adverse event 40.46 10.15 147 627490 32006 70268801
Breath sounds abnormal 40.39 10.15 227 627410 13004 70287803
Agitation 40.35 10.15 582 627055 92793 70208014
Device issue 40.28 10.15 96 627541 23929 70276878
Psychotic disorder 40.14 10.15 184 627453 37517 70263290
Hepatocellular injury 39.88 10.15 601 627036 45490 70255317
Somnolence 39.84 10.15 1532 626105 214074 70086733
Shock 39.73 10.15 203 627434 40222 70260585
Aggression 39.71 10.15 258 627379 48188 70252619
Neuroleptic malignant syndrome 39.69 10.15 109 627528 25898 70274909
Status epilepticus 39.55 10.15 100 627537 24426 70276381
Poisoning deliberate 39.44 10.15 56 627581 17004 70283803
Benign prostatic hyperplasia 39.37 10.15 190 627447 10253 70290554
Interstitial lung disease 39.34 10.15 670 626967 104015 70196792
Lung diffusion test abnormal 38.99 10.15 26 627611 238 70300569
Bladder cancer 38.48 10.15 58 627579 17184 70283623
Erysipelas 38.46 10.15 182 627455 9742 70291065
Caesarean section 38.32 10.15 28 627609 11579 70289228
Multiple-drug resistance 38.28 10.15 9 627628 7346 70293461
Tachyarrhythmia 38.26 10.15 134 627503 6248 70294559
Normocytic anaemia 37.99 10.15 93 627544 3537 70297270
Pre-eclampsia 37.84 10.15 6 627631 6479 70294328
Drug withdrawal syndrome 37.68 10.15 155 627482 32560 70268247
Disseminated intravascular coagulation 37.57 10.15 161 627476 33437 70267370
Discontinued product administered 37.55 10.15 16 627621 50 70300757
Hyperkinesia 37.36 10.15 76 627561 2547 70298260
Rash maculo-papular 37.34 10.15 642 626995 49903 70250904
Faecaloma 37.16 10.15 187 627450 10264 70290543
Blood pressure systolic increased 36.94 10.15 712 626925 56547 70244260
Dysuria 36.90 10.15 590 627047 45204 70255603
Thrombocytopenia 36.83 10.15 2522 625115 236588 70064219
Gamma-glutamyltransferase increased 36.80 10.15 642 626995 50043 70250764
Presyncope 36.30 10.15 498 627139 36940 70263867
Gestational diabetes 36.29 10.15 5 627632 5996 70294811
Cytomegalovirus viraemia 36.28 10.15 30 627607 11655 70289152
Jaundice 36.13 10.15 634 627003 49474 70251333
Infective exacerbation of chronic obstructive airways disease 36.05 10.15 73 627564 2438 70298369
Device difficult to use 36.04 10.15 26 627611 10823 70289984
Gastrointestinal bacterial overgrowth 35.45 10.15 30 627607 405 70300402
Upper gastrointestinal haemorrhage 35.32 10.15 496 627141 36981 70263826
Type I hypersensitivity 35.29 10.15 92 627545 3640 70297167
Mobility decreased 34.68 10.15 672 626965 102327 70198480
Vomiting 34.52 10.15 5859 621778 587252 69713555
Neutropenic sepsis 34.32 10.15 109 627528 24721 70276086
Vertigo 34.19 10.15 760 626877 61883 70238924
Tetany 34.13 10.15 67 627570 2187 70298620
Gastrointestinal pain 33.95 10.15 155 627482 8172 70292635
Extrapyramidal disorder 33.93 10.15 84 627553 20666 70280141
Body temperature increased 33.92 10.15 518 627119 39316 70261491
Fluid intake reduced 33.85 10.15 118 627519 5489 70295318
Treatment noncompliance 33.78 10.15 257 627380 46317 70254490
Foetal exposure during pregnancy 33.45 10.15 5 627632 5640 70295167
Mucosal haemorrhage 33.37 10.15 69 627568 2340 70298467
Subileus 33.31 10.15 112 627525 5115 70295692
Hiatus hernia 33.19 10.15 309 627328 20825 70279982
Flatulence 32.70 10.15 497 627140 37684 70263123
Gastritis erosive 32.69 10.15 176 627461 9919 70290888
Photodermatosis 32.62 10.15 41 627596 902 70299905
Blood pressure diastolic abnormal 32.55 10.15 242 627395 15262 70285545
Vision blurred 32.50 10.15 618 627019 94366 70206441
Injection site urticaria 32.43 10.15 33 627604 11605 70289202
Painful respiration 32.32 10.15 81 627556 3127 70297680
Injection site rash 32.19 10.15 60 627577 16350 70284457
Paresis 32.18 10.15 91 627546 3779 70297028
Pneumonia aspiration 32.17 10.15 374 627263 61915 70238892
Depressed level of consciousness 32.07 10.15 562 627075 86869 70213938
Tongue disorder 32.00 10.15 42 627595 13185 70287622
Granuloma skin 31.86 10.15 14 627623 7668 70293139
Cerebral infarction 31.82 10.15 236 627401 42773 70258034
Urogenital haemorrhage 31.50 10.15 37 627600 757 70300050
Glomerular filtration rate decreased 31.37 10.15 301 627336 20455 70280352
Bronchopulmonary aspergillosis 31.32 10.15 89 627548 20913 70279894
Sinusitis 31.27 10.15 1813 625824 167382 70133425
Hypochromic anaemia 31.11 10.15 69 627568 2458 70298349
Red blood cell sedimentation rate increased 31.06 10.15 207 627430 38435 70262372
Bursitis 31.04 10.15 367 627270 26306 70274501
Balance disorder 30.96 10.15 586 627051 89542 70211265
Epstein-Barr virus infection 30.83 10.15 43 627594 13155 70287652
Myocardial infarction 30.75 10.15 1224 626413 170421 70130386
Cardiac failure congestive 30.70 10.15 938 626699 134519 70166288
Musculoskeletal stiffness 30.67 10.15 1035 626602 146725 70154082
Medication error 30.60 10.15 689 626948 56223 70244584
Visual acuity reduced 30.52 10.15 135 627502 27795 70273012
Haematotoxicity 30.52 10.15 46 627591 13628 70287179
Breast cancer 30.46 10.15 173 627464 33376 70267431
Cardiac failure 30.46 10.15 1558 626079 141983 70158824
Lethargy 30.46 10.15 475 627162 74775 70226032
Weight increased 30.44 10.15 2515 625122 239816 70060991
Alcohol interaction 30.32 10.15 3 627634 4650 70296157
Iron deficiency anaemia 30.27 10.15 325 627312 22747 70278060
