pantoprazole ๐Ÿถ 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 ยตM/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 716.24 10.05 2710 419205 139724 50043485
Chronic kidney disease 556.19 10.05 1104 420811 38667 50144542
Completed suicide 499.78 10.05 237 421678 131652 50051557
Toxicity to various agents 487.70 10.05 634 421281 211865 49971344
Drug ineffective 440.90 10.05 4544 417371 814789 49368420
Exposure during pregnancy 332.52 10.05 311 421604 120704 50062505
Folliculitis 323.44 10.05 885 421030 38340 50144869
Muscle injury 311.69 10.05 843 421072 36268 50146941
Irritable bowel syndrome 275.84 10.05 1000 420915 50441 50132768
Haematochezia 273.13 10.05 842 421073 39040 50144169
Lower respiratory tract infection 216.77 10.05 1448 420467 93753 50089456
Product prescribing error 214.33 10.05 513 421402 20448 50162761
Acute kidney injury 210.85 10.05 2862 419053 225196 49958013
Maternal exposure during pregnancy 204.26 10.05 667 421248 159111 50024098
Sleep disorder due to general medical condition, insomnia type 203.42 10.05 651 421264 30796 50152413
Impaired healing 198.30 10.05 1124 420791 68662 50114547
Off label use 187.99 10.05 2805 419110 471621 49711588
Treatment failure 181.90 10.05 566 421349 137071 50046138
Death 180.86 10.05 1787 420128 323592 49859617
Device expulsion 178.33 10.05 17 421898 28805 50154404
Anaemia 176.84 10.05 3022 418893 249434 49933775
End stage renal disease 174.37 10.05 227 421688 5510 50177699
Injection site pain 168.57 10.05 427 421488 110597 50072612
Abdominal pain upper 167.23 10.05 2047 419868 157262 50025947
Injection site erythema 167.13 10.05 228 421687 74708 50108501
Renal injury 164.82 10.05 274 421641 8337 50174872
Dyspnoea 152.99 10.05 5790 416125 541818 49641391
Ill-defined disorder 150.47 10.05 873 421042 53781 50129428
Gastrointestinal disorder 150.16 10.05 1321 420594 93135 50090074
Peripheral swelling 149.92 10.05 2481 419434 203455 49979754
Abortion spontaneous 147.76 10.05 82 421833 41690 50141519
Drug hypersensitivity 147.24 10.05 1360 420555 249650 49933559
Stomatitis 145.73 10.05 1387 420528 99957 50083252
Intentional overdose 143.63 10.05 186 421729 62318 50120891
Hyponatraemia 142.85 10.05 1325 420590 94814 50088395
Blister 141.72 10.05 1206 420709 84212 50098997
Injection site reaction 141.60 10.05 125 421790 49907 50133302
Hypomagnesaemia 141.32 10.05 470 421445 22686 50160523
Muscle spasticity 132.06 10.05 378 421537 16806 50166403
Confusional state 116.70 10.05 2188 419727 183740 49999469
Drug intolerance 112.28 10.05 1226 420689 217878 49965331
Asthenia 110.29 10.05 3459 418456 315583 49867626
Ear pain 110.19 10.05 498 421417 27785 50155424
Drug abuse 109.94 10.05 207 421708 59639 50123570
Labelled drug-drug interaction medication error 108.81 10.05 258 421657 10219 50172990
Tubulointerstitial nephritis 107.71 10.05 325 421590 14886 50168323
Body temperature increased 105.50 10.05 529 421386 30812 50152397
Alopecia 104.04 10.05 1428 420487 243619 49939590
Pruritus 99.43 10.05 3080 418835 280488 49902721
Wrong technique in product usage process 98.49 10.05 196 421719 55314 50127895
Night sweats 98.13 10.05 545 421370 33029 50150180
Product monitoring error 97.78 10.05 118 421797 2646 50180563
Sinusitis 93.53 10.05 1967 419948 168591 50014618
Haematemesis 93.34 10.05 468 421447 27257 50155952
Injection site swelling 93.22 10.05 127 421788 41646 50141563
Orthostatic intolerance 92.99 10.05 72 421843 906 50182303
Abdominal pain 89.02 10.05 2589 419326 233639 49949570
Product dose omission issue 86.98 10.05 1047 420868 182791 50000418
Injection site pruritus 85.09 10.05 128 421787 40283 50142926
Systemic infection 84.94 10.05 100 421815 2183 50181026
Hypokalaemia 84.30 10.05 1112 420803 86880 50096329
Hepatic function abnormal 82.82 10.05 90 421825 32591 50150618
Melaena 81.14 10.05 440 421475 26424 50156785
Subacute cutaneous lupus erythematosus 77.44 10.05 94 421821 2121 50181088
Hypocalcaemia 71.62 10.05 425 421490 26391 50156818
Therapeutic response decreased 69.84 10.05 184 421731 47047 50136162
Accidental exposure to product 69.69 10.05 54 421861 23003 50160206
Respiratory disorder 67.71 10.05 469 421446 30718 50152491
Drug resistance 67.55 10.05 37 421878 18952 50164257
Therapeutic product effect incomplete 66.84 10.05 467 421448 91048 50092161
No adverse event 65.38 10.05 112 421803 33466 50149743
Pemphigus 65.29 10.05 663 421252 119503 50063706
Cardio-respiratory arrest 64.02 10.05 232 421683 53660 50129549
Agranulocytosis 63.44 10.05 349 421566 21072 50162137
Foetal exposure during pregnancy 61.22 10.05 83 421832 27276 50155933
Overdose 60.68 10.05 535 421380 99192 50084017
Systemic lupus erythematosus 60.48 10.05 817 421098 139805 50043404
Respiratory arrest 60.37 10.05 98 421817 29911 50153298
Product use in unapproved indication 58.08 10.05 651 421264 115168 50068041
Gastrointestinal haemorrhage 57.22 10.05 894 421021 72427 50110782
Suicidal ideation 56.60 10.05 253 421662 55132 50128077
Seizure 56.21 10.05 670 421245 117204 50066005
Injection site bruising 56.08 10.05 141 421774 36627 50146582
Hypoaesthesia 54.85 10.05 739 421176 126518 50056691
Premature delivery 54.78 10.05 70 421845 23593 50159616
Infection 54.14 10.05 1854 420061 171100 50012109
Renal failure 53.99 10.05 1216 420699 105417 50077792
Foetal death 52.86 10.05 4 421911 8176 50175033
Pyrexia 52.74 10.05 3763 418152 376440 49806769
Musculoskeletal stiffness 52.56 10.05 754 421161 127727 50055482
Sedation complication 52.09 10.05 6 421909 8760 50174449
Eosinophilia 50.05 10.05 296 421619 18356 50164853
Product use issue 49.92 10.05 911 421004 148564 50034645
Leukopenia 49.55 10.05 815 421100 66713 50116496
Weight increased 48.89 10.05 2104 419811 199787 49983422
Neuropathy peripheral 48.84 10.05 543 421372 96214 50086995
Anaphylactic reaction 48.81 10.05 258 421657 53797 50129412
Faecaloma 48.57 10.05 150 421765 6958 50176251
Sedation 48.56 10.05 115 421800 30495 50152714
Abdominal discomfort 47.24 10.05 1521 420394 230120 49953089
Blood loss anaemia 46.84 10.05 162 421753 7977 50175232
Gastritis 46.66 10.05 450 421465 32533 50150676
Hypertensive nephropathy 46.04 10.05 36 421879 460 50182749
Intentional product misuse 45.08 10.05 218 421697 46516 50136693
Knee arthroplasty 44.80 10.05 151 421764 35695 50147514
Coma 44.15 10.05 285 421630 56594 50126615
Disease progression 44.14 10.05 549 421366 95317 50087892
Pallor 44.11 10.05 338 421577 22861 50160348
Pneumonia viral 43.75 10.05 141 421774 6693 50176516
Adverse drug reaction 43.73 10.05 275 421640 54947 50128262
Rebound acid hypersecretion 43.61 10.05 29 421886 282 50182927
Caesarean section 43.13 10.05 40 421875 15599 50167610
Contusion 43.13 10.05 1233 420682 110950 50072259
Malaise 42.81 10.05 2324 419591 333208 49850001
Electrolyte imbalance 42.61 10.05 267 421648 16902 50166307
Feeling abnormal 42.47 10.05 763 421152 124729 50058480
Drug reaction with eosinophilia and systemic symptoms 42.30 10.05 392 421523 28032 50155177
Intentional self-injury 41.51 10.05 81 421834 23031 50160178
Loss of personal independence in daily activities 40.34 10.05 381 421534 69669 50113540
Hip arthroplasty 40.24 10.05 125 421790 30304 50152905
Injection site warmth 40.00 10.05 34 421881 13832 50169377
Vomiting 39.00 10.05 4399 417516 456359 49726850
Irritability 38.86 10.05 115 421800 28311 50154898
Depression 38.47 10.05 1067 420848 164356 50018853
Stillbirth 38.21 10.05 3 421912 5949 50177260
Granuloma skin 37.16 10.05 3 421912 5815 50177394
Therapeutic drug monitoring analysis not performed 36.95 10.05 37 421878 668 50182541
Flushing 36.69 10.05 369 421546 66646 50116563
Drug dependence 36.58 10.05 68 421847 19691 50163518
Pre-eclampsia 36.18 10.05 11 421904 8033 50175176
Dystonia 35.95 10.05 28 421887 11898 50171311
Angina pectoris 35.92 10.05 355 421560 25833 50157376
Genital haemorrhage 35.54 10.05 6 421909 6568 50176641
Blood parathyroid hormone decreased 35.29 10.05 8 421907 7106 50176103
Dehydration 34.73 10.05 1579 420336 150870 50032339
Colitis ulcerative 34.56 10.05 250 421665 16604 50166605
Hyperkinesia 34.45 10.05 51 421864 1401 50181808
Breast cancer 34.26 10.05 213 421702 42677 50140532
White blood cell count decreased 34.22 10.05 727 421188 115995 50067214
Polyneuropathy 34.17 10.05 195 421720 11936 50171273
Device issue 34.16 10.05 72 421843 19900 50163309
Therapy non-responder 34.06 10.05 267 421648 50755 50132454
Mycotic allergy 34.06 10.05 38 421877 781 50182428
Gestational diabetes 33.96 10.05 10 421905 7455 50175754
Drug eruption 33.36 10.05 94 421821 23512 50159697
Injection site haemorrhage 33.22 10.05 81 421834 21265 50161944
Premature baby 33.16 10.05 64 421851 18273 50164936
Hypoparathyroidism secondary 32.92 10.05 13 421902 34 50183175
Device difficult to use 32.71 10.05 21 421894 9865 50173344
Atrial fibrillation 32.65 10.05 1094 420821 100651 50082558
Neutropenic sepsis 32.59 10.05 42 421873 14105 50169104
Suicide attempt 32.57 10.05 275 421640 51457 50131752
Injection site rash 32.38 10.05 53 421862 16124 50167085
Gastroenteritis clostridial 32.26 10.05 31 421884 531 50182678
Haemoglobin decreased 32.17 10.05 1332 420583 125884 50057325
Product quality issue 32.10 10.05 140 421775 30718 50152491
Cholestasis 31.81 10.05 338 421577 25063 50158146
Soft tissue disorder 31.70 10.05 92 421823 4122 50179087
Restlessness 31.54 10.05 335 421580 24838 50158371
Haematoma 31.49 10.05 391 421524 30119 50153090
Glossodynia 31.26 10.05 729 421186 114840 50068369
Joint stiffness 31.23 10.05 138 421777 30170 50153039
Normal newborn 30.37 10.05 9 421906 6682 50176527
Cellulitis 30.17 10.05 412 421503 70386 50112823
Eructation 29.71 10.05 128 421787 6993 50176216
Breath sounds abnormal 29.45 10.05 136 421779 7656 50175553
Platelet count decreased 29.34 10.05 628 421287 100098 50083111
Somnolence 29.14 10.05 1028 420887 153957 50029252
Abdominal pain lower 28.91 10.05 293 421622 21463 50161746
Diabetic nephropathy 28.90 10.05 45 421870 1294 50181915
Abnormal behaviour 28.74 10.05 77 421838 19581 50163628
Painful respiration 28.57 10.05 62 421853 2313 50180896
Product storage error 28.46 10.05 36 421879 12188 50171021
Infusion related reaction 28.26 10.05 1141 420774 168416 50014793
Panniculitis 28.22 10.05 18 421897 8485 50174724
Device dislocation 28.14 10.05 89 421826 21457 50161752
Device use error 28.04 10.05 5 421910 5261 50177948
Glomerulonephropathy 28.02 10.05 14 421901 74 50183135
Arthropathy 27.97 10.05 1055 420860 156851 50026358
Drug ineffective for unapproved indication 27.73 10.05 88 421827 21193 50162016
Pulmonary embolism 27.59 10.05 1073 420842 100631 50082578
Balance disorder 27.55 10.05 418 421497 70172 50113037
Acute abdomen 27.42 10.05 46 421869 1410 50181799
Injection site urticaria 27.39 10.05 37 421878 12180 50171029
Myelosuppression 27.32 10.05 44 421871 13473 50169736
Hypochromic anaemia 27.29 10.05 50 421865 1646 50181563
Duodenitis 27.19 10.05 74 421841 3194 50180015
Food allergy 27.13 10.05 137 421778 8000 50175209
Nephrogenic anaemia 27.10 10.05 50 421865 1655 50181554
Neutrophil count decreased 27.07 10.05 249 421666 45777 50137432
Adverse event 26.94 10.05 234 421681 43529 50139680
Lung diffusion test abnormal 26.75 10.05 17 421898 152 50183057
Uterine perforation 26.72 10.05 10 421905 6405 50176804
Nasopharyngitis 26.06 10.05 1906 420009 191021 49992188
Clostridium difficile colitis 26.05 10.05 244 421671 17498 50165711
Clostridium test positive 25.97 10.05 55 421860 2017 50181192
Temperature regulation disorder 25.97 10.05 86 421829 4141 50179068
Rheumatoid factor positive 25.87 10.05 278 421637 49581 50133628
Febrile infection 25.84 10.05 40 421875 1144 50182065
Cardiac arrest 25.70 10.05 517 421398 83134 50100075
Enthesopathy 25.61 10.05 14 421901 7179 50176030
Helicobacter infection 25.52 10.05 568 421347 49134 50134075
Hand deformity 25.46 10.05 638 421277 99561 50083648
Vision blurred 25.40 10.05 482 421433 78165 50105044
Hiatus hernia 25.32 10.05 249 421666 18095 50165114
Pain in jaw 25.23 10.05 202 421713 38226 50144983
Pregnancy 25.15 10.05 144 421771 29433 50153776
