esomeprazole ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antiulcer, benzimidazole derivatives 1055 119141-88-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • esomeprazole magnesium dihydrate
  • esomeprazole
  • (S)-Esomeprazole
  • (S)-Omeprazole
  • (-)-Omeprazole
  • esomeprazole magnesium
  • esomeprazole sodium
  • nexium control
  • esomeprazole magnesium hydrate
  • esomeprazole strontium
The S-isomer of omeprazole.
  • 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
30 mg O
30 mg P
0.50 g O

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) 0.50 % 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
BA (Bioavailability) 53 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.85 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.03 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.83 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 20, 2001 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
Chronic kidney disease 877.06 9.29 948 219573 41108 56030438
Pemphigus 553.54 9.29 13 220508 157199 55914347
Drug ineffective 463.23 9.29 1946 218575 917043 55154503
Glossodynia 431.45 9.29 47 220474 152411 55919135
Systemic lupus erythematosus 405.09 9.29 103 220418 179975 55891571
Maternal exposure during pregnancy 381.68 9.29 133 220388 189420 55882126
Hand deformity 376.65 9.29 43 220478 134449 55937097
Synovitis 361.36 9.29 93 220428 161212 55910334
Renal injury 334.52 9.29 278 220243 8609 56062937
Anti-cyclic citrullinated peptide antibody positive 329.49 9.29 13 220508 98587 55972959
Wound 301.49 9.29 85 220436 138719 55932827
Pericarditis 299.57 9.29 37 220484 108886 55962660
Alopecia 295.96 9.29 432 220089 293026 55778520
Acute kidney injury 290.19 9.29 1772 218749 238991 55832555
Contraindicated product administered 286.10 9.29 189 220332 186097 55885449
Gastrooesophageal reflux disease 281.42 9.29 840 219681 82417 55989129
End stage renal disease 280.97 9.29 215 220306 5896 56065650
Rheumatoid arthritis 263.53 9.29 705 219816 381899 55689647
Arthropathy 247.01 9.29 252 220269 200023 55871523
Completed suicide 241.34 9.29 111 220410 133722 55937824
Duodenal ulcer perforation 231.80 9.29 8 220513 68334 56003212
Off label use 222.49 9.29 1275 219246 554905 55516641
Discomfort 200.36 9.29 157 220364 141604 55929942
Drug intolerance 197.61 9.29 468 220053 264350 55807196
Rheumatoid factor positive 196.01 9.29 21 220500 69039 56002507
Infusion related reaction 192.01 9.29 327 220194 208604 55862942
Hepatocellular injury 190.25 9.29 359 220162 26155 56045391
Helicobacter infection 182.79 9.29 33 220488 73235 55998311
Carotid artery thrombosis 179.29 9.29 111 220410 2133 56069413
Joint swelling 176.76 9.29 565 219956 289235 55782311
Cholestasis 176.73 9.29 351 220170 26562 56044984
Treatment failure 176.35 9.29 246 220275 170146 55901400
Neurologic neglect syndrome 176.32 9.29 109 220412 2089 56069457
Swelling 171.56 9.29 433 220088 239338 55832208
Hepatic enzyme increased 165.12 9.29 260 220261 171124 55900422
Interstitial lung disease 160.92 9.29 541 219980 56522 56015024
Cholecystitis chronic 159.56 9.29 194 220327 9554 56061992
Exposure during pregnancy 158.62 9.29 180 220341 136162 55935384
Adjustment disorder 158.47 9.29 104 220417 2219 56069327
Folliculitis 155.30 9.29 17 220504 54962 56016584
Muscle injury 154.13 9.29 14 220507 52486 56019060
Hyponatraemia 147.19 9.29 789 219732 101350 55970196
Therapeutic product effect decreased 143.32 9.29 279 220242 169173 55902373
Product use issue 142.52 9.29 324 220197 185717 55885829
Personality disorder 141.31 9.29 135 220386 5038 56066508
Renal failure 133.89 9.29 815 219706 109685 55961861
Toxicity to various agents 125.81 9.29 454 220067 224110 55847436
Hemiplegia 122.77 9.29 158 220363 8246 56063300
Abdominal discomfort 120.18 9.29 618 219903 276656 55794890
Sensitisation 117.03 9.29 87 220434 2281 56069265
Peripheral swelling 115.91 9.29 499 220022 234227 55837319
Biliary dyskinesia 115.25 9.29 89 220432 2474 56069072
Fatigue 110.91 9.29 2304 218217 786248 55285298
Dysphagia 108.00 9.29 618 219903 81329 55990217
Death 107.81 9.29 839 219682 340587 55730959
Tubulointerstitial nephritis 107.79 9.29 216 220305 16449 56055097
Product use in unapproved indication 107.20 9.29 246 220275 140576 55930970
Intentional product use issue 102.11 9.29 145 220376 99588 55971958
Polycystic ovaries 99.20 9.29 91 220430 3223 56068323
Hypertensive nephropathy 92.13 9.29 44 220477 490 56071056
Ejection fraction 91.52 9.29 66 220455 1649 56069897
Blister 91.39 9.29 180 220341 108707 55962839
Coordination abnormal 90.66 9.29 171 220350 12450 56059096
Psoriatic arthropathy 90.14 9.29 94 220427 73914 55997632
Sleep disorder due to general medical condition, insomnia type 89.57 9.29 29 220492 43309 56028237
Agranulocytosis 88.53 9.29 241 220280 22418 56049128
Motor dysfunction 85.87 9.29 142 220379 9315 56062231
Affect lability 83.95 9.29 146 220375 9979 56061567
Inappropriate antidiuretic hormone secretion 81.54 9.29 172 220349 13584 56057962
Rash maculo-papular 81.41 9.29 274 220247 28633 56042913
Eosinophilia 79.90 9.29 215 220306 19862 56051684
Rhinitis allergic 77.96 9.29 128 220393 8346 56063200
Lower respiratory tract infection 76.91 9.29 214 220307 114580 55956966
C-reactive protein abnormal 75.42 9.29 25 220496 36784 56034762
Hypersensitivity 75.39 9.29 642 219879 255766 55815780
Toxic skin eruption 72.17 9.29 149 220372 11590 56059956
Pain 71.72 9.29 2015 218506 661169 55410377
Irritable bowel syndrome 71.59 9.29 98 220423 68360 56003186
Gastritis 71.11 9.29 297 220224 34405 56037141
Ill-defined disorder 69.81 9.29 100 220421 68443 56003103
Sensory loss 69.13 9.29 125 220396 8810 56062736
Abdominal pain upper 67.99 9.29 1028 219493 177285 55894261
Hypomagnesaemia 66.84 9.29 233 220288 24782 56046764
Nephrectomy 65.46 9.29 47 220474 1166 56070380
Systemic lupus erythematosus rash 65.05 9.29 57 220464 1899 56069647
Condition aggravated 64.07 9.29 958 219563 343940 55727606
Device expulsion 63.59 9.29 20 220501 30429 56041117
Drug reaction with eosinophilia and systemic symptoms 63.38 9.29 261 220260 30043 56041503
Gastric polyps 61.26 9.29 69 220452 3129 56068417
Epigastric discomfort 61.06 9.29 97 220424 6151 56065395
Hemiparesis 60.78 9.29 204 220317 21286 56050260
Rash 59.53 9.29 1474 219047 491573 55579973
Hiatus hernia 58.66 9.29 190 220331 19462 56052084
Bronchial neoplasm 58.50 9.29 31 220490 437 56071109
Hypocalcaemia 56.48 9.29 243 220278 28517 56043029
Knee arthroplasty 56.42 9.29 54 220467 44205 56027341
Hepatic cytolysis 56.29 9.29 129 220392 10777 56060769
Sleep apnoea syndrome 55.72 9.29 226 220295 25835 56045711
Eating disorder 55.30 9.29 170 220351 16935 56054611
Pleural fibrosis 55.25 9.29 68 220453 3391 56068155
Loss of employment 53.76 9.29 51 220470 1886 56069660
Gallbladder disorder 53.02 9.29 169 220352 17165 56054381
Presbyacusis 52.27 9.29 60 220461 2778 56068768
Anxiety 52.16 9.29 1054 219467 192118 55879428
Gallbladder injury 51.71 9.29 42 220479 1258 56070288
Aphasia 51.53 9.29 246 220275 30169 56041377
Pregnancy 51.33 9.29 33 220488 33000 56038546
Nephropathy 49.29 9.29 83 220438 5526 56066020
Pleural thickening 49.20 9.29 57 220464 2666 56068880
Acute generalised exanthematous pustulosis 49.04 9.29 115 220406 9754 56061792
Blood magnesium increased 48.73 9.29 59 220462 2892 56068654
Rebound acid hypersecretion 48.39 9.29 24 220497 292 56071254
Mobility decreased 47.84 9.29 212 220309 98779 55972767
Nephrogenic anaemia 46.98 9.29 47 220474 1857 56069689
Nasal turbinate hypertrophy 46.41 9.29 31 220490 682 56070864
Diabetic nephropathy 45.87 9.29 40 220481 1324 56070222
Nasopharyngitis 45.86 9.29 600 219921 220359 55851187
Abortion spontaneous 45.37 9.29 63 220458 43690 56027856
Impaired healing 45.04 9.29 181 220340 86660 55984886
Hip arthroplasty 44.87 9.29 51 220470 38572 56032974
Bronchial disorder 44.50 9.29 37 220484 1146 56070400
Angina pectoris 44.33 9.29 222 220299 27754 56043792
Arterial occlusive disease 43.54 9.29 77 220444 5333 56066213
Anaemia 43.44 9.29 1363 219158 266148 55805398
Deafness neurosensory 43.27 9.29 71 220450 4627 56066919
Bronchial haemorrhage 43.10 9.29 27 220494 530 56071016
Osteosclerosis 43.09 9.29 62 220459 3601 56067945
Live birth 42.54 9.29 12 220509 19593 56051953
Drug abuse 42.38 9.29 130 220391 67480 56004066
Cholelithiasis 42.14 9.29 282 220239 39182 56032364
Hypothyroidism 42.03 9.29 275 220246 37921 56033625
Premature delivery 40.74 9.29 28 220493 27032 56044514
Prescription form tampering 39.93 9.29 26 220495 547 56070999
Gamma-glutamyltransferase increased 39.63 9.29 232 220289 30773 56040773
Therapy non-responder 39.16 9.29 117 220404 61238 56010308
Abdominal pain 39.00 9.29 1307 219214 257498 55814048
Carpal tunnel syndrome 38.51 9.29 157 220364 17987 56053559
Pancreatitis 38.30 9.29 305 220216 44775 56026771
Pancreatitis acute 38.15 9.29 197 220324 24927 56046619
Asthenia 38.13 9.29 1675 218846 341298 55730248
Gastric disorder 37.70 9.29 241 220280 32969 56038577
Adverse drug reaction 37.53 9.29 130 220391 65002 56006544
Musculoskeletal stiffness 36.78 9.29 412 220109 155595 55915951
Cholecystitis 36.46 9.29 132 220389 14303 56057243
Axonal neuropathy 36.20 9.29 30 220491 925 56070621
Hypokalaemia 35.77 9.29 544 219977 93893 55977653
Stomatitis 35.67 9.29 302 220219 120508 55951038
Fall 35.64 9.29 1727 218794 355783 55715763
Dermatitis bullous 35.21 9.29 86 220435 7487 56064059
COVID-19 34.91 9.29 163 220358 74895 55996651
Lung disorder 34.88 9.29 337 220184 52260 56019286
Red blood cell sedimentation rate abnormal 34.39 9.29 15 220506 18658 56052888
Dysarthria 34.37 9.29 269 220252 39281 56032265
Cross sensitivity reaction 34.28 9.29 41 220480 1984 56069562
Nephritic syndrome 34.27 9.29 18 220503 249 56071297
Infection 34.11 9.29 565 219956 199641 55871905
Foetal exposure during pregnancy 33.79 9.29 50 220471 33773 56037773
Endometrial ablation 33.41 9.29 28 220493 877 56070669
Tenosynovitis stenosans 33.35 9.29 46 220475 2568 56068978
Injection site erythema 32.69 9.29 174 220347 77274 55994272
Drug resistance 32.64 9.29 20 220501 20522 56051024
Drug interaction 32.53 9.29 1063 219458 208692 55862854
Renal disorder 32.48 9.29 213 220308 29392 56042154
Impaired work ability 32.46 9.29 128 220393 14444 56057102
Dyspepsia 32.07 9.29 482 220039 82989 55988557
Iron deficiency anaemia 31.86 9.29 147 220374 17772 56053774
Intentional overdose 31.64 9.29 148 220373 67969 56003577
Phlebitis 31.50 9.29 73 220448 6143 56065403
Vascular purpura 30.90 9.29 32 220489 1318 56070228
Cholestatic liver injury 30.81 9.29 41 220480 2211 56069335
Drug hypersensitivity 30.65 9.29 832 219689 274373 55797173
Gastric antral vascular ectasia 30.22 9.29 22 220499 558 56070988
Urate nephropathy 29.92 9.29 13 220508 114 56071432
Bone cyst 29.77 9.29 39 220482 2071 56069475
Rhabdomyolysis 29.72 9.29 266 220255 40392 56031154
Caesarean section 29.52 9.29 13 220508 16078 56055468
