pantoprazole 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 ┬ÁM/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 730.52 9.73 2153 332896 113616 46237397
Chronic kidney disease 603.79 9.73 1066 333983 39805 46311208
Completed suicide 497.63 9.73 212 334837 145708 46205305
Drug ineffective 423.66 9.73 2992 332057 674846 45676167
Toxicity to various agents 394.10 9.73 568 334481 211198 46139815
Exposure during pregnancy 297.71 9.73 206 334843 108006 46243007
Maternal exposure during pregnancy 291.84 9.73 188 334861 102361 46248652
Haematochezia 271.98 9.73 734 334315 36759 46314254
Acute kidney injury 228.33 9.73 2642 332407 233213 46117800
Anaemia 190.01 9.73 2729 332320 253050 46097963
Product prescribing error 184.79 9.73 430 334619 19617 46331396
End stage renal disease 177.14 9.73 215 334834 5671 46345342
Death 168.00 9.73 1569 333480 333979 46017034
Rheumatoid arthritis 167.80 9.73 1023 334026 239192 46111821
Renal injury 156.77 9.73 261 334788 9280 46341733
Device expulsion 154.94 9.73 11 335038 27531 46323482
Pemphigus 153.82 9.73 66 334983 45208 46305805
Hyponatraemia 141.39 9.73 1225 333824 100107 46250906
Drug intolerance 135.81 9.73 568 334481 146481 46204532
Drug hypersensitivity 135.68 9.73 1109 333940 242716 46108297
Treatment failure 135.43 9.73 291 334758 92796 46258217
Abortion spontaneous 133.99 9.73 73 334976 43573 46307440
Off label use 132.23 9.73 1925 333124 377916 45973097
Hypomagnesaemia 127.52 9.73 400 334649 21810 46329203
Systemic lupus erythematosus 126.85 9.73 169 334880 65011 46286002
Injection site erythema 124.55 9.73 214 334835 74213 46276800
Intentional overdose 109.34 9.73 186 334863 64758 46286255
Abdominal pain upper 109.12 9.73 1554 333495 143751 46207262
Alopecia 108.98 9.73 700 334349 161714 46189299
Injection site pain 107.75 9.73 400 334649 106752 46244261
Injection site reaction 102.67 9.73 115 334934 47734 46303279
Tubulointerstitial nephritis 101.72 9.73 284 334765 14504 46336509
Hypokalaemia 100.64 9.73 1020 334029 87004 46264009
Orthostatic intolerance 96.35 9.73 74 334975 1080 46349933
Melaena 92.45 9.73 420 334629 27352 46323661
Drug abuse 89.10 9.73 202 334847 63206 46287807
Hand deformity 85.86 9.73 73 334976 34501 46316512
Abdominal pain 83.36 9.73 2201 332848 227830 46123183
Haematemesis 82.39 9.73 417 334632 28389 46322624
Asthenia 80.28 9.73 2855 332194 308220 46042793
Gastrointestinal haemorrhage 78.80 9.73 876 334173 76497 46274516
Hepatic function abnormal 75.75 9.73 81 334968 34340 46316673
Foetal exposure during pregnancy 73.84 9.73 67 334982 30680 46320333
Glossodynia 72.93 9.73 129 334920 44244 46306769
Cardio-respiratory arrest 70.84 9.73 208 334841 59661 46291352
Agranulocytosis 70.51 9.73 331 334718 21854 46329159
Injection site swelling 70.19 9.73 113 334936 40214 46310799
Renal failure 69.22 9.73 1173 333876 112421 46238592
Hypocalcaemia 69.21 9.73 377 334672 26408 46324605
Wrong technique in product usage process 68.90 9.73 183 334866 54239 46296774
Dyspnoea 68.70 9.73 4431 330618 511117 45839896
Respiratory arrest 64.44 9.73 89 334960 33727 46317286
No adverse event 64.33 9.73 91 334958 34140 46316873
Leukopenia 62.98 9.73 759 334290 67584 46283429
Gastritis 62.49 9.73 442 334607 33936 46317077
Subacute cutaneous lupus erythematosus 60.99 9.73 72 334977 1843 46349170
Arthropathy 60.96 9.73 357 334692 84343 46266670
Product monitoring error 60.65 9.73 73 334976 1908 46349105
Injection site pruritus 60.51 9.73 121 334928 39622 46311391
Blood loss anaemia 53.69 9.73 159 334890 8398 46342615
Product dose omission issue 50.72 9.73 877 334172 167643 46183370
Gastrooesophageal reflux disease 50.61 9.73 782 334267 73562 46277451
Drug resistance 49.15 9.73 32 335017 17336 46333677
Pneumonia viral 48.33 9.73 130 334919 6494 46344519
Overdose 48.23 9.73 483 334566 101496 46249517
Foetal death 47.74 9.73 4 335045 8739 46342274
Gastroenteritis clostridial 47.63 9.73 35 335014 476 46350537
Therapeutic product effect incomplete 45.42 9.73 351 334698 77802 46273211
Pregnancy 45.40 9.73 78 334971 27059 46323954
Therapeutic response decreased 44.70 9.73 159 334890 42986 46308027
Accidental exposure to product 43.77 9.73 52 334997 21029 46329984
Suicidal ideation 43.08 9.73 233 334816 56149 46294864
Rash 42.34 9.73 2109 332940 354403 45996610
Labelled drug-drug interaction medication error 42.10 9.73 152 334897 8909 46342104
Folliculitis 41.55 9.73 118 334931 6085 46344928
Anti-cyclic citrullinated peptide antibody positive 41.08 9.73 46 335003 19099 46331914
Hypertensive nephropathy 41.01 9.73 29 335020 370 46350643
Faecaloma 40.32 9.73 135 334914 7617 46343396
Premature delivery 40.16 9.73 60 334989 22009 46329004
Loss of personal independence in daily activities 40.09 9.73 243 334806 56940 46294073
Caesarean section 40.08 9.73 36 335013 16567 46334446
Anaphylactic reaction 39.74 9.73 221 334828 52891 46298122
Soft tissue disorder 38.80 9.73 90 334959 4096 46346917
Atrial fibrillation 38.54 9.73 995 334054 102595 46248418
Seizure 37.78 9.73 638 334411 122416 46228597
Clostridium difficile colitis 37.57 9.73 245 334804 18308 46332705
Angina pectoris 37.45 9.73 324 334725 26451 46324562
Abdominal discomfort 36.86 9.73 815 334234 150350 46200663
Live birth 36.81 9.73 14 335035 10316 46340697
Swelling 35.85 9.73 653 334396 123858 46227155
Injection site bruising 35.81 9.73 133 334916 35503 46315510
Rebound acid hypersecretion 35.76 9.73 23 335026 248 46350765
Hypoaesthesia 35.62 9.73 619 334430 118250 46232763
Haemoglobin decreased 35.52 9.73 1193 333856 127756 46223257
Dehydration 35.47 9.73 1441 333608 158099 46192914
Pallor 35.42 9.73 286 334763 22880 46328133
Stillbirth 35.36 9.73 3 335046 6488 46344525
Polyneuropathy 35.02 9.73 171 334878 11473 46339540
Muscle injury 35 9.73 95 334954 4771 46346242
Product quality issue 34.56 9.73 135 334914 35513 46315500
Electrolyte imbalance 33.98 9.73 226 334823 17000 46334013
Infusion related reaction 33.64 9.73 517 334532 100691 46250322
Breast cancer 33.19 9.73 191 334858 45327 46305686
Fall 33.17 9.73 2767 332282 326330 46024683
Intentional self-injury 33.12 9.73 78 334971 24088 46326925
Hypoparathyroidism secondary 33.06 9.73 13 335036 41 46350972
Blood pressure systolic increased 32.11 9.73 332 334717 28455 46322558
Injection site warmth 31.90 9.73 31 335018 13741 46337272
Eructation 31.90 9.73 120 334929 7175 46343838
