omeprazole ๐Ÿถ Veterinary Use | 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: 2.56
  • 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 ยตM/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 1071.01 9.94 3309 410545 816024 49375246
Pemphigus 914.64 9.94 13 413841 120153 50071117
Contraindicated product administered 819.22 9.94 121 413733 148837 50042433
Synovitis 781.68 9.94 61 413793 123804 50067466
Drug intolerance 747.54 9.94 432 413422 218672 49972598
Hand deformity 674.82 9.94 35 413819 100164 50091106
Systemic lupus erythematosus 626.29 9.94 186 413668 140436 50050834
Treatment failure 611.25 9.94 183 413671 137454 50053816
Chronic kidney disease 604.56 9.94 1131 412723 38640 50152630
Glossodynia 568.07 9.94 125 413729 115444 50075826
Hypomagnesaemia 552.67 9.94 807 413047 22349 50168921
Anti-cyclic citrullinated peptide antibody positive 539.77 9.94 7 413847 70580 50120690
Maternal exposure during pregnancy 529.24 9.94 326 413528 159452 50031818
Wound 478.20 9.94 136 413718 105658 50085612
Tubulointerstitial nephritis 451.52 9.94 589 413265 14622 50176648
Therapeutic product effect decreased 440.29 9.94 285 413569 135765 50055505
Pericarditis 401.31 9.94 78 413776 78611 50112659
Joint swelling 386.12 9.94 900 412954 244386 49946884
Off label use 386.09 9.94 2289 411565 472137 49719133
Infusion related reaction 380.66 9.94 497 413357 169060 50022210
Rheumatoid factor positive 376.63 9.94 6 413848 49853 50141417
Hyponatraemia 352.10 9.94 1639 412215 94500 50096770
Arthropathy 351.22 9.94 466 413388 157440 50033830
Acute kidney injury 348.19 9.94 3112 410742 224946 49966324
Drug interaction 338.82 9.94 2789 411065 196832 49994438
Drug hypersensitivity 320.70 9.94 1020 412834 249990 49941280
Alopecia 306.61 9.94 1005 412849 244042 49947228
Duodenal ulcer perforation 297.60 9.94 19 413835 45592 50145678
Rheumatoid arthritis 288.44 9.94 782 413072 201768 49989502
Discomfort 282.99 9.94 281 413573 108099 50083171
Hepatic enzyme increased 274.43 9.94 437 413417 136943 50054327
Subacute cutaneous lupus erythematosus 270.02 9.94 188 413666 2027 50189243
Abdominal discomfort 263.57 9.94 989 412865 230652 49960618
Product use issue 254.29 9.94 525 413329 148950 50042320
Muscle injury 252.84 9.94 12 413842 37099 50154171
Helicobacter infection 233.75 9.94 59 413795 49643 50141627
Folliculitis 232.09 9.94 25 413829 39200 50152070
Completed suicide 224.51 9.94 463 413391 131426 50059844
Sleep disorder due to general medical condition, insomnia type 221.49 9.94 8 413846 31439 50159831
Hypocalcaemia 218.35 9.94 595 413259 26221 50165049
Renal injury 212.56 9.94 305 413549 8306 50182964
Swelling 211.66 9.94 884 412970 199988 49991282
Hypersensitivity 195.79 9.94 999 412855 214162 49977108
Exposure during pregnancy 184.58 9.94 451 413403 120564 50070706
End stage renal disease 176.26 9.94 226 413628 5511 50185759
Therapeutic product effect incomplete 161.92 9.94 314 413540 91201 50100069
Diarrhoea 152.33 9.94 6065 407789 582411 49608859
C-reactive protein abnormal 147.28 9.94 25 413829 27784 50163486
Drug abuse 129.49 9.94 180 413674 59666 50131604
Rash 125.58 9.94 2676 411178 434795 49756475
Orthostatic hypotension 124.75 9.94 525 413329 28956 50162314
Constipation 124.69 9.94 2173 411681 183535 50007735
Rheumatic fever 123.48 9.94 3 413851 16864 50174406
Abdominal pain 122.95 9.94 2659 411195 233569 49957701
Fall 115.23 9.94 3568 410286 331364 49859906
Irritable bowel syndrome 114.04 9.94 152 413702 51289 50139981
Ill-defined disorder 111.76 9.94 171 413683 54483 50136787
Creatinine renal clearance decreased 111.44 9.94 278 413576 11603 50179667
Balance disorder 111.38 9.94 971 412883 69619 50121651
Cholecystitis chronic 110.04 9.94 244 413610 9425 50181845
Sedation complication 108.68 9.94 229 413625 8537 50182733
Abortion spontaneous 108.17 9.94 109 413745 41663 50149607
Impaired healing 104.85 9.94 262 413592 69524 50121746
Blood calcium decreased 103.92 9.94 389 413465 20317 50170953
Red blood cell sedimentation rate abnormal 100.39 9.94 9 413845 16334 50174936
Hypokalaemia 100.20 9.94 1131 412723 86861 50104409
Infection 96.04 9.94 927 412927 172027 50019243
Tetany 93.73 9.94 89 413765 1532 50189738
Musculoskeletal stiffness 93.64 9.94 640 413214 127841 50063429
Plasma cell myeloma 89.31 9.94 498 413356 30824 50160446
Pain 88.61 9.94 3853 410001 575050 49616220
Nasopharyngitis 86.81 9.94 1085 412769 191842 49999428
Device expulsion 85.73 9.94 66 413788 28756 50162514
Cognitive disorder 85.39 9.94 636 413218 43487 50147783
Toxicity to various agents 84.07 9.94 1227 412627 211272 49979998
Muscle spasms 82 9.94 1463 412391 124090 50067180
Intentional product use issue 80.58 9.94 339 413515 76579 50114691
Condition aggravated 76.58 9.94 1847 412007 295211 49896059
Stomatitis 75.74 9.94 501 413353 100843 50090427
Hypertensive nephropathy 72.20 9.94 47 413807 449 50190821
Drug resistance 71.20 9.94 33 413821 18956 50172314
Product use in unapproved indication 70.23 9.94 607 413247 115212 50076058
Hypoparathyroidism 66.81 9.94 48 413806 546 50190724
Coma 66.40 9.94 240 413614 56639 50134631
Dizziness 66.34 9.94 3465 410389 342904 49848366
Renal failure 64.54 9.94 1228 412626 105405 50085865
Gastric pH decreased 64.36 9.94 49 413805 613 50190657
Gastrointestinal disorder 61.83 9.94 485 413369 93971 50097299
Vomiting 61.22 9.94 4464 409390 456294 49734976
Arthralgia 59.69 9.94 2956 410898 435746 49755524
Drug tolerance decreased 59.20 9.94 4 413850 9156 50182114
Asthenia 58.73 9.94 3180 410674 315862 49875408
Swollen tongue 57.86 9.94 417 413437 28213 50163057
Cogwheel rigidity 57.76 9.94 72 413782 1705 50189565
Blood pressure systolic increased 57.29 9.94 128 413726 35321 50155949
Gastritis 56.93 9.94 463 413391 32520 50158750
Blister 56.65 9.94 437 413417 84981 50106289
Rheumatoid nodule 56.34 9.94 17 413837 12718 50178552
Dehydration 56.28 9.94 1639 412215 150810 50040460
Gastrointestinal haemorrhage 55.02 9.94 874 412980 72447 50118823
Pregnancy 54.47 9.94 99 413755 29478 50161792
Infective pulmonary exacerbation of cystic fibrosis 54.21 9.94 165 413689 7744 50183526
Pancreatitis acute 54.14 9.94 357 413497 23455 50167815
Hip arthroplasty 54.14 9.94 104 413750 30325 50160945
Malaise 53.99 9.94 3304 410550 332228 49859042
Overdose 53.43 9.94 539 413315 99188 50092082
Sedation 51.92 9.94 428 413426 30182 50161088
Bone erosion 50.99 9.94 16 413838 11671 50179599
Metabolic alkalosis 50.94 9.94 85 413769 2646 50188624
Intentional overdose 49.76 9.94 303 413551 62201 50129069
Chest pain 49.17 9.94 1839 412015 175043 50016227
Abdominal pain upper 48.63 9.94 1674 412180 157635 50033635
Haematemesis 48.29 9.94 390 413464 27335 50163935
Vision blurred 48.02 9.94 907 412947 77740 50113530
Therapy non-responder 47.38 9.94 235 413619 50787 50140483
Peripheral swelling 47.25 9.94 1302 412552 204634 49986636
Tenosynovitis 46.93 9.94 14 413840 10551 50180719
Therapeutic response decreased 46.52 9.94 213 413641 47018 50144252
Hiatus hernia 46.02 9.94 282 413572 18062 50173208
Live birth 45.78 9.94 40 413814 16368 50174902
Accidental exposure to product 45.36 9.94 74 413780 22983 50168287
Red blood cell sedimentation rate increased 45.30 9.94 109 413745 29307 50161963
Lethargy 44.45 9.94 608 413246 48824 50142446
Paraesthesia 44.15 9.94 1292 412562 118951 50072319
Malignant neoplasm progression 43.55 9.94 352 413502 67772 50123498
Urinary tract infection 43.39 9.94 2244 411610 221776 49969494
Gallbladder disorder 43.04 9.94 259 413595 16483 50174787
Hypertrichosis 43.02 9.94 47 413807 962 50190308
Gastrooesophageal reflux disease 42.47 9.94 869 412985 75559 50115711
Sinusitis 42.09 9.94 1067 412787 169491 50021779
Muscle spasticity 42.06 9.94 47 413807 17137 50174133
Nausea 41.94 9.94 6473 407381 698925 49492345
Disorientation 41.68 9.94 459 413395 35025 50156245
Chronic obstructive pulmonary disease 41.62 9.94 641 413213 52794 50138476
Gastric polyps 40.95 9.94 76 413778 2578 50188692
Anaemia 40.93 9.94 2488 411366 249968 49941302
Biliary dyskinesia 40.58 9.94 74 413780 2476 50188794
Burning mouth syndrome 40.44 9.94 31 413823 392 50190878
Dry mouth 40.03 9.94 664 413190 55514 50135756
General physical health deterioration 39.88 9.94 874 412980 141560 50049710
Flatulence 39.78 9.94 392 413462 29066 50162204
Liver function test abnormal 39.72 9.94 545 413309 43794 50147476
Product formulation issue 39.54 9.94 34 413820 511 50190759
Feeling of despair 39.25 9.94 64 413790 1954 50189316
Type 2 diabetes mellitus 38.84 9.94 147 413707 34228 50157042
Syncope 38.70 9.94 1110 412744 101892 50089378
Premature delivery 38.60 9.94 85 413769 23578 50167692
Suicide attempt 38.50 9.94 256 413598 51476 50139794
Diabetic nephropathy 38.41 9.94 51 413803 1288 50189982
Knee arthroplasty 38.14 9.94 157 413697 35689 50155581
Deep vein thrombosis 37.98 9.94 825 413029 72479 50118791
Pulmonary embolism 37.11 9.94 1092 412762 100612 50090658
Caesarean section 36.96 9.94 44 413810 15595 50175675
International normalised ratio increased 36.87 9.94 526 413328 42626 50148644
Abdominal distension 36.35 9.94 816 413038 72087 50119183
Lip swelling 35.79 9.94 334 413520 24402 50166868
Derealisation 34.99 9.94 43 413811 1003 50190267
Depersonalisation/derealisation disorder 34.94 9.94 46 413808 1152 50190118
Parkinsonism 34.69 9.94 154 413700 8693 50182577
Nephropathy 34.47 9.94 108 413746 5150 50186120
Device difficult to use 34.34 9.94 19 413835 9867 50181403
Swelling face 33.99 9.94 612 413242 51983 50139287
Tremor 33.70 9.94 1202 412652 113701 50077569
Confusional state 33.69 9.94 1851 412003 184077 50007193
Psoriatic arthropathy 33.38 9.94 236 413618 46796 50144474
Hallucinations, mixed 33.35 9.94 91 413763 4012 50187258
Dyspnoea 33.15 9.94 5031 408823 542577 49648693
Atrial fibrillation 33.03 9.94 1077 412777 100668 50090602
H1N1 influenza 32.91 9.94 52 413802 1545 50189725
Palatal oedema 32.50 9.94 28 413826 422 50190848
Toxic epidermal necrolysis 32.18 9.94 287 413567 20705 50170565
Depression 32.00 9.94 1657 412197 163766 50027504
Lower respiratory tract infection 31.83 9.94 567 413287 94634 50096636
Clostridium difficile infection 31.70 9.94 333 413521 25106 50166164
Panniculitis 31.54 9.94 15 413839 8488 50182782
Upper gastrointestinal haemorrhage 31.51 9.94 232 413622 15803 50175467
Rhabdomyolysis 31.48 9.94 471 413383 38556 50152714
Blood pressure diastolic abnormal 31.08 9.94 19 413835 9342 50181928
Pulmonary malformation 31.08 9.94 20 413834 187 50191083
Loss of personal independence in daily activities 30.69 9.94 396 413458 69654 50121616
Intestinal dilatation 30.53 9.94 48 413806 1420 50189850
Sepsis 30.24 9.94 1353 412501 131572 50059698
Cholelithiasis 29.75 9.94 456 413398 37517 50153753
Hypoparathyroidism secondary 29.68 9.94 12 413842 35 50191235
Blood pressure systolic abnormal 29.50 9.94 13 413841 7693 50183577