Dry eye 29.44 9.29 240 220281 35476 56036070
Sleep disorder due to a general medical condition 29.06 9.29 90 220431 9000 56062546
Hypergastrinaemia 28.56 9.29 12 220509 96 56071450
Cell death 28.38 9.29 40 220481 2279 56069267
Palpitations 27.92 9.29 547 219974 99125 55972421
Anal abscess 27.86 9.29 55 220466 4142 56067404
Nausea 27.84 9.29 3408 217113 760770 55310776
Arthralgia 27.70 9.29 1646 218875 500023 55571523
Malnutrition 27.23 9.29 118 220403 13890 56057656
Nephritis allergic 26.89 9.29 13 220508 149 56071397
Erythema dyschromicum perstans 26.81 9.29 10 220511 56 56071490
Muscle spasticity 26.58 9.29 151 220370 19809 56051737
Respiratory tract congestion 26.33 9.29 126 220395 15465 56056081
Synovial fluid analysis 26.08 9.29 35 220486 1903 56069643
Accidental exposure to product 26.05 9.29 35 220486 24612 56046934
Muscular weakness 25.90 9.29 563 219958 103889 55967657
Sinus congestion 25.78 9.29 126 220395 15598 56055948
Occupational asthma 25.74 9.29 12 220509 126 56071420
Chest pain 25.70 9.29 947 219574 188850 55882696
Therapy interrupted 25.48 9.29 38 220483 25587 56045959
Angina bullosa haemorrhagica 25.25 9.29 12 220509 132 56071414
Blood test abnormal 25.09 9.29 108 220413 12676 56058870
Ejection fraction abnormal 25.04 9.29 26 220495 1074 56070472
Renal impairment 25.04 9.29 450 220071 80263 55991283
Bone erosion 24.61 9.29 14 220507 14960 56056586
Muscle contractions involuntary 24.54 9.29 35 220486 2016 56069530
Dry mouth 24.37 9.29 370 220151 63835 56007711
No adverse event 24.20 9.29 68 220453 36306 56035240
Face oedema 24.18 9.29 139 220382 18313 56053233
Crepitations 24.07 9.29 71 220450 6913 56064633
Eosinophilic fasciitis 23.77 9.29 12 220509 152 56071394
Gangrene 23.75 9.29 61 220460 5479 56066067
Cutaneous lupus erythematosus 23.73 9.29 39 220482 2545 56069001
Gallbladder polyp 23.56 9.29 21 220500 716 56070830
Muscle haemorrhage 23.50 9.29 42 220479 2933 56068613
Kidney infection 23.28 9.29 150 220371 20575 56050971
Macular degeneration 23.03 9.29 24 220497 18884 56052662
Rheumatoid nodule 22.91 9.29 117 220404 14740 56056806
Oesophagitis 22.59 9.29 112 220409 13945 56057601
Lip oedema 22.39 9.29 45 220476 3433 56068113
Cyst 22.11 9.29 104 220417 12674 56058872
Asthma 21.95 9.29 588 219933 112182 55959364
Mesenteric panniculitis 21.79 9.29 10 220511 101 56071445
Hypocapnia 21.73 9.29 15 220506 349 56071197
Electric shock 21.62 9.29 24 220497 1071 56070475
Scleritis 21.53 9.29 46 220475 3665 56067881
Pancreatic neuroendocrine tumour 21.47 9.29 16 220505 421 56071125
Injection site pain 21.44 9.29 326 220195 116792 55954754
Cerebral haematoma 21.40 9.29 43 220478 3280 56068266
Schizophreniform disorder 21.32 9.29 9 220512 73 56071473
General physical health deterioration 21.31 9.29 505 220016 169505 55902041
Neutropenic sepsis 21.20 9.29 17 220504 15168 56056378
Poisoning 21.03 9.29 12 220509 12801 56058745
Gastrointestinal haemorrhage 20.99 9.29 416 220105 75535 55996011
Febrile bone marrow aplasia 20.95 9.29 65 220456 6507 56065039
Gallbladder hypofunction 20.88 9.29 17 220504 511 56071035
Herpes simplex test positive 20.70 9.29 11 220510 156 56071390
Haematoma 20.66 9.29 204 220317 31815 56039731
Neurotoxicity 20.45 9.29 19 220502 15776 56055770
Dehydration 20.42 9.29 788 219733 158037 55913509
Adverse event 20.38 9.29 130 220391 55246 56016300
Flatulence 20.02 9.29 199 220322 31089 56040457
Oesophageal dilatation 19.97 9.29 14 220507 334 56071212
Nephrosclerosis 19.95 9.29 22 220499 974 56070572
Cholecystectomy 19.92 9.29 83 220438 9601 56061945
Subacute cutaneous lupus erythematosus 19.64 9.29 34 220487 2315 56069231
Blood alkaline phosphatase increased 19.53 9.29 236 220285 38709 56032837
Contusion 19.45 9.29 370 220151 128060 55943486
Hepatic steatosis 19.41 9.29 172 220349 26042 56045504
Burning sensation 19.40 9.29 283 220238 48413 56023133
Supraventricular extrasystoles 19.38 9.29 47 220474 4073 56067473
Type 2 diabetes mellitus 19.38 9.29 106 220415 46756 56024790
Gastrointestinal motility disorder 19.33 9.29 51 220470 4655 56066891
Haemoglobin decreased 19.30 9.29 674 219847 133463 55938083
Myelosuppression 19.26 9.29 24 220497 17431 56054115
Medication error 19.06 9.29 93 220428 42242 56029304
Tetany 18.97 9.29 28 220493 1664 56069882
Haematotoxicity 18.43 9.29 5 220516 8378 56063168
Liver function test increased 18.42 9.29 53 220468 28080 56043466
Small cell carcinoma 18.38 9.29 10 220511 149 56071397
International normalised ratio increased 18.36 9.29 258 220263 43783 56027763
Therapeutic response decreased 18.34 9.29 126 220395 52632 56018914
Rectosigmoid cancer 18.32 9.29 10 220511 150 56071396
Hepatitis cholestatic 18.23 9.29 61 220460 6353 56065193
Hepatotoxicity 18.06 9.29 62 220459 31091 56040455
Acute hepatitis B 17.95 9.29 13 220508 327 56071219
Pneumobilia 17.83 9.29 9 220512 114 56071432
Bradypnoea 17.78 9.29 39 220482 3164 56068382
Congenital osteodystrophy 17.52 9.29 6 220515 25 56071521
Anaemia macrocytic 17.47 9.29 38 220483 3065 56068481
Bile duct stone 17.36 9.29 40 220481 3354 56068192
Normal newborn 17.31 9.29 4 220517 7466 56064080
Gastric ulcer 17.21 9.29 149 220372 22414 56049132
Nerve injury 17.15 9.29 75 220446 8862 56062684
Hyperchlorhydria 17.07 9.29 26 220495 1589 56069957
Drug eruption 17.04 9.29 165 220356 25598 56045948
Device dependence 16.96 9.29 5 220516 11 56071535
Livedo reticularis 16.95 9.29 31 220490 2204 56069342
Ulcer 16.89 9.29 148 220373 22337 56049209
Erosive oesophagitis 16.77 9.29 26 220495 1614 56069932
Muscle swelling 16.75 9.29 14 220507 437 56071109
Osteopenia 16.66 9.29 125 220396 18016 56053530
Sedation 16.61 9.29 75 220446 34779 56036767
Bunion operation 16.58 9.29 22 220499 1183 56070363
Eczema 16.57 9.29 166 220355 25987 56045559
Injection site bruising 16.56 9.29 86 220435 38435 56033111
Emotional distress 16.55 9.29 184 220337 29579 56041967
IIIrd nerve paresis 16.49 9.29 9 220512 135 56071411
Anaemia folate deficiency 16.48 9.29 10 220511 185 56071361
Mixed liver injury 16.47 9.29 43 220478 3901 56067645
Pathological fracture 16.39 9.29 69 220452 8020 56063526
Genital infection female 16.37 9.29 8 220513 94 56071452
Arterial spasm 16.35 9.29 7 220514 59 56071487
Hunger 16.34 9.29 48 220473 4663 56066883
Diverticulum 16.27 9.29 86 220435 10980 56060566
Injection site swelling 16.19 9.29 102 220419 43476 56028070
Skin lesion 16.14 9.29 175 220346 27960 56043586
Vertigo 16.13 9.29 302 220219 54270 56017276
Cerebrovascular accident 16.12 9.29 506 220015 98764 55972782
Angina unstable 16.08 9.29 61 220460 6760 56064786
Oesophageal polyp 15.96 9.29 4 220517 3 56071543
Tooth infection 15.88 9.29 111 220410 15641 56055905
Non-economic loss 15.86 9.29 5 220516 15 56071531
Escherichia pyelonephritis 15.79 9.29 13 220508 397 56071149
Jaundice 15.76 9.29 170 220351 27124 56044422
Cardiac disorder 15.73 9.29 260 220261 45627 56025919
Injection site pruritus 15.66 9.29 98 220423 41833 56029713
Nasal discharge discolouration 15.58 9.29 27 220494 1840 56069706
Renal cyst 15.55 9.29 75 220446 9234 56062312
Photophobia 15.54 9.29 112 220409 15938 56055608
Blood chromogranin A increased 15.49 9.29 11 220510 268 56071278
Angioedema 15.38 9.29 238 220283 41215 56030331
Transient ischaemic attack 15.35 9.29 200 220321 33377 56038169
Rhonchi 15.35 9.29 31 220490 2373 56069173
Prescribed overdose 15.34 9.29 41 220480 22255 56049291
Blood potassium increased 15.33 9.29 118 220403 17143 56054403
Deformity 15.28 9.29 80 220441 10175 56061371
Prothrombin time ratio decreased 15.28 9.29 13 220508 416 56071130
Chondrocalcinosis pyrophosphate 15.17 9.29 21 220500 1176 56070370
Pancreatitis chronic 15.15 9.29 30 220491 2264 56069282
Oesophagitis ulcerative 15.14 9.29 14 220507 501 56071045
Proteinuria 14.99 9.29 119 220402 17451 56054095
Early satiety 14.99 9.29 18 220503 875 56070671
Adenocarcinoma gastric 14.93 9.29 14 220507 510 56071036
Thrombocytopenia 14.80 9.29 664 219857 135560 55935986
Weight increased 14.79 9.29 742 219779 228961 55842585
Therapy partial responder 14.74 9.29 6 220515 7779 56063767
Keratoacanthoma 14.69 9.29 13 220508 439 56071107
Dialysis 14.68 9.29 76 220445 9626 56061920
Cerebellar haematoma 14.67 9.29 12 220509 363 56071183
Product dose omission issue 14.65 9.29 654 219867 204099 55867447
Premature labour 14.56 9.29 15 220506 11867 56059679
Synovial cyst 14.51 9.29 73 220448 9141 56062405
Meningitis aseptic 14.48 9.29 44 220477 4355 56067191
Renal tubular disorder 14.46 9.29 31 220490 2475 56069071
Disease progression 14.42 9.29 308 220213 104865 55966681
Eyelid oedema 14.42 9.29 76 220445 9692 56061854
Hyperparathyroidism secondary 14.30 9.29 22 220499 1357 56070189
Sudden death 14.29 9.29 75 220446 9550 56061996
Drug tolerance decreased 14.22 9.29 19 220502 13392 56058154
Neutropenia 14.19 9.29 492 220029 157675 55913871
Pleuritic pain 14.14 9.29 60 220461 6997 56064549
Hepatitis 14.13 9.29 206 220315 35235 56036311
Hyperthermia 14.02 9.29 67 220454 8218 56063328
Melaena 14.00 9.29 171 220350 28119 56043427
Ingrowing nail 13.92 9.29 28 220493 2137 56069409
Body temperature increased 13.86 9.29 78 220443 34164 56037382
Pre-eclampsia 13.85 9.29 8 220513 8478 56063068
Dermatitis exfoliative 13.85 9.29 49 220472 5250 56066296
Protein-losing gastroenteropathy 13.84 9.29 9 220512 189 56071357
Uveal melanoma 13.82 9.29 4 220517 8 56071538
Calcium metabolism disorder 13.78 9.29 8 220513 136 56071410
Chronic cutaneous lupus erythematosus 13.76 9.29 10 220511 253 56071293
Oedema peripheral 13.75 9.29 811 219710 170443 55901103
Purging 13.67 9.29 6 220515 54 56071492
Haemorrhoids 13.66 9.29 130 220391 20076 56051470
Gastrinoma 13.64 9.29 3 220518 0 56071546
Erythema 13.59 9.29 744 219777 155195 55916351
Type I hypersensitivity 13.56 9.29 30 220491 2448 56069098
Gastrointestinal tract mucosal pigmentation 13.47 9.29 14 220507 579 56070967
Multi-organ disorder 13.45 9.29 21 220500 1312 56070234
Renal hypertrophy 13.41 9.29 5 220516 28 56071518
Faeces discoloured 13.36 9.29 113 220408 16883 56054663
Teeth brittle 13.35 9.29 13 220508 497 56071049
Vitamin B12 decreased 13.33 9.29 34 220487 3041 56068505
Illness 13.23 9.29 80 220441 34431 56037115
Hypoplastic anaemia 13.21 9.29 4 220517 10 56071536
Abortion induced 13.21 9.29 11 220510 9634 56061912
Creatinine renal clearance decreased 13.15 9.29 23 220498 14536 56057010
Hyponatraemic seizure 13.13 9.29 12 220509 423 56071123
Musculoskeletal chest pain 13.09 9.29 126 220395 19515 56052031
Liver injury 13.08 9.29 103 220418 41745 56029801
Lordosis 13.07 9.29 10 220511 274 56071272
Brucellosis 13.04 9.29 6 220515 61 56071485
Renal haemangioma 12.98 9.29 5 220516 31 56071515
Atelectasis 12.94 9.29 124 220397 19184 56052362
Intestinal infarction 12.94 9.29 18 220503 1013 56070533
Campylobacter colitis 12.85 9.29 5 220516 32 56071514
Female sterilisation 12.82 9.29 13 220508 522 56071024
Chest discomfort 12.82 9.29 491 220030 98366 55973180
Antinuclear antibody positive 12.82 9.29 57 220464 6784 56064762