Muscle spasticity 31.59 9.73 164 334885 11276 46339737
Therapeutic product effect decreased 31.31 9.73 411 334638 82190 46268823
Product used for unknown indication 31.29 9.73 28 335021 511 46350502
Intentional product misuse 31.11 9.73 204 334845 46924 46304089
Irritability 31.11 9.73 105 334944 28841 46322172
Musculoskeletal stiffness 31.08 9.73 505 334544 97488 46253525
Neuropathy peripheral 30.99 9.73 462 334587 90431 46260582
Genital haemorrhage 30.91 9.73 5 335044 6561 46344452
Drug dependence 30.80 9.73 60 334989 19841 46331172
Hip arthroplasty 30.35 9.73 52 334997 18060 46332953
Eosinophilia 30.34 9.73 239 334810 18978 46332035
Psoriasis 30.21 9.73 390 334659 78214 46272799
Dyspepsia 30.10 9.73 673 334376 67799 46283214
Product use in unapproved indication 30.04 9.73 461 334588 89812 46261201
Pulmonary embolism 30.00 9.73 1005 334044 107580 46243433
Painful respiration 29.76 9.73 60 334989 2477 46348536
Feeling abnormal 29.70 9.73 677 334372 124383 46226630
Ear pain 29.69 9.73 265 334784 21827 46329186
Hiatus hernia 29.66 9.73 229 334820 18073 46332940
Device issue 29.42 9.73 62 334987 19918 46331095
Restlessness 29.25 9.73 296 334753 25228 46325785
Synovitis 28.98 9.73 289 334760 60786 46290227
Gestational diabetes 28.87 9.73 8 335041 7211 46343802
Colitis ulcerative 28.81 9.73 222 334827 17510 46333503
Vomiting 28.11 9.73 3684 331365 449110 45901903
Therapy non-responder 27.74 9.73 177 334872 40975 46310038
Gamma-glutamyltransferase increased 27.71 9.73 349 334700 31391 46319622
Pancytopenia 27.66 9.73 803 334246 84255 46266758
Cholestasis 27.59 9.73 305 334744 26588 46324425
Diabetic nephropathy 27.42 9.73 41 335008 1327 46349686
Body temperature increased 27.39 9.73 286 334763 24575 46326438
Adverse event 27.38 9.73 139 334910 34045 46316968
Uterine perforation 27.34 9.73 9 335040 7258 46343755
Cardiac arrest 27.31 9.73 470 334579 89929 46261084
Cholecystitis chronic 27.27 9.73 148 334901 10351 46340662
Cardiac failure 27.17 9.73 759 334290 79189 46271824
Body temperature decreased 27.10 9.73 177 334872 13232 46337781
Depression 26.91 9.73 974 334075 169130 46181883
White blood cell count decreased 26.80 9.73 607 334442 111624 46239389
Haematoma 26.79 9.73 348 334701 31524 46319489
Pre-eclampsia 26.60 9.73 12 335037 7982 46343031
Dystonia 26.47 9.73 25 335024 11232 46339781
Hypotension 26.41 9.73 1974 333075 230615 46120398
Internal haemorrhage 26.27 9.73 81 334968 4374 46346639
Device use error 25.97 9.73 3 335046 5078 46345935
Hepatitis acute 25.69 9.73 122 334927 8092 46342921
Therapeutic drug monitoring analysis not performed 25.61 9.73 24 335025 466 46350547
Thrombocytopenia 25.57 9.73 1132 333917 125449 46225564
Premature baby 25.19 9.73 58 334991 18054 46332959
Knee arthroplasty 24.65 9.73 87 334962 23578 46327435
Nephrogenic anaemia 24.57 9.73 47 335002 1866 46349147
Duodenitis 24.53 9.73 65 334984 3218 46347795
Adverse drug reaction 24.49 9.73 202 334847 44160 46306853
Night sweats 24.38 9.73 301 334748 26949 46324064
Rapid eye movement sleep behaviour disorder 24.27 9.73 15 335034 150 46350863
Colitis erosive 24.23 9.73 12 335037 74 46350939
Coagulation test abnormal 24.17 9.73 27 335022 650 46350363
Febrile infection 24.11 9.73 37 335012 1226 46349787
Diarrhoea 23.98 9.73 4460 330589 555142 45795871
Gastric haemorrhage 23.81 9.73 95 334954 5839 46345174
Urinary tract infection enterococcal 23.53 9.73 53 334996 2365 46348648
Nausea 23.39 9.73 5418 329631 682036 45668977
Oesophagitis 23.35 9.73 173 334876 13478 46337535
Coma 23.35 9.73 287 334762 58062 46292951
Hepatitis cholestatic 22.98 9.73 102 334947 6575 46344438
Abnormal behaviour 22.89 9.73 76 334973 20982 46330031
Acute abdomen 22.66 9.73 40 335009 1492 46349521
Food allergy 22.44 9.73 104 334945 6829 46344184
Lactic acidosis 22.42 9.73 355 334694 33554 46317459
Device difficult to use 22.30 9.73 15 335034 7989 46343024
Somatic symptom disorder 22.17 9.73 45 335004 1867 46349146
Haematotoxicity 22.16 9.73 11 335038 6922 46344091
Device dislocation 22.15 9.73 81 334968 21721 46329292
Urosepsis 22.11 9.73 187 334862 15166 46335847
Neutrophil count decreased 22.08 9.73 202 334847 43224 46307789
Cerebral ischaemia 22.06 9.73 97 334952 6228 46344785
Malaise 22.03 9.73 2062 332987 329170 46021843
Peripheral swelling 21.89 9.73 1364 333685 156707 46194306
Hypertensive crisis 21.86 9.73 170 334879 13445 46337568
Hyperkalaemia 21.84 9.73 497 334552 50212 46300801
Drug reaction with eosinophilia and systemic symptoms 21.73 9.73 315 334734 29233 46321780
Injection site rash 21.70 9.73 51 334998 15762 46335251
Abortion induced 21.63 9.73 25 335024 10235 46340778
Nephritis allergic 21.61 9.73 14 335035 153 46350860
Gastric ulcer 21.54 9.73 246 334803 21617 46329396
Rectal haemorrhage 21.47 9.73 390 334659 37865 46313148
Trimethylaminuria 21.46 9.73 14 335035 155 46350858
Injection site urticaria 21.32 9.73 33 335016 11934 46339079
Brain contusion 21.28 9.73 23 335026 533 46350480
Reactive gastropathy 21.13 9.73 19 335030 349 46350664
Prothrombin time shortened 21.11 9.73 42 335007 1717 46349296
Neutropenic sepsis 21.00 9.73 35 335014 12289 46338724
Injection site haemorrhage 20.99 9.73 77 334972 20632 46330381
Breath sounds abnormal 20.87 9.73 111 334938 7704 46343309
Pancreatitis 20.83 9.73 434 334615 43193 46307820
Hypochromic anaemia 20.62 9.73 37 335012 1398 46349615
Prerenal failure 20.58 9.73 37 335012 1400 46349613
Dysuria 20.58 9.73 297 334752 27536 46323477
Product storage error 20.55 9.73 33 335016 11759 46339254
Drug withdrawal syndrome 20.45 9.73 114 334935 27270 46323743
Suicide attempt 20.43 9.73 275 334774 54761 46296252
Monoparesis 20.43 9.73 38 335011 1477 46349536
Synovial fluid analysis 20.39 9.73 36 335013 1343 46349670
Urinary tract obstruction 20.26 9.73 41 335008 1697 46349316
Glomerulonephropathy 20.16 9.73 11 335038 85 46350928
Irritable bowel syndrome 20.13 9.73 194 334855 16321 46334692
Product use issue 20.09 9.73 521 334528 94123 46256890
Tachyarrhythmia 20.09 9.73 76 334973 4556 46346457
Hepatitis 20.08 9.73 334 334715 31881 46319132
Device breakage 20.02 9.73 24 335025 9668 46341345
Syncope 20.02 9.73 932 334117 103871 46247142
Substance abuse 20.01 9.73 3 335046 4164 46346849
Dyspnoea exertional 19.86 9.73 487 334562 49802 46301211
Fracture 19.84 9.73 193 334856 16278 46334735
Neuropathy vitamin B12 deficiency 19.72 9.73 5 335044 0 46351013