Mydriasis 25.05 10.05 31 421884 10596 50172613
Gamma-glutamyltransferase increased 24.96 10.05 366 421549 29257 50153952
Drug withdrawal syndrome 24.77 10.05 116 421799 24965 50158244
Trimethylaminuria 24.67 10.05 15 421900 123 50183086
Fall 24.61 10.05 3170 418745 331762 49851447
Abortion induced 24.49 10.05 25 421890 9319 50173890
Sleep disorder 24.38 10.05 638 421277 56645 50126564
Coagulation test abnormal 24.14 10.05 29 421886 647 50182562
Substance abuse 24.07 10.05 3 421912 4121 50179088
Hepatitis cholestatic 24.04 10.05 108 421807 6009 50177200
Brain contusion 24.02 10.05 26 421889 516 50182693
Musculoskeletal disorder 23.85 10.05 70 421845 17279 50165930
Body temperature decreased 23.34 10.05 224 421691 16171 50167038
Hyperkalaemia 23.27 10.05 545 421370 47544 50135665
Drug-induced liver injury 23.23 10.05 346 421569 27749 50155460
Cardiac failure 23.22 10.05 813 421102 75227 50107982
Cholecystitis chronic 23.15 10.05 149 421766 9520 50173689
Hepatitis acute 23.10 10.05 129 421786 7832 50175377
Dyspnoea exertional 23.09 10.05 575 421340 50658 50132551
Fear of injection 23.04 10.05 11 421904 6092 50177117
Premature rupture of membranes 23.02 10.05 5 421910 4575 50178634
Underdose 22.97 10.05 89 421826 20189 50163020
Treatment noncompliance 22.92 10.05 152 421763 29998 50153211
Urosepsis 22.86 10.05 213 421702 15252 50167957
Pancreatic steatosis 22.58 10.05 33 421882 896 50182313
Blood pressure systolic increased 22.46 10.05 418 421497 35031 50148178
Dysphoria 22.45 10.05 6 421909 4768 50178441
Folate deficiency 22.35 10.05 50 421865 1905 50181304
Bursitis 22.13 10.05 282 421633 21853 50161356
Internal haemorrhage 22.10 10.05 84 421831 4333 50178876
Wheelchair user 22.00 10.05 7 421908 4965 50178244
Live birth 21.98 10.05 67 421848 16341 50166868
Anxiety 21.70 10.05 1235 420680 176371 50006838
Red blood cell sedimentation rate increased 21.52 10.05 150 421765 29266 50153943
Condition aggravated 21.43 10.05 2159 419756 294899 49888310
Hypertensive crisis 21.41 10.05 185 421730 12969 50170240
Complication of device insertion 21.16 10.05 12 421903 6029 50177180
Synovial fluid analysis 21.14 10.05 44 421871 1594 50181615
Dysuria 20.89 10.05 344 421571 28160 50155049
Peripheral arterial occlusive disease 20.88 10.05 71 421844 3466 50179743
Joint injury 20.80 10.05 102 421813 21687 50161522
Total lung capacity decreased 20.70 10.05 38 421877 1253 50181956
Haematocrit decreased 20.65 10.05 408 421507 34568 50148641
Abdominal wall wound 20.63 10.05 11 421904 68 50183141
Duodenal ulcer perforation 20.58 10.05 512 421403 45099 50138110
Clostridium difficile infection 20.53 10.05 312 421603 25127 50158082
Asthma 20.47 10.05 926 420989 88411 50094798
Heavy menstrual bleeding 20.42 10.05 64 421851 15473 50167736
Device breakage 20.33 10.05 30 421885 9517 50173692
Somatic symptom disorder 20.32 10.05 48 421867 1896 50181313
Oesophageal dilatation 20.32 10.05 19 421896 314 50182895
Liver injury 20.31 10.05 305 421610 24501 50158708
Rapid eye movement sleep behaviour disorder 20.31 10.05 15 421900 175 50183034
Disseminated intravascular coagulation 20.19 10.05 74 421841 17061 50166148
Depressed level of consciousness 20.15 10.05 308 421607 51645 50131564
Urinary tract infection enterococcal 20.13 10.05 55 421860 2379 50180830
Mixed liver injury 20.13 10.05 69 421846 3382 50179827
Cachexia 20.09 10.05 83 421832 4450 50178759
Nephritis allergic 20.09 10.05 14 421901 148 50183061
Colitis erosive 20.00 10.05 11 421904 73 50183136
Neuroleptic malignant syndrome 19.99 10.05 39 421876 11091 50172118
Amenorrhoea 19.74 10.05 25 421890 8459 50174750
Serotonin syndrome 19.60 10.05 123 421792 24590 50158619
Renal impairment 19.29 10.05 793 421122 74868 50108341
Headache 19.28 10.05 3828 418087 502707 49680502
Urinary tract obstruction 19.19 10.05 44 421871 1704 50181505
Basal cell carcinoma 19.17 10.05 115 421800 23241 50159968
Tenosynovitis stenosans 19.14 10.05 51 421864 2173 50181036
Tetany 19.14 10.05 42 421873 1579 50181630
Hepatitis B 19.10 10.05 3 421912 3463 50179746
Gastric haemorrhage 19.06 10.05 96 421819 5600 50177609
Neuropathy vitamin B12 deficiency 18.98 10.05 5 421910 0 50183209
Shock 18.95 10.05 98 421817 20552 50162657
Sopor 18.92 10.05 251 421664 19628 50163581
Sensory level abnormal 18.91 10.05 12 421903 107 50183102
Fracture 18.80 10.05 219 421696 16614 50166595
Low birth weight baby 18.78 10.05 13 421902 5868 50177341
Pharyngeal dystonia 18.66 10.05 6 421909 6 50183203
Jaundice 18.65 10.05 317 421598 26112 50157097
Hepatocellular injury 18.59 10.05 312 421603 25635 50157574
Chronic gastritis 18.57 10.05 52 421863 2282 50180927
Thrombocytopenia 18.20 10.05 1267 420648 126406 50056803
Therapeutic drug monitoring analysis incorrectly performed 18.15 10.05 13 421902 144 50183065
Tachyarrhythmia 18.07 10.05 75 421840 4030 50179179
Device malfunction 18.02 10.05 65 421850 15056 50168153
Prerenal failure 17.99 10.05 39 421876 1454 50181755
Multiple sclerosis relapse 17.95 10.05 251 421664 42713 50140496
Deep vein thrombosis 17.94 10.05 765 421150 72539 50110670
Poisoning 17.93 10.05 49 421866 12380 50170829
Maternal drugs affecting foetus 17.90 10.05 10 421905 5067 50178142
Injection site discolouration 17.90 10.05 19 421896 6955 50176254
Pancytopenia 17.76 10.05 864 421051 83166 50100043
Spontaneous haemorrhage 17.68 10.05 16 421899 253 50182956
Spinal pain 17.62 10.05 152 421763 10651 50172558
Reactive gastropathy 17.51 10.05 19 421896 378 50182831
Iron deficiency anaemia 17.48 10.05 216 421699 16618 50166591
Gastric ulcer 17.46 10.05 262 421653 21043 50162166
Complication associated with device 17.46 10.05 63 421852 14592 50168617
Hepatic cyst 17.41 10.05 79 421836 4414 50178795
Cerebral ischaemia 17.32 10.05 96 421819 5812 50177397
Agitation 17.29 10.05 327 421588 53057 50130152
Prothrombin time shortened 17.25 10.05 41 421874 1626 50181583
Device deployment issue 17.20 10.05 4 421911 3492 50179717
Pseudarthrosis 16.90 10.05 19 421896 394 50182815
Suspected suicide 16.89 10.05 12 421903 5345 50177864
Adenovirus infection 16.89 10.05 3 421912 3165 50180044
Subileus 16.83 10.05 56 421859 2703 50180506
Megacolon 16.63 10.05 41 421874 1665 50181544
Haematotoxicity 16.62 10.05 25 421890 7870 50175339
Neck pain 16.55 10.05 356 421559 56711 50126498
Pseudomembranous colitis 16.52 10.05 56 421859 2729 50180480
Arterial stenosis 16.50 10.05 22 421893 547 50182662
Exposure to toxic agent 16.46 10.05 5 421910 3653 50179556
Deafness 16.43 10.05 71 421844 15620 50167589
Akathisia 16.43 10.05 27 421888 8202 50175007
Pathogen resistance 16.35 10.05 14 421901 5675 50177534
Paresis 16.34 10.05 46 421869 2025 50181184
Surgery 16.24 10.05 167 421748 30038 50153171
Gastritis erosive 16.12 10.05 85 421830 5049 50178160
Aortic valve stenosis 16.07 10.05 58 421857 2917 50180292
Haemarthrosis 15.97 10.05 57 421858 2851 50180358
Skin disorder 15.92 10.05 126 421789 23904 50159305
Osteomyelitis 15.85 10.05 115 421800 22238 50160971
Patent ductus arteriosus 15.83 10.05 6 421909 3814 50179395
Occupational asthma 15.81 10.05 11 421904 116 50183093
Oesophagitis 15.80 10.05 176 421739 13207 50170002
Poisoning deliberate 15.76 10.05 26 421889 7886 50175323
Vaginal haemorrhage 15.68 10.05 130 421785 24421 50158788
Renal cyst 15.65 10.05 125 421790 8562 50174647
Lipoedema 15.56 10.05 15 421900 258 50182951
Skin necrosis 15.56 10.05 43 421872 10824 50172385
Syncope 15.53 10.05 1027 420888 101975 50081234
Hypochloraemia 15.44 10.05 39 421876 1608 50181601
Carcinoid tumour of the stomach 15.43 10.05 12 421903 152 50183057
Flatulence 15.23 10.05 337 421578 29121 50154088
Lactic acidosis 15.22 10.05 375 421540 32980 50150229
Injection site mass 15.20 10.05 73 421842 15607 50167602
Solar urticaria 15.20 10.05 8 421907 48 50183161
Acute graft versus host disease 15.15 10.05 7 421908 3951 50179258
Monoparesis 15.14 10.05 36 421879 1428 50181781
Rectal haemorrhage 15.14 10.05 425 421490 38133 50145076
Nephropathy 15.12 10.05 85 421830 5173 50178036
Neutrophil function disorder 15.11 10.05 6 421909 16 50183193
Strangury 15.08 10.05 5 421910 6 50183203
Stoma site discharge 15.01 10.05 33 421882 1242 50181967
Pharyngitis 14.99 10.05 85 421830 17418 50165791
Complication of device removal 14.98 10.05 8 421907 4156 50179053
Biliary dyskinesia 14.89 10.05 51 421864 2499 50180710
Epstein-Barr virus infection 14.88 10.05 22 421893 6975 50176234
Therapy partial responder 14.74 10.05 20 421895 6571 50176638
Dysphagia 14.73 10.05 789 421126 76729 50106480
Neurotoxicity 14.65 10.05 68 421847 14672 50168537
Discontinued product administered 14.64 10.05 7 421908 33 50183176
Hepatic vein dilatation 14.60 10.05 6 421909 18 50183191
Coeliac disease 14.58 10.05 123 421792 8562 50174647
Diverticulum intestinal 14.56 10.05 92 421823 5841 50177368
Joint swelling 14.53 10.05 2293 419622 242993 49940216
Mobility decreased 14.40 10.05 533 421382 79415 50103794
Post procedural pulmonary embolism 14.33 10.05 14 421901 245 50182964
Bicytopenia 14.31 10.05 42 421873 1894 50181315
Productive cough 14.29 10.05 556 421359 52138 50131071
Pulmonary tuberculosis 14.24 10.05 9 421906 4264 50178945
Type I hypersensitivity 14.19 10.05 48 421867 2337 50180872
Bradycardia 14.15 10.05 665 421250 63761 50119448
Eosinophils urine present 14.14 10.05 6 421909 20 50183189
Hyperplastic cholecystopathy 14.11 10.05 9 421906 81 50183128
Gastrointestinal toxicity 14.07 10.05 11 421904 4666 50178543
Dyspepsia 14.05 10.05 754 421161 73343 50109866
Arterial occlusive disease 14.01 10.05 78 421837 4730 50178479
Clostridium colitis 13.91 10.05 39 421876 1713 50181496
Laboratory test abnormal 13.88 10.05 125 421790 23083 50160126
Lethargy 13.87 10.05 310 421605 49122 50134087
Pancreatitis 13.86 10.05 459 421456 42155 50141054
Product complaint 13.85 10.05 49 421866 11417 50171792
Tooth disorder 13.84 10.05 132 421783 24096 50159113
Ischaemic stroke 13.81 10.05 198 421717 15750 50167459
Musculoskeletal pain 13.79 10.05 735 421180 71442 50111767
Demyelination 13.77 10.05 18 421897 6008 50177201
Smear cervix abnormal 13.76 10.05 3 421912 2738 50180471
White blood cell count abnormal 13.76 10.05 15 421900 5425 50177784
Waist circumference increased 13.76 10.05 23 421892 703 50182506
Injection site induration 13.76 10.05 31 421884 8366 50174843
Medication error 13.63 10.05 396 421519 35708 50147501
Atelectasis 13.58 10.05 221 421694 18049 50165160
Nasal obstruction 13.57 10.05 28 421887 1008 50182201
Incorrect dosage administered 13.46 10.05 38 421877 1676 50181533
Toothache 13.44 10.05 84 421831 16810 50166399
Ear infection 13.39 10.05 145 421770 25825 50157384
Swelling face 13.32 10.05 335 421580 52260 50130949
Breast cancer female 13.25 10.05 23 421892 6839 50176370
Status epilepticus 13.24 10.05 62 421853 13344 50169865
Cholecystitis 13.14 10.05 175 421740 13696 50169513
Obstructive airways disorder 13.03 10.05 193 421722 15459 50167750
Intermenstrual bleeding 13.02 10.05 23 421892 6791 50176418
Retroperitoneal haematoma 13.01 10.05 50 421865 2593 50180616
Inflammation 12.98 10.05 368 421547 56544 50126665
Product administered to patient of inappropriate age 12.96 10.05 3 421912 2627 50180582
Tuberculosis 12.92 10.05 42 421873 10041 50173168
Oedema peripheral 12.87 10.05 1505 420410 156456 50026753
Mood swings 12.86 10.05 79 421836 15875 50167334
Salpingo-oophorectomy unilateral 12.83 10.05 19 421896 522 50182687
Feeling jittery 12.83 10.05 146 421769 11014 50172195
Lymphoproliferative disorder 12.82 10.05 4 421911 2873 50180336
Tongue disorder 12.80 10.05 37 421878 9179 50174030
Rib deformity 12.79 10.05 11 421904 162 50183047
Respiratory depression 12.79 10.05 54 421861 11956 50171253
Hypergastrinaemia 12.77 10.05 9 421906 97 50183112
Abnormal dreams 12.77 10.05 38 421877 9339 50173870
Skin test positive 12.75 10.05 21 421894 634 50182575
Metabolic surgery 12.73 10.05 27 421888 991 50182218
Metastases to lung 12.72 10.05 48 421867 10972 50172237
Hepatitis 12.71 10.05 348 421567 31105 50152104
Food aversion 12.69 10.05 18 421897 475 50182734