Bladder sphincter atony 12.77 9.29 8 220513 157 56071389
Renal atrophy 12.76 9.29 21 220500 1372 56070174
Thymus disorder 12.74 9.29 10 220511 285 56071261
Sinus bradycardia 12.70 9.29 94 220427 13492 56058054
Lipase increased 12.67 9.29 69 220452 8910 56062636
Congenital bowing of long bones 12.63 9.29 6 220515 66 56071480
Hyperlipasaemia 12.62 9.29 13 220508 532 56071014
Rash scarlatiniform 12.60 9.29 7 220514 109 56071437
Clinically isolated syndrome 12.59 9.29 5 220516 34 56071512
Musculoskeletal disorder 12.58 9.29 36 220485 19111 56052435
Eructation 12.58 9.29 61 220460 7527 56064019
Renal tubular necrosis 12.55 9.29 79 220442 10749 56060797
Hyperkalaemia 12.55 9.29 274 220247 50591 56020955
Sneezing 12.52 9.29 104 220417 15456 56056090
Bursitis 12.49 9.29 164 220357 27418 56044128
Monoclonal gammopathy 12.48 9.29 14 220507 632 56070914
Immunodeficiency 12.46 9.29 28 220493 16129 56055417
Disability 12.46 9.29 27 220494 15753 56055793
Hyperphosphatasaemia 12.45 9.29 4 220517 13 56071533
Rectal haemorrhage 12.44 9.29 230 220291 41237 56030309
Malabsorption 12.37 9.29 38 220483 3783 56067763
Sinus disorder 12.37 9.29 130 220391 20604 56050942
Paranasal sinus inflammation 12.34 9.29 12 220509 458 56071088
Infusion site scar 12.32 9.29 11 220510 376 56071170
Tongue oedema 12.28 9.29 39 220482 3953 56067593
Purpura 12.26 9.29 76 220445 10286 56061260
Gastrointestinal ischaemia 12.14 9.29 8 220513 172 56071374
Obesity 12.14 9.29 46 220475 22402 56049144
Intervertebral discitis 12.13 9.29 31 220490 2776 56068770
Aspartate aminotransferase increased 12.11 9.29 416 220105 82186 55989360
Regurgitation 12.10 9.29 21 220500 1433 56070113
Complication of device insertion 12.09 9.29 5 220516 6419 56065127
Hypoosmolar state 12.02 9.29 8 220513 175 56071371
Coronary artery occlusion 12.01 9.29 61 220460 7668 56063878
Neurosis 11.94 9.29 9 220512 241 56071305
Diarrhoea 11.92 9.29 2748 217773 635759 55435787
Essential hypertension 11.92 9.29 43 220478 4650 56066896
Poor personal hygiene 11.86 9.29 10 220511 316 56071230
Drug ineffective for unapproved indication 11.82 9.29 56 220465 25637 56045909
Device dislocation 11.79 9.29 47 220474 22559 56048987
Maternal exposure before pregnancy 11.77 9.29 6 220515 6817 56064729
Allergy to chemicals 11.71 9.29 28 220493 2405 56069141
Dilatation atrial 11.69 9.29 24 220497 1859 56069687
Wrong technique in product usage process 11.66 9.29 159 220362 58009 56013537
Crystal arthropathy 11.66 9.29 9 220512 250 56071296
Aeromonas infection 11.62 9.29 6 220515 80 56071466
Hypofibrinogenaemia 11.59 9.29 18 220503 1119 56070427
Hypoparathyroidism secondary 11.59 9.29 5 220516 43 56071503
Vitreous detachment 11.59 9.29 24 220497 1871 56069675
Platelet adhesiveness decreased 11.57 9.29 3 220518 3 56071543
Gastric adenoma 11.57 9.29 3 220518 3 56071543
Colitis ischaemic 11.55 9.29 73 220448 9947 56061599
Colitis 11.55 9.29 229 220292 41582 56029964
Atrioventricular block complete 11.54 9.29 59 220462 7435 56064111
Loss of personal independence in daily activities 11.53 9.29 237 220284 81132 55990414
Rhinalgia 11.50 9.29 18 220503 1127 56070419
Breast cancer stage I 11.48 9.29 5 220516 6225 56065321
Unintentional medical device removal 11.43 9.29 4 220517 5690 56065856
Muscle enzyme increased 11.42 9.29 7 220514 132 56071414
Polyglandular autoimmune syndrome type II 11.40 9.29 5 220516 45 56071501
Hypertensive crisis 11.39 9.29 94 220427 13942 56057604
Enterocolitis haemorrhagic 11.35 9.29 20 220501 1381 56070165
Dysphonia 11.33 9.29 229 220292 41718 56029828
Therapeutic response shortened 11.33 9.29 12 220509 9374 56062172
Gastric ulcer haemorrhage 11.29 9.29 42 220479 4611 56066935
Retinal artery occlusion 11.25 9.29 21 220500 1517 56070029
Stent placement 11.21 9.29 35 220486 3516 56068030
Septic shock 11.21 9.29 315 220206 60520 56011026
Vulvovaginal burning sensation 11.19 9.29 22 220499 1652 56069894
Hepatic function abnormal 11.18 9.29 194 220327 34364 56037182
Tachycardia paroxysmal 11.15 9.29 9 220512 267 56071279
Purpura senile 11.15 9.29 12 220509 517 56071029
Vulval disorder 11.10 9.29 14 220507 716 56070830
Rectal cancer metastatic 11.07 9.29 9 220512 270 56071276
Blood thyroid stimulating hormone increased 11.05 9.29 53 220468 6510 56065036
Finger deformity 11.02 9.29 6 220515 6571 56064975
Anaemia vitamin B12 deficiency 11.02 9.29 10 220511 349 56071197
Blood magnesium decreased 11.01 9.29 82 220439 11792 56059754
Nikolsky's sign 10.94 9.29 6 220515 91 56071455
Dysgeusia 10.93 9.29 223 220298 40692 56030854
Dermatosis 10.93 9.29 9 220512 275 56071271
Purple glove syndrome 10.92 9.29 8 220513 205 56071341
Hypoparathyroidism 10.90 9.29 13 220508 627 56070919
Diverticulum oesophageal 10.89 9.29 7 220514 144 56071402
Iron deficiency 10.88 9.29 51 220470 6205 56065341
Dystonia 10.88 9.29 20 220501 12401 56059145
Dysuria 10.86 9.29 175 220346 30554 56040992
Acute sinusitis 10.84 9.29 35 220486 3578 56067968
Thrombocytopenic purpura 10.84 9.29 19 220502 1307 56070239
Seizure 10.80 9.29 391 220130 124728 55946818
Lumbar spinal stenosis 10.79 9.29 40 220481 4383 56067163
Blood gastrin increased 10.78 9.29 4 220517 22 56071524
Throat irritation 10.77 9.29 184 220337 32499 56039047
Bicytopenia 10.75 9.29 25 220496 2108 56069438
Heat stroke 10.74 9.29 14 220507 740 56070806
Affective disorder 10.74 9.29 47 220474 5556 56065990
Concussion 10.73 9.29 62 220459 8184 56063362
Renal hypertension 10.72 9.29 7 220514 148 56071398
Gastric haemorrhage 10.72 9.29 49 220472 5901 56065645
Gastrointestinal disorder 10.71 9.29 348 220173 112354 55959192
Laboratory test abnormal 10.69 9.29 55 220466 24640 56046906
Acute cutaneous lupus erythematosus 10.66 9.29 9 220512 285 56071261
Cholangitis 10.64 9.29 43 220478 4906 56066640
Vulvovaginal inflammation 10.61 9.29 14 220507 749 56070797
Transplant rejection 10.60 9.29 14 220507 9920 56061626
Oesophageal ulcer 10.58 9.29 38 220483 4101 56067445
Gastric cancer 10.55 9.29 37 220484 3946 56067600
Acute coronary syndrome 10.54 9.29 70 220451 9698 56061848
Dislocation of vertebra 10.54 9.29 4 220517 5411 56066135
Carnitine deficiency 10.52 9.29 7 220514 153 56071393
Placental calcification 10.50 9.29 4 220517 24 56071522
Oedema mouth 10.49 9.29 26 220495 2284 56069262
Dyslipidaemia 10.48 9.29 51 220470 6302 56065244
Cholecystitis acute 10.47 9.29 57 220464 7359 56064187
Pyelonephritis acute 10.44 9.29 39 220482 4290 56067256
Antipsychotic drug level above therapeutic 10.42 9.29 16 220505 985 56070561
Acute myeloid leukaemia 10.37 9.29 33 220488 16939 56054607
Bronchopneumopathy 10.37 9.29 8 220513 222 56071324
Hepatobiliary scan abnormal 10.37 9.29 5 220516 57 56071489
Cardiothoracic ratio increased 10.36 9.29 4 220517 25 56071521
Resorption bone increased 10.33 9.29 18 220503 1232 56070314
Vomiting 10.33 9.29 2155 218366 496073 55575473
Pulmonary embolism 10.32 9.29 516 220005 106608 55964938
Abdominal adhesions 10.31 9.29 30 220491 2899 56068647
Peripheral artery thrombosis 10.28 9.29 22 220499 1755 56069791
Renal infarct 10.27 9.29 19 220502 1363 56070183
Tongue pruritus 10.24 9.29 11 220510 473 56071073
Eye haematoma 10.23 9.29 4 220517 26 56071520
Pulmonary artery stenosis 10.21 9.29 7 220514 161 56071385
Crohn's disease 10.18 9.29 51 220470 6376 56065170
Deep vein thrombosis 10.14 9.29 383 220138 76594 55994952
Skin haemorrhage 10.14 9.29 62 220459 8351 56063195
Tonic clonic movements 10.12 9.29 18 220503 1252 56070294
Portal vein dilatation 10.10 9.29 4 220517 27 56071519
Language disorder 10.06 9.29 23 220498 1918 56069628
Respiratory depression 10.05 9.29 21 220500 12414 56059132
Fracture nonunion 10.04 9.29 25 220496 2202 56069344
Erythema multiforme 10.03 9.29 68 220453 9486 56062060
Breast cancer stage II 10.02 9.29 5 220516 5753 56065793
Tri-iodothyronine free decreased 10.02 9.29 9 220512 310 56071236
Cough 10.00 9.29 1164 219357 258797 55812749
Fungal oesophagitis 9.95 9.29 12 220509 586 56070960
Blood loss anaemia 9.91 9.29 61 220460 8236 56063310
Urinary incontinence 9.91 9.29 167 220354 29418 56042128
Hypoxic-ischaemic encephalopathy 9.90 9.29 36 220485 3909 56067637
Atypical fracture 9.85 9.29 12 220509 592 56070954
Vagus nerve disorder 9.84 9.29 6 220515 112 56071434
Small intestinal stenosis 9.83 9.29 11 220510 495 56071051
Unintended pregnancy 9.83 9.29 4 220517 5187 56066359
Hypertriglyceridaemia 9.82 9.29 47 220474 5769 56065777
Spinal osteoarthritis 9.80 9.29 95 220426 14741 56056805
Renal lymphocele 9.79 9.29 5 220516 65 56071481
Arterial fibrosis 9.77 9.29 3 220518 8 56071538
Coma acidotic 9.75 9.29 6 220515 114 56071432
Renal tuberculosis 9.74 9.29 4 220517 30 56071516
Oesophageal irritation 9.70 9.29 6 220515 115 56071431
Mandibular mass 9.70 9.29 7 220514 175 56071371
Subdural haematoma 9.70 9.29 88 220433 13411 56058135
Blood creatine phosphokinase decreased 9.69 9.29 10 220511 410 56071136
Rhinitis 9.69 9.29 64 220457 8852 56062694
Liver abscess 9.67 9.29 28 220493 2698 56068848
Grip strength decreased 9.66 9.29 32 220489 16224 56055322
Lichen planus 9.61 9.29 24 220497 2118 56069428
Neuroleptic malignant syndrome 9.60 9.29 19 220502 11459 56060087
Microcytic anaemia 9.59 9.29 31 220490 3171 56068375
Low turnover osteopathy 9.57 9.29 36 220485 3972 56067574
Actinic keratosis 9.56 9.29 25 220496 2270 56069276
Blood cholesterol increased 9.53 9.29 214 220307 72365 55999181
Therapy cessation 9.53 9.29 65 220456 27199 56044347
Haemorrhagic cyst 9.50 9.29 7 220514 181 56071365
Diverticulum intestinal 9.43 9.29 50 220471 6390 56065156
Body height decreased 9.42 9.29 65 220456 9120 56062426
Renal tubular atrophy 9.39 9.29 13 220508 728 56070818
Biliary colic 9.36 9.29 32 220489 3370 56068176
Tenosynovitis 9.35 9.29 82 220439 12379 56059167
Vertigo positional 9.32 9.29 27 220494 2602 56068944
Vitamin B12 deficiency 9.31 9.29 38 220483 4355 56067191

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
Chronic kidney disease 552.21 10.03 728 129143 37247 31530226
Toxicity to various agents 218.76 10.03 253 129618 181234 31386239
End stage renal disease 201.38 10.03 205 129666 7904 31559569
Death 194.66 10.03 790 129081 359779 31207694
Drug abuse 190.69 10.03 61 129810 87697 31479776
Acute kidney injury 187.77 10.03 1858 128013 277856 31289617
Drug ineffective 178.85 10.03 925 128946 394648 31172825
Completed suicide 161.18 10.03 87 129784 91427 31476046
Cholestasis 152.21 10.03 325 129546 24750 31542723
Gastrooesophageal reflux disease 142.79 10.03 381 129490 33490 31533983
Off label use 142.55 10.03 838 129033 346436 31221037
Hepatocellular injury 139.82 10.03 287 129584 21257 31546216
Toxic skin eruption 130.88 10.03 184 129687 9996 31557477
Renal injury 130.10 10.03 188 129683 10477 31556996
Interstitial lung disease 129.76 10.03 547 129324 60856 31506617
Hypomagnesaemia 95.56 10.03 229 129642 18829 31548644
Eosinophilia 92.41 10.03 256 129615 22997 31544476
Agranulocytosis 80.59 10.03 230 129641 21017 31546456