Somnolence 19.68 9.73 920 334129 155601 46195412
Pharyngeal dystonia 19.55 9.73 6 335043 6 46351007
Pleural effusion 19.52 9.73 754 334295 82198 46268815
Chronic gastritis 19.42 9.73 49 335000 2354 46348659
Poisoning 19.31 9.73 45 335004 13949 46337064
Drug-induced liver injury 19.27 9.73 272 334777 25096 46325917
Peripheral arterial occlusive disease 19.21 9.73 65 334984 3687 46347326
Therapeutic drug monitoring analysis incorrectly performed 19.19 9.73 13 335036 154 46350859
Haemarthrosis 19.14 9.73 56 334993 2937 46348076
Arthralgia 19.11 9.73 2308 332741 362295 45988718
Hyperkinesia 19.09 9.73 41 335008 1771 46349242
Platelet count decreased 19.07 9.73 559 334490 99465 46251548
Underdose 19.00 9.73 74 334975 19484 46331529
Hepatic cyst 18.88 9.73 76 334973 4690 46346323
Flushing 18.85 9.73 338 334711 64276 46286737
Gastritis erosive 18.78 9.73 82 334967 5248 46345765
Pseudomembranous colitis 18.76 9.73 58 334991 3137 46347876
Tetany 18.57 9.73 40 335009 1731 46349282
Cellulitis 18.57 9.73 374 334675 69914 46281099
Nephropathy 18.41 9.73 78 334971 4927 46346086
Abdominal distension 18.28 9.73 671 334378 72680 46278333
Drug interaction 18.16 9.73 1693 333356 201401 46149612
Temperature regulation disorder 17.91 9.73 59 334990 3301 46347712
Biliary dyskinesia 17.85 9.73 52 334997 2721 46348292
Total lung capacity decreased 17.77 9.73 30 335019 1079 46349934
Disease progression 17.72 9.73 509 334540 90791 46260222
Clostridium test positive 17.72 9.73 41 335008 1863 46349150
Diverticulum intestinal 17.66 9.73 88 334961 5953 46345060
Hepatocellular injury 17.64 9.73 304 334745 29218 46321795
Joint stiffness 17.56 9.73 118 334931 26990 46324023
Incorrect dosage administered 17.51 9.73 38 335011 1653 46349360
Bradycardia 17.39 9.73 610 334439 65688 46285325
Gastrointestinal inflammation 17.37 9.73 69 334980 4232 46346781
Pain 17.32 9.73 3086 331963 473862 45877151
Blood parathyroid hormone decreased 17.25 9.73 5 335044 4376 46346637
Bursitis 17.25 9.73 218 334831 19624 46331389
Solar urticaria 17.19 9.73 8 335041 42 46350971
Pancreatic steatosis 17.19 9.73 28 335021 977 46350036
Haematocrit decreased 17.15 9.73 350 334699 34707 46316306
Disseminated intravascular coagulation 17.15 9.73 74 334975 18931 46332082
Deep vein thrombosis 17.13 9.73 718 334331 79055 46271958
Treatment noncompliance 17.04 9.73 134 334915 29597 46321416
Anxiety 17.04 9.73 1101 333948 180856 46170157
Arterial occlusive disease 17.00 9.73 74 334975 4730 46346283
Contraindicated product administered 16.99 9.73 440 334609 79507 46271506
Hepatitis B 16.97 9.73 3 335046 3690 46347323
Clostridium colitis 16.94 9.73 40 335009 1842 46349171
Drug eruption 16.92 9.73 87 334962 21242 46329771
Sensory level abnormal 16.91 9.73 12 335037 154 46350859
Carcinoid tumour of the stomach 16.85 9.73 12 335037 155 46350858
Paresis 16.82 9.73 42 335007 2004 46349009
Arterial stenosis 16.76 9.73 22 335027 629 46350384
Dysphoria 16.72 9.73 6 335043 4583 46346430
Neurotoxicity 16.70 9.73 47 335002 13670 46337343
Sedation complication 16.66 9.73 3 335046 3642 46347371
Vertigo 16.54 9.73 490 334559 51558 46299455
Clostridium difficile infection 16.29 9.73 262 334787 24841 46326172
Hepatic vein dilatation 16.26 9.73 6 335043 15 46350998
Subileus 16.25 9.73 53 334996 2950 46348063
Iron deficiency anaemia 16.24 9.73 192 334857 17014 46333999
Intestinal haemorrhage 16.05 9.73 54 334995 3054 46347959
Tenosynovitis stenosans 16.02 9.73 40 335009 1909 46349104
Neutrophil function disorder 15.98 9.73 6 335043 16 46350997
Therapeutic reaction time decreased 15.94 9.73 28 335021 1040 46349973
Maternal drugs affecting foetus 15.84 9.73 10 335039 5508 46345505
Strangury 15.82 9.73 5 335044 6 46351007
Shock 15.74 9.73 92 334957 21753 46329260
Systemic infection 15.74 9.73 22 335027 669 46350344
Sopor 15.63 9.73 214 334835 19614 46331399
Pseudarthrosis 15.62 9.73 17 335032 397 46350616
Abdominal wall wound 15.56 9.73 8 335041 54 46350959
Device malfunction 15.43 9.73 47 335002 13327 46337686
Presyncope 15.41 9.73 254 334795 24200 46326813
Amenorrhoea 15.40 9.73 25 335024 8870 46342143
Blood creatinine increased 15.36 9.73 683 334366 75720 46275293
Epigastric discomfort 15.36 9.73 81 334968 5603 46345410
Headache 15.35 9.73 3115 331934 475237 45875776
Anuria 15.30 9.73 137 334912 11294 46339719
Metabolic surgery 15.22 9.73 26 335023 944 46350069
Sedation 15.20 9.73 99 334950 22811 46328202
Vision blurred 15.06 9.73 446 334603 79262 46271751
Carotid arteriosclerosis 15.03 9.73 26 335023 954 46350059
Flatulence 15.03 9.73 291 334758 28587 46322426
Sleep disorder due to general medical condition, insomnia type 15.01 9.73 76 334973 5173 46345840
Renal haemangioma 15.01 9.73 7 335042 37 46350976
Hypertransaminasaemia 14.94 9.73 57 334992 3431 46347582
Hypochloraemia 14.93 9.73 38 335011 1835 46349178
Folate deficiency 14.91 9.73 36 335013 1682 46349331
Transaminases increased 14.87 9.73 281 334768 27480 46323533
Oedema peripheral 14.82 9.73 1335 333714 158371 46192642
Cachexia 14.81 9.73 71 334978 4728 46346285
Faecal calprotectin increased 14.77 9.73 37 335012 1769 46349244
Feeling jittery 14.77 9.73 132 334917 10876 46340137
Oesophageal dilatation 14.68 9.73 15 335034 325 46350688
Complication associated with device 14.63 9.73 59 334990 15382 46335631
Pulmonary renal syndrome 14.63 9.73 16 335033 376 46350637
Bicytopenia 14.58 9.73 35 335014 1629 46349384
Lipoedema 14.53 9.73 11 335038 157 46350856
Spinal pain 14.52 9.73 121 334928 9771 46341242
Mydriasis 14.51 9.73 34 335015 10519 46340494
Maternal exposure before pregnancy 14.49 9.73 7 335042 4474 46346539
Confusional state 14.45 9.73 1334 333715 158558 46192455
Gastric polyps 14.41 9.73 42 335007 2198 46348815
Productive cough 14.41 9.73 471 334578 50244 46300769
Glomerulonephritis chronic 14.35 9.73 11 335038 160 46350853
Agitation 14.29 9.73 296 334753 55119 46295894
Occupational asthma 14.18 9.73 10 335039 127 46350886
Tuberculosis 14.17 9.73 33 335016 10232 46340781
Type I hypersensitivity 14.16 9.73 43 335006 2303 46348710
Disorientation 14.12 9.73 356 334693 36562 46314451
Jaundice 14.12 9.73 288 334761 28557 46322456
Oesophageal candidiasis 13.98 9.73 74 334975 5126 46345887
Rapid correction of hyponatraemia 13.92 9.73 10 335039 131 46350882
Dermatitis allergic 13.89 9.73 145 334904 12458 46338555