Diverticulum intestinal 30.10 10.15 146 627491 7895 70292912
Alopecia 30.07 10.15 1442 626195 197048 70103759
Withdrawal syndrome 29.94 10.15 116 627521 24788 70276019
Alanine aminotransferase abnormal 29.94 10.15 17 627620 8042 70292765
Anxiety 29.86 10.15 1619 626018 218711 70082096
Sickle cell anaemia with crisis 29.79 10.15 8 627629 5970 70294837
Tricuspid valve incompetence 29.76 10.15 264 627373 17553 70283254
Schizophrenia 29.73 10.15 65 627572 16703 70284104
Exposure to toxic agent 29.55 10.15 9 627628 6185 70294622
Urosepsis 29.43 10.15 333 627304 23616 70277191
Adenovirus infection 29.42 10.15 16 627621 7752 70293055
Pyrexia 29.41 10.15 5940 621697 601012 69699795
Oesophageal carcinoma 29.14 10.15 24 627613 9342 70291465
Hydrocholecystis 28.52 10.15 25 627612 355 70300452
Tuberculosis 28.50 10.15 55 627582 14793 70286014
Joint stiffness 28.49 10.15 188 627449 34988 70265819
Contusion 28.47 10.15 1396 626241 126640 70174167
Pain in jaw 28.39 10.15 241 627396 42428 70258379
Product quality issue 28.07 10.15 157 627480 30404 70270403
Exposure via ingestion 27.68 10.15 5 627632 4910 70295897
Haematocrit decreased 27.66 10.15 683 626954 56575 70244232
Diarrhoea 27.62 10.15 7556 620081 775785 69525022
Dystonia 27.59 10.15 86 627551 19620 70281187
Underdose 27.51 10.15 150 627487 29233 70271574
Dyspepsia 27.44 10.15 1005 626632 88072 70212735
Carotid arteriosclerosis 27.36 10.15 64 627573 2363 70298444
Chronic graft versus host disease 27.05 10.15 13 627624 6757 70294050
Blood parathyroid hormone decreased 27.00 10.15 24 627613 9000 70291807
Mucormycosis 26.89 10.15 19 627618 7995 70292812
Genital haemorrhage 26.77 10.15 9 627628 5806 70295001
Fear of injection 26.37 10.15 13 627624 6659 70294148
Trimethylaminuria 26.29 10.15 17 627620 147 70300660
Eructation 26.27 10.15 162 627475 9598 70291209
Restlessness 26.21 10.15 521 627116 41607 70259200
Gastrointestinal angiodysplasia 26.20 10.15 38 627599 963 70299844
Hyperammonaemic encephalopathy 26.18 10.15 4 627633 4439 70296368
Substance abuse 26.17 10.15 29 627608 9808 70290999
Osteonecrosis 26.14 10.15 151 627486 29009 70271798
Coagulation test abnormal 26.11 10.15 42 627595 1168 70299639
Pulmonary function test abnormal 26.04 10.15 78 627559 3347 70297460
Clostridium test positive 26.00 10.15 98 627539 4738 70296069
Immune reconstitution inflammatory syndrome 25.92 10.15 47 627590 12943 70287864
Abnormal faeces 25.80 10.15 121 627516 6452 70294355
Pulmonary tuberculosis 25.80 10.15 19 627618 7826 70292981
Lactic acidosis 25.80 10.15 756 626881 64268 70236539
Colitis erosive 25.78 10.15 15 627622 105 70300702
Rebound acid hypersecretion 25.68 10.15 14 627623 85 70300722
Uterine perforation 25.62 10.15 10 627627 5881 70294926
Device malfunction 25.53 10.15 85 627552 18999 70281808
Peripheral venous disease 25.46 10.15 172 627465 10515 70290292
Tendonitis 25.36 10.15 105 627532 22017 70278790
Gastroenteritis clostridial 25.07 10.15 34 627603 808 70299999
Joint injury 24.93 10.15 138 627499 26794 70274013
Tetanus 24.86 10.15 12 627625 54 70300753
Red blood cell count decreased 24.84 10.15 621 627016 51540 70249267
Colorectal cancer 24.78 10.15 23 627614 8447 70292360
Obstructive airways disorder 24.77 10.15 346 627291 25767 70275040
Mood swings 24.77 10.15 81 627556 18205 70282602
Duodenitis 24.69 10.15 125 627512 6877 70293930
Hypertensive crisis 24.65 10.15 270 627367 18992 70281815
Rhinitis perennial 24.61 10.15 22 627615 321 70300486
Nephrogenic anaemia 24.37 10.15 79 627558 3539 70297268
Gastric ulcer 24.28 10.15 406 627231 31384 70269423
Urinary hesitation 24.23 10.15 80 627557 3619 70297188
Premature rupture of membranes 24.17 10.15 3 627634 3895 70296912
Musculoskeletal disorder 24.02 10.15 93 627544 19878 70280929
Multiple sclerosis relapse 23.91 10.15 254 627383 42763 70258044
Asphyxia 23.85 10.15 34 627603 10308 70290499
Clostridium difficile infection 23.80 10.15 479 627158 38337 70262470
Panniculitis 23.74 10.15 36 627601 10640 70290167
Hepatic cyst 23.69 10.15 105 627532 5466 70295341
Respiratory depression 23.67 10.15 126 627511 24705 70276102
Pruritus 23.66 10.15 3445 624192 342115 69958692
Bicytopenia 23.66 10.15 84 627553 3944 70296863
Dysentery 23.53 10.15 36 627601 958 70299849
Lower gastrointestinal haemorrhage 23.51 10.15 216 627421 14504 70286303
Congenital hiatus hernia 23.50 10.15 27 627610 539 70300268
Productive cough 23.44 10.15 881 626756 77456 70223351
Stillbirth 23.42 10.15 3 627634 3802 70297005
Mycotic allergy 23.39 10.15 38 627599 1066 70299741
Heavy menstrual bleeding 23.37 10.15 48 627589 12617 70288190
Breast cancer stage II 23.37 10.15 9 627628 5337 70295470
Food allergy 23.27 10.15 142 627495 8382 70292425
Solar lentigo 23.21 10.15 37 627600 1021 70299786
Nausea 23.17 10.15 8135 619502 843953 69456854
Pancreatic steatosis 23.16 10.15 37 627600 1023 70299784
Drug tolerance 23.15 10.15 19 627618 7409 70293398
C-reactive protein increased 23.12 10.15 1198 626439 109319 70191488
Nightmare 23.07 10.15 109 627528 22047 70278760
Cardiotoxicity 23.04 10.15 39 627598 11031 70289776
Weight decreased 23.04 10.15 3110 624527 307378 69993429
Temperature regulation disorder 23.02 10.15 89 627548 4355 70296452
Stomatitis 22.96 10.15 1373 626264 127138 70173669
