omeprazole Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antiulcer, benzimidazole derivatives 1990 73590-58-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • omeprazole sodium
  • omeprazole
  • omeprazole magnesium
  • omeprazole sodium bicarbonate
A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
  • Molecular weight: 345.42
  • Formula: C17H19N3O3S
  • CLOGP: 2.57
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 77.10
  • ALOGS: -2.98
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
20 mg O
20 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.50 mg/mL 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) 5.79 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.24 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.05 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.58 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 14, 1989 FDA ASTRAZENECA PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 661.45 9.76 3035 374674 674803 45633550
Chronic kidney disease 539.23 9.76 1088 376621 39783 46268570
Rheumatoid arthritis 523.56 9.76 707 377002 239508 46068845
Hypomagnesaemia 459.46 9.76 720 376989 21490 46286863
Tubulointerstitial nephritis 404.30 9.76 547 377162 14241 46294112
Contraindicated product administered 353.12 9.76 104 377605 79843 46228510
Treatment failure 345.73 9.76 160 377549 92927 46215426
Drug intolerance 343.73 9.76 410 377299 146639 46161714
Drug hypersensitivity 328.43 9.76 952 376757 242873 46065480
Synovitis 318.63 9.76 55 377654 61020 46247333
Pemphigus 310.05 9.76 13 377696 45261 46263092
Completed suicide 307.02 9.76 440 377269 145480 46162873
Off label use 298.62 9.76 1826 375883 378015 45930338
Maternal exposure during pregnancy 280.22 9.76 250 377459 102299 46206054
Acute kidney injury 241.76 9.76 2943 374766 232912 46075441
Drug interaction 232.47 9.76 2589 375120 200505 46107848
Hyponatraemia 228.46 9.76 1503 376206 99829 46208524
Exposure during pregnancy 185.43 9.76 372 377337 107840 46200513
Toxicity to various agents 181.00 9.76 990 376719 210776 46097577
Drug abuse 177.50 9.76 151 377558 63257 46245096
Hand deformity 176.27 9.76 33 377676 34541 46273812
Renal injury 169.77 9.76 289 377420 9252 46299101
Hypocalcaemia 160.84 9.76 530 377179 26255 46282098
Systemic lupus erythematosus 159.46 9.76 175 377534 65005 46243348
Subacute cutaneous lupus erythematosus 153.59 9.76 126 377583 1789 46306564
End stage renal disease 152.24 9.76 212 377497 5674 46302679
Therapeutic product effect decreased 149.30 9.76 275 377434 82326 46226027
Rheumatoid factor positive 139.67 9.76 6 377703 20455 46287898
Abortion spontaneous 134.79 9.76 94 377615 43552 46264801
Anti-cyclic citrullinated peptide antibody positive 129.41 9.76 6 377703 19139 46289214
Therapeutic product effect incomplete 122.75 9.76 282 377427 77871 46230482
Joint swelling 119.04 9.76 820 376889 165253 46143100
Gastrooesophageal reflux disease 115.20 9.76 1010 376699 73334 46235019
Glossodynia 109.78 9.76 118 377591 44255 46264098
C-reactive protein abnormal 109.07 9.76 20 377689 21250 46287103
Wound 103.49 9.76 116 377593 42686 46265667
Infusion related reaction 102.65 9.76 445 377264 100763 46207590
Cholecystitis chronic 97.39 9.76 243 377466 10256 46298097
Diarrhoea 94.29 9.76 5476 372233 554126 45754227
Device expulsion 93.75 9.76 53 377656 27489 46280864
Tetany 86.07 9.76 88 377621 1683 46306670
Product use issue 86.02 9.76 433 377276 94211 46214142
Red blood cell sedimentation rate abnormal 84.13 9.76 7 377702 13642 46294711
Abdominal pain 82.39 9.76 2440 375269 227591 46080762
Overdose 78.33 9.76 493 377216 101486 46206867
Coma 73.22 9.76 235 377474 58114 46250239
Alopecia 72.12 9.76 904 376805 161510 46146843
Arthropathy 70.03 9.76 400 377309 84300 46224053
Drug resistance 65.77 9.76 29 377680 17339 46291014
Product use in unapproved indication 64.98 9.76 445 377264 89828 46218525
Hepatic enzyme increased 64.56 9.76 392 377317 81395 46226958
Hypertensive nephropathy 63.91 9.76 40 377669 359 46307994
Confusional state 61.03 9.76 1710 375999 158182 46150171
Hypoparathyroidism 61.01 9.76 47 377662 606 46307747
Death 59.34 9.76 2169 375540 333379 45974974
Hypokalaemia 57.30 9.76 1016 376693 87008 46221345
Intentional overdose 54.06 9.76 306 377403 64638 46243715
Metabolic alkalosis 51.92 9.76 84 377625 2576 46305777
Abdominal pain upper 50.51 9.76 1536 376173 143769 46164584
Suicide attempt 47.62 9.76 256 377453 54780 46253573
Constipation 47.50 9.76 1789 375920 172308 46136045
Hypertrichosis 46.21 9.76 47 377662 893 46307460
Fall 45.90 9.76 3170 374539 325927 45982426
Dyspepsia 45.87 9.76 794 376915 67678 46240675
Pericarditis 45.61 9.76 77 377632 23850 46284503
Abdominal discomfort 45.31 9.76 906 376803 150259 46158094
Pregnancy 44.16 9.76 96 377613 27041 46281312
Premature delivery 43.96 9.76 69 377640 22000 46286353
Malignant neoplasm progression 43.82 9.76 326 377383 64600 46243753
Muscle spasms 43.74 9.76 1305 376404 121808 46186545
Respiratory arrest 42.55 9.76 136 377573 33680 46274673
Gastritis 41.37 9.76 443 377266 33935 46274418
Caesarean section 41.23 9.76 44 377665 16559 46291794
Rash 40.02 9.76 2419 375290 354093 45954260
Burning mouth syndrome 39.51 9.76 30 377679 378 46307975
Bone erosion 38.65 9.76 14 377695 9429 46298924
Therapeutic response decreased 37.70 9.76 200 377509 42945 46265408
Swollen tongue 37.69 9.76 382 377327 28850 46279503
Product formulation issue 37.31 9.76 36 377673 640 46307713
Renal failure 37.13 9.76 1192 376517 112402 46195951
Dry mouth 36.81 9.76 637 377072 54289 46254064
Blood pressure systolic increased 36.77 9.76 115 377594 28672 46279681
Biliary dyskinesia 36.75 9.76 74 377635 2699 46305654
Hypersensitivity 36.24 9.76 932 376777 149389 46158964
Gastrointestinal haemorrhage 36.08 9.76 850 376859 76523 46231830
Haematemesis 35.98 9.76 374 377335 28432 46279921