Hypocalcaemia 76.74 10.03 231 129640 21747 31545726
Hepatic cytolysis 75.97 10.03 149 129722 10674 31556799
Treatment failure 75.93 10.03 36 129835 40756 31526717
Renal failure 68.64 10.03 790 129081 122540 31444933
Product use in unapproved indication 66.15 10.03 198 129673 98973 31468500
Nephrogenic anaemia 65.07 10.03 60 129811 2043 31565430
Tubulointerstitial nephritis 64.20 10.03 194 129677 18302 31549171
Foetal exposure during pregnancy 59.55 10.03 48 129823 40828 31526645
Occult blood 55.02 10.03 34 129837 621 31566852
COVID-19 54.23 10.03 88 129783 54733 31512740
Hypertensive nephropathy 49.39 10.03 28 129843 433 31567040
Hepatojugular reflux 49.22 10.03 30 129841 534 31566939
Drug reaction with eosinophilia and systemic symptoms 48.98 10.03 248 129623 29770 31537703
Pancreatitis acute 48.64 10.03 221 129650 25379 31542094
Hyperkalaemia 47.08 10.03 436 129435 63915 31503558
Gamma-glutamyltransferase increased 45.48 10.03 230 129641 27595 31539878
Drug resistance 44.72 10.03 20 129851 23433 31544040
Hypergastrinaemia 43.83 10.03 15 129856 59 31567414
Jaundice 41.79 10.03 239 129632 30048 31537425
Ventricular hypokinesia 41.05 10.03 72 129799 4734 31562739
Electrocardiogram Q wave abnormal 39.56 10.03 23 129848 374 31567099
Degenerative mitral valve disease 39.49 10.03 19 129852 205 31567268
Nephropathy 39.14 10.03 76 129795 5403 31562070
Rash maculo-papular 37.51 10.03 206 129665 25513 31541960
Nicotine dependence 37.11 10.03 24 129847 476 31566997
Lung disorder 37.01 10.03 243 129628 32069 31535404
Colitis microscopic 36.31 10.03 43 129828 1967 31565506
Hepatitis cholestatic 35.96 10.03 86 129785 7060 31560413
Thrombocytopenia 35.63 10.03 800 129071 141947 31425526
Systolic dysfunction 35.02 10.03 46 129825 2340 31565133
Pulmonary vascular disorder 34.64 10.03 25 129846 597 31566876
Product dose omission issue 34.03 10.03 273 129598 105313 31462160
Cholestatic liver injury 33.98 10.03 41 129830 1913 31565560
Gastric polyps 33.73 10.03 31 129840 1051 31566422
Cell death 33.26 10.03 42 129829 2054 31565419
Intentional product use issue 33.25 10.03 98 129773 49249 31518224
Vascular purpura 32.94 10.03 35 129836 1419 31566054
Hiatus hernia 32.19 10.03 81 129790 6866 31560607
Chronic kidney disease-mineral and bone disorder 31.95 10.03 20 129851 374 31567099
Drug intolerance 31.79 10.03 108 129763 51925 31515548
Diabetic nephropathy 31.28 10.03 40 129831 1981 31565492
Hyponatraemia 30.97 10.03 449 129422 73350 31494123
Hypokalaemia 30.56 10.03 345 129526 53229 31514244
Eye injury 28.34 10.03 23 129848 657 31566816
Mixed liver injury 28.21 10.03 41 129830 2296 31565177
Intentional overdose 28.03 10.03 82 129789 41307 31526166
Hemiplegia 27.69 10.03 75 129796 6647 31560826
Therapy non-responder 27.52 10.03 61 129810 33750 31533723
Drug hypersensitivity 26.10 10.03 182 129689 72417 31495056
Drug ineffective for unapproved indication 25.77 10.03 21 129850 17769 31549704
Physical deconditioning 25.68 10.03 25 129846 912 31566561
Eosinophilic colitis 25.30 10.03 14 129857 206 31567267
Therapeutic product effect incomplete 25.15 10.03 93 129778 43603 31523870
Disease progression 25.12 10.03 243 129628 90221 31477252
Face oedema 24.31 10.03 97 129774 10519 31556954
Occupational dermatitis 24.27 10.03 10 129861 72 31567401
Anaemia macrocytic 24.19 10.03 43 129828 2857 31564616
Eczema 24.19 10.03 126 129745 15291 31552182
Inferior vena cava dilatation 24.07 10.03 21 129850 664 31566809
Rhabdomyolysis 24.03 10.03 380 129491 63201 31504272
Ocular myasthenia 24.00 10.03 14 129857 229 31567244
Granulomatous rosacea 23.54 10.03 12 129859 148 31567325
Tubulointerstitial nephritis and uveitis syndrome 23.37 10.03 10 129861 80 31567393
Cholangitis 23.36 10.03 79 129792 7907 31559566
Gastroenteritis eosinophilic 23.33 10.03 12 129859 151 31567322
Pain 23.24 10.03 585 129286 186174 31381299
Hypophosphataemic osteomalacia 22.84 10.03 11 129860 119 31567354
Idiopathic pulmonary fibrosis 22.19 10.03 51 129820 4079 31563394
Chest pain 21.93 10.03 631 129240 116326 31451147
Overlap syndrome 21.89 10.03 10 129861 95 31567378
Brain scan abnormal 21.86 10.03 22 129849 836 31566637
Device dependence 21.84 10.03 8 129863 40 31567433
Renal cyst 21.82 10.03 80 129791 8336 31559137
Cardiac failure 21.50 10.03 482 129389 85471 31482002
Hyperchlorhydria 21.25 10.03 19 129852 621 31566852
Dermatitis bullous 21.19 10.03 65 129806 6180 31561293
Peripheral swelling 21.15 10.03 177 129694 67688 31499785
Dyspepsia 21.06 10.03 215 129656 32338 31535135
Ureteric compression 21.01 10.03 13 129858 238 31567235
Contraindicated product administered 20.24 10.03 31 129840 19741 31547732
Hyperthermia 20.23 10.03 88 129783 9916 31557557
Radiation pneumonitis 20.08 10.03 36 129835 2408 31565065
Acute pulmonary oedema 19.83 10.03 69 129802 7007 31560466
Gastric cancer 19.66 10.03 62 129809 5983 31561490
Helicobacter test positive 19.64 10.03 20 129851 771 31566702
Adverse drug reaction 19.28 10.03 47 129824 25154 31542319
Plasma cell myeloma 19.21 10.03 144 129727 56387 31511086
Injection site pain 19.10 10.03 75 129796 34559 31532914
Low birth weight baby 18.80 10.03 3 129868 6967 31560506
Acute generalised exanthematous pustulosis 18.78 10.03 61 129810 5979 31561494
Therapy interrupted 18.74 10.03 10 129861 10586 31556887
Cross sensitivity reaction 18.64 10.03 25 129846 1298 31566175
Occupational exposure to air contaminants 18.57 10.03 10 129861 139 31567334
Cardiac aneurysm 18.38 10.03 20 129851 833 31566640
Fixed eruption 18.28 10.03 26 129845 1427 31566046
Mitral valve incompetence 18.23 10.03 109 129762 13924 31553549
Phaeochromocytoma malignant 17.89 10.03 8 129863 72 31567401
Premature baby 17.85 10.03 29 129842 18037 31549436
Hepatic haematoma 17.83 10.03 14 129857 381 31567092
Hyperkaliuria 17.73 10.03 9 129862 110 31567363
Multiple sclerosis relapse 17.72 10.03 14 129857 12033 31555440
Acute coronary syndrome 17.69 10.03 101 129770 12688 31554785
Circumoral oedema 17.66 10.03 7 129864 45 31567428
Cardiac arrest 17.51 10.03 258 129613 88804 31478669
Febrile bone marrow aplasia 17.41 10.03 71 129800 7775 31559698
Craniotabes 17.40 10.03 5 129866 9 31567464
Hypoparathyroidism 17.34 10.03 16 129855 545 31566928
Hospitalisation 17.34 10.03 126 129745 49681 31517792
Duodenal polyp 17.33 10.03 11 129860 211 31567262
Respiratory distress 17.32 10.03 212 129659 33341 31534132
Haematotoxicity 17.29 10.03 4 129867 7133 31560340
Pathogen resistance 17.26 10.03 7 129864 8694 31558779
Helicobacter gastritis 17.25 10.03 23 129848 1187 31566286
Carotid arteriosclerosis 17.23 10.03 28 129843 1729 31565744
Inappropriate antidiuretic hormone secretion 17.13 10.03 92 129779 11295 31556178
Essential hypertension 17.04 10.03 35 129836 2592 31564881
Type III immune complex mediated reaction 16.68 10.03 12 129859 285 31567188
Myelosuppression 16.65 10.03 22 129849 14898 31552575
Anaemia 16.59 10.03 1050 128821 212472 31355001
Anticoagulation drug level increased 16.51 10.03 15 129856 501 31566972
Oesophagitis ulcerative 16.45 10.03 17 129854 667 31566806
Weight increased 16.40 10.03 240 129631 82707 31484766
Xerosis 16.38 10.03 15 129856 506 31566967
Nerve degeneration 16.36 10.03 10 129861 179 31567294
Joint swelling 16.36 10.03 140 129731 53291 31514182
Abdominal pain upper 16.34 10.03 360 129511 63642 31503831
Vitamin B12 deficiency 16.27 10.03 41 129830 3478 31563995
Aggression 16.25 10.03 88 129783 37203 31530270
Dermatitis exfoliative 16.23 10.03 61 129810 6431 31561042
Hypovitaminosis 16.21 10.03 15 129856 513 31566960
Ischaemic stroke 16.13 10.03 122 129749 16849 31550624
Duodenitis 16.12 10.03 46 129825 4202 31563271
Sudden death 16.11 10.03 108 129763 14349 31553124
Neurotoxicity 16.08 10.03 26 129845 16200 31551273
Hepatitis 15.86 10.03 149 129722 21917 31545556
Cardiac failure congestive 15.59 10.03 230 129641 79157 31488316
Respiratory depression 15.59 10.03 22 129849 14488 31552985
Carotid artery stenosis 15.40 10.03 48 129823 4604 31562869
Poisoning 15.38 10.03 12 129859 10379 31557094
Eosinophilic oesophagitis 15.37 10.03 11 129860 259 31567214
Brief psychotic disorder with marked stressors 15.30 10.03 10 129861 202 31567271
Loss of personal independence in daily activities 15.13 10.03 62 129809 28226 31539247
Nipple swelling 15.06 10.03 8 129863 108 31567365
Neuroleptic malignant syndrome 14.94 10.03 29 129842 16840 31550633
Hyperkinetic heart syndrome 14.93 10.03 8 129863 110 31567363
Cerebral artery thrombosis 14.92 10.03 17 129854 746 31566727
Lethargy 14.82 10.03 95 129776 38546 31528927
Immune-mediated hepatic disorder 14.78 10.03 15 129856 576 31566897
Intentional product misuse 14.71 10.03 93 129778 37858 31529615
Jaundice cholestatic 14.68 10.03 46 129825 4424 31563049
Hypotension 14.66 10.03 687 129184 203931 31363542
Eructation 14.65 10.03 44 129827 4135 31563338
Venoocclusive liver disease 14.64 10.03 6 129865 7406 31560067
Gastritis 14.58 10.03 137 129734 20155 31547318
Hepatic encephalopathy 14.56 10.03 101 129770 13570 31553903
Tachycardia 14.55 10.03 222 129649 75985 31491488
Renal haemangioma 14.54 10.03 5 129866 20 31567453
Sensitisation 14.53 10.03 9 129862 165 31567308
Antiphospholipid antibodies positive 14.34 10.03 11 129860 289 31567184
Haematoma muscle 14.31 10.03 21 129850 1186 31566287
High frequency ablation 14.30 10.03 9 129862 170 31567303
Coronary artery stenosis 14.26 10.03 73 129798 8797 31558676
Prurigo 14.18 10.03 15 129856 605 31566868
Fatigue 14.15 10.03 1182 128689 334024 31233449
Peripheral venous disease 14.12 10.03 31 129840 2405 31565068
Immune reconstitution inflammatory syndrome 14.05 10.03 8 129863 8170 31559303
Psoriasis 14.04 10.03 123 129748 46596 31520877
Ventricular arrhythmia 13.97 10.03 48 129823 4843 31562630
No adverse event 13.93 10.03 38 129833 19587 31547886
Ventricular enlargement 13.89 10.03 13 129858 451 31567022
Blood alkaline phosphatase increased 13.89 10.03 183 129688 29270 31538203
Accidental exposure to product 13.83 10.03 16 129855 11479 31555994
Fracture delayed union 13.81 10.03 6 129865 50 31567423
Psychotic disorder 13.79 10.03 46 129825 22247 31545226
Echocardiogram abnormal 13.76 10.03 18 129853 912 31566561
Mucormycosis 13.74 10.03 3 129868 5567 31561906
Essential tremor 13.74 10.03 16 129855 719 31566754
Pancreatitis 13.59 10.03 214 129657 35557 31531916
Benign abdominal neoplasm 13.55 10.03 7 129864 89 31567384
Oesophageal adenocarcinoma 13.52 10.03 17 129854 828 31566645
Muscle haemorrhage 13.51 10.03 38 129833 3442 31564031
Bronchial injury 13.51 10.03 3 129868 0 31567473
Acquired cystic kidney disease 13.51 10.03 3 129868 0 31567473
Stevens-Johnson syndrome 13.35 10.03 119 129752 17253 31550220
Oesophageal dilatation 13.35 10.03 8 129863 138 31567335
Cancer pain 13.30 10.03 31 129840 2502 31564971
Antibody test abnormal 13.15 10.03 9 129862 197 31567276
Thrombocytopenic purpura 13.07 10.03 19 129852 1064 31566409
Neutropenic sepsis 13.07 10.03 19 129852 12360 31555113