Haematuria 22.79 10.15 730 626907 62843 70237964
Arrhythmia 22.62 10.15 654 626983 55489 70245318
Alanine aminotransferase increased 22.61 10.15 1070 626567 146410 70154397
Rash 22.51 10.15 4076 623561 506486 69794321
Product used for unknown indication 22.43 10.15 47 627590 1609 70299198
Injection site mass 22.33 10.15 85 627552 18258 70282549
Injection site discolouration 22.28 10.15 18 627619 7074 70293733
Troponin increased 22.25 10.15 235 627402 16379 70284428
Accidental overdose 22.20 10.15 201 627436 34920 70265887
Reactive gastropathy 22.14 10.15 24 627613 448 70300359
Renal failure 22.12 10.15 1952 625685 187118 70113689
Dysplastic naevus 21.98 10.15 26 627611 536 70300271
Generalised tonic-clonic seizure 21.96 10.15 249 627388 41412 70259395
Colitis ulcerative 21.94 10.15 422 627215 33501 70267306
Bronchial wall thickening 21.93 10.15 55 627582 2124 70298683
Paradoxical drug reaction 21.92 10.15 16 627621 6620 70294187
Osteomyelitis 21.65 10.15 168 627469 30150 70270657
Wheezing 21.61 10.15 1030 626607 93140 70207667
Miosis 21.59 10.15 59 627578 14042 70286765
N-terminal prohormone brain natriuretic peptide increased 21.50 10.15 80 627557 3844 70296963
Abnormal dreams 21.48 10.15 38 627599 10565 70290242
Obstruction 21.44 10.15 76 627561 3565 70297242
Cognitive disorder 21.34 10.15 395 627242 60561 70240246
Autoimmune colitis 21.32 10.15 44 627593 1490 70299317
Acute generalised exanthematous pustulosis 21.19 10.15 219 627418 15178 70285629
Headache 21.13 10.15 4679 622958 575726 69725081
Peripheral arterial occlusive disease 21.08 10.15 126 627511 7383 70293424
Exercise tolerance decreased 21.02 10.15 135 627502 8113 70292694
Tenosynovitis 21.01 10.15 59 627578 13917 70286890
Dizziness 21.01 10.15 4528 623109 459613 69841194
Neurotoxicity 20.96 10.15 166 627471 29660 70271147
Sexual dysfunction 20.93 10.15 17 627620 6664 70294143
Hyperreflexia 20.85 10.15 21 627616 7421 70293386
Right ventricular hypertrophy 20.84 10.15 42 627595 1398 70299409
Therapeutic drug monitoring analysis incorrectly performed 20.79 10.15 20 627617 322 70300485
Creatinine renal clearance decreased 20.75 10.15 80 627557 17120 70283687
Cardiorenal syndrome 20.74 10.15 43 627594 1461 70299346
Graft versus host disease in skin 20.74 10.15 12 627625 5618 70295189
Dyskinesia 20.68 10.15 248 627389 40826 70259981
Bone marrow failure 20.64 10.15 307 627330 48703 70252104
Pancytopenia 20.55 10.15 1578 626059 149529 70151278
Suspected suicide 20.42 10.15 29 627608 8805 70292002
Renal cyst 20.40 10.15 194 627443 13151 70287656
Soft tissue disorder 20.36 10.15 71 627566 3303 70297504
Cytomegalovirus infection reactivation 20.33 10.15 18 627619 6763 70294044
Rectal prolapse 20.20 10.15 51 627586 1978 70298829
Acute graft versus host disease in skin 20.16 10.15 20 627617 7117 70293690
Vitamin B12 deficiency 19.94 10.15 105 627532 5867 70294940
Cytomegalovirus chorioretinitis 19.94 10.15 11 627626 5287 70295520
Pulmonary embolism 19.93 10.15 1620 626017 154247 70146560
Serum ferritin abnormal 19.89 10.15 21 627616 380 70300427
Pulmonary valve disease 19.79 10.15 18 627619 269 70300538
Thrombotic microangiopathy 19.67 10.15 86 627551 17762 70283045
Paralysis 19.64 10.15 49 627588 12023 70288784
Osteochondrosis 19.63 10.15 44 627593 1579 70299228
Hallucination 19.58 10.15 519 627118 75741 70225066
Sopor 19.55 10.15 387 627250 30880 70269927
Respiratory tract haemorrhage 19.49 10.15 45 627592 1647 70299160
Occupational dermatitis 19.49 10.15 13 627624 119 70300688
Victim of child abuse 19.48 10.15 32 627605 906 70299901
Degenerative mitral valve disease 19.47 10.15 17 627620 240 70300567
Adrenal insufficiency 19.24 10.15 137 627500 25058 70275749
Anal haemorrhage 19.20 10.15 76 627561 3760 70297047
Lung neoplasm malignant 19.16 10.15 134 627503 24608 70276199
Akathisia 19.15 10.15 51 627586 12242 70288565
Hyperkalaemia 19.08 10.15 1139 626498 105452 70195355
Respiratory disorder 18.99 10.15 467 627170 38656 70262151
Unevaluable event 18.98 10.15 335 627302 51728 70249079
Blood pressure systolic abnormal 18.92 10.15 186 627451 12723 70288084
Intraocular pressure increased 18.86 10.15 31 627606 8870 70291937
Appendicitis 18.82 10.15 80 627557 16653 70284154
Mania 18.77 10.15 83 627554 17091 70283716
Premature labour 18.75 10.15 26 627611 7974 70292833
Graft versus host disease 18.69 10.15 69 627568 14954 70285853
Biliary dilatation 18.69 10.15 55 627582 2337 70298470
Microcytic anaemia 18.68 10.15 88 627549 4701 70296106
Hepatojugular reflux 18.66 10.15 25 627612 587 70300220
Synovial fluid analysis 18.63 10.15 47 627590 1822 70298985
Normal newborn 18.56 10.15 17 627620 6283 70294524
Altered state of consciousness 18.52 10.15 246 627391 39776 70261031
Folate deficiency 18.50 10.15 64 627573 2966 70297841
Faeces pale 18.49 10.15 59 627578 2621 70298186
Hypertransaminasaemia 18.44 10.15 139 627498 8804 70292003
Stenosis 18.36 10.15 50 627587 2031 70298776
Product administered to patient of inappropriate age 18.30 10.15 10 627627 4833 70295974
Clostridium difficile colitis 18.17 10.15 359 627278 28637 70272170
Full blood count abnormal 18.16 10.15 410 627227 33468 70267339
Stress 18.13 10.15 460 627177 67506 70233301
Multiple sclerosis 18.11 10.15 140 627497 25145 70275662