Accidental exposure to product 35.62 9.76 73 377636 21008 46287345
Gallbladder disorder 35.48 9.76 253 377456 17245 46291108
Musculoskeletal stiffness 35.47 9.76 568 377141 97425 46210928
Malaise 35.04 9.76 3123 374586 328109 45980244
Orthostatic hypotension 34.11 9.76 327 377382 24331 46284022
Hiatus hernia 33.90 9.76 259 377450 18043 46290310
Flatulence 33.77 9.76 370 377339 28508 46279845
Chest pain 33.71 9.76 1747 375962 174577 46133776
Gastric pH decreased 33.07 9.76 26 377683 346 46308007
Intentional product misuse 32.10 9.76 236 377473 46892 46261461
Injection site pain 31.55 9.76 644 377065 106508 46201845
Sedation complication 31.35 9.76 82 377627 3563 46304790
Rheumatoid nodule 31.21 9.76 17 377692 9003 46299350
Nephropathy 30.90 9.76 100 377609 4905 46303448
Cogwheel rigidity 30.38 9.76 48 377661 1442 46306911
No adverse event 30.29 9.76 158 377551 34073 46274280
Condition aggravated 30.12 9.76 1648 376061 243404 46064949
Cardiac arrest 30.10 9.76 532 377177 89867 46218486
Asthenia 29.89 9.76 2913 374796 308162 46000191
Discomfort 29.77 9.76 238 377471 46432 46261921
Palatal oedema 29.70 9.76 28 377681 483 46307870
Vomiting 29.44 9.76 4135 373574 448659 45859694
Gastric polyps 28.77 9.76 59 377650 2181 46306172
Blood calcium decreased 28.59 9.76 221 377488 15452 46292901
Hypoparathyroidism secondary 28.19 9.76 12 377697 42 46308311
Foetal death 28.10 9.76 18 377691 8725 46299628
Paraesthesia 28.09 9.76 1190 376519 116247 46192106
Dyspnoea 28.04 9.76 4661 373048 510887 45797466
Balance disorder 28.02 9.76 702 377007 63819 46244534
Device difficult to use 27.82 9.76 15 377694 7989 46300364
Foetal exposure during pregnancy 27.72 9.76 141 377568 30606 46277747
Hypergammaglobulinaemia 27.69 9.76 26 377683 446 46307907
Gallbladder injury 27.65 9.76 44 377665 1330 46307023
Stillbirth 27.64 9.76 9 377700 6482 46301871
Poisoning 27.64 9.76 44 377665 13950 46294403
Sopor 26.91 9.76 77 377632 19751 46288602
Duodenal ulcer perforation 26.66 9.76 18 377691 8484 46299869
Insulin autoimmune syndrome 26.60 9.76 12 377697 50 46308303
Intestinal dilatation 26.51 9.76 47 377662 1555 46306798
Nasopharyngitis 26.34 9.76 999 376710 152999 46155354
Unintentional medical device removal 26.31 9.76 3 377706 4550 46303803
Tenosynovitis 26.24 9.76 14 377695 7501 46300852
Pain 26.08 9.76 3421 374288 473527 45834826
Infection 25.97 9.76 853 376856 132739 46175614
Poisoning deliberate 25.92 9.76 16 377693 7910 46300443
Blood pressure fluctuation 25.58 9.76 143 377566 30305 46278048
Liver function test abnormal 25.58 9.76 523 377186 45964 46262389
Dizziness 25.53 9.76 3136 374573 337278 45971075
Red blood cell sedimentation rate increased 25.47 9.76 97 377612 22792 46285561
Dilatation intrahepatic duct acquired 25.43 9.76 31 377678 725 46307628
Abdominal distension 25.35 9.76 775 376934 72576 46235777
Creatinine renal clearance decreased 25.23 9.76 117 377592 6803 46301550
Limb reduction defect 25.13 9.76 22 377687 343 46308010
Bone marrow failure 25.11 9.76 139 377570 29530 46278823
Lethargy 25.04 9.76 566 377143 50605 46257748
Congenital thrombocytopenia 24.73 9.76 11 377698 44 46308309
Urinary tract infection 24.21 9.76 2083 375626 218183 46090170
Upper gastrointestinal haemorrhage 24.16 9.76 224 377485 16514 46291839
Clostridium difficile infection 23.79 9.76 309 377400 24794 46283559
Injection site swelling 23.76 9.76 210 377499 40117 46268236
Cholelithiasis 23.58 9.76 442 377267 38239 46270114
Injection site erythema 23.52 9.76 442 377267 73985 46234368
Pancreatitis acute 23.50 9.76 306 377403 24566 46283787
Abdominal tenderness 23.45 9.76 117 377592 7011 46301342
Loss of personal independence in daily activities 23.25 9.76 324 377385 56859 46251494
Injection site reaction 23.25 9.76 261 377448 47588 46260765
Torus fracture 23.09 9.76 13 377696 94 46308259
Infective pulmonary exacerbation of cystic fibrosis 22.93 9.76 158 377551 10649 46297704
Bicytopenia 22.77 9.76 45 377664 1619 46306734
Dehydration 22.74 9.76 1540 376169 158000 46150353
Toxic epidermal necrolysis 22.72 9.76 278 377431 22000 46286353
Therapy non-responder 22.64 9.76 218 377491 40934 46267419
Nephroangiosclerosis 22.62 9.76 15 377694 150 46308203
Moraxella test positive 22.62 9.76 8 377701 14 46308339
Device dislocation 22.61 9.76 95 377614 21707 46286646
Interstitial lung disease 22.54 9.76 304 377405 53645 46254708
Drug dispensed to wrong patient 22.54 9.76 17 377692 212 46308141
Diabetic nephropathy 22.46 9.76 40 377669 1328 46307025
Hypergastrinaemia 22.43 9.76 13 377696 100 46308253
International normalised ratio increased 22.14 9.76 516 377193 46367 46261986
Intentional product use issue 21.84 9.76 298 377411 52482 46255871
Product packaging confusion 21.37 9.76 14 377695 137 46308216
Sleep disorder due to general medical condition, insomnia type 21.11 9.76 8 377701 5241 46303112
Breast cancer 21.06 9.76 251 377458 45267 46263086
Inappropriate antidiuretic hormone secretion 21.00 9.76 190 377519 13912 46294441
Oesophagitis 20.88 9.76 185 377524 13466 46294887
Hip fracture 20.39 9.76 315 377394 26241 46282112
Abnormal loss of weight 20.31 9.76 87 377622 4888 46303465
Lip swelling 20.18 9.76 303 377406 25092 46283261
Cholecystitis 20.09 9.76 192 377517 14274 46294079
Device use error 20.02 9.76 8 377701 5073 46303280
Vision blurred 19.80 9.76 811 376898 78897 46229456
Abortion induced 19.57 9.76 33 377676 10227 46298126
Target skin lesion 19.48 9.76 11 377698 80 46308273
Skin test positive 19.43 9.76 27 377682 721 46307632
Neutropenic sepsis 19.36 9.76 168 377541 12156 46296197
Blood chromogranin A increased 19.21 9.76 14 377695 165 46308188
C-reactive protein increased 19.12 9.76 346 377363 58244 46250109
Viral diarrhoea 19.05 9.76 12 377697 109 46308244
Ankylosing spondylitis 18.90 9.76 16 377693 6721 46301632
Thermohypoaesthesia 18.87 9.76 12 377697 111 46308242