Prostatitis Escherichia coli 13.04 10.03 5 129866 29 31567444
Cataract 12.98 10.03 152 129719 23655 31543818
Chest expansion decreased 12.90 10.03 8 129863 147 31567326
Poisoning deliberate 12.88 10.03 7 129864 7337 31560136
Rebound acid hypersecretion 12.83 10.03 7 129864 100 31567373
Synovitis 12.82 10.03 19 129852 12264 31555209
Sepsis 12.77 10.03 501 129370 151428 31416045
Myoglobinaemia 12.71 10.03 7 129864 102 31567371
Urticaria papular 12.70 10.03 6 129865 62 31567411
Excessive cerumen production 12.61 10.03 10 129861 276 31567197
Oesophageal candidiasis 12.52 10.03 41 129830 4036 31563437
Bladder cancer 12.45 10.03 26 129845 14699 31552774
Renal atrophy 12.39 10.03 19 129852 1116 31566357
Drug dependence 12.38 10.03 49 129822 22530 31544943
Renal tubular disorder 12.35 10.03 43 129828 4367 31563106
Psoriatic arthropathy 12.32 10.03 41 129830 19842 31547631
Physical examination abnormal 12.22 10.03 10 129861 289 31567184
Dyspnoea at rest 12.21 10.03 37 129834 3494 31563979
Hyperparathyroidism secondary 12.19 10.03 22 129849 1479 31565994
Aortic valve incompetence 12.18 10.03 50 129821 5491 31561982
Suicide attempt 12.12 10.03 96 129775 37152 31530321
Progressive multifocal leukoencephalopathy 12.00 10.03 12 129859 9201 31558272
Renal mass 11.99 10.03 23 129848 1620 31565853
Cholecystitis 11.96 10.03 75 129796 9742 31557731
Prostate cancer 11.74 10.03 98 129773 37503 31529970
Malnutrition 11.71 10.03 84 129787 11409 31556064
Oedema peripheral 11.64 10.03 556 129315 109283 31458190
Pulmonary valve disease 11.57 10.03 10 129861 312 31567161
Oral pustule 11.55 10.03 9 129862 242 31567231
Febrile neutropenia 11.54 10.03 396 129475 121453 31446020
Hepatotoxicity 11.47 10.03 40 129831 19086 31548387
Cutaneous vasculitis 11.45 10.03 37 129834 3617 31563856
Exposure during pregnancy 11.43 10.03 11 129860 8587 31558886
Respiratory arrest 11.42 10.03 62 129809 26195 31541278
Intestinal obstruction 11.42 10.03 132 129739 20478 31546995
Microcytic anaemia 11.40 10.03 26 129845 2069 31565404
Crohn's disease 11.39 10.03 40 129831 4081 31563392
Erythema of eyelid 11.17 10.03 15 129856 780 31566693
Sacroiliitis 11.15 10.03 20 129851 1338 31566135
Rash 11.15 10.03 694 129177 200792 31366681
Dialysis 11.10 10.03 78 129793 10525 31556948
Septic arthritis staphylococcal 11.09 10.03 12 129859 497 31566976
Food interaction 11.08 10.03 16 129855 891 31566582
Cardiorenal syndrome 11.06 10.03 14 129857 686 31566787
Lumbar radiculopathy 11.03 10.03 15 129856 789 31566684
Thrombotic cerebral infarction 11.00 10.03 10 129861 334 31567139
Carbohydrate antigen 19-9 increased 10.94 10.03 8 129863 195 31567278
Bronchomalacia 10.92 10.03 6 129865 87 31567386
Heat stroke 10.91 10.03 16 129855 903 31566570
Laboratory test abnormal 10.85 10.03 40 129831 18774 31548699
Enterochromaffin cell hyperplasia 10.76 10.03 4 129867 21 31567452
Wheezing 10.70 10.03 95 129776 35891 31531582
Unresponsive to stimuli 10.64 10.03 62 129809 25738 31541735
Musculoskeletal stiffness 10.63 10.03 113 129758 41212 31526261
Pericarditis 10.63 10.03 70 129801 9246 31558227
Anal erosion 10.61 10.03 4 129867 22 31567451
Hypotrichosis 10.61 10.03 4 129867 22 31567451
Drug interaction 10.60 10.03 992 128879 207551 31359922
Oesophagitis 10.56 10.03 87 129784 12329 31555144
Abnormal behaviour 10.51 10.03 56 129815 23772 31543701
Nephropathy toxic 10.51 10.03 19 129852 11334 31556139
Coombs negative haemolytic anaemia 10.44 10.03 7 129864 148 31567325
Bicytopenia 10.36 10.03 25 129846 2064 31565409
Injection site reaction 10.34 10.03 20 129851 11631 31555842
Epstein-Barr virus infection 10.33 10.03 8 129863 6945 31560528
Hypoalbuminaemia 10.33 10.03 79 129792 10949 31556524
Barrett's oesophagus 10.31 10.03 11 129860 448 31567025
Septic shock 10.29 10.03 349 129522 65809 31501664
Rheumatoid arthritis 10.28 10.03 136 129735 47673 31519800
Microcytosis 10.27 10.03 7 129864 152 31567321
C-reactive protein abnormal 10.25 10.03 10 129861 7759 31559714
Platelet toxicity 10.23 10.03 3 129868 6 31567467
Infective exacerbation of chronic obstructive airways disease 10.20 10.03 22 129849 1686 31565787
Conjunctival ulcer 10.15 10.03 5 129866 57 31567416
Nasal crusting 10.13 10.03 10 129861 371 31567102
Diverticulum 10.13 10.03 53 129818 6441 31561032
Haemorrhage intracranial 10.13 10.03 30 129841 15058 31552415
Biliary anastomosis complication 10.09 10.03 6 129865 102 31567371
Tongue oedema 10.06 10.03 29 129842 2664 31564809

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
Chronic kidney disease 611.38 9.18 972 284446 60085 70582941
Completed suicide 421.77 9.18 193 285225 226942 70416084
Drug ineffective 408.14 9.18 2175 283243 937577 69705449
Toxicity to various agents 323.48 9.18 657 284761 381515 70261511
Gastrooesophageal reflux disease 318.70 9.18 945 284473 89894 70553132
Hepatocellular injury 316.45 9.18 622 284796 45469 70597557
Cholestasis 301.20 9.18 623 284795 47249 70595777
Acute kidney injury 296.04 9.18 3063 282355 471561 70171465
Interstitial lung disease 293.32 9.18 1008 284410 103677 70539349
Synovitis 270.73 9.18 91 285327 129137 70513889
Off label use 268.44 9.18 1821 283597 741239 69901787
Pemphigus 266.68 9.18 17 285401 83019 70560007
Death 236.00 9.18 1153 284265 508908 70134118
Anti-cyclic citrullinated peptide antibody positive 229.53 9.18 13 285405 70172 70572854
End stage renal disease 228.14 9.18 252 285166 10881 70632145
Drug abuse 223.41 9.18 160 285258 147096 70495930
Hand deformity 215.26 9.18 43 285375 86439 70556587
Maternal exposure during pregnancy 200.37 9.18 107 285311 115238 70527788
Glossodynia 195.43 9.18 53 285365 86434 70556592
Systemic lupus erythematosus 180.74 9.18 92 285326 101810 70541216
Toxic skin eruption 178.79 9.18 304 285114 19858 70623168
Carotid artery thrombosis 173.35 9.18 115 285303 2431 70640595
Duodenal ulcer perforation 171.77 9.18 8 285410 51104 70591922
Eosinophilia 166.38 9.18 445 284973 39874 70603152
Neurologic neglect syndrome 165.64 9.18 109 285309 2272 70640754
Wound 159.50 9.18 100 285318 98632 70544394
Alopecia 153.78 9.18 358 285060 198132 70444894
Agranulocytosis 153.58 9.18 432 284986 39866 70603160
Hypomagnesaemia 150.49 9.18 432 284986 40332 70602694
Hyponatraemia 147.39 9.18 1126 284292 158961 70484065
Product use in unapproved indication 144.61 9.18 395 285023 207083 70435943
Arthropathy 142.63 9.18 240 285178 149817 70493209
Pericarditis 142.14 9.18 82 285336 84623 70558403
Hemiplegia 141.45 9.18 223 285195 13672 70629354
Cholecystitis chronic 140.58 9.18 181 285237 9195 70633831
Contraindicated product administered 137.69 9.18 205 285213 134407 70508619
Hypocalcaemia 135.34 9.18 443 284975 44416 70598610
Treatment failure 134.74 9.18 233 285185 143909 70499117
Rheumatoid factor positive 129.30 9.18 20 285398 48380 70594646
Drug intolerance 128.92 9.18 470 284948 225217 70417809
Adjustment disorder 127.75 9.18 104 285314 3040 70639986
Joint swelling 125.30 9.18 558 284860 252653 70390373
Rheumatoid arthritis 124.29 9.18 678 284740 291127 70351899
Renal failure 124.00 9.18 1234 284184 187836 70455190
Personality disorder 123.15 9.18 131 285287 5417 70637609
Sensitisation 118.15 9.18 90 285328 2383 70640643
Tubulointerstitial nephritis 114.87 9.18 343 285075 32733 70610293
Renal injury 112.62 9.18 219 285199 15875 70627151
Helicobacter infection 111.72 9.18 42 285376 55614 70587412
Rash maculo-papular 111.64 9.18 451 284967 50094 70592932
Discomfort 110.33 9.18 158 285260 105278 70537748
Infusion related reaction 109.12 9.18 417 285001 197117 70445909
Intentional product use issue 107.07 9.18 200 285218 119942 70523084
Biliary dyskinesia 105.24 9.18 83 285335 2316 70640710
Folliculitis 102.16 9.18 23 285395 42547 70600479
Muscle injury 98.19 9.18 18 285400 38476 70604550
Polycystic ovaries 98.17 9.18 86 285332 2786 70640240
Drug reaction with eosinophilia and systemic symptoms 97.40 9.18 477 284941 57536 70585490
Peripheral swelling 96.70 9.18 557 284861 236006 70407020
Exposure during pregnancy 93.21 9.18 130 285288 87587 70555439
Swelling 92.32 9.18 417 285001 188122 70454904
Dysphagia 88.82 9.18 766 284652 112068 70530958
Ejection fraction 88.34 9.18 66 285352 1696 70641330
Hepatic enzyme increased 83.75 9.18 336 285082 156654 70486372
Nephrogenic anaemia 83.10 9.18 87 285331 3531 70639495
Gamma-glutamyltransferase increased 78.92 9.18 408 285010 50277 70592749
Psoriatic arthropathy 78.23 9.18 87 285331 64684 70578342
Gastric polyps 78.10 9.18 82 285336 3339 70639687
Drug resistance 78.03 9.18 28 285390 38162 70604864
Inappropriate antidiuretic hormone secretion 77.65 9.18 238 285180 23038 70619988
Hepatic cytolysis 77.33 9.18 210 285208 18982 70624044
Therapeutic product effect decreased 75.71 9.18 307 285111 142711 70500315
Pancreatitis acute 75.31 9.18 371 285047 44853 70598173
Rhinitis allergic 74.41 9.18 134 285284 9161 70633865
Hypertensive nephropathy 73.23 9.18 45 285373 829 70642197
C-reactive protein abnormal 72.73 9.18 32 285386 38547 70604479
Abdominal pain upper 71.76 9.18 1136 284282 192466 70450560
Hiatus hernia 71.35 9.18 217 285201 20917 70622109
Affect lability 68.49 9.18 136 285282 10010 70633016
Intentional overdose 68.08 9.18 188 285230 98247 70544779
Motor dysfunction 67.32 9.18 157 285261 12913 70630113
COVID-19 66.62 9.18 211 285207 105546 70537480
Hypergastrinaemia 66.59 9.18 26 285392 163 70642863
Fatigue 65.60 9.18 2683 282735 821636 69821390
Vascular purpura 64.81 9.18 67 285351 2679 70640347
Acute generalised exanthematous pustulosis 64.58 9.18 171 285247 15226 70627800
Gastritis 63.33 9.18 350 285068 44241 70598785
Hypokalaemia 62.27 9.18 804 284614 130384 70512642
Sleep disorder due to general medical condition, insomnia type 62.24 9.18 33 285385 35699 70607327
Coordination abnormal 60.97 9.18 172 285246 15894 70627132
Lung disorder 60.70 9.18 483 284935 69001 70574025
Product use issue 58.74 9.18 453 284965 179484 70463542
Bronchial neoplasm 57.22 9.18 31 285387 445 70642581
Cholestatic liver injury 57.13 9.18 77 285341 4091 70638935
Therapy non-responder 56.92 9.18 142 285276 76773 70566253
Sensory loss 55.38 9.18 134 285284 11285 70631741
Irritable bowel syndrome 54.38 9.18 75 285343 50775 70592251
Systemic lupus erythematosus rash 54.18 9.18 48 285370 1579 70641447
Jaundice 53.88 9.18 366 285052 49742 70593284
Nephrectomy 51.85 9.18 49 285369 1754 70641272
Pain 51.57 9.18 2039 283379 626777 70016249
Anaemia 51.56 9.18 2048 283370 401375 70241651
Blister 51.20 9.18 219 285199 100307 70542719
Dermatitis bullous 50.81 9.18 139 285279 12618 70630408
Cross sensitivity reaction 50.36 9.18 66 285352 3412 70639614
Hypothyroidism 50.27 9.18 336 285082 45419 70597607
Condition aggravated 50.02 9.18 1324 284094 426311 70216715
Hyperkalaemia 49.63 9.18 651 284767 105940 70537086
Pancreatitis 49.59 9.18 426 284992 62242 70580784
Hypersensitivity 48.61 9.18 642 284776 229170 70413856
Gallbladder disorder 48.20 9.18 169 285249 17543 70625483
Lower respiratory tract infection 48.13 9.18 259 285159 111654 70531372