Dermatitis allergic 12.69 10.05 162 421753 12558 50170651
Application site pain 12.66 10.05 8 421907 3790 50179419
Incorrect dose administered 12.63 10.05 307 421608 48107 50135102
Blood iron abnormal 12.55 10.05 6 421909 3320 50179889
Cytomegalovirus infection 12.45 10.05 93 421822 17869 50165340
Carotid arteriosclerosis 12.43 10.05 26 421889 945 50182264
Anuria 12.43 10.05 146 421769 11098 50172111
Pulmonary renal syndrome 12.43 10.05 16 421899 384 50182825
Hepatic enzyme abnormal 12.40 10.05 76 421839 4773 50178436
Neutropenia 12.27 10.05 1064 420851 146901 50036308
Renal haemangioma 12.27 10.05 6 421909 30 50183179
Disorientation 12.27 10.05 385 421530 35099 50148110
Red blood cell count decreased 12.20 10.05 369 421546 33466 50149743
Cushingoid 12.18 10.05 96 421819 6549 50176660
Amnesia 12.15 10.05 264 421651 41996 50141213
Injection site irritation 12.15 10.05 11 421904 4339 50178870
Foot deformity 12.14 10.05 102 421813 19108 50164101
Hypotension 12.14 10.05 2185 419730 233284 49949925
Stenosis 12.14 10.05 29 421886 1154 50182055
Natural killer cell count decreased 12.12 10.05 6 421909 31 50183178
Diarrhoea 12.11 10.05 5253 416662 583223 49599986
Metastases to bone 12.09 10.05 94 421821 17901 50165308
Intraocular pressure increased 12.07 10.05 17 421898 5499 50177710
Neurosensory hypoacusis 12.06 10.05 12 421903 215 50182994
Vitamin B12 decreased 12.05 10.05 51 421864 2764 50180445
Vocal cord dysfunction 12.00 10.05 15 421900 349 50182860
Faeces discoloured 11.97 10.05 195 421720 15929 50167280
Spigelian hernia 11.96 10.05 6 421909 32 50183177
Blood pressure diastolic abnormal 11.93 10.05 125 421790 9236 50173973
Hypomania 11.87 10.05 12 421903 4493 50178716
Glomerulonephritis chronic 11.87 10.05 10 421905 143 50183066
Sacroiliitis 11.87 10.05 48 421867 2549 50180660
Cerebellar ataxia 11.82 10.05 24 421891 854 50182355
Haemoptysis 11.81 10.05 288 421627 25285 50157924
Rash pruritic 11.78 10.05 306 421609 47540 50135669
Arterial haemorrhage 11.72 10.05 34 421881 1523 50181686
Inappropriate antidiuretic hormone secretion 11.71 10.05 164 421751 12979 50170230
Gastrointestinal inflammation 11.70 10.05 72 421843 4528 50178681
Femoral hernia incarcerated 11.70 10.05 22 421893 739 50182470
Presyncope 11.63 10.05 274 421641 23924 50159285
N-terminal prohormone brain natriuretic peptide increased 11.60 10.05 36 421879 1674 50181535
Administration site discomfort 11.60 10.05 8 421907 83 50183126
Enterochromaffin cell hyperplasia 11.55 10.05 7 421908 57 50183152
Abdominal distension 11.55 10.05 730 421185 72173 50111036
Cholangitis acute 11.49 10.05 16 421899 415 50182794
Bacterial test 11.48 10.05 28 421887 1129 50182080
Flank pain 11.43 10.05 163 421752 12952 50170257
Automatism epileptic 11.39 10.05 3 421912 0 50183209
Speech rehabilitation 11.39 10.05 3 421912 0 50183209
Spleen atrophy 11.39 10.05 3 421912 0 50183209
Blood pressure ambulatory abnormal 11.39 10.05 3 421912 0 50183209
Low density lipoprotein 11.39 10.05 3 421912 0 50183209
Wound infection fungal 11.32 10.05 9 421906 118 50183091
Thrombosis prophylaxis 11.29 10.05 5 421910 19 50183190
Immature granulocyte percentage increased 11.19 10.05 4 421911 7 50183202
Thrombosis 11.16 10.05 571 421344 55262 50127947
Hyperchlorhydria 11.15 10.05 33 421882 1495 50181714
Lung opacity 11.12 10.05 39 421876 1934 50181275
Rhabdomyolysis 11.11 10.05 414 421501 38613 50144596
Infusion site pain 11.10 10.05 59 421856 12287 50170922
Rapid correction of hyponatraemia 11.07 10.05 9 421906 122 50183087
Gait deviation 11.07 10.05 7 421908 62 50183147
Alanine aminotransferase abnormal 11.03 10.05 11 421904 4145 50179064
Renal atrophy 11.03 10.05 29 421886 1226 50181983
Unevaluable event 10.98 10.05 296 421619 45770 50137439
Pneumonia aspiration 10.96 10.05 187 421728 30817 50152392
Sexual dysfunction 10.88 10.05 7 421908 3285 50179924
Abnormal faeces 10.88 10.05 66 421849 4130 50179079
Lipase increased 10.86 10.05 114 421801 8427 50174782
Throat clearing 10.85 10.05 28 421887 1170 50182039
Cytomegalovirus viraemia 10.83 10.05 14 421901 4695 50178514
Vascular stent stenosis 10.81 10.05 17 421898 493 50182716
Hypertransaminasaemia 10.80 10.05 59 421856 3552 50179657
Premature labour 10.79 10.05 54 421861 11422 50171787
Myeloblast percentage decreased 10.76 10.05 6 421909 41 50183168
Squamous cell carcinoma of the oral cavity 10.75 10.05 13 421902 292 50182917
Vertigo 10.75 10.05 532 421383 51300 50131909
Fine motor skill dysfunction 10.73 10.05 11 421904 4092 50179117
Lymphatic fistula 10.69 10.05 21 421894 729 50182480
Stoma site inflammation 10.69 10.05 15 421900 392 50182817
Macular degeneration 10.67 10.05 174 421741 14214 50168995
Inflammatory marker increased 10.66 10.05 82 421833 5552 50177657
Gastritis fungal 10.64 10.05 8 421907 96 50183113
Glomerular filtration rate decreased 10.63 10.05 146 421769 11506 50171703
Graft versus host disease in skin 10.62 10.05 4 421911 2552 50180657
Acquired diaphragmatic eventration 10.57 10.05 15 421900 396 50182813
Haematuria 10.53 10.05 284 421631 25329 50157880
Chronic spontaneous urticaria 10.47 10.05 17 421898 507 50182702
Wound treatment 10.42 10.05 10 421905 171 50183038
Adrenocortical insufficiency acute 10.36 10.05 31 421884 1413 50181796
Influenza like illness 10.36 10.05 383 421532 57076 50126133
Nightmare 10.35 10.05 85 421830 16001 50167208
Psychomotor retardation 10.33 10.05 56 421859 3362 50179847
Sputum discoloured 10.32 10.05 163 421752 13232 50169977
Gastrointestinal complication associated with device 10.25 10.05 4 421911 10 50183199
Duodenal polyp 10.25 10.05 8 421907 102 50183107
Intestinal haemorrhage 10.23 10.05 53 421862 3127 50180082
Anal polyp 10.20 10.05 6 421909 46 50183163
Oesophageal candidiasis 10.19 10.05 74 421841 4920 50178289
Enteritis 10.17 10.05 96 421819 6899 50176310
Gastric mucosa erythema 10.14 10.05 10 421905 177 50183032
Mucormycosis 10.13 10.05 4 421911 2479 50180730
Arrhythmia 10.05 10.05 354 421561 32778 50150431

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 839.96 10.73 2387 257363 100470 29214307
Toxicity to various agents 486.64 10.73 485 259265 173176 29141601
Drug ineffective 442.22 10.73 1672 258078 361498 28953279
Completed suicide 403.84 10.73 144 259606 90102 29224675
Chronic kidney disease 310.05 10.73 859 258891 35557 29279220
Drug abuse 279.99 10.73 178 259572 79705 29235072
Hypomagnesaemia 250.31 10.73 505 259245 16963 29297814
Product prescribing error 211.81 10.73 480 259270 17496 29297281
Haematochezia 179.03 10.73 721 259029 36262 29278515
Anaemia 167.32 10.73 2584 257166 198367 29116410
Systemic infection 140.33 10.73 129 259621 1972 29312805
Hypocalcaemia 138.42 10.73 448 259302 20217 29294560
Death 133.75 10.73 2158 257592 339926 28974851
End stage renal disease 121.21 10.73 231 259519 7433 29307344
Hepatic function abnormal 108.10 10.73 111 259639 39148 29275629
Foetal exposure during pregnancy 98.75 10.73 91 259659 33776 29281001
Renal injury 95.15 10.73 249 259501 9953 29304824
Intentional overdose 88.99 10.73 125 259625 38403 29276374
Acute kidney injury 87.38 10.73 2993 256757 262274 29052503
Dyspnoea 86.05 10.73 3596 256154 323136 28991641
Cholestasis 85.93 10.73 421 259329 23041 29291736
Product monitoring error 85.86 10.73 111 259639 2534 29312243
Off label use 81.30 10.73 2017 257733 298783 29015994
Overdose 79.05 10.73 396 259354 79423 29235354
Electrolyte imbalance 78.76 10.73 248 259502 11026 29303751
Intentional product misuse 73.71 10.73 119 259631 34542 29280235
Hypokalaemia 67.87 10.73 707 259043 49496 29265281
Treatment failure 67.68 10.73 139 259611 36800 29277977
Drug resistance 67.52 10.73 54 259696 21486 29293291
Neuropathy peripheral 65.49 10.73 361 259389 70666 29244111
Melaena 63.34 10.73 480 259270 30696 29284081
Haematemesis 62.91 10.73 401 259349 24225 29290552
Respiratory arrest 62.50 10.73 81 259669 25752 29289025
Syncope 61.69 10.73 1031 258719 80340 29234437
Hypoparathyroidism 61.57 10.73 43 259707 431 29314346
Abdominal pain lower 61.24 10.73 191 259559 8447 29306330
Abdominal pain 60.88 10.73 1588 258162 133769 29181008
Abdominal pain upper 59.10 10.73 806 258944 60187 29254590
Erysipelas 57.96 10.73 120 259630 4105 29310672
Cardiac arrest 56.55 10.73 480 259270 85111 29229666
Oedema peripheral 55.63 10.73 1245 258505 102312 29212465
Agranulocytosis 54.95 10.73 336 259414 20004 29294773
Blood loss anaemia 54.63 10.73 164 259586 7102 29307675
Product dose omission issue 53.24 10.73 565 259185 95818 29218959
Normocytic anaemia 51.67 10.73 75 259675 1917 29312860
Irritability 51.02 10.73 72 259678 22080 29292697
Premature baby 50.88 10.73 46 259704 17234 29297543
Acute abdomen 48.59 10.73 68 259682 1679 29313098
Abnormal behaviour 47.68 10.73 81 259669 23046 29291731
Hepatitis cholestatic 47.57 10.73 151 259599 6742 29308035
Cardio-respiratory arrest 47.28 10.73 256 259494 50345 29264432
Febrile infection 47.03 10.73 72 259678 1932 29312845
Atrial fibrillation 46.76 10.73 1237 258513 104409 29210368
Type I hypersensitivity 46.28 10.73 52 259698 1020 29313757
Suicide attempt 45.17 10.73 151 259599 33959 29280818
Diastolic dysfunction 44.59 10.73 121 259629 4943 29309834
Pallor 44.57 10.73 327 259423 20697 29294080
Gastrointestinal haemorrhage 43.90 10.73 960 258790 78573 29236204
Cytomegalovirus infection 42.82 10.73 87 259663 23128 29291649
Dyspnoea at rest 42.59 10.73 90 259660 3124 29311653
Lower respiratory tract infection 41.86 10.73 108 259642 26394 29288383
Product use in unapproved indication 41.46 10.73 526 259224 86349 29228428
Feeling abnormal 41.24 10.73 294 259456 54151 29260626
Infective exacerbation of chronic obstructive airways disease 41.17 10.73 61 259689 1589 29313188
Suicidal ideation 40.50 10.73 162 259588 34554 29280223
Hypoparathyroidism secondary 40.40 10.73 21 259729 115 29314662
Shock haemorrhagic 39.07 10.73 177 259573 9374 29305403
Gastrointestinal bacterial overgrowth 38.49 10.73 18 259732 75 29314702
Neutrophil count decreased 38.22 10.73 225 259525 43342 29271435
Immune reconstitution inflammatory syndrome 37.41 10.73 11 259739 7791 29306986
Musculoskeletal pain 37.36 10.73 404 259346 28549 29286228
Rectal haemorrhage 36.98 10.73 465 259285 34084 29280693
Labelled drug-drug interaction medication error 36.81 10.73 207 259543 11952 29302825
Therapeutic drug monitoring analysis not performed 36.51 10.73 32 259718 458 29314319
Injection site pain 36.23 10.73 154 259596 32292 29282485
Stomatitis 36.21 10.73 185 259565 36928 29277849
Mucosal haemorrhage 36.20 10.73 55 259695 1466 29313311
Psychotic disorder 36.10 10.73 78 259672 20276 29294501
Dyspnoea exertional 36.06 10.73 484 259266 36006 29278771
Agitation 36.02 10.73 283 259467 51021 29263756
Platelet count decreased 35.91 10.73 675 259075 103997 29210780
Sedation 35.84 10.73 61 259689 17344 29297433
Right atrial hypertrophy 35.66 10.73 33 259717 509 29314268
Malaise 35.52 10.73 1099 258651 158503 29156274
Asthenia 35.50 10.73 2267 257483 212983 29101794
Cardiac failure 34.95 10.73 928 258822 78359 29236418
Haematoma 34.79 10.73 334 259416 22878 29291899
Pathogen resistance 34.50 10.73 14 259736 8102 29306675
Exposure during pregnancy 34.39 10.73 16 259734 8538 29306239
Aortic valve stenosis 34.23 10.73 66 259684 2142 29312635
Drug hypersensitivity 33.83 10.73 411 259339 67995 29246782
Hypertensive nephropathy 33.78 10.73 29 259721 403 29314374
Visual acuity reduced 33.61 10.73 49 259701 14827 29299950
Drug withdrawal syndrome 33.51 10.73 67 259683 17917 29296860
C-reactive protein increased 33.20 10.73 560 259190 43703 29271074
Drug reaction with eosinophilia and systemic symptoms 33.12 10.73 384 259366 27608 29287169
Insomnia 32.78 10.73 565 259185 88196 29226581
Aggression 32.54 10.73 181 259569 35360 29279417
Occult blood 32.37 10.73 32 259718 538 29314239
Bronchial wall thickening 32.36 10.73 43 259707 1009 29313768
Synovitis 32.05 10.73 29 259721 10861 29303916
Leukopenia 31.95 10.73 671 259079 54532 29260245
Drug ineffective for unapproved indication 31.94 10.73 47 259703 14167 29300610
Haematoma muscle 30.81 10.73 40 259710 917 29313860