Gallbladder injury 29.28 9.94 44 413810 1250 50190020
Dilatation intrahepatic duct acquired 29.18 9.94 31 413823 614 50190656
Weight increased 28.80 9.94 1353 412501 200538 49990732
Hypergammaglobulinaemia 28.76 9.94 26 413828 419 50190851
Blood sodium decreased 28.35 9.94 281 413573 20866 50170404
Blood pressure fluctuation 28.33 9.94 174 413680 35649 50155621
Serotonin syndrome 28.26 9.94 318 413536 24395 50166875
Hypotension 28.09 9.94 2263 411591 233206 49958064
Sopor 28.04 9.94 77 413777 19802 50171468
C-reactive protein increased 27.95 9.94 379 413475 66095 50125175
Torus fracture 27.88 9.94 16 413838 119 50191151
Nephrogenic anaemia 27.80 9.94 50 413804 1655 50189615
Enthesopathy 27.75 9.94 12 413842 7181 50184089
Abdominal tenderness 27.26 9.94 125 413729 7155 50184115
Injection site pain 27.25 9.94 695 413159 110329 50080941
Hip fracture 27.13 9.94 328 413526 25603 50165667
Adverse event 27.11 9.94 228 413626 43535 50147735
Unintentional medical device removal 26.43 9.94 6 413848 5429 50185841
Poisoning deliberate 26.35 9.94 16 413838 7896 50183374
Hypoaesthesia oral 26.33 9.94 164 413690 10564 50180706
Feeling of body temperature change 26.18 9.94 87 413767 4280 50186990
Rebound acid hypersecretion 25.88 9.94 21 413833 290 50190980
Lipase increased 25.82 9.94 138 413716 8403 50182867
Respiratory arrest 25.74 9.94 142 413712 29867 50161403
Cholecystitis 25.73 9.94 198 413656 13673 50177597
Inappropriate antidiuretic hormone secretion 25.73 9.94 190 413664 12953 50178317
Mania 25.63 9.94 165 413689 10751 50180519
Calcium deficiency 25.45 9.94 35 413819 915 50190355
Pneumonia 25.42 9.94 3498 410356 374903 49816367
Dissociation 25.16 9.94 57 413797 2234 50189036
Drug dispensed to wrong patient 24.83 9.94 17 413837 178 50191092
Pancreatitis 24.82 9.94 488 413366 42126 50149144
Myalgia 24.79 9.94 1249 412605 123070 50068200
Acute generalised exanthematous pustulosis 24.74 9.94 141 413713 8797 50182473
Grip strength decreased 24.70 9.94 38 413816 12083 50179187
Congenital thrombocytopenia 24.62 9.94 11 413843 44 50191226
Blood magnesium decreased 24.57 9.94 166 413688 10994 50180276
Parosmia 24.51 9.94 86 413768 4350 50186920
Insulin autoimmune syndrome 23.85 9.94 12 413842 66 50191204
Maternal exposure before pregnancy 23.82 9.94 8 413846 5589 50185681
Limb reduction defect 23.82 9.94 22 413832 365 50190905
Dysgeusia 23.81 9.94 449 413405 38467 50152803
Cystic fibrosis 23.76 9.94 64 413790 2800 50188470
Haemoglobin decreased 23.72 9.94 1270 412584 125946 50065324
Faeces discoloured 23.47 9.94 218 413636 15906 50175364
Cholecystectomy 23.33 9.94 143 413711 9160 50182110
Oesophagitis 23.16 9.94 188 413666 13195 50178075
Pregnancy with contraceptive device 23.13 9.94 3 413851 4076 50187194
Hypergastrinaemia 23.07 9.94 13 413841 93 50191177
Product substitution issue 23.01 9.94 195 413659 13862 50177408
Blood parathyroid hormone decreased 22.85 9.94 15 413839 7099 50184171
Giardiasis 22.83 9.94 9 413845 24 50191246
Cross sensitivity reaction 22.76 9.94 50 413804 1919 50189351
Foetal death 22.75 9.94 20 413834 8160 50183110
Moraxella test positive 22.54 9.94 8 413846 14 50191256
Nephroangiosclerosis 22.38 9.94 14 413840 124 50191146
Electrocardiogram QT prolonged 22.28 9.94 569 413285 51317 50139953
Fear of injection 22.28 9.94 11 413843 6092 50185178
Memory impairment 22.23 9.94 826 413028 78534 50112736
Injection site reaction 22.22 9.94 282 413572 49750 50141520
Abnormal loss of weight 22.06 9.94 91 413763 4973 50186297
Skin test positive 22.03 9.94 27 413827 628 50190642
Temperature regulation disorder 21.94 9.94 4 413850 4223 50187047
Truncus coeliacus thrombosis 21.91 9.94 7 413847 7 50191263
Device use error 21.60 9.94 8 413846 5258 50186012
Injection site swelling 21.04 9.94 229 413625 41544 50149726
Blood cholesterol increased 21.03 9.94 321 413533 54894 50136376
Rectal haemorrhage 20.95 9.94 437 413417 38121 50153149
Drooling 20.81 9.94 68 413786 3316 50187954
Hallucination 20.73 9.94 514 413340 46143 50145127
Foetal exposure during pregnancy 20.55 9.94 135 413719 27224 50164046
Product packaging confusion 20.49 9.94 14 413840 146 50191124
Fatigue 20.49 9.94 5310 408544 702291 49488979
Neutropenic sepsis 20.45 9.94 191 413663 13956 50177314
Muscle disorder 20.41 9.94 80 413774 4270 50187000
Injection site erythema 20.33 9.94 462 413392 74474 50116796
Hyperchlorhydria 20.21 9.94 41 413813 1487 50189783
Anxiety 20.06 9.94 1700 412154 175906 50015364
Mouth swelling 20.01 9.94 74 413780 3842 50187428
Stillbirth 19.87 9.94 12 413842 5940 50185330
Dyspepsia 19.75 9.94 767 413087 73330 50117940
Long QT syndrome 19.50 9.94 61 413793 2906 50188364
Lung cyst 19.43 9.94 14 413840 160 50191110
Ankylosing spondylitis 19.35 9.94 18 413836 7147 50184123
Duodenal stenosis 19.25 9.94 22 413832 474 50190796
Body temperature decreased 19.25 9.94 69 413785 16326 50174944
Hypoglycaemia 19.18 9.94 574 413280 53007 50138263
Blood alkaline phosphatase increased 19.00 9.94 421 413433 37105 50154165
Melaena 18.94 9.94 317 413537 26547 50164723
Small intestinal obstruction 18.94 9.94 208 413646 15860 50175410
Cutaneous lupus erythematosus 18.85 9.94 53 413801 2378 50188892
Transient ischaemic attack 18.81 9.94 369 413485 31841 50159429
Congenital ovarian anomaly 18.78 9.94 6 413848 6 50191264
Thermohypoaesthesia 18.75 9.94 12 413842 111 50191159
Skin necrosis 18.59 9.94 38 413816 10829 50180441
Viral diarrhoea 18.58 9.94 12 413842 113 50191157
Metastases to lymph nodes 18.56 9.94 18 413836 7006 50184264
Akathisia 18.55 9.94 24 413830 8205 50183065
Stevens-Johnson syndrome 18.52 9.94 265 413589 21487 50169783
Type I hypersensitivity 18.50 9.94 52 413802 2333 50188937
Hypophosphataemia 18.43 9.94 125 413729 8289 50182981
Catatonia 18.42 9.94 4 413850 3732 50187538
Injection site bruising 18.35 9.94 202 413652 36566 50154704
Angioedema 18.24 9.94 420 413434 37256 50154014
Bone marrow failure 17.99 9.94 142 413712 27482 50163788
Polyserositis 17.90 9.94 16 413838 254 50191016
Bicytopenia 17.84 9.94 45 413809 1891 50189379
Product dose omission issue 17.63 9.94 1739 412115 182099 50009171
Feeling abnormal 17.62 9.94 1222 412632 124270 50067000
Maternal exposure timing unspecified 17.60 9.94 4 413850 3616 50187654
Presyncope 17.60 9.94 287 413567 23911 50167359
Tinnitus 17.35 9.94 325 413529 27807 50163463
Intravascular haemolysis 17.25 9.94 16 413838 267 50191003
Wrong technique in product usage process 17.18 9.94 335 413519 55175 50136095
Target skin lesion 17.08 9.94 11 413843 103 50191167
Restless legs syndrome 17.03 9.94 202 413652 15695 50175575
Obstructive airways disorder 17.00 9.94 68 413786 15584 50175686
Avian influenza 16.99 9.94 9 413845 56 50191214
Palpitations 16.93 9.94 940 412914 93566 50097704
Poisoning 16.90 9.94 49 413805 12380 50178890
Liver injury 16.86 9.94 126 413728 24680 50166590
Aplastic anaemia 16.82 9.94 23 413831 7680 50183590
Blood chromogranin A increased 16.78 9.94 15 413839 238 50191032
Lower gastrointestinal haemorrhage 16.78 9.94 105 413749 6774 50184496
Normal newborn 16.71 9.94 18 413836 6673 50184597
Subdural haemorrhage 16.69 9.94 55 413799 2694 50188576
Eyelid retraction 16.51 9.94 8 413846 40 50191230
Cholecystitis acute 16.43 9.94 107 413747 6999 50184271
Sight disability 16.40 9.94 11 413843 111 50191159
Sensory loss 16.39 9.94 114 413740 7624 50183646
Hyperkalaemia 16.37 9.94 512 413342 47577 50143693
Dysphagia 16.32 9.94 783 413071 76735 50114535
Urinary retention 16.30 9.94 303 413551 25887 50165383
Pulmonary toxicity 16.21 9.94 13 413841 5549 50185721
Bromhidrosis 16.17 9.94 5 413849 4 50191266
Respiratory tract malformation 16.14 9.94 10 413844 87 50191183
Head discomfort 16.05 9.94 149 413705 10870 50180400
Hyperhidrosis 15.92 9.94 889 412965 88537 50102733
Muscle rigidity 15.90 9.94 136 413718 9693 50181577
Nervousness 15.88 9.94 316 413538 27335 50163935
Full blood count decreased 15.87 9.94 264 413590 22082 50169188
Skin discolouration 15.80 9.94 365 413489 32392 50158878
Miosis 15.73 9.94 17 413837 6293 50184977
Intentional product misuse 15.72 9.94 278 413576 46456 50144814
Oedema peripheral 15.69 9.94 1498 412356 156463 50034807
Therapeutic product ineffective 15.54 9.94 33 413821 1237 50190033
Drug eruption 15.53 9.94 121 413733 23485 50167785
Disturbance in attention 15.51 9.94 349 413505 30837 50160433
Multiple-drug resistance 15.45 9.94 4 413850 3310 50187960
Cardiotoxicity 15.33 9.94 21 413833 7006 50184264
Macular degeneration 15.31 9.94 63 413791 14325 50176945
Beta haemolytic streptococcal infection 15.29 9.94 41 413813 1789 50189481
Prescription drug used without a prescription 15.13 9.94 39 413815 1661 50189609
Agitation 15.04 9.94 556 413298 52828 50138442
Cytomegalovirus viraemia 15.03 9.94 10 413844 4699 50186571
Chromaturia 15.02 9.94 184 413670 14406 50176864
Respirovirus test positive 14.96 9.94 6 413848 17 50191253
Multimorbidity 14.95 9.94 20 413834 509 50190761
Non-cardiac chest pain 14.94 9.94 89 413765 5643 50185627
Acute respiratory failure 14.92 9.94 324 413530 28458 50162812
Transplant dysfunction 14.88 9.94 10 413844 4674 50186596
Norovirus test positive 14.82 9.94 11 413843 132 50191138
Soft tissue disorder 14.78 9.94 8 413846 4206 50187064
Iron deficiency anaemia 14.70 9.94 206 413648 16628 50174642
Chest discomfort 14.65 9.94 912 412942 91810 50099460
Pathogen resistance 14.55 9.94 15 413839 5674 50185596
Oedematous pancreatitis 14.53 9.94 17 413837 376 50190894
Nightmare 14.51 9.94 198 413656 15888 50175382
Chronic kidney disease-mineral and bone disorder 14.46 9.94 9 413845 79 50191191
Gastrointestinal erosion 14.44 9.94 21 413833 579 50190691
Hepatitis acute 14.41 9.94 113 413741 7848 50183422
Genital blister 14.27 9.94 9 413845 81 50191189
Compartment syndrome 14.20 9.94 42 413812 1940 50189330
Superior mesenteric artery syndrome 14.18 9.94 9 413845 82 50191188
Atrioventricular block first degree 14.11 9.94 93 413761 6108 50185162
Blood pressure diastolic decreased 14.07 9.94 80 413774 16701 50174569
Tongue blistering 14.05 9.94 33 413821 1325 50189945
Endoscopy abnormal 14.00 9.94 5 413849 9 50191261
Gallbladder cholesterolosis 13.95 9.94 23 413831 709 50190561
Device dislocation 13.92 9.94 111 413743 21435 50169835
Cardiac arrest 13.90 9.94 551 413303 83100 50108170
Drug dose titration not performed 13.82 9.94 18 413836 446 50190824
Gastrointestinal stoma complication 13.81 9.94 35 413819 1475 50189795
Limb hypoplasia congenital 13.76 9.94 12 413842 184 50191086
Necrosis ischaemic 13.76 9.94 24 413830 775 50190495
Diverticulum 13.73 9.94 140 413714 10474 50180796
Metastases to liver 13.72 9.94 102 413752 20002 50171268
Injection site pruritus 13.71 9.94 240 413614 40171 50151099
Hyperreflexia 13.68 9.94 80 413774 5038 50186232
Intestinal obstruction 13.68 9.94 297 413557 26086 50165184