Truncus coeliacus thrombosis 18.84 9.76 6 377703 6 46308347
Congenital ovarian anomaly 18.84 9.76 6 377703 6 46308347
Cardiotoxicity 18.81 9.76 16 377693 6706 46301647
Injection site bruising 18.68 9.76 191 377518 35445 46272908
Wrong technique in product usage process 18.52 9.76 319 377390 54103 46254250
Catatonia 18.32 9.76 4 377705 3758 46304595
Faeces discoloured 18.23 9.76 212 377497 16575 46291778
Live birth 18.11 9.76 35 377674 10295 46298058
Deep vein thrombosis 18.10 9.76 804 376905 78969 46229384
Panniculitis 17.99 9.76 12 377697 5692 46302661
Cutaneous lupus erythematosus 17.91 9.76 53 377656 2476 46305877
Rhabdomyolysis 17.90 9.76 455 377254 41454 46266899
Serotonin syndrome 17.73 9.76 285 377424 23935 46284418
Injection site pruritus 17.69 9.76 221 377488 39522 46268831
Chronic obstructive pulmonary disease 17.59 9.76 600 377109 57033 46251320
Premature labour 17.54 9.76 41 377668 11258 46297095
Akathisia 17.47 9.76 22 377687 7692 46300661
Nephrogenic anaemia 17.45 9.76 44 377665 1869 46306484
Intravascular haemolysis 17.45 9.76 16 377693 266 46308087
Polyserositis 17.35 9.76 16 377693 268 46308085
Miosis 17.26 9.76 17 377692 6640 46301713
Gallbladder adenocarcinoma 17.24 9.76 10 377699 77 46308276
Fear of injection 17.22 9.76 6 377703 4141 46304212
Electrocardiogram QT prolonged 17.13 9.76 540 377169 50785 46257568
Psoriatic arthropathy 17.06 9.76 200 377509 36179 46272174
Blood pressure systolic abnormal 16.87 9.76 12 377697 5505 46302848
Swelling 16.85 9.76 829 376880 123682 46184671
Blood magnesium decreased 16.83 9.76 149 377560 10843 46297510
Long QT syndrome 16.77 9.76 59 377650 3021 46305332
Sight disability 16.51 9.76 11 377698 111 46308242
Myalgia 16.46 9.76 1182 376527 121906 46186447
Type I hypersensitivity 16.45 9.76 49 377660 2297 46306056
Blood pressure diastolic abnormal 16.40 9.76 16 377693 6278 46302075
Cardio-respiratory arrest 16.40 9.76 364 377345 59505 46248848
Duodenal stenosis 16.33 9.76 22 377687 570 46307783
Pathogen resistance 16.26 9.76 15 377694 6045 46302308
Maternal exposure before pregnancy 16.17 9.76 8 377701 4473 46303880
Memory impairment 16.15 9.76 773 376936 76564 46231789
Giardiasis 16.13 9.76 7 377702 26 46308327
Body temperature decreased 16.13 9.76 55 377654 13354 46294999
Tremor 16.07 9.76 1114 376595 114525 46193828
Rebound acid hypersecretion 16.04 9.76 15 377694 256 46308097
Metastases to lymph nodes 15.99 9.76 18 377691 6613 46301740
Rectal haemorrhage 15.95 9.76 414 377295 37841 46270512
Normal newborn 15.93 9.76 15 377694 5986 46302367
Discoloured vomit 15.88 9.76 20 377689 484 46307869
Soft tissue disorder 15.83 9.76 7 377702 4179 46304174
Premature baby 15.80 9.76 84 377625 18028 46290325
Gastrointestinal erosion 15.60 9.76 22 377687 596 46307757
Disorientation 15.53 9.76 400 377309 36518 46271835
Temperature regulation disorder 15.52 9.76 4 377705 3356 46304997
Pulmonary malformation 15.51 9.76 10 377699 95 46308258
Dysgeusia 15.40 9.76 433 377276 40058 46268295
Cytomegalovirus infection 15.36 9.76 85 377624 18059 46290294
Cognitive disorder 15.33 9.76 399 377310 36484 46271869
Immune-mediated encephalitis 15.29 9.76 8 377701 49 46308304
Herpes zoster 15.24 9.76 425 377284 67447 46240906
Avian influenza 15.16 9.76 8 377701 50 46308303
Cholecystectomy 15.13 9.76 125 377584 8917 46299436
Muscle spasticity 15.11 9.76 45 377664 11395 46296958
Product substitution issue 15.08 9.76 187 377522 14844 46293509
Calcium deficiency 14.95 9.76 26 377683 847 46307506
Feeling of despair 14.91 9.76 40 377669 1765 46306588
Metastases to liver 14.86 9.76 95 377614 19490 46288863
Hand-eye coordination impaired 14.78 9.76 6 377703 18 46308335
Beta haemolytic streptococcal infection 14.74 9.76 41 377668 1848 46306505
Pneumonia aspiration 14.73 9.76 174 377535 31431 46276922
Mouth swelling 14.67 9.76 64 377645 3625 46304728
Aplastic anaemia 14.60 9.76 22 377687 7131 46301222
Limb hypoplasia congenital 14.59 9.76 12 377697 171 46308182
Transplant dysfunction 14.56 9.76 10 377699 4672 46303681
Drug dose titration not performed 14.47 9.76 17 377692 382 46307971
Norovirus test positive 14.46 9.76 11 377698 139 46308214
Lipase increased 14.43 9.76 119 377590 8484 46299869
Exposure via ingestion 14.43 9.76 5 377704 3462 46304891
Developmental hip dysplasia 14.41 9.76 32 377677 1251 46307102
Genital blister 14.36 9.76 9 377700 81 46308272
Subdural haemorrhage 14.35 9.76 54 377655 2858 46305495
Dental discomfort 14.26 9.76 15 377694 297 46308056
Compartment syndrome 14.26 9.76 42 377667 1957 46306396
Renal haemangioma 14.21 9.76 7 377702 37 46308316
Chronic kidney disease-mineral and bone disorder 14.19 9.76 14 377695 256 46308097
Syncope 14.11 9.76 1007 376702 103796 46204557
Febrile bone marrow aplasia 14.10 9.76 21 377688 6841 46301512
Hyperchlorhydria 14.09 9.76 32 377677 1270 46307083
Eyelid retraction 14.08 9.76 8 377701 59 46308294
Small intestinal obstruction 14.06 9.76 196 377513 15976 46292377
Endoscopy abnormal 14.05 9.76 5 377704 9 46308344
Intestinal ulcer 14.00 9.76 28 377681 1016 46307337
Superior mesenteric artery syndrome 14 9.76 9 377700 85 46308268
Chronic pigmented purpura 13.97 9.76 8 377701 60 46308293
Rheumatic fever 13.89 9.76 3 377706 2840 46305513
Atrial fibrillation 13.88 9.76 995 376714 102595 46205758
Hyperreflexia 13.74 9.76 81 377628 5173 46303180
Bromhidrosis 13.71 9.76 5 377704 10 46308343
Haemoglobin decreased 13.61 9.76 1216 376493 127733 46180620
Iron deficiency anaemia 13.56 9.76 205 377504 17001 46291352
Drug eruption 13.49 9.76 109 377600 21220 46287133
Hepatic rupture 13.49 9.76 6 377703 24 46308329
Drug tolerance decreased 13.46 9.76 4 377705 3055 46305298
Depersonalisation/derealisation disorder 13.44 9.76 27 377682 983 46307370
Antineutrophil cytoplasmic antibody positive 13.43 9.76 18 377691 464 46307889