Rash 30.60 10.73 1359 258391 188460 29126317
Seizure 30.57 10.73 605 259145 92518 29222259
Disease progression 29.42 10.73 524 259226 81392 29233385
Bronchial secretion retention 29.31 10.73 43 259707 1110 29313667
Subileus 29.11 10.73 72 259678 2778 29311999
Hyperlipasaemia 28.89 10.73 28 259722 459 29314318
Low birth weight baby 28.75 10.73 11 259739 6597 29308180
Acute graft versus host disease 28.31 10.73 8 259742 5816 29308961
Nephrogenic anaemia 27.96 10.73 57 259693 1928 29312849
Serum ferritin decreased 27.71 10.73 28 259722 484 29314293
Tricuspid valve incompetence 27.49 10.73 146 259604 8248 29306529
Therapy partial responder 27.49 10.73 6 259744 5193 29309584
Benign prostatic hyperplasia 27.07 10.73 186 259564 11524 29303253
Troponin increased 26.92 10.73 155 259595 9028 29305749
Fracture 26.90 10.73 115 259635 5938 29308839
Arrhythmia 26.81 10.73 405 259345 30908 29283869
Accidental overdose 26.79 10.73 73 259677 17520 29297257
Wrong technique in product usage process 26.67 10.73 164 259586 31264 29283513
Tetanus 26.62 10.73 12 259738 45 29314732
Therapeutic response decreased 26.54 10.73 119 259631 24592 29290185
Serotonin syndrome 26.42 10.73 73 259677 17439 29297338
Cerebral infarction 26.40 10.73 119 259631 24556 29290221
Vertigo 26.36 10.73 301 259449 21560 29293217
Tachyarrhythmia 26.20 10.73 71 259679 2898 29311879
Angina pectoris 26.13 10.73 366 259384 27484 29287293
Interstitial lung disease 25.86 10.73 354 259396 57364 29257413
Accidental exposure to product 25.71 10.73 34 259716 10719 29304058
Intentional self-injury 25.36 10.73 44 259706 12417 29302360
Eosinophilia 25.33 10.73 302 259448 21859 29292918
Liver disorder 25.03 10.73 142 259608 27607 29287170
Chronic graft versus host disease 24.99 10.73 3 259747 4026 29310751
Adjustment disorder 24.97 10.73 37 259713 964 29313813
Solar lentigo 24.78 10.73 24 259726 393 29314384
Rash maculo-papular 24.76 10.73 324 259426 23965 29290812
Product use issue 24.71 10.73 311 259439 51133 29263644
Hepatocellular injury 24.50 10.73 290 259460 20953 29293824
Dizziness 24.38 10.73 1958 257792 187726 29127051
Injection site erythema 24.32 10.73 54 259696 13902 29300875
Dysplastic naevus 24.21 10.73 24 259726 405 29314372
Gastritis 24.10 10.73 270 259480 19247 29295530
Colitis microscopic 24.10 10.73 50 259700 1713 29313064
Lactic acidosis 23.53 10.73 385 259365 29862 29284915
Hypersensitivity 23.51 10.73 325 259425 52578 29262199
Hydrocholecystis 23.35 10.73 20 259730 277 29314500
Photodermatosis 22.85 10.73 24 259726 435 29314342
Rebound acid hypersecretion 22.79 10.73 13 259737 88 29314689
Injection site haemorrhage 22.75 10.73 24 259726 8362 29306415
Gastrooesophageal reflux disease 22.72 10.73 396 259354 31100 29283677
Therapeutic product effect incomplete 22.66 10.73 228 259522 39077 29275700
Bronchiectasis 22.58 10.73 116 259634 6469 29308308
Post transplant lymphoproliferative disorder 22.51 10.73 10 259740 5483 29309294
Occupational dermatitis 22.48 10.73 12 259738 70 29314707
Urticaria 22.47 10.73 341 259409 54319 29260458
Injection site swelling 22.29 10.73 30 259720 9387 29305390
Flushing 22.22 10.73 156 259594 28836 29285941
Right ventricular hypertrophy 22.19 10.73 38 259712 1123 29313654
Fear of disease 22.13 10.73 18 259732 231 29314546
Joint swelling 22.02 10.73 305 259445 49325 29265452
Tetany 21.83 10.73 28 259722 634 29314143
Upper gastrointestinal haemorrhage 21.78 10.73 291 259459 21623 29293154
Pulmonary function test abnormal 21.69 10.73 53 259697 2029 29312748
Degenerative mitral valve disease 21.63 10.73 17 259733 207 29314570
Memory impairment 21.26 10.73 211 259539 36259 29278518
Glomerular filtration rate decreased 20.96 10.73 170 259580 11096 29303681
Polyneuropathy 20.82 10.73 180 259570 11972 29302805
Anger 20.78 10.73 40 259710 10850 29303927
Therapy non-responder 20.55 10.73 173 259577 30738 29284039
Gastrointestinal angiodysplasia 20.46 10.73 25 259725 538 29314239
Withdrawal syndrome 20.44 10.73 41 259709 10951 29303826
Neuroleptic malignant syndrome 20.35 10.73 73 259677 16075 29298702
Drug use disorder 20.14 10.73 3 259747 3419 29311358
Ventricular arrhythmia 20.10 10.73 87 259663 4517 29310260
Presyncope 20.06 10.73 223 259527 15866 29298911
Congenital hiatus hernia 20.05 10.73 22 259728 420 29314357
Nicotine dependence 19.97 10.73 23 259727 464 29314313
Diverticulum intestinal 19.96 10.73 69 259681 3221 29311556
Lower gastrointestinal haemorrhage 19.91 10.73 132 259618 8081 29306696
Gastritis erosive 19.90 10.73 97 259653 5296 29309481
Acute graft versus host disease in skin 19.90 10.73 8 259742 4656 29310121
Body temperature decreased 19.89 10.73 161 259589 10503 29304274
Thrombocytopenia 19.86 10.73 1407 258343 133416 29181361
Urogenital haemorrhage 19.85 10.73 23 259727 467 29314310
Hiatus hernia 19.81 10.73 114 259636 6638 29308139
Extrapyramidal disorder 19.63 10.73 41 259709 10790 29303987
Cold sweat 19.59 10.73 139 259611 8703 29306074
Iron deficiency anaemia 19.48 10.73 140 259610 8802 29305975
Anaphylactic reaction 19.39 10.73 152 259598 27421 29287356
Mood swings 19.39 10.73 21 259729 7230 29307547
Victim of child abuse 19.33 10.73 30 259720 815 29313962
Helicobacter gastritis 19.30 10.73 34 259716 1028 29313749
Gamma-glutamyltransferase increased 19.22 10.73 336 259414 26401 29288376
Foetal malformation 19.06 10.73 13 259737 125 29314652
Gastrointestinal pain 19.04 10.73 59 259691 2600 29312177
Serum ferritin abnormal 19.01 10.73 16 259734 216 29314561
Osteochondrosis 18.95 10.73 29 259721 778 29313999
Hyponatraemia 18.94 10.73 750 259000 66883 29247894
Gravitational oedema 18.93 10.73 24 259726 537 29314240
No adverse event 18.87 10.73 84 259666 17394 29297383
Chest injury 18.84 10.73 40 259710 1393 29313384
Poisoning 18.81 10.73 37 259713 9956 29304821
Full blood count abnormal 18.68 10.73 208 259542 14805 29299972
Apparent death 18.62 10.73 4 259746 3500 29311277
Peripheral arterial occlusive disease 18.52 10.73 91 259659 4985 29309792
Cytomegalovirus viraemia 18.39 10.73 17 259733 6303 29308474
Jaundice 18.23 10.73 360 259390 28936 29285841
Drug screen false positive 18.22 10.73 26 259724 654 29314123
Mania 18.17 10.73 30 259720 8633 29306144
Product storage error 18.14 10.73 18 259732 6452 29308325
Autoimmune colitis 18.09 10.73 30 259720 863 29313914
Cardiac failure congestive 18.07 10.73 523 259227 76058 29238719
Hyperkinesia 18.06 10.73 42 259708 1557 29313220
Paresis 18.06 10.73 46 259704 1808 29312969
Fall 18.01 10.73 1798 257952 175380 29139397
Mitral valve incompetence 17.85 10.73 187 259563 13106 29301671
Altered state of consciousness 17.82 10.73 102 259648 19787 29294990
Colitis ulcerative 17.80 10.73 181 259569 12588 29302189
Rhinitis perennial 17.79 10.73 15 259735 203 29314574
Dermatitis infected 17.68 10.73 11 259739 89 29314688
Subacute cutaneous lupus erythematosus 17.59 10.73 29 259721 830 29313947
Depression 17.55 10.73 592 259158 84555 29230222
Cerebellar ischaemia 17.54 10.73 12 259738 116 29314661
Miosis 17.49 10.73 27 259723 7982 29306795
Bronchopulmonary aspergillosis 17.49 10.73 53 259697 12291 29302486
Pulmonary valve disease 17.43 10.73 17 259733 281 29314496
Cardiotoxicity 17.40 10.73 10 259740 4734 29310043
Microcytic anaemia 17.35 10.73 48 259702 1983 29312794
White blood cell count decreased 17.32 10.73 579 259171 82783 29231994
Pericardial disease 17.30 10.73 19 259731 363 29314414
Haematotoxicity 17.26 10.73 20 259730 6679 29308098
Cardiac aneurysm 17.17 10.73 28 259722 794 29313983
Systolic dysfunction 17.17 10.73 50 259700 2128 29312649
Drug eruption 17.16 10.73 82 259668 16659 29298118
Injection site bruising 17.09 10.73 25 259725 7555 29307222
Trisomy 18 17.06 10.73 14 259736 182 29314595
Mean cell haemoglobin concentration 16.98 10.73 8 259742 34 29314743
Obstruction 16.94 10.73 46 259704 1880 29312897
Erectile dysfunction 16.87 10.73 91 259659 17918 29296859
Chest X-ray abnormal 16.80 10.73 72 259678 3722 29311055
Mean cell haemoglobin decreased 16.76 10.73 37 259713 1324 29313453
Urinary hesitation 16.68 10.73 50 259700 2163 29312614
Discontinued product administered 16.67 10.73 6 259744 10 29314767
Drug dependence 16.52 10.73 112 259638 20869 29293908
Sexual dysfunction 16.50 10.73 16 259734 5798 29308979
Thrombotic microangiopathy 16.47 10.73 32 259718 8649 29306128
Abnormal dreams 16.43 10.73 22 259728 6898 29307879
Headache 16.33 10.73 1311 258439 172696 29142081
Adverse event 16.20 10.73 74 259676 15217 29299560
Alveolar lung disease 16.10 10.73 18 259732 351 29314426
Therapeutic product effect decreased 16.09 10.73 173 259577 29278 29285499
Bradyarrhythmia 16.07 10.73 46 259704 1939 29312838
Vitamin B12 deficiency 15.99 10.73 64 259686 3207 29311570
Drug intolerance 15.95 10.73 314 259436 48065 29266712
Lethargy 15.94 10.73 233 259517 37347 29277430
Electrocardiogram QT prolonged 15.92 10.73 423 259327 35714 29279063
N-terminal prohormone brain natriuretic peptide increased 15.86 10.73 45 259705 1887 29312890
Abnormal faeces 15.78 10.73 56 259694 2649 29312128
COVID-19 pneumonia 15.77 10.73 140 259610 9382 29305395
Perihepatic abscess 15.77 10.73 10 259740 84 29314693
Base excess decreased 15.77 10.73 14 259736 204 29314573
Chronic kidney disease-mineral and bone disorder 15.75 10.73 18 259732 360 29314417
Thrombophlebitis 15.71 10.73 57 259693 2726 29312051
Drug abuser 15.63 10.73 7 259743 3820 29310957
Disseminated intravascular coagulation 15.56 10.73 107 259643 19873 29294904
Jugular vein distension 15.44 10.73 23 259727 602 29314175
Phalangeal hypoplasia 15.42 10.73 9 259741 64 29314713
Cachexia 15.36 10.73 102 259648 6247 29308530
Faeces pale 15.25 10.73 34 259716 1225 29313552
Peripheral venous disease 15.16 10.73 50 259700 2278 29312499
Alanine aminotransferase increased 15.15 10.73 491 259259 70453 29244324
Flatulence 15.13 10.73 229 259521 17480 29297297
Bronchial obstruction 15.12 10.73 36 259714 1355 29313422
Saliva altered 15.08 10.73 12 259738 149 29314628
Hyperreflexia 15.07 10.73 3 259747 2769 29312008
Injection site phlebitis 15.00 10.73 7 259743 29 29314748
Duodenogastric reflux 14.98 10.73 4 259746 0 29314777
Aortic valve incompetence 14.95 10.73 85 259665 4928 29309849
Exercise tolerance decreased 14.83 10.73 75 259675 4156 29310621
Plasma cell myeloma 14.81 10.73 429 259321 36686 29278091
Epstein-Barr virus infection 14.81 10.73 22 259728 6607 29308170
Burns second degree 14.76 10.73 17 259733 343 29314434
Hypertrophy 14.75 10.73 19 259731 432 29314345
Generalised tonic-clonic seizure 14.65 10.73 103 259647 19036 29295741
Renal cyst 14.54 10.73 119 259631 7788 29306989
Tendonitis 14.54 10.73 30 259720 7931 29306846
Device leakage 14.42 10.73 11 259739 4484 29310293
Cellulitis 14.37 10.73 300 259450 45540 29269237
Myocardial infarction 14.37 10.73 807 258943 109489 29205288
Hypovolaemic shock 14.36 10.73 97 259653 5975 29308802
Impaired work ability 14.36 10.73 17 259733 5623 29309154
Intestinal angioedema 14.34 10.73 13 259737 195 29314582
Blood pressure fluctuation 14.30 10.73 250 259500 19644 29295133
Weight decreased 14.27 10.73 1524 258226 149381 29165396
Treatment noncompliance 14.19 10.73 140 259610 24087 29290690
Dependence on oxygen therapy 14.14 10.73 12 259738 164 29314613
Mastitis 14.14 10.73 12 259738 164 29314613
Hypertransaminasaemia 14.13 10.73 66 259684 3540 29311237
Nightmare 14.13 10.73 52 259698 11365 29303412
Underdose 14.08 10.73 55 259695 11814 29302963
Uveitis 14.02 10.73 19 259731 5928 29308849
Neoplasm malignant 14.00 10.73 89 259661 16836 29297941
Benign gastrointestinal neoplasm 13.99 10.73 11 259739 134 29314643
Cytomegalovirus infection reactivation 13.98 10.73 6 259744 3358 29311419
Graft versus host disease 13.89 10.73 41 259709 9587 29305190
Pulpitis dental 13.84 10.73 17 259733 368 29314409
Hospitalisation 13.83 10.73 303 259447 45685 29269092
Injection site reaction 13.82 10.73 51 259699 11137 29303640
Syringe issue 13.80 10.73 8 259742 3770 29311007
Disinhibition 13.80 10.73 3 259747 2604 29312173
Substance abuse 13.78 10.73 24 259726 6763 29308014