Abnormal weight gain 13.64 9.94 34 413820 1418 50189852
Hand-eye coordination impaired 13.62 9.94 6 413848 23 50191247
Gastrointestinal polyp 13.43 9.94 6 413848 24 50191246
Hepatic rupture 13.43 9.94 6 413848 24 50191246
Decreased appetite 13.40 9.94 1857 411997 199066 49992204
Emotional distress 13.40 9.94 318 413536 28345 50162925
Hepatic encephalopathy 13.38 9.94 129 413725 9507 50181763
Therapeutic response shortened 13.37 9.94 25 413829 7364 50183906
Dental discomfort 13.36 9.94 16 413838 363 50190907
Post transplant lymphoproliferative disorder 13.32 9.94 9 413845 4195 50187075
Myelosuppression 13.28 9.94 61 413793 13456 50177814
Interstitial lung disease 13.27 9.94 332 413522 52844 50138426
Body height decreased 13.25 9.94 121 413733 8787 50182483
No adverse event 13.20 9.94 194 413660 33384 50157886
Product odour abnormal 13.19 9.94 28 413826 1049 50190221
Acute graft versus host disease 13.19 9.94 8 413846 3950 50187320
Gallbladder adenocarcinoma 13.16 9.94 9 413845 94 50191176
Acute psychosis 13.11 9.94 44 413810 2176 50189094
Pneumonia streptococcal 13.08 9.94 36 413818 1595 50189675
Fear of eating 13.06 9.94 15 413839 325 50190945
Rash macular 13.05 9.94 226 413628 19051 50172219
Colitis 13.05 9.94 410 413444 38119 50153151
Dolichocolon 13.04 9.94 4 413850 3 50191267
Sweat discolouration 13.04 9.94 4 413850 3 50191267
Hair injury 13.04 9.94 4 413850 3 50191267
Vitamin B12 deficiency 13.04 9.94 65 413789 3851 50187419
Blood potassium decreased 13.01 9.94 395 413459 36550 50154720
Malnutrition 13.01 9.94 165 413689 13024 50178246
Parkinsonian rest tremor 13.01 9.94 9 413845 96 50191174
Labelled drug-drug interaction medication error 12.99 9.94 137 413717 10340 50180930
Dysphonia 12.95 9.94 413 413441 38479 50152791
Aquagenic pruritus 12.88 9.94 6 413848 27 50191243
Goitre 12.85 9.94 81 413773 5239 50186031
Back pain 12.83 9.94 2018 411836 218012 49973258
Pneumonitis 12.78 9.94 324 413530 29186 50162084
Lipidosis 12.77 9.94 5 413849 13 50191257
Urinary tract infection pseudomonal 12.60 9.94 23 413831 770 50190500
Abortion induced 12.58 9.94 37 413817 9307 50181963
Vertigo 12.53 9.94 531 413323 51301 50139969
Intestinal ulcer 12.48 9.94 28 413826 1090 50190180
Antineutrophil cytoplasmic antibody positive 12.47 9.94 18 413836 493 50190777
Large intestine infection 12.44 9.94 35 413819 1571 50189699
Oral pain 12.41 9.94 280 413574 24753 50166517
Blood urea increased 12.39 9.94 266 413588 23319 50167951
Renal haemangioma 12.38 9.94 6 413848 30 50191240
Dysuria 12.36 9.94 313 413541 28191 50163079
Derailment 12.32 9.94 7 413847 51 50191219
International normalised ratio abnormal 12.31 9.94 51 413803 2792 50188478
Complication of device insertion 12.25 9.94 19 413835 6022 50185248
Hypocoagulable state 12.24 9.94 25 413829 911 50190359
Pneumonia aspiration 12.24 9.94 179 413675 30825 50160445
Urine chloride decreased 12.15 9.94 8 413846 78 50191192
Chronic pigmented purpura 12.15 9.94 8 413846 78 50191192
Anaemia folate deficiency 12.13 9.94 11 413843 178 50191092
Blood iron abnormal 12.13 9.94 6 413848 3320 50187950
Rapid eye movement sleep behaviour disorder 12.08 9.94 11 413843 179 50191091
Dialysis 11.97 9.94 124 413730 9314 50181956
Occult blood positive 11.95 9.94 56 413798 3235 50188035
Cardiac steatosis 11.93 9.94 6 413848 33 50191237
Choluria 11.92 9.94 10 413844 145 50191125
Developmental hip dysplasia 11.89 9.94 30 413824 1261 50190009
Hypophagia 11.88 9.94 304 413550 27424 50163846
Cellulitis 11.86 9.94 700 413154 70098 50121172
Cytomegalovirus infection 11.85 9.94 92 413762 17870 50173400
Congenital oral malformation 11.84 9.94 11 413843 184 50191086
Drug ineffective for unapproved indication 11.81 9.94 114 413740 21167 50170103
Premature rupture of membranes 11.80 9.94 12 413842 4568 50186702
Discoloured vomit 11.80 9.94 20 413834 631 50190639
Salmonellosis 11.77 9.94 24 413830 874 50190396
Mesenteric artery thrombosis 11.76 9.94 10 413844 148 50191122
Febrile bone marrow aplasia 11.73 9.94 21 413833 6290 50184980
Peptic ulcer perforation 11.70 9.94 10 413844 149 50191121
Product blister packaging issue 11.70 9.94 10 413844 149 50191121
Jaundice 11.69 9.94 291 413563 26138 50165132
Injection site warmth 11.68 9.94 66 413788 13800 50177470
Heart rate decreased 11.68 9.94 219 413635 36278 50154992
Pallor 11.66 9.94 260 413594 22939 50168331
Incontinence 11.65 9.94 129 413725 9856 50181414
Single functional kidney 11.65 9.94 10 413844 150 50191120
Tympanic membrane hyperaemia 11.64 9.94 4 413850 6 50191264
Ear pain 11.62 9.94 162 413692 28121 50163149
Gastric antral vascular ectasia 11.61 9.94 18 413836 526 50190744
Herpes zoster 11.60 9.94 467 413387 70319 50120951
Hypertensive cardiomyopathy 11.60 9.94 11 413843 189 50191081
Agitated depression 11.54 9.94 9 413845 117 50191153
Immune reconstitution inflammatory syndrome 11.52 9.94 17 413837 5499 50185771
Prevertebral soft tissue swelling of cervical space 11.51 9.94 6 413848 36 50191234
DNA antibody 11.51 9.94 6 413848 36 50191234
Shunt thrombosis 11.51 9.94 6 413848 36 50191234
Biliary colic 11.50 9.94 55 413799 3204 50188066
Metastases to bone 11.49 9.94 93 413761 17902 50173368
Presumed ocular histoplasmosis syndrome 11.44 9.94 3 413851 0 50191270
Occupational problem environmental 11.44 9.94 3 413851 0 50191270
Breast discolouration 11.44 9.94 3 413851 0 50191270
Barrett's oesophagus 11.44 9.94 19 413835 589 50190681
Respiratory tract procedural complication 11.44 9.94 3 413851 0 50191270
Hyperchromic anaemia 11.37 9.94 6 413848 37 50191233
Antithrombin III 11.28 9.94 10 413844 157 50191113
Polyuria 11.24 9.94 98 413756 7023 50184247
Femur fracture 11.24 9.94 393 413461 37071 50154199
Disability 11.20 9.94 60 413794 12715 50178555
Feeling jittery 11.17 9.94 140 413714 11020 50180250
Mood swings 11.15 9.94 188 413666 15766 50175504
Acquired oesophageal web 11.15 9.94 11 413843 199 50191071
Second primary malignancy 11.14 9.94 25 413829 6889 50184381
Malignant mediastinal neoplasm 11.12 9.94 18 413836 546 50190724
Muscular weakness 11.12 9.94 912 412942 94101 50097169
Gastrointestinal polyp haemorrhage 11.07 9.94 10 413844 161 50191109
Acinetobacter test positive 11.01 9.94 7 413847 64 50191206
Body temperature increased 11 9.94 185 413669 31156 50160114
Secondary adrenocortical insufficiency 10.99 9.94 27 413827 1116 50190154
Respiratory disorder 10.98 9.94 184 413670 31003 50160267
Urticaria vesiculosa 10.93 9.94 4 413850 8 50191262
Colitis ischaemic 10.83 9.94 122 413732 9361 50181909
BK virus infection 10.81 9.94 5 413849 2876 50188394
Chronic graft versus host disease 10.72 9.94 5 413849 2862 50188408
Suspected suicide 10.72 9.94 17 413837 5340 50185930
Bipolar I disorder 10.72 9.94 32 413822 1486 50189784
Duodenitis 10.71 9.94 54 413800 3214 50188056
Extrasystoles 10.71 9.94 70 413784 4585 50186685
Premature baby 10.71 9.94 97 413757 18240 50173030
Product complaint 10.70 9.94 142 413712 11324 50179946
Product taste abnormal 10.67 9.94 35 413819 1710 50189560
Urine output increased 10.67 9.94 27 413827 1137 50190133
Atrophic vulvovaginitis 10.66 9.94 33 413821 1563 50189707
Gastritis bacterial 10.66 9.94 7 413847 68 50191202
Tendon sheath incision 10.66 9.94 7 413847 68 50191202
Osteochondritis 10.65 9.94 5 413849 23 50191247
Oesophageal stenosis 10.65 9.94 49 413805 2809 50188461
Magnesium metabolism disorder 10.64 9.94 6 413848 43 50191227
Cleft palate 10.62 9.94 24 413830 939 50190331
Cholangitis 10.62 9.94 69 413785 4510 50186760
Renal artery arteriosclerosis 10.62 9.94 4 413850 9 50191261
Product physical consistency issue 10.61 9.94 16 413838 456 50190814
Tenderness 10.50 9.94 99 413755 18466 50172804
Gastroenteritis aeromonas 10.48 9.94 5 413849 24 50191246
Infective exacerbation of chronic obstructive airways disease 10.47 9.94 26 413828 1082 50190188
Listless 10.45 9.94 43 413811 2347 50188923
Device deployment issue 10.40 9.94 8 413846 3488 50187782
Vulvar basal cell carcinoma 10.32 9.94 5 413849 25 50191245
Inflammation 10.31 9.94 371 413483 56541 50134729
Exposure via ingestion 10.31 9.94 5 413849 2798 50188472
Poliomyelitis 10.31 9.94 6 413848 46 50191224
Deformity 10.29 9.94 32 413822 7908 50183362
Hepatitis toxic 10.28 9.94 48 413806 2768 50188502
Breast cancer stage III 10.28 9.94 7 413847 3249 50188021
Device issue 10.25 9.94 109 413745 19863 50171407
Renal disorder 10.21 9.94 296 413558 27209 50164061
Stress ulcer 10.20 9.94 6 413848 47 50191223
Tongue discomfort 10.14 9.94 36 413818 1832 50189438
Tanning 10.09 9.94 7 413847 75 50191195
Cystic fibrosis lung 10.07 9.94 8 413846 107 50191163
Vertigo positional 10.07 9.94 44 413810 2467 50188803
Cerebrovascular accident 10.01 9.94 902 412952 93778 50097492
Adverse drug reaction 10.00 9.94 360 413494 54862 50136408
Joint stiffness 9.97 9.94 181 413673 30127 50161143
Polymyositis 9.94 9.94 32 413822 1548 50189722

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 567.56 10.78 757 275929 16711 29281130
Drug abuse 390.67 10.78 130 276556 79753 29218088
Off label use 355.40 10.78 1529 275157 299271 28998570
Drug ineffective 286.45 10.78 2108 274578 361062 28936779
Chronic kidney disease 267.37 10.78 849 275837 35567 29262274
Hypocalcaemia 228.09 10.78 559 276127 20106 29277735
Toxicity to various agents 209.22 10.78 875 275811 172786 29125055
Tubulointerstitial nephritis 182.87 10.78 466 276220 17177 29280664
Hypertrichosis 158.51 10.78 73 276613 269 29297572
Completed suicide 139.20 10.78 409 276277 89837 29208004
Product use in unapproved indication 134.52 10.78 393 276293 86482 29211359
End stage renal disease 107.51 10.78 228 276458 7436 29290405
Treatment failure 101.96 10.78 117 276569 36822 29261019
Product formulation issue 97.91 10.78 59 276627 417 29297424
Tetany 94.01 10.78 65 276621 597 29297244
Death 92.29 10.78 2467 274219 339617 28958224
Therapeutic product effect incomplete 86.95 10.78 146 276540 39159 29258682
Hypoparathyroidism 80.45 10.78 52 276634 422 29297419
Hyponatraemia 75.23 10.78 965 275721 66668 29231173
Drug resistance 75.14 10.78 55 276631 21485 29276356
Acute kidney injury 69.56 10.78 3089 273597 262178 29035663
Foetal exposure during pregnancy 69.33 10.78 132 276554 33735 29264106
Renal injury 68.65 10.78 231 276455 9971 29287870
Intentional product use issue 62.33 10.78 197 276489 42301 29255540
Subacute cutaneous lupus erythematosus 60.76 10.78 56 276630 803 29297038
Lower respiratory tract infection 58.67 10.78 437 276249 26065 29271776
Gastrooesophageal reflux disease 57.55 10.78 497 276189 30999 29266842
Intentional product misuse 57.16 10.78 152 276534 34509 29263332
Inappropriate antidiuretic hormone secretion 57.09 10.78 228 276458 10704 29287137
Diarrhoea 56.61 10.78 3721 272965 328977 28968864
Overdose 55.19 10.78 479 276207 79340 29218501