Biliary cirrhosis 18.02 10.15 14 627623 166 70300641
Intracranial mass 18.01 10.15 50 627587 2054 70298753
Tinnitus 17.99 10.15 219 627418 35957 70264850
Haematoma muscle 17.98 10.15 53 627584 2254 70298553
Aortic dilatation 17.98 10.15 43 627594 1611 70299196
Thrombosis prophylaxis 17.97 10.15 7 627630 16 70300791
Osteonecrosis of jaw 17.91 10.15 255 627382 40747 70260060
Pericarditis 17.88 10.15 919 626718 83786 70217021
Bronchial secretion retention 17.87 10.15 63 627574 2947 70297860
Pneumonia cytomegaloviral 17.86 10.15 9 627628 4552 70296255
Dissociation 17.83 10.15 4 627633 3372 70297435
Insomnia 17.62 10.15 1673 625964 216133 70084674
Chronic gastritis 17.62 10.15 71 627566 3542 70297265
Device dependence 17.59 10.15 9 627628 47 70300760
Bacteriuria 17.59 10.15 34 627603 1097 70299710
Serum ferritin decreased 17.56 10.15 49 627588 2019 70298788
Intestinal haemorrhage 17.53 10.15 102 627535 5918 70294889
Posterior reversible encephalopathy syndrome 17.53 10.15 135 627502 24267 70276540
Herpes zoster 17.45 10.15 598 627039 84637 70216170
Nocardiosis 17.42 10.15 12 627625 5117 70295690
Lymphoproliferative disorder 17.41 10.15 13 627624 5316 70295491
Hyperparathyroidism secondary 17.36 10.15 56 627581 2502 70298305
Blood pressure increased 17.33 10.15 1914 625723 186603 70114204
Organic brain syndrome 17.31 10.15 21 627616 445 70300362
SARS-CoV-2 antibody test positive 17.27 10.15 19 627618 361 70300446
Internal haemorrhage 17.22 10.15 127 627510 7989 70292818
Spinal pain 17.16 10.15 192 627445 13578 70287229
Abortion induced 17.12 10.15 20 627617 6605 70294202
Procalcitonin abnormal 17.10 10.15 19 627618 365 70300442
Wound 17.10 10.15 1052 626585 97680 70203127
Aortic valve incompetence 17.03 10.15 136 627501 8768 70292039
Throat clearing 17.03 10.15 43 627594 1668 70299139
Food aversion 17.02 10.15 27 627610 742 70300065
Drug dose omission by device 16.96 10.15 8 627629 4204 70296603
Electroencephalogram abnormal 16.95 10.15 13 627624 5245 70295562
Incorrect dose administered by device 16.95 10.15 9 627628 4420 70296387
Drug effective for unapproved indication 16.90 10.15 10 627627 4625 70296182
Transplant rejection 16.88 10.15 93 627544 18078 70282729
Systolic dysfunction 16.87 10.15 68 627569 3393 70297414
Cholecystitis 16.79 10.15 267 627370 20434 70280373
Amenorrhoea 16.77 10.15 22 627615 6908 70293899
Delusion 16.77 10.15 100 627537 19065 70281742
BK virus infection 16.76 10.15 28 627609 7961 70292846
Hyperlipasaemia 16.65 10.15 32 627605 1028 70299779
Hepatitis 16.65 10.15 569 627068 49411 70251396
Glaucoma 16.58 10.15 93 627544 17999 70282808
Mean cell haemoglobin concentration 16.57 10.15 8 627629 36 70300771
Accidental death 16.40 10.15 7 627630 3901 70296906
Gravitational oedema 16.37 10.15 43 627594 1709 70299098
Vaginal haemorrhage 16.37 10.15 109 627528 20243 70280564
Hypovolaemic shock 16.30 10.15 157 627480 10680 70290127
Pericardial disease 16.28 10.15 22 627615 521 70300286
Activated partial thromboplastin time prolonged 16.24 10.15 187 627450 13318 70287489
Retroperitoneal haematoma 16.20 10.15 87 627550 4898 70295909
Disseminated tuberculosis 16.19 10.15 8 627629 4092 70296715
Loss of personal independence in daily activities 16.18 10.15 601 627036 84309 70216498
Taste disorder 16.18 10.15 163 627474 11222 70289585
Complication of device insertion 16.17 10.15 14 627623 5318 70295489
Rib deformity 16.14 10.15 13 627624 163 70300644
Tachypnoea 16.12 10.15 349 627288 28289 70272518
Anosognosia 16.11 10.15 3 627634 2882 70297925
Frequent bowel movements 16.10 10.15 270 627367 20883 70279924
Disorientation 16.05 10.15 646 626991 57277 70243530
Sputum discoloured 15.99 10.15 245 627392 18606 70282201
Bradycardia 15.90 10.15 1295 626342 123320 70177487
Fatigue 15.88 10.15 7778 619859 816541 69484266
Immature granulocyte count increased 15.87 10.15 22 627615 534 70300273
Pseudomembranous colitis 15.81 10.15 88 627549 5023 70295784
Pancreatitis 15.80 10.15 692 626945 61976 70238831
Tenosynovitis stenosans 15.77 10.15 51 627586 2282 70298525
Device leakage 15.76 10.15 37 627600 9271 70291536
Cystostomy 15.71 10.15 9 627628 61 70300746
Tardive dyskinesia 15.61 10.15 41 627596 9888 70290919
Toxic skin eruption 15.58 10.15 258 627379 19904 70280903
Electrocardiogram Q wave abnormal 15.57 10.15 22 627615 544 70300263
Epileptic encephalopathy 15.54 10.15 19 627618 406 70300401
Adjustment disorder 15.51 10.15 62 627575 3082 70297725
Pneumonia viral 15.51 10.15 126 627511 8166 70292641
Meralgia paraesthetica 15.50 10.15 19 627618 407 70300400
Hepatotoxicity 15.41 10.15 285 627352 43701 70257106
Waist circumference increased 15.39 10.15 38 627599 1453 70299354
Sleep disorder due to a general medical condition 15.38 10.15 151 627486 10325 70290482
Circulatory collapse 15.34 10.15 417 627220 35057 70265750
Blood pressure fluctuation 15.18 10.15 653 626984 58359 70242448
Mean cell haemoglobin decreased 15.17 10.15 89 627548 5179 70295628
Swelling face 15.15 10.15 434 627203 62730 70238077
Faeces hard 15.14 10.15 51 627586 2331 70298476
Solar urticaria 15.02 10.15 9 627628 67 70300740
Pneumocystis jirovecii pneumonia 15.00 10.15 182 627455 29900 70270907
Hypomania 14.98 10.15 19 627618 6053 70294754