Dermatosis 13.77 10.73 15 259735 284 29314493
Mucormycosis 13.72 10.73 15 259735 5143 29309634
Asthma 13.72 10.73 392 259358 33457 29281320
Myelosuppression 13.67 10.73 58 259692 12169 29302608
Device issue 13.64 10.73 30 259720 7750 29307027
Upper motor neurone lesion 13.56 10.73 10 259740 110 29314667
Sinusitis 13.54 10.73 216 259534 34134 29280643
Vision blurred 13.48 10.73 260 259490 39916 29274861
Product quality issue 13.45 10.73 83 259667 15812 29298965
Somnolence 13.44 10.73 681 259069 93274 29221503
Puncture site haematoma 13.28 10.73 11 259739 145 29314632
Symmetrical drug-related intertriginous and flexural exanthema 13.27 10.73 13 259737 216 29314561
Procalcitonin abnormal 13.24 10.73 15 259735 297 29314480
Procalcitonin increased 13.24 10.73 38 259712 1604 29313173
Prolonged expiration 13.16 10.73 11 259739 147 29314630
Anxiety 13.14 10.73 614 259136 84751 29230026
Granulomatous dermatitis 13.13 10.73 13 259737 219 29314558
Electrocardiogram Q wave abnormal 13.12 10.73 15 259735 300 29314477
Nuchal rigidity 13.09 10.73 18 259732 437 29314340
Hallucination 13.04 10.73 296 259454 44416 29270361
Physical examination abnormal 13.02 10.73 14 259736 261 29314516
Device dislocation 13.00 10.73 76 259674 4451 29310326
Urinary straining 13 10.73 5 259745 11 29314766
Myelocyte count increased 13.00 10.73 16 259734 347 29314430
Blood iron decreased 12.99 10.73 75 259675 4373 29310404
Adenovirus infection 12.90 10.73 12 259738 4435 29310342
Thrombocytosis 12.87 10.73 61 259689 3292 29311485
Blindness 12.85 10.73 58 259692 11965 29302812
Phlebitis infective 12.84 10.73 10 259740 120 29314657
Scan abnormal 12.83 10.73 6 259744 25 29314752
Status epilepticus 12.82 10.73 50 259700 10744 29304033
Respiratory tract haemorrhage 12.78 10.73 27 259723 937 29313840
Metastatic malignant melanoma 12.74 10.73 40 259710 1775 29313002
Rhythm idioventricular 12.73 10.73 14 259736 268 29314509
Lichenoid keratosis 12.72 10.73 45 259705 2125 29312652
Leptospirosis 12.65 10.73 6 259744 26 29314751
Bladder cancer 12.62 10.73 46 259704 10081 29304696
Eosinophilic pneumonia 12.59 10.73 54 259696 2792 29311985
Stoma site discharge 12.53 10.73 26 259724 891 29313886
Pneumonia cytomegaloviral 12.46 10.73 4 259746 2678 29312099
Bone marrow failure 12.42 10.73 168 259582 27281 29287496
Tuberculosis 12.41 10.73 28 259722 7168 29307609
Ocular hyperaemia 12.36 10.73 40 259710 9087 29305690
Painful respiration 12.35 10.73 30 259720 1144 29313633
Activated partial thromboplastin time shortened 12.32 10.73 17 259733 414 29314363
Carotid arteriosclerosis 12.30 10.73 34 259716 1404 29313373
Xyphoid retraction 12.30 10.73 11 259739 162 29314615
Hypertensive crisis 12.29 10.73 114 259636 7734 29307043
Osteonecrosis 12.29 10.73 69 259681 13450 29301327
Hyperferritinaemia 12.27 10.73 15 259735 323 29314454
Arteriosclerotic gangrene 12.25 10.73 8 259742 71 29314706
Confabulation 12.25 10.73 10 259740 129 29314648
Muscular weakness 12.18 10.73 434 259316 61618 29253159
Clostridium difficile infection 12.02 10.73 204 259546 15937 29298840
Paranasal sinus discomfort 12.02 10.73 22 259728 686 29314091
Hepatorenal syndrome 11.99 10.73 46 259704 2260 29312517
Pulmonary sepsis 11.98 10.73 40 259710 1834 29312943
Tobacco abuse 11.96 10.73 16 259734 378 29314399
Epidural lipomatosis 11.95 10.73 22 259728 689 29314088
Wound haemorrhage 11.94 10.73 39 259711 1768 29313009
Leptotrichia infection 11.89 10.73 8 259742 75 29314702
Hypergammaglobulinaemia 11.89 10.73 12 259738 207 29314570
Gastrointestinal motility disorder 11.85 10.73 44 259706 2128 29312649
Fluid intake reduced 11.84 10.73 54 259696 2868 29311909
Pancreatitis acute 11.78 10.73 289 259461 24096 29290681
Taste disorder 11.72 10.73 77 259673 4699 29310078
Idiopathic pulmonary fibrosis 11.70 10.73 57 259693 3111 29311666
Splenic thrombosis 11.68 10.73 5 259745 16 29314761
Bicytopenia 11.68 10.73 39 259711 1788 29312989
Hallucination, auditory 11.67 10.73 44 259706 9549 29305228
Peripheral paralysis 11.67 10.73 6 259744 32 29314745
Incorrect route of product administration 11.61 10.73 52 259698 10749 29304028
Lymph node calcification 11.59 10.73 10 259740 140 29314637
Acute coronary syndrome 11.57 10.73 162 259588 12163 29302614
Pancreatic duct stenosis 11.56 10.73 11 259739 176 29314601
Haemorrhagic disorder 11.52 10.73 19 259731 544 29314233
Mood altered 11.37 10.73 35 259715 8076 29306701
Brain stem ischaemia 11.36 10.73 9 259741 111 29314666
Left ventricular hypertrophy 11.33 10.73 99 259651 6604 29308173
Productive cough 11.31 10.73 357 259393 30902 29283875
Disorganised speech 11.31 10.73 21 259729 662 29314115
Road traffic accident 11.31 10.73 85 259665 15476 29299301
Pulmonary interstitial emphysema syndrome 11.30 10.73 17 259733 449 29314328
Epileptic encephalopathy 11.29 10.73 9 259741 112 29314665
Dysmorphism 11.28 10.73 6 259744 2965 29311812
SARS-CoV-2 antibody test positive 11.27 10.73 12 259738 221 29314556
Portal fibrosis 11.26 10.73 14 259736 307 29314470
Device dependence 11.24 10.73 6 259744 35 29314742
Cardiovascular somatic symptom disorder 11.24 10.73 6 259744 35 29314742
Fibrin D dimer 11.23 10.73 3 259747 0 29314777
Bladder diverticulitis 11.23 10.73 3 259747 0 29314777
Spinal cord herniation 11.23 10.73 3 259747 0 29314777
Band neutrophil count decreased 11.23 10.73 3 259747 0 29314777
Achlorhydria 11.23 10.73 3 259747 0 29314777
Urosepsis 11.22 10.73 144 259606 10602 29304175
Pulmonary vascular disorder 11.18 10.73 19 259731 558 29314219
Polypectomy 11.15 10.73 18 259732 506 29314271
Retinitis viral 11.15 10.73 8 259742 84 29314693
Foetal growth restriction 11.12 10.73 10 259740 3756 29311021
Meralgia paraesthetica 11.08 10.73 10 259740 149 29314628
Vitamin D decreased 11.07 10.73 53 259697 2872 29311905
Pneumonia aspiration 11.06 10.73 242 259508 36495 29278282
Skin pressure mark 11.02 10.73 7 259743 59 29314718
Fibrin D dimer increased 11.01 10.73 55 259695 3033 29311744
Arthritis 11.00 10.73 154 259596 24865 29289912
Pulmonary tuberculosis 10.99 10.73 13 259737 4302 29310475
Hepatojugular reflux 10.97 10.73 17 259733 461 29314316
Paranoia 10.95 10.73 47 259703 9830 29304947
Stoma site hypergranulation 10.92 10.73 10 259740 152 29314625
Prostate cancer 10.92 10.73 158 259592 25369 29289408
Blood triglycerides increased 10.87 10.73 67 259683 12767 29302010
Gastroenteritis eosinophilic 10.87 10.73 10 259740 153 29314624
Degenerative aortic valve disease 10.85 10.73 5 259745 20 29314757
Renal haemangioma 10.85 10.73 5 259745 20 29314757
Autoimmune encephalopathy 10.84 10.73 6 259744 38 29314739
Hypochromic anaemia 10.83 10.73 22 259728 742 29314035
Obstructive airways disorder 10.83 10.73 146 259604 10870 29303907
Left ventricular enlargement 10.74 10.73 20 259730 632 29314145

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 1532.11 10.20 4585 558654 199840 63735653
Toxicity to various agents 1022.34 10.20 1001 562238 362512 63572981
Completed suicide 980.17 10.20 367 562872 224047 63711446
Drug ineffective 640.64 10.20 4508 558731 835739 63099754
Haematochezia 472.81 10.20 1464 561775 64909 63870584
Product prescribing error 445.47 10.20 965 562274 34304 63901189
Drug abuse 373.07 10.20 363 562876 132011 63803482
Hypomagnesaemia 368.42 10.20 928 562311 36448 63899045
Chronic kidney disease 349.93 10.20 1208 562031 56711 63878782
Anaemia 346.36 10.20 4926 558313 373754 63561739
Intentional overdose 250.65 10.20 249 562990 89695 63845798
Exposure during pregnancy 235.48 10.20 199 563040 77476 63858017
Hypocalcaemia 224.18 10.20 838 562401 40915 63894578
Systemic infection 219.89 10.20 228 563011 4093 63931400
Dyspnoea 201.36 10.20 7921 555318 710753 63224740
Death 200.76 10.20 2987 560252 479718 63455775
Off label use 197.21 10.20 4123 559116 628683 63306810
Abdominal pain upper 186.06 10.20 2341 560898 172689 63762804
Product monitoring error 178.26 10.20 229 563010 5225 63930268
Hepatic function abnormal 171.31 10.20 185 563054 64128 63871365
Acute kidney injury 167.72 10.20 5120 558119 444120 63491373
Injection site pain 167.06 10.20 462 562777 110946 63824547
Injection site erythema 161.96 10.20 229 563010 70571 63864922
Abdominal pain 152.87 10.20 3688 559551 308687 63626806
Haematemesis 149.21 10.20 807 562432 46192 63889301
Asthenia 146.48 10.20 4828 558411 423216 63512277
Melaena 142.28 10.20 877 562362 52671 63882822
Drug hypersensitivity 140.22 10.20 1363 561876 236452 63699041
Drug resistance 137.70 10.20 67 563172 35035 63900458
Treatment failure 136.18 10.20 541 562698 116275 63819218
Cardio-respiratory arrest 134.51 10.20 426 562813 97967 63837526
Overdose 133.69 10.20 830 562409 158736 63776757
Respiratory arrest 132.87 10.20 160 563079 52825 63882668
Device expulsion 131.95 10.20 15 563224 21121 63914372
Labelled drug-drug interaction medication error 130.46 10.20 457 562782 21605 63913888
Folliculitis 128.23 10.20 562 562677 29515 63905978
Hypokalaemia 127.57 10.20 1626 561613 120277 63815216
Muscle injury 126.74 10.20 512 562727 25925 63909568
Hyponatraemia 125.82 10.20 1906 561333 146433 63789060
Injection site reaction 124.53 10.20 134 563105 46530 63888963
End stage renal disease 121.41 10.20 277 562962 10198 63925295
Agranulocytosis 119.71 10.20 654 562585 37575 63897918
Irritable bowel syndrome 119.53 10.20 643 562596 36726 63898767
Electrolyte imbalance 117.15 10.20 484 562755 24759 63910734
Cholestasis 112.42 10.20 724 562515 44148 63891345
Intentional product misuse 111.21 10.20 296 562943 71999 63863494
Sleep disorder due to general medical condition, insomnia type 109.82 10.20 488 562751 25782 63909711
Injection site swelling 107.87 10.20 121 563118 41232 63894261
Maternal exposure during pregnancy 106.78 10.20 452 562787 95432 63840061
Neuropathy peripheral 105.47 10.20 598 562641 116927 63818566
Wrong technique in product usage process 104.58 10.20 260 562979 64714 63870779
Drug intolerance 100.68 10.20 1102 562137 186890 63748603
Product dose omission issue 97.87 10.20 1158 562081 193589 63741904
Blood loss anaemia 94.78 10.20 302 562937 13590 63921903
Product use in unapproved indication 91.54 10.20 1043 562196 175575 63759918
Pallor 90.66 10.20 615 562624 38166 63897327
Subacute cutaneous lupus erythematosus 89.56 10.20 121 563118 2904 63932589
Sedation 89.09 10.20 140 563099 41322 63894171
Impaired healing 88.56 10.20 862 562377 59611 63875882
Suicidal ideation 86.85 10.20 294 562945 66248 63869245
Gastrointestinal haemorrhage 85.15 10.20 1626 561613 130686 63804807
Suicide attempt 84.55 10.20 326 562913 70681 63864812
Accidental exposure to product 84.32 10.20 64 563175 26300 63909193
Cardiac arrest 84.12 10.20 899 562340 153165 63782328
Injection site pruritus 81.96 10.20 127 563112 37699 63897794
Therapeutic response decreased 80.02 10.20 214 563025 51974 63883519
Abdominal pain lower 79.65 10.20 448 562791 26021 63909472
Neutrophil count decreased 79.27 10.20 375 562864 76821 63858672
Abortion spontaneous 76.69 10.20 64 563175 25079 63910414
Orthostatic intolerance 75.32 10.20 81 563158 1519 63933974
Leukopenia 74.96 10.20 1272 561967 99970 63835523
Eosinophilia 74.15 10.20 578 562661 37498 63897995
Syncope 73.62 10.20 1850 561389 155785 63779708
Drug reaction with eosinophilia and systemic symptoms 72.74 10.20 759 562480 53458 63882035
Acute abdomen 71.79 10.20 105 563134 2719 63932774
Therapeutic drug monitoring analysis not performed 70.95 10.20 69 563170 1143 63934350
Atrial fibrillation 70.72 10.20 1976 561263 169113 63766380
Hepatitis cholestatic 70.33 10.20 250 562989 11905 63923588
Oedema peripheral 70.12 10.20 2366 560873 207951 63727542
Renal injury 69.38 10.20 293 562946 15136 63920357
Hypoparathyroidism secondary 68.21 10.20 34 563205 169 63935324
Abnormal behaviour 65.37 10.20 121 563118 33501 63901992
Therapeutic product effect incomplete 65.24 10.20 583 562656 102899 63832594
Injection site bruising 64.62 10.20 138 563101 36235 63899258
Hypoparathyroidism 64.51 10.20 57 563182 830 63934663
Malaise 64.25 10.20 2817 560422 393430 63542063
Febrile infection 64.02 10.20 101 563138 2800 63932693