Loss of employment 47.78 9.18 52 285366 2207 70640819
Presbyacusis 47.77 9.18 56 285362 2581 70640445
Thrombocytopenia 47.69 9.18 1280 284138 237830 70405196
Epigastric discomfort 47.68 9.18 96 285322 7137 70635889
Nephropathy 47.65 9.18 108 285310 8717 70634309
Pregnancy 47.63 9.18 18 285400 23763 70619263
Hepatitis cholestatic 47.59 9.18 135 285283 12515 70630511
Cell death 46.39 9.18 70 285348 4130 70638896
Mobility decreased 45.06 9.18 237 285181 102762 70540264
Hepatojugular reflux 44.98 9.18 29 285389 583 70642443
Rhabdomyolysis 44.64 9.18 585 284833 95175 70547851
Ill-defined disorder 43.75 9.18 97 285321 54644 70588382
Eating disorder 43.68 9.18 169 285249 18396 70624630
Device expulsion 42.65 9.18 18 285400 22228 70620798
Sedation complication 42.30 9.18 3 285415 13407 70629619
Angina pectoris 42.08 9.18 336 285082 48047 70594979
Knee arthroplasty 41.50 9.18 46 285372 34255 70608771
Pleural thickening 41.41 9.18 54 285364 2778 70640248
Abdominal discomfort 41.01 9.18 612 284806 214046 70428980
Diabetic nephropathy 40.74 9.18 53 285365 2720 70640306
Sleep apnoea syndrome 40.74 9.18 248 285170 32465 70610561
Hip arthroplasty 40.52 9.18 32 285386 28008 70615018
Therapy interrupted 40.21 9.18 25 285393 24777 70618249
Nasal turbinate hypertrophy 40.16 9.18 27 285391 584 70642442
Carpal tunnel syndrome 39.91 9.18 155 285263 16902 70626124
Cholecystitis 39.72 9.18 177 285241 20524 70622502
Mixed liver injury 38.90 9.18 81 285337 6168 70636858
Bone erosion 38.90 9.18 7 285411 15166 70627860
Therapeutic response decreased 38.67 9.18 114 285304 58339 70584687
Aphasia 38.52 9.18 302 285116 42947 70600079
Gallbladder injury 38.39 9.18 34 285384 1118 70641908
Iron deficiency anaemia 38.21 9.18 189 285229 22883 70620143
Occult blood 38.08 9.18 38 285380 1456 70641570
Pleural fibrosis 37.47 9.18 63 285355 4076 70638950
Degenerative mitral valve disease 37.34 9.18 19 285399 238 70642788
Cardiac failure 37.29 9.18 797 284621 142744 70500282
Premature delivery 36.63 9.18 20 285398 21284 70621742
Dyspepsia 36.57 9.18 532 284886 88545 70554481
Poisoning 36.40 9.18 23 285395 22599 70620427
Neutropenic sepsis 36.31 9.18 28 285390 24802 70618224
Device dependence 35.93 9.18 12 285406 44 70642982
Hemiparesis 35.72 9.18 233 285185 31236 70611790
Injection site pain 35.66 9.18 302 285116 117317 70525709
Musculoskeletal stiffness 35.30 9.18 402 285016 147358 70495668
Cardiac arrest 35.08 9.18 443 284975 159391 70483635
Face oedema 34.91 9.18 199 285219 25440 70617586
Accidental exposure to product 34.62 9.18 37 285381 28014 70615012
Stomatitis 34.61 9.18 340 285078 128171 70514855
Endometrial ablation 34.58 9.18 28 285390 812 70642214
Nasopharyngitis 34.16 9.18 659 284759 221547 70421479
Eczema 34.11 9.18 243 285175 33538 70609488
Myelosuppression 33.72 9.18 43 285375 30102 70612924
Haematotoxicity 33.60 9.18 7 285411 13667 70629359
Red blood cell sedimentation rate abnormal 33.36 9.18 18 285400 19285 70623741
Blood magnesium increased 33.27 9.18 53 285365 3278 70639748
Osteosclerosis 33.02 9.18 56 285362 3649 70639377
Cholangitis 33.00 9.18 112 285306 11437 70631589
Neurotoxicity 32.89 9.18 43 285375 29783 70613243
Muscle haemorrhage 32.88 9.18 73 285345 5811 70637215
Weight increased 32.74 9.18 734 284684 241597 70401429
Drug hypersensitivity 32.67 9.18 805 284613 261654 70381372
Nephritic syndrome 32.57 9.18 19 285399 317 70642709
Disease progression 31.91 9.18 441 284977 156231 70486795
Drug ineffective for unapproved indication 31.86 9.18 67 285351 38471 70604555
Tenosynovitis stenosans 31.83 9.18 43 285375 2290 70640736
Sudden death 31.71 9.18 168 285250 20896 70622130
Chronic kidney disease-mineral and bone disorder 31.17 9.18 24 285394 646 70642380
Hepatitis 30.69 9.18 322 285096 49658 70593368
Electrocardiogram Q wave abnormal 30.17 9.18 22 285396 544 70642482
Urate nephropathy 30.09 9.18 14 285404 142 70642884
Chest pain 30.07 9.18 1267 284151 249993 70393033
Cholelithiasis 30.02 9.18 307 285111 47033 70595993
Arterial occlusive disease 29.49 9.18 83 285335 7659 70635367
Phlebitis 29.42 9.18 86 285332 8108 70634918
Drug interaction 29.39 9.18 1844 283574 379597 70263429
Occupational dermatitis 29.10 9.18 13 285405 119 70642907
Post transplant lymphoproliferative disorder 28.99 9.18 4 285414 10541 70632485
Anaemia macrocytic 28.85 9.18 64 285354 5091 70637935
Malnutrition 28.53 9.18 159 285259 20158 70622868
Bronchial haemorrhage 28.27 9.18 30 285388 1237 70641789
Dry eye 27.97 9.18 224 285194 32058 70610968
Eosinophilic fasciitis 27.96 9.18 16 285402 257 70642769
Respiratory arrest 27.76 9.18 117 285301 53816 70589210
Medication error 27.75 9.18 126 285292 56786 70586240
Muscle contractions involuntary 27.71 9.18 49 285369 3302 70639724
Oesophagitis ulcerative 27.53 9.18 26 285392 930 70642096
Palpitations 27.50 9.18 611 284807 110142 70532884
Rash 27.46 9.18 1729 283689 508833 70134193
Gastric disorder 27.14 9.18 228 285190 33094 70609932
Adverse drug reaction 26.67 9.18 117 285301 53227 70589799
Abdominal pain 26.54 9.18 1655 283763 340472 70302554
Respiratory distress 26.36 9.18 336 285082 54314 70588712
Synovial fluid analysis 26.34 9.18 35 285383 1834 70641192
Muscle spasticity 26.27 9.18 152 285266 19537 70623489
Respiratory depression 26.17 9.18 37 285381 24794 70618232
Gallbladder polyp 26.15 9.18 25 285393 908 70642118
Hepatotoxicity 26.14 9.18 90 285328 43896 70599130
Erythema dyschromicum perstans 26.12 9.18 10 285408 59 70642967
Eosinophilic colitis 25.85 9.18 18 285400 413 70642613
Pulmonary vascular disorder 25.68 9.18 25 285393 929 70642097
Bronchial disorder 25.67 9.18 39 285379 2315 70640711
Ventricular hypokinesia 25.57 9.18 82 285336 8130 70634896
Injection site erythema 25.50 9.18 180 285238 72744 70570282
Blood alkaline phosphatase increased 25.41 9.18 353 285065 58168 70584858
Renal disorder 25.32 9.18 249 285169 37760 70605266
Neuroleptic malignant syndrome 25.24 9.18 41 285377 25966 70617060
Live birth 25.08 9.18 12 285406 13767 70629259
Laboratory test abnormal 24.79 9.18 41 285377 25782 70617244
Anxiety 24.79 9.18 1104 284314 219226 70423800
Idiopathic pulmonary fibrosis 24.68 9.18 58 285360 4793 70638233
Drug dependence 24.53 9.18 73 285345 37248 70605778
Hyperthermia 24.44 9.18 132 285286 16539 70626487
Hypoparathyroidism 24.40 9.18 25 285393 989 70642037
Tetany 24.09 9.18 37 285381 2217 70640809
Nicotine dependence 24.05 9.18 23 285395 836 70642190
Product dose omission issue 23.89 9.18 679 284739 216789 70426237
Inferior vena cava dilatation 23.74 9.18 22 285396 768 70642258
Lip oedema 23.41 9.18 62 285356 5521 70637505
Febrile bone marrow aplasia 23.36 9.18 103 285315 11888 70631138
Aggression 23.18 9.18 108 285310 48338 70594688
Dermatitis exfoliative 23.17 9.18 94 285324 10457 70632569
Sinus congestion 23.10 9.18 134 285284 17239 70625787
Oesophagitis 22.90 9.18 163 285255 22489 70620537
Caesarean section 22.89 9.18 9 285409 11598 70631428
Pancreatic neuroendocrine tumour 22.70 9.18 20 285398 653 70642373
Renal cyst 22.58 9.18 110 285308 13235 70629791
Bunion operation 22.44 9.18 22 285396 825 70642201
Nephrosclerosis 22.39 9.18 31 285387 1690 70641336
Acute coronary syndrome 22.38 9.18 148 285270 19931 70623095
Pyelocaliectasis 22.37 9.18 22 285396 828 70642198
Cerebral haematoma 22.37 9.18 73 285345 7305 70635721
Axonal neuropathy 22.33 9.18 33 285385 1911 70641115
Deafness neurosensory 22.29 9.18 68 285350 6564 70636462
Mucormycosis 22.13 9.18 3 285415 8011 70635015
Injection site pruritus 22.12 9.18 82 285336 39128 70603898
Sleep disorder due to a general medical condition 21.96 9.18 92 285326 10384 70632642
Ejection fraction abnormal 21.81 9.18 31 285387 1732 70641294
Vitamin B12 deficiency 21.75 9.18 63 285355 5909 70637117
Cardiac disorder 21.74 9.18 348 285070 59067 70583959
Systolic dysfunction 21.71 9.18 45 285373 3416 70639610
Bone cyst 21.20 9.18 40 285378 2834 70640192
Injection site bruising 21.16 9.18 80 285338 37952 70605074
Ureteric compression 21.13 9.18 13 285405 240 70642786
Carotid artery stenosis 21.06 9.18 77 285341 8159 70634867
Hepatic haematoma 20.99 9.18 21 285397 807 70642219
Eyelid oedema 20.89 9.18 104 285314 12623 70630403
Radiation pneumonitis 20.84 9.18 46 285372 3647 70639379
Respiratory tract congestion 20.83 9.18 132 285286 17521 70625505
Hyperchlorhydria 20.72 9.18 31 285387 1815 70641211
Mesenteric panniculitis 20.71 9.18 13 285405 249 70642777
Pathogen resistance 20.69 9.18 14 285404 13265 70629761
Hyperparathyroidism secondary 20.63 9.18 37 285381 2521 70640505
Contusion 20.50 9.18 377 285041 127659 70515367
Hyperlipidaemia 20.35 9.18 165 285253 23698 70619328
Scleritis 20.31 9.18 45 285373 3577 70639449
Hypovitaminosis 20.29 9.18 23 285395 1022 70642004
Abortion spontaneous 20.28 9.18 48 285370 26431 70616595
Infection 20.25 9.18 670 284748 210115 70432911
Rectosigmoid cancer 20.13 9.18 13 285405 262 70642764
Fall 20.13 9.18 2061 283357 442035 70200991
Ocular myasthenia 20.02 9.18 15 285403 387 70642639
Granulomatous rosacea 20.02 9.18 12 285406 211 70642815
Hepatic encephalopathy 20.00 9.18 155 285263 21963 70621063
Renal tubular disorder 19.94 9.18 62 285356 6048 70636978
Impaired healing 19.92 9.18 197 285221 74177 70568849
Deformity 19.91 9.18 76 285342 8221 70634805
Campylobacter colitis 19.74 9.18 7 285411 32 70642994
Arthralgia 19.66 9.18 1751 283667 501639 70141387
Injection site swelling 19.60 9.18 98 285320 43059 70599967
Rebound acid hypersecretion 19.46 9.18 9 285409 90 70642936
Obesity 19.35 9.18 50 285368 26721 70616305
Bicytopenia 19.25 9.18 47 285371 3981 70639045
Unresponsive to stimuli 19.24 9.18 126 285292 51805 70591221
Osteopenia 19.18 9.18 124 285294 16573 70626453
Drug eruption 19.12 9.18 243 285175 39253 70603773
Helicobacter test positive 19.01 9.18 24 285394 1195 70641831
Acute graft versus host disease in skin 18.94 9.18 3 285415 7134 70635892
Acute pulmonary oedema 18.86 9.18 105 285313 13307 70629719
Colitis microscopic 18.81 9.18 79 285339 8926 70634100
Febrile neutropenia 18.79 9.18 653 284765 203665 70439361
Occupational exposure to air contaminants 18.74 9.18 10 285408 139 70642887
Stevens-Johnson syndrome 18.71 9.18 224 285194 35683 70607343
Duodenal polyp 18.68 9.18 13 285405 298 70642728
Dialysis 18.64 9.18 127 285291 17275 70625751
Heat stroke 18.63 9.18 27 285391 1536 70641490
Haematoma 18.63 9.18 286 285132 48132 70594894
Genital infection female 18.63 9.18 8 285410 66 70642960
Gastric antral vascular ectasia 18.59 9.18 20 285398 838 70642188
Impaired work ability 18.56 9.18 121 285297 16219 70626807
Immune reconstitution inflammatory syndrome 18.55 9.18 15 285403 12975 70630051
Mucosal inflammation 18.47 9.18 179 285239 67671 70575355
Bradypnoea 18.37 9.18 56 285362 5403 70637623
Therapy partial responder 18.32 9.18 14 285404 12460 70630566
Type I hypersensitivity 18.32 9.18 44 285374 3688 70639338
Dystonia 18.26 9.18 32 285386 19674 70623352
Disability 18.23 9.18 20 285398 14963 70628063