Acute graft versus host disease 13.37 9.76 8 377701 4022 46304331
Cytomegalovirus viraemia 13.36 9.76 10 377699 4468 46303885
Anaemia 13.34 9.76 2308 375401 253471 46054882
Enthesopathy 13.33 9.76 11 377698 4679 46303674
Immune reconstitution inflammatory syndrome 13.31 9.76 16 377693 5709 46302644
Plasma cell myeloma 13.31 9.76 462 377247 44016 46264337
Gastrointestinal stoma complication 13.31 9.76 35 377674 1526 46306827
Pancreatitis 13.27 9.76 454 377255 43173 46265180
Oedematous pancreatitis 13.19 9.76 15 377694 325 46308028
Muscle injury 13.11 9.76 12 377697 4854 46303499
Dolichocolon 13.09 9.76 4 377705 3 46308350
Gallbladder cholesterolosis 13.04 9.76 23 377686 758 46307595
Necrosis ischaemic 12.98 9.76 24 377685 821 46307532
Unintended pregnancy 12.97 9.76 16 377693 5644 46302709
Aquagenic pruritus 12.94 9.76 6 377703 27 46308326
Nausea 12.90 9.76 5942 371767 681512 45626841
Respiratory tract malformation 12.86 9.76 8 377701 71 46308282
Fear of eating 12.84 9.76 15 377694 335 46308018
Parkinsonism 12.83 9.76 109 377600 7839 46300514
Swelling face 12.75 9.76 538 377171 52521 46255832
Knee arthroplasty 12.75 9.76 126 377583 23539 46284814
Second primary malignancy 12.72 9.76 21 377688 6563 46301790
Arthralgia 12.64 9.76 2682 375027 361921 45946432
Full blood count decreased 12.58 9.76 251 377458 21960 46286393
Cholecystitis acute 12.50 9.76 104 377605 7434 46300919
Parkinsonian rest tremor 12.50 9.76 9 377700 104 46308249
Pneumonia streptococcal 12.46 9.76 36 377673 1659 46306694
Sepsis 12.34 9.76 1269 376440 134745 46173608
General physical health deterioration 12.33 9.76 789 376920 114980 46193373
Urine chloride decreased 12.23 9.76 8 377701 78 46308275
Hip arthroplasty 12.19 9.76 91 377618 18021 46290332
Oxygen saturation decreased 12.19 9.76 447 377262 68717 46239636
Pulmonary embolism 12.09 9.76 1028 376681 107557 46200796
Lipidosis 12.08 9.76 5 377704 16 46308337
BK virus infection 12.05 9.76 4 377705 2845 46305508
Gastrointestinal polyp haemorrhage 12.02 9.76 10 377699 145 46308208
Labelled drug-drug interaction medication error 11.96 9.76 119 377590 8942 46299411
Diverticulum 11.94 9.76 141 377568 11065 46297288
Apparent life threatening event 11.82 9.76 8 377701 83 46308270
Non-cardiac chest pain 11.81 9.76 87 377622 5991 46302362
Blood sodium decreased 11.81 9.76 244 377465 21482 46286871
Device issue 11.79 9.76 104 377605 19876 46288477
Congenital oral malformation 11.75 9.76 11 377698 188 46308165
Tongue blistering 11.73 9.76 32 377677 1426 46306927
Sweat discolouration 11.68 9.76 4 377705 6 46308347
Lower gastrointestinal haemorrhage 11.61 9.76 100 377609 7220 46301133
Therapeutic response shortened 11.60 9.76 15 377694 5184 46303169
Cleft palate 11.60 9.76 24 377685 893 46307460
Choluria 11.58 9.76 10 377699 153 46308200
Dysuria 11.54 9.76 301 377408 27532 46280821
Occupational problem environmental 11.48 9.76 3 377706 0 46308353
Presumed ocular histoplasmosis syndrome 11.48 9.76 3 377706 0 46308353
Breast discolouration 11.48 9.76 3 377706 0 46308353
Hair injury 11.48 9.76 3 377706 0 46308353
Chromaturia 11.47 9.76 178 377531 14841 46293512
DNULL antibody 11.43 9.76 6 377703 37 46308316
Injection site warmth 11.39 9.76 65 377644 13707 46294646
Barrett's oesophagus 11.36 9.76 20 377689 658 46307695
Bladder irritation 11.32 9.76 10 377699 158 46308195
Hypoaesthesia oral 11.31 9.76 133 377576 10426 46297927
Complication of device insertion 11.30 9.76 14 377695 4930 46303423
Liver function test increased 11.29 9.76 124 377585 22702 46285651
Polyuria 11.26 9.76 98 377611 7097 46301256
Peptic ulcer perforation 11.21 9.76 10 377699 160 46308193
Metastases to bone 11.20 9.76 89 377620 17387 46290966
Shunt thrombosis 11.18 9.76 6 377703 39 46308314
Forced expiratory volume decreased 11.11 9.76 15 377694 5089 46303264
Blood pressure increased 11.08 9.76 878 376831 125788 46182565
Derailment 11.08 9.76 7 377702 64 46308289
Agitated depression 11.07 9.76 9 377700 126 46308227
Pulmonary toxicity 11.04 9.76 13 377696 4680 46303673
Post transplant lymphoproliferative disorder 11.01 9.76 9 377700 3847 46304506
Blood iron abnormal 10.93 9.76 6 377703 3164 46305189
Ill-defined disorder 10.90 9.76 152 377557 26675 46281678
Intentional self-injury 10.89 9.76 134 377575 24032 46284321
Folliculitis 10.89 9.76 21 377688 6182 46302171
Pharyngeal haematoma 10.87 9.76 5 377704 22 46308331
Suspected suicide 10.87 9.76 13 377696 4648 46303705
Gastric antral vascular ectasia 10.85 9.76 18 377691 564 46307789
Acute generalised exanthematous pustulosis 10.76 9.76 120 377589 9285 46299068
Altered state of consciousness 10.70 9.76 129 377580 23219 46285134
Antithrombin III 10.68 9.76 10 377699 171 46308182
Premature rupture of membranes 10.67 9.76 12 377697 4411 46303942
Intraductal papillary breast neoplasm 10.66 9.76 4 377705 9 46308344
International normalised ratio abnormal 10.63 9.76 51 377658 3008 46305345
Pleural fibrosis 10.61 9.76 8 377701 3561 46304792
Stevens-Johnson syndrome 10.56 9.76 255 377454 23042 46285311
Generalised tonic-clonic seizure 10.56 9.76 155 377554 26967 46281386
Gastrointestinal mucosal exfoliation 10.52 9.76 8 377701 101 46308252
Tongue discomfort 10.52 9.76 35 377674 1742 46306611
Hallucinations, mixed 10.49 9.76 60 377649 3789 46304564
Abnormal weight gain 10.49 9.76 31 377678 1447 46306906
Urinary tract infection pseudomonal 10.41 9.76 22 377687 831 46307522
Poliomyelitis 10.37 9.76 6 377703 46 46308307
Single functional kidney 10.33 9.76 8 377701 104 46308249
Ectopic pregnancy 10.28 9.76 4 377705 2578 46305775
Dysphonia 10.27 9.76 394 377315 38020 46270333
Oesophageal stenosis 10.26 9.76 48 377661 2801 46305552
Acquired oesophageal web 10.25 9.76 11 377698 223 46308130
Asthma 10.24 9.76 621 377088 90921 46217432
Oral pain 10.23 9.76 268 377441 24529 46283824
Device deployment issue 10.22 9.76 8 377701 3495 46304858