Cerebellar ataxia 13.88 9.73 24 335025 880 46350133
Hyperplastic cholecystopathy 13.84 9.73 9 335040 99 46350914
Retroperitoneal haematoma 13.75 9.73 46 335003 2594 46348419
Complication of device removal 13.71 9.73 4 335045 3486 46347527
Atelectasis 13.69 9.73 200 334849 18590 46332423
Blood iron abnormal 13.67 9.73 3 335046 3167 46347846
Pruritus 13.64 9.73 1961 333088 240391 46110622
Mycotic allergy 13.60 9.73 18 335031 519 46350494
Inappropriate antidiuretic hormone secretion 13.59 9.73 158 334891 13944 46337069
Hypergastrinaemia 13.47 9.73 9 335040 104 46350909
Pain in jaw 13.43 9.73 194 334855 38178 46312835
Wound infection fungal 13.38 9.73 8 335041 75 46350938
Injection site discolouration 13.35 9.73 18 335031 6892 46344121
Sacroiliitis 13.32 9.73 40 335009 2129 46348884
Vitamin B12 decreased 13.27 9.73 47 335002 2728 46348285
Decreased appetite 13.25 9.73 1587 333462 192249 46158764
Spontaneous haemorrhage 13.23 9.73 11 335038 181 46350832
Infective pulmonary exacerbation of cystic fibrosis 13.18 9.73 37 335012 10770 46340243
Duodenal polyp 13.11 9.73 8 335041 78 46350935
Mood swings 13.06 9.73 66 334983 16186 46334827
Vaginal haemorrhage 13.06 9.73 119 334930 25485 46325528
Skin test positive 13.01 9.73 21 335028 727 46350286
Drug ineffective for unapproved indication 12.99 9.73 67 334982 16346 46334667
Food aversion 12.98 9.73 16 335033 429 46350584
Hypophysitis 12.97 9.73 30 335019 1363 46349650
International normalised ratio increased 12.96 9.73 434 334615 46449 46304564
Bacterial test 12.95 9.73 28 335021 1215 46349798
Respiratory disorder 12.84 9.73 271 334778 27029 46323984
Complication of device insertion 12.82 9.73 10 335039 4934 46346079
Enthesopathy 12.79 9.73 9 335040 4681 46346332
Blood pressure diastolic abnormal 12.67 9.73 83 334966 6211 46344802
Haemoptysis 12.66 9.73 261 334788 25928 46325085
Abdominal pain lower 12.62 9.73 218 334831 20963 46330050
Cholangitis acute 12.55 9.73 16 335033 444 46350569
Juvenile idiopathic arthritis 12.55 9.73 7 335042 4125 46346888
White blood cell count abnormal 12.54 9.73 11 335038 5121 46345892
Patent ductus arteriosus 12.54 9.73 6 335043 3856 46347157
Aortic valve stenosis 12.53 9.73 50 334999 3074 46347939
Pathogen resistance 12.52 9.73 15 335034 6045 46344968
Eosinophils urine present 12.44 9.73 5 335044 17 46350996
Spigelian hernia 12.39 9.73 6 335043 35 46350978
Thrombosis 12.34 9.73 506 334543 55563 46295450
Renal cyst 12.25 9.73 106 334943 8653 46342360
Device related bacteraemia 12.22 9.73 5 335044 18 46350995
Neuroleptic malignant syndrome 12.19 9.73 40 335009 11082 46339931
Glomerular filtration rate decreased 12.17 9.73 133 334916 11561 46339452
Intentional product use issue 12.16 9.73 287 334762 52493 46298520
Inflammatory marker increased 12.14 9.73 74 334975 5401 46345612
Enterochromaffin cell hyperplasia 12.13 9.73 7 335042 61 46350952
Surgery 12.12 9.73 140 334909 28645 46322368
Squamous cell carcinoma of the oral cavity 12.11 9.73 13 335036 299 46350714
Device deployment issue 12.07 9.73 5 335044 3498 46347515
Musculoskeletal disorder 12 9.73 64 334985 15481 46335532
Acute graft versus host disease 11.99 9.73 7 335042 4023 46346990
Application site pain 11.95 9.73 7 335042 4016 46346997
Deafness 11.94 9.73 67 334982 16001 46335012
Wheelchair user 11.87 9.73 7 335042 4001 46347012
Lethargy 11.86 9.73 278 334771 50893 46300120
Automatism epileptic 11.83 9.73 3 335046 0 46351013
Low density lipoprotein 11.83 9.73 3 335046 0 46351013
Arterial haemorrhage 11.82 9.73 33 335016 1685 46349328
Low birth weight baby 11.72 9.73 13 335036 5421 46345592
Escherichia infection 11.71 9.73 124 334925 10693 46340320
Pharyngitis 11.66 9.73 76 334973 17507 46333506
Vascular stent stenosis 11.63 9.73 17 335032 539 46350474
Blood pressure increased 11.62 9.73 1058 333991 125608 46225405
Myeloblast percentage decreased 11.61 9.73 6 335043 41 46350972
Dysphagia 11.60 9.73 672 334377 76640 46274373
Lung opacity 11.58 9.73 26 335023 1158 46349855
Grunting 11.56 9.73 11 335038 218 46350795
Frequent bowel movements 11.50 9.73 140 334909 12492 46338521
Ureteric stenosis 11.50 9.73 18 335031 607 46350406
Nightmare 11.38 9.73 71 334978 16527 46334486
Administration site discomfort 11.38 9.73 8 335041 101 46350912
Natural killer cell count decreased 11.37 9.73 6 335043 43 46350970
Dysentery 11.35 9.73 20 335029 745 46350268
Erysipelas 11.35 9.73 87 334962 6851 46344162
Micturition disorder 11.34 9.73 32 335017 1644 46349369
Arrhythmia 11.34 9.73 329 334720 34512 46316501
Bile duct stone 11.21 9.73 52 334997 3415 46347598
Pneumonia 11.17 9.73 2949 332100 373371 45977642
Gait deviation 11.16 9.73 7 335042 72 46350941
Wound treatment 11.15 9.73 10 335039 183 46350830
Neurofibrosarcoma 11.08 9.73 9 335040 143 46350870
Blood pressure diastolic decreased 11.05 9.73 153 334896 14058 46336955
Metabolic alkalosis 11.01 9.73 43 335006 2617 46348396
Upper gastrointestinal haemorrhage 10.98 9.73 175 334874 16563 46334450
Sputum discoloured 10.94 9.73 140 334909 12638 46338375
Gastrointestinal toxicity 10.93 9.73 9 335040 4322 46346691
Hypoparathyroidism 10.91 9.73 18 335031 635 46350378
Epstein-Barr virus infection 10.89 9.73 20 335029 6764 46344249
Foetal growth restriction 10.87 9.73 19 335030 6548 46344465
SJS-TEN overlap 10.83 9.73 9 335040 148 46350865
Faeces discoloured 10.82 9.73 175 334874 16612 46334401
Product administered to patient of inappropriate age 10.76 9.73 3 335046 2693 46348320
Lip erosion 10.72 9.73 20 335029 779 46350234
Psoriatic arthropathy 10.71 9.73 190 334859 36189 46314824
Red blood cell sedimentation rate increased 10.57 9.73 109 334940 22780 46328233
Pulmonary tuberculosis 10.56 9.73 11 335038 4720 46346293
Cholecystitis 10.55 9.73 154 334895 14312 46336701
Cushingoid 10.49 9.73 79 334970 6187 46344826
Neurosensory hypoacusis 10.48 9.73 12 335037 297 46350716
Constipation 10.43 9.73 1414 333635 172683 46178330
Head banging 10.41 9.73 14 335035 410 46350603
Leukoplakia oral 10.40 9.73 8 335041 117 46350896
Rectal cancer metastatic 10.38 9.73 11 335038 249 46350764
Hypersensitivity pneumonitis 10.35 9.73 39 335010 2334 46348679
C-reactive protein increased 10.33 9.73 517 334532 58073 46292940
Synovial cyst 10.33 9.73 89 334960 7257 46343756
Bronchitis chronic 10.33 9.73 58 334991 4109 46346904
Microgenia 10.32 9.73 4 335045 12 46351001