Tubulointerstitial nephritis 63.99 10.20 476 562763 30433 63905060
Anaphylactic reaction 62.87 10.20 347 562892 68317 63867176
Night sweats 62.00 10.20 532 562707 35514 63899979
Seizure 61.66 10.20 1055 562184 165837 63769656
Musculoskeletal pain 60.03 10.20 1021 562218 80273 63855220
Platelet count decreased 58.20 10.20 1072 562167 166639 63768854
Angina pectoris 57.62 10.20 625 562614 44456 63891037
Product use issue 57.36 10.20 955 562284 150760 63784733
Feeling abnormal 56.59 10.20 823 562416 132779 63802714
Colitis ulcerative 56.11 10.20 369 562870 22659 63912834
Irritability 56.09 10.20 151 563088 36595 63898898
Haematoma 55.37 10.20 633 562606 45617 63889876
Enthesopathy 55.05 10.20 9 563230 9629 63925864
Fracture 54.83 10.20 315 562924 18440 63917053
White blood cell count decreased 54.42 10.20 1010 562229 156827 63778666
Intentional self-injury 53.44 10.20 108 563131 28936 63906557
Cytomegalovirus infection 52.99 10.20 158 563081 37041 63898452
Drug ineffective for unapproved indication 52.13 10.20 122 563117 31011 63904482
Injection site haemorrhage 52.13 10.20 82 563157 24196 63911297
Drug eruption 51.10 10.20 154 563085 35982 63899511
Flushing 50.94 10.20 440 562799 78208 63857285
Post transplant lymphoproliferative disorder 50.07 10.20 11 563228 9533 63925960
Myelosuppression 49.75 10.20 82 563157 23748 63911745
Cellulitis 49.70 10.20 550 562689 93107 63842386
Rectal haemorrhage 49.19 10.20 786 562453 61031 63874462
Muscle spasticity 48.75 10.20 280 562959 16389 63919104
Hypoaesthesia 48.00 10.20 890 562349 138218 63797275
Fall 47.57 10.20 4242 558997 412584 63522909
Unintentional medical device removal 46.88 10.20 3 563236 6731 63928762
Acute graft versus host disease 46.60 10.20 11 563228 9073 63926420
Pathogen resistance 46.15 10.20 26 563213 12517 63922976
Alopecia 45.48 10.20 1100 562139 164590 63770903
Dehydration 45.08 10.20 2320 560919 214443 63721050
Diastolic dysfunction 45.05 10.20 175 563064 8700 63926793
Polyneuropathy 45.01 10.20 313 562926 19581 63915912
Gastritis 44.77 10.20 569 562670 42049 63893444
Premature delivery 44.65 10.20 58 563181 18531 63916962
Musculoskeletal stiffness 44.16 10.20 783 562456 122423 63813070
Ill-defined disorder 44.11 10.20 583 562656 43469 63892024
Hypertensive nephropathy 43.92 10.20 45 563194 796 63934697
Therapy non-responder 43.87 10.20 366 562873 65533 63869960
Serotonin syndrome 43.82 10.20 185 563054 39097 63896396
Disease progression 43.59 10.20 924 562315 140756 63794737
Hepatocellular injury 43.38 10.20 594 562645 44641 63890852
Aortic valve stenosis 43.33 10.20 112 563127 4468 63931025
Device issue 42.72 10.20 83 563156 22565 63912928
Haemoglobin decreased 42.05 10.20 2095 561144 192968 63742525
Mydriasis 41.94 10.20 43 563196 15269 63920224
Sedation complication 41.78 10.20 19 563220 10335 63925158
Ear pain 41.68 10.20 368 562871 24768 63910725
Granuloma skin 41.43 10.20 3 563236 6071 63929422
Poisoning 41.43 10.20 80 563159 21799 63913694
Drug dependence 40.91 10.20 151 563088 33161 63902332
Dyspnoea exertional 40.44 10.20 885 562354 72845 63862648
Adverse drug reaction 40.40 10.20 232 563007 45232 63890261
Injection site warmth 40.16 10.20 35 563204 13427 63922066
Pre-eclampsia 39.97 10.20 4 563235 6227 63929266
Therapy partial responder 39.53 10.20 20 563219 10228 63925265
Device use error 39.39 10.20 5 563234 6466 63929027
Normocytic anaemia 39.08 10.20 88 563151 3211 63932282
Gastrointestinal disorder 38.70 10.20 1042 562197 88667 63846826
Type I hypersensitivity 38.67 10.20 92 563147 3482 63932011
Gamma-glutamyltransferase increased 38.67 10.20 617 562622 47893 63887600
Body temperature decreased 38.64 10.20 371 562868 25557 63909936
Depression 38.04 10.20 1265 561974 182026 63753467
Neuroleptic malignant syndrome 37.93 10.20 103 563136 24893 63910600
Cardiac failure 37.90 10.20 1464 561775 130909 63804584
Shock haemorrhagic 37.89 10.20 264 562975 16527 63918966
Agitation 37.88 10.20 543 562696 87824 63847669
Jaundice 37.54 10.20 614 562625 47898 63887595
Helicobacter infection 37.29 10.20 505 562734 37857 63897636
Peripheral swelling 37.28 10.20 2207 561032 206946 63728547
Hyperkinesia 37.22 10.20 74 563165 2472 63933021
Faecaloma 37.16 10.20 176 563063 9552 63925941
Product storage error 36.93 10.20 37 563202 13281 63922212
Gastrointestinal bacterial overgrowth 36.79 10.20 28 563211 326 63935167
Tachyarrhythmia 36.64 10.20 126 563113 5900 63929593
Caesarean section 36.53 10.20 27 563212 11247 63924246
Tetany 36.52 10.20 67 563172 2105 63933388
Vertigo 36.51 10.20 721 562518 58290 63877203
Infective exacerbation of chronic obstructive airways disease 35.81 10.20 71 563168 2367 63933126
Right atrial hypertrophy 35.66 10.20 33 563206 512 63934981
Hiatus hernia 35.62 10.20 297 562942 19660 63915833
Subileus 35.61 10.20 110 563129 4867 63930626
Mucosal haemorrhage 35.41 10.20 68 563171 2213 63933280
Somnolence 35.19 10.20 1437 561802 202208 63733285
Drug withdrawal syndrome 35.13 10.20 147 563092 31144 63904349
Coma 34.93 10.20 546 562693 87069 63848424
Breath sounds abnormal 34.77 10.20 197 563042 11472 63924021
Lactic acidosis 34.60 10.20 740 562499 60670 63874823
Asthma 34.47 10.20 1082 562157 94143 63841350
Confusional state 34.41 10.20 2687 560552 258457 63677036
Shock 34.05 10.20 195 563044 38045 63897448
Cytomegalovirus viraemia 33.72 10.20 27 563212 10801 63924692
Device difficult to use 33.69 10.20 22 563217 9776 63925717
Dysuria 33.55 10.20 535 562704 41522 63893971
No adverse event 33.43 10.20 132 563107 28429 63907064
Haematotoxicity 33.34 10.20 38 563201 12858 63922635
Gestational diabetes 32.42 10.20 5 563234 5585 63929908
Erysipelas 32.32 10.20 161 563078 8920 63926573
Blood parathyroid hormone decreased 32.18 10.20 12 563227 7354 63928139
Body temperature increased 32.16 10.20 474 562765 36192 63899301
Epstein-Barr virus infection 32.06 10.20 37 563202 12451 63923042
Aggression 32.04 10.20 254 562985 45978 63889515
Paresis 32.01 10.20 85 563154 3447 63932046
Painful respiration 31.93 10.20 78 563161 3003 63932490
Cachexia 31.81 10.20 162 563077 9055 63926438
Vomiting 31.70 10.20 5373 557866 545744 63389749
Thrombocytopenia 31.69 10.20 2316 560923 221485 63714008
Disseminated intravascular coagulation 31.54 10.20 160 563079 32188 63903305
Visual acuity reduced 31.41 10.20 126 563113 27015 63908478
Multiple-drug resistance 31.20 10.20 9 563230 6493 63929000
Underdose 31.12 10.20 118 563121 25711 63909782
Injection site urticaria 31.08 10.20 31 563208 11150 63924343
Presyncope 30.93 10.20 454 562785 34635 63900858
Neutropenic sepsis 30.92 10.20 102 563137 23170 63912323
Blister 30.90 10.20 926 562313 80041 63855452
Psychotic disorder 30.43 10.20 177 563062 34401 63901092
Injection site rash 30.29 10.20 57 563182 15685 63919808
Discontinued product administered 30.13 10.20 13 563226 43 63935450
Hypochromic anaemia 30.12 10.20 65 563174 2303 63933190
Photodermatosis 30.05 10.20 38 563201 853 63934640
Lower respiratory tract infection 29.88 10.20 1058 562181 93556 63841937
Dyspnoea at rest 29.87 10.20 122 563117 6207 63929286
Adenovirus infection 29.77 10.20 13 563226 7242 63928251
Drug use disorder 29.76 10.20 8 563231 6046 63929447
Duodenal ulcer perforation 29.74 10.20 446 562793 34179 63901314
Genital haemorrhage 29.72 10.20 6 563233 5516 63929977
Gastrointestinal pain 29.64 10.20 138 563101 7436 63928057
Clostridium difficile infection 29.59 10.20 462 562777 35701 63899792
Gastritis erosive 29.26 10.20 163 563076 9432 63926061
Coagulation test abnormal 29.02 10.20 42 563197 1077 63934416
Knee arthroplasty 28.99 10.20 129 563110 26870 63908623
Benign prostatic hyperplasia 28.83 10.20 157 563082 9008 63926485
Interstitial lung disease 28.71 10.20 642 562597 97090 63838403
Exposure to toxic agent 28.70 10.20 9 563230 6150 63929343
Iron deficiency anaemia 28.68 10.20 305 562934 21584 63913909
Extrapyramidal disorder 28.61 10.20 82 563157 19470 63916023
Hydrocholecystis 28.40 10.20 24 563215 328 63935165
Foetal exposure during pregnancy 28.39 10.20 3 563236 4473 63931020
Treatment noncompliance 28.26 10.20 243 562996 43239 63892254
Cerebral infarction 28.21 10.20 226 563013 40818 63894675
Mobility decreased 28.12 10.20 554 562685 85286 63850207
Alcohol interaction 27.78 10.20 3 563236 4398 63931095
Tongue disorder 27.69 10.20 39 563200 12041 63923452
Glomerular filtration rate decreased 27.68 10.20 277 562962 19295 63916198
Helicobacter gastritis 27.54 10.20 60 563179 2140 63933353
Tenosynovitis 27.32 10.20 38 563201 11795 63923698
Arrhythmia 27.30 10.20 630 562609 52314 63883179
Pneumonia aspiration 27.27 10.20 359 562880 58912 63876581
Duodenitis 27.25 10.20 124 563115 6617 63928876
Vision blurred 27.19 10.20 591 562648 89725 63845768
Medication error 27.15 10.20 599 562640 49367 63886126
Nephrogenic anaemia 27.13 10.20 77 563162 3248 63932245
Joint stiffness 27.09 10.20 155 563084 30249 63905244
Exposure via ingestion 27.07 10.20 5 563234 4897 63930596
Rash 26.87 10.20 3551 559688 454998 63480495
Myocardial infarction 26.77 10.20 1179 562060 164642 63770851
Status epilepticus 26.73 10.20 98 563141 21565 63913928
Tetanus 26.69 10.20 12 563227 45 63935448
Rebound acid hypersecretion 26.67 10.20 14 563225 79 63935414
Mycotic allergy 26.67 10.20 38 563201 960 63934533
Panniculitis 26.59 10.20 23 563216 8856 63926637
Normal newborn 26.55 10.20 8 563231 5609 63929884
Lethargy 26.43 10.20 460 562779 72134 63863359
Troponin increased 26.34 10.20 227 563012 15172 63920321
Chronic graft versus host disease 26.14 10.20 11 563228 6265 63929228
Rash maculo-papular 25.95 10.20 565 562674 46461 63889032
Urosepsis 25.82 10.20 301 562938 21793 63913700
Gastroenteritis clostridial 25.82 10.20 33 563206 749 63934744
Food allergy 25.72 10.20 136 563103 7715 63927778
Restlessness 25.59 10.20 489 562750 39296 63896197
Cardiac failure congestive 25.50 10.20 908 562331 129672 63805821
Pain in jaw 25.50 10.20 230 563009 40525 63894968
Arthropathy 25.05 10.20 835 562404 120132 63815361
Product quality issue 24.93 10.20 155 563084 29644 63905849
Flatulence 24.90 10.20 444 562795 35222 63900271
Haematocrit decreased 24.77 10.20 639 562600 54016 63881477
Blood pressure systolic increased 24.74 10.20 586 562653 48867 63886626
Diverticulum intestinal 24.63 10.20 129 563110 7291 63928202
Uterine perforation 24.57 10.20 10 563229 5810 63929683
Mucormycosis 24.54 10.20 17 563222 7324 63928169
Anxiety 24.48 10.20 1484 561755 201165 63734328
Sickle cell anaemia with crisis 24.47 10.20 8 563231 5324 63930169
Bronchopulmonary aspergillosis 24.44 10.20 85 563154 19000 63916493
Diarrhoea 24.42 10.20 6871 556368 715833 63219660
Fluid intake reduced 24.36 10.20 100 563139 5100 63930393
Trimethylaminuria 24.32 10.20 16 563223 145 63935348
Lung diffusion test abnormal 24.32 10.20 16 563223 145 63935348
Mood swings 24.30 10.20 75 563164 17393 63918100
Tricuspid valve incompetence 24.22 10.20 241 562998 16762 63918731
Withdrawal syndrome 24.18 10.20 114 563125 23378 63912115
Gastrointestinal angiodysplasia 24.17 10.20 35 563204 898 63934595
Pruritus 24.14 10.20 3098 560141 309302 63626191
Pulmonary embolism 24.13 10.20 1534 561705 144822 63790671
Suspected suicide 24.05 10.20 24 563215 8630 63926863
Pulmonary tuberculosis 23.92 10.20 17 563222 7227 63928266
Depressed level of consciousness 23.91 10.20 535 562704 80901 63854592
Hypertransaminasaemia 23.85 10.20 125 563114 7066 63928427
Renal failure 23.83 10.20 1869 561370 179819 63755674
Haematoma muscle 23.71 10.20 50 563189 1743 63933750
Tendonitis 23.57 10.20 94 563145 20188 63915305
Osteonecrosis 23.53 10.20 147 563092 28082 63907411
Pancreatic steatosis 23.51 10.20 36 563203 972 63934521
Dystonia 23.50 10.20 85 563154 18780 63916713
Adverse event 23.36 10.20 226 563013 39263 63896230
Hypertensive crisis 23.32 10.20 253 562986 17995 63917498
Hepatic cyst 23.16 10.20 99 563140 5141 63930352
Poisoning deliberate 23.13 10.20 52 563187 13406 63922087
Balance disorder 23.06 10.20 557 562682 83369 63852124
C-reactive protein increased 22.91 10.20 1031 562208 93878 63841615
Eructation 22.83 10.20 148 563091 9043 63926450