Eczema eyelids 10.21 9.76 8 377701 106 46308247
Adjusted calcium decreased 10.21 9.76 8 377701 106 46308247
Symmetrical drug-related intertriginous and flexural exanthema 10.20 9.76 12 377697 270 46308083
Obstructive airways disorder 10.20 9.76 65 377644 13347 46295006
Multiple-drug resistance 10.17 9.76 4 377705 2561 46305792
Prevertebral soft tissue swelling of cervical space 10.16 9.76 6 377703 48 46308305
Complication of device removal 10.15 9.76 8 377701 3482 46304871
Derealisation 10.14 9.76 21 377688 782 46307571
Feeling of body temperature change 10.13 9.76 64 377645 4188 46304165
Breast cancer recurrent 10.12 9.76 10 377699 3901 46304452
Hypertensive cardiomyopathy 10.10 9.76 11 377698 227 46308126
Jaw clicking 10.06 9.76 5 377704 27 46308326
Hepatotoxicity 10.06 9.76 142 377567 24867 46283486
Lung cyst 10.02 9.76 8 377701 109 46308244
Occult blood positive 9.96 9.76 56 377653 3514 46304839
Mesenteric panniculitis 9.95 9.76 6 377703 50 46308303
Back pain 9.95 9.76 1886 375823 208153 46100200
Kidney small 9.89 9.76 9 377700 148 46308205
Lichen planus 9.89 9.76 35 377674 1798 46306555
Urticaria vesiculosa 9.85 9.76 4 377705 12 46308341
Smear cervix abnormal 9.85 9.76 4 377705 2512 46305841
Biliary colic 9.85 9.76 55 377654 3443 46304910
Gastrointestinal sounds abnormal 9.79 9.76 55 377654 3451 46304902
Lipase decreased 9.76 9.76 6 377703 52 46308301

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
Hypomagnesaemia 493.90 10.59 659 256147 15939 29679733
Drug abuse 375.63 10.59 118 256688 81954 29613718
Chronic kidney disease 251.47 10.59 805 256001 37033 29658639
Off label use 211.95 10.59 1262 255544 248028 29447644
Toxicity to various agents 202.00 10.59 808 255998 176375 29519297
Hypocalcaemia 179.29 10.59 494 256312 20882 29674790
Drug ineffective 177.95 10.59 1965 254841 338422 29357250
Tubulointerstitial nephritis 176.16 10.59 439 256367 17452 29678220
Hypertrichosis 173.08 10.59 72 256734 217 29695455
Completed suicide 158.21 10.59 390 256416 99102 29596570
Gastrooesophageal reflux disease 149.32 10.59 610 256196 31645 29664027
Death 132.83 10.59 2211 254595 355072 29340600
End stage renal disease 121.31 10.59 224 256582 7211 29688461
Product use in unapproved indication 105.63 10.59 304 256502 73389 29622283
Product formulation issue 95.99 10.59 59 256747 479 29695193
Tetany 88.29 10.59 64 256742 702 29694970
Foetal exposure during pregnancy 83.91 10.59 116 256690 36755 29658917
Treatment failure 81.05 10.59 107 256699 34572 29661100
Hyponatraemia 72.91 10.59 889 255917 66313 29629359
Hypoparathyroidism 65.39 10.59 44 256762 424 29695248
Overdose 59.33 10.59 451 256355 83886 29611786
Therapeutic product effect incomplete 57.41 10.59 128 256678 33706 29661966
Rheumatoid arthritis 56.79 10.59 173 256633 41024 29654648
Drug resistance 55.89 10.59 54 256752 20079 29675593
Intentional product misuse 55.73 10.59 135 256671 34532 29661140
Acute kidney injury 55.12 10.59 2872 253934 270970 29424702
Intentional overdose 54.51 10.59 178 256628 41303 29654369
Dyspepsia 52.05 10.59 441 256365 29888 29665784
Inappropriate antidiuretic hormone secretion 52.03 10.59 215 256591 11207 29684465
Drug interaction 50.35 10.59 2141 254665 197427 29498245
Renal injury 47.45 10.59 213 256593 11516 29684156
Hypoparathyroidism secondary 46.75 10.59 23 256783 113 29695559
Abdominal pain 45.15 10.59 1501 255305 134153 29561519
Suicide attempt 45.14 10.59 162 256644 36535 29659137
Renal tubular acidosis 44.73 10.59 66 256740 1756 29693916
Diarrhoea 44.35 10.59 3380 253426 330723 29364949
Respiratory arrest 43.14 10.59 119 256687 29139 29666533
Myalgia 42.79 10.59 908 255898 75759 29619913
Drug hypersensitivity 42.44 10.59 379 256427 68140 29627532
Immune reconstitution inflammatory syndrome 41.74 10.59 13 256793 9088 29686584
Abdominal pain upper 41.35 10.59 760 256046 61791 29633881
Lower respiratory tract infection 39.96 10.59 377 256429 26337 29669335
Hypertensive nephropathy 39.81 10.59 32 256774 414 29695258
Poisoning 38.55 10.59 25 256781 11357 29684315
Synovitis 38.18 10.59 18 256788 9765 29685907
General physical health deterioration 37.69 10.59 616 256190 99328 29596344
Gastric polyps 37.36 10.59 45 256761 978 29694694
C-reactive protein abnormal 36.64 10.59 3 256803 5590 29690082
Hepatocellular injury 36.52 10.59 105 256701 25366 29670306
Coma 35.13 10.59 203 256603 40246 29655426
Intentional product use issue 34.89 10.59 177 256629 36263 29659409
Occupational dermatitis 34.70 10.59 16 256790 66 29695606
Chromaturia 33.70 10.59 219 256587 13646 29682026
Premature baby 33.65 10.59 57 256749 16634 29679038
Gastritis 32.72 10.59 290 256516 19908 29675764
Iron deficiency anaemia 32.19 10.59 158 256648 8866 29686806
Asthenia 31.69 10.59 2253 254553 219037 29476635
Drug intolerance 31.45 10.59 243 256563 45048 29650624
Multiple organ dysfunction syndrome 30.78 10.59 372 256434 63115 29632557
Substance abuse 30.64 10.59 11 256795 7029 29688643
Interstitial lung disease 30.23 10.59 350 256456 59847 29635825
Drug dependence 29.65 10.59 89 256717 21206 29674466
Mesenteric vein thrombosis 29.48 10.59 29 256777 497 29695175
Nephrogenic anaemia 29.46 10.59 60 256746 2079 29693593
Jejunal ulcer perforation 29.25 10.59 14 256792 64 29695608
Hyperchlorhydria 29.22 10.59 32 256774 625 29695047
Myocardial infarction 28.86 10.59 838 255968 124787 29570885
Dry mouth 28.66 10.59 311 256495 22539 29673133
Upper gastrointestinal haemorrhage 28.65 10.59 302 256504 21726 29673946
Infective pulmonary exacerbation of cystic fibrosis 28.41 10.59 147 256659 8425 29687247
Subacute cutaneous lupus erythematosus 28.36 10.59 32 256774 647 29695025
Haemophagocytic lymphohistiocytosis 27.48 10.59 26 256780 9765 29685907
Granuloma annulare 27.19 10.59 15 256791 97 29695575
Tetanus 26.90 10.59 12 256794 45 29695627
