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

Stem definitionDrug idCAS RN
antiulcer, benzimidazole derivatives 1547 103577-45-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • prevacid
  • lansoprazole
  • A-65006
  • AG 1749
  • AG-1749
A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.
  • Molecular weight: 369.36
  • Formula: C16H14F3N3O2S
  • CLOGP: 2.79
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 67.87
  • ALOGS: -3.17
  • ROTB: 6

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.35 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 81 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.28 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 10, 1995 FDA TAKEDA PHARMS USA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Chronic kidney disease 914.79 9.39 877 167678 38894 50397675
Drug ineffective 642.11 9.39 1095 167460 818238 49618331
Renal injury 402.91 9.39 287 168268 8324 50428245
Hyponatraemia 396.87 9.39 943 167612 95196 50341373
Colitis microscopic 360.88 9.39 241 168314 6279 50430290
Acute kidney injury 325.60 9.39 1562 166993 226496 50210073
End stage renal disease 298.28 9.39 204 168351 5533 50431036
Completed suicide 272.54 9.39 54 168501 131835 50304734
Drug intolerance 259.01 9.39 210 168345 218894 50217675
Contraindicated product administered 236.44 9.39 100 168455 148858 50287711
Hypomagnesaemia 187.50 9.39 302 168253 22854 50413715
Treatment failure 184.76 9.39 115 168440 137522 50299047
Pemphigus 182.30 9.39 86 168469 120080 50316489
Fatigue 172.27 9.39 1520 167035 706081 49730488
Product dose omission issue 171.72 9.39 216 168339 183622 50252947
Synovitis 168.32 9.39 102 168453 123763 50312806
Arthropathy 167.75 9.39 167 168388 157739 50278830
Maternal exposure during pregnancy 165.17 9.39 173 168382 159605 50276964
Alopecia 161.32 9.39 361 168194 244686 50191883
Therapeutic product effect incomplete 161.05 9.39 52 168503 91463 50345106
Off label use 158.46 9.39 930 167625 473496 49963073
Subacute cutaneous lupus erythematosus 157.73 9.39 96 168459 2119 50434450
Death 152.20 9.39 564 167991 324815 50111754
Systemic lupus erythematosus 151.34 9.39 147 168408 140475 50296094
Renal failure 147.92 9.39 725 167830 105908 50330661
Pain 142.64 9.39 1239 167316 577664 49858905
Therapeutic product effect decreased 132.13 9.39 155 168400 135895 50300674
Hand deformity 125.97 9.39 90 168465 100109 50336460
Joint swelling 125.50 9.39 409 168146 244877 50191692
Hypertensive nephropathy 112.02 9.39 47 168508 449 50436120
Neutropenic sepsis 111.11 9.39 182 168373 13965 50422604
Glossodynia 110.78 9.39 133 168422 115436 50321133
Exposure during pregnancy 109.01 9.39 146 168409 120869 50315700
Abdominal discomfort 107.22 9.39 403 168152 231238 50205331
Product use issue 102.57 9.39 215 168340 149260 50287309
Cerebral infarction 101.26 9.39 223 168332 21381 50415188
Interstitial lung disease 100.69 9.39 397 168158 52779 50383790
Melaena 99.52 9.39 253 168302 26611 50409958
Anti-cyclic citrullinated peptide antibody positive 98.86 9.39 56 168499 70531 50366038
Hepatic function abnormal 98.25 9.39 285 168270 32396 50404173
Toxicity to various agents 94.28 9.39 376 168179 212123 50224446
Hypokalaemia 88.85 9.39 549 168006 87443 50349126
Swelling 85.61 9.39 361 168194 200511 50236058
Haematemesis 85.49 9.39 244 168311 27481 50409088
Peripheral swelling 85.38 9.39 374 168181 205562 50231007
Renal impairment 84.69 9.39 485 168070 75176 50361393
Abdominal pain 83.47 9.39 1175 167380 235053 50201516
Electric shock 82.17 9.39 48 168507 980 50435589
Injection site pain 78.43 9.39 157 168398 110867 50325702
Wound 74.39 9.39 150 168405 105644 50330925