Lung adenocarcinoma stage III 10.32 9.73 4 335045 12 46351001
Osteochondrosis 10.28 9.73 22 335027 948 46350065
Right atrial enlargement 10.26 9.73 7 335042 84 46350929
Lymphatic fistula 10.25 9.73 21 335028 877 46350136
Soft tissue swelling 10.25 9.73 21 335028 877 46350136
Genital herpes simplex 10.25 9.73 9 335040 160 46350853
Intracranial mass 10.24 9.73 25 335024 1176 46349837
Pericarditis 10.22 9.73 116 334933 23811 46327202
Suspected suicide 10.22 9.73 11 335038 4650 46346363
Colitis 10.13 9.73 345 334704 37002 46314011
Serotonin syndrome 10.12 9.73 118 334931 24102 46326911
Medication error 10.09 9.73 292 334757 30619 46320394
Device dependence 10.08 9.73 4 335045 13 46351000
Intraocular pressure increased 10.08 9.73 17 335032 5940 46345073
Femoral hernia incarcerated 10.08 9.73 21 335028 888 46350125
Vibratory sense increased 10.07 9.73 5 335044 31 46350982
Stenosis 10.06 9.73 20 335029 817 46350196
Mixed liver injury 10.06 9.73 47 335002 3096 46347917
Pneumocystis jirovecii pneumonia 10.06 9.73 66 334983 15182 46335831
Laboratory test abnormal 10.06 9.73 110 334939 22737 46328276
Conjunctivitis 10.02 9.73 161 334888 15263 46335750
Multiple sclerosis relapse 10.00 9.73 228 334821 41897 46309116
White matter lesion 10.00 9.73 24 335025 1117 46349896
Swelling face 9.99 9.73 297 334752 52762 46298251
N-terminal prohormone brain natriuretic peptide increased 9.99 9.73 31 335018 1680 46349333
Mucous stools 9.97 9.73 40 335009 2465 46348548
Autoimmune nephritis 9.96 9.73 12 335037 314 46350699
Thiopurine methyltransferase decreased 9.96 9.73 12 335037 314 46350699
Gingivitis ulcerative 9.94 9.73 9 335040 167 46350846
Abnormal dreams 9.91 9.73 39 335010 10240 46340773
Panniculitis 9.91 9.73 16 335033 5688 46345325
Gastrointestinal wall thickening 9.90 9.73 21 335028 899 46350114
Musculoskeletal pain 9.85 9.73 606 334443 69522 46281491
Ulcer haemorrhage 9.84 9.73 50 334999 3408 46347605
Product complaint 9.80 9.73 49 335000 12052 46338961
Abnormal faeces 9.80 9.73 56 334993 3993 46347020
Retrograde portal vein flow 9.77 9.73 3 335046 3 46351010
Peripheral nerve paresis 9.77 9.73 3 335046 3 46351010
Tinea capitis 9.77 9.73 3 335046 3 46351010
Blood pressure ambulatory abnormal 9.77 9.73 3 335046 3 46351010
Cephalhaematoma 9.77 9.73 3 335046 3 46351010
Intestinal mucosal atrophy 9.77 9.73 3 335046 3 46351010
Poisoning deliberate 9.77 9.73 27 335022 7899 46343114
Oesophageal discomfort 9.76 9.73 9 335040 171 46350842
Helicobacter gastritis 9.74 9.73 28 335021 1454 46349559

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 696.07 10.55 1997 225692 97947 29626842
Toxicity to various agents 426.64 10.55 431 227258 176752 29548037
Completed suicide 394.74 10.55 132 227557 99360 29625429
Chronic kidney disease 312.73 10.55 806 226883 37032 29687757
Drug ineffective 311.27 10.55 1432 226257 338955 29385834
Drug abuse 264.89 10.55 147 227542 81925 29642864
Hypomagnesaemia 210.25 10.55 419 227270 16179 29708610
Product prescribing error 173.19 10.55 389 227300 16344 29708445
End stage renal disease 141.05 10.55 224 227465 7211 29717578
Death 139.67 10.55 1897 225792 355386 29369403
Anaemia 138.27 10.55 2284 225405 205708 29519081
Haematochezia 133.56 10.55 565 227124 33657 29691132
Hypocalcaemia 121.15 10.55 398 227291 20978 29703811
Hepatic function abnormal 98.44 10.55 104 227585 41841 29682948
Acute kidney injury 97.23 10.55 2746 224943 271096 29453693
Foetal exposure during pregnancy 96.36 10.55 83 227606 36788 29688001
Renal injury 82.93 10.55 236 227453 11493 29713296
Cholestasis 82.35 10.55 392 227297 24558 29700231
Overdose 78.24 10.55 352 227337 83985 29640804
Intentional product misuse 77.98 10.55 89 227600 34578 29690211
Product monitoring error 77.18 10.55 80 227609 1661 29723128
Intentional overdose 74.74 10.55 125 227564 41356 29683433
Melaena 67.98 10.55 451 227238 31986 29692803
Electrolyte imbalance 67.75 10.55 217 227472 11283 29713506
Haematemesis 66.66 10.55 383 227306 25820 29698969
Blood loss anaemia 63.49 10.55 163 227526 7464 29717325
Erysipelas 61.89 10.55 118 227571 4406 29720383
Hypokalaemia 61.71 10.55 618 227071 49574 29675215
Syncope 59.80 10.55 942 226747 83961 29640828
Respiratory arrest 59.64 10.55 81 227608 29177 29695612
Agranulocytosis 55.34 10.55 320 227369 21622 29703167
Abdominal pain 54.13 10.55 1382 226307 134272 29590517
Dyspnoea 53.99 10.55 3071 224618 330224 29394565
Gastrointestinal haemorrhage 50.39 10.55 903 226786 82543 29642246
Abdominal pain upper 49.86 10.55 709 226980 61842 29662947
Off label use 49.81 10.55 1479 226210 247811 29476978
Neuropathy peripheral 49.40 10.55 323 227366 70152 29654637
Cardiac arrest 49.01 10.55 460 227229 92390 29632399
Cardio-respiratory arrest 47.99 10.55 248 227441 57058 29667731
Hepatitis cholestatic 46.79 10.55 149 227540 7723 29717066
Drug resistance 46.02 10.55 51 227638 20082 29704707
Treatment failure 45.39 10.55 125 227564 34554 29690235
Irritability 44.80 10.55 66 227623 22984 29701805
Type I hypersensitivity 44.64 10.55 45 227644 903 29723886
Rectal haemorrhage 44.29 10.55 433 227256 34506 29690283
Hypoparathyroidism secondary 43.27 10.55 21 227668 115 29724674
Abnormal behaviour 42.74 10.55 81 227608 25542 29699247
Gastrointestinal bacterial overgrowth 41.73 10.55 17 227672 56 29724733
Musculoskeletal pain 40.48 10.55 386 227303 30554 29694235
Haematoma muscle 39.26 10.55 34 227655 558 29724231
Therapeutic product effect incomplete 39.22 10.55 129 227560 33705 29691084
Drug withdrawal syndrome 39.21 10.55 56 227633 19753 29705036
Subileus 39.16 10.55 78 227611 3009 29721780
Pallor 38.99 10.55 284 227405 20765 29704024
Feeling abnormal 38.32 10.55 263 227426 56493 29668296
Abdominal pain lower 38.06 10.55 150 227539 8648 29716141
Leukopenia 37.60 10.55 618 227071 55541 29669248
Hypoparathyroidism 37.52 10.55 30 227659 438 29724351
Shock haemorrhagic 37.02 10.55 161 227528 9704 29715085
Lower respiratory tract infection 36.69 10.55 94 227595 26620 29698169
Hypertensive nephropathy 36.64 10.55 29 227660 417 29724372
Product dose omission issue 36.45 10.55 484 227205 91147 29633642
Mucosal haemorrhage 36.42 10.55 50 227639 1408 29723381
Immune reconstitution inflammatory syndrome 36.17 10.55 12 227677 9089 29715700
Tachyarrhythmia 34.89 10.55 74 227615 2987 29721802
Therapeutic drug monitoring analysis not performed 34.71 10.55 27 227662 378 29724411