Cerebellar ischaemia 14.93 10.15 12 627625 150 70300657
Drug abuser 14.83 10.15 18 627619 5846 70294961
Abdominal wall haemorrhage 14.82 10.15 23 627614 620 70300187
Mitral valve incompetence 14.81 10.15 325 627312 26403 70274404
Haemophagocytic lymphohistiocytosis 14.80 10.15 107 627530 19505 70281302
Vena cava injury 14.79 10.15 16 627621 298 70300509
Hepatitis B 14.76 10.15 31 627606 8083 70292724
Anger 14.75 10.15 83 627554 16049 70284758
Migraine 14.74 10.15 507 627130 71731 70229076
Nasal obstruction 14.72 10.15 39 627598 1558 70299249
Urinary tract infection enterococcal 14.71 10.15 61 627576 3083 70297724
Premature baby 14.69 10.15 6 627631 3433 70297374
Ventricular arrhythmia 14.65 10.15 119 627518 7711 70293096
Monocyte count increased 14.64 10.15 135 627502 9074 70291733
Blood glucose increased 14.64 10.15 753 626884 102229 70198578
Skin disorder 14.63 10.15 185 627452 30172 70270635
Hepatic enzyme increased 14.58 10.15 1595 626042 155395 70145412
Thrombophlebitis 14.57 10.15 96 627541 5820 70294987
Arteriosclerotic gangrene 14.49 10.15 9 627628 72 70300735
Gastrointestinal vascular malformation haemorrhagic 14.46 10.15 25 627612 739 70300068
Stupor 14.43 10.15 22 627615 6487 70294320
Retinal haemorrhage 14.42 10.15 29 627608 7681 70293126
Device deployment issue 14.41 10.15 4 627633 2920 70297887
Viral mutation identified 14.40 10.15 7 627630 3615 70297192
Activated partial thromboplastin time shortened 14.34 10.15 27 627610 854 70299953
Haemorrhagic erosive gastritis 14.28 10.15 21 627616 539 70300268
Physical examination abnormal 14.27 10.15 15 627622 270 70300537
Product administered at inappropriate site 14.24 10.15 6 627631 3370 70297437
Vascular purpura 14.23 10.15 55 627582 2691 70298116
Cholecystitis chronic 14.18 10.15 136 627501 9240 70291567
Epigastric discomfort 14.12 10.15 111 627526 7122 70293685
Perihepatic abscess 14.12 10.15 11 627626 131 70300676
Confabulation 14.02 10.15 19 627618 451 70300356
Memory impairment 14.02 10.15 673 626964 91968 70208839
Polycystic ovaries 14.02 10.15 4 627633 2868 70297939
Hepatitis B reactivation 14.02 10.15 16 627621 5339 70295468
Endophthalmitis 14.00 10.15 21 627616 6234 70294573
Cold sweat 14.00 10.15 220 627417 16796 70284011
Coronavirus test positive 13.97 10.15 30 627607 1045 70299762
Influenza like illness 13.93 10.15 456 627181 64875 70235932
Syringe issue 13.86 10.15 16 627621 5312 70295495
Cerebral ischaemia 13.81 10.15 147 627490 10265 70290542
Intraductal papillary mucinous neoplasm 13.80 10.15 25 627612 767 70300040
Cryptococcosis 13.78 10.15 6 627631 3304 70297503
Infection 13.77 10.15 2096 625541 208689 70092118
Intraventricular haemorrhage 13.76 10.15 76 627561 4325 70296482
Second primary malignancy 13.71 10.15 64 627573 12987 70287820
Benign gastrointestinal neoplasm 13.65 10.15 11 627626 138 70300669
Strongyloidiasis 13.62 10.15 8 627629 3715 70297092
Abdominal wall wound 13.62 10.15 9 627628 81 70300726
Red blood cell sedimentation rate 13.59 10.15 14 627623 4896 70295911
Periarthritis calcarea 13.53 10.15 9 627628 82 70300725
Ventricular fibrillation 13.53 10.15 164 627473 26947 70273860
Renal cancer 13.51 10.15 56 627581 11740 70289067
Apparent death 13.51 10.15 4 627633 2800 70298007
Asthma 13.49 10.15 1243 626394 119550 70181257
Petit mal epilepsy 13.47 10.15 17 627620 5427 70295380
Sensory level abnormal 13.46 10.15 11 627626 141 70300666
Bile duct stone 13.44 10.15 85 627552 5081 70295726
Rhinitis allergic 13.42 10.15 40 627597 9255 70291552
Dysphoria 13.42 10.15 12 627625 4486 70296321
Pancreatic enzyme abnormality 13.41 10.15 10 627627 111 70300696
Diffuse large B-cell lymphoma recurrent 13.40 10.15 7 627630 3469 70297338
Somatic symptom disorder 13.38 10.15 44 627593 1986 70298821
Thinking abnormal 13.32 10.15 58 627579 11993 70288814
Occult blood 13.28 10.15 36 627601 1458 70299349
Lipase increased 13.26 10.15 199 627438 15047 70285760
Complication of device removal 13.25 10.15 7 627630 3447 70297360
Faecal calprotectin increased 13.23 10.15 76 627561 4389 70296418
Flank pain 13.18 10.15 223 627414 17279 70283528
Urine alcohol test positive 13.17 10.15 6 627631 23 70300784
Cystitis haemorrhagic 13.12 10.15 36 627601 8557 70292250
Dermatosis 13.08 10.15 20 627617 532 70300275
Chest X-ray abnormal 13.06 10.15 108 627529 7036 70293771
Carcinoid tumour of the stomach 13.05 10.15 12 627625 182 70300625
Stoma site discharge 13.04 10.15 40 627597 1739 70299068
Alcohol use 13.03 10.15 13 627624 4614 70296193
Stasis dermatitis 13.00 10.15 33 627604 1284 70299523
Gastrointestinal toxicity 12.94 10.15 23 627614 6382 70294425
Upper respiratory tract irritation 12.91 10.15 11 627626 150 70300657
Hyperprolactinaemia 12.89 10.15 12 627625 4401 70296406
Dysphagia 12.89 10.15 1163 626474 111671 70189136
Demyelination 12.87 10.15 28 627609 7208 70293599
Rapid eye movement sleep behaviour disorder 12.83 10.15 16 627621 349 70300458
Arterial stenosis 12.82 10.15 34 627603 1359 70299448
Application site pain 12.82 10.15 12 627625 4390 70296417
Dental caries 12.82 10.15 53 627584 11118 70289689
Eosinophils urine present 12.78 10.15 8 627629 65 70300742
Chronic kidney disease-mineral and bone disorder 12.78 10.15 22 627615 648 70300159
Glomerulonephropathy 12.76 10.15 15 627622 307 70300500