Synovitis 52.69 10.78 18 276668 10872 29286969
Intentional overdose 51.45 10.78 186 276500 38342 29259499
Drug intolerance 51.37 10.78 255 276431 48124 29249717
Drug interaction 49.99 10.78 2291 274395 195094 29102747
Renal tubular acidosis 49.36 10.78 72 276614 1731 29296110
C-reactive protein abnormal 49.11 10.78 3 276683 6533 29291308
Abdominal pain 48.58 10.78 1632 275054 133725 29164116
Suicide attempt 48.01 10.78 161 276525 33949 29263892
Infective pulmonary exacerbation of cystic fibrosis 47.20 10.78 147 276539 6089 29291752
General physical health deterioration 47.02 10.78 678 276008 102179 29195662
Drug hypersensitivity 45.75 10.78 414 276272 67992 29229849
Hypoparathyroidism secondary 44.85 10.78 23 276663 113 29297728
Abdominal pain upper 43.43 10.78 807 275879 60186 29237655
Hypertensive nephropathy 42.45 10.78 34 276652 398 29297443
Gastric polyps 41.73 10.78 49 276637 945 29296896
Multiple organ dysfunction syndrome 40.90 10.78 385 276301 62731 29235110
Hyperchlorhydria 40.86 10.78 39 276647 586 29297255
Myalgia 40.47 10.78 942 275744 73077 29224764
Blood pressure fluctuation 40.31 10.78 78 276608 19816 29278025
Dyspepsia 40.14 10.78 445 276241 29680 29268161
Immune reconstitution inflammatory syndrome 39.33 10.78 12 276674 7790 29290051
Plasma cell myeloma 39.33 10.78 525 276161 36590 29261251
Hiatus hernia 38.67 10.78 145 276541 6607 29291234
Coma 38.48 10.78 214 276472 39236 29258605
Asthenia 38.03 10.78 2416 274270 212834 29085007
Febrile neutropenia 38.00 10.78 781 275905 111459 29186382
Infusion related reaction 37.60 10.78 248 276438 43638 29254203
Chromaturia 37.29 10.78 226 276460 12576 29285265
Product use issue 37.22 10.78 305 276381 51139 29246702
Respiratory arrest 36.31 10.78 122 276564 25711 29272130
Drug dependence 36.13 10.78 90 276596 20891 29276950
Loss of personal independence in daily activities 35.85 10.78 120 276566 25320 29272521
Poisoning 35.52 10.78 25 276661 9968 29287873
Gastritis 35.14 10.78 307 276379 19210 29278631
Drug ineffective for unapproved indication 35.07 10.78 49 276637 14165 29283676
Nephrogenic anaemia 35.01 10.78 65 276621 1920 29295921
Condition aggravated 33.71 10.78 1077 275609 145218 29152623
Occupational dermatitis 33.37 10.78 16 276670 66 29297775
Premature baby 33.09 10.78 70 276616 17210 29280631
Haemophagocytic lymphohistiocytosis 32.68 10.78 30 276656 10474 29287367
Interstitial lung disease 32.09 10.78 365 276321 57353 29240488
Substance abuse 31.51 10.78 12 276674 6775 29291066
Iron deficiency anaemia 30.74 10.78 165 276521 8777 29289064
Hypokalaemia 30.61 10.78 649 276037 49554 29248287
Malignant neoplasm progression 29.62 10.78 499 276187 73360 29224481
Rheumatoid arthritis 29.44 10.78 178 276508 31974 29265867
Blood magnesium decreased 29.37 10.78 114 276572 5280 29292561
Muscle spasms 29.00 10.78 806 275880 64276 29233565
Mesenteric vein thrombosis 28.69 10.78 29 276657 469 29297372
Dry mouth 28.20 10.78 320 276366 21464 29276377
Jejunal ulcer perforation 28.09 10.78 14 276672 64 29297777
Right hemisphere deficit syndrome 28.02 10.78 9 276677 7 29297834
Mucormycosis 27.75 10.78 7 276679 5151 29292690
Product label on wrong product 27.48 10.78 9 276677 8 29297833
Gastric mucosal hypertrophy 27.42 10.78 15 276671 86 29297755
Hepatocellular injury 26.76 10.78 105 276581 21138 29276703
Pathogen resistance 26.68 10.78 22 276664 8094 29289747
Fatigue 26.53 10.78 3367 273319 313454 28984387
Confusional state 26.45 10.78 1456 275230 126421 29171420
Tetanus 25.90 10.78 12 276674 45 29297796
Lip swelling 25.43 10.78 201 276485 12209 29285632
Cytomegalovirus infection 25.42 10.78 121 276565 23094 29274747
Dizziness 25.22 10.78 2081 274605 187603 29110238
Chest pain 25.18 10.78 1285 275401 110688 29187153
Exposure during pregnancy 24.80 10.78 26 276660 8528 29289313
Upper gastrointestinal haemorrhage 24.47 10.78 313 276373 21601 29276240
Hepatic function abnormal 24.35 10.78 242 276444 39017 29258824
Multiple-drug resistance 23.65 10.78 4 276682 3896 29293945
Therapeutic response decreased 23.58 10.78 135 276551 24576 29273265
Vomiting 23.52 10.78 2298 274388 209962 29087879
Altered state of consciousness 23.37 10.78 101 276585 19788 29278053
Dysgeusia 23.30 10.78 319 276367 22355 29275486
Cardiogenic shock 22.83 10.78 97 276589 19093 29278748
Apparent death 22.61 10.78 3 276683 3501 29294340
Venoocclusive liver disease 22.43 10.78 19 276667 6898 29290943
Granuloma annulare 22.31 10.78 15 276671 131 29297710
Lupus endocarditis 22.09 10.78 6 276680 0 29297841
Drug use disorder 21.91 10.78 3 276683 3419 29294422
Respiratory depression 21.76 10.78 60 276626 13463 29284378
Pneumocystis jirovecii pneumonia 21.74 10.78 82 276604 16697 29281144
Lethargy 21.68 10.78 482 276204 37098 29260743
Respiratory tract infection 21.67 10.78 233 276453 15418 29282423
Obstructive airways disorder 21.62 10.78 44 276642 10972 29286869
Flatulence 21.52 10.78 257 276429 17452 29280389
Meconium abnormal 21.46 10.78 11 276675 54 29297787
Haematotoxicity 21 10.78 19 276667 6680 29291161
Helicobacter test positive 20.44 10.78 28 276658 634 29297207
Low birth weight baby 20.41 10.78 19 276667 6589 29291252
Rectal haemorrhage 20.21 10.78 444 276242 34105 29263736
Acute interstitial pneumonitis 19.99 10.78 21 276665 356 29297485
Device dependence 19.78 10.78 9 276677 32 29297809
Accidental exposure to product 19.40 10.78 45 276641 10708 29287133
Abnormal loss of weight 19.14 10.78 76 276610 3558 29294283
Coronary artery bypass 19.06 10.78 10 276676 4675 29293166
Ageusia 19.00 10.78 146 276540 8792 29289049
Cerebral infarction 18.90 10.78 144 276542 24531 29273310
Blood copper increased 18.89 10.78 7 276679 12 29297829
Bone marrow failure 18.83 10.78 165 276521 27284 29270557
Type I hypersensitivity 18.78 10.78 35 276651 1037 29296804
Cystitis haemorrhagic 18.73 10.78 11 276675 4831 29293010
Oesophagitis 18.66 10.78 182 276504 11741 29286100
Inappropriate schedule of product administration 18.63 10.78 298 276388 44174 29253667
Blood gastrin increased 18.58 10.78 8 276678 24 29297817
Renal failure 18.54 10.78 1318 275368 117281 29180560
Therapy partial responder 18.49 10.78 13 276673 5186 29292655
Gastric xanthoma 18.41 10.78 5 276681 0 29297841
Veillonella infection 18.41 10.78 5 276681 0 29297841
Hypocalcaemic seizure 18.41 10.78 5 276681 0 29297841
Tenosynovitis 18.36 10.78 6 276680 3727 29294114
Heart rate decreased 18.33 10.78 147 276539 24765 29273076
Cerebral atrophy congenital 18.19 10.78 10 276676 58 29297783
Dyspnoea 18.06 10.78 3393 273293 323339 28974502
Cardio-respiratory arrest 18.03 10.78 349 276337 50252 29247589
Ceruloplasmin increased 17.98 10.78 6 276680 6 29297835
Urine calcium decreased 17.98 10.78 6 276680 6 29297835
Sopor 17.98 10.78 48 276638 10886 29286955
Blood chromogranin A increased 17.90 10.78 15 276671 188 29297653
Indifference 17.82 10.78 13 276673 131 29297710
Brain scan abnormal 17.79 10.78 30 276656 820 29297021
Diabetic nephropathy 17.54 10.78 48 276638 1847 29295994
Weight increased 17.49 10.78 565 276121 76102 29221739
Stoma site haemorrhage 17.31 10.78 27 276659 690 29297151
Chronic graft versus host disease 17.30 10.78 8 276678 4021 29293820
Hepatic encephalopathy 17.11 10.78 192 276494 12843 29284998
Lipodystrophy acquired 17.03 10.78 4 276682 3090 29294751
Liver function test abnormal 17.03 10.78 372 276314 28546 29269295
Myelosuppression 17.00 10.78 58 276628 12169 29285672
Akathisia 16.88 10.78 23 276663 6719 29291122
Barrett's oesophagus 16.81 10.78 21 276665 433 29297408
Nephritis 16.77 10.78 51 276635 2085 29295756
Gastric pH decreased 16.60 10.78 12 276674 119 29297722
Steatorrhoea 16.57 10.78 26 276660 668 29297173
Aplastic anaemia 16.50 10.78 28 276658 7482 29290359
Chronic kidney disease-mineral and bone disorder 16.48 10.78 19 276667 359 29297482
Graft versus host disease in gastrointestinal tract 16.44 10.78 5 276681 3253 29294588
Carcinoid tumour of the gastrointestinal tract 16.39 10.78 9 276677 52 29297789
Gastroenteritis eosinophilic 16.38 10.78 13 276673 150 29297691
Electrocardiogram QRS complex prolonged 16.38 10.78 9 276677 4101 29293740
Macrocephaly 16.36 10.78 20 276666 403 29297438
Ventricular flutter 16.33 10.78 10 276676 73 29297768
Faeces discoloured 16.33 10.78 194 276492 13157 29284684
Nephrosclerosis 16.07 10.78 28 276658 786 29297055
Neuroleptic malignant syndrome 16.07 10.78 87 276599 16061 29281780
Crohn's disease 15.90 10.78 63 276623 2946 29294895
Product substitution issue 15.85 10.78 143 276543 9029 29288812
Pneumatosis intestinalis 15.75 10.78 5 276681 3164 29294677
Gastrointestinal haemorrhage 15.73 10.78 902 275784 78631 29219210
Stress 15.72 10.78 127 276559 21363 29276478
Graft versus host disease in skin 15.64 10.78 6 276680 3373 29294468
Post transplant lymphoproliferative disorder 15.59 10.78 17 276669 5476 29292365
Myocardial infarction 15.24 10.78 860 275826 109436 29188405
Oropharyngeal blistering 15.19 10.78 13 276673 168 29297673
Dystonia 15.14 10.78 44 276642 9705 29288136
Oxygen saturation decreased 15.09 10.78 313 276373 44624 29253217
Neutropenic sepsis 15.06 10.78 172 276514 11555 29286286
Multimorbidity 14.96 10.78 22 276664 533 29297308
Ischaemic stroke 14.90 10.78 221 276465 15756 29282085
Cardiac arrest 14.80 10.78 652 276034 84939 29212902
Blood calcium decreased 14.78 10.78 141 276545 9041 29288800
Blood pressure increased 14.73 10.78 553 276133 73250 29224591
Latent tetany 14.73 10.78 4 276682 0 29297841
Degenerative mitral valve disease 14.69 10.78 14 276672 210 29297631
Dermatitis infected 14.63 10.78 10 276676 90 29297751
Aggression 14.61 10.78 239 276447 35302 29262539
Pancreatic abscess 14.56 10.78 9 276677 67 29297774
High-grade B-cell lymphoma 14.56 10.78 9 276677 67 29297774
Chronic obstructive pulmonary disease 14.45 10.78 493 276193 40462 29257379
Gastric neoplasm 14.34 10.78 9 276677 69 29297772
Oesophageal stenosis 14.33 10.78 39 276647 1496 29296345
Posterior reversible encephalopathy syndrome 14.31 10.78 40 276646 8936 29288905
Epstein-Barr virus infection 14.31 10.78 25 276661 6604 29291237
Nephropathy 14.13 10.78 91 276595 5172 29292669
Laboratory test 14.09 10.78 5 276681 7 29297834
Lymphoma 14.09 10.78 46 276640 9782 29288059
Blood pressure systolic increased 14.02 10.78 96 276590 16749 29281092
BK virus infection 14.00 10.78 14 276672 4693 29293148
Cerebral artery thrombosis 13.98 10.78 25 276661 717 29297124
Constipation 13.97 10.78 1245 275441 112915 29184926
Product substitution error 13.94 10.78 6 276680 18 29297823
International normalised ratio increased 13.90 10.78 527 276159 43845 29253996
Febrile bone marrow aplasia 13.89 10.78 30 276656 7321 29290520
Faeces pale 13.82 10.78 34 276652 1225 29296616
Progressive multifocal leukoencephalopathy 13.80 10.78 39 276647 8680 29289161
Pyloric stenosis 13.78 10.78 25 276661 725 29297116