Interstitial lung disease 34.48 10.55 292 227397 59905 29664884
Insomnia 34.27 10.55 501 227188 92835 29631954
Neutrophil count decreased 34.27 10.55 186 227503 42268 29682521
Systemic infection 33.98 10.55 34 227655 676 29724113
Febrile infection 33.67 10.55 52 227637 1633 29723156
Malaise 33.67 10.55 989 226700 165973 29558816
Premature baby 33.22 10.55 47 227642 16644 29708145
Acute abdomen 33.10 10.55 53 227636 1718 29723071
Suicidal ideation 32.70 10.55 152 227537 35962 29688827
Drug hypersensitivity 32.58 10.55 348 227341 68171 29656618
Stomatitis 31.96 10.55 160 227529 37119 29687670
Gastritis 31.58 10.55 262 227427 19936 29704853
Gastrooesophageal reflux disease 31.28 10.55 379 227310 31876 29692913
Platelet count decreased 31.01 10.55 594 227095 105535 29619254
Agitation 30.65 10.55 263 227426 53810 29670979
Seizure 30.06 10.55 547 227142 97928 29626861
C-reactive protein increased 29.69 10.55 480 227209 42993 29681796
Asthenia 29.57 10.55 2006 225683 219284 29505505
Nephrogenic anaemia 29.52 10.55 56 227633 2083 29722706
Suicide attempt 29.49 10.55 161 227528 36536 29688253
Haematoma 29.45 10.55 295 227394 23658 29701131
Labelled drug-drug interaction medication error 29.44 10.55 158 227531 10380 29714409
Hyperlipasaemia 29.42 10.55 27 227662 480 29724309
Pathogen resistance 28.67 10.55 14 227675 8396 29716393
Tetanus 28.29 10.55 12 227677 45 29724744
Fracture 28.11 10.55 105 227584 5901 29718888
Intentional self-injury 28.04 10.55 37 227652 13495 29711294
Exposure during pregnancy 27.86 10.55 18 227671 9243 29715546
Drug dependence 27.68 10.55 77 227612 21218 29703571
Visual acuity reduced 27.39 10.55 49 227640 15797 29708992
Rash 26.79 10.55 1189 226500 190700 29534089
Liver disorder 26.38 10.55 126 227563 29596 29695193
Psychotic disorder 26.36 10.55 80 227609 21435 29703354
Wrong technique in product usage process 25.97 10.55 135 227554 31020 29693769
Polyneuropathy 25.74 10.55 166 227523 11657 29713132
Aggression 25.42 10.55 170 227519 36737 29688052
Vitamin B12 deficiency 25.22 10.55 59 227630 2546 29722243
Thrombocytopenia 25.09 10.55 1278 226411 135766 29589023
Myocardial infarction 25.09 10.55 745 226944 124880 29599909
Cardiac failure congestive 24.47 10.55 473 227216 83934 29640855
Cytomegalovirus infection 24.29 10.55 95 227594 23579 29701210
Oedema peripheral 24.13 10.55 1009 226680 104823 29619966
Occupational dermatitis 24.12 10.55 12 227677 70 29724719
Colitis microscopic 24.01 10.55 45 227644 1658 29723131
Atrial fibrillation 24.00 10.55 1028 226661 107096 29617693
Hyponatraemia 23.71 10.55 674 227015 66528 29658261
Solar lentigo 23.51 10.55 20 227669 320 29724469
Hepatocellular injury 23.28 10.55 296 227393 25175 29699614
Synovitis 23.23 10.55 24 227665 9759 29715030
Bradyarrhythmia 23.19 10.55 48 227641 1904 29722885
Fear of disease 23.02 10.55 17 227672 219 29724570
Product use in unapproved indication 22.90 10.55 408 227281 73285 29651504
Acute graft versus host disease 22.84 10.55 8 227681 5856 29718933
Dysplastic naevus 22.52 10.55 20 227669 340 29724449
Headache 22.19 10.55 1146 226543 181160 29543629
Rebound acid hypersecretion 22.17 10.55 10 227679 45 29724744
Hydrocholecystis 22.00 10.55 16 227673 201 29724588
Vertigo 21.96 10.55 266 227423 22369 29702420
Psoriasis 21.80 10.55 212 227477 42294 29682495
Tetany 21.80 10.55 28 227661 738 29724051
Injection site pain 21.69 10.55 138 227551 30172 29694617
Serum ferritin decreased 21.56 10.55 22 227667 448 29724341
Chronic graft versus host disease 21.28 10.55 3 227686 4116 29720673
Upper gastrointestinal haemorrhage 21.00 10.55 258 227431 21770 29703019
Low birth weight baby 20.89 10.55 10 227679 6066 29718723
Sedation 20.69 10.55 60 227629 16313 29708476
Paresis 20.45 10.55 44 227645 1794 29722995
Depression 20.44 10.55 527 227162 89910 29634879
Troponin increased 20.30 10.55 126 227563 8731 29716058
Accidental overdose 20.27 10.55 71 227618 18204 29706585
Injection site haemorrhage 20.13 10.55 18 227671 7837 29716952
Cerebral infarction 19.95 10.55 118 227571 26255 29698534
Poisoning 19.85 10.55 35 227654 11347 29713442
Drug interaction 19.84 10.55 1768 225921 197800 29526989
Dyspnoea exertional 19.82 10.55 379 227310 35051 29689738
Joint swelling 19.75 10.55 245 227444 46701 29678088
Anxiety 19.71 10.55 526 227163 89345 29635444
Rheumatoid arthritis 19.67 10.55 209 227480 40988 29683801
Microcytic anaemia 19.65 10.55 48 227641 2130 29722659
Foetal malformation 19.62 10.55 13 227676 139 29724650
Respiratory depression 19.50 10.55 36 227653 11467 29713322
Cardiac failure 19.39 10.55 797 226892 82621 29642168
Arrhythmia 19.31 10.55 357 227332 32812 29691977
Photodermatosis 19.30 10.55 20 227669 415 29724374
Abnormal dreams 19.16 10.55 20 227669 8095 29716694
Peritoneal dialysis complication 19.14 10.55 4 227685 4123 29720666
Urticaria 19.04 10.55 296 227393 54310 29670479
Neuroleptic malignant syndrome 18.97 10.55 62 227627 16233 29708556
Gamma-glutamyltransferase increased 18.90 10.55 321 227368 29029 29695760
Drug reaction with eosinophilia and systemic symptoms 18.87 10.55 313 227376 28175 29696614
Injection site erythema 18.75 10.55 49 227640 13785 29711004
Normocytic anaemia 18.58 10.55 37 227652 1427 29723362
Nightmare 18.58 10.55 40 227649 12036 29712753
Gravitational oedema 18.47 10.55 23 227666 587 29724202
Occupational exposure to air contaminants 18.30 10.55 9 227680 51 29724738
Serotonin syndrome 18.22 10.55 72 227617 17819 29706970
Cerebellar ischaemia 18.18 10.55 11 227678 99 29724690
Intestinal angioedema 18.17 10.55 13 227676 159 29724630
Subacute cutaneous lupus erythematosus 18.05 10.55 24 227665 655 29724134
Mania 17.99 10.55 26 227663 9128 29715661
Drug screen false positive 17.94 10.55 25 227664 714 29724075
Therapeutic response decreased 17.86 10.55 110 227579 24239 29700550
Mood swings 17.78 10.55 19 227670 7607 29717182
Dizziness 17.60 10.55 1715 225974 193194 29531595
Memory impairment 17.58 10.55 189 227500 36985 29687804
Eosinophilia 17.57 10.55 251 227438 21909 29702880
Lactic acidosis 17.50 10.55 334 227355 30879 29693910
Infective exacerbation of chronic obstructive airways disease 17.50 10.55 36 227653 1422 29723367
Mean cell haemoglobin concentration 17.23 10.55 8 227681 39 29724750
Urinary hesitation 17.17 10.55 47 227642 2237 29722552
Disorganised speech 17.11 10.55 21 227668 528 29724261