Pulmonary function test abnormal 22.70 10.20 70 563169 3094 63932399
Upper gastrointestinal haemorrhage 22.69 10.20 433 562806 34787 63900706
Premature rupture of membranes 22.53 10.20 3 563236 3741 63931752
Contusion 22.50 10.20 1214 562025 112751 63822742
Plasma cell myeloma 22.45 10.20 544 562695 45531 63889962
Immune reconstitution inflammatory syndrome 22.41 10.20 47 563192 12423 63923070
Red blood cell sedimentation rate increased 22.40 10.20 170 563069 31065 63904428
Solar lentigo 22.38 10.20 33 563206 861 63934632
Substance abuse 22.31 10.20 29 563210 9263 63926230
Osteomyelitis 22.30 10.20 145 563094 27442 63908051
Colitis erosive 22.27 10.20 13 563226 93 63935400
Respiratory depression 22.27 10.20 117 563122 23326 63912167
Autoimmune colitis 22.25 10.20 42 563197 1349 63934144
Abnormal dreams 22.21 10.20 35 563204 10321 63925172
Exercise tolerance decreased 22.21 10.20 129 563110 7581 63927912
Peripheral arterial occlusive disease 22.18 10.20 120 563119 6867 63928626
Temperature regulation disorder 22.16 10.20 84 563155 4127 63931366
Intestinal haemorrhage 21.97 10.20 101 563138 5413 63930080
Tuberculosis 21.90 10.20 51 563188 12987 63922506
Asphyxia 21.81 10.20 31 563208 9535 63925958
Bursitis 21.78 10.20 285 562954 21200 63914293
Productive cough 21.75 10.20 813 562426 72390 63863103
Alanine aminotransferase abnormal 21.67 10.20 17 563222 6871 63928622
Neurotoxicity 21.67 10.20 145 563094 27259 63908234
Stillbirth 21.65 10.20 3 563236 3630 63931863
Pyrexia 21.65 10.20 5343 557896 553301 63382192
Bronchial wall thickening 21.63 10.20 50 563189 1857 63933636
Rheumatoid factor positive 21.50 10.20 198 563041 34740 63900753
Urogenital haemorrhage 21.36 10.20 28 563211 652 63934841
Sopor 21.33 10.20 371 562868 29290 63906203
Hepatitis 21.26 10.20 535 562704 45047 63890446
Soft tissue disorder 21.25 10.20 70 563169 3206 63932287
Generalised tonic-clonic seizure 21.16 10.20 234 563005 39623 63895870
Reactive gastropathy 21.08 10.20 22 563217 398 63935095
Cytomegalovirus infection reactivation 21.08 10.20 12 563227 5744 63929749
Headache 21.07 10.20 4191 559048 525276 63410217
Nausea 20.97 10.20 7402 555837 778398 63157095
Alanine aminotransferase increased 20.92 10.20 996 562243 138035 63797458
Cardiotoxicity 20.85 10.20 36 563203 10238 63925255
Accidental overdose 20.73 10.20 190 563049 33367 63902126
Fear of injection 20.70 10.20 13 563226 5899 63929594
Loss of personal independence in daily activities 20.70 10.20 478 562761 71976 63863517
Serum ferritin abnormal 20.52 10.20 21 563218 371 63935122
Heavy menstrual bleeding 20.48 10.20 47 563192 12030 63923463
Faeces pale 20.46 10.20 59 563180 2512 63932981
Bone marrow failure 20.42 10.20 295 562944 47657 63887836
N-terminal prohormone brain natriuretic peptide increased 20.42 10.20 73 563166 3486 63932007
Injection site discolouration 20.36 10.20 18 563221 6857 63928636
Urinary hesitation 20.14 10.20 72 563167 3438 63932055
Bronchial secretion retention 20.12 10.20 58 563181 2469 63933024
Serum ferritin decreased 20.06 10.20 47 563192 1761 63933732
Hyperkalaemia 19.91 10.20 1077 562162 100052 63835441
Multiple sclerosis relapse 19.72 10.20 247 562992 40888 63894605
Folate deficiency 19.71 10.20 61 563178 2702 63932791
Degenerative mitral valve disease 19.67 10.20 17 563222 240 63935253
Hyperreflexia 19.66 10.20 20 563219 7128 63928365
Occupational dermatitis 19.65 10.20 13 563226 119 63935374
Sinusitis 19.60 10.20 1504 561735 144424 63791069
Hypovolaemic shock 19.52 10.20 155 563084 10111 63925382
Pulmonary valve disease 19.33 10.20 17 563222 246 63935247
Product administered to patient of inappropriate age 19.27 10.20 8 563231 4593 63930900
Dysplastic naevus 19.25 10.20 23 563216 486 63935007
Congenital hiatus hernia 19.23 10.20 21 563218 401 63935092
Miosis 19.14 10.20 56 563183 13210 63922283
Premature labour 19.11 10.20 23 563216 7597 63927896
Sexual dysfunction 19.09 10.20 17 563222 6454 63929039
Device malfunction 19.08 10.20 84 563155 17549 63917944
Breast cancer 18.90 10.20 163 563076 28985 63906508
Bicytopenia 18.86 10.20 72 563167 3550 63931943
Abnormal faeces 18.86 10.20 101 563138 5758 63929735
Injection site mass 18.85 10.20 82 563157 17188 63918305
Victim of child abuse 18.77 10.20 30 563209 841 63934652
Synovial fluid analysis 18.75 10.20 42 563197 1527 63933966
Nightmare 18.72 10.20 107 563132 20886 63914607
Red blood cell count decreased 18.63 10.20 554 562685 47832 63887661
Abdominal discomfort 18.50 10.20 1356 561883 180966 63754527
Graft versus host disease in skin 18.39 10.20 12 563227 5335 63930158
Intracranial mass 18.35 10.20 49 563190 1994 63933499
Amenorrhoea 18.32 10.20 18 563221 6521 63928972
Tinnitus 18.28 10.20 200 563039 33933 63901560
Pancytopenia 18.26 10.20 1471 561768 141838 63793655
Lower gastrointestinal haemorrhage 18.15 10.20 194 563045 13745 63921748
Paradoxical drug reaction 18.15 10.20 16 563223 6104 63929389
Obstruction 18.11 10.20 66 563173 3182 63932311
Memory impairment 18.07 10.20 590 562649 85092 63850401
Gravitational oedema 18.05 10.20 43 563196 1629 63933864
Osteochondrosis 17.99 10.20 40 563199 1447 63934046
Mania 17.98 10.20 77 563162 16209 63919284
Acute graft versus host disease in skin 17.94 10.20 20 563219 6835 63928658
Abdominal distension 17.86 10.20 1017 562222 94977 63840516
Organic brain syndrome 17.83 10.20 21 563218 437 63935056
Food aversion 17.81 10.20 26 563213 672 63934821
Mean cell haemoglobin concentration 17.79 10.20 8 563231 30 63935463
Musculoskeletal disorder 17.78 10.20 88 563151 17818 63917675
Microcytic anaemia 17.78 10.20 84 563155 4554 63930939
Obstructive airways disorder 17.77 10.20 293 562946 22892 63912601
Sputum discoloured 17.74 10.20 236 563003 17620 63917873
Hepatocellular carcinoma 17.73 10.20 130 563109 8273 63927220
Device dependence 17.70 10.20 9 563230 47 63935446
Gastrooesophageal reflux disease 17.69 10.20 892 562347 82251 63853242
Right ventricular hypertrophy 17.68 10.20 37 563202 1283 63934210
Dizziness 17.64 10.20 4125 559114 426038 63509455
Dyskinesia 17.60 10.20 240 562999 39148 63896345
Haematuria 17.58 10.20 670 562569 59801 63875692
Vaginal haemorrhage 17.57 10.20 98 563141 19246 63916247
Internal haemorrhage 17.56 10.20 121 563118 7546 63927947
Chronic kidney disease-mineral and bone disorder 17.56 10.20 22 563217 489 63935004
Paralysis 17.43 10.20 48 563191 11547 63923946
Chronic gastritis 17.36 10.20 65 563174 3175 63932318
Insomnia 17.35 10.20 1489 561750 196347 63739146
Swelling face 17.28 10.20 389 562850 58777 63876716
Infusion related reaction 17.20 10.20 1220 562019 163247 63772246
Metastatic malignant melanoma 17.12 10.20 55 563184 2486 63933007
Unevaluable event 17.10 10.20 324 562915 50165 63885328
Pharyngeal dystonia 17.08 10.20 6 563233 9 63935484
Blood pressure diastolic abnormal 17.01 10.20 169 563070 11748 63923745
Rhinitis perennial 17 10.20 15 563224 218 63935275
Clostridium difficile colitis 16.96 10.20 333 562906 26890 63908603
Osteonecrosis of jaw 16.96 10.20 245 562994 39580 63895913
Peripheral venous disease 16.95 10.20 104 563135 6234 63929259
Cytomegalovirus chorioretinitis 16.93 10.20 11 563228 4901 63930592
Urinary tract infection enterococcal 16.87 10.20 60 563179 2858 63932635
Clostridium test positive 16.86 10.20 76 563163 4039 63931454
Application site pain 16.82 10.20 8 563231 4240 63931253
Carotid arteriosclerosis 16.82 10.20 48 563191 2031 63933462
Disorientation 16.82 10.20 621 562618 55207 63880286
Bladder cancer 16.82 10.20 45 563194 10929 63924564
Hyperlipasaemia 16.79 10.20 31 563208 979 63934514
Hepatitis B 16.78 10.20 26 563213 7719 63927774
Drug tolerance 16.76 10.20 17 563222 6068 63929425
Waist circumference increased 16.72 10.20 37 563202 1334 63934159
Pseudomembranous colitis 16.68 10.20 86 563153 4830 63930663
Blood pressure increased 16.51 10.20 1735 561504 170817 63764676
Pneumonia viral 16.50 10.20 121 563118 7701 63927792
Thrombotic microangiopathy 16.45 10.20 82 563157 16573 63918920
Coeliac disease 16.41 10.20 116 563123 7296 63928197
Retroperitoneal haematoma 16.40 10.20 83 563156 4628 63930865
Akathisia 16.31 10.20 49 563190 11461 63924032
Epileptic encephalopathy 16.29 10.20 19 563220 391 63935102
Faecal calprotectin increased 16.27 10.20 69 563170 3571 63931922
Pericardial disease 16.22 10.20 21 563218 483 63935010
Electroencephalogram abnormal 16.17 10.20 13 563226 5190 63930303
Cold sweat 16.15 10.20 217 563022 16238 63919255
Cholecystitis 16.12 10.20 251 562988 19385 63916108
Intraocular pressure increased 16.03 10.20 30 563209 8272 63927221
Pneumonia cytomegaloviral 15.95 10.20 9 563230 4330 63931163
Thrombophlebitis 15.90 10.20 94 563145 5560 63929933
Respiratory disorder 15.72 10.20 420 562819 35691 63899802
Tenosynovitis stenosans 15.62 10.20 45 563194 1915 63933578
Dysentery 15.61 10.20 28 563211 864 63934629
Pancreatitis 15.60 10.20 653 562586 58954 63876539
Lymphoproliferative disorder 15.55 10.20 13 563226 5090 63930403
Cerebellar ischaemia 15.54 10.20 12 563227 143 63935350
Altered state of consciousness 15.51 10.20 235 563004 37667 63897826
Bradycardia 15.47 10.20 1216 562023 117003 63818490
Renal cyst 15.47 10.20 173 563066 12397 63923096
Posterior reversible encephalopathy syndrome 15.47 10.20 127 563112 22819 63912674
Cholecystitis chronic 15.41 10.20 136 563103 9151 63926342
Strongyloidiasis 15.35 10.20 4 563235 3086 63932407
Therapeutic drug monitoring analysis incorrectly performed 15.30 10.20 13 563226 179 63935314
Abortion induced 15.27 10.20 20 563219 6368 63929125
Weight decreased 15.20 10.20 2775 560464 282964 63652529
Anosognosia 15.20 10.20 3 563236 2802 63932691
Vascular purpura 15.16 10.20 53 563186 2503 63932990
Herpes zoster 15.14 10.20 552 562687 78635 63856858
Solar urticaria 15.13 10.20 9 563230 67 63935426
Thinking abnormal 15.11 10.20 51 563188 11505 63923988
Joint injury 15.02 10.20 128 563111 22819 63912674
Complication of device insertion 14.99 10.20 13 563226 4999 63930494
Retinal haemorrhage 14.94 10.20 26 563213 7372 63928121
Procalcitonin abnormal 14.92 10.20 16 563223 299 63935194
Weight increased 14.88 10.20 2103 561136 211245 63724248
Premature baby 14.86 10.20 5 563234 3267 63932226
Thrombosis prophylaxis 14.84 10.20 6 563233 16 63935477
Accidental death 14.78 10.20 7 563232 3718 63931775
Vitamin B12 deficiency 14.77 10.20 90 563149 5382 63930111
Dissociation 14.76 10.20 4 563235 3007 63932486
Hypotension 14.75 10.20 3644 559595 377330 63558163
Stasis dermatitis 14.71 10.20 31 563208 1080 63934413
Nocardiosis 14.70 10.20 12 563227 4755 63930738
Mixed liver injury 14.70 10.20 90 563149 5391 63930102
Dermatosis 14.62 10.20 20 563219 486 63935007
Arteriosclerotic gangrene 14.60 10.20 9 563230 72 63935421
Confabulation 14.57 10.20 19 563220 440 63935053
Drug dose omission by device 14.50 10.20 6 563233 3451 63932042
Hip arthroplasty 14.47 10.20 118 563121 21233 63914260
Sensory level abnormal 14.46 10.20 11 563228 128 63935365
Influenza like illness 14.45 10.20 419 562820 61283 63874210
Gastric ulcer 14.44 10.20 356 562883 29878 63905615
Full blood count abnormal 14.40 10.20 351 562888 29406 63906087
Incorrect dose administered by device 14.36 10.20 9 563230 4088 63931405
Biliary dilatation 14.30 10.20 48 563191 2220 63933273
Synovitis 14.29 10.20 713 562526 98377 63837116
Frequent bowel movements 14.28 10.20 232 563007 18073 63917420
Perihepatic abscess 14.25 10.20 11 563228 131 63935362
Hallucination 14.24 10.20 506 562733 72282 63863211
Activated partial thromboplastin time prolonged 14.20 10.20 173 563066 12658 63922835
Rash pruritic 14.16 10.20 387 562852 57017 63878476
Hepatitis acute 14.16 10.20 179 563060 13210 63922283
Device leakage 14.15 10.20 32 563207 8234 63927259
Bile duct stone 14.15 10.20 83 563156 4895 63930598
Ventricular arrhythmia 14.12 10.20 112 563127 7303 63928190
Drug abuser 14.07 10.20 18 563221 5790 63929703
Taste disorder 14.07 10.20 135 563104 9298 63926195
Haemophagocytic lymphohistiocytosis 14.01 10.20 93 563146 17516 63917977
Rapid eye movement sleep behaviour disorder 13.88 10.20 16 563223 325 63935168