Essential hypertension 18.22 9.18 56 285362 5428 70637598
Thrombocytopenic purpura 18.17 9.18 33 285385 2271 70640755
Hepatic function abnormal 18.12 9.18 379 285039 67617 70575409
Renal tubular necrosis 18.05 9.18 157 285261 23014 70620012
Phaeochromocytoma malignant 18.03 9.18 8 285410 72 70642954
Brain scan abnormal 18.01 9.18 23 285395 1159 70641867
Suicide attempt 17.95 9.18 219 285199 79291 70563735
Transient ischaemic attack 17.91 9.18 272 285146 45672 70597354
Electric shock 17.81 9.18 23 285395 1172 70641854
Type III immune complex mediated reaction 17.75 9.18 17 285401 619 70642407
Ischaemic stroke 17.73 9.18 196 285222 30624 70612402
Angina bullosa haemorrhagica 17.70 9.18 11 285407 207 70642819
Immunodeficiency 17.68 9.18 27 285391 17528 70625498
Eructation 17.64 9.18 82 285336 9678 70633348
Chronic graft versus host disease 17.63 9.18 3 285415 6767 70636259
Kidney infection 17.40 9.18 136 285282 19319 70623707
Chronic cutaneous lupus erythematosus 17.33 9.18 13 285405 336 70642690
Fear of injection 17.28 9.18 3 285415 6669 70636357
Burning sensation 17.27 9.18 304 285114 52566 70590460
Hyperkinetic heart syndrome 17.26 9.18 9 285409 119 70642907
Cataract 17.13 9.18 317 285101 55328 70587698
Crepitations 17.09 9.18 75 285343 8639 70634387
Memory impairment 17.03 9.18 266 285152 92375 70550651
Angina unstable 17.03 9.18 116 285302 15777 70627249
Venoocclusive liver disease 16.98 9.18 11 285407 10667 70632359
Synovial cyst 16.96 9.18 75 285343 8667 70634359
Carotid arteriosclerosis 16.95 9.18 33 285385 2394 70640632
Eye injury 16.92 9.18 27 285391 1672 70641354
Rash scarlatiniform 16.85 9.18 11 285407 226 70642800
Nausea 16.84 9.18 3772 281646 848316 69794710
Gastric cancer 16.75 9.18 76 285342 8879 70634147
Psoriasis 16.65 9.18 287 285131 98146 70544880
Rhinitis 16.64 9.18 91 285327 11456 70631570
Hyperphosphatasaemia 16.63 9.18 8 285410 88 70642938
Pre-eclampsia 16.61 9.18 3 285415 6482 70636544
Nerve injury 16.60 9.18 72 285346 8252 70634774
Cerebellar haematoma 16.54 9.18 16 285402 590 70642436
Diverticulum 16.54 9.18 103 285315 13590 70629436
Gastroenteritis eosinophilic 16.48 9.18 11 285407 235 70642791
Tongue oedema 16.41 9.18 59 285359 6200 70636826
Prescription form tampering 16.35 9.18 13 285405 367 70642659
Nephropathy toxic 16.32 9.18 31 285387 18483 70624543
Cardiac aneurysm 16.31 9.18 24 285394 1384 70641642
Helicobacter gastritis 16.27 9.18 32 285386 2339 70640687
Tachycardia 16.17 9.18 500 284918 158046 70484980
Rheumatoid nodule 16.16 9.18 110 285308 14957 70628069
Regurgitation 16.15 9.18 31 285387 2225 70640801
Premature labour 16.11 9.18 6 285412 7994 70635032
Microcytic anaemia 16 9.18 49 285369 4740 70638286
Gastrointestinal motility disorder 15.92 9.18 54 285364 5512 70637514
Gangrene 15.91 9.18 71 285347 8238 70634788
Subacute cutaneous lupus erythematosus 15.90 9.18 38 285380 3175 70639851
Creatinine renal clearance decreased 15.88 9.18 28 285390 17172 70625854
CSF volume increased 15.87 9.18 6 285412 34 70642992
Substance abuse 15.83 9.18 10 285408 9827 70633199
Nipple swelling 15.74 9.18 8 285410 100 70642926
Thrombophlebitis 15.71 9.18 56 285362 5860 70637166
Coronary artery stenosis 15.61 9.18 90 285328 11554 70631472
Nerve degeneration 15.51 9.18 11 285407 260 70642766
Schizophreniform disorder 15.43 9.18 9 285409 150 70642876
Dehydration 15.37 9.18 1082 284336 225060 70417966
Occupational exposure to product 15.31 9.18 17 285401 738 70642288
Diverticulum oesophageal 15.28 9.18 9 285409 153 70642873
Escherichia pyelonephritis 15.27 9.18 14 285404 482 70642544
Localised infection 15.23 9.18 75 285343 33083 70609943
Urticaria papular 15.23 9.18 9 285409 154 70642872
Duodenitis 15.08 9.18 62 285356 6940 70636086
Sedation 15.07 9.18 118 285300 46613 70596413
Physical examination abnormal 15.02 9.18 11 285407 274 70642752
Allergy to chemicals 15.00 9.18 28 285390 1968 70641058
Renal impairment 14.84 9.18 715 284703 143222 70499804
Gait inability 14.80 9.18 120 285298 47055 70595971
Liver disorder 14.76 9.18 338 285080 61230 70581796
High frequency ablation 14.74 9.18 11 285407 282 70642744
Psychotic disorder 14.72 9.18 90 285328 37611 70605415
Hypocapnia 14.71 9.18 15 285403 590 70642436
Purging 14.69 9.18 6 285412 43 70642983
Cerebral infarction 14.66 9.18 249 285169 42760 70600266
Septic shock 14.54 9.18 571 284847 111687 70531339
IIIrd nerve paresis 14.54 9.18 9 285409 168 70642858
Subdural haematoma 14.50 9.18 181 285237 29117 70613909
Acute hepatitis B 14.44 9.18 13 285405 437 70642589
Cutaneous lupus erythematosus 14.44 9.18 34 285384 2814 70640212
Cardiotoxicity 14.34 9.18 14 285404 11056 70631970
Antinuclear antibody positive 14.32 9.18 60 285358 6773 70636253
Vulvovaginal burning sensation 14.25 9.18 21 285397 1213 70641813
Transplant dysfunction 14.23 9.18 5 285413 6904 70636122
Nasal discharge discolouration 14.17 9.18 28 285390 2053 70640973
Anticoagulation drug level increased 14.17 9.18 16 285402 708 70642318
Hunger 14.12 9.18 47 285371 4751 70638275
Oesophageal adenocarcinoma 14.12 9.18 17 285401 806 70642220
Pleuritic pain 14.11 9.18 72 285346 8825 70634201
Flatulence 14.10 9.18 224 285194 37957 70605069
Small cell carcinoma 14.10 9.18 11 285407 302 70642724
Hyperkaliuria 14.09 9.18 9 285409 178 70642848
Gastrinoma 14.08 9.18 5 285413 23 70643003
Pancreatitis chronic 14.06 9.18 40 285378 3714 70639312
Gallbladder hypofunction 14.02 9.18 13 285405 454 70642572
Coronary artery disease 13.99 9.18 341 285077 62395 70580631
Normal newborn 13.97 9.18 4 285414 6296 70636730
Therapy cessation 13.89 9.18 79 285339 33597 70609429
Haemorrhage intracranial 13.86 9.18 52 285366 24725 70618301
Bile duct stone 13.80 9.18 49 285369 5117 70637909
Cardiorenal syndrome 13.76 9.18 23 285395 1481 70641545
Nephritis allergic 13.76 9.18 15 285403 638 70642388
Blood test abnormal 13.61 9.18 103 285315 14487 70628539
Exposure to toxic agent 13.61 9.18 4 285414 6190 70636836
Loss of personal independence in daily activities 13.59 9.18 250 285168 84660 70558366
Graft versus host disease in skin 13.59 9.18 3 285415 5627 70637399
Tooth demineralisation 13.56 9.18 3 285415 0 70643026
Erosive oesophagitis 13.50 9.18 32 285386 2659 70640367
Erythema 13.41 9.18 954 284464 198609 70444417
Melaena 13.39 9.18 309 285109 56046 70586980
Injection site haemorrhage 13.37 9.18 55 285363 25472 70617554
Cognitive disorder 13.34 9.18 169 285249 60787 70582239
Haematoma muscle 13.32 9.18 29 285389 2278 70640748
Cardiothoracic ratio increased 13.24 9.18 6 285412 57 70642969
Alanine aminotransferase abnormal 13.23 9.18 8 285410 8051 70634975
Cutaneous vasculitis 13.22 9.18 61 285357 7177 70635849
Aspergillus infection 13.20 9.18 33 285385 17835 70625191
Hypotension 13.20 9.18 1425 283993 402956 70240070
Bronchopneumopathy 13.19 9.18 15 285403 669 70642357
Renal hypertension 13.14 9.18 9 285409 201 70642825
Oedema peripheral 13.11 9.18 1077 284341 227014 70416012
Gastric ulcer 13.09 9.18 190 285228 31600 70611426
Transplant rejection 13.09 9.18 34 285384 18137 70624889
Vitreous detachment 13.06 9.18 27 285391 2046 70640980
Diarrhoea 12.99 9.18 3441 281977 779900 69863126
No adverse event 12.95 9.18 76 285342 32077 70610949
Cholecystectomy 12.95 9.18 68 285350 8429 70634597
Hyperuricaemia 12.94 9.18 82 285336 10884 70632142
Gastric ulcer haemorrhage 12.86 9.18 68 285350 8450 70634576
Intentional product misuse 12.85 9.18 234 285184 79361 70563665
Uveal melanoma 12.84 9.18 4 285414 11 70643015
Pneumobilia 12.83 9.18 9 285409 209 70642817
Heart rate decreased 12.82 9.18 174 285244 61841 70581185
Renal atrophy 12.79 9.18 24 285394 1693 70641333
Pulmonary valve disease 12.74 9.18 10 285408 277 70642749
Ventricular enlargement 12.71 9.18 13 285405 513 70642513
Supraventricular extrasystoles 12.66 9.18 54 285364 6144 70636882
Pleurisy 12.65 9.18 75 285343 9724 70633302
Renal infarct 12.55 9.18 30 285388 2507 70640519
Thymus disorder 12.53 9.18 10 285408 284 70642742
Graft versus host disease 12.52 9.18 26 285392 14997 70628029
Circumoral oedema 12.50 9.18 10 285408 285 70642741
Angiopathy 12.48 9.18 56 285362 6511 70636515
Seizure 12.44 9.18 587 284831 177375 70465651
Blood lactic acid increased 12.43 9.18 16 285402 11157 70631869
Adverse event 12.43 9.18 133 285285 49328 70593698
Parkinsonism 12.37 9.18 27 285391 15298 70627728
Schizophrenia 12.37 9.18 31 285387 16737 70626289
Adrenocorticotropic hormone deficiency 12.34 9.18 18 285400 1030 70641996
Tooth disorder 12.33 9.18 149 285269 23789 70619237
Myoglobinaemia 12.31 9.18 7 285411 111 70642915
Appendicitis 12.29 9.18 31 285387 16702 70626324
Juvenile idiopathic arthritis 12.29 9.18 4 285414 5796 70637230
Ulcer 12.27 9.18 158 285260 25596 70617430
Asthenia 12.21 9.18 2057 283361 455609 70187417
Infusion site scar 12.21 9.18 10 285408 295 70642731
Dermatophytosis of nail 12.19 9.18 8 285410 166 70642860
Drug use disorder 12.16 9.18 9 285409 8142 70634884
Prurigo 12.13 9.18 20 285398 1273 70641753
Neutrophilia 12.10 9.18 7 285411 7214 70635812
Vertigo 12.08 9.18 334 285084 62309 70580717
Dry mouth 12.03 9.18 370 285048 70087 70572939
Intestinal infarction 12.03 9.18 20 285398 1282 70641744
Inappropriate schedule of product administration 12.01 9.18 335 285083 107220 70535806
Cardiac murmur functional 11.99 9.18 5 285413 38 70642988
Cyst 11.98 9.18 90 285328 12629 70630397
Cholecystitis acute 11.95 9.18 86 285332 11908 70631118
Hypertriglyceridaemia 11.94 9.18 85 285333 11726 70631300
Device use error 11.93 9.18 6 285412 6690 70636336
Placental calcification 11.91 9.18 4 285414 15 70643011
Teeth brittle 11.85 9.18 12 285406 468 70642558
Cerebral artery thrombosis 11.83 9.18 18 285400 1070 70641956
Unintentional medical device removal 11.80 9.18 7 285411 7117 70635909
Bronchopulmonary aspergillosis 11.80 9.18 44 285374 20958 70622068
Fixed eruption 11.79 9.18 29 285389 2467 70640559
Clinically isolated syndrome 11.77 9.18 5 285413 40 70642986
Shock haemorrhagic 11.76 9.18 118 285300 17988 70625038
Lipase increased 11.72 9.18 103 285315 15143 70627883
Wrong technique in product usage process 11.72 9.18 200 285218 68498 70574528
Dermatitis exfoliative generalised 11.68 9.18 54 285364 6360 70636666
Colitis ischaemic 11.65 9.18 97 285321 14040 70628986
Tubulointerstitial nephritis and uveitis syndrome 11.65 9.18 10 285408 315 70642711
Liver function test increased 11.61 9.18 84 285334 33763 70609263
Blood gastrin increased 11.56 9.18 5 285413 42 70642984
Food interaction 11.54 9.18 22 285396 1571 70641455
Traumatic haematoma 11.54 9.18 25 285393 1957 70641069
Hypoplastic anaemia 11.51 9.18 4 285414 17 70643009
Platelet adhesiveness decreased 11.49 9.18 3 285415 3 70643023
Overdose 11.45 9.18 562 284856 169183 70473843
Vulval disorder 11.44 9.18 12 285406 488 70642538
Prothrombin time ratio decreased 11.44 9.18 15 285403 776 70642250
Haemorrhoids 11.37 9.18 155 285263 25433 70617593
Chest expansion decreased 11.36 9.18 8 285410 187 70642839
Lethargy 11.29 9.18 224 285194 75026 70568000