Cold sweat 17.08 10.55 123 227566 8959 29715830
Cachexia 17.05 10.55 97 227592 6514 29718275
Product quality issue 17.00 10.55 79 227610 18695 29706094
Base excess decreased 16.93 10.55 14 227675 215 29724574
Peripheral arterial occlusive disease 16.90 10.55 81 227608 5087 29719702
Disease progression 16.86 10.55 470 227219 79404 29645385
Accidental exposure to product 16.84 10.55 32 227657 10083 29714706
Hypersensitivity 16.82 10.55 299 227390 53729 29671060
Perihepatic abscess 16.81 10.55 10 227679 87 29724702
Osteochondrosis 16.75 10.55 24 227665 704 29724085
Burns second degree 16.44 10.55 17 227672 352 29724437
Post transplant lymphoproliferative disorder 16.39 10.55 10 227679 5296 29719493
Injection site swelling 16.24 10.55 26 227663 8754 29716035
Trisomy 18 16.20 10.55 14 227675 229 29724560
Mean cell haemoglobin decreased 16.10 10.55 31 227658 1166 29723623
Fall 16.08 10.55 1598 226091 180274 29544515
Lower gastrointestinal haemorrhage 16.01 10.55 109 227580 7795 29716994
Glomerular filtration rate decreased 15.99 10.55 144 227545 11218 29713571
No adverse event 15.95 10.55 73 227616 17346 29707443
Erectile dysfunction 15.91 10.55 77 227612 18025 29706764
Withdrawal syndrome 15.90 10.55 39 227650 11211 29713578
Jaundice 15.69 10.55 340 227349 32146 29692643
Renal haemangioma 15.60 10.55 7 227682 31 29724758
Chest injury 15.57 10.55 33 227656 1331 29723458
Duodenogastric reflux 15.55 10.55 4 227685 0 29724789
Adverse event 15.46 10.55 62 227627 15279 29709510
Anaphylactic reaction 15.45 10.55 137 227552 27845 29696944
Respiratory tract haemorrhage 15.35 10.55 25 227664 822 29723967
Apparent death 15.30 10.55 4 227685 3538 29721251
Serum ferritin abnormal 15.28 10.55 13 227676 208 29724581
Hallucination 15.11 10.55 272 227417 48787 29676002
Pulpitis dental 15.09 10.55 17 227672 389 29724400
Gastrointestinal pain 15.03 10.55 50 227639 2652 29722137
Dermatitis infected 15.01 10.55 10 227679 108 29724681
Angina pectoris 14.92 10.55 311 227378 29207 29695582
Polypectomy 14.90 10.55 19 227670 497 29724292
Gastritis erosive 14.90 10.55 83 227606 5530 29719259
Procalcitonin abnormal 14.86 10.55 10 227679 110 29724679
Mastitis 14.80 10.55 12 227677 179 29724610
Upper motor neurone lesion 14.78 10.55 10 227679 111 29724678
Pulmonary embolism 14.76 10.55 731 226958 77404 29647385
Granulomatous dermatitis 14.73 10.55 13 227676 219 29724570
Thrombocytosis 14.61 10.55 58 227631 3355 29721434
Altered state of consciousness 14.61 10.55 90 227599 19829 29704960
Osteonecrosis 14.55 10.55 68 227621 16067 29708722
Wound haemorrhage 14.53 10.55 38 227651 1760 29723029
Body temperature decreased 14.43 10.55 124 227565 9531 29715258
Flushing 14.33 10.55 149 227540 29343 29695446
Ascites 14.30 10.55 366 227323 35555 29689234
Injection site bruising 14.27 10.55 21 227668 7317 29717472
Jugular vein distension 14.22 10.55 19 227670 521 29724268
Injection site phlebitis 14.18 10.55 7 227682 40 29724749
Faecal calprotectin increased 14.12 10.55 29 227660 1144 29723645
Pancreatitis acute 14.08 10.55 274 227415 25421 29699368
Drug abuser 14.01 10.55 8 227681 4393 29720396
Presyncope 14.00 10.55 185 227504 15871 29708918
Sexual dysfunction 13.94 10.55 15 227674 5986 29718803
Product use issue 13.90 10.55 256 227433 45760 29679029
Anger 13.87 10.55 41 227648 11079 29713710
Disseminated intravascular coagulation 13.86 10.55 105 227584 22066 29702723
Faeces pale 13.81 10.55 33 227656 1444 29723345
Thrombophlebitis 13.74 10.55 50 227639 2774 29722015
Product storage error 13.73 10.55 17 227672 6374 29718415
Urinary straining 13.70 10.55 5 227684 11 29724778
Puncture site haematoma 13.68 10.55 11 227678 162 29724627
Device issue 13.66 10.55 24 227665 7792 29716997
Rash maculo-papular 13.57 10.55 270 227419 25148 29699641
Iron deficiency anaemia 13.54 10.55 116 227573 8908 29715881
Hypertransaminasaemia 13.52 10.55 62 227627 3823 29720966
Uveitis 13.50 10.55 13 227676 5464 29719325
Drug eruption 13.48 10.55 78 227611 17448 29707341
Leptospirosis 13.48 10.55 6 227683 26 29724763
Autoimmune colitis 13.45 10.55 23 227666 788 29724001
Food aversion 13.42 10.55 14 227675 293 29724496
Drug use disorder 13.41 10.55 4 227685 3244 29721545
Multiple-drug resistance 13.33 10.55 3 227686 2938 29721851
Myelocyte count increased 13.32 10.55 8 227681 71 29724718
Arteriosclerotic gangrene 13.32 10.55 8 227681 71 29724718
Muscular weakness 13.30 10.55 375 227314 63270 29661519
Benign gastrointestinal neoplasm 13.22 10.55 10 227679 134 29724655
Atrial septal defect 13.20 10.55 19 227670 6682 29718107
Gastrooesophageal sphincter insufficiency 13.13 10.55 8 227681 73 29724716
Post procedural haemorrhage 13.12 10.55 104 227585 7806 29716983
Product prescribing issue 13.00 10.55 23 227666 810 29723979
Jejunostomy 12.96 10.55 6 227683 29 29724760
Drug ineffective for unapproved indication 12.94 10.55 41 227648 10839 29713950
Substance abuse 12.87 10.55 21 227668 7019 29717770
Thrombotic microangiopathy 12.85 10.55 29 227660 8581 29716208
Lethargy 12.85 10.55 217 227472 39302 29685487
Device leakage 12.82 10.55 6 227683 3688 29721101
Therapy partial responder 12.80 10.55 6 227683 3685 29721104
Hiatus hernia 12.75 10.55 95 227594 6995 29717794
Hyperkinesia 12.73 10.55 40 227649 2058 29722731
Erythropenia 12.73 10.55 12 227677 221 29724568
Hepatorenal syndrome 12.68 10.55 45 227644 2466 29722323
Hyperreflexia 12.66 10.55 3 227686 2836 29721953
Bladder tamponade 12.65 10.55 16 227673 415 29724374
Diverticulum intestinal 12.65 10.55 54 227635 3228 29721561
Blood pressure fluctuation 12.60 10.55 195 227494 17308 29707481
Cytomegalovirus viraemia 12.56 10.55 15 227674 5714 29719075
Rhythm idioventricular 12.54 10.55 13 227676 270 29724519
Renal cyst 12.53 10.55 103 227586 7814 29716975
Phlebitis infective 12.40 10.55 10 227679 148 29724641
Eosinophilic pneumonia 12.36 10.55 47 227642 2664 29722125
Failure to suspend medication 12.36 10.55 8 227681 82 29724707
Hospitalisation 12.34 10.55 250 227439 44069 29680720
Hypochromic anaemia 12.29 10.55 22 227667 782 29724007
Chronic kidney disease-mineral and bone disorder 12.28 10.55 15 227674 375 29724414
Tuberculosis 12.22 10.55 27 227662 8050 29716739
Weight decreased 12.18 10.55 1318 226371 149603 29575186
Paranasal sinus discomfort 12.18 10.55 19 227670 602 29724187
Seroma 12.18 10.55 19 227670 602 29724187
Alveolar lung disease 12.16 10.55 15 227674 379 29724410