Amino acid level increased 13.78 10.78 17 276669 346 29297495
Diverticulum 13.78 10.78 104 276582 6228 29291613
Leukopenia 13.76 10.78 402 276284 54801 29243040
Alveolitis 13.68 10.78 39 276647 1537 29296304
Polymyositis 13.68 10.78 35 276651 1293 29296548
Therapeutic product effect decreased 13.48 10.78 194 276492 29257 29268584
Acute graft versus host disease 13.47 10.78 21 276665 5803 29292038
Paraesthesia 13.36 10.78 624 276062 53221 29244620
Discoloured vomit 13.33 10.78 19 276667 447 29297394
Splenomegaly 13.31 10.78 186 276500 13093 29284748
Fear 13.27 10.78 45 276641 9459 29288382
Virologic failure 13.27 10.78 5 276681 2842 29294999
Breast inflammation 13.26 10.78 6 276680 21 29297820
Immunosuppressant drug level increased 13.17 10.78 83 276603 4682 29293159
Bronchopulmonary aspergillosis 13.13 10.78 65 276621 12279 29285562
Jaundice 13.09 10.78 363 276323 28933 29268908
Pulmonary embolism 13.09 10.78 857 275829 75677 29222164
Diffuse large B-cell lymphoma recurrent 13.08 10.78 4 276682 2593 29295248
Cytomegalovirus chorioretinitis 13.04 10.78 7 276679 3231 29294610
Ectopic gastric mucosa 13.01 10.78 5 276681 10 29297831
Blood sodium decreased 12.90 10.78 202 276484 14565 29283276
Abdominal sepsis 12.84 10.78 27 276659 875 29296966
Lymphangitis 12.77 10.78 20 276666 513 29297328
Intercepted product preparation error 12.75 10.78 3 276683 2314 29295527
Blood pressure diastolic abnormal 12.72 10.78 4 276682 2547 29295294
Soft tissue mass 12.72 10.78 22 276664 614 29297227
Pancreatic pseudocyst 12.64 10.78 25 276661 775 29297066
Dehydration 12.63 10.78 1242 275444 113506 29184335
Yellow skin 12.53 10.78 43 276643 1875 29295966
Intestinal fistula infection 12.51 10.78 4 276682 3 29297838
Aspartate aminotransferase increased 12.48 10.78 445 276241 59280 29238561
Pleural mass 12.47 10.78 8 276678 64 29297777
Labelled drug-drug interaction medication error 12.46 10.78 171 276515 11988 29285853
Oesophageal perforation 12.42 10.78 24 276662 731 29297110
Pharyngeal oedema 12.37 10.78 94 276592 5640 29292201
Antipsychotic drug level decreased 12.36 10.78 26 276660 843 29296998
Agitated depression 12.35 10.78 13 276673 221 29297620
Amyloidosis 12.29 10.78 44 276642 1960 29295881
Dermatomyositis 12.25 10.78 29 276657 1019 29296822
Viral mutation identified 12.23 10.78 4 276682 2484 29295357
Incorrect dose administered 12.21 10.78 226 276460 32758 29265083
Hypoosmolar state 12.17 10.78 8 276678 67 29297774
Red blood cell analysis abnormal 12.12 10.78 5 276681 13 29297828
Intestinal infarction 12.11 10.78 19 276667 488 29297353
Dry throat 12.08 10.78 43 276643 1910 29295931
Pseudoporphyria 12.06 10.78 15 276671 308 29297533
Body temperature decreased 12.02 10.78 55 276631 10609 29287232
Oropharyngeal swelling 11.91 10.78 18 276668 447 29297394
Suspected suicide 11.90 10.78 12 276674 4008 29293833
Product complaint 11.89 10.78 89 276597 5316 29292525
Lymphopenia 11.83 10.78 76 276610 13457 29284384
Intestinal angioedema 11.78 10.78 12 276674 196 29297645
Muscular weakness 11.74 10.78 701 275985 61351 29236490
Neonatal respiratory distress syndrome 11.71 10.78 11 276675 3799 29294042
Vitamin B12 deficiency 11.68 10.78 61 276625 3210 29294631
Urinary tract infection pseudomonal 11.66 10.78 22 276664 658 29297183
Hepatitis B 11.62 10.78 21 276665 5476 29292365
Hepatitis B reactivation 11.58 10.78 8 276678 3221 29294620
Cholelithiasis obstructive 11.53 10.78 4 276682 5 29297836
Hyperferritinaemia 11.51 10.78 15 276671 323 29297518
Uveitis 11.46 10.78 24 276662 5923 29291918
Polyomavirus-associated nephropathy 11.42 10.78 9 276677 3387 29294454
Peripheral sensory neuropathy 11.42 10.78 24 276662 5915 29291926
Cerebral vasoconstriction 11.40 10.78 12 276674 204 29297637
Pedal pulse decreased 11.38 10.78 5 276681 16 29297825
Deep vein thrombosis 11.35 10.78 651 276035 56748 29241093
Nicotine dependence 11.29 10.78 18 276668 469 29297372
Hallucination 11.27 10.78 519 276167 44193 29253648
Shock 11.25 10.78 137 276549 21267 29276574
Fracture 11.19 10.78 25 276661 6028 29291813
Hepatitis cholestatic 11.17 10.78 106 276580 6787 29291054
Accidental death 11.15 10.78 3 276683 2115 29295726
Urinary tract discomfort 11.12 10.78 9 276677 107 29297734
Incision site cellulitis 11.12 10.78 4 276682 6 29297835
Claustrophobia 11.08 10.78 12 276674 211 29297630
Bone erosion 11.07 10.78 6 276680 2754 29295087
Pulmonary resection 11.04 10.78 3 276683 0 29297841
Platelet production decreased 11.04 10.78 3 276683 0 29297841
Mean platelet volume abnormal 11.04 10.78 3 276683 0 29297841
Carotid pulse abnormal 11.04 10.78 3 276683 0 29297841
Prosthesis user 11.04 10.78 3 276683 0 29297841
Infection 11.04 10.78 596 276090 76155 29221686
Aspiration pleural cavity abnormal 11.04 10.78 3 276683 0 29297841
Anal chlamydia infection 11.04 10.78 3 276683 0 29297841
COVID-19 treatment 11.02 10.78 13 276673 252 29297589
Herpes simplex 10.96 10.78 18 276668 4872 29292969
Intestinal metaplasia 10.94 10.78 5 276681 18 29297823
Incorrect route of product administration 10.85 10.78 58 276628 10743 29287098
Status epilepticus 10.83 10.78 58 276628 10736 29287105
Choluria 10.82 10.78 10 276676 144 29297697
Neutrophil count increased 10.81 10.78 196 276490 14546 29283295

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypomagnesaemia 1105.73 10.18 1483 553912 35893 63907444
Drug ineffective 929.03 10.18 3910 551485 836337 63107000
Synovitis 639.89 10.18 58 555337 99032 63844305
Tubulointerstitial nephritis 574.49 10.18 988 554407 29921 63913416
Off label use 567.64 10.18 3168 552227 629638 63313699
Drug intolerance 547.98 10.18 487 554908 187505 63755832
Drug abuse 457.70 10.18 287 555108 132087 63811250
Hypocalcaemia 455.85 10.18 1069 554326 40684 63902653
Pemphigus 437.66 10.18 20 555375 60681 63882656
Hyponatraemia 428.22 10.18 2456 552939 145883 63797454
Treatment failure 423.94 10.18 239 555156 116577 63826760
Hand deformity 404.53 10.18 37 555358 62734 63880603
Anti-cyclic citrullinated peptide antibody positive 395.35 10.18 6 555389 49556 63893781
Contraindicated product administered 395.06 10.18 218 555177 107611 63835726
Drug interaction 386.70 10.18 4789 550606 357294 63586043
Completed suicide 377.20 10.18 860 554535 223554 63719783
Chronic kidney disease 372.32 10.18 1222 554173 56697 63886640
Acute kidney injury 310.23 10.18 5511 549884 443729 63499608
Infusion related reaction 303.25 10.18 598 554797 163869 63779468
Subacute cutaneous lupus erythematosus 297.06 10.18 230 555165 2795 63940542
Maternal exposure during pregnancy 295.67 10.18 235 555160 95649 63847688
Drug hypersensitivity 285.43 10.18 1068 554327 236747 63706590
Therapeutic product effect decreased 277.53 10.18 351 555044 115000 63828337
Systemic lupus erythematosus 271.34 10.18 166 555229 77446 63865891
Joint swelling 267.84 10.18 953 554442 214429 63728908
Rheumatoid factor positive 267.60 10.18 7 555388 34931 63908406
Wound 262.63 10.18 167 555228 76310 63867027
Toxicity to various agents 239.98 10.18 1990 553405 361523 63581814
Pericarditis 225.18 10.18 129 555266 62387 63880950
Rheumatoid arthritis 224.78 10.18 697 554698 163597 63779740
Glossodynia 211.74 10.18 149 555246 64547 63878790
Arthropathy 208.44 10.18 457 554938 120510 63822827
Duodenal ulcer perforation 199.33 10.18 30 555365 34595 63908742
Therapeutic product effect incomplete 196.12 10.18 370 555025 103112 63840225
Tetany 181.01 10.18 150 555245 2022 63941315
Sleep disorder due to general medical condition, insomnia type 179.01 10.18 12 555383 26258 63917079
Product use in unapproved indication 178.49 10.18 847 554548 175771 63767566
C-reactive protein abnormal 177.14 10.18 21 555374 29026 63914311
Hypertrichosis 174.64 10.18 114 555281 1034 63942303
Hepatic enzyme increased 162.05 10.18 574 554821 129369 63813968
Product use issue 157.75 10.18 720 554675 150995 63792342
Hypoparathyroidism 154.64 10.18 96 555299 791 63942546
Folliculitis 152.00 10.18 36 555359 30041 63913296
Diarrhoea 150.24 10.18 7631 547764 715073 63228264
Discomfort 149.90 10.18 293 555102 80585 63862752
Muscle injury 141.01 10.18 28 555367 26409 63916928
Helicobacter infection 139.81 10.18 78 555317 38284 63905053
Abdominal pain 139.23 10.18 3598 551797 308777 63634560
End stage renal disease 134.27 10.18 286 555109 10189 63933148
Alopecia 131.69 10.18 860 554535 164830 63778507
Product formulation issue 129.40 10.18 84 555311 754 63942583
Exposure during pregnancy 126.05 10.18 303 555092 77372 63865965
Intentional product use issue 123.79 10.18 414 554981 94950 63848387
Drug resistance 122.77 10.18 75 555320 35027 63908310
Orthostatic hypotension 121.93 10.18 754 554641 45984 63897353
Blood calcium decreased 120.00 10.18 487 554908 25067 63918270
Hypokalaemia 119.76 10.18 1589 553806 120314 63823023
Nasopharyngitis 118.25 10.18 1098 554297 194975 63748362
Creatinine renal clearance decreased 113.83 10.18 327 555068 14094 63929243
Hypersensitivity 113.00 10.18 1113 554282 195339 63747998
Red blood cell sedimentation rate abnormal 112.44 10.18 7 555388 16299 63927038
Constipation 107.83 10.18 2661 552734 226676 63716661
Coma 103.31 10.18 396 554999 87219 63856118
Overdose 97.73 10.18 890 554505 158676 63784661
Sedation complication 92.85 10.18 246 555149 10108 63933229
Cholecystitis chronic 91.91 10.18 229 555166 9058 63934279
Infective pulmonary exacerbation of cystic fibrosis 91.68 10.18 266 555129 11530 63931807
Balance disorder 91.33 10.18 1115 554280 82811 63860526
Muscle spasms 90.23 10.18 1711 553684 139312 63804025
Plasma cell myeloma 88.66 10.18 690 554705 45385 63897952
Intentional overdose 86.37 10.18 439 554956 89505 63853832
Infection 85.94 10.18 1099 554296 183781 63759556
Irritable bowel syndrome 84.44 10.18 119 555276 37250 63906087
Vomiting 83.68 10.18 5660 549735 545457 63397880
Condition aggravated 82.59 10.18 2509 552886 369917 63573420
Asthenia 80.37 10.18 4479 550916 423565 63519772
Impaired healing 80.21 10.18 260 555135 60213 63883124
Inappropriate antidiuretic hormone secretion 77.77 10.18 389 555006 21900 63921437
Cognitive disorder 77.45 10.18 770 554625 54317 63889020
Therapeutic response decreased 77.41 10.18 213 555182 51975 63891362
Confusional state 75.58 10.18 2855 552540 258289 63685048
Swelling 75.34 10.18 950 554445 159268 63784069
Blood pressure fluctuation 75.24 10.18 214 555181 51657 63891680
Musculoskeletal stiffness 75.07 10.18 688 554707 122518 63820819
Gastritis 74.82 10.18 625 554770 41993 63901344
Lethargy 72.82 10.18 950 554445 71644 63871693
Stomatitis 72.12 10.18 600 554795 109005 63834332
Gastric polyps 71.86 10.18 107 555288 2858 63940479
Blood pressure systolic increased 71.75 10.18 204 555191 49249 63894088
Hypoparathyroidism secondary 71.64 10.18 35 555360 168 63943169
Gastrointestinal haemorrhage 71.61 10.18 1566 553829 130746 63812591