Pseudarthrosis 12.68 10.15 14 627623 267 70300540
Unresponsive to stimuli 12.66 10.15 356 627281 51575 70249232
Feeling jittery 12.64 10.15 157 627480 11386 70289421
Facet joint syndrome 12.60 10.15 95 627542 6018 70294789
Inferior vena cava dilatation 12.59 10.15 24 627613 766 70300041
Surgery 12.57 10.15 188 627449 29801 70271006
Mitochondrial toxicity 12.56 10.15 5 627632 2905 70297902
Crepitations 12.50 10.15 125 627512 8589 70292218
Chronic sinusitis 12.50 10.15 122 627515 8329 70292478
Gastrointestinal inflammation 12.49 10.15 102 627535 6621 70294186
Gingival hypertrophy 12.47 10.15 5 627632 2893 70297914
Umbilical hernia 12.46 10.15 84 627553 5132 70295675
Pancreatic duct stenosis 12.45 10.15 13 627624 232 70300575
Lipoedema 12.44 10.15 12 627625 194 70300613
Leptospirosis 12.43 10.15 6 627631 27 70300780
Aspartate aminotransferase increased 12.40 10.15 961 626676 126017 70174790
Coma scale abnormal 12.40 10.15 34 627603 8082 70292725
Intermenstrual bleeding 12.37 10.15 17 627620 5233 70295574
Lumbar vertebral fracture 12.31 10.15 93 627544 5894 70294913
Inappropriate antidiuretic hormone secretion 12.26 10.15 281 627356 22995 70277812
Metastatic malignant melanoma 12.24 10.15 58 627579 3106 70297701
Xyphoid retraction 12.22 10.15 11 627626 162 70300645
Incorrect route of product administration 12.20 10.15 163 627474 26329 70274478
Anaphylactic shock 12.18 10.15 208 627429 32282 70268525
Prothrombin time shortened 12.17 10.15 55 627582 2887 70297920
Duodenogastric reflux 12.15 10.15 7 627630 48 70300759
Puncture site haematoma 12.12 10.15 11 627626 164 70300643
Poor venous access 12.10 10.15 193 627444 14778 70286029
Renal cyst haemorrhage 12.09 10.15 21 627616 623 70300184
Salpingo-oophorectomy unilateral 12.07 10.15 21 627616 624 70300183
Retro-orbital neoplasm 12.03 10.15 7 627630 49 70300758
Bone disorder 11.99 10.15 98 627539 17392 70283415
Iron deficiency 11.98 10.15 113 627524 7643 70293164
Rheumatoid nodule 11.96 10.15 81 627556 14986 70285821
Bladder hypertrophy 11.96 10.15 20 627617 575 70300232
Granulocytopenia 11.92 10.15 51 627586 10596 70290211
Troponin abnormal 11.88 10.15 5 627632 15 70300792
Internal fixation of fracture 11.86 10.15 15 627622 332 70300475
Gastroenteritis viral 11.79 10.15 127 627510 21328 70279479
Enteritis 11.76 10.15 169 627468 12662 70288145
Left ventricular enlargement 11.74 10.15 22 627615 693 70300114
Dermatitis exfoliative generalised 11.74 10.15 97 627540 6317 70294490
Coeliac disease 11.74 10.15 127 627510 8906 70291901
Left ventricular hypertrophy 11.71 10.15 140 627497 10062 70290745
Hepatitis acute 11.67 10.15 181 627456 13781 70287026
Alkalosis 11.66 10.15 18 627619 483 70300324
Scleritis 11.63 10.15 63 627574 3559 70297248
Acute respiratory distress syndrome 11.60 10.15 277 627360 40977 70259830
Maternal exposure before pregnancy 11.60 10.15 10 627627 3806 70297001
Alveolar lung disease 11.59 10.15 19 627618 537 70300270
Neurosensory hypoacusis 11.59 10.15 12 627625 212 70300595
Occupational exposure to air contaminants 11.58 10.15 10 627627 139 70300668
Bradyarrhythmia 11.53 10.15 67 627570 3886 70296921
COVID-19 11.52 10.15 793 626844 104964 70195843
Blood iron decreased 11.50 10.15 173 627464 13088 70287719
Injection site induration 11.48 10.15 42 627595 9126 70291681
Vascular anastomotic haemorrhage 11.45 10.15 13 627624 256 70300551
Hyperplastic cholecystopathy 11.35 10.15 10 627627 143 70300664
Vocal cord dysfunction 11.32 10.15 17 627620 445 70300362
Pneumonitis chemical 11.30 10.15 15 627622 349 70300458
Skin necrosis 11.30 10.15 91 627546 16200 70284607
Total lung capacity abnormal 11.29 10.15 11 627626 180 70300627
Arthritis 11.29 10.15 731 626906 97249 70203558
Paronychia 11.29 10.15 29 627608 7045 70293762
Hostility 11.27 10.15 3 627634 2252 70298555
Periodontitis 11.25 10.15 13 627624 4315 70296492
Erectile dysfunction 11.23 10.15 72 627565 13490 70287317
Anuria 11.22 10.15 240 627397 19413 70281394
Typical aura without headache 11.21 10.15 3 627634 0 70300807
Vascular dissection 11.21 10.15 3 627634 0 70300807
Bladder diverticulitis 11.21 10.15 3 627634 0 70300807
Scrotal inflammation 11.21 10.15 3 627634 0 70300807
Vascular access site complication 11.21 10.15 3 627634 0 70300807
Ulcerative duodenitis 11.21 10.15 3 627634 0 70300807
Anaesthesia oral 11.21 10.15 3 627634 0 70300807
Lymphatic fistula 11.18 10.15 23 627614 777 70300030
Spontaneous haemorrhage 11.18 10.15 18 627619 501 70300306
Hypotension 11.18 10.15 3864 623773 400517 69900290
Disability assessment scale score increased 11.16 10.15 54 627583 2917 70297890
Anaemia of malignant disease 11.15 10.15 22 627615 721 70300086
Base excess decreased 11.14 10.15 15 627622 354 70300453
Retinal detachment 11.13 10.15 38 627599 8429 70292378
Fibrin D dimer increased 11.12 10.15 107 627530 7276 70293531
Hyperammonaemia 11.10 10.15 50 627587 10243 70290564
Pulmonary interstitial emphysema syndrome 11.09 10.15 17 627620 453 70300354
Hypochloraemia 11.08 10.15 43 627594 2108 70298699
Arterial occlusive disease 11.08 10.15 111 627526 7631 70293176
Transfusion 11.07 10.15 231 627406 18605 70282202
Cardiovascular somatic symptom disorder 11.06 10.15 6 627631 36 70300771
Femoral hernia incarcerated 11.04 10.15 23 627614 784 70300023
Spontaneous haematoma 11.03 10.15 31 627606 1283 70299524
Meningitis cryptococcal 11.02 10.15 8 627629 3320 70297487
Heart rate 10.97 10.15 7 627630 59 70300748
Nasal polyps 10.95 10.15 73 627564 4443 70296364
Procalcitonin increased 10.89 10.15 49 627588 2567 70298240
Cerebral haemorrhage 10.88 10.15 582 627055 53282 70247525
Hypoxic-ischaemic encephalopathy 10.88 10.15 31 627606 7277 70293530
Lung disorder 10.87 10.15 734 626903 68750 70232057
Aortic arteriosclerosis 10.86 10.15 112 627525 7757 70293050
Cell death 10.86 10.15 69 627568 4131 70296676
Oesophageal variceal ligation 10.85 10.15 9 627628 118 70300689
Uterine cancer 10.84 10.15 9 627628 3490 70297317
Toxic neuropathy 10.84 10.15 24 627613 854 70299953
Adverse event 10.84 10.15 344 627293 49117 70251690
Asthenopia 10.83 10.15 3 627634 2193 70298614
Biliary dyskinesia 10.80 10.15 46 627591 2353 70298454
Multiple organ dysfunction syndrome 10.79 10.15 820 626817 107695 70193112
Gait deviation 10.78 10.15 7 627630 61 70300746
Vaccination site reaction 10.73 10.15 9 627628 120 70300687
Deafness 10.72 10.15 114 627523 19189 70281618
Soft tissue swelling 10.69 10.15 29 627608 1175 70299632
Rash pruritic 10.67 10.15 452 627185 62539 70238268
Hemiparesis 10.67 10.15 359 627278 31110 70269697
Application site erythema 10.64 10.15 16 627621 4745 70296062
Virologic failure 10.63 10.15 11 627626 3839 70296968
Limb deformity 10.63 10.15 9 627628 3456 70297351
Chronic actinic dermatitis 10.62 10.15 5 627632 21 70300786
Product complaint 10.61 10.15 64 627573 12167 70288640
Thoracic vertebral fracture 10.60 10.15 76 627561 4738 70296069
Rheumatoid lung 10.59 10.15 9 627628 3450 70297357
Heart rate decreased 10.59 10.15 660 626977 61355 70239452
Gastric cancer 10.58 10.15 42 627595 8913 70291894
Toothache 10.58 10.15 108 627529 18322 70282485
Anaemia macrocytic 10.56 10.15 80 627557 5075 70295732
Wound infection fungal 10.55 10.15 11 627626 196 70300611
Bacteraemia 10.55 10.15 189 627448 29120 70271687
Hyperparathyroidism 10.47 10.15 54 627583 2993 70297814
Perineal cyst 10.46 10.15 12 627625 239 70300568
Neutrophil function disorder 10.44 10.15 5 627632 22 70300785
Parkinsonism 10.44 10.15 86 627551 15239 70285568
Myeloblast percentage decreased 10.43 10.15 6 627631 41 70300766
Craniocerebral injury 10.41 10.15 73 627564 4518 70296289
Eye infection 10.41 10.15 50 627587 10068 70290739
Adrenal cyst 10.40 10.15 10 627627 161 70300646
Erythema multiforme 10.38 10.15 95 627542 16469 70284338
Emotional distress 10.37 10.15 250 627387 36938 70263869
Incision site haemorrhage 10.34 10.15 26 627611 1006 70299801
Therapeutic reaction time decreased 10.34 10.15 48 627589 2549 70298258
Focal dyscognitive seizures 10.33 10.15 9 627628 3408 70297399
Histoplasmosis 10.31 10.15 3 627634 2124 70298683
Cerebrovascular insufficiency 10.31 10.15 9 627628 127 70300680
Accidental exposure to product by child 10.31 10.15 6 627631 2800 70298007
Blood pressure diastolic decreased 10.30 10.15 300 627337 25480 70275327
Injury associated with device 10.29 10.15 7 627630 3005 70297802
Hepatic steatosis 10.29 10.15 381 627256 33432 70267375
Foot deformity 10.28 10.15 125 627512 20530 70280277
Gastrointestinal wall thickening 10.27 10.15 45 627592 2331 70298476
Pulmonary sepsis 10.27 10.15 57 627580 3250 70297557
Gastroenteritis salmonella 10.26 10.15 25 627612 948 70299859
Renal atrophy 10.25 10.15 36 627601 1681 70299126
Autoimmune nephritis 10.24 10.15 19 627618 594 70300213
Chondrocalcinosis pyrophosphate 10.22 10.15 37 627600 1754 70299053
Obsessive-compulsive disorder 10.21 10.15 20 627617 5350 70295457
Abdominal wall cyst 10.20 10.15 6 627631 43 70300764
Endoscopy upper gastrointestinal tract 10.20 10.15 9 627628 129 70300678
Jejunostomy 10.16 10.15 7 627630 68 70300739
Autoimmune encephalopathy 10.15 10.15 8 627629 97 70300710

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BC02 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BD04 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD11 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
FDA MoA N0000000147 Proton Pump Inhibitors
FDA EPC N0000175525 Proton Pump Inhibitor
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D054328 Proton Pump Inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:49200 proton pump inhibitors
CHEBI has role CHEBI:49201 anti-ulcer drugs
CHEBI has role CHEBI:78298 environmental contaminants

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

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Erosive esophagitis indication 40719004
Zollinger-Ellison syndrome indication 53132006 DOID:0050782
Multiple endocrine adenomas indication 60549007
Gastroesophageal reflux disease indication 235595009 DOID:8534
Maintenance of Healing Erosive Esophagitis indication
Gastric Hypersecretory Conditions indication
Upper gastrointestinal hemorrhage off-label use 37372002
Duodenal ulcer disease off-label use 51868009 DOID:1724
Gastric ulcer off-label use 397825006 DOID:10808
Pathological Gastric Hypersecretory Condition off-label use
Duodenal Ulcer due to H. Pylori off-label use
Prevention of NSAID-Induced Gastric Ulcer off-label use
Osteoporosis contraindication 64859006 DOID:11476
Pernicious anemia contraindication 84027009 DOID:13381
Fracture of bone contraindication 125605004
Hypomagnesemia contraindication 190855004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.42 acidic
pKa2 3.58 Basic
pKa3 2.32 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 40MG BASE PROTONIX WYETH PHARMS N022020 Nov. 14, 2007 RX FOR SUSPENSION, DELAYED RELEASE ORAL 7550153 Sept. 30, 2024 EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD
EQ 40MG BASE PROTONIX WYETH PHARMS N022020 Nov. 14, 2007 RX FOR SUSPENSION, DELAYED RELEASE ORAL 7553498 Sept. 30, 2024 EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD
EQ 40MG BASE PROTONIX WYETH PHARMS N022020 Nov. 14, 2007 RX FOR SUSPENSION, DELAYED RELEASE ORAL 7838027 Sept. 30, 2024 EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS IN PATIENTS WITH GERD

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Potassium-transporting ATPase Transporter INHIBITOR CHEMBL CHEMBL
Fatty acid synthase Enzyme Ki 5.39 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 5.82 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 5.55 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 4.36 CHEMBL
N(G),N(G)-dimethylarginine dimethylaminohydrolase 1 Enzyme IC50 4.20 CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-1 Transporter WOMBAT-PK
Indoleamine 2,3-dioxygenase 2 Enzyme IC50 4.90 CHEMBL
Potassium-transporting ATPase Enzyme IC50 6 SCIENTIFIC LITERATURE

External reference:

IDSource
4021208 VUID
N0000148654 NUI
D02593 KEGG_DRUG
164579-32-2 SECONDARY_CAS_RN
4021208 VANDF
4021209 VANDF
C0081876 UMLSCUI
CHEBI:7915 CHEBI
CHEMBL1502 ChEMBL_ID
DB00213 DRUGBANK_ID
CHEMBL3989559 ChEMBL_ID
CHEMBL1200408 ChEMBL_ID
D000077402 MESH_DESCRIPTOR_UI
4679 PUBCHEM_CID
7260 IUPHAR_LIGAND_ID
6548 INN_ID
D8TST4O562 UNII
236632 RXNORM
130104 MMSL
8654 MMSL
d04514 MMSL
006006 NDDF
006493 NDDF
009120 NDDF
116510001 SNOMEDCT_US
317317009 SNOMEDCT_US
395821003 SNOMEDCT_US
432408008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Protonix Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 0008-0841 TABLET, DELAYED RELEASE 40 mg ORAL NDA 30 sections
Protonix Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 0008-0841 TABLET, DELAYED RELEASE 40 mg ORAL NDA 30 sections
Protonix Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 0008-0843 TABLET, DELAYED RELEASE 20 mg ORAL NDA 30 sections
Protonix Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 0008-0843 TABLET, DELAYED RELEASE 20 mg ORAL NDA 30 sections
Protonix Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 0008-0844 GRANULE, DELAYED RELEASE 40 mg ORAL NDA 30 sections
Protonix Delayed-Release HUMAN PRESCRIPTION DRUG LABEL 1 0008-0844 GRANULE, DELAYED RELEASE 40 mg ORAL NDA 30 sections
Protonix I.V. HUMAN PRESCRIPTION DRUG LABEL 1 0008-0923 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS NDA 28 sections
Protonix I.V. HUMAN PRESCRIPTION DRUG LABEL 1 0008-0923 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS NDA 28 sections
Protonix I.V. HUMAN PRESCRIPTION DRUG LABEL 1 0008-2001 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS NDA 27 sections
Protonix I.V. HUMAN PRESCRIPTION DRUG LABEL 1 0008-2001 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS NDA 27 sections
Protonix I.V. HUMAN PRESCRIPTION DRUG LABEL 1 0008-4001 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS NDA 28 sections
Protonix I.V. HUMAN PRESCRIPTION DRUG LABEL 1 0008-4001 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS NDA 28 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9284 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 40 mg INTRAVENOUS NDA 26 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9284 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 40 mg INTRAVENOUS NDA 26 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9300 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 40 mg INTRAVENOUS NDA 26 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9300 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 40 mg INTRAVENOUS NDA 26 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-6688 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-6688 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-6689 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-6689 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0480-4111 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS ANDA 28 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-7629 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-8113 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-8113 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-8308 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 29 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-8308 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 29 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0781-3232 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS ANDA 28 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0781-3232 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS ANDA 28 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6474 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6474 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 27 sections