Physical examination abnormal 13.87 10.20 14 563225 243 63935250
Enteritis 13.87 10.20 164 563075 11913 63923580
Stenosis 13.82 10.20 41 563198 1774 63933719
Gastrointestinal vascular malformation haemorrhagic 13.81 10.20 23 563216 668 63934825
Glomerulonephropathy 13.79 10.20 15 563224 285 63935208
Transplant rejection 13.79 10.20 92 563147 17309 63918184
Benign gastrointestinal neoplasm 13.78 10.20 11 563228 138 63935355
Systolic dysfunction 13.77 10.20 60 563179 3142 63932351
Abdominal wall wound 13.73 10.20 9 563230 81 63935412
Decreased appetite 13.63 10.20 2719 560520 278570 63656923
Anger 13.62 10.20 81 563158 15660 63919833
Anuria 13.56 10.20 237 563002 18727 63916766
Blood iron decreased 13.56 10.20 164 563075 11978 63923515
Prothrombin time shortened 13.51 10.20 55 563184 2794 63932699
Device deployment issue 13.40 10.20 4 563235 2822 63932671
Dyspepsia 13.27 10.20 842 562397 79470 63856023
BK virus infection 13.26 10.20 28 563211 7384 63928109
Rheumatoid nodule 13.25 10.20 61 563178 12590 63922903
Urine alcohol test positive 13.24 10.20 6 563233 23 63935470
Arterial stenosis 13.24 10.20 34 563205 1351 63934142
Second primary malignancy 13.21 10.20 59 563180 12278 63923215
Carcinoid tumour of the stomach 13.19 10.20 12 563227 182 63935311
Cognitive disorder 13.17 10.20 373 562866 54714 63880779
Rectal prolapse 13.15 10.20 39 563200 1687 63933806
Somatic symptom disorder 13.10 10.20 41 563198 1827 63933666
Graft versus host disease 13.08 10.20 69 563170 13744 63921749
Leptospirosis 13.05 10.20 6 563233 24 63935469
Lipoedema 12.98 10.20 12 563227 186 63935307
Intraventricular haemorrhage 12.97 10.20 71 563168 4082 63931411
Delusion 12.93 10.20 98 563141 17916 63917577
Activated partial thromboplastin time shortened 12.93 10.20 24 563215 761 63934732
Cryptococcosis 12.88 10.20 4 563235 2751 63932742
Pseudarthrosis 12.88 10.20 14 563225 266 63935227
Eosinophils urine present 12.88 10.20 8 563231 65 63935428
Meralgia paraesthetica 12.83 10.20 14 563225 267 63935226
Acute generalised exanthematous pustulosis 12.83 10.20 183 563056 13875 63921618
Petit mal epilepsy 12.82 10.20 15 563224 5017 63930476
Stoma site discharge 12.81 10.20 38 563201 1644 63933849
Disseminated tuberculosis 12.78 10.20 8 563231 3637 63931856
Cerebral haemorrhage 12.77 10.20 557 562682 50533 63884960
Anaphylactic shock 12.77 10.20 187 563052 30141 63905352
Pulmonary sepsis 12.76 10.20 57 563182 3018 63932475
Joint destruction 12.72 10.20 8 563231 3628 63931865
Hyperparathyroidism secondary 12.70 10.20 47 563192 2283 63933210
Nasal polyps 12.68 10.20 64 563175 3565 63931928
Upper respiratory tract irritation 12.63 10.20 9 563230 94 63935399
Dysphagia 12.59 10.20 1090 562149 105722 63829771
Flank pain 12.56 10.20 205 563034 15984 63919509
Alcohol use 12.52 10.20 13 563226 4589 63930904
Pregnancy 12.51 10.20 119 563120 20746 63914747
Puncture site haematoma 12.46 10.20 11 563228 160 63935333
Hypochloraemia 12.45 10.20 43 563196 2018 63933475
Toxic skin eruption 12.39 10.20 237 563002 19047 63916446
Dysphoria 12.39 10.20 12 563227 4376 63931117
Circulatory collapse 12.39 10.20 384 562855 33348 63902145
Stupor 12.38 10.20 21 563218 6014 63929479
Jejunostomy 12.36 10.20 7 563232 47 63935446
Inferior vena cava dilatation 12.35 10.20 23 563216 731 63934762
Xyphoid retraction 12.35 10.20 11 563228 162 63935331
Adrenal insufficiency 12.34 10.20 131 563108 22356 63913137
Scleritis 12.32 10.20 55 563184 2911 63932582
Apparent death 12.31 10.20 4 563235 2672 63932821
Incorrect route of product administration 12.28 10.20 137 563102 23161 63912332
Alveolar lung disease 12.27 10.20 19 563220 518 63934975
Bradyarrhythmia 12.24 10.20 65 563174 3693 63931800
Duodenogastric reflux 12.24 10.20 7 563232 48 63935445
Hypomania 12.23 10.20 19 563220 5635 63929858
Viral mutation identified 12.22 10.20 7 563232 3339 63932154
Spinal pain 12.21 10.20 166 563073 12455 63923038
Retro-orbital neoplasm 12.12 10.20 7 563232 49 63935444
Product administered at inappropriate site 12.10 10.20 6 563233 3104 63932389
Arthritis 12.10 10.20 603 562636 83211 63852282
Laboratory test abnormal 12.10 10.20 143 563096 23920 63911573
Autoimmune hepatitis 12.06 10.20 138 563101 9946 63925547
Autoimmune nephritis 12.01 10.20 19 563220 528 63934965
Drug interaction 11.87 10.20 3439 559800 358644 63576849
Unresponsive to stimuli 11.85 10.20 342 562897 50051 63885442
Oedema 11.85 10.20 669 562570 91266 63844227
Complication of device removal 11.78 10.20 7 563232 3273 63932220
Respiratory tract haemorrhage 11.76 10.20 34 563205 1450 63934043
Live birth 11.75 10.20 54 563185 11150 63924343
Maternal exposure before pregnancy 11.73 10.20 8 563231 3475 63932018
Neurosensory hypoacusis 11.72 10.20 12 563227 212 63935281
Fibrin D dimer increased 11.71 10.20 100 563139 6665 63928828
Tardive dyskinesia 11.67 10.20 41 563198 9137 63926356
Acute coronary syndrome 11.63 10.20 235 563004 19075 63916418
Virologic failure 11.62 10.20 8 563231 3458 63932035
Dermatitis allergic 11.60 10.20 191 563048 14918 63920575
Bladder hypertrophy 11.58 10.20 19 563220 545 63934948
Transfusion 11.51 10.20 221 563018 17773 63917720
Toxic neuropathy 11.47 10.20 23 563216 773 63934720
Erythema multiforme 11.47 10.20 85 563154 15616 63919877
Vitreous floaters 11.47 10.20 24 563215 6349 63929144
Vena cava injury 11.46 10.20 12 563227 218 63935275
Pulmonary interstitial emphysema syndrome 11.46 10.20 17 563222 446 63935047
Lumbar hernia 11.46 10.20 7 563232 55 63935438
Road traffic accident 11.45 10.20 194 563045 30551 63904942
Therapeutic reaction time decreased 11.40 10.20 40 563199 1892 63933601
Cytomegalovirus test positive 11.40 10.20 17 563222 5127 63930366
Left ventricular enlargement 11.38 10.20 21 563218 663 63934830
Lip oedema 11.36 10.20 81 563158 5108 63930385
Dental caries 11.35 10.20 52 563187 10748 63924745
Stress 11.34 10.20 423 562816 60111 63875382
Cerebral ischaemia 11.32 10.20 135 563104 9827 63925666
Hepatotoxicity 11.31 10.20 264 562975 39698 63895795
Intermenstrual bleeding 11.30 10.20 17 563222 5108 63930385
Base excess decreased 11.29 10.20 15 563224 354 63935139
Typical aura without headache 11.25 10.20 3 563236 0 63935493
Ulcerative duodenitis 11.25 10.20 3 563236 0 63935493
Bladder diverticulitis 11.25 10.20 3 563236 0 63935493
Vascular dissection 11.25 10.20 3 563236 0 63935493
Paronychia 11.22 10.20 25 563214 6467 63929026
Gastroenteritis viral 11.21 10.20 114 563125 19615 63915878
Hyperplastic cholecystopathy 11.21 10.20 9 563230 114 63935379
Breast cancer female 11.18 10.20 17 563222 5086 63930407
Hepatojugular reflux 11.15 10.20 18 563221 509 63934984
Gingival hypertrophy 11.15 10.20 5 563234 2742 63932751
Cardiovascular somatic symptom disorder 11.14 10.20 6 563233 36 63935457
Appendicitis 11.13 10.20 71 563168 13498 63921995
Thoracic vertebral fracture 11.12 10.20 73 563166 4480 63931013
Wound infection fungal 11.08 10.20 11 563228 187 63935306
Pneumocystis jirovecii pneumonia 11.08 10.20 172 563067 27462 63908031
Pancreatic duct stenosis 11.08 10.20 12 563227 227 63935266
Lymphatic fistula 11.04 10.20 22 563217 736 63934757
Heparin-induced thrombocytopenia 11.04 10.20 118 563121 8361 63927132
Autoimmune encephalopathy 11.04 10.20 8 563231 86 63935407
Lipase increased 11.03 10.20 182 563057 14220 63921273
Periodontitis 11.03 10.20 12 563227 4147 63931346
Bacteriuria 11.02 10.20 25 563214 917 63934576
Hepatitis B reactivation 10.99 10.20 16 563223 4873 63930620
Femoral hernia incarcerated 10.98 10.20 22 563217 739 63934754
Aortic dilatation 10.97 10.20 32 563207 1371 63934122
SJS-TEN overlap 10.97 10.20 17 563222 464 63935029
Procalcitonin increased 10.96 10.20 47 563192 2444 63933049
Cerebrovascular insufficiency 10.95 10.20 9 563230 118 63935375
Oesophageal variceal ligation 10.95 10.20 9 563230 118 63935375
Gastrointestinal inflammation 10.95 10.20 92 563147 6103 63929390
Throat clearing 10.93 10.20 31 563208 1307 63934186
Spontaneous haematoma 10.93 10.20 30 563209 1241 63934252
Alkalosis 10.92 10.20 16 563223 415 63935078
Diffuse large B-cell lymphoma recurrent 10.90 10.20 7 563232 3139 63932354
Rib deformity 10.89 10.20 9 563230 119 63935374
Pain in extremity 10.87 10.20 2411 560828 300674 63634819
Mitochondrial toxicity 10.87 10.20 5 563234 2701 63932792
Gait deviation 10.86 10.20 7 563232 61 63935432
Surgery 10.84 10.20 177 563062 28036 63907457
Immature granulocyte count increased 10.84 10.20 17 563222 469 63935024
Hyperammonaemia 10.83 10.20 47 563192 9857 63925636
Glaucoma 10.79 10.20 91 563148 16257 63919236
Monocyte count increased 10.78 10.20 113 563126 7966 63927527
Spontaneous haemorrhage 10.78 10.20 16 563223 420 63935073
Fatigue 10.78 10.20 6915 556324 741815 63193678
Occupational exposure to air contaminants 10.77 10.20 9 563230 121 63935372
Adjustment disorder 10.73 10.20 50 563189 2695 63932798
Tachypnoea 10.71 10.20 306 562933 26265 63909228
Hostility 10.69 10.20 3 563236 2204 63933289
Chronic actinic dermatitis 10.69 10.20 5 563234 21 63935472
Syringe issue 10.68 10.20 13 563226 4273 63931220
Prerenal failure 10.68 10.20 56 563183 3166 63932327
SARS-CoV-2 antibody test positive 10.67 10.20 12 563227 237 63935256
Metabolic surgery 10.67 10.20 24 563215 875 63934618
Perfume sensitivity 10.67 10.20 20 563219 639 63934854
Chest X-ray abnormal 10.66 10.20 97 563142 6584 63928909
Migraine 10.65 10.20 443 562796 62234 63873259
Injection site induration 10.63 10.20 41 563198 8891 63926602
Drug effective for unapproved indication 10.63 10.20 10 563229 3698 63931795
Biliary dyskinesia 10.63 10.20 45 563194 2327 63933166
Stomatitis 10.61 10.20 1103 562136 108502 63826991
Hypophysitis 10.55 10.20 60 563179 3499 63931994
Granulocytopenia 10.55 10.20 51 563188 10389 63925104
Hemiparesis 10.55 10.20 338 562901 29489 63906004
Tumour pain 10.54 10.20 39 563200 1894 63933599
Skin disorder 10.53 10.20 174 563065 27506 63907987
Cardiac aneurysm 10.52 10.20 30 563209 1269 63934224
Cell death 10.51 10.20 66 563173 3988 63931505
Oesophageal infection 10.51 10.20 18 563221 535 63934958
Neutrophil function disorder 10.51 10.20 5 563234 22 63935471
Myeloblast percentage decreased 10.50 10.20 6 563233 41 63935452
Demyelination 10.49 10.20 28 563211 6806 63928687
Granulomatous dermatitis 10.49 10.20 14 563225 332 63935161
Hyperprolactinaemia 10.48 10.20 12 563227 4053 63931440
Cystitis haemorrhagic 10.48 10.20 35 563204 7921 63927572
Soft tissue swelling 10.48 10.20 27 563212 1075 63934418
Rectal cancer metastatic 10.42 10.20 16 563223 433 63935060
Pharyngitis 10.42 10.20 111 563128 18928 63916565
Catatonia 10.40 10.20 33 563206 7587 63927906
Coma scale abnormal 10.38 10.20 34 563205 7740 63927753
Vascular stent stenosis 10.38 10.20 30 563209 1279 63934214
Injury associated with device 10.37 10.20 6 563233 2847 63932646
Abdominal wall cyst 10.36 10.20 4 563235 9 63935484
Feeling jittery 10.33 10.20 140 563099 10495 63924998
Blood glucose increased 10.33 10.20 727 562512 97346 63838147
Retching 10.32 10.20 189 563050 15067 63920426
Renal atrophy 10.30 10.20 35 563204 1629 63933864
Chondrocalcinosis pyrophosphate 10.30 10.20 35 563204 1629 63933864
Toothache 10.29 10.20 100 563139 17359 63918134
Acute respiratory distress syndrome 10.26 10.20 260 562979 38675 63896818
Dermatitis infected 10.24 10.20 11 563228 206 63935287
Craniocerebral injury 10.22 10.20 67 563172 4109 63931384

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.42 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 0378-6689 TABLET, DELAYED RELEASE 40 mg ORAL 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 0615-8308 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 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
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6870 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-096 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-096 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-429 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-429 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 27 sections