Hepatic function abnormal 26.85 10.59 230 256576 41715 29653957
Product label on wrong product 26.82 10.59 9 256797 11 29695661
Exposure during pregnancy 26.69 10.59 24 256782 9237 29686435
Hiatus hernia 26.64 10.59 126 256680 6964 29688708
Oesophagitis 26.27 10.59 175 256631 10996 29684676
Febrile neutropenia 26.22 10.59 705 256101 105988 29589684
Mucormycosis 25.12 10.59 7 256799 5261 29690411
Muscle spasms 24.85 10.59 730 256076 64108 29631564
Infusion related reaction 24.83 10.59 225 256581 40339 29655333
Cardio-respiratory arrest 24.75 10.59 344 256462 56962 29638710
Product use issue 24.50 10.59 264 256542 45752 29649920
Blood pressure fluctuation 24.47 10.59 73 256733 17430 29678242
Dizziness 24.29 10.59 1963 254843 192946 29502726
Blood magnesium decreased 24.03 10.59 102 256704 5381 29690291
Cardiac arrest 24.01 10.59 609 256197 92241 29603431
Pathogen resistance 23.99 10.59 22 256784 8388 29687284
Cytomegalovirus infection 23.81 10.59 113 256693 23561 29672111
Right hemisphere deficit syndrome 23.55 10.59 9 256797 20 29695652
Confusional state 22.89 10.59 1393 255413 133441 29562231
Malignant neoplasm progression 22.68 10.59 460 256346 71827 29623845
Lupus endocarditis 22.61 10.59 6 256800 0 29695672
Lip swelling 22.22 10.59 186 256620 12558 29683114
Blood copper increased 22.09 10.59 7 256799 6 29695666
Flatulence 21.93 10.59 245 256561 17884 29677788
Altered state of consciousness 21.88 10.59 92 256714 19827 29675845
Blood gastrin increased 21.58 10.59 7 256799 7 29695665
Fatigue 20.98 10.59 3094 253712 317579 29378093
Abnormal loss of weight 20.94 10.59 76 256730 3726 29691946
Acute interstitial pneumonitis 20.53 10.59 21 256785 378 29695294
Cerebral infarction 20.49 10.59 137 256669 26236 29669436
Apparent death 20.43 10.59 3 256803 3539 29692133
Blood parathyroid hormone decreased 20.42 10.59 23 256783 464 29695208
Pneumocystis jirovecii pneumonia 20.12 10.59 77 256729 17043 29678629
Lethargy 20.11 10.59 462 256344 39057 29656615
Type I hypersensitivity 19.98 10.59 32 256774 916 29694756
Dysgeusia 19.90 10.59 311 256495 24490 29671182
Loss of personal independence in daily activities 19.82 10.59 106 256700 21429 29674243
Bone marrow failure 19.66 10.59 162 256644 29623 29666049
Coronary artery bypass 19.39 10.59 10 256796 5152 29690520
Venoocclusive liver disease 19.22 10.59 17 256789 6596 29689076
Chest pain 18.99 10.59 1210 255596 116417 29579255
Veillonella infection 18.84 10.59 5 256801 0 29695672
Barrett's oesophagus 18.67 10.59 23 256783 512 29695160
Gastric mucosal hypertrophy 18.67 10.59 11 256795 82 29695590
Regurgitation 18.55 10.59 30 256776 866 29694806
Ceruloplasmin increased 18.50 10.59 6 256800 6 29695666
Lipodystrophy acquired 18.40 10.59 4 256802 3556 29692116
Device dependence 18.35 10.59 8 256798 28 29695644
Drug use disorder 18.16 10.59 3 256803 3245 29692427
Condition aggravated 18.05 10.59 982 255824 136884 29558788
Ageusia 17.99 10.59 135 256671 8818 29686854
Rectal haemorrhage 17.64 10.59 408 256398 34531 29661141
Carcinoid tumour of the gastrointestinal tract 17.56 10.59 9 256797 49 29695623
Macrocephaly 17.38 10.59 18 256788 329 29695343
Helicobacter infection 17.30 10.59 48 256758 2036 29693636
Occupational exposure to air contaminants 17.27 10.59 9 256797 51 29695621
Indifference 17.25 10.59 13 256793 152 29695520
Pyloric stenosis 17.14 10.59 23 256783 559 29695113
Neutropenic sepsis 17.05 10.59 161 256645 11248 29684424
Chronic graft versus host disease 16.99 10.59 7 256799 4112 29691560
Drug ineffective for unapproved indication 16.99 10.59 43 256763 10837 29684835
Vitamin B12 deficiency 16.90 10.59 55 256751 2550 29693122
Ventricular flutter 16.86 10.59 9 256797 54 29695618
Liver function test abnormal 16.75 10.59 365 256441 30585 29665087
Fear 16.73 10.59 43 256763 10782 29684890
Therapeutic response decreased 16.73 10.59 131 256675 24218 29671454
Vomiting 16.69 10.59 2140 254666 217678 29477994
Faeces discoloured 16.66 10.59 188 256618 13758 29681914
Haematotoxicity 16.60 10.59 17 256789 6153 29689519
Cardiac failure 16.59 10.59 567 256239 82851 29612821
Steatorrhoea 16.51 10.59 25 256781 681 29694991
Nephrosclerosis 16.31 10.59 27 256779 795 29694877
Sopor 15.98 10.59 45 256761 10946 29684726
Gastrointestinal haemorrhage 15.85 10.59 871 255935 82575 29613097
Obstructive airways disorder 15.59 10.59 34 256772 9025 29686647
Cystitis haemorrhagic 15.56 10.59 11 256795 4776 29690896
Cerebral atrophy congenital 15.26 10.59 8 256798 46 29695626
Acute graft versus host disease in skin 15.18 10.59 10 256796 4506 29691166
Oesophageal polyp 15.07 10.59 4 256802 0 29695672
Oropharyngeal blistering 15.05 10.59 13 256793 187 29695485
Lymphoma 15.04 10.59 41 256765 10080 29685592
Electrocardiogram QRS complex prolonged 15.03 10.59 9 256797 4268 29691404
Accidental exposure to product 15.01 10.59 41 256765 10074 29685598
Cardiac amyloidosis 14.84 10.59 25 256781 747 29694925
Renal haemangioma 14.80 10.59 7 256799 31 29695641
Urinary tract discomfort 14.75 10.59 9 256797 72 29695600
Graft versus host disease in skin 14.68 10.59 5 256801 3302 29692370
Gastroenteritis eosinophilic 14.66 10.59 13 256793 194 29695478
Blood chromogranin A increased 14.63 10.59 12 256794 160 29695512
Intestinal angioedema 14.63 10.59 12 256794 160 29695512
Gastric neoplasm 14.55 10.59 9 256797 74 29695598
Gastric pH decreased 14.50 10.59 11 256795 130 29695542
Tenosynovitis 14.45 10.59 6 256800 3509 29692163
Pancreatic abscess 14.45 10.59 9 256797 75 29695597
Blood calcium decreased 14.32 10.59 135 256671 9427 29686245
Febrile bone marrow aplasia 14.26 10.59 30 256776 8067 29687605
Hepatic encephalopathy 14.20 10.59 185 256621 14007 29681665
Nephritis 14.10 10.59 45 256761 2065 29693607
Virologic failure 14.06 10.59 5 256801 3214 29692458
Aggression 14.05 10.59 227 256579 36680 29658992
Splenomegaly 14.03 10.59 177 256629 13303 29682369