Anal erythema 11.29 9.18 8 285410 189 70642837
Product substitution issue 11.24 9.18 119 285299 18394 70624632
Cytomegalovirus infection 11.20 9.18 104 285314 39654 70603372
Hypoalbuminaemia 11.18 9.18 122 285296 19000 70624026
Pruritus 11.17 9.18 1570 283848 343990 70299036
Xerosis 11.16 9.18 17 285401 1011 70642015
Creatinine renal clearance abnormal 11.13 9.18 12 285406 504 70642522
Purple glove syndrome 11.12 9.18 9 285409 261 70642765
Mitral valve incompetence 11.11 9.18 160 285258 26568 70616458
Sinus disorder 11.10 9.18 121 285297 18838 70624188
Enterochromaffin cell hyperplasia 11.08 9.18 6 285412 86 70642940
Hypoparathyroidism secondary 11.04 9.18 8 285410 196 70642830
Blood thyroid stimulating hormone increased 11.02 9.18 65 285353 8414 70634612
Hyponatraemic seizure 11.01 9.18 12 285406 510 70642516
Epstein-Barr virus infection 10.86 9.18 23 285395 13175 70629851
Abdominal strangulated hernia 10.84 9.18 6 285412 90 70642936
Enterocolitis haemorrhagic 10.82 9.18 25 285393 2043 70640983
Therapeutic product effect incomplete 10.82 9.18 384 285034 119498 70523528
Multi-organ disorder 10.79 9.18 27 285391 2322 70640704
Breast cancer stage II 10.78 9.18 4 285414 5342 70637684
Complication of device insertion 10.74 9.18 4 285414 5328 70637698
Respiratory syncytial virus infection 10.73 9.18 9 285409 7646 70635380
Brief psychotic disorder with marked stressors 10.61 9.18 9 285409 279 70642747
Drug specific antibody present 10.50 9.18 5 285413 5753 70637273
Dermatosis 10.46 9.18 12 285406 540 70642486
Photophobia 10.45 9.18 118 285300 18532 70624494
Idiosyncratic drug reaction 10.45 9.18 18 285400 1188 70641838
Campylobacter gastroenteritis 10.44 9.18 18 285400 1189 70641837
Bladder cancer 10.43 9.18 35 285383 17207 70625819
Systemic infection 10.39 9.18 7 285411 6650 70636376
Toxic epidermal necrolysis 10.38 9.18 220 285198 39337 70603689
Oesophageal candidiasis 10.28 9.18 64 285354 8443 70634583
Hallucination, olfactory 10.24 9.18 11 285407 460 70642566
Coagulation factor decreased 10.23 9.18 7 285411 156 70642870
Anaemia folate deficiency 10.18 9.18 9 285409 295 70642731
Vulvovaginal erythema 10.18 9.18 8 285410 222 70642804
Pericardial haemorrhage 10.16 9.18 39 285379 4229 70638797
Aortic valve incompetence 10.15 9.18 66 285352 8838 70634188
Facet joint syndrome 10.13 9.18 6 285412 6107 70636919
Vulval oedema 10.12 9.18 4 285414 26 70643000
Haematuria 10.11 9.18 331 285087 63242 70579784
Drug tolerance 10.09 9.18 9 285409 7419 70635607
Nocardiosis 10.08 9.18 4 285414 5125 70637901
Brain injury 10.06 9.18 17 285401 10600 70632426
Hepatocellular carcinoma 10.05 9.18 73 285345 10135 70632891
Biliary tract disorder 10.05 9.18 20 285398 1474 70641552
Sinus bradycardia 10.05 9.18 142 285276 23481 70619545
Acute myeloid leukaemia 10.03 9.18 78 285340 30862 70612164
Dyshidrotic eczema 9.98 9.18 12 285406 568 70642458
Arterial spasm 9.96 9.18 7 285411 163 70642863
Withdrawal syndrome 9.96 9.18 59 285359 24845 70618181
Pyelonephritis 9.93 9.18 115 285303 18174 70624852
Cytomegalovirus viraemia 9.93 9.18 20 285398 11665 70631361
Illness 9.91 9.18 81 285337 31710 70611316
Enterocolitis 9.90 9.18 88 285330 12978 70630048
Prostate cancer 9.90 9.18 79 285339 31084 70611942
Intervertebral discitis 9.89 9.18 38 285380 4123 70638903
Therapeutic embolisation 9.88 9.18 11 285407 479 70642547
Herpes simplex test positive 9.86 9.18 10 285408 391 70642635
Vulvovaginal inflammation 9.84 9.18 11 285407 481 70642545
Neurosis 9.83 9.18 10 285408 392 70642634
Hepatobiliary scan abnormal 9.80 9.18 5 285413 63 70642963
Muscle swelling 9.77 9.18 14 285404 788 70642238
Eosinophilic oesophagitis 9.74 9.18 11 285407 487 70642539
Unevaluable event 9.73 9.18 149 285269 51914 70591112
Intentional self-injury 9.71 9.18 81 285337 31569 70611457
Impaired quality of life 9.68 9.18 13 285405 8903 70634123
Change in seizure presentation 9.67 9.18 9 285409 316 70642710
Zinc deficiency 9.66 9.18 5 285413 65 70642961
Faecal vomiting 9.63 9.18 16 285402 1025 70642001
Tarsal tunnel syndrome 9.61 9.18 11 285407 494 70642532
False negative investigation result 9.59 9.18 8 285410 242 70642784
Hepatitis fulminant 9.57 9.18 52 285366 6529 70636497
Malaise 9.54 9.18 1927 283491 431005 70212021
Brain contusion 9.53 9.18 18 285400 1276 70641750
Carbohydrate antigen 19-9 increased 9.53 9.18 10 285408 407 70642619
Hyperammonaemic encephalopathy 9.52 9.18 3 285415 4440 70638586
Multiple sclerosis relapse 9.51 9.18 119 285299 42898 70600128
Purpura senile 9.50 9.18 11 285407 500 70642526
Acute sinusitis 9.49 9.18 38 285380 4203 70638823
Circulatory collapse 9.48 9.18 94 285324 35380 70607646
Cytomegalovirus infection reactivation 9.47 9.18 8 285410 6773 70636253
Eosinophilic pneumonia 9.45 9.18 42 285376 4863 70638163
Mesenteric artery stenosis 9.44 9.18 3 285415 9 70643017
Tongue pruritus 9.43 9.18 11 285407 504 70642522
Aspartate aminotransferase increased 9.41 9.18 612 284806 126366 70516660
Grip strength decreased 9.38 9.18 32 285386 15653 70627373
Altered state of consciousness 9.37 9.18 219 285199 39803 70603223
Hyperbilirubinaemia 9.34 9.18 135 285283 22433 70620593
Tongue disorder 9.34 9.18 25 285393 13202 70629824
Abnormal behaviour 9.27 9.18 92 285326 34617 70608409
Oesophageal ulcer 9.24 9.18 51 285367 6443 70636583
Lordosis 9.23 9.18 9 285409 335 70642691
Tricuspid valve incompetence 9.22 9.18 111 285307 17706 70625320
Endophthalmitis 9.21 9.18 7 285411 6248 70636778
Arteriovenous fistula site haematoma 9.21 9.18 4 285414 34 70642992
Rhonchi 9.20 9.18 34 285384 3621 70639405

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BC05 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BD06 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 M01AE52 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
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
CHEBI has role CHEBI:37956 antihistamines
CHEBI has role CHEBI:38623 monoamine oxidase inhibitors

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

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Erosive esophagitis indication 40719004
Zollinger-Ellison syndrome indication 53132006 DOID:0050782
Peptic reflux disease indication 57643001
Gastroesophageal reflux disease indication 235595009 DOID:8534
Prevention of NSAID-Induced Gastric Ulcer indication
Osteoarthritis in Patients at High Ulcer Risk indication
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Pathological Gastric Hypersecretory Condition indication
Duodenal Ulcer due to H. Pylori indication
Maintenance of Healing Erosive Esophagitis indication
Upper gastrointestinal hemorrhage off-label use 37372002
Hepatic failure contraindication 59927004
Osteoporosis contraindication 64859006 DOID:11476
Atrophic gastritis contraindication 84568007 DOID:8929
Fracture of bone contraindication 125605004
Hypomagnesemia contraindication 190855004




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.71 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
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9220698 March 10, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Potassium-transporting ATPase Transporter INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
4021259 VUID
N0000189434 NUI
D01984 KEGG_DRUG
217087-10-0 SECONDARY_CAS_RN
217087-09-7 SECONDARY_CAS_RN
161796-78-7 SECONDARY_CAS_RN
4019439 VANDF
4021259 VANDF
4021260 VANDF
4025229 VANDF
4032661 VANDF
C0937846 UMLSCUI
CHEBI:50275 CHEBI
CHEBI:7772 CHEBI
1C6 PDB_CHEM_ID
CHEMBL1201320 ChEMBL_ID
DB00736 DRUGBANK_ID
CHEMBL2146133 ChEMBL_ID
CHEMBL1200470 ChEMBL_ID
D064098 MESH_DESCRIPTOR_UI
4594 PUBCHEM_CID
5488 IUPHAR_LIGAND_ID
7766 INN_ID
934714-36-0 SECONDARY_CAS_RN
N3PA6559FT UNII
DB00338 DRUGBANK_ID
1294569 RXNORM
19233 MMSL
205449 MMSL
211151 MMSL
232889 MMSL
29630 MMSL
45807 MMSL
5201 MMSL
d00325 MMSL
d04749 MMSL
003476 NDDF
008590 NDDF
008918 NDDF
008919 NDDF
015173 NDDF
129489006 SNOMEDCT_US
25673006 SNOMEDCT_US
317331009 SNOMEDCT_US
387137007 SNOMEDCT_US
396047003 SNOMEDCT_US
426956003 SNOMEDCT_US
725855001 SNOMEDCT_US
C0028978 UMLSCUI
CHEMBL2146140 ChEMBL_ID
5081 INN_ID
D009853 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Esomeprazole Magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0093-6450 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Esomeprazole Magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0093-6450 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Esomeprazole Magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0093-6451 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
Esomeprazole Magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0093-6451 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
good sense esomeprazole magnesium HUMAN OTC DRUG LABEL 1 0113-0651 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
basic care esomeprazole magnesium HUMAN OTC DRUG LABEL 1 0113-0732 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
Good Sense Esomeprazole Magnesium HUMAN OTC DRUG LABEL 1 0113-0898 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
Esomeprazole magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0186-0382 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA authorized generic 28 sections
Esomeprazole magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0186-0384 CAPSULE, DELAYED RELEASE 40 mg ORAL NDA authorized generic 28 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4010 GRANULE, DELAYED RELEASE 10 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4010 GRANULE, DELAYED RELEASE 10 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4010 GRANULE, DELAYED RELEASE 10 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4020 GRANULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4020 GRANULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4020 GRANULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4025 GRANULE, DELAYED RELEASE 2.50 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4025 GRANULE, DELAYED RELEASE 2.50 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4025 GRANULE, DELAYED RELEASE 2.50 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4040 GRANULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4040 GRANULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4040 GRANULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4050 GRANULE, DELAYED RELEASE 5 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4050 GRANULE, DELAYED RELEASE 5 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4050 GRANULE, DELAYED RELEASE 5 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5020 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5020 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5020 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5040 CAPSULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5040 CAPSULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5040 CAPSULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections