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

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

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • omeprazole sodium
  • omeprazole
  • omeprazole magnesium
  • omeprazole sodium bicarbonate
A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
  • Molecular weight: 345.42
  • Formula: C17H19N3O3S
  • CLOGP: 2.56
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 77.10
  • ALOGS: -2.98
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
20 mg O
20 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.02 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 5.79 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.24 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.05 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.58 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 0.50 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
Sept. 14, 1989 FDA ASTRAZENECA PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pemphigus 1272.70 10.29 13 464456 183713 62840840
Drug ineffective 1221.60 10.29 3775 460694 1040990 61983563
Contraindicated product administered 1109.30 10.29 142 464327 217506 62807047
Synovitis 1062.14 10.29 80 464389 186838 62837715
Drug intolerance 1038.23 10.29 480 463989 308181 62716372
Hand deformity 1003.24 10.29 37 464432 159420 62865133
Systemic lupus erythematosus 862.72 10.29 231 464238 208687 62815866
Glossodynia 861.66 10.29 138 464331 178738 62845815
Treatment failure 822.01 10.29 220 464249 198823 62825730
Anti-cyclic citrullinated peptide antibody positive 810.35 10.29 7 464462 116205 62908348
Wound 732.28 10.29 151 464318 163112 62861441
Hypomagnesaemia 698.19 10.29 953 463516 27784 62996769
Chronic kidney disease 673.14 10.29 1199 463270 44199 62980354
Therapeutic product effect decreased 608.94 10.29 327 464142 192860 62831693
Maternal exposure during pregnancy 608.48 10.29 434 464035 219628 62804925
Rheumatoid factor positive 584.09 10.29 6 464463 84400 62940153
Pericarditis 569.08 10.29 132 464337 131447 62893106
Infusion related reaction 556.50 10.29 585 463884 244936 62779617
Duodenal ulcer perforation 549.16 10.29 20 464449 87189 62937364
Arthropathy 542.80 10.29 550 463919 234242 62790311
Joint swelling 523.21 10.29 1002 463467 326664 62697889
Drug interaction 488.16 10.29 3106 461363 226025 62798528
Tubulointerstitial nephritis 486.40 10.29 662 463807 19241 63005312
Hepatic enzyme increased 468.66 10.29 473 463996 201855 62822698
Off label use 466.90 10.29 2958 461511 671504 62353049
Helicobacter infection 459.37 10.29 66 464403 92719 62931834
Hyponatraemia 458.63 10.29 1826 462643 110074 62914479
Discomfort 448.38 10.29 341 464128 167033 62857520
Acute kidney injury 446.23 10.29 3376 461093 260039 62764514
Muscle injury 414.85 10.29 14 464455 65331 62959222
Product use issue 412.07 10.29 609 463860 219911 62804642
Alopecia 409.48 10.29 1194 463275 336342 62688211
Folliculitis 399.42 10.29 30 464439 70287 62954266
Abdominal discomfort 360.79 10.29 1175 463294 319710 62704843
Rheumatoid arthritis 347.70 10.29 845 463624 252974 62771579
Sleep disorder due to general medical condition, insomnia type 339.42 10.29 9 464460 52208 62972345
Swelling 333.90 10.29 974 463495 274404 62750149
Drug hypersensitivity 327.94 10.29 1169 463300 309518 62715035
Hypersensitivity 312.39 10.29 1096 463373 291589 62732964
Rheumatic fever 294.02 10.29 4 464465 43107 62981446
Subacute cutaneous lupus erythematosus 291.33 10.29 202 464267 2441 63022112
Hypocalcaemia 257.01 10.29 655 463814 31058 62993495
C-reactive protein abnormal 244.70 10.29 26 464443 46070 62978483
Exposure during pregnancy 232.18 10.29 494 463975 155053 62869500
Renal injury 223.14 10.29 309 464160 9130 63015423
Therapeutic product effect incomplete 220.38 10.29 359 464110 124697 62899856
Diarrhoea 213.55 10.29 6788 457681 708578 62315975
Irritable bowel syndrome 211.63 10.29 175 464294 82237 62942316
Orthostatic hypotension 204.47 10.29 656 463813 35504 62989049
Impaired healing 201.46 10.29 273 464196 102269 62922284
Completed suicide 199.26 10.29 485 463984 145188 62879365
End stage renal disease 192.09 10.29 241 464228 6452 63018101
Constipation 180.24 10.29 2472 461997 222471 62802082
Creatinine renal clearance decreased 179.60 10.29 380 464089 15928 63008625
Fall 178.67 10.29 3937 460532 388397 62636156
Balance disorder 174.19 10.29 1136 463333 83286 62941267
Musculoskeletal stiffness 172.50 10.29 729 463740 183889 62840664
Blood calcium decreased 172.07 10.29 504 463965 25947 62998606
Ill-defined disorder 166.38 10.29 212 464257 81543 62943010
Cognitive disorder 163.05 10.29 824 463645 54991 62969562
Sedation complication 161.50 10.29 330 464139 13492 63011061
Hypokalaemia 150.06 10.29 1284 463185 102520 62922033
Blister 150.04 10.29 469 464000 129345 62895208
Liver injury 148.70 10.29 134 464335 60386 62964167
Infection 144.73 10.29 1031 463438 228142 62796411
Psoriatic arthropathy 143.86 10.29 282 464187 91238 62933315
Rash 139.72 10.29 3084 461385 557787 62466766
Intentional product use issue 136.15 10.29 479 463990 127413 62897140
Condition aggravated 135.24 10.29 2099 462370 400118 62624435
Type 2 diabetes mellitus 133.74 10.29 162 464307 63706 62960847
Stomatitis 127.56 10.29 551 463918 138174 62886379
Abdominal pain 127.50 10.29 2926 461543 290530 62734023
Cholecystitis chronic 121.80 10.29 248 464221 10113 63014440
Nasopharyngitis 112.84 10.29 1252 463217 253005 62771548
Red blood cell sedimentation rate abnormal 110.74 10.29 9 464460 19773 63004780
Hip arthroplasty 108.34 10.29 113 464356 47533 62977020
General physical health deterioration 105.02 10.29 954 463515 200448 62824105
Plasma cell myeloma 104.79 10.29 530 463939 35375 62989178
Drug tolerance decreased 103.49 10.29 6 464463 17467 63007086
Therapy non-responder 101.93 10.29 255 464214 75646 62948907
Pain 99.07 10.29 4421 460048 736207 62288346
Sedation 98.34 10.29 551 463918 38258 62986295
Vomiting 97.11 10.29 5013 459456 554604 62469949
Abortion spontaneous 96.40 10.29 122 464347 47073 62977480
Gastrointestinal disorder 93.07 10.29 570 463899 130669 62893884
Dehydration 91.92 10.29 1780 462689 171574 62852979
Drug abuse 91.01 10.29 252 464217 72266 62952287
Renal failure 90.07 10.29 1283 463186 116369 62908184
Red blood cell sedimentation rate increased 88.49 10.29 115 464354 43867 62980686
Product use in unapproved indication 88.32 10.29 860 463609 178220 62846333
Tetany 88.10 10.29 90 464379 1911 63022642
Blood cholesterol increased 85.49 10.29 375 464094 93657 62930896
Device expulsion 84.97 10.29 78 464391 34844 62989709
Hypertensive nephropathy 84.25 10.29 55 464414 597 63023956
Arthralgia 82.24 10.29 3371 461098 566339 62458214
Gastrointestinal haemorrhage 81.57 10.29 931 463538 80245 62944308
Bone erosion 80.16 10.29 16 464453 17701 63006852
Nausea 78.93 10.29 7263 457206 847208 62177345
Live birth 78.30 10.29 45 464424 25585 62998968
Prescribed overdose 77.64 10.29 81 464388 34072 62990481
Muscle spasms 77.63 10.29 1588 462881 154562 62869991
Drug resistance 76.38 10.29 36 464433 22897 63001656
Gastritis 75.71 10.29 500 463969 36803 62987750
Adverse event 75.29 10.29 248 464221 67311 62957242
Rheumatoid nodule 74.53 10.29 17 464452 17138 63007415
Dizziness 72.77 10.29 3843 460626 426082 62598471
Gastric pH decreased 71.20 10.29 53 464416 721 63023832
Blood pressure systolic increased 70.26 10.29 151 464318 47246 62977307
Pancreatitis acute 69.69 10.29 387 464082 26779 62997774
Infective pulmonary exacerbation of cystic fibrosis 69.24 10.29 180 464289 8637 63015916
Haematemesis 68.13 10.29 418 464051 29994 62994559
Fibromyalgia 67.02 10.29 331 464138 80089 62944464
Urinary tract infection 66.91 10.29 2466 462003 262218 62762335
Swollen tongue 66.76 10.29 460 464009 34340 62990213
Cogwheel rigidity 66.45 10.29 77 464392 1893 63022660
Hypoparathyroidism 65.91 10.29 48 464421 630 63023923
Lip swelling 65.87 10.29 421 464048 30642 62993911
Lower respiratory tract infection 65.80 10.29 634 463835 131673 62892880
Asthenia 65.09 10.29 3430 461039 380174 62644379
Knee arthroplasty 64.62 10.29 193 464276 54013 62970540
Hypotension 63.72 10.29 2518 461951 270086 62754467
Disorientation 62.32 10.29 498 463971 38954 62985599
Therapeutic response decreased 61.14 10.29 237 464232 61288 62963265
Pregnancy 60.95 10.29 110 464359 36726 62987827
Anaemia 60.56 10.29 2675 461794 290755 62733798
Tremor 60.26 10.29 1328 463141 130911 62893642
Grip strength decreased 60.13 10.29 45 464424 22242 63002311
Malaise 59.86 10.29 3664 460805 412290 62612263
Lethargy 59.75 10.29 650 463819 55357 62969196
Liver function test abnormal 59.42 10.29 576 463893 47605 62976948
Tenosynovitis 59.28 10.29 14 464455 13781 63010772
Gastric polyps 58.43 10.29 96 464373 3309 63021244
Vision blurred 57.90 10.29 970 463499 90954 62933599
Hiatus hernia 56.98 10.29 310 464159 21284 63003269
Syncope 56.75 10.29 1189 463280 116196 62908357
Deep vein thrombosis postoperative 56.45 10.29 8 464461 11361 63013192
Dyspnoea 55.81 10.29 5587 458882 655726 62368827
Chest pain 55.03 10.29 2014 462455 213945 62810608
Peripheral swelling 54.87 10.29 1503 462966 264439 62760114
Flatulence 54.79 10.29 438 464031 34264 62990289
Lip dry 53.53 10.29 23 464446 15447 63009106
Chronic obstructive pulmonary disease 53.02 10.29 696 463773 61990 62962563
Sinusitis 52.89 10.29 1258 463211 225395 62799158
Breast cancer stage III 52.29 10.29 7 464462 10379 63014174
International normalised ratio increased 51.95 10.29 544 463925 45881 62978672
Pulmonary embolism 51.65 10.29 1167 463302 115517 62909036
Weight increased 51.22 10.29 1484 462985 259308 62765245
Facet joint syndrome 50.83 10.29 13 464456 12125 63012428
Metabolic alkalosis 50.78 10.29 85 464384 2976 63021577
Deep vein thrombosis 49.78 10.29 876 463593 82924 62941629
Loss of personal independence in daily activities 49.73 10.29 463 464006 96827 62927726
Rhabdomyolysis 49.65 10.29 516 463953 43435 62981118
C-reactive protein increased 48.28 10.29 451 464018 94256 62930297
Abdominal pain upper 48.00 10.29 1906 462563 204538 62820015
Transient ischaemic attack 47.37 10.29 453 464016 37300 62987253
Depression 47.06 10.29 1820 462649 194672 62829881
Gallbladder disorder 46.72 10.29 266 464203 18576 63005977
Abdominal distension 46.42 10.29 891 463578 85724 62938829
Feeling of despair 45.73 10.29 70 464399 2269 63022284
Atrial fibrillation 45.68 10.29 1147 463322 115489 62909064
Gastrooesophageal reflux disease 45.66 10.29 967 463502 94672 62929881
Sepsis 45.28 10.29 1453 463016 151670 62872883
Intentional overdose 45.09 10.29 337 464132 73815 62950738
Angioedema 45.02 10.29 543 463926 47422 62977131
Muscle spasticity 44.86 10.29 56 464413 21738 63002815
Diabetic nephropathy 44.37 10.29 54 464415 1400 63023153
Joint range of motion decreased 44.27 10.29 108 464361 32320 62992233
Biliary dyskinesia 44.23 10.29 75 464394 2654 63021899
Toxicity to various agents 43.87 10.29 1426 463043 245824 62778729
Hypertrichosis 43.87 10.29 48 464421 1106 63023447
Hallucination 43.62 10.29 602 463867 54215 62970338
Blood sodium decreased 43.27 10.29 315 464154 23937 63000616
Pulmonary malformation 43.04 10.29 27 464442 272 63024281
Tinnitus 42.98 10.29 424 464045 35204 62989349
Adjustment disorder with depressed mood 42.59 10.29 11 464458 10193 63014360
Parkinsonism 42.42 10.29 170 464299 10269 63014284
Nephropathy 42.36 10.29 122 464347 6219 63018334
Myalgia 42.17 10.29 1386 463083 145143 62879410
Macular degeneration 41.95 10.29 71 464398 24305 63000248
Depersonalisation/derealisation disorder 41.94 10.29 51 464418 1321 63023232
Feeling abnormal 41.78 10.29 1400 463069 146992 62877561
Toxic epidermal necrolysis 41.22 10.29 322 464147 25012 62999541
Product formulation issue 41.10 10.29 34 464435 544 63024009
Panniculitis 40.90 10.29 16 464453 11369 63013184
Product dose omission issue 40.44 10.29 2099 462370 232214 62792339
Prescribed underdose 40.43 10.29 99 464370 29590 62994963
Derealisation 40.38 10.29 47 464422 1161 63023392
Swelling face 40.04 10.29 670 463799 62805 62961748
Haemoglobin decreased 39.55 10.29 1367 463102 144118 62880435
Breast cancer stage II 39.29 10.29 8 464461 8728 63015825
Lipase increased 38.46 10.29 159 464310 9741 63014812
Upper gastrointestinal haemorrhage 38.44 10.29 253 464216 18599 63005954
Burning mouth syndrome 38.32 10.29 31 464438 480 63024073
H1N1 influenza 38.24 10.29 55 464414 1684 63022869
Electrocardiogram QT prolonged 38.15 10.29 630 463839 58900 62965653
Coma 37.96 10.29 295 464174 64069 62960484
X-ray abnormal 37.37 10.29 7 464462 8103 63016450
Back pain 37.22 10.29 2323 462146 261822 62762731
Blood pressure diastolic abnormal 37.17 10.29 31 464438 14511 63010042
Inappropriate antidiuretic hormone secretion 36.85 10.29 216 464253 15246 63009307
Dysgeusia 36.77 10.29 512 463957 46198 62978355
Premature delivery 36.68 10.29 107 464362 30174 62994379
Palpitations 36.22 10.29 1081 463388 111689 62912864
Hallucinations, mixed 35.30 10.29 96 464373 4733 63019820
Accidental exposure to product 35.30 10.29 94 464375 27311 62997242
Blood magnesium decreased 35.18 10.29 190 464279 13008 63011545
Maternal exposure timing unspecified 35.16 10.29 5 464464 7082 63017471
Suicide attempt 35.09 10.29 281 464188 60637 62963916
Inflammation 34.91 10.29 409 464060 81864 62942689
Disturbance in attention 34.83 10.29 430 464039 37759 62986794
Hypoglycaemia 34.64 10.29 625 463844 59440 62965113
Pulmonary toxicity 34.44 10.29 13 464456 9442 63015111
Device difficult to use 34.31 10.29 26 464443 12770 63011783
Retinitis 34.18 10.29 3 464466 6193 63018360
Neutropenic sepsis 33.75 10.29 221 464248 16217 63008336
Mouth swelling 33.43 10.29 93 464376 4647 63019906
Hip fracture 33.27 10.29 346 464123 29128 62995425
Blood parathyroid hormone decreased 33.18 10.29 15 464454 9776 63014777
Cystic fibrosis 33.09 10.29 74 464395 3222 63021331
Dislocation of vertebra 32.95 10.29 11 464458 8624 63015929
Parosmia 32.75 10.29 110 464359 6096 63018457
Foetal death 32.52 10.29 20 464449 10960 63013593
Blood pressure systolic abnormal 32.44 10.29 30 464439 13356 63011197
Nightmare 32.36 10.29 246 464223 18948 63005605
Nephrogenic anaemia 31.89 10.29 57 464412 2105 63022448
Caesarean section 31.78 10.29 47 464422 16985 63007568
Abdominal tenderness 31.61 10.29 131 464338 8035 63016518
Pancreatitis 31.38 10.29 519 463950 48536 62976017
Tension headache 31.07 10.29 96 464373 5090 63019463
Cholelithiasis 30.84 10.29 472 463997 43453 62981100
Hypophosphataemia 30.80 10.29 165 464304 11261 63013292
Anxiety 30.79 10.29 1914 462555 215627 62808926
Palatal oedema 30.77 10.29 29 464440 556 63023997
Cross sensitivity reaction 30.62 10.29 56 464413 2106 63022447
Dilatation intrahepatic duct acquired 30.47 10.29 31 464438 655 63023898
Clostridium difficile infection 30.41 10.29 344 464125 29578 62994975
Drug ineffective for unapproved indication 30.25 10.29 137 464332 33926 62990627
Intestinal dilatation 30.16 10.29 49 464420 1673 63022880
Carotid artery occlusion 30.10 10.29 89 464380 4605 63019948
Bursitis 29.97 10.29 154 464315 36887 62987666
Gallbladder injury 29.83 10.29 44 464425 1379 63023174
Hypoparathyroidism secondary 29.80 10.29 12 464457 40 63024513
Mania 29.63 10.29 173 464296 12194 63012359
Autoimmune disorder 29.59 10.29 50 464419 17127 63007426
Torus fracture 29.56 10.29 17 464452 144 63024409
Drug dispensed to wrong patient 29.51 10.29 22 464447 300 63024253
Pneumonia 29.42 10.29 3793 460676 452974 62571579
Depressed level of consciousness 29.40 10.29 627 463842 61451 62963102
Malignant neoplasm progression 29.40 10.29 423 464046 81698 62942855
Urinary retention 29.30 10.29 345 464124 29956 62994597
Malignant mediastinal neoplasm 29.30 10.29 44 464425 1402 63023151
Serotonin syndrome 29.27 10.29 330 464139 28352 62996201
Myelosuppression 29.26 10.29 83 464386 23620 63000933
Respiratory tract malformation 29.23 10.29 18 464451 175 63024378
Hypoaesthesia oral 29.10 10.29 179 464290 12854 63011699
Cardiospasm 29.06 10.29 51 464418 1856 63022697
Rebound acid hypersecretion 29.03 10.29 22 464447 308 63024245
Atrial tachycardia 28.74 10.29 82 464387 4158 63020395
Feeling of body temperature change 28.73 10.29 90 464379 4807 63019746
Cholecystectomy 28.66 10.29 154 464315 10523 63014030
Oesophagitis 28.56 10.29 198 464271 14810 63009743
Cholecystitis 28.16 10.29 201 464268 15176 63009377
Overdose 28.13 10.29 634 463835 114444 62910109
Blood alkaline phosphatase increased 28.00 10.29 456 464013 42511 62982042
Enthesopathy 27.96 10.29 14 464455 8600 63015953
Paraesthesia 27.85 10.29 1410 463059 155556 62868997
Chest discomfort 27.83 10.29 1025 463444 108944 62915609
Hypergammaglobulinaemia 27.73 10.29 26 464443 495 63024058
Product substitution issue 27.53 10.29 206 464263 15790 63008763
Drooling 27.39 10.29 76 464393 3792 63020761
Palmoplantar keratoderma 27.19 10.29 51 464418 1956 63022597
Calcium deficiency 27.13 10.29 37 464432 1077 63023476
Pruritus genital 27.11 10.29 60 464409 2594 63021959
Melaena 26.87 10.29 340 464129 30025 62994528
Hyperkalaemia 26.82 10.29 551 463918 53652 62970901
Abnormal loss of weight 26.64 10.29 98 464371 5684 63018869
Vertigo 26.50 10.29 599 463870 59288 62965265
Rectal haemorrhage 26.47 10.29 505 463964 48525 62976028
Nephroangiosclerosis 26.47 10.29 16 464453 150 63024403
Lung cyst 26.07 10.29 21 464448 323 63024230
Faeces discoloured 25.70 10.29 227 464242 18282 63006271
Oral pain 25.58 10.29 319 464150 28075 62996478
Skin necrosis 25.54 10.29 39 464430 13911 63010642
Memory impairment 25.48 10.29 968 463501 103290 62921263
Pulmonary fibrosis 25.12 10.29 179 464290 39630 62984923
Emotional distress 24.90 10.29 355 464114 32194 62992359
Bicytopenia 24.88 10.29 56 464413 2449 63022104
Temperature regulation disorder 24.86 10.29 7 464462 6125 63018428
Agitation 24.68 10.29 592 463877 59165 62965388
Chronic spontaneous urticaria 24.58 10.29 36 464433 1121 63023432
Muscle rigidity 24.46 10.29 156 464313 11344 63013209
Obstructive airways disorder 24.45 10.29 74 464395 20625 63003928
Dissociation 24.38 10.29 61 464408 2858 63021695
Blood pressure fluctuation 24.27 10.29 219 464250 46098 62978455
Dry skin 24.24 10.29 566 463903 56321 62968232
Multiple drug therapy 24.21 10.29 70 464399 3576 63020977
Limb reduction defect 24.11 10.29 22 464447 404 63024149
Poisoning deliberate 23.96 10.29 28 464441 11190 63013363
Acute generalised exanthematous pustulosis 23.88 10.29 151 464318 10948 63013605
Congenital thrombocytopenia 23.87 10.29 11 464458 55 63024498
Hyperhidrosis 23.74 10.29 990 463479 106846 62917707
Maternal exposure before pregnancy 23.73 10.29 13 464456 7590 63016963
Stevens-Johnson syndrome 23.65 10.29 283 464186 24667 62999886
Disability 23.58 10.29 63 464406 18284 63006269
Sopor 23.57 10.29 83 464386 22081 63002472
Small intestinal obstruction 23.48 10.29 221 464248 18116 63006437
Hypergastrinaemia 23.12 10.29 13 464456 105 63024448
Unintentional medical device removal 22.97 10.29 8 464461 6107 63018446
Mood swings 22.91 10.29 219 464250 18029 63006524
Muscle disorder 22.71 10.29 84 464385 4885 63019668
Restless legs syndrome 22.58 10.29 221 464248 18310 63006243
Blood potassium decreased 22.40 10.29 432 464037 41594 62982959
Sleep disorder due to a general medical condition 22.39 10.29 34 464435 12154 63012399
Ventilation perfusion mismatch 22.27 10.29 23 464446 495 63024058
Acute respiratory failure 22.11 10.29 365 464104 34120 62990433
Adjusted calcium decreased 22.07 10.29 15 464454 175 63024378
Skin test positive 22.04 10.29 27 464442 705 63023848
Chronic kidney disease-mineral and bone disorder 21.97 10.29 12 464457 91 63024462
Pregnancy with contraceptive device 21.74 10.29 4 464465 4690 63019863
Atrioventricular block first degree 21.67 10.29 108 464361 7165 63017388
Peripheral venous disease 21.55 10.29 51 464418 15426 63009127
Dysphagia 21.53 10.29 822 463647 87763 62936790
Hyperchlorhydria 21.51 10.29 44 464425 1800 63022753
Moraxella test positive 21.25 10.29 8 464461 21 63024532
Chromaturia 21.17 10.29 201 464268 16516 63008037
Nervousness 21.02 10.29 331 464138 30648 62993905
Respiratory arrest 20.98 10.29 146 464323 32499 62992054
Truncus coeliacus thrombosis 20.95 10.29 7 464462 11 63024542
Cutaneous lupus erythematosus 20.92 10.29 55 464414 2657 63021896
Long QT syndrome 20.86 10.29 62 464407 3217 63021336
Device use error 20.85 10.29 8 464461 5753 63018800
Insulin autoimmune syndrome 20.83 10.29 12 464457 102 63024451
Adverse drug reaction 20.68 10.29 435 464034 79279 62945274
Product packaging confusion 20.62 10.29 14 464455 163 63024390
Cellulitis 20.51 10.29 763 463706 81195 62943358
Dysuria 20.14 10.29 353 464116 33385 62991168
Deformity 20.14 10.29 34 464435 11650 63012903
Large intestine infection 20.13 10.29 44 464425 1886 63022667
Non-cardiac chest pain 20.02 10.29 95 464374 6177 63018376
Blood urea increased 19.90 10.29 287 464182 26092 62998461
Skin discolouration 19.87 10.29 388 464081 37440 62987113
Tachycardia 19.86 10.29 1056 463413 117100 62907453
Breast cancer stage I 19.79 10.29 13 464456 6876 63017677
Tongue blistering 19.73 10.29 39 464430 1556 63022997
Target skin lesion 19.72 10.29 12 464457 114 63024439
Body temperature decreased 19.72 10.29 79 464390 20240 63004313
Duodenal stenosis 19.66 10.29 22 464447 520 63024033
Dialysis 19.51 10.29 137 464332 10290 63014263
Atrioventricular block complete 19.49 10.29 115 464354 8136 63016417
Cerebrovascular accident 19.49 10.29 972 463497 107052 62917501
Sciatica 19.46 10.29 159 464310 34165 62990388
Intestinal obstruction 19.42 10.29 326 464143 30573 62993980
Sleep terror 19.31 10.29 53 464416 2627 63021926
Presyncope 19.28 10.29 298 464171 27487 62997066
Aplastic anaemia 19.26 10.29 25 464444 9544 63015009
Therapeutic product ineffective 19.17 10.29 41 464428 1731 63022822
Thermohypoaesthesia 19.12 10.29 12 464457 121 63024432
Drug eruption 19.10 10.29 127 464342 28567 62995986
Type I hypersensitivity 19.07 10.29 56 464413 2886 63021667
Prescription drug used without a prescription 19.03 10.29 49 464420 2337 63022216
Fatigue 19.03 10.29 6009 458460 882019 62142534
Multiple-drug resistance 19.01 10.29 7 464462 5163 63019390
Metastases to lymph nodes 18.94 10.29 19 464450 8139 63016414
Ear pain 18.83 10.29 171 464298 35947 62988606
Facial pain 18.74 10.29 137 464332 10424 63014129
International normalised ratio abnormal 18.72 10.29 60 464409 3244 63021309
Giardiasis 18.62 10.29 9 464460 51 63024502
Emotional disorder 18.53 10.29 164 464305 13215 63011338
Incontinence 18.46 10.29 147 464322 11485 63013068
Pneumonitis 18.41 10.29 361 464108 34861 62989692
Full blood count decreased 18.40 10.29 280 464189 25744 62998809
Catatonia 18.36 10.29 5 464464 4472 63020081
Hepatic encephalopathy 18.13 10.29 143 464326 11139 63013414
Confusional state 18.11 10.29 1985 462484 234395 62790158
Impaired quality of life 18.09 10.29 167 464302 13616 63010937
Lower gastrointestinal haemorrhage 18.02 10.29 109 464360 7781 63016772
Electrolyte imbalance 17.85 10.29 225 464244 19851 63004702
Joint stiffness 17.81 10.29 208 464261 41661 62982892
Jaundice 17.80 10.29 307 464162 28944 62995609
Joint destruction 17.68 10.29 12 464457 6240 63018313
Cholecystitis acute 17.54 10.29 112 464357 8148 63016405
Blood pressure diastolic decreased 17.48 10.29 96 464373 22610 63001943
Femur fracture 17.34 10.29 414 464055 41342 62983211
Head discomfort 17.34 10.29 162 464307 13253 63011300
Cough 17.07 10.29 2417 462052 290326 62734227
Avian influenza 17.07 10.29 9 464460 63 63024490
Congenital ovarian anomaly 17.05 10.29 6 464463 12 63024541
Iron deficiency anaemia 16.99 10.29 222 464247 19747 63004806
Chills 16.85 10.29 1002 463467 112376 62912177
Essential hypertension 16.63 10.29 77 464392 4956 63019597
Blast cells present 16.59 10.29 19 464450 461 63024092
Beta haemolytic streptococcal infection 16.58 10.29 42 464427 1983 63022570
Stillbirth 16.51 10.29 15 464454 6735 63017818
Injection site reaction 16.49 10.29 315 464154 58209 62966344
Eyelid retraction 16.46 10.29 8 464461 46 63024507
Multimorbidity 16.43 10.29 21 464448 573 63023980
Body height decreased 16.34 10.29 128 464341 9950 63014603
Blood chromogranin A increased 16.24 10.29 15 464454 280 63024273
Subdural haemorrhage 16.22 10.29 55 464414 3063 63021490
Hyperreflexia 16.21 10.29 86 464383 5848 63018705
Hepatotoxicity 16.15 10.29 183 464286 36858 62987695
Diverticulum 16.10 10.29 146 464323 11845 63012708
Malnutrition 16.06 10.29 177 464292 15121 63009432
Dementia 16.02 10.29 209 464260 18585 63005968
Goitre 16.01 10.29 86 464383 5875 63018678
Hepatitis acute 16.00 10.29 118 464351 9002 63015551
Sight disability 15.93 10.29 11 464458 132 63024421
Endocrine ophthalmopathy 15.91 10.29 22 464447 649 63023904
Blood immunoglobulin E increased 15.89 10.29 63 464406 3786 63020767
Intravascular haemolysis 15.84 10.29 16 464453 335 63024218
Hyperbilirubinaemia 15.83 10.29 139 464330 11175 63013378
Pancytopenia 15.82 10.29 864 463605 96069 62928484
Immunisation 15.77 10.29 30 464439 1163 63023390
Bone pain 15.74 10.29 517 463952 54124 62970429
Rash macular 15.61 10.29 249 464220 23115 63001438
Dry mouth 15.61 10.29 708 463761 77155 62947398
Sensory loss 15.50 10.29 128 464341 10110 63014443
Dolichocolon 15.30 10.29 5 464464 7 63024546
Gallbladder adenocarcinoma 15.28 10.29 10 464459 109 63024444
Polyuria 15.26 10.29 111 464358 8431 63016122
Seronegative arthritis 15.18 10.29 5 464464 3954 63020599
Mesenteric artery thrombosis 15.17 10.29 13 464456 219 63024334
Post transplant lymphoproliferative disorder 15.13 10.29 9 464460 5022 63019531
Circulatory collapse 15.11 10.29 235 464234 21703 63002850
Polycystic ovaries 14.92 10.29 7 464462 4464 63020089
Viral diarrhoea 14.87 10.29 12 464457 185 63024368
Biliary colic 14.77 10.29 59 464410 3558 63020995
Pathogen resistance 14.74 10.29 15 464454 6383 63018170
Obesity 14.67 10.29 144 464325 29808 62994745
Sputum retention 14.67 10.29 20 464449 582 63023971
Proctitis 14.66 10.29 11 464458 5430 63019123
Drug dose titration not performed 14.65 10.29 19 464450 526 63024027
Urinary tract infection pseudomonal 14.57 10.29 24 464445 829 63023724
Renal artery arteriosclerosis 14.54 10.29 5 464464 9 63024544
Gastrointestinal erosion 14.50 10.29 21 464448 647 63023906
Cytomegalovirus viraemia 14.49 10.29 12 464457 5637 63018916
Necrosis ischaemic 14.42 10.29 24 464445 836 63023717
Subarachnoid haemorrhage 14.42 10.29 164 464305 14119 63010434
Superior mesenteric artery syndrome 14.40 10.29 9 464460 90 63024463
Lung disorder 14.37 10.29 346 464123 61915 62962638
Compartment syndrome 14.36 10.29 43 464426 2241 63022312
Cyanosis 14.30 10.29 188 464281 16747 63007806
Limb hypoplasia congenital 14.25 10.29 12 464457 197 63024356
Hypophagia 14.25 10.29 314 464155 30945 62993608
Genital blister 14.24 10.29 9 464460 92 63024461
Gallbladder cholesterolosis 14.20 10.29 23 464446 783 63023770
Genital pain 14.17 10.29 17 464452 434 63024119
Respirovirus test positive 14.07 10.29 6 464463 24 63024529
Anosmia 13.95 10.29 92 464377 6768 63017785
Foetal exposure during pregnancy 13.90 10.29 158 464311 31804 62992749
Polyserositis 13.88 10.29 16 464453 391 63024162
Incorrect route of product administration 13.87 10.29 131 464338 27321 62997232
Hallucination, visual 13.79 10.29 208 464261 19090 63005463
Oedema peripheral 13.77 10.29 1586 462883 187925 62836628
Lichen planus 13.75 10.29 43 464426 2295 63022258
Vertigo positional 13.73 10.29 49 464420 2800 63021753
Normal newborn 13.71 10.29 25 464444 8316 63016237
Gastrointestinal stoma complication 13.68 10.29 37 464432 1818 63022735
Abnormal dreams 13.60 10.29 127 464342 10389 63014164
Rash papular 13.55 10.29 175 464294 15527 63009026
Acute psychosis 13.54 10.29 45 464424 2480 63022073
Thrombocytopenia 13.53 10.29 1283 463186 149874 62874679
Occult blood positive 13.52 10.29 58 464411 3612 63020941
Pulmonary pain 13.52 10.29 56 464413 3434 63021119
Poisoning 13.46 10.29 53 464416 13647 63010906
Speech disorder 13.45 10.29 391 464078 40238 62984315
Epistaxis 13.45 10.29 656 463813 72069 62952484
Genital ulceration 13.37 10.29 20 464449 635 63023918
Parkinsonian rest tremor 13.24 10.29 9 464460 105 63024448
Allergy to chemicals 13.24 10.29 3 464466 3039 63021514
Hepatitis toxic 13.24 10.29 53 464416 3200 63021353
Pneumonia streptococcal 13.24 10.29 36 464433 1775 63022778
Acute graft versus host disease 13.21 10.29 8 464461 4420 63020133
Dental discomfort 13.18 10.29 17 464452 468 63024085
Hand-eye coordination impaired 13.18 10.29 6 464463 29 63024524
Oesophageal stenosis 13.12 10.29 53 464416 3213 63021340
Product taste abnormal 13.07 10.29 39 464430 2028 63022525
Bromhidrosis 13.05 10.29 5 464464 14 63024539
Endoscopy abnormal 13.05 10.29 5 464464 14 63024539
Aphasia 13.05 10.29 325 464144 32675 62991878
Miosis 13.04 10.29 21 464448 7332 63017221
Breast cancer female 12.98 10.29 53 464416 13506 63011047
Oral mucosal blistering 12.96 10.29 79 464390 5654 63018899
Transplant dysfunction 12.93 10.29 10 464459 4862 63019691
Injection site bruising 12.93 10.29 222 464247 41688 62982865
Febrile bone marrow aplasia 12.92 10.29 21 464448 7304 63017249
Vitamin D deficiency 12.91 10.29 157 464312 13735 63010818
Muscle twitching 12.91 10.29 209 464260 19459 63005094
Developmental hip dysplasia 12.89 10.29 30 464439 1342 63023211
Illness 12.83 10.29 459 464010 48600 62975953
Thrombosis 12.81 10.29 588 463881 64167 62960386
Atrophic vulvovaginitis 12.78 10.29 35 464434 1733 63022820
Gastroenteritis 12.73 10.29 269 464200 26321 62998232
Abnormal behaviour 12.72 10.29 224 464245 21202 63003351
Colitis ischaemic 12.70 10.29 127 464342 10581 63013972
Ankylosing spondylitis 12.69 10.29 37 464432 10437 63014116
Fear of eating 12.69 10.29 15 464454 377 63024176
Symmetrical drug-related intertriginous and flexural exanthema 12.67 10.29 17 464452 487 63024066
Duodenitis 12.66 10.29 58 464411 3717 63020836
Renal cyst 12.62 10.29 123 464346 10179 63014374
Dyskinesia 12.60 10.29 315 464154 31687 62992866
Haemorrhoids 12.60 10.29 230 464239 21920 63002633
Acute myocardial infarction 12.59 10.29 316 464153 31808 62992745
Dysphonia 12.58 10.29 446 464023 47168 62977385
Drug dose omission by device 12.56 10.29 10 464459 4791 63019762
Aquagenic pruritus 12.56 10.29 6 464463 33 63024520
Burning sensation 12.54 10.29 502 463967 53905 62970648
Renal disorder 12.52 10.29 323 464146 32651 62991902
Acquired oesophageal web 12.44 10.29 12 464457 237 63024316
Exostosis 12.43 10.29 78 464391 17784 63006769
Renal haemangioma 12.42 10.29 6 464463 34 63024519
Barrett's oesophagus 12.41 10.29 19 464450 616 63023937
Injury 12.36 10.29 425 464044 72822 62951731
Congenital oral malformation 12.33 10.29 11 464458 196 63024357
Therapeutic response shortened 12.32 10.29 45 464424 11843 63012710
Derailment 12.30 10.29 7 464462 58 63024495
Heart rate decreased 12.30 10.29 247 464222 45313 62979240
Labelled drug-drug interaction medication error 12.27 10.29 151 464318 13248 63011305
Acidosis 12.27 10.29 131 464338 11102 63013451
Feeling jittery 12.25 10.29 151 464318 13252 63011301
Antithrombin III 12.25 10.29 10 464459 157 63024396
Urine chloride decreased 12.24 10.29 8 464461 87 63024466
Liver disorder 12.22 10.29 299 464170 53388 62971165
Tongue oedema 12.21 10.29 66 464403 4520 63020033
Salmonellosis 12.21 10.29 27 464442 1167 63023386
Colitis 12.19 10.29 452 464017 48076 62976477
Toxic shock syndrome 12.17 10.29 22 464447 820 63023733
Prevertebral soft tissue swelling of cervical space 12.14 10.29 6 464463 36 63024517
White blood cell count increased 12.13 10.29 452 464017 48109 62976444
Muscular weakness 12.08 10.29 1046 463423 121307 62903246
Sweat discolouration 12.08 10.29 4 464465 6 63024547
Tympanic membrane hyperaemia 12.08 10.29 4 464465 6 63024547
Osteoarthritis 12.05 10.29 572 463897 94771 62929782
Abnormal weight gain 12.02 10.29 35 464434 1795 63022758
Hypertensive cardiomyopathy 12.01 10.29 11 464458 203 63024350
Musculoskeletal pain 11.99 10.29 552 463917 91725 62932828
Escherichia urinary tract infection 11.92 10.29 137 464332 11825 63012728
Poor sucking reflex 11.90 10.29 13 464456 299 63024254
Soft tissue disorder 11.84 10.29 9 464460 4413 63020140
Product odour abnormal 11.80 10.29 28 464441 1268 63023285
Chronic sinusitis 11.80 10.29 51 464418 12792 63011761
Cerebrovascular arteriovenous malformation 11.80 10.29 8 464461 93 63024460
Keratorhexis 11.78 10.29 3 464466 0 63024553
Presumed ocular histoplasmosis syndrome 11.78 10.29 3 464466 0 63024553
Pallor 11.77 10.29 300 464169 30268 62994285
Cardiac steatosis 11.75 10.29 6 464463 39 63024514
Cholestasis 11.67 10.29 290 464179 29144 62995409
Diplopia 11.67 10.29 241 464228 23487 63001066
Cleft palate 11.63 10.29 24 464445 988 63023565
Pelvic fracture 11.61 10.29 149 464320 13199 63011354
Torsade de pointes 11.60 10.29 149 464320 13202 63011351
Device dislocation 11.60 10.29 126 464343 25579 62998974
Product complaint 11.58 10.29 144 464325 12665 63011888
Blood iron abnormal 11.56 10.29 7 464462 3869 63020684
Hair injury 11.54 10.29 5 464464 21 63024532
Erythrodermic psoriasis 11.53 10.29 24 464445 994 63023559
Urine output increased 11.52 10.29 29 464440 1364 63023189
Weight decreased 11.49 10.29 2244 462225 274554 62749999
Supraventricular tachycardia 11.46 10.29 157 464312 14114 63010439
Stoma site infection 11.46 10.29 21 464448 791 63023762
Loss of consciousness 11.38 10.29 1008 463461 117113 62907440
DNA antibody 11.38 10.29 6 464463 42 63024511
Renal atrophy 11.38 10.29 30 464439 1452 63023101
Neutrophil count increased 11.37 10.29 177 464292 16350 63008203
Renal pain 11.36 10.29 85 464384 6514 63018039
Anaemia folate deficiency 11.34 10.29 11 464458 219 63024334
Sinonasal obstruction 11.33 10.29 12 464457 266 63024287
Vitamin B12 deficiency 11.32 10.29 72 464397 5231 63019322
Wound infection 11.32 10.29 101 464368 21309 63003244
Fear of injection 11.31 10.29 22 464447 7142 63017411
Crohn's disease 11.30 10.29 68 464401 4845 63019708
Aphonia 11.29 10.29 118 464351 9945 63014608
Food allergy 11.27 10.29 44 464425 11357 63013196
Magnesium metabolism disorder 11.27 10.29 6 464463 43 63024510
Discoloured vomit 11.23 10.29 22 464447 872 63023681
Laryngeal oedema 11.21 10.29 76 464393 5642 63018911
Ventricular tachycardia 11.20 10.29 207 464262 19772 63004781
Gastric antral vascular ectasia 11.20 10.29 18 464451 609 63023944
Osteochondritis 11.18 10.29 5 464464 23 63024530
Norovirus test positive 11.18 10.29 11 464458 223 63024330
Listless 11.16 10.29 46 464423 2814 63021739
BK virus infection 11.15 10.29 5 464464 3274 63021279
Calcium metabolism disorder 11.14 10.29 9 464460 139 63024414
Antineutrophil cytoplasmic antibody positive 11.13 10.29 18 464451 612 63023941
Abortion induced 11.13 10.29 38 464431 10204 63014349
Lactation disorder 11.12 10.29 14 464455 376 63024177
Malabsorption 11.11 10.29 59 464410 4013 63020540
Pituitary tumour benign 11.10 10.29 36 464433 1959 63022594
Secondary adrenocortical insufficiency 11.06 10.29 29 464440 1399 63023154
Coeliac disease 11.05 10.29 52 464417 12745 63011808
Increased tendency to bruise 11.04 10.29 122 464347 10430 63014123
Hypervolaemia 10.99 10.29 279 464190 28134 62996419
Peptic ulcer perforation 10.99 10.29 10 464459 183 63024370
Extrasystoles 10.98 10.29 70 464399 5090 63019463
Mood altered 10.96 10.29 160 464309 14583 63009970
Cholangitis 10.96 10.29 74 464395 5487 63019066
Wrong technique in product usage process 10.92 10.29 360 464109 61980 62962573
Haematuria 10.89 10.29 285 464184 28872 62995681
Blindness 10.87 10.29 221 464248 21478 63003075
Urinary incontinence 10.85 10.29 309 464160 31705 62992848
Pulseless electrical activity 10.84 10.29 93 464376 7428 63017125
Oedematous pancreatitis 10.82 10.29 17 464452 564 63023989
Gastric haemorrhage 10.79 10.29 82 464387 6316 63018237
Gingival pain 10.77 10.29 99 464370 8063 63016490
Anal incontinence 10.76 10.29 149 464320 13427 63011126
Photopsia 10.75 10.29 63 464406 4446 63020107
Gastrointestinal polyp 10.72 10.29 6 464463 48 63024505
Hyperchromic anaemia 10.72 10.29 6 464463 48 63024505
Cardiac failure congestive 10.71 10.29 800 463669 91633 62932920
Decreased appetite 10.70 10.29 2038 462431 249014 62775539
Microalbuminuria 10.68 10.29 14 464455 392 63024161
Acinetobacter test positive 10.64 10.29 7 464462 77 63024476
Aortic stenosis 10.62 10.29 68 464401 4952 63019601
Head injury 10.59 10.29 269 464200 27127 62997426
Tendon sheath incision 10.57 10.29 7 464462 78 63024475
Injection site swelling 10.54 10.29 266 464203 47306 62977247
Suspected suicide 10.52 10.29 20 464449 6548 63018005
Respiratory disorder 10.51 10.29 212 464257 38870 62985683
Lung opacity 10.51 10.29 5 464464 3163 63021390
Injection site pain 10.51 10.29 812 463657 128988 62895565
Clostridium difficile colitis 10.47 10.29 210 464259 20359 63004194
Female genital tract fistula 10.45 10.29 25 464444 7534 63017019
Dermatitis atopic 10.43 10.29 113 464356 9611 63014942
Choluria 10.43 10.29 10 464459 196 63024357
Insomnia 10.42 10.29 1759 462710 213493 62811060
Stress ulcer 10.42 10.29 6 464463 51 63024502
Colonic abscess 10.41 10.29 23 464446 993 63023560
Product residue present 10.41 10.29 57 464412 3922 63020631
Gastroenteritis aeromonas 10.40 10.29 5 464464 28 63024525
Streptococcus test positive 10.35 10.29 27 464442 1298 63023255
Low birth weight baby 10.33 10.29 23 464446 7106 63017447
Cystic fibrosis lung 10.32 10.29 8 464461 116 63024437
Poliomyelitis 10.32 10.29 6 464463 52 63024501
Polymyositis 10.31 10.29 33 464436 1783 63022770
Blood phosphorus increased 10.31 10.29 48 464421 3097 63021456

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypomagnesaemia 618.62 10.93 856 305210 20995 34629870
Off label use 440.80 10.93 2035 304031 417489 34233376
Drug abuse 422.97 10.93 169 305897 98927 34551938
Drug ineffective 364.10 10.93 2427 303639 454324 34196541
Chronic kidney disease 296.85 10.93 914 305152 40296 34610569
Hypocalcaemia 245.71 10.93 610 305456 23679 34627186
Toxicity to various agents 225.75 10.93 945 305121 199417 34451448
Tubulointerstitial nephritis 203.23 10.93 519 305547 20505 34630360
Hypertrichosis 150.00 10.93 73 305993 340 34650525
Completed suicide 144.88 10.93 412 305654 97756 34553109
Treatment failure 138.25 10.93 123 305943 46574 34604291
Product use in unapproved indication 136.62 10.93 547 305519 116952 34533913
End stage renal disease 120.16 10.93 250 305816 8611 34642254
Therapeutic product effect incomplete 107.15 10.93 173 305893 50368 34600497
Product formulation issue 91.72 10.93 59 306007 511 34650354
Drug resistance 89.91 10.93 58 306008 25869 34624996
Drug interaction 88.63 10.93 2597 303469 223349 34427516
Tetany 87.17 10.93 66 306000 760 34650105
General physical health deterioration 82.80 10.93 721 305345 127548 34523317
Acute kidney injury 82.34 10.93 3357 302709 301631 34349234
Death 77.98 10.93 2778 303288 395271 34255594
Renal injury 73.87 10.93 241 305825 10954 34639911
Hypoparathyroidism 72.07 10.93 52 306014 553 34650312
Lower respiratory tract infection 70.03 10.93 496 305570 31141 34619724
Drug intolerance 70.01 10.93 276 305790 59294 34591571
Foetal exposure during pregnancy 69.52 10.93 143 305923 37958 34612907
Abdominal pain upper 67.93 10.93 939 305127 70551 34580314
Synovitis 66.82 10.93 20 306046 14046 34636819
Inappropriate antidiuretic hormone secretion 64.00 10.93 251 305815 12502 34638363
C-reactive protein abnormal 63.56 10.93 3 306063 8707 34642158
Diarrhoea 61.86 10.93 4080 301986 385832 34265033
Drug ineffective for unapproved indication 61.56 10.93 70 305996 23645 34627220
Lip swelling 60.39 10.93 290 305776 15790 34635075
Subacute cutaneous lupus erythematosus 60.33 10.93 58 306008 944 34649921
Gastrooesophageal reflux disease 57.18 10.93 545 305521 37379 34613486
Cardiospasm 55.44 10.93 69 305997 1519 34649346
Blood pressure fluctuation 54.85 10.93 85 305981 25164 34625701
Renal tubular acidosis 52.77 10.93 82 305984 2237 34648628
Condition aggravated 52.31 10.93 1282 304784 190914 34459951
Suicide attempt 52.07 10.93 172 305894 38944 34611921
Multiple organ dysfunction syndrome 51.78 10.93 425 305641 76141 34574724
Palmoplantar keratoderma 51.52 10.93 74 305992 1879 34648986
Hyponatraemia 51.38 10.93 1013 305053 81678 34569187
Infective pulmonary exacerbation of cystic fibrosis 50.94 10.93 153 305913 6648 34644217
Overdose 50.57 10.93 531 305535 90528 34560337
Drug hypersensitivity 50.45 10.93 456 305610 80073 34570792
Febrile neutropenia 49.26 10.93 872 305194 135977 34514888
Intentional overdose 49.02 10.93 206 305860 43468 34607397
Myalgia 48.17 10.93 1018 305048 83092 34567773
Hypertensive nephropathy 46.95 10.93 37 306029 454 34650411
Coma 46.73 10.93 223 305843 45455 34605410
Intentional product use issue 46.64 10.93 319 305747 59497 34591368
Product use issue 45.95 10.93 344 305722 62872 34587993
Poisoning 45.70 10.93 25 306041 12201 34638664
Cardiogenic shock 45.17 10.93 104 305962 26514 34624351
Therapy partial responder 45.08 10.93 14 306052 9602 34641263
Chest pain 43.47 10.93 1434 304632 125328 34525537
Hypoparathyroidism secondary 43.31 10.93 23 306043 133 34650732
Drug dependence 42.41 10.93 93 305973 24124 34626741
Hyperchlorhydria 41.80 10.93 40 306026 647 34650218
Plasma cell myeloma 41.48 10.93 556 305510 41481 34609384
Infusion related reaction 41.34 10.93 283 305783 52774 34598091
Gastric polyps 40.78 10.93 52 306014 1174 34649691
Nephrogenic anaemia 40.63 10.93 71 305995 2140 34648725
Immune reconstitution inflammatory syndrome 40.62 10.93 13 306053 8746 34642119
Hiatus hernia 39.61 10.93 152 305914 7493 34643372
Pruritus genital 39.50 10.93 70 305996 2134 34648731
Chromaturia 38.39 10.93 238 305828 14282 34636583
Asthenia 38.33 10.93 2564 303502 242687 34408178
Gastritis 37.90 10.93 324 305742 21549 34629316
Loss of personal independence in daily activities 37.54 10.93 156 305910 33023 34617842
Anosmia 36.48 10.93 97 305969 3927 34646938
Haemophagocytic lymphohistiocytosis 36.23 10.93 36 306030 12937 34637928
Tension headache 35.73 10.93 81 305985 2961 34647904
Premature baby 35.54 10.93 74 305992 19559 34631306
Dizziness 35.11 10.93 2290 303776 216231 34434634
Immunisation 34.76 10.93 45 306021 1032 34649833
Myelosuppression 34.55 10.93 73 305993 19192 34631673
Sleep terror 34.52 10.93 68 305998 2250 34648615
Atrial tachycardia 34.20 10.93 89 305977 3556 34647309
Occupational dermatitis 34.14 10.93 17 306049 84 34650781
Respiratory arrest 33.53 10.93 129 305937 27914 34622951
Interstitial lung disease 32.94 10.93 389 305677 64893 34585972
Confusional state 32.80 10.93 1560 304506 142600 34508265
Heart rate decreased 32.45 10.93 155 305911 31590 34619275
Facial pain 32.28 10.93 88 305978 3616 34647249
Dyspepsia 32.28 10.93 476 305590 36256 34614609
Multiple-drug resistance 32.12 10.93 4 306062 5235 34645630
Blood pressure systolic increased 31.89 10.93 99 305967 22853 34628012
Gastric mucosal hypertrophy 31.47 10.93 18 306048 123 34650742
Fatigue 31.21 10.93 3703 302363 366950 34283915
Mucormycosis 30.99 10.93 7 306059 5935 34644930
Abdominal pain 30.62 10.93 1738 304328 161880 34488985
Weight increased 30.59 10.93 602 305464 92431 34558434
Stress 30.54 10.93 149 305917 30198 34620667
Pathogen resistance 30.50 10.93 23 306043 9459 34641406
Rheumatoid arthritis 30.26 10.93 203 305863 38035 34612830
Tinnitus 30.26 10.93 289 305777 19829 34631036
Malignant neoplasm progression 30.09 10.93 566 305500 87480 34563385
Hypokalaemia 29.96 10.93 694 305372 57520 34593345
Iron deficiency anaemia 29.66 10.93 173 305893 10156 34640709
Upper gastrointestinal haemorrhage 29.66 10.93 348 305718 25170 34625695
Cytomegalovirus infection 29.49 10.93 123 305943 26012 34624853
Substance abuse 29.48 10.93 15 306051 7626 34643239
Inappropriate schedule of product administration 28.87 10.93 378 305688 61918 34588947
Obstructive airways disorder 28.39 10.93 58 306008 15436 34635429
Palpitations 28.33 10.93 500 305566 39486 34611379
Pain of skin 28.07 10.93 117 305949 5992 34644873
Muscle spasms 27.92 10.93 857 305209 74144 34576721
Systemic infection 27.46 10.93 6 306060 5206 34645659
Blood magnesium decreased 27.19 10.93 120 305946 6303 34644562
Multimorbidity 26.79 10.93 37 306029 905 34649960
Blood pressure diastolic abnormal 26.52 10.93 5 306061 4813 34646052
Jejunal ulcer perforation 26.50 10.93 14 306052 80 34650785
Drug use disorder 26.18 10.93 3 306063 4188 34646677
Aplastic anaemia 25.96 10.93 28 306038 9688 34641177
Vomiting 25.84 10.93 2510 303556 245111 34405754
Lethargy 25.26 10.93 503 305563 40619 34610246
Intentional product misuse 24.89 10.93 267 305799 45344 34605521
Tetanus 24.81 10.93 12 306054 55 34650810
Hallucination 24.69 10.93 608 305458 50890 34599975
Device dependence 24.69 10.93 11 306055 40 34650825
Right hemisphere deficit syndrome 24.67 10.93 9 306057 16 34650849
Pneumocystis jirovecii pneumonia 24.65 10.93 89 305977 19621 34631244
Therapeutic response decreased 24.53 10.93 153 305913 29160 34621705
Carotid artery occlusion 24.25 10.93 80 305986 3657 34647208
Hepatocellular injury 24.16 10.93 106 305960 22105 34628760
Respiratory depression 24.06 10.93 68 305998 16177 34634688
Oesophageal perforation 24.01 10.93 40 306026 1159 34649706
Altered state of consciousness 23.85 10.93 111 305955 22782 34628083
Haematotoxicity 23.74 10.93 22 306044 8172 34642693
Muscle twitching 23.69 10.93 163 305903 10135 34640730
Venoocclusive liver disease 23.54 10.93 21 306045 7945 34642920
Dysgeusia 23.53 10.93 344 305722 26153 34624712
Appendicitis 23.42 10.93 60 306006 14747 34636118
Product label on wrong product 23.37 10.93 9 306057 20 34650845
Diabetic nephropathy 23.17 10.93 55 306011 2073 34648792
Low birth weight baby 23.17 10.93 21 306045 7884 34642981
Soft tissue mass 23.14 10.93 36 306030 983 34649882
Granuloma annulare 23.07 10.93 16 306050 159 34650706
Intercepted product preparation error 22.95 10.93 4 306062 4074 34646791
Incorrect route of product administration 22.84 10.93 61 306005 14784 34636081
Tenosynovitis 22.63 10.93 6 306060 4564 34646301
Dyspnoea 22.57 10.93 3690 302376 373092 34277773
Meconium abnormal 22.51 10.93 12 306054 70 34650795
Exposure during pregnancy 22.51 10.93 27 306039 8907 34641958
Hepatic function abnormal 22.51 10.93 264 305802 44099 34606766
Renal failure 22.35 10.93 1376 304690 129181 34521684
Respiratory tract infection 22.11 10.93 267 305799 19445 34631420
Therapy non-responder 21.82 10.93 228 305838 38918 34611947
Apparent death 21.81 10.93 3 306063 3641 34647224
Oesophagitis 21.71 10.93 194 305872 13067 34637798
Muscular weakness 21.32 10.93 810 305256 72087 34578778
Migraine 21.04 10.93 240 305826 17238 34633627
Cystitis haemorrhagic 20.67 10.93 12 306054 5667 34645198
Immunosuppressant drug level increased 20.46 10.93 106 305960 5949 34644916
Lymphoma 20.31 10.93 50 306016 12457 34638408
Nephropathy 20.29 10.93 104 305962 5813 34645052
Blood pressure increased 20.18 10.93 602 305464 87500 34563365
Hepatic encephalopathy 20.16 10.93 207 305859 14478 34636387
Chronic kidney disease-mineral and bone disorder 20.07 10.93 21 306045 380 34650485
Helicobacter test positive 20.00 10.93 31 306035 844 34650021
Blood pressure systolic abnormal 19.90 10.93 5 306061 3943 34646922
Rectal haemorrhage 19.84 10.93 477 305589 39772 34611093
Pneumatosis intestinalis 19.71 10.93 5 306061 3918 34646947
Angioedema 19.67 10.93 447 305619 36927 34613938
Ageusia 19.63 10.93 156 305910 10152 34640713
Dehydration 19.40 10.93 1354 304712 128615 34522250
Acute interstitial pneumonitis 19.38 10.93 22 306044 438 34650427
Mesenteric vein thrombosis 19.29 10.93 30 306036 819 34650046
Cerebral infarction 19.19 10.93 151 305915 27304 34623561
Liver function test abnormal 19.05 10.93 380 305686 30694 34620171
Gastrointestinal haemorrhage 18.75 10.93 951 305115 87526 34563339
Flatulence 18.74 10.93 275 305791 20923 34629942
Sopor 18.57 10.93 50 306016 12086 34638779
Abnormal loss of weight 18.53 10.93 78 305988 4012 34646853
Brain scan abnormal 18.49 10.93 30 306036 850 34650015
Lupus endocarditis 18.38 10.93 6 306060 6 34650859
Post transplant lymphoproliferative disorder 18.36 10.93 18 306048 6510 34644355
Dry skin 18.32 10.93 380 305686 30907 34619958
Blood chromogranin A increased 18.32 10.93 17 306049 264 34650601
Degenerative mitral valve disease 18.27 10.93 17 306049 265 34650600
Product substitution issue 18.26 10.93 151 305915 9944 34640921
Swollen tongue 18.24 10.93 202 305864 14403 34636462
Nephritis 18.23 10.93 55 306011 2396 34648469
Bladder cancer 18.12 10.93 77 305989 16201 34634664
Incorrect dose administered 17.98 10.93 248 305818 40267 34610598
Graft versus host disease in gastrointestinal tract 17.93 10.93 5 306061 3678 34647187
Faeces discoloured 17.78 10.93 204 305862 14674 34636191
Chronic graft versus host disease 17.76 10.93 8 306058 4365 34646500
Rash papular 17.67 10.93 152 305914 10126 34640739
Indifference 17.66 10.93 13 306053 143 34650722
Blood gastrin increased 17.57 10.93 8 306058 31 34650834
Body temperature decreased 17.56 10.93 57 306009 12977 34637888
Therapeutic product effect decreased 17.53 10.93 207 305859 34536 34616329
Cerebral atrophy congenital 17.52 10.93 10 306056 68 34650797
Eye pruritus 17.50 10.93 119 305947 7370 34643495
Blood copper increased 17.48 10.93 7 306059 18 34650847
Barrett's oesophagus 17.45 10.93 21 306045 446 34650419
Lipodystrophy acquired 17.32 10.93 4 306062 3340 34647525
Bone marrow failure 17.29 10.93 168 305898 29085 34621780
Crohn's disease 17.00 10.93 63 306003 3054 34647811
Stoma site haemorrhage 16.90 10.93 29 306037 861 34650004
Bone erosion 16.86 10.93 7 306059 4008 34646857
Ceruloplasmin increased 16.68 10.93 6 306060 10 34650855
Labelled drug-drug interaction medication error 16.60 10.93 202 305864 14737 34636128
Cardio-respiratory arrest 16.58 10.93 363 305703 54910 34595955
Nephrosclerosis 16.55 10.93 30 306036 931 34649934
Lymphopenia 16.55 10.93 80 305986 16255 34634610
Steatorrhoea 16.53 10.93 26 306040 717 34650148
Diffuse large B-cell lymphoma recurrent 16.44 10.93 4 306062 3224 34647641
Virologic failure 16.43 10.93 5 306061 3475 34647390
Veillonella infection 16.41 10.93 5 306061 3 34650862
Blood pressure diastolic increased 16.41 10.93 12 306054 5013 34645852
Neuroleptic malignant syndrome 16.39 10.93 91 305975 17843 34633022
Ischaemic nephropathy 16.24 10.93 7 306059 23 34650842
Graft versus host disease in skin 16.23 10.93 7 306059 3918 34646947
Type I hypersensitivity 16.11 10.93 36 306030 1303 34649562
Jaundice 16.06 10.93 379 305687 31503 34619362
Carcinoid tumour of the gastrointestinal tract 16.04 10.93 9 306057 59 34650806
Infection 16.00 10.93 642 305424 90273 34560592
Urine calcium decreased 15.99 10.93 6 306060 12 34650853
Ventricular flutter 15.99 10.93 10 306056 82 34650783
Aminoaciduria 15.99 10.93 16 306050 274 34650591
Oesophageal stenosis 15.98 10.93 42 306024 1688 34649177
BK virus infection 15.93 10.93 16 306050 5722 34645143
Myoclonic dystonia 15.92 10.93 9 306057 60 34650805
Cytomegalovirus infection reactivation 15.73 10.93 13 306053 5105 34645760
Transient ischaemic attack 15.72 10.93 334 305732 27279 34623586
Nicotine dependence 15.69 10.93 23 306043 595 34650270
Abdominal discomfort 15.67 10.93 657 305409 59178 34591687
Febrile bone marrow aplasia 15.67 10.93 30 306036 8179 34642686
Coronary artery bypass 15.63 10.93 12 306054 4890 34645975
Gastric pH decreased 15.51 10.93 13 306053 175 34650690
Hyperhidrosis 15.51 10.93 811 305255 74881 34575984
Ischaemic stroke 15.45 10.93 235 305831 18015 34632850
Myasthenia gravis 15.42 10.93 23 306043 6917 34643948
Oxygen saturation decreased 15.42 10.93 356 305710 53462 34597403
Aggression 15.39 10.93 244 305822 38720 34612145
Malignant spinal cord compression 15.38 10.93 12 306054 145 34650720
Rales 15.37 10.93 143 305923 9740 34641125
Epstein-Barr virus infection 15.34 10.93 27 306039 7601 34643264
Bronchopulmonary aspergillosis 15.32 10.93 71 305995 14588 34636277
Gastric xanthoma 15.31 10.93 5 306061 5 34650860
Posterior reversible encephalopathy syndrome 15.24 10.93 41 306025 9913 34640952
Accidental exposure to product 15.23 10.93 59 306007 12743 34638122
Drug level increased 15.19 10.93 275 305791 21821 34629044
Sleep disorder due to a general medical condition 15.15 10.93 14 306052 5207 34645658
Status epilepticus 15.09 10.93 58 306008 12556 34638309
Oropharyngeal blistering 14.87 10.93 13 306053 186 34650679
International normalised ratio increased 14.83 10.93 530 305536 46797 34604068
Neutropenic sepsis 14.80 10.93 185 305881 13582 34637283
Unintentional medical device removal 14.72 10.93 3 306063 2733 34648132
Suspected suicide 14.66 10.93 12 306054 4736 34646129
Gastroenteritis eosinophilic 14.65 10.93 13 306053 190 34650675
Macrocephaly 14.52 10.93 20 306046 488 34650377
Hepatitis B reactivation 14.48 10.93 8 306058 3883 34646982
Blood lactate dehydrogenase increased 14.46 10.93 130 305936 22860 34628005
Cardiac arrest 14.45 10.93 691 305375 95468 34555397
Malaise 14.45 10.93 1848 304218 183977 34466888
Viral mutation identified 14.40 10.93 4 306062 2950 34647915
Progressive multifocal leukoencephalopathy 14.37 10.93 41 306025 9723 34641142
Akathisia 14.31 10.93 31 306035 8078 34642787
Cerebral artery thrombosis 14.27 10.93 25 306041 755 34650110
Disease progression 14.27 10.93 787 305279 107290 34543575
Pancreatic abscess 14.18 10.93 9 306057 76 34650789
Polymyositis 14.17 10.93 36 306030 1417 34649448
Dermatitis infected 14.12 10.93 10 306056 103 34650762
Rebound acid hypersecretion 14.12 10.93 10 306056 103 34650762
Insomnia 14.05 10.93 1074 304992 102833 34548032
Alveolitis 13.99 10.93 40 306026 1690 34649175
Uveitis 13.98 10.93 28 306038 7507 34643358
Cytomegalovirus chorioretinitis 13.91 10.93 7 306059 3582 34647283
Abdominal sepsis 13.80 10.93 29 306037 1006 34649859
Blood calcium decreased 13.77 10.93 142 305924 9942 34640923
Eye injury 13.77 10.93 26 306040 833 34650032
Gastric neoplasm 13.71 10.93 9 306057 81 34650784
Skin toxicity 13.68 10.93 13 306053 4771 34646094
Product substitution error 13.64 10.93 6 306060 21 34650844
Colorectal cancer 13.54 10.93 13 306053 4748 34646117
Pyloric stenosis 13.45 10.93 26 306040 848 34650017
Cytomegalovirus viraemia 13.45 10.93 28 306038 7402 34643463
No adverse event 13.41 10.93 132 305934 22795 34628070
Oral administration complication 13.38 10.93 8 306058 60 34650805
Visceral pain 13.38 10.93 8 306058 60 34650805
Endophthalmitis 13.36 10.93 7 306059 3501 34647364
Miosis 13.33 10.93 41 306025 9494 34641371
Electrocardiogram QRS complex prolonged 13.19 10.93 14 306052 4880 34645985
Sedation 13.12 10.93 119 305947 20887 34629978
Device malfunction 13.07 10.93 47 306019 10374 34640491
Pancreatitis 13.06 10.93 439 305627 38452 34612413
Aspergillus infection 13.01 10.93 59 306007 12195 34638670
Disinhibition 12.95 10.93 6 306060 3220 34647645
Pharyngeal oedema 12.91 10.93 94 305972 5953 34644912
Diverticulum 12.91 10.93 107 305959 7052 34643813
Faeces pale 12.90 10.93 34 306032 1369 34649496
Lymphangitis 12.89 10.93 20 306046 545 34650320
Blister 12.85 10.93 276 305790 22582 34628283
Occupational exposure to air contaminants 12.83 10.93 11 306055 153 34650712
Product complaint 12.83 10.93 92 305974 5798 34645067
Pancreatic pseudocyst 12.80 10.93 25 306041 822 34650043
Polyomavirus-associated nephropathy 12.79 10.93 9 306057 3835 34647030
Psoriasis 12.75 10.93 437 305629 38375 34612490
Aspartate aminotransferase increased 12.73 10.93 475 305591 67308 34583557
Accidental death 12.60 10.93 3 306063 2453 34648412
Headache 12.53 10.93 1970 304096 198665 34452200
Yellow skin 12.52 10.93 44 306022 2078 34648787
Amyloidosis 12.50 10.93 44 306022 2079 34648786
Breast inflammation 12.49 10.93 6 306060 27 34650838
Discoloured vomit 12.48 10.93 19 306047 509 34650356
Somatosensory evoked potentials abnormal 12.44 10.93 11 306055 160 34650705
Pseudoporphyria 12.39 10.93 16 306050 366 34650499
Syncope 12.32 10.93 945 305121 90506 34560359
Periodontal disease 12.31 10.93 24 306042 788 34650077
Back pain 12.30 10.93 1232 304834 120557 34530308
Latent tetany 12.25 10.93 4 306062 4 34650861
Urinary tract infection 12.20 10.93 874 305192 83207 34567658
Hepatitis B 12.19 10.93 21 306045 5962 34644903
Pleural mass 12.18 10.93 8 306058 72 34650793
Laboratory test 12.18 10.93 5 306061 14 34650851
Agitated depression 12.14 10.93 13 306053 242 34650623
Nervous system disorder 12.12 10.93 76 305990 14467 34636398
Amino acid level increased 12.03 10.93 17 306049 425 34650440
Ectopic gastric mucosa 11.93 10.93 5 306061 15 34650850
Catatonia 11.81 10.93 16 306050 5009 34645856
Peripheral sensory neuropathy 11.80 10.93 26 306040 6734 34644131
Herpes simplex 11.80 10.93 19 306047 5540 34645325
Blood sodium decreased 11.79 10.93 204 305862 16047 34634818
Intestinal infarction 11.77 10.93 19 306047 536 34650329
Oropharyngeal swelling 11.75 10.93 18 306048 485 34650380
Exposure to toxic agent 11.71 10.93 9 306057 3666 34647199
Pedal pulse decreased 11.70 10.93 5 306061 16 34650849
Musculoskeletal stiffness 11.69 10.93 315 305751 46365 34604500
Blood phosphorus increased 11.67 10.93 32 306034 7689 34643176
Radiation inflammation 11.65 10.93 25 306041 880 34649985
Pneumonia 11.62 10.93 3449 302617 359178 34291687
Intestinal angioedema 11.56 10.93 12 306054 215 34650650
Somnolence 11.56 10.93 827 305239 110289 34540576
Induration 11.49 10.93 26 306040 949 34649916
Neonatal respiratory distress syndrome 11.49 10.93 11 306055 4023 34646842
Wrong technique in product usage process 11.47 10.93 234 305832 35752 34615113
Fracture 11.42 10.93 27 306039 6822 34644043
Memory impairment 11.42 10.93 476 305590 42842 34608023
Cytopenia 11.38 10.93 65 306001 12658 34638207
Acute graft versus host disease 11.36 10.93 25 306041 6478 34644387
Hyponatraemic encephalopathy 11.34 10.93 7 306059 56 34650809
Red blood cell analysis abnormal 11.26 10.93 5 306061 18 34650847
Tracheobronchitis bacterial 11.26 10.93 5 306061 18 34650847
Hypocalcaemic seizure 11.26 10.93 6 306060 35 34650830
Leukopenia 11.24 10.93 443 305623 62413 34588452
Platelet production decreased 11.24 10.93 3 306063 0 34650865
Aspiration pleural cavity abnormal 11.24 10.93 3 306063 0 34650865
Anal chlamydia infection 11.24 10.93 3 306063 0 34650865
COVID-19 treatment 11.21 10.93 13 306053 265 34650600
Rheumatoid nodule 11.05 10.93 6 306060 2941 34647924
Deep vein thrombosis 11.02 10.93 687 305379 64561 34586304
Depressed level of consciousness 11.01 10.93 288 305778 42553 34608312
Vasculitis 10.97 10.93 149 305917 11147 34639718

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hypomagnesaemia 1314.12 10.04 1725 621684 45186 79075793
Drug ineffective 1130.51 10.04 4495 618914 1076418 78044561
Synovitis 892.29 10.04 77 623332 150657 78970322
Drug intolerance 805.08 10.04 538 622871 263581 78857398
Off label use 710.79 10.04 4177 619232 903038 78217941
Pemphigus 682.08 10.04 21 623388 99561 79021418
Hand deformity 658.51 10.04 38 623371 103881 79017098
Treatment failure 635.82 10.04 268 623141 170218 78950761
Tubulointerstitial nephritis 632.65 10.04 1100 622309 37135 79083844
Anti-cyclic citrullinated peptide antibody positive 616.20 10.04 6 623403 83137 79037842
Drug interaction 594.81 10.04 5393 618016 409790 78711189
Contraindicated product administered 577.34 10.04 254 623155 157284 78963695
Hypocalcaemia 513.01 10.04 1177 622232 48747 79072232
Hyponatraemia 481.06 10.04 2696 620713 175152 78945827
Wound 437.33 10.04 180 623229 115999 79004980
Chronic kidney disease 432.68 10.04 1318 622091 64836 79056143
Rheumatoid factor positive 431.55 10.04 7 623402 59832 79061147
Infusion related reaction 431.33 10.04 709 622700 229528 78891451
Drug abuse 421.46 10.04 390 623019 162301 78958678
Therapeutic product effect decreased 419.57 10.04 397 623012 163466 78957513
Systemic lupus erythematosus 416.71 10.04 213 623196 120936 79000043
Acute kidney injury 401.95 10.04 5989 617420 513415 78607564
Duodenal ulcer perforation 399.53 10.04 31 623378 66180 79054799
Glossodynia 387.50 10.04 161 623248 103176 79017803
Joint swelling 378.14 10.04 1085 622324 287561 78833418
Maternal exposure during pregnancy 368.43 10.04 315 623094 136223 78984756
Completed suicide 354.26 10.04 881 622528 244886 78876093
Drug hypersensitivity 333.43 10.04 1207 622202 297709 78823270
Arthropathy 317.30 10.04 561 622848 176550 78944429
Subacute cutaneous lupus erythematosus 315.71 10.04 245 623164 3316 79117663
Helicobacter infection 305.90 10.04 83 623326 69621 79051358
Hepatic enzyme increased 294.36 10.04 616 622793 181994 78938985
C-reactive protein abnormal 293.64 10.04 22 623387 48345 79072634
Rheumatoid arthritis 286.77 10.04 765 622644 207705 78913274
Sleep disorder due to general medical condition, insomnia type 285.14 10.04 13 623396 43543 79077436
Therapeutic product effect incomplete 273.80 10.04 427 622982 141218 78979761
Muscle injury 271.07 10.04 31 623378 48530 79072449
Pericarditis 267.38 10.04 252 623157 103984 79016995
Folliculitis 260.48 10.04 57 623352 55323 79065656
Product use issue 256.50 10.04 814 622595 209008 78911971
Discomfort 250.19 10.04 371 623038 125246 78995733
Diarrhoea 201.28 10.04 8603 614806 871886 78249093
Product use in unapproved indication 201.04 10.04 1141 622268 249218 78871761
Rheumatic fever 199.05 10.04 5 623404 28520 79092459
Hypersensitivity 195.34 10.04 1224 622185 261015 78859964
Toxicity to various agents 188.46 10.04 2248 621161 419292 78701687
Blood calcium decreased 177.14 10.04 600 622809 31219 79089760
Creatinine renal clearance decreased 175.65 10.04 430 622979 18572 79102407
Orthostatic hypotension 175.26 10.04 886 622523 55278 79065701
Hypertrichosis 173.21 10.04 114 623295 1168 79119811
Alopecia 168.10 10.04 1088 622321 230267 78890712
Tetany 167.86 10.04 152 623257 2576 79118403
Cognitive disorder 167.45 10.04 1027 622382 68899 79052080
Exposure during pregnancy 164.71 10.04 339 623070 100793 79020186
Irritable bowel syndrome 161.33 10.04 149 623260 62092 79058887
Impaired healing 159.31 10.04 275 623134 87380 79033599
Hypokalaemia 156.89 10.04 1770 621639 142270 78978709
End stage renal disease 156.40 10.04 315 623094 11905 79109074
Nasopharyngitis 152.19 10.04 1261 622148 252620 78868359
General physical health deterioration 146.18 10.04 1410 621999 273828 78847151
Swelling 146.04 10.04 1042 622367 215669 78905310
Condition aggravated 145.30 10.04 2903 620506 498221 78622758
Hypoparathyroidism 144.38 10.04 96 623313 1002 79119977
Intentional product use issue 144.36 10.04 654 622755 151458 78969521
Psoriatic arthropathy 144.23 10.04 242 623167 77757 79043222
Musculoskeletal stiffness 140.74 10.04 797 622612 174211 78946768
Infection 140.62 10.04 1210 622199 240502 78880477
Balance disorder 137.86 10.04 1278 622131 97579 79023400
Drug resistance 135.28 10.04 81 623328 42132 79078847
Red blood cell sedimentation rate abnormal 134.83 10.04 7 623402 20956 79100023
Sedation complication 133.74 10.04 344 623065 15325 79105654
Constipation 133.18 10.04 3022 620387 280028 78840951
Product formulation issue 125.44 10.04 84 623325 888 79120091
Abdominal pain 120.76 10.04 3940 619469 385629 78735350
Lip swelling 119.73 10.04 634 622775 40277 79080702
Stomatitis 116.02 10.04 672 622737 146085 78974894
Vomiting 114.05 10.04 6327 617082 659501 78461478
Blood pressure systolic increased 106.15 10.04 228 623181 66758 79054221
Ill-defined disorder 105.41 10.04 223 623186 65652 79055327
Plasma cell myeloma 104.92 10.04 745 622664 52514 79068465
Infective pulmonary exacerbation of cystic fibrosis 104.43 10.04 277 623132 12574 79108405
Fibromyalgia 102.79 10.04 218 623191 64122 79056857
Weight increased 102.43 10.04 1538 621871 275848 78845131
Gastrointestinal haemorrhage 101.81 10.04 1672 621737 146047 78974932
Cholecystitis chronic 98.92 10.04 231 623178 9675 79111304
Therapy non-responder 98.00 10.04 380 623029 91925 79029054
Inappropriate antidiuretic hormone secretion 97.27 10.04 436 622973 25877 79095102
Gastritis 96.68 10.04 675 622734 47318 79073661
Abdominal discomfort 93.32 10.04 1388 622021 249339 78871640
Therapeutic response decreased 92.08 10.04 245 623164 66608 79054371
Bone erosion 91.08 10.04 15 623394 17832 79103147
Chest pain 90.21 10.04 2866 620543 279438 78841541
Lethargy 89.86 10.04 1002 622407 80290 79040689
Fall 89.79 10.04 4666 618743 482963 78638016
Gastric polyps 88.59 10.04 127 623282 3620 79117359
Rheumatoid nodule 88.23 10.04 15 623394 17423 79103556
Myalgia 86.29 10.04 1979 621430 183662 78937317
Cardiospasm 85.67 10.04 117 623292 3184 79117795
Hip arthroplasty 85.31 10.04 92 623317 35664 79085315
Liver function test abnormal 84.64 10.04 823 622586 63652 79057327
Intentional overdose 83.83 10.04 485 622924 105475 79015504
Hallucination 83.30 10.04 1031 622378 84714 79036265
Dizziness 82.78 10.04 4965 618444 521476 78599503
Drug ineffective for unapproved indication 82.35 10.04 173 623236 51065 79069914
Abdominal pain upper 82.23 10.04 2312 621097 221507 78899472
Asthenia 81.61 10.04 4832 618577 506857 78614122
Swollen tongue 81.25 10.04 591 622818 41979 79079000
Blood pressure fluctuation 80.91 10.04 262 623147 66883 79054096
Red blood cell sedimentation rate increased 80.87 10.04 147 623262 45795 79075184
Palmoplantar keratoderma 80.70 10.04 121 623288 3595 79117384
Coma 80.53 10.04 459 622950 100190 79020789
Renal failure 78.93 10.04 2094 621315 198874 78922105
Dehydration 77.54 10.04 2513 620896 245674 78875305
Muscle spasms 77.00 10.04 1849 621560 172881 78948098
Sinusitis 76.67 10.04 1071 622338 194430 78926549
Gastric pH decreased 76.47 10.04 60 623349 826 79120153
Dyspnoea 76.28 10.04 7730 615679 849295 78271684
Hypertensive nephropathy 73.45 10.04 62 623347 952 79120027
Upper gastrointestinal haemorrhage 71.39 10.04 561 622848 40819 79080160
Tenosynovitis 71.16 10.04 17 623392 15537 79105442
Hypoparathyroidism secondary 70.99 10.04 35 623374 193 79120786
Angioedema 70.34 10.04 906 622503 75129 79045850
Loss of personal independence in daily activities 69.64 10.04 492 622917 102088 79018891
Transient ischaemic attack 69.34 10.04 673 622736 52022 79068957
Therapy partial responder 68.67 10.04 25 623384 17372 79103607
Tinnitus 68.40 10.04 586 622823 43747 79077232
Renal injury 68.32 10.04 288 623121 16639 79104340
Hiatus hernia 67.34 10.04 360 623049 22952 79098027
Pruritus genital 66.42 10.04 123 623286 4363 79116616
Tension headache 65.39 10.04 162 623247 7049 79113930
Blood pressure diastolic abnormal 64.16 10.04 35 623374 19167 79101812
Facet joint syndrome 63.61 10.04 7 623402 11295 79109684
Arthralgia 63.42 10.04 3741 619668 568062 78552917
Atrial tachycardia 63.37 10.04 159 623250 6974 79114005
Confusional state 62.79 10.04 3064 620345 314933 78806046
Respiratory arrest 62.32 10.04 235 623174 57315 79063664
Device expulsion 62.30 10.04 66 623343 25795 79095184
Syncope 61.85 10.04 1839 621570 177610 78943369
Drug tolerance decreased 61.75 10.04 13 623396 12965 79108014
Suicide attempt 61.19 10.04 388 623021 82544 79038435
Overdose 60.73 10.04 1043 622366 183163 78937816
Pulmonary embolism 60.21 10.04 1763 621646 169891 78951088
Haematemesis 59.95 10.04 649 622760 51615 79069364
Abortion spontaneous 59.84 10.04 86 623323 29421 79091558
Palpitations 59.83 10.04 1353 622056 125257 78995722
Sleep terror 59.56 10.04 117 623292 4341 79116638
Grip strength decreased 59.50 10.04 50 623359 21819 79099160
Live birth 58.62 10.04 37 623372 18707 79102272
Blood cholesterol increased 58.58 10.04 398 623011 83322 79037657
Blister 58.00 10.04 625 622784 118851 79002128
Myelosuppression 57.54 10.04 145 623264 40151 79080828
Carotid artery occlusion 56.33 10.04 159 623250 7488 79113491
Adverse event 55.84 10.04 261 623148 59953 79061026
Panniculitis 55.66 10.04 14 623395 12357 79108622
Breast cancer stage III 55.52 10.04 6 623403 9820 79111159
Deep vein thrombosis postoperative 54.95 10.04 9 623400 10743 79110236
Type 2 diabetes mellitus 54.51 10.04 245 623164 56877 79064102
Enthesopathy 54.47 10.04 12 623397 11596 79109383
Blood pressure systolic abnormal 54.00 10.04 34 623375 17213 79103766
Pregnancy 53.72 10.04 79 623330 26772 79094207
Poisoning 51.90 10.04 73 623336 25199 79095780
International normalised ratio increased 51.86 10.04 941 622468 83780 79037199
Deep vein thrombosis 51.57 10.04 1274 622135 119645 79001334
Pancreatitis acute 51.47 10.04 604 622805 49000 79071979
Chromaturia 51.20 10.04 361 623048 25385 79095594
Urinary tract infection 50.66 10.04 2628 620781 271884 78849095
Blood sodium decreased 49.96 10.04 437 622972 32818 79088161
Aplastic anaemia 49.88 10.04 40 623369 17865 79103114
Swelling face 49.38 10.04 807 622602 70405 79050574
Heart rate decreased 49.33 10.04 334 623075 69982 79050997
Immunisation 49.12 10.04 72 623337 2095 79118884
Flatulence 48.75 10.04 530 622879 42194 79078785
Rectal haemorrhage 48.66 10.04 853 622556 75447 79045532
Breast cancer stage II 48.42 10.04 4 623405 8116 79112863
Blood magnesium decreased 48.38 10.04 256 623153 16256 79104723
Obstructive airways disorder 48.25 10.04 109 623300 31350 79089629
Gastrooesophageal reflux disease 48.00 10.04 1110 622299 103136 79017843
Anosmia 47.67 10.04 165 623244 8679 79112300
Sedation 47.00 10.04 616 622793 51279 79069700
Nausea 46.92 10.04 8331 615078 948865 78172114
Prescribed overdose 46.91 10.04 146 623263 37737 79083242
Nephrogenic anaemia 46.88 10.04 98 623311 3804 79117175
Facial pain 46.67 10.04 206 623203 12144 79108835
Malaise 46.55 10.04 4440 618969 485429 78635550
Tremor 46.49 10.04 1696 621713 168387 78952592
Malignant neoplasm progression 46.44 10.04 765 622644 135225 78985754
Sopor 46.19 10.04 120 623289 32890 79088089
Lip dry 46.10 10.04 32 623377 15386 79105593
Abnormal loss of weight 45.78 10.04 157 623252 8219 79112760
Disorientation 45.63 10.04 717 622692 62059 79058920
Adjustment disorder with depressed mood 45.56 10.04 8 623401 9078 79111901
Rhabdomyolysis 45.30 10.04 1091 622318 102040 79018939
Immune reconstitution inflammatory syndrome 45.14 10.04 26 623383 13815 79107164
Liver injury 44.84 10.04 259 623150 56355 79064624
Jaundice 44.11 10.04 623 622786 52726 79068253
Gastrointestinal disorder 43.21 10.04 683 622726 121522 78999457
Joint range of motion decreased 42.84 10.04 126 623283 33156 79087823
Dysgeusia 42.30 10.04 655 622754 56522 79064457
Premature delivery 42.28 10.04 74 623335 23393 79097586
Autoimmune disorder 41.60 10.04 41 623368 16571 79104408
Dry skin 41.18 10.04 754 622655 67241 79053738
Inflammation 40.99 10.04 502 622907 93251 79027728
Atrial fibrillation 40.77 10.04 1915 621494 195971 78925008
Cytomegalovirus infection 40.63 10.04 183 623226 42461 79078518
Occupational dermatitis 40.11 10.04 21 623388 134 79120845
Accidental exposure to product 40.01 10.04 119 623290 31203 79089776
Toxic epidermal necrolysis 39.47 10.04 527 622882 44054 79076925
Iron deficiency anaemia 39.42 10.04 339 623070 25333 79095646
Neutropenic sepsis 39.29 10.04 353 623056 26711 79094268
Mucormycosis 39.25 10.04 9 623400 8460 79112519
Biliary dyskinesia 39.22 10.04 71 623338 2474 79118505
Body temperature decreased 39.02 10.04 125 623284 32020 79088959
Multimorbidity 38.86 10.04 52 623357 1387 79119592
Cogwheel rigidity 38.80 10.04 79 623330 3009 79117970
Mouth swelling 38.09 10.04 119 623290 5932 79115047
Oesophagitis 37.96 10.04 322 623087 23967 79097012
Rash 37.85 10.04 3951 619458 574407 78546572
Faeces discoloured 37.83 10.04 371 623038 28756 79092223
Multiple-drug resistance 37.68 10.04 11 623398 8797 79112182
Type I hypersensitivity 36.96 10.04 96 623313 4302 79116677
Systemic infection 36.85 10.04 15 623394 9737 79111242
Gallbladder disorder 36.62 10.04 268 623141 19072 79101907
Haemophagocytic lymphohistiocytosis 36.56 10.04 72 623337 21765 79099214
Pathogen resistance 36.38 10.04 35 623374 14307 79106672
Inappropriate schedule of product administration 36.25 10.04 782 622627 132846 78988133
Chronic obstructive pulmonary disease 36.12 10.04 899 622510 84520 79036459
Hepatic encephalopathy 36.01 10.04 317 623092 23849 79097130
Device difficult to use 35.93 10.04 31 623378 13354 79107625
Bursitis 35.87 10.04 151 623258 35693 79085286
Hyperhidrosis 35.83 10.04 1487 621922 150005 78970974
Labelled drug-drug interaction medication error 35.82 10.04 352 623057 27298 79093681
Renal tubular acidosis 35.78 10.04 84 623325 3530 79117449
Blood pressure increased 35.78 10.04 1321 622088 210039 78910940
Metabolic alkalosis 35.71 10.04 96 623313 4393 79116586
Catatonia 35.56 10.04 12 623397 8744 79112235
Dislocation of vertebra 35.29 10.04 9 623400 7871 79113108
Anaemia 34.80 10.04 3981 619428 441034 78679945
Disability 34.61 10.04 50 623359 17070 79103909
Vision blurred 34.52 10.04 1078 622331 104820 79016159
C-reactive protein increased 34.45 10.04 757 622652 128270 78992709
Muscle twitching 34.43 10.04 320 623089 24444 79096535
Cardiogenic shock 34.14 10.04 190 623219 41724 79079255
Muscle spasticity 34.10 10.04 73 623336 21402 79099577
Post transplant lymphoproliferative disorder 34.00 10.04 24 623385 11440 79109539
Oral pain 33.79 10.04 389 623020 31409 79089570
Nephropathy 33.50 10.04 158 623251 9580 79111399
Interstitial lung disease 33.50 10.04 649 622760 111951 79009028
Epstein-Barr virus infection 33.39 10.04 38 623371 14378 79106601
Sleep disorder due to a general medical condition 32.67 10.04 38 623371 14239 79106740
Depersonalisation/derealisation disorder 32.67 10.04 55 623354 1807 79119172
Knee arthroplasty 32.59 10.04 201 623208 43047 79077932
Osteoarthritis 32.55 10.04 483 622926 86826 79034153
Red blood cell sedimentation rate 32.48 10.04 3 623406 5562 79115417
Burning mouth syndrome 32.44 10.04 30 623379 523 79120456
Product substitution issue 32.43 10.04 270 623139 19986 79100993
Haemoglobin decreased 32.40 10.04 2082 621327 220037 78900942
H1N1 influenza 32.31 10.04 65 623344 2454 79118525
Stress 32.31 10.04 433 622976 79179 79041800
Feeling abnormal 32.23 10.04 1538 621871 157661 78963318
Pulmonary malformation 32.16 10.04 21 623388 212 79120767
Disturbance in attention 32.05 10.04 567 622842 50234 79070745
Hyperchlorhydria 32.04 10.04 58 623351 2021 79118958
Device use error 32.02 10.04 8 623401 7093 79113886
Feeling of despair 31.76 10.04 69 623340 2752 79118227
Blood pressure diastolic decreased 31.67 10.04 125 623284 30091 79090888
Muscular weakness 31.53 10.04 1548 621861 159181 78961798
Caesarean section 31.32 10.04 31 623378 12504 79108475
Gastric mucosal hypertrophy 31.24 10.04 22 623387 254 79120725
Pain 31.09 10.04 4930 618479 698872 78422107
Feeling of body temperature change 31.03 10.04 102 623307 5224 79115755
Pain of skin 30.89 10.04 208 623201 14405 79106574
Pancreatitis 30.89 10.04 728 622681 67847 79053132
Derealisation 30.67 10.04 50 623359 1599 79119380
Unintentional medical device removal 30.58 10.04 11 623398 7701 79113278
Retinitis 30.51 10.04 4 623405 5639 79115340
Cross sensitivity reaction 30.15 10.04 80 623329 3632 79117347
Device dependence 30.04 10.04 13 623396 50 79120929
Diabetic nephropathy 29.73 10.04 69 623340 2878 79118101
Drooling 29.66 10.04 108 623301 5826 79115153
Cytomegalovirus viraemia 29.48 10.04 34 623375 12787 79108192
Rash papular 29.37 10.04 281 623128 21635 79099344
Blood potassium decreased 28.59 10.04 517 622892 45995 79074984
Dilatation intrahepatic duct acquired 28.59 10.04 32 623377 706 79120273
Blindness 28.30 10.04 343 623066 28040 79092939
Poisoning deliberate 28.26 10.04 66 623343 18762 79102217
C-reactive protein 28.24 10.04 3 623406 4976 79116003
Obesity 28.19 10.04 160 623249 34965 79086014
Non-cardiac chest pain 28.14 10.04 148 623261 9376 79111603
Bladder cancer 28.08 10.04 70 623339 19456 79101523
Parosmia 28.04 10.04 119 623290 6895 79114084
Hypophosphataemia 28.02 10.04 258 623151 19655 79101324
Pneumonia 28.00 10.04 5706 617703 654540 78466439
Mania 27.97 10.04 241 623168 18019 79102960
Paraesthesia 27.79 10.04 1664 621745 174659 78946320
Back pain 27.66 10.04 2749 620660 301431 78819548
Hallucinations, mixed 27.54 10.04 117 623292 6782 79114197
Breast cancer stage I 27.53 10.04 9 623400 6691 79114288
Palatal oedema 27.44 10.04 44 623365 1387 79119592
Chronic kidney disease-mineral and bone disorder 27.28 10.04 27 623382 514 79120465
Respiratory depression 27.28 10.04 117 623292 27513 79093466
Lung disorder 27.22 10.04 454 622955 80103 79040876
Blood chromogranin A increased 27.09 10.04 26 623383 476 79120503
Hypergastrinaemia 27.06 10.04 18 623391 188 79120791
Hypoglycaemia 27.01 10.04 1010 622399 100584 79020395
Presyncope 26.90 10.04 461 622948 40593 79080386
Electrocardiogram QT prolonged 26.85 10.04 910 622499 89476 79031503
Hepatitis cholestatic 26.83 10.04 193 623216 13659 79107320
Malignant mediastinal neoplasm 26.44 10.04 43 623366 1372 79119607
Product complaint 26.44 10.04 187 623222 13162 79107817
Human herpesvirus 6 infection 26.34 10.04 5 623404 5365 79115614
Polymyositis 26.27 10.04 67 623342 2969 79118010
Tetanus 26.10 10.04 12 623397 55 79120924
Right hemisphere deficit syndrome 26.02 10.04 9 623400 15 79120964
Skin necrosis 25.89 10.04 65 623344 18022 79102957
Drug use disorder 25.81 10.04 18 623391 8633 79112346
Sciatica 25.77 10.04 153 623256 33069 79087910
Lung cyst 25.56 10.04 21 623388 310 79120669
Multiple organ dysfunction syndrome 25.47 10.04 730 622679 119516 79001463
BK virus infection 25.37 10.04 19 623390 8785 79112194
Calcium deficiency 25.07 10.04 33 623376 866 79120113
Foetal death 24.99 10.04 16 623393 8028 79112951
Incorrect route of product administration 24.95 10.04 165 623244 34764 79086215
Rash macular 24.91 10.04 340 623069 28559 79092420
Chronic graft versus host disease 24.71 10.04 11 623398 6770 79114209
Arthritis 24.70 10.04 696 622713 114184 79006795
Hypoaesthesia oral 24.64 10.04 192 623217 13932 79107047
Electrocardiogram QRS complex prolonged 24.61 10.04 29 623380 10804 79110175
Barrett's oesophagus 24.60 10.04 31 623378 778 79120201
Blood alkaline phosphatase increased 24.57 10.04 662 622747 63002 79057977
Long QT syndrome 24.56 10.04 102 623307 5853 79115126
Blood gastrin increased 24.53 10.04 11 623398 47 79120932
Colorectal cancer 24.49 10.04 19 623390 8628 79112351
Haematotoxicity 24.43 10.04 53 623356 15466 79105513
Acute graft versus host disease 24.43 10.04 26 623383 10141 79110838
Parkinsonism 24.43 10.04 217 623192 16367 79104612
Peripheral swelling 24.36 10.04 1796 621613 267821 78853158
Therapeutic response shortened 24.30 10.04 55 623354 15808 79105171
Colitis ischaemic 24.21 10.04 204 623205 15155 79105824
Gallbladder injury 24.04 10.04 38 623371 1183 79119796
Pulmonary toxicity 23.93 10.04 40 623369 12874 79108105
Graft versus host disease in gastrointestinal tract 23.66 10.04 10 623399 6346 79114633
Jejunal ulcer perforation 23.64 10.04 14 623395 117 79120862
Truncus coeliacus thrombosis 23.64 10.04 8 623401 12 79120967
Wrong technique in product usage process 23.46 10.04 421 622988 73454 79047525
Dialysis 23.41 10.04 234 623175 18228 79102751
Suspected suicide 23.30 10.04 29 623380 10547 79110432
Miosis 23.18 10.04 56 623353 15733 79105246
Substance abuse 23.05 10.04 29 623380 10497 79110482
Pneumocystis jirovecii pneumonia 23.00 10.04 154 623255 32354 79088625
Product label on wrong product 22.71 10.04 9 623400 26 79120953
Cutaneous lupus erythematosus 22.67 10.04 63 623346 2940 79118039
Febrile bone marrow aplasia 22.61 10.04 42 623367 12978 79108001
Melaena 22.61 10.04 630 622779 60260 79060719
Cystitis haemorrhagic 22.55 10.04 23 623386 9149 79111830
Soft tissue mass 22.54 10.04 38 623371 1250 79119729
Exposure to toxic agent 22.48 10.04 23 623386 9135 79111844
Oesophageal stenosis 22.40 10.04 80 623329 4274 79116705
Subarachnoid haemorrhage 22.40 10.04 291 623118 24174 79096805
Drug level increased 22.05 10.04 434 622975 39217 79081762
Nephrosclerosis 22.03 10.04 46 623363 1784 79119195
Abdominal tenderness 21.92 10.04 150 623259 10444 79110535
Graft versus host disease in skin 21.90 10.04 10 623399 6063 79114916
Intestinal dilatation 21.74 10.04 58 623351 2642 79118337
Hypergammaglobulinaemia 21.73 10.04 28 623381 719 79120260
Dissociation 21.66 10.04 75 623334 3946 79117033
Dysphagia 21.64 10.04 1165 622244 120971 79000008
Cholecystectomy 21.61 10.04 137 623272 9295 79111684
Eye pruritus 21.57 10.04 251 623158 20319 79100660
Hypophagia 21.47 10.04 485 622924 44882 79076097
Bone marrow failure 21.45 10.04 276 623133 50831 79070148
Neutrophil count increased 21.45 10.04 336 623073 29060 79091919
Electrolyte imbalance 21.42 10.04 350 623059 30531 79090448
Essential hypertension 21.40 10.04 99 623310 5954 79115025
Metastases to lymph nodes 21.38 10.04 30 623379 10367 79110612
Altered state of consciousness 21.35 10.04 229 623180 43593 79077386
Product packaging confusion 21.31 10.04 17 623392 240 79120739
Febrile neutropenia 21.31 10.04 1536 621873 229463 78891516
Acute interstitial pneumonitis 21.29 10.04 36 623373 1187 79119792
Musculoskeletal pain 21.27 10.04 623 622786 101731 79019248
Memory impairment 21.26 10.04 1073 622336 110661 79010318
Chest discomfort 21.23 10.04 1300 622109 136744 78984235
Discoloured vomit 21.23 10.04 40 623369 1438 79119541
Ageusia 21.18 10.04 211 623198 16421 79104558
Injection site pain 21.18 10.04 815 622594 129023 78991956
Rebound acid hypersecretion 21.12 10.04 12 623397 92 79120887
Adjusted calcium decreased 21.09 10.04 16 623393 209 79120770
Occult blood positive 21.05 10.04 108 623301 6775 79114204
Clostridium difficile infection 21.05 10.04 459 622950 42226 79078753
Accidental death 21.04 10.04 4 623405 4287 79116692
Joint destruction 20.99 10.04 10 623399 5915 79115064
Diverticulum 20.96 10.04 193 623216 14703 79106276
Tongue blistering 20.93 10.04 41 623368 1518 79119461
Chronic sinusitis 20.91 10.04 44 623365 12982 79107997
Pneumonitis 20.75 10.04 623 622786 60237 79060742
Moraxella test positive 20.74 10.04 8 623401 21 79120958
Injection site bruising 20.49 10.04 213 623196 40789 79080190
Cholelithiasis 20.43 10.04 548 622861 52116 79068863
Duodenitis 20.33 10.04 119 623290 7848 79113131
Dyspepsia 20.32 10.04 1042 622367 107645 79013334
X-ray abnormal 20.31 10.04 10 623399 5803 79115176
Lower gastrointestinal haemorrhage 20.26 10.04 204 623205 15921 79105058
Blood pressure diastolic increased 20.24 10.04 53 623356 14489 79106490
Viral mutation identified 20.24 10.04 3 623406 3855 79117124
Haemoptysis 20.12 10.04 577 622832 55422 79065557
Chronic spontaneous urticaria 19.96 10.04 35 623374 1189 79119790
Breast cancer female 19.88 10.04 37 623372 11424 79109555
Alanine aminotransferase abnormal 19.86 10.04 24 623385 8843 79112136
Liver disorder 19.86 10.04 423 622986 71994 79048985
Nightmare 19.80 10.04 298 623111 25563 79095416
Vitamin B12 deficiency 19.69 10.04 110 623299 7131 79113848
Drug eruption 19.67 10.04 234 623175 43701 79077278
Nasal polyps 19.63 10.04 17 623392 7310 79113669
Skin exfoliation 19.60 10.04 567 622842 54533 79066446
Intentional product misuse 19.59 10.04 580 622829 94585 79026394
Pulmonary pain 19.55 10.04 78 623331 4395 79116584
Cerebrovascular accident 19.54 10.04 1438 621971 153854 78967125
Circulatory collapse 19.52 10.04 408 623001 37260 79083719
Pneumatosis intestinalis 19.50 10.04 13 623396 6384 79114595
Product dose omission issue 19.39 10.04 2215 621194 245322 78875657
Oxygen saturation decreased 19.34 10.04 818 622591 128229 78992750
Prescribed underdose 19.32 10.04 143 623266 29371 79091608
Progressive multifocal leukoencephalopathy 19.27 10.04 89 623320 20511 79100468
Respiratory tract malformation 19.25 10.04 12 623397 111 79120868
Oropharyngeal blistering 19.17 10.04 27 623382 757 79120222
Hypotension 19.09 10.04 3810 619599 436507 78684472
Depression 19.08 10.04 1955 621454 214835 78906144
Agitated depression 18.99 10.04 20 623389 411 79120568
Indifference 18.87 10.04 17 623392 286 79120693
Torus fracture 18.77 10.04 11 623398 90 79120889
Pancreatic abscess 18.77 10.04 11 623398 90 79120889
Malignant spinal cord compression 18.76 10.04 13 623396 146 79120833
Infective exacerbation of chronic obstructive airways disease 18.69 10.04 56 623353 2728 79118251
Faecal calprotectin increased 18.66 10.04 10 623399 5531 79115448
Aminoaciduria 18.65 10.04 19 623390 375 79120604
Vasoplegia syndrome 18.64 10.04 3 623406 3627 79117352
Mesenteric artery thrombosis 18.58 10.04 24 623385 618 79120361
Aspergillus infection 18.39 10.04 82 623327 19079 79101900
Oesophageal perforation 18.35 10.04 39 623370 1532 79119447
Degenerative mitral valve disease 18.31 10.04 17 623392 298 79120681
Blood parathyroid hormone decreased 18.28 10.04 34 623375 10502 79110477
Poor sucking reflex 18.23 10.04 12 623397 123 79120856
Immunosuppressant drug level increased 18.20 10.04 127 623282 8900 79112079
Oesophageal atresia 18.18 10.04 11 623398 96 79120883
Choluria 18.17 10.04 19 623390 387 79120592
Joint stiffness 18.08 10.04 218 623191 40612 79080367
Personality disorder 18.05 10.04 13 623396 6133 79114846
Anxiety 18.04 10.04 2213 621196 246299 78874680
Restless legs syndrome 17.98 10.04 238 623171 19854 79101125
Polyuria 17.94 10.04 188 623221 14826 79106153
Lung opacity 17.92 10.04 9 623400 5165 79115814
Posterior reversible encephalopathy syndrome 17.85 10.04 126 623283 26155 79094824
Food allergy 17.85 10.04 36 623373 10788 79110191
Cardiac arrest 17.76 10.04 1133 622276 170963 78950016
Polyomavirus-associated nephropathy 17.74 10.04 11 623398 5616 79115363
Temperature regulation disorder 17.70 10.04 12 623397 5841 79115138
Vasculitis 17.60 10.04 285 623124 24817 79096162
Polycystic ovaries 17.55 10.04 4 623405 3775 79117204
Hyperkalaemia 17.53 10.04 1077 622332 113321 79007658
Acute generalised exanthematous pustulosis 17.41 10.04 209 623200 17045 79103934
Skin discolouration 17.38 10.04 432 622977 40602 79080377
Drug dose omission by device 17.36 10.04 14 623395 6236 79114743
Genital ulceration 17.35 10.04 31 623378 1069 79119910
Endophthalmitis 17.12 10.04 15 623394 6413 79114566
Atrioventricular block complete 17.12 10.04 202 623207 16408 79104571
Ventilation perfusion mismatch 17.09 10.04 23 623386 617 79120362
Normal newborn 17.09 10.04 18 623391 7054 79113925
Target skin lesion 17.08 10.04 12 623397 138 79120841
Muscle disorder 17.08 10.04 89 623320 5618 79115361
Transplant rejection 17.00 10.04 86 623323 19351 79101628
Death 16.98 10.04 4048 619361 562466 78558513
Cytomegalovirus chorioretinitis 16.94 10.04 11 623398 5479 79115500
Multiple drug therapy 16.94 10.04 70 623339 4008 79116971
Cerebral infarction 16.91 10.04 253 623156 45423 79075556
Yellow skin 16.85 10.04 63 623346 3442 79117537
Thermohypoaesthesia 16.85 10.04 11 623398 111 79120868
Carcinoid tumour of the gastrointestinal tract 16.84 10.04 10 623399 84 79120895
Avian influenza 16.74 10.04 10 623399 85 79120894
Pregnancy with contraceptive device 16.70 10.04 4 623405 3650 79117329
Nocardiosis 16.70 10.04 12 623397 5667 79115312
Blood copper increased 16.57 10.04 7 623402 25 79120954
Cystic fibrosis 16.43 10.04 67 623342 3813 79117166
Pharyngeal oedema 16.38 10.04 197 623212 16075 79104904
Ceruloplasmin increased 16.34 10.04 6 623403 13 79120966
Burning sensation 16.33 10.04 586 622823 58046 79062933
Wound infection 16.31 10.04 115 623294 23876 79097103
Myoclonic dystonia 16.28 10.04 9 623400 65 79120914
Brain scan abnormal 16.22 10.04 32 623377 1191 79119788
Impaired quality of life 16.20 10.04 178 623231 14208 79106771
Adverse drug reaction 16.18 10.04 395 623014 65997 79054982
Calcium metabolism disorder 16.17 10.04 9 623400 66 79120913
Gastrointestinal polyp haemorrhage 16.09 10.04 20 623389 495 79120484
Tongue oedema 16.07 10.04 103 623306 7014 79113965
Intercepted product preparation error 16.07 10.04 4 623405 3556 79117423
Hand-eye coordination impaired 15.97 10.04 7 623402 28 79120951
Urinary tract infection pseudomonal 15.89 10.04 40 623369 1758 79119221
Gastric xanthoma 15.87 10.04 5 623404 5 79120974
Fear of eating 15.80 10.04 19 623390 454 79120525
Akathisia 15.79 10.04 52 623357 13207 79107772
Ectopic gastric mucosa 15.76 10.04 6 623403 15 79120964
Product residue present 15.73 10.04 62 623347 3474 79117505
Use of accessory respiratory muscles 15.72 10.04 20 623389 507 79120472
Intestinal ulcer 15.63 10.04 43 623366 1995 79118984
Genital pain 15.57 10.04 25 623384 789 79120190
Sepsis neonatal 15.42 10.04 8 623401 50 79120929
Acute myocardial infarction 15.32 10.04 743 622666 76293 79044686
Injury 15.28 10.04 475 622934 77021 79043958
Hepatitis B 15.26 10.04 26 623383 8306 79112673
Acute psychosis 15.25 10.04 69 623340 4111 79116868
Ventricular flutter 15.15 10.04 10 623399 103 79120876
Cholecystitis 15.13 10.04 251 623158 21961 79099018
Acquired oesophageal web 15.11 10.04 16 623393 331 79120648
Ischaemic nephropathy 15.07 10.04 7 623402 33 79120946
Seronegative arthritis 15.04 10.04 9 623400 4683 79116296
Nephroangiosclerosis 15.03 10.04 16 623393 333 79120646
Injection site reaction 15.03 10.04 320 623089 54465 79066514
Metastases to lung 14.97 10.04 82 623327 18081 79102898
Virologic failure 14.96 10.04 7 623402 4184 79116795
Lower limb fracture 14.95 10.04 113 623296 23102 79097877
Fear of injection 14.94 10.04 22 623387 7452 79113527
Finger deformity 14.94 10.04 22 623387 7452 79113527
Respiratory tract infection 14.91 10.04 492 622917 48197 79072782
Blood glucose increased 14.86 10.04 1067 622342 113908 79007071
Abnormal weight gain 14.84 10.04 50 623359 2594 79118385
Mood swings 14.80 10.04 228 623181 19652 79101327
Sensory loss 14.75 10.04 161 623248 12830 79108149
Injection site haemorrhage 14.67 10.04 143 623266 27727 79093252
White blood cell count increased 14.67 10.04 719 622690 73914 79047065
Carotid artery thrombosis 14.65 10.04 3 623406 3050 79117929
Product taste abnormal 14.61 10.04 45 623364 2226 79118753
Bronchopulmonary aspergillosis 14.60 10.04 108 623301 22186 79098793
Hepatic haematoma 14.54 10.04 25 623384 836 79120143
Hypertension 14.50 10.04 2319 621090 328673 78792306
Insomnia 14.41 10.04 2156 621253 243014 78877965
Superinfection 14.36 10.04 76 623333 4826 79116153
Abdominal sepsis 14.34 10.04 42 623367 2020 79118959
Hypomania 14.32 10.04 23 623386 7521 79113458
Injection site erythema 14.30 10.04 484 622925 77713 79043266
Helicobacter test positive 14.24 10.04 32 623377 1306 79119673
Stevens-Johnson syndrome 14.19 10.04 404 623005 38762 79082217
Blood urea increased 14.18 10.04 490 622919 48300 79072679
Deformity 14.15 10.04 34 623375 9571 79111408
Bleeding time prolonged 14.04 10.04 31 623378 1250 79119729
Endoscopy abnormal 14.01 10.04 8 623401 62 79120917
Intestinal metaplasia 14.00 10.04 7 623402 40 79120939
Supraventricular tachycardia 13.99 10.04 239 623170 21031 79099948
Drug dispensed to wrong patient 13.94 10.04 22 623387 684 79120295
Prothrombin level decreased 13.93 10.04 36 623373 1608 79119371
Occupational exposure to air contaminants 13.93 10.04 11 623398 153 79120826
Postictal paralysis 13.91 10.04 16 623393 364 79120615
Secondary immunodeficiency 13.91 10.04 4 623405 3230 79117749
Enterococcal infection 13.86 10.04 69 623340 15591 79105388
Lactation disorder 13.77 10.04 13 623396 233 79120746
Abdominal distension 13.73 10.04 1100 622309 118550 79002429
Transplant dysfunction 13.72 10.04 22 623387 7199 79113780
Gallbladder adenocarcinoma 13.68 10.04 10 623399 123 79120856
Radiation inflammation 13.63 10.04 25 623384 880 79120099
Hyponatraemic syndrome 13.63 10.04 23 623386 757 79120222
Incontinence 13.61 10.04 170 623239 13994 79106985
Visceral pain 13.61 10.04 9 623400 93 79120886
Viral diarrhoea 13.61 10.04 16 623393 373 79120606
Diffuse large B-cell lymphoma recurrent 13.58 10.04 8 623401 4199 79116780
Skin test positive 13.54 10.04 29 623380 1145 79119834
Cytomegalovirus infection reactivation 13.53 10.04 30 623379 8686 79112293
Dermatitis atopic 13.51 10.04 129 623280 9927 79111052
Duodenal stenosis 13.48 10.04 23 623386 764 79120215
Venoocclusive liver disease 13.45 10.04 47 623362 11724 79109255
Tongue discomfort 13.43 10.04 46 623363 2407 79118572
Metastases to liver 13.38 10.04 149 623260 28165 79092814
Sickle cell anaemia with crisis 13.37 10.04 26 623383 7896 79113083
Hypoosmolar state 13.36 10.04 15 623394 332 79120647
Agitation 13.34 10.04 928 622481 98787 79022192
Acute respiratory failure 13.29 10.04 581 622828 58960 79062019
Drop attacks 13.27 10.04 27 623382 1028 79119951
Therapeutic product ineffective 13.23 10.04 39 623370 1883 79119096
Non-small cell lung cancer stage III 13.22 10.04 4 623405 3 79120976
Diplopia 13.20 10.04 349 623060 33117 79087862
Hepatitis B reactivation 13.19 10.04 17 623392 6091 79114888
Maternal exposure before pregnancy 13.18 10.04 9 623400 4364 79116615
Delusional disorder, persecutory type 13.17 10.04 18 623391 490 79120489
Oral herpes 13.16 10.04 144 623265 27310 79093669
Bone pain 13.13 10.04 547 622862 55195 79065784
Oesophageal adenocarcinoma 13.10 10.04 24 623385 844 79120135
Epistaxis 13.08 10.04 1027 622382 110488 79010491
Hip fracture 13.07 10.04 324 623085 30437 79090542
Vertigo 13.05 10.04 663 622746 68419 79052560
Drug dependence 13.05 10.04 232 623177 40537 79080442
Small intestinal obstruction 13.05 10.04 292 623117 26980 79093999
Sight disability 13.03 10.04 10 623399 133 79120846
Peripheral venous disease 13.02 10.04 72 623337 15837 79105142
Haemodialysis 13.01 10.04 207 623202 17961 79103018
Drug dose titration not performed 13.00 10.04 23 623386 787 79120192
Hepatic rupture 12.99 10.04 9 623400 101 79120878
Alcohol use disorder 12.97 10.04 6 623403 28 79120951
Urine calcium decreased 12.97 10.04 6 623403 28 79120951
Coronary artery bypass 12.96 10.04 17 623392 6045 79114934
Catarrh 12.95 10.04 42 623367 2136 79118843
Vasculitic rash 12.88 10.04 42 623367 2142 79118837
Retching 12.88 10.04 200 623209 17267 79103712
Retroperitoneal fibrosis 12.87 10.04 21 623388 672 79120307
Gastrointestinal erosion 12.87 10.04 27 623382 1051 79119928
Subdural haemorrhage 12.77 10.04 85 623324 5863 79115116
Bromhidrosis 12.73 10.04 5 623404 14 79120965
Idiopathic pulmonary fibrosis 12.70 10.04 66 623343 4162 79116817
Latent tetany 12.70 10.04 4 623405 4 79120975
Intraductal papillary breast neoplasm 12.70 10.04 4 623405 4 79120975
Derailment 12.66 10.04 8 623401 76 79120903
Dactylitis 12.64 10.04 3 623406 2754 79118225
Granuloma annulare 12.62 10.04 20 623389 624 79120355
Device dislocation 12.54 10.04 136 623273 25834 79095145
Photopsia 12.53 10.04 78 623331 5258 79115721
Mesenteric vein thrombosis 12.50 10.04 37 623372 1790 79119189
Achlorhydria 12.48 10.04 5 623404 15 79120964
Gastroenteritis 12.47 10.04 352 623057 33730 79087249
Renal cell carcinoma 12.36 10.04 91 623318 6487 79114492
Gastrointestinal mucosal exfoliation 12.31 10.04 12 623397 224 79120755
Graft versus host disease 12.30 10.04 68 623341 14958 79106021
Cerebral haematoma 12.26 10.04 105 623304 7837 79113142
Vertigo positional 12.17 10.04 55 623354 3275 79117704
Muscle contractions involuntary 12.17 10.04 60 623349 3705 79117274
Urine flow decreased 12.15 10.04 27 623382 1094 79119885
Tracheo-oesophageal fistula 12.13 10.04 19 623390 587 79120392
Amino acid level increased 12.11 10.04 21 623388 707 79120272
Endocrine ophthalmopathy 12.11 10.04 21 623388 707 79120272
Administration related reaction 12.10 10.04 12 623397 229 79120750
Malabsorption 12.10 10.04 74 623335 4958 79116021
Amnesia 12.08 10.04 606 622803 62451 79058528
Large intestine infection 12.08 10.04 53 623356 3116 79117863
Somatosensory evoked potentials abnormal 12.02 10.04 11 623398 189 79120790
Blood immunoglobulin E increased 12.00 10.04 83 623326 5799 79115180
Epigastric discomfort 11.98 10.04 104 623305 7792 79113187
Asphyxia 11.96 10.04 49 623360 11671 79109308
Cardio-respiratory arrest 11.96 10.04 710 622699 107800 79013179
Walking aid user 11.94 10.04 40 623369 10108 79110871
Genital blister 11.90 10.04 9 623400 117 79120862
Metastatic renal cell carcinoma 11.89 10.04 43 623366 2312 79118667
Coronary arterial stent insertion 11.88 10.04 18 623391 6026 79114953
Coeliac disease 11.87 10.04 47 623362 11304 79109675
Dolichocolon 11.82 10.04 4 623405 6 79120973
Respiratory symptom 11.80 10.04 12 623397 4779 79116200
Joint injury 11.80 10.04 173 623236 31162 79089817
No adverse event 11.79 10.04 212 623197 36980 79083999
Drug tolerance 11.78 10.04 32 623377 8643 79112336
Odynophagia 11.78 10.04 138 623271 11189 79109790
Prevertebral soft tissue swelling of cervical space 11.76 10.04 6 623403 36 79120943
Portal vein thrombosis 11.76 10.04 82 623327 5745 79115234
Herpes zoster 11.74 10.04 601 622808 92482 79028497
Device malfunction 11.73 10.04 109 623300 21339 79099640
Second primary malignancy 11.71 10.04 65 623344 14285 79106694
Thrombotic microangiopathy 11.69 10.04 101 623308 20068 79100911
Blood electrolytes decreased 11.67 10.04 31 623378 1408 79119571
Reaction to excipient 11.66 10.04 33 623376 1556 79119423
Antipsychotic drug level decreased 11.63 10.04 28 623381 1196 79119783
DNA antibody 11.63 10.04 6 623403 37 79120942
Hair injury 11.60 10.04 5 623404 19 79120960
Nephrostomy tube removal 11.58 10.04 3 623406 0 79120979
Vertigo labyrinthine 11.58 10.04 3 623406 0 79120979
Anal chlamydia infection 11.58 10.04 3 623406 0 79120979
Lipase increased 11.56 10.04 187 623222 16279 79104700
Device issue 11.52 10.04 146 623263 26962 79094017
Oral mucosal blistering 11.48 10.04 86 623323 6165 79114814
Spondylitis 11.48 10.04 12 623397 4719 79116260
Renal hypertension 11.43 10.04 11 623398 202 79120777
Gastroenteritis eosinophilic 11.43 10.04 13 623396 292 79120687
Blood creatine phosphokinase increased 11.42 10.04 629 622780 65461 79055518
Product dispensing error 11.41 10.04 156 623253 13107 79107872
Pharyngeal swelling 11.37 10.04 101 623308 7618 79113361
Exostosis 11.36 10.04 81 623328 16777 79104202
Hepatitis toxic 11.32 10.04 74 623335 5073 79115906
Injection site swelling 11.32 10.04 281 623128 46851 79074128
Foot deformity 11.25 10.04 127 623282 23947 79097032
Sweat discolouration 11.25 10.04 6 623403 40 79120939
COVID-19 treatment 11.21 10.04 16 623393 454 79120525
Cerebral artery thrombosis 11.19 10.04 26 623383 1085 79119894
Muscle rigidity 11.18 10.04 218 623191 19664 79101315
Sarcoidosis 11.13 10.04 31 623378 8304 79112675
Alcohol interaction 11.12 10.04 13 623396 4861 79116118
Sensitisation 11.11 10.04 6 623403 3305 79117674
Hepatitis acute 11.10 10.04 177 623232 15365 79105614
Atrophic vulvovaginitis 11.09 10.04 28 623381 1233 79119746
Petechiae 11.07 10.04 224 623185 20341 79100638
Blood 1,25-dihydroxycholecalciferol decreased 11.04 10.04 5 623404 22 79120957
Headache 11.04 10.04 5449 617960 648323 78472656
Abnormal dreams 10.98 10.04 137 623272 11275 79109704
Amylase increased 10.97 10.04 135 623274 11074 79109905
High-grade B-cell lymphoma 10.95 10.04 9 623400 133 79120846
Paradoxical drug reaction 10.93 10.04 25 623384 7160 79113819
Angina pectoris 10.93 10.04 502 622907 51230 79069749
Myocardial ischaemia 10.91 10.04 269 623140 25250 79095729
Laryngeal discomfort 10.90 10.04 18 623391 582 79120397
Amyloidosis 10.89 10.04 46 623363 2660 79118319
Oedema mouth 10.86 10.04 50 623359 3001 79117978
Stillbirth 10.81 10.04 9 623400 3946 79117033
Borderline personality disorder 10.81 10.04 23 623386 904 79120075
Urinary retention 10.80 10.04 544 622865 56086 79064893
Magnesium metabolism disorder 10.78 10.04 6 623403 44 79120935
Coronary artery occlusion 10.78 10.04 174 623235 15141 79105838
Hypocalcaemic seizure 10.78 10.04 7 623402 70 79120909
Urine chloride decreased 10.77 10.04 8 623401 101 79120878
Gallbladder hypofunction 10.74 10.04 17 623392 530 79120449
Eyelid retraction 10.67 10.04 6 623403 45 79120934
Serotonin syndrome 10.64 10.04 442 622967 44585 79076394
Acne 10.63 10.04 149 623260 27041 79093938
Pleural thickening 10.62 10.04 5 623404 2977 79118002
Jealous delusion 10.60 10.04 13 623396 317 79120662
Sinonasal obstruction 10.54 10.04 13 623396 319 79120660
Gastrinoma 10.53 10.04 5 623404 25 79120954
Salmonellosis 10.53 10.04 35 623374 1803 79119176
Body height decreased 10.52 10.04 108 623301 8472 79112507
Eczema eyelids 10.51 10.04 10 623399 181 79120798
Superior mesenteric artery syndrome 10.47 10.04 10 623399 182 79120797
Eosinophilic fasciitis 10.43 10.04 12 623397 273 79120706
Red blood cell analysis abnormal 10.38 10.04 5 623404 26 79120953
Cystic fibrosis lung 10.36 10.04 9 623400 144 79120835
Acute lymphocytic leukaemia recurrent 10.36 10.04 13 623396 4711 79116268
Prostate cancer stage IV 10.36 10.04 3 623406 2411 79118568
Cushingoid 10.34 10.04 39 623370 9513 79111466
Emotional disorder 10.33 10.04 164 623245 14223 79106756
Gastric antral vascular ectasia 10.30 10.04 23 623386 935 79120044
Laryngeal oedema 10.29 10.04 103 623306 8026 79112953
Status epilepticus 10.23 10.04 136 623273 24905 79096074
Non-small cell lung cancer stage IV 10.21 10.04 10 623399 188 79120791
Neurologic neglect syndrome 10.16 10.04 5 623404 2902 79118077
Cardiac steatosis 10.15 10.04 6 623403 50 79120929
Product substitution error 10.15 10.04 6 623403 50 79120929
Cytopenia 10.14 10.04 106 623303 20277 79100702
Oesophageal cancer metastatic 10.10 10.04 12 623397 283 79120696
Intestinal obstruction 10.10 10.04 422 622987 42598 79078381
Gastroenteritis aeromonas 10.08 10.04 5 623404 28 79120951
Herpes simplex 10.06 10.04 55 623354 12132 79108847
Hepatocellular injury 10.06 10.04 289 623120 47304 79073675
Injection site warmth 10.05 10.04 71 623338 14736 79106243
Rheumatoid lung 10.04 10.04 11 623398 4234 79116745

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BC01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BD01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD05 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD16 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
FDA MoA N0000000147 Proton Pump Inhibitors
FDA EPC N0000175525 Proton Pump Inhibitor
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D054328 Proton Pump Inhibitors
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:49200 proton pump inhibitors
CHEBI has role CHEBI:49201 anti-ulcer drugs
CHEBI has role CHEBI:50183 P450 inhibitors
CHEBI has role CHEBI:77746 Homo sapiens metabolite
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors

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

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




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Horses Gastric ulcers Indication

๐Ÿถ Veterinary products

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

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Potassium-transporting ATPase Transporter INHIBITOR IC50 5.70 CHEMBL CHEMBL
Multidrug resistance protein 1 Transporter IC50 4.05 WOMBAT-PK
ATP-binding cassette sub-family G member 2 Transporter IC50 4.75 CHEMBL
Cytochrome P450 2C9 Enzyme Ki 4.35 WOMBAT-PK
Cytochrome P450 1A2 Enzyme IC50 4.74 WOMBAT-PK
Cytochrome P450 2C19 Enzyme Ki 5.30 WOMBAT-PK
Fatty acid synthase Enzyme Ki 5.47 CHEMBL
N(G),N(G)-dimethylarginine dimethylaminohydrolase 1 Enzyme IC50 4.70 CHEMBL
Glutathione S-transferase omega-1 Unclassified IC50 5.34 CHEMBL
Cytosolic endo-beta-N-acetylglucosaminidase Enzyme IC50 4.60 CHEMBL
Cytochrome P450 3A4 Enzyme Km 4.31 WOMBAT-PK
Potassium-transporting ATPase Enzyme IC50 5.42 CHEMBL
Potassium-transporting ATPase Enzyme IC50 6.16 SCIENTIFIC LITERATURE

External reference:

IDSource
4019439 VUID
N0000147569 NUI
D00455 KEGG_DRUG
95510-70-6 SECONDARY_CAS_RN
95382-33-5 SECONDARY_CAS_RN
4019439 VANDF
4025702 VANDF
4029343 VANDF
C0028978 UMLSCUI
CHEBI:7772 CHEBI
1C6 PDB_CHEM_ID
CHEMBL1503 ChEMBL_ID
CHEMBL2105294 ChEMBL_ID
DB00338 DRUGBANK_ID
CHEMBL1567328 ChEMBL_ID
D009853 MESH_DESCRIPTOR_UI
4594 PUBCHEM_CID
4279 IUPHAR_LIGAND_ID
5081 INN_ID
KG60484QX9 UNII
1792108 RXNORM
174165 MMSL
34509 MMSL
38031 MMSL
45807 MMSL
5201 MMSL
d00325 MMSL
d05770 MMSL
003476 NDDF
005065 NDDF
006090 NDDF
25673006 SNOMEDCT_US
384973006 SNOMEDCT_US
387137007 SNOMEDCT_US
420878004 SNOMEDCT_US
441570004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Good Sense Omeprazole and Sodium Bicarbonate HUMAN OTC DRUG LABEL 2 0113-0058 CAPSULE, GELATIN COATED 20 mg ORAL ANDA 15 sections
good sense omeprazole HUMAN OTC DRUG LABEL 1 0113-0520 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Good Sense Omeprazole HUMAN OTC DRUG LABEL 1 0113-0915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Good Sense Omeprazole HUMAN OTC DRUG LABEL 1 0113-1723 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
good sense omeprazole delayed release HUMAN OTC DRUG LABEL 1 0113-1803 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Basic Care Omeprazole HUMAN OTC DRUG LABEL 1 0113-7401 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
basic care omeprazole HUMAN OTC DRUG LABEL 1 0113-7520 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Basic Care Omeprazole HUMAN OTC DRUG LABEL 1 0113-7915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-0007 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-0007 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Omeprazole Magnesium HUMAN OTC DRUG LABEL 1 0363-0042 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
Omeprazole and sodium bicarbonate HUMAN OTC DRUG LABEL 2 0363-0732 CAPSULE, GELATIN COATED 20 mg ORAL ANDA 15 sections
Omeprazole and sodium bicarbonate HUMAN OTC DRUG LABEL 2 0363-0732 CAPSULE, GELATIN COATED 20 mg ORAL ANDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-0915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-0915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Acid Reducer Human OTC Drug Label 1 0363-1008 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
Omeprazole HUMAN OTC DRUG LABEL 1 0363-1607 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-1819 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-1819 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-6101 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Omeprazole HUMAN OTC DRUG LABEL 1 0363-9980 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
Acid Reducer Human OTC Drug Label 1 0536-1322 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-1359 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8079 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8079 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8320 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8406 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8406 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8406 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2234 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 28 sections