Dizziness 71.39 10.18 4452 550943 425711 63517626
Gastric pH decreased 70.25 10.18 55 555340 680 63942657
Respiratory arrest 70.14 10.18 228 555167 52757 63890580
Ill-defined disorder 68.98 10.18 175 555220 43877 63899460
Abdominal pain upper 68.19 10.18 1982 553413 173048 63770289
General physical health deterioration 67.66 10.18 1296 554099 203129 63740208
Liver function test abnormal 67.16 10.18 795 554600 58606 63884731
Abdominal discomfort 66.92 10.18 1135 554260 181187 63762150
Chest pain 66.39 10.18 2572 552823 233408 63709929
Intentional product misuse 65.42 10.18 360 555035 71935 63871402
Myalgia 64.23 10.18 1805 553590 156812 63786525
Rheumatoid nodule 64.20 10.18 15 555380 12636 63930701
Rheumatic fever 64.05 10.18 4 555391 9290 63934047
Hypertensive nephropathy 63.75 10.18 55 555340 786 63942551
Renal injury 62.37 10.18 281 555114 15148 63928189
Swollen tongue 62.10 10.18 514 554881 34440 63908897
Abortion spontaneous 60.96 10.18 76 555319 25067 63918270
Suicide attempt 60.80 10.18 360 555035 70647 63872690
Hiatus hernia 58.50 10.18 332 555063 19625 63923712
Upper gastrointestinal haemorrhage 58.40 10.18 510 554885 34710 63908627
Bone erosion 58.35 10.18 14 555381 11581 63931756
Device expulsion 57.69 10.18 58 555337 21078 63922259
Renal failure 57.57 10.18 2007 553388 179681 63763656
Fall 57.11 10.18 4246 551149 412580 63530757
Lip swelling 56.04 10.18 468 554927 31439 63911898
Weight increased 55.79 10.18 1404 553991 211944 63731393
Pulmonary embolism 55.54 10.18 1652 553743 144704 63798633
Accidental exposure to product 54.70 10.18 89 555306 26275 63917062
Tenosynovitis 54.46 10.18 17 555378 11816 63931521
Malignant neoplasm progression 54.27 10.18 666 554729 112205 63831132
Sinusitis 53.35 10.18 909 554486 145019 63798318
Enthesopathy 51.84 10.18 10 555385 9628 63933709
Paraesthesia 51.20 10.18 1519 553876 133003 63810334
Gastrooesophageal reflux disease 51.18 10.18 1003 554392 82140 63861197
Sopor 51.10 10.18 112 555283 29549 63913788
Poisoning 50.10 10.18 69 555326 21810 63921527
Dyspnoea 49.41 10.18 6982 548413 711692 63231645
Haematemesis 48.79 10.18 619 554776 46380 63896957
Swelling face 46.87 10.18 743 554652 58423 63884914
Blood pressure diastolic abnormal 46.74 10.18 22 555373 11895 63931442
Arthralgia 46.45 10.18 3231 552164 439029 63504308
Immune reconstitution inflammatory syndrome 45.95 10.18 25 555370 12445 63930892
Chromaturia 45.38 10.18 342 555053 22269 63921068
Cytomegalovirus infection 45.22 10.18 166 555229 37033 63906304
Red blood cell sedimentation rate increased 44.47 10.18 130 555265 31105 63912232
Therapy non-responder 44.13 10.18 359 555036 65540 63877797
Dehydration 43.91 10.18 2285 553110 214478 63728859
Premature delivery 43.20 10.18 58 555337 18531 63924806
Deep vein thrombosis 43.13 10.18 1199 554196 103983 63839354
Pancreatitis acute 43.04 10.18 561 554834 42294 63901043
Rectal haemorrhage 42.28 10.18 758 554637 61059 63882278
Psoriatic arthropathy 42.25 10.18 210 555185 43071 63900266
Loss of personal independence in daily activities 42.23 10.18 409 554986 72045 63871292
Syncope 42.16 10.18 1709 553686 155926 63787411
Malaise 42.09 10.18 3960 551435 392287 63551050
Pregnancy 41.84 10.18 72 555323 20793 63922544
Abnormal loss of weight 41.29 10.18 149 555246 7251 63936086
Dry mouth 41.02 10.18 740 554655 59678 63883659
Nephrogenic anaemia 40.57 10.18 89 555306 3236 63940101
Panniculitis 40.43 10.18 13 555382 8866 63934471
Blood sodium decreased 40.42 10.18 410 554985 29072 63914265
Hallucination 39.84 10.18 863 554532 71925 63871412
International normalised ratio increased 39.68 10.18 927 554468 78240 63865097
Blood pressure systolic abnormal 39.54 10.18 18 555377 9924 63933413
Drug ineffective for unapproved indication 39.13 10.18 137 555258 30996 63912341
Interstitial lung disease 38.62 10.18 600 554795 97132 63846205
Blood magnesium decreased 38.59 10.18 228 555167 13677 63929660
Occupational dermatitis 38.49 10.18 20 555375 112 63943225
Type I hypersensitivity 38.44 10.18 91 555304 3483 63939854
Aplastic anaemia 38.22 10.18 38 555357 13882 63929455
Obstructive airways disorder 37.95 10.18 90 555305 23095 63920242
Injection site pain 37.84 10.18 703 554692 110705 63832632
Flatulence 37.55 10.18 471 554924 35195 63908142
Gallbladder disorder 37.29 10.18 263 555132 16767 63926570
Metabolic alkalosis 36.94 10.18 95 555300 3833 63939504
Iron deficiency anaemia 36.83 10.18 318 555077 21571 63921766
Dyspepsia 36.81 10.18 929 554466 79383 63863954
Mucormycosis 36.67 10.18 9 555386 7332 63936005
Heart rate decreased 36.41 10.18 301 555094 54766 63888571
Chronic obstructive pulmonary disease 36.25 10.18 834 554561 70214 63873123
Unintentional medical device removal 36.19 10.18 7 555388 6727 63936610
Biliary dyskinesia 35.42 10.18 69 555326 2303 63941034
Urinary tract infection 35.24 10.18 2380 553015 229216 63714121
Hip arthroplasty 34.85 10.18 83 555312 21268 63922069
Pathogen resistance 34.71 10.18 34 555361 12509 63930828
Rash 34.35 10.18 3441 551954 455108 63488229
Therapy partial responder 34.32 10.18 23 555372 10225 63933112
Haemophagocytic lymphohistiocytosis 34.19 10.18 62 555333 17547 63925790
Faeces discoloured 33.94 10.18 355 555040 25374 63917963
Substance abuse 33.70 10.18 19 555376 9273 63934064
Body temperature decreased 33.33 10.18 113 555282 25815 63917522
Catatonia 33.23 10.18 12 555383 7608 63935729
Death 33.23 10.18 3644 551751 479061 63464276
Jaundice 33.22 10.18 595 554800 47917 63895420
Burning mouth syndrome 32.86 10.18 30 555365 464 63942873
Blood pressure increased 32.83 10.18 1185 554210 171367 63771970
Multiple-drug resistance 32.43 10.18 8 555387 6494 63936843
Drug tolerance decreased 32.30 10.18 10 555385 6988 63936349
Bone marrow failure 32.21 10.18 261 555134 47691 63895646
Device use error 32.20 10.18 8 555387 6463 63936874
Cogwheel rigidity 32.17 10.18 74 555321 2779 63940558
Epstein-Barr virus infection 32.14 10.18 36 555359 12452 63930885
Caesarean section 31.85 10.18 30 555365 11244 63932093
Vision blurred 31.73 10.18 1010 554385 89306 63854031
Dysgeusia 31.50 10.18 575 554820 46472 63896865
Nausea 31.17 10.18 7422 547973 778378 63164959
Grip strength decreased 31.06 10.18 33 555362 11691 63931646
Akathisia 30.94 10.18 32 555363 11478 63931859
Product substitution issue 30.85 10.18 261 555134 17600 63925737
Labelled drug-drug interaction medication error 30.82 10.18 308 555087 21754 63921583
Atrial fibrillation 30.58 10.18 1783 553612 169306 63774031
Device dependence 30.31 10.18 13 555382 43 63943294
Oesophagitis 30.23 10.18 302 555093 21328 63922009
Device difficult to use 30.20 10.18 24 555371 9774 63933563
Hyperchlorhydria 30.18 10.18 55 555340 1744 63941593
Renal tubular acidosis 30.05 10.18 74 555321 2905 63940432
Post transplant lymphoproliferative disorder 29.90 10.18 23 555372 9521 63933816
Right hemisphere deficit syndrome 29.32 10.18 9 555386 6 63943331
Anaemia 29.28 10.18 3706 551689 374974 63568363
H1N1 influenza 29.19 10.18 62 555333 2204 63941133
Live birth 29.17 10.18 32 555363 11172 63932165
Toxic epidermal necrolysis 29.16 10.18 466 554929 36700 63906637
Pain 28.92 10.18 4253 551142 549258 63394079
Palatal oedema 28.73 10.18 43 555352 1154 63942183
Cardiac arrest 28.64 10.18 1061 554334 153003 63790334
Poisoning deliberate 28.32 10.18 45 555350 13413 63929924
Acute graft versus host disease 28.32 10.18 22 555373 9062 63934275
Feeling of despair 28.29 10.18 66 555329 2502 63940835
Disorientation 28.06 10.18 654 554741 55174 63888163
Injection site erythema 27.85 10.18 435 554960 70365 63872972
Feeling of body temperature change 27.78 10.18 98 555297 4716 63938621
Dilatation intrahepatic duct acquired 27.67 10.18 32 555363 662 63942675
Neutropenic sepsis 27.43 10.18 314 555081 22958 63920379
Wrong technique in product usage process 27.35 10.18 394 555001 64580 63878757
Depersonalisation/derealisation disorder 27.34 10.18 50 555345 1590 63941747
Peripheral swelling 27.32 10.18 1497 553898 207656 63735681
Palpitations 27.28 10.18 1130 554265 103358 63839979
Myelosuppression 27.25 10.18 109 555286 23721 63919616
Cytomegalovirus viraemia 27.02 10.18 32 555363 10796 63932541
Respiratory depression 26.95 10.18 107 555288 23336 63920001
Tetanus 26.85 10.18 12 555383 45 63943292
Blood chromogranin A increased 26.82 10.18 24 555371 361 63942976
Hepatic encephalopathy 26.54 10.18 288 555107 20778 63922559
Rhabdomyolysis 26.52 10.18 1003 554392 90723 63852614
Multiple organ dysfunction syndrome 26.31 10.18 668 554727 100745 63842592
Vitamin B12 deficiency 26.26 10.18 105 555290 5367 63937970
Mouth swelling 26.13 10.18 100 555295 5007 63938330
Calcium deficiency 26.08 10.18 32 555363 706 63942631
Tremor 25.96 10.18 1542 553853 146688 63796649
Stress 25.86 10.18 366 555029 60168 63883169
Inappropriate schedule of product administration 25.83 10.18 601 554794 91685 63851652
Hallucinations, mixed 25.81 10.18 112 555283 5940 63937397
Febrile neutropenia 25.66 10.18 1337 554058 186320 63757017
Electrocardiogram QRS complex prolonged 25.65 10.18 25 555370 9219 63934118
Product label on wrong product 25.55 10.18 9 555386 14 63943323
Chronic graft versus host disease 25.53 10.18 11 555384 6265 63937072
Muscle spasticity 25.49 10.18 67 555328 16602 63926735
Derealisation 25.45 10.18 46 555349 1449 63941888
Gastric mucosal hypertrophy 25.36 10.18 19 555376 219 63943118
Hypergastrinaemia 25.27 10.18 17 555378 163 63943174
Product complaint 25.24 10.18 183 555212 11771 63931566
Multimorbidity 25.22 10.18 37 555358 975 63942362
Truncus coeliacus thrombosis 25.14 10.18 8 555387 7 63943330
Polymyositis 24.92 10.18 65 555330 2645 63940692
Cardiogenic shock 24.88 10.18 170 555225 32257 63911080
Injection site bruising 24.88 10.18 197 555198 36176 63907161
Hypoaesthesia oral 24.87 10.18 178 555217 11402 63931935
Diabetic nephropathy 24.76 10.18 64 555331 2590 63940747
Human herpesvirus 6 infection 24.67 10.18 5 555390 4649 63938688
Gastrointestinal disorder 24.61 10.18 586 554809 89123 63854214
BK virus infection 24.34 10.18 17 555378 7395 63935942
Pancreatitis 24.29 10.18 679 554716 58928 63884409
Nephropathy 24.24 10.18 139 555256 8247 63935090
Fibromyalgia 23.76 10.18 195 555200 35536 63907801
Jejunal ulcer perforation 23.74 10.18 14 555381 104 63943233
Muscular weakness 23.70 10.18 1332 554063 126006 63817331
Intestinal dilatation 23.65 10.18 57 555338 2207 63941130
Haematotoxicity 23.64 10.18 47 555348 12849 63930488
Agitated depression 23.58 10.18 20 555375 279 63943058
Mania 23.54 10.18 229 555166 16057 63927280
Dissociation 23.50 10.18 68 555327 2943 63940394
Angioedema 23.48 10.18 698 554697 61123 63882214
Sedation 23.46 10.18 494 554901 40968 63902369
Oxygen saturation decreased 23.44 10.18 723 554672 106453 63836884
Cross sensitivity reaction 23.40 10.18 73 555322 3294 63940043
Hepatitis cholestatic 23.36 10.18 182 555213 11973 63931364
Altered state of consciousness 23.35 10.18 211 555184 37691 63905646
Barrett's oesophagus 23.29 10.18 31 555364 744 63942593
Transient ischaemic attack 23.27 10.18 521 554874 43661 63899676
Presyncope 23.19 10.18 428 554967 34661 63908676
Pneumocystis jirovecii pneumonia 23.18 10.18 141 555254 27493 63915844
Fear of injection 23.06 10.18 11 555384 5901 63937436
Gallbladder injury 23.05 10.18 38 555357 1110 63942227
Blood gastrin increased 22.89 10.18 10 555385 35 63943302
Discoloured vomit 22.84 10.18 38 555357 1119 63942218
Chronic kidney disease-mineral and bone disorder 22.83 10.18 25 555370 486 63942851
Cystitis haemorrhagic 22.68 10.18 21 555374 7935 63935402
Non-cardiac chest pain 22.61 10.18 140 555255 8540 63934797
Graft versus host disease in gastrointestinal tract 22.57 10.18 10 555385 5602 63937735
Adverse event 22.55 10.18 224 555171 39265 63904072
Clostridium difficile infection 22.50 10.18 437 554958 35726 63907611
Blood pressure diastolic decreased 22.46 10.18 107 555288 22194 63921143
Hypergammaglobulinaemia 22.37 10.18 28 555367 631 63942706
Graft versus host disease in skin 22.35 10.18 9 555386 5338 63937999
Drooling 22.35 10.18 98 555297 5221 63938116
Moraxella test positive 22.13 10.18 8 555387 14 63943323
C-reactive protein increased 22.06 10.18 635 554760 94274 63849063
Hyperhidrosis 21.96 10.18 1300 554095 123620 63819717
Red blood cell sedimentation rate 21.88 10.18 3 555392 3711 63939626
Rash macular 21.70 10.18 305 555090 23380 63919957
Acute interstitial pneumonitis 21.49 10.18 35 555360 1012 63942325
Product packaging confusion 21.46 10.18 17 555378 214 63943123
Nephrosclerosis 21.42 10.18 44 555351 1527 63941810
Cerebral infarction 21.33 10.18 238 555157 40806 63902531
Miosis 21.31 10.18 52 555343 13214 63930123
Suspected suicide 21.14 10.18 26 555369 8628 63934709
Abdominal tenderness 21.03 10.18 146 555249 9259 63934078
Cholelithiasis 21.03 10.18 527 554868 44979 63898358
Cytomegalovirus chorioretinitis 20.98 10.18 8 555387 4904 63938433
Pulmonary malformation 20.83 10.18 14 555381 134 63943203
Lower gastrointestinal haemorrhage 20.64 10.18 197 555198 13742 63929595
Oesophageal stenosis 20.38 10.18 76 555319 3758 63939579
Cutaneous lupus erythematosus 20.38 10.18 60 555335 2622 63940715
Hypophagia 20.28 10.18 465 554930 39122 63904215
Oral pain 20.19 10.18 341 555054 27152 63916185
Cardio-respiratory arrest 20.02 10.18 670 554725 97723 63845614
Parosmia 19.88 10.18 86 555309 4554 63938783
Drug eruption 19.80 10.18 207 555188 35929 63907408
Febrile bone marrow aplasia 19.80 10.18 42 555353 11213 63932124
Parkinsonism 19.76 10.18 200 555195 14173 63929164
Accidental death 19.75 10.18 4 555391 3721 63939616
Adverse drug reaction 19.73 10.18 274 555121 45190 63898147
Blood potassium decreased 19.61 10.18 471 554924 39928 63903409
Injection site swelling 19.49 10.18 245 555150 41108 63902229
Pancreatic abscess 19.42 10.18 11 555384 75 63943262
Blood alkaline phosphatase increased 19.40 10.18 628 554767 55651 63887686
Oesophageal atresia 19.39 10.18 10 555385 55 63943282
Ageusia 19.37 10.18 193 555202 13620 63929717
Lung cyst 19.30 10.18 14 555381 153 63943184
Diverticulum 19.28 10.18 186 555209 13012 63930325
Indifference 19.20 10.18 17 555378 252 63943085
Choluria 19.14 10.18 19 555376 328 63943009
Acute generalised exanthematous pustulosis 19.03 10.18 195 555200 13863 63929474
Viral mutation identified 19.03 10.18 3 555392 3343 63939994
Hypophosphataemia 18.90 10.18 202 555193 14518 63928819
Haemoglobin decreased 18.84 10.18 1937 553458 193126 63750211
Gastric xanthoma 18.82 10.18 5 555390 0 63943337
Transplant dysfunction 18.78 10.18 18 555377 6690 63936647
Tinnitus 18.77 10.18 405 554990 33728 63909609
Posterior reversible encephalopathy syndrome 18.76 10.18 118 555277 22828 63920509
Progressive multifocal leukoencephalopathy 18.64 10.18 87 555308 18145 63925192
Oral herpes 18.59 10.18 113 555282 22039 63921298
Disability 18.56 10.18 49 555346 12123 63931214
Metastases to lymph nodes 18.48 10.18 29 555366 8688 63934649
Pneumonia 18.42 10.18 5244 550151 554332 63389005
Cardiotoxicity 18.36 10.18 38 555357 10236 63933101
Skin exfoliation 18.20 10.18 511 554884 44374 63898963
Urinary tract infection pseudomonal 18.20 10.18 39 555356 1395 63941942
Hepatitis B 18.17 10.18 24 555371 7721 63935616
Cholecystectomy 18.15 10.18 125 555270 7907 63935430
Oropharyngeal blistering 18.09 10.18 26 555369 672 63942665
Injection site reaction 17.92 10.18 288 555107 46376 63896961
Therapeutic response shortened 17.85 10.18 38 555357 10132 63933205
Transplant rejection 17.81 10.18 83 555312 17318 63926019
Pregnancy with contraceptive device 17.70 10.18 3 555392 3171 63940166
Long QT syndrome 17.44 10.18 89 555306 5050 63938287
Occult blood positive 17.39 10.18 103 555292 6184 63937153
Blood pressure diastolic increased 17.39 10.18 42 555353 10710 63932627
Skin necrosis 17.38 10.18 64 555331 14265 63929072
Blood copper increased 17.32 10.18 7 555388 19 63943318
Injection site haemorrhage 17.30 10.18 130 555265 24148 63919189
Abdominal distension 17.25 10.18 1001 554394 94993 63848344
Hypoglycaemia 17.25 10.18 943 554452 88949 63854388
Torus fracture 17.21 10.18 10 555385 72 63943265
Carcinoid tumour of the gastrointestinal tract 17.21 10.18 10 555385 72 63943265
Mesenteric vein thrombosis 17.21 10.18 36 555359 1266 63942071
Ceruloplasmin increased 17.16 10.18 6 555389 9 63943328
Pneumatosis intestinalis 17.16 10.18 12 555383 5217 63938120
Hepatic rupture 17.10 10.18 9 555386 52 63943285
Coronary artery bypass 16.99 10.18 15 555380 5800 63937537
Neutrophil count increased 16.97 10.18 308 555087 24866 63918471
Aspergillus infection 16.84 10.18 78 555317 16301 63927036
Hand-eye coordination impaired 16.82 10.18 7 555388 21 63943316
Intestinal metaplasia 16.82 10.18 7 555388 21 63943316
Ectopic gastric mucosa 16.78 10.18 6 555389 10 63943327
Enterococcal infection 16.77 10.18 62 555333 13804 63929533
Thermohypoaesthesia 16.74 10.18 11 555384 101 63943236
Metastases to liver 16.68 10.18 129 555266 23812 63919525
Avian influenza 16.66 10.18 10 555385 77 63943260
Herpes zoster 16.63 10.18 537 554858 78650 63864687
Foetal death 16.50 10.18 16 555379 5914 63937423
Duodenitis 16.49 10.18 107 555288 6634 63936703
Gastrointestinal polyp haemorrhage 16.49 10.18 20 555375 436 63942901
Abnormal weight gain 16.33 10.18 49 555346 2164 63941173
Polyomavirus-associated nephropathy 16.33 10.18 11 555384 4877 63938460
Intestinal ulcer 16.32 10.18 41 555354 1630 63941707
Fear of eating 16.32 10.18 19 555376 396 63942941
Muscle disorder 16.29 10.18 85 555310 4866 63938471
Tongue blistering 16.22 10.18 35 555360 1258 63942079
Inflammation 16.17 10.18 433 554962 64867 63878470
Infective exacerbation of chronic obstructive airways disease 16.16 10.18 52 555343 2386 63940951
Drug dispensed to wrong patient 16.08 10.18 18 555377 359 63942978
Bromhidrosis 15.91 10.18 5 555390 4 63943333
Arthritis 15.83 10.18 576 554819 83238 63860099
Viral diarrhoea 15.82 10.18 15 555380 244 63943093
Sepsis neonatal 15.81 10.18 8 555387 42 63943295
Haemoptysis 15.81 10.18 543 554852 48505 63894832
Device issue 15.80 10.18 122 555273 22526 63920811
Electrolyte imbalance 15.69 10.18 305 555090 24938 63918399
Exposure to toxic agent 15.59 10.18 18 555377 6141 63937196
Melaena 15.58 10.18 586 554809 52962 63890375
Restless legs syndrome 15.52 10.18 220 555175 16896 63926441
Endophthalmitis 15.48 10.18 14 555381 5351 63937986
Endoscopy abnormal 15.37 10.18 8 555387 45 63943292
Target skin lesion 15.26 10.18 11 555384 119 63943218
Mesenteric artery thrombosis 15.16 10.18 21 555374 524 63942813
Dialysis 15.15 10.18 217 555178 16703 63926634
Coronary arterial stent insertion 15.10 10.18 16 555379 5676 63937661
Brain scan abnormal 15.10 10.18 32 555363 1136 63942201
Intraductal papillary breast neoplasm 15.05 10.18 4 555391 0 63943337
Latent tetany 15.05 10.18 4 555391 0 63943337
Ventricular flutter 15.03 10.18 10 555385 94 63943243
Drug use disorder 14.99 10.18 18 555377 6036 63937301
Acute psychosis 14.91 10.18 68 555327 3684 63939653
Hepatocellular injury 14.87 10.18 287 555108 44948 63898389
Antipsychotic drug level decreased 14.76 10.18 28 555367 916 63942421
Knee arthroplasty 14.65 10.18 155 555240 26844 63916493
Vasoplegia syndrome 14.61 10.18 3 555392 2764 63940573
Cholecystitis 14.58 10.18 244 555151 19392 63923945
Alanine aminotransferase abnormal 14.53 10.18 23 555372 6865 63936472
Chest discomfort 14.40 10.18 1174 554221 114932 63828405
Pneumonitis 14.38 10.18 550 554845 49815 63893522
Injection site pruritus 14.34 10.18 234 555161 37592 63905745
Maternal exposure before pregnancy 14.34 10.18 6 555389 3477 63939860
High-grade B-cell lymphoma 14.32 10.18 9 555386 76 63943261
Calcium metabolism disorder 14.31 10.18 8 555387 53 63943284
Nocardiosis 14.29 10.18 12 555383 4755 63938582
Depression 14.28 10.18 1795 553600 181496 63761841
Acquired oesophageal web 14.26 10.18 15 555380 278 63943059
Cystic fibrosis 14.22 10.18 63 555332 3371 63939966
Teratogenicity 14.22 10.18 9 555386 77 63943260
Sensory loss 14.22 10.18 142 555253 10027 63933310
Pleural thickening 14.18 10.18 3 555392 2707 63940630
Alcohol use disorder 14.18 10.18 6 555389 19 63943318
Duodenal stenosis 14.12 10.18 23 555372 665 63942672
Food allergy 14.06 10.18 29 555366 7822 63935515
Degenerative mitral valve disease 14.04 10.18 14 555381 243 63943094
Prothrombin level decreased 14.04 10.18 36 555359 1450 63941887
Personality disorder 13.95 10.18 12 555383 4699 63938638
Skin discolouration 13.92 10.18 400 554995 34855 63908482
Faecal calprotectin increased 13.85 10.18 7 555388 3633 63939704
Hepatitis B reactivation 13.82 10.18 13 555382 4876 63938461
Skin test positive 13.78 10.18 29 555366 1024 63942313
Helicobacter test positive 13.77 10.18 29 555366 1025 63942312
Second primary malignancy 13.75 10.18 57 555338 12280 63931057
Urine calcium decreased 13.74 10.18 6 555389 21 63943316
Hypoosmolar state 13.72 10.18 14 555381 250 63943087
Yellow skin 13.71 10.18 58 555337 3041 63940296
Bleeding time prolonged 13.63 10.18 31 555364 1155 63942182
Normal newborn 13.59 10.18 17 555378 5600 63937737
Sight disability 13.58 10.18 10 555385 112 63943225
Rebound acid hypersecretion 13.58 10.18 9 555386 84 63943253
Product taste abnormal 13.53 10.18 43 555352 1960 63941377
Graft versus host disease 13.49 10.18 67 555328 13746 63929591
Amino acid level increased 13.48 10.18 21 555374 584 63942753
Sleep disorder due to a general medical condition 13.45 10.18 32 555363 8202 63935135
Electrocardiogram QT prolonged 13.43 10.18 824 554571 78624 63864713
Lipidosis 13.41 10.18 5 555390 10 63943327
Achlorhydria 13.41 10.18 5 555390 10 63943327
Pulmonary toxicity 13.41 10.18 34 555361 8527 63934810
Tongue oedema 13.40 10.18 93 555302 5897 63937440
Nephroangiosclerosis 13.37 10.18 15 555380 300 63943037
Injection site warmth 13.32 10.18 65 555330 13397 63929940
Respiratory tract infection 13.31 10.18 419 554976 36988 63906349
Genital blister 13.23 10.18 9 555386 88 63943249
Tongue discomfort 13.22 10.18 44 555351 2055 63941282
Bronchopulmonary aspergillosis 13.22 10.18 103 555292 18982 63924355
Dysphagia 13.08 10.18 1079 554316 105733 63837604
Product residue present 13.07 10.18 59 555336 3183 63940154
Decreased appetite 13.02 10.18 2677 552718 278612 63664725
Gastrointestinal mucosal exfoliation 12.97 10.18 12 555383 189 63943148
Tracheo-oesophageal fistula 12.91 10.18 19 555376 502 63942835
Drug dose titration not performed 12.91 10.18 22 555373 661 63942676
Retroperitoneal fibrosis 12.87 10.18 20 555375 555 63942782
Hair injury 12.84 10.18 4 555391 3 63943334
Gastrointestinal erosion 12.80 10.18 27 555368 955 63942382
Colitis ischaemic 12.80 10.18 174 555221 13240 63930097
Vasculitic rash 12.78 10.18 42 555353 1949 63941388
Hypocalcaemic seizure 12.76 10.18 6 555389 26 63943311
Virologic failure 12.70 10.18 7 555388 3459 63939878
Derailment 12.68 10.18 8 555387 68 63943269
Venoocclusive liver disease 12.63 10.18 44 555351 9971 63933366
Hepatic function abnormal 12.60 10.18 440 554955 63873 63879464
Lung disorder 12.42 10.18 413 554982 60287 63883050
Hyponatraemic syndrome 12.39 10.18 23 555372 740 63942597
Stillbirth 12.38 10.18 8 555387 3625 63939712
Red blood cell analysis abnormal 12.26 10.18 5 555390 14 63943323
Hepatic haematoma 12.26 10.18 24 555371 804 63942533
Metastases to lung 12.22 10.18 79 555316 15185 63928152
Drop attacks 12.19 10.18 27 555368 988 63942349
Postictal paralysis 12.19 10.18 15 555380 332 63943005
Temperature regulation disorder 12.14 10.18 11 555384 4200 63939137
Jaundice cholestatic 12.09 10.18 121 555274 8549 63934788
Memory impairment 12.05 10.18 875 554520 84807 63858530
Burning sensation 12.03 10.18 533 554862 49131 63894206
Pneumonia aspiration 11.96 10.18 404 554991 58867 63884470
DNA antibody 11.93 10.18 6 555389 31 63943306
Soft tissue mass 11.86 10.18 25 555370 884 63942453
Spinal cord herniation 11.85 10.18 4 555391 5 63943332
Sweat discolouration 11.78 10.18 6 555389 32 63943305
Eczema eyelids 11.76 10.18 10 555385 140 63943197
Premature rupture of membranes 11.76 10.18 9 555386 3735 63939602
Gallbladder adenocarcinoma 11.72 10.18 9 555386 108 63943229
Pharyngeal swelling 11.68 10.18 85 555310 5474 63937863
Systemic infection 11.63 10.18 12 555383 4309 63939028
Joint stiffness 11.55 10.18 188 555207 30216 63913121
Fibrinolysis 11.55 10.18 7 555388 55 63943282
Paradoxical drug reaction 11.48 10.18 22 555373 6098 63937239
Gastric antral vascular ectasia 11.46 10.18 23 555372 785 63942552
Immunosuppressant drug level increased 11.46 10.18 104 555291 7155 63936182
Type 2 diabetes mellitus 11.44 10.18 215 555180 33805 63909532
Gastroenteritis eosinophilic 11.43 10.18 12 555383 222 63943115
Blister 11.41 10.18 575 554820 80392 63862945
Blood 1,25-dihydroxycholecalciferol decreased 11.34 10.18 5 555390 18 63943319
Device dislocation 11.33 10.18 122 555273 21056 63922281
Non-small cell lung cancer stage III 11.29 10.18 3 555392 0 63943337
Carotid pulse abnormal 11.29 10.18 3 555392 0 63943337
Anal chlamydia infection 11.29 10.18 3 555392 0 63943337
Multiple endocrine neoplasia Type 1 11.29 10.18 3 555392 0 63943337
Breast discolouration 11.29 10.18 3 555392 0 63943337
Supportive care 11.29 10.18 3 555392 0 63943337
Vertigo labyrinthine 11.29 10.18 3 555392 0 63943337
Circulatory collapse 11.26 10.18 375 555020 33357 63909980
Dermatomyositis 11.26 10.18 51 555344 2755 63940582
Polyuria 11.26 10.18 162 555233 12481 63930856
Metastatic renal cell carcinoma 11.24 10.18 43 555352 2153 63941184
Product monitoring error 11.23 10.18 83 555312 5371 63937966
Eyelid retraction 11.22 10.18 6 555389 36 63943301
Prevertebral soft tissue swelling of cervical space 11.22 10.18 6 555389 36 63943301
Borderline personality disorder 11.15 10.18 23 555372 801 63942536
Subdural haemorrhage 11.09 10.18 81 555314 5222 63938115
Oesophageal adenocarcinoma 11.04 10.18 22 555373 747 63942590
White blood cell count increased 11.03 10.18 684 554711 65330 63878007
Alcohol interaction 10.99 10.18 13 555382 4388 63938949
Shock 10.98 10.18 248 555147 37992 63905345
Product odour abnormal 10.96 10.18 28 555367 1125 63942212
Lung opacity 10.96 10.18 7 555388 3192 63940145
Cerebrovascular accident 10.92 10.18 1349 554046 136234 63807103
Hypomania 10.89 10.18 20 555375 5634 63937703
Small intestinal obstruction 10.89 10.18 273 555122 23300 63920037
Portal vein thrombosis 10.88 10.18 77 555318 4914 63938423
Occupational exposure to air contaminants 10.88 10.18 9 555386 121 63943216
Anaemia folate deficiency 10.77 10.18 12 555383 238 63943099
Urinary tract discomfort 10.77 10.18 14 555381 328 63943009
Urine chloride decreased 10.77 10.18 8 555387 91 63943246
Gastrinoma 10.75 10.18 5 555390 21 63943316
Stevens-Johnson syndrome 10.74 10.18 378 555017 33871 63909466
Superior mesenteric artery syndrome 10.73 10.18 10 555385 159 63943178
Urticaria vesiculosa 10.73 10.18 4 555391 8 63943329
Product substitution error 10.70 10.18 6 555389 40 63943297
Therapeutic product ineffective 10.70 10.18 33 555362 1480 63941857
Exposure via ingestion 10.69 10.18 16 555379 4886 63938451
Essential hypertension 10.67 10.18 79 555316 5115 63938222
Amylase increased 10.67 10.18 129 555266 9556 63933781
COVID-19 treatment 10.65 10.18 16 555379 431 63942906
Mitochondrial toxicity 10.61 10.18 5 555390 2701 63940636
Regurgitation 10.55 10.18 41 555354 2068 63941269
Amyloidosis 10.52 10.18 46 555349 2448 63940889
Device malfunction 10.50 10.18 99 555296 17534 63925803
Osteoarthritis 10.49 10.18 442 554953 62894 63880443
Pharyngeal oedema 10.46 10.18 190 555205 15341 63927996
Breast cancer stage III 10.45 10.18 6 555389 2899 63940438
Intestinal fistula infection 10.42 10.18 4 555391 9 63943328
Osteochondritis 10.40 10.18 5 555390 23 63943314
Plethoric face 10.40 10.18 5 555390 23 63943314
Appendicitis perforated 10.40 10.18 50 555345 2770 63940567
Cerebral haematoma 10.37 10.18 101 555294 7084 63936253
Cerebral artery thrombosis 10.36 10.18 26 555369 1033 63942304
Idiopathic pulmonary fibrosis 10.35 10.18 62 555333 3738 63939599
Superinfection 10.32 10.18 63 555332 3823 63939514
Cystic fibrosis lung 10.30 10.18 9 555386 131 63943206
Hyperkalaemia 10.30 10.18 1008 554387 100121 63843216
Gallbladder hypofunction 10.25 10.18 16 555379 446 63942891
Cardiac steatosis 10.24 10.18 6 555389 44 63943293
Magnesium metabolism disorder 10.24 10.18 6 555389 44 63943293
Varicella zoster virus infection 10.24 10.18 11 555384 3877 63939460
Gastroenteritis aeromonas 10.23 10.18 5 555390 24 63943313
Deafness neurosensory 10.23 10.18 25 555370 6349 63936988
Use of accessory respiratory muscles 10.21 10.18 14 555381 346 63942991
Blood electrolytes decreased 10.20 10.18 29 555366 1242 63942095

FDA Adverse Event Reporting System (Pediatric)

None

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
ATC A02BD16 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 anticonvulsants
CHEBI has role CHEBI:49200 proton pump inhibitors
CHEBI has role CHEBI:49201 anti-ulcer drugs
CHEBI has role CHEBI:50183 P450 inhibitors
CHEBI has role CHEBI:77746 Homo sapiens metabolite
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

ProductApplicantIngredients
GastroGard Boehringer lngelheim Animal Health USA Inc. 1
UlcerGard Boehringer lngelheim Animal Health USA Inc. 1

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9364439 May 31, 2022 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9364439 May 31, 2022 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 6926907 Feb. 28, 2023 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 8206741 Feb. 28, 2023 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 6926907 Feb. 28, 2023 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 8206741 Feb. 28, 2023 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9987231 Jan. 2, 2033 FOR SECONDARY PREVENTION OF CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN PATIENTS AT RISK OF DEVELOPING ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9987231 Jan. 2, 2033 FOR SECONDARY PREVENTION OF CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN PATIENTS AT RISK OF DEVELOPING ASPIRIN-ASSOCIATED GASTRIC ULCERS
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9539214 March 13, 2033 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9539214 March 13, 2033 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 11135172 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9050263 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9498445 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9603806 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS

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
Multidrug resistance protein 1 Transporter IC50 4.05 WOMBAT-PK
Cytochrome P450 2C9 Enzyme Ki 4.35 WOMBAT-PK
Cytochrome P450 1A2 Enzyme IC50 4.74 WOMBAT-PK
Cytochrome P450 2C19 Enzyme Ki 5.30 WOMBAT-PK
Fatty acid synthase Enzyme Ki 5.47 CHEMBL
N(G),N(G)-dimethylarginine dimethylaminohydrolase 1 Enzyme IC50 4.70 CHEMBL
Glutathione S-transferase omega-1 Unclassified IC50 5.34 CHEMBL
Cytosolic endo-beta-N-acetylglucosaminidase Enzyme IC50 4.60 CHEMBL
Cytochrome P450 3A4 Enzyme Km 4.31 WOMBAT-PK
Potassium-transporting ATPase Enzyme IC50 5.42 CHEMBL
Potassium-transporting ATPase Enzyme IC50 6.16 SCIENTIFIC LITERATURE

External reference:

IDSource
4019439 VUID
N0000147569 NUI
D00455 KEGG_DRUG
95510-70-6 SECONDARY_CAS_RN
95382-33-5 SECONDARY_CAS_RN
4019439 VANDF
4025702 VANDF
4029343 VANDF
C0028978 UMLSCUI
CHEBI:7772 CHEBI
1C6 PDB_CHEM_ID
CHEMBL1503 ChEMBL_ID
CHEMBL2105294 ChEMBL_ID
DB00338 DRUGBANK_ID
CHEMBL1567328 ChEMBL_ID
D009853 MESH_DESCRIPTOR_UI
4594 PUBCHEM_CID
4279 IUPHAR_LIGAND_ID
5081 INN_ID
KG60484QX9 UNII
1792108 RXNORM
174165 MMSL
34509 MMSL
38031 MMSL
45807 MMSL
5201 MMSL
d00325 MMSL
d05770 MMSL
003476 NDDF
005065 NDDF
006090 NDDF
25673006 SNOMEDCT_US
384973006 SNOMEDCT_US
387137007 SNOMEDCT_US
420878004 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
good sense omeprazole delayed release HUMAN OTC DRUG LABEL 1 0113-1803 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 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 0615-8079 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 0615-8406 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 0781-2234 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 0781-2785 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 0781-2790 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 0781-2859 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