Weight increased 14.02 10.59 513 256293 74400 29621272
Low birth weight baby 13.93 10.59 19 256787 6057 29689615
Dermatitis infected 13.92 10.59 10 256796 108 29695564
Hepatitis B 13.91 10.59 19 256787 6053 29689619
Paraesthesia 13.90 10.59 584 256222 53743 29641929
Eructation 13.89 10.59 63 256743 3421 29692251
Multiple-drug resistance 13.85 10.59 4 256802 2937 29692735
Breast inflammation 13.76 10.59 6 256800 21 29695651
Dermatomyositis 13.74 10.59 29 256777 1031 29694641
Alveolitis 13.72 10.59 39 256767 1678 29693994
Brain scan abnormal 13.71 10.59 22 256784 631 29695041
Aspartate aminotransferase increased 13.57 10.59 427 256379 62995 29632677
Product substitution error 13.55 10.59 6 256800 22 29695650
Peritonitis bacterial 13.48 10.59 51 256755 11327 29684345
Nephropathy 13.44 10.59 86 256720 5330 29690342
Ectopic gastric mucosa 13.43 10.59 5 256801 10 29695662
Cardiogenic shock 13.39 10.59 87 256719 16774 29678898
Constipation 13.37 10.59 1133 255673 111773 29583899
Wrong technique in product usage process 13.10 10.59 188 256618 30967 29664705
Catatonia 13.05 10.59 11 256795 4369 29691303
Graft versus host disease in gastrointestinal tract 13.01 10.59 5 256801 3064 29692608
Agitated depression 12.98 10.59 13 256793 228 29695444
Pancreatic pseudocyst 12.90 10.59 24 256782 777 29694895
Intestinal fistula infection 12.86 10.59 4 256802 3 29695669
Polymyositis 12.85 10.59 34 256772 1402 29694270
Stoma site haemorrhage 12.82 10.59 26 256780 898 29694774
Substance-induced mood disorder 12.82 10.59 5 256801 12 29695660
Antipsychotic drug level decreased 12.74 10.59 25 256781 843 29694829
Endophthalmitis 12.69 10.59 7 256799 3473 29692199
Dry throat 12.67 10.59 42 256764 1966 29693706
Therapy partial responder 12.65 10.59 8 256798 3683 29691989
Epstein-Barr virus infection 12.53 10.59 24 256782 6682 29688990
Yellow skin 12.52 10.59 43 256763 2050 29693622
Product complaint 12.50 10.59 89 256717 5717 29689955
Hypokalaemia 12.49 10.59 538 256268 49654 29646018
Cerebral vasoconstriction 12.47 10.59 12 256794 200 29695472
Posterior reversible encephalopathy syndrome 12.40 10.59 36 256770 8671 29687001
Amino acid level increased 12.36 10.59 16 256790 375 29695297
Laboratory test 12.33 10.59 4 256802 4 29695668
Reaction to excipient 12.20 10.59 16 256790 380 29695292
Lentigo maligna 12.15 10.59 13 256793 247 29695425
Bronchopulmonary aspergillosis 12.14 10.59 59 256747 12225 29683447
Pupils unequal 12.14 10.59 31 256775 1251 29694421
Arthropod sting 12.03 10.59 13 256793 250 29695422
Intestinal infarction 12.01 10.59 19 256787 538 29695134
Neuroleptic malignant syndrome 11.99 10.59 86 256720 16209 29679463
Hypoosmolar state 11.98 10.59 8 256798 76 29695596
Abdominal discomfort 11.92 10.59 522 256284 48269 29647403
Hypotension 11.89 10.59 1522 255284 199043 29496629
Shock 11.82 10.59 132 256674 22727 29672945
Muscular weakness 11.82 10.59 663 256143 62982 29632690
Red blood cell analysis abnormal 11.80 10.59 5 256801 16 29695656
Post transplant lymphoproliferative disorder 11.76 10.59 17 256789 5289 29690383
Asthma 11.70 10.59 229 256577 35945 29659727
Blood sodium decreased 11.66 10.59 196 256610 15660 29680012
Monocytosis 11.61 10.59 15 256791 351 29695321
Viral mutation identified 11.60 10.59 4 256802 2622 29693050
Diverticulum 11.60 10.59 98 256708 6635 29689037
Pharyngeal oedema 11.58 10.59 95 256711 6376 29689296
Dyspnoea 11.57 10.59 3117 253689 330178 29365494
Cerebral artery thrombosis 11.55 10.59 18 256788 503 29695169
Blood triglycerides decreased 11.47 10.59 7 256799 56 29695616
Oxygen saturation decreased 11.46 10.59 284 256522 43156 29652516
Incision site cellulitis 11.46 10.59 4 256802 6 29695666
Renal vascular thrombosis 11.46 10.59 4 256802 6 29695666
Gastrointestinal mucosal exfoliation 11.46 10.59 4 256802 6 29695666
Incorrect route of product administration 11.38 10.59 54 256752 11261 29684411
Crohn's disease 11.36 10.59 70 256736 4282 29691390
Hyperosmolar state 11.35 10.59 16 256790 408 29695264
Cytomegalovirus chorioretinitis 11.31 10.59 7 256799 3261 29692411
Atrial septal defect acquired 11.30 10.59 3 256803 0 29695672
Aspiration pleural cavity abnormal 11.30 10.59 3 256803 0 29695672
Carotid pulse abnormal 11.30 10.59 3 256803 0 29695672
Hypocalcaemic seizure 11.30 10.59 3 256803 0 29695672
Platelet production decreased 11.30 10.59 3 256803 0 29695672
Latent tetany 11.30 10.59 3 256803 0 29695672
Dystonia 11.27 10.59 44 256762 9683 29685989
Nail pigmentation 11.25 10.59 8 256798 85 29695587
Necrotising panniculitis 11.24 10.59 6 256800 36 29695636
Eye infection fungal 11.22 10.59 14 256792 316 29695356
Anaphylactic shock 11.21 10.59 72 256734 13921 29681751
Alcohol use disorder 11.16 10.59 5 256801 19 29695653
Respiratory tract infection 11.16 10.59 191 256615 15315 29680357
Akathisia 11.15 10.59 21 256785 5883 29689789
Peripheral sensory neuropathy 11.13 10.59 21 256785 5880 29689792
Refractory cytopenia with unilineage dysplasia 11.12 10.59 17 256789 467 29695205
Post procedural constipation 11.08 10.59 4 256802 7 29695665
International normalised ratio increased 11.06 10.59 508 256298 47231 29648441
Renal failure 11.01 10.59 1265 255541 127701 29567971
Acute graft versus host disease 10.95 10.59 21 256785 5843 29689829
Hepatic enzyme abnormal 10.93 10.59 43 256763 2191 29693481
Renal mass 10.91 10.59 33 256773 1471 29694201
Respiratory distress 10.89 10.59 208 256598 32764 29662908
Chronic kidney disease-mineral and bone disorder 10.86 10.59 15 256791 375 29695297
Neonatal respiratory distress syndrome 10.86 10.59 11 256795 4001 29691671
Claustrophobia 10.85 10.59 12 256794 237 29695435
Polyomavirus-associated nephropathy 10.78 10.59 7 256799 3178 29692494
Uveitis 10.77 10.59 19 256787 5458 29690214
Carcinoid tumour of the small bowel 10.75 10.59 4 256802 8 29695664
Parotid gland enlargement 10.74 10.59 13 256793 284 29695388
Pleural mass 10.71 10.59 7 256799 64 29695608
BK virus infection 10.67 10.59 13 256793 4351 29691321
Oedema genital 10.66 10.59 14 256792 333 29695339
Blood lactate dehydrogenase increased 10.64 10.59 119 256687 20482 29675190
COVID-19 treatment 10.64 10.59 13 256793 287 29695385
Induration 10.61 10.59 23 256783 833 29694839
Social problem 10.60 10.59 21 256785 713 29694959
Infection 10.60 10.59 554 256252 77520 29618152
Prothrombin level decreased 10.59 10.59 28 256778 1154 29694518

Pharmacologic Action:

SourceCodeDescription
ATC A02BC01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BD01 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 A02BD05 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:35623 antiepileptic
CHEBI has role CHEBI:49200 proton pump inhibitors
CHEBI has role CHEBI:49201 anti-ulcer agents
CHEBI has role CHEBI:50183 cytochrome p450 inhibitor
CHEBI has role CHEBI:77746 h. sapiens metabolites
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Erosive esophagitis indication 40719004
Duodenal ulcer disease indication 51868009 DOID:1724
Zollinger-Ellison syndrome indication 53132006 DOID:0050782
Peptic reflux disease indication 57643001
Gastroesophageal reflux disease indication 235595009 DOID:8534
Gastric ulcer indication 397825006 DOID:10808
Gastric Hypersecretory Conditions indication
Duodenal Ulcer due to H. Pylori indication
Maintenance of Healing Erosive Esophagitis indication
Pathological Gastric Hypersecretory Condition indication
Upper gastrointestinal hemorrhage off-label use 37372002
Chronic heart failure contraindication 48447003
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Osteoporosis contraindication 64859006 DOID:11476
Oliguria contraindication 83128009
Atrophic gastritis contraindication 84568007 DOID:8929
Fracture of bone contraindication 125605004
Hypomagnesemia contraindication 190855004
Disease of liver contraindication 235856003 DOID:409
Edema contraindication 267038008

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.71 acidic
pKa2 4.44 Basic
pKa3 2.53 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Potassium-transporting ATPase Transporter INHIBITOR IC50 5.70 CHEMBL CHEMBL
Cytochrome P450 2C19 Enzyme Ki 5.30 WOMBAT-PK
Cytochrome P450 1A2 Enzyme IC50 4.74 WOMBAT-PK
Cytochrome P450 2C9 Enzyme Ki 4.35 WOMBAT-PK
Cytochrome P450 3A4 Enzyme Km 4.31 WOMBAT-PK
Multidrug resistance protein 1 Transporter IC50 4.05 WOMBAT-PK
Fatty acid synthase Enzyme Ki 5.47 CHEMBL
Potassium-transporting ATPase Enzyme IC50 5.42 CHEMBL
Potassium-transporting ATPase Enzyme IC50 6.15 SCIENTIFIC LITERATURE

External reference:

IDSource
4019439 VUID
N0000147569 NUI
D00455 KEGG_DRUG
95382-33-5 SECONDARY_CAS_RN
4019439 VANDF
4029343 VANDF
C0028978 UMLSCUI
CHEBI:7772 CHEBI
1C6 PDB_CHEM_ID
CHEMBL1503 ChEMBL_ID
CHEMBL1567328 ChEMBL_ID
CHEMBL2105294 ChEMBL_ID
D009853 MESH_DESCRIPTOR_UI
DB00338 DRUGBANK_ID
4279 IUPHAR_LIGAND_ID
5081 INN_ID
KG60484QX9 UNII
4594 PUBCHEM_CID
1792108 RXNORM
34509 MMSL
38031 MMSL
45807 MMSL
5201 MMSL
d00325 MMSL
003476 NDDF
005065 NDDF
006090 NDDF
25673006 SNOMEDCT_US
384973006 SNOMEDCT_US
387137007 SNOMEDCT_US
441570004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Good Sense Omeprazole and Sodium Bicarbonate HUMAN OTC DRUG LABEL 2 0113-0058 CAPSULE, GELATIN COATED 20 mg ORAL ANDA 15 sections
good sense omeprazole HUMAN OTC DRUG LABEL 1 0113-0520 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Good Sense Omeprazole HUMAN OTC DRUG LABEL 1 0113-0915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Good Sense Omeprazole HUMAN OTC DRUG LABEL 1 0113-1723 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Basic Care Omeprazole HUMAN OTC DRUG LABEL 1 0113-7401 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
basic care omeprazole HUMAN OTC DRUG LABEL 1 0113-7520 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Basic Care Omeprazole HUMAN OTC DRUG LABEL 1 0113-7915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Omeprazole Magnesium HUMAN OTC DRUG LABEL 1 0179-8104 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-0007 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Omeprazole Magnesium HUMAN OTC DRUG LABEL 1 0363-0042 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
Omeprazole and sodium bicarbonate HUMAN OTC DRUG LABEL 2 0363-0732 CAPSULE, GELATIN COATED 20 mg ORAL ANDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-0915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Acid Reducer Human OTC Drug Label 1 0363-1008 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
Omeprazole HUMAN OTC DRUG LABEL 1 0363-1607 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-1819 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Omeprazole HUMAN OTC DRUG LABEL 1 0363-9980 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
Acid Reducer Human OTC Drug Label 1 0536-1322 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-1359 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-2302 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-2305 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8079 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8320 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2234 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2785 CAPSULE, DELAYED RELEASE 10 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2790 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2859 CAPSULE, DELAYED RELEASE 10 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2868 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-5684 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 26 sections
omeprazole HUMAN OTC DRUG LABEL 1 0904-5834 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-6144 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 28 sections