Acute coronary syndrome 12.09 10.55 157 227532 13416 29711373
Bicytopenia 12.01 10.55 35 227654 1727 29723062
Acute graft versus host disease in skin 12.00 10.55 10 227679 4506 29720283
Arteriovenous fistula 11.95 10.55 19 227670 612 29724177
Prolonged expiration 11.87 10.55 11 227678 198 29724591
Pulmonary sepsis 11.87 10.55 38 227651 1975 29722814
Haemorrhagic disorder 11.85 10.55 18 227671 557 29724232
Intestinal haemorrhage 11.82 10.55 52 227637 3149 29721640
Confabulation 11.81 10.55 9 227680 122 29724667
Macrocytosis 11.78 10.55 23 227666 874 29723915
Miosis 11.76 10.55 26 227663 7750 29717039
Splenic thrombosis 11.74 10.55 5 227684 19 29724770
Dyspnoea at rest 11.73 10.55 45 227644 2561 29722228
Bronchial obstruction 11.73 10.55 31 227658 1445 29723344
Treatment noncompliance 11.70 10.55 129 227560 25124 29699665
Resting tremor 11.68 10.55 18 227671 564 29724225
Bladder diverticulitis 11.66 10.55 3 227686 0 29724789
Spinal cord herniation 11.66 10.55 3 227686 0 29724789
Pulmonary fistula 11.66 10.55 6 227683 38 29724751
Saliva altered 11.65 10.55 10 227679 162 29724627
Renal impairment 11.64 10.55 522 227167 83662 29641127
Hypovolaemic shock 11.63 10.55 87 227602 6413 29718376
Status epilepticus 11.63 10.55 44 227645 11028 29713761
Haematoma infection 11.63 10.55 24 227665 950 29723839
Generalised tonic-clonic seizure 11.57 10.55 94 227595 19457 29705332
Lymphoedema 11.56 10.55 55 227634 3444 29721345
Graft versus host disease 11.55 10.55 39 227650 10111 29714678
Degenerative aortic valve disease 11.54 10.55 5 227684 20 29724769
Peripheral paralysis 11.53 10.55 6 227683 39 29724750
Helicobacter gastritis 11.51 10.55 22 227667 823 29723966
Tricuspid valve incompetence 11.48 10.55 108 227581 8515 29716274
Xyphoid retraction 11.45 10.55 10 227679 166 29724623
Peritonitis bacterial 11.45 10.55 46 227643 11332 29713457
Cardiotoxicity 11.45 10.55 10 227679 4404 29720385
Chronic actinic dermatitis 11.35 10.55 5 227684 21 29724768
Neoplasm malignant 11.31 10.55 84 227605 17730 29707059
Oxygen consumption decreased 11.31 10.55 10 227679 169 29724620
Hypogammaglobulinaemia 11.26 10.55 14 227675 5238 29719551
Lip ulceration 11.24 10.55 21 227668 772 29724017
Inflammatory marker increased 11.18 10.55 51 227638 3137 29721652
Therapy non-responder 11.18 10.55 157 227532 29296 29695493
Painful respiration 11.16 10.55 28 227661 1264 29723525
Road traffic accident 11.08 10.55 80 227609 16991 29707798
Adenocarcinoma gastric 11.07 10.55 26 227663 1125 29723664
Renal artery thrombosis 11.06 10.55 13 227676 312 29724477
Listeria encephalitis 11.05 10.55 6 227683 43 29724746
Meralgia paraesthetica 11.02 10.55 10 227679 175 29724614
Hyperferritinaemia 11.01 10.55 14 227675 365 29724424
Ureteric dilatation 11.00 10.55 9 227680 136 29724653
Suture rupture 10.99 10.55 14 227675 366 29724423
Renal failure 10.93 10.55 1130 226559 127836 29596953
Electrocardiogram QT prolonged 10.91 10.55 353 227336 35482 29689307
Oesophageal infection 10.90 10.55 11 227678 221 29724568
Bone marrow failure 10.87 10.55 160 227529 29625 29695164
Euphoric mood 10.79 10.55 10 227679 4280 29720509
Influenza virus test positive 10.77 10.55 8 227681 104 29724685
Myalgia 10.67 10.55 475 227214 76192 29648597
Vasculitis 10.60 10.55 100 227589 7890 29716899
Pneumonia cytomegaloviral 10.57 10.55 4 227685 2792 29721997
Pancreatic duct stenosis 10.57 10.55 10 227679 185 29724604

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 agents
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (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

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)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 40MG BASE PANTOPRAZOLE SODIUM SUN PHARM A213725 June 30, 2020 RX FOR SUSPENSION, DELAYED RELEASE ORAL Feb. 9, 2021 PATENT CHALLENGE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Potassium-transporting ATPase Transporter INHIBITOR CHEMBL CHEMBL
Solute carrier family 22 member 2 Transporter IC50 5.82 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 4.36 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 5.55 CHEMBL
Sodium/potassium-transporting ATPase subunit alpha-1 Transporter WOMBAT-PK
Fatty acid synthase Enzyme Ki 5.39 CHEMBL
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
CHEMBL1200408 ChEMBL_ID
CHEMBL3989559 ChEMBL_ID
D000077402 MESH_DESCRIPTOR_UI
DB00213 DRUGBANK_ID
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 0008-0843 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 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 0008-4001 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 0143-9300 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 0615-7916 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 29 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 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 0904-6870 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 13668-429 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
PANTOPRAZOLE SODIUMDELAYED RELEASE HUMAN PRESCRIPTION DRUG LABEL 1 16590-635 TABLET, DELAYED RELEASE 20 mg ORAL NDA 30 sections
PROTONIXDELAYED-RELEASE HUMAN PRESCRIPTION DRUG LABEL 1 16590-939 TABLET, DELAYED RELEASE 20 mg ORAL NDA 30 sections
Protonix HUMAN PRESCRIPTION DRUG LABEL 1 21695-108 TABLET, DELAYED RELEASE 40 mg ORAL NDA 27 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-771 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
PANTOPRAZOLE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 31722-712 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 26 sections
PANTOPRAZOLE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 31722-713 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 26 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 33261-629 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 29 sections
Pantoprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 33358-536 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Pantoprazole Sodium Human Prescription Drug Label 1 35573-428 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
PANTOPRAZOLE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 42254-124 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
PANTOPRAZOLE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 42291-765 TABLET, DELAYED RELEASE 40 mg ORAL ANDA 26 sections