Nephrogenic anaemia 73.31 9.39 54 168501 1651 50434918
Cholecystitis chronic 71.39 9.39 121 168434 9548 50427021
Device expulsion 70.69 9.39 7 168548 28815 50407754
Diabetic nephropathy 70.52 9.39 48 168507 1291 50435278
Drug hypersensitivity 69.90 9.39 519 168036 250491 50186078
Swollen tongue 69.68 9.39 232 168323 28398 50408171
Tubulointerstitial nephritis 69.02 9.39 155 168400 15056 50421513
Hepatic enzyme increased 68.16 9.39 232 168323 137148 50299421
Rheumatoid factor positive 67.76 9.39 41 168514 49818 50386751
Weight increased 67.53 9.39 395 168160 201496 50235073
Sinusitis 66.93 9.39 316 168239 170242 50266327
Rheumatoid arthritis 66.31 9.39 399 168156 202151 50234418
Electrocardiogram QT prolonged 65.02 9.39 343 168212 51543 50385026
Nephropathy 63.66 9.39 83 168472 5175 50431394
Infusion related reaction 62.58 9.39 321 168234 169236 50267333
Infective pulmonary exacerbation of cystic fibrosis 61.10 9.39 101 168454 7808 50428761
Arthralgia 60.47 9.39 1063 167492 437639 49998930
Chest pain 59.70 9.39 873 167682 176009 50260560
Loss of personal independence in daily activities 59.58 9.39 88 168467 69962 50366607
Drug abuse 59.34 9.39 67 168488 59779 50376790
Discomfort 58.66 9.39 176 168379 108204 50328365
Hypocalcaemia 57.19 9.39 208 168347 26608 50409961
Labile blood pressure 56.99 9.39 46 168509 1614 50434955
Rebound acid hypersecretion 55.63 9.39 25 168530 286 50436283
Faeces discoloured 54.75 9.39 147 168408 15977 50420592
Sopor 53.74 9.39 167 168388 19712 50416857
Pericarditis 53.26 9.39 114 168441 78575 50357994
Nasopharyngitis 52.21 9.39 402 168153 192525 50244044
Intervertebral discitis 50.74 9.39 53 168502 2603 50433966
Gastritis 49.11 9.39 229 168326 32754 50403815
Agranulocytosis 48.98 9.39 170 168385 21251 50415318
Confusional state 48.68 9.39 880 167675 185048 50251521
Hepatocellular injury 48.52 9.39 193 168362 25754 50410815
International normalised ratio increased 47.86 9.39 276 168279 42876 50393693
Intentional product use issue 46.77 9.39 118 168437 76800 50359769
Vomiting 46.58 9.39 1926 166629 458832 49977737
Anaemia 45.97 9.39 1133 167422 251323 50185246
Cholestasis 45.16 9.39 186 168369 25215 50411354
Angioedema 45.12 9.39 246 168309 37430 50399139
Lip swelling 44.66 9.39 182 168373 24554 50412015
Brain stem glioma 44.25 9.39 17 168538 126 50436443
Dysphagia 44.09 9.39 423 168132 77095 50359474
Coordination abnormal 43.10 9.39 109 168446 11425 50425144
Rectal haemorrhage 43.01 9.39 247 168308 38311 50398258
Accidental exposure to product 42.54 9.39 12 168543 23045 50413524
Neutrophil count decreased 42.02 9.39 280 168275 45746 50390823
Biliary dyskinesia 41.91 9.39 47 168508 2503 50434066
Jaundice 41.20 9.39 186 168369 26243 50410326
Circulatory collapse 40.86 9.39 153 168402 19847 50416722
Foetal exposure during pregnancy 40.81 9.39 20 168535 27339 50409230
Liver function test abnormal 40.63 9.39 270 168285 44069 50392500
Drug interaction 40.33 9.39 909 167646 198712 50237857
Injection site pruritus 40.32 9.39 45 168510 40366 50396203
Lethargy 40.00 9.39 292 168263 49140 50387429
Coma scale abnormal 39.67 9.39 63 168492 4708 50431861
Hypersensitivity 39.38 9.39 493 168062 214668 50221901
Swelling face 39.35 9.39 305 168250 52290 50384279
Upper respiratory tract inflammation 39.21 9.39 44 168511 2345 50434224
Anaphylactic reaction 39.08 9.39 311 168244 53744 50382825
Drug resistance 38.72 9.39 8 168547 18981 50417588
Hyperglycaemia 38.53 9.39 230 168325 36175 50400394
Injection site swelling 37.99 9.39 50 168505 41723 50394846
Hypophosphataemic osteomalacia 37.94 9.39 16 168539 155 50436414
Nephrocalcinosis 37.77 9.39 29 168526 945 50435624
Reflux gastritis 37.76 9.39 28 168527 865 50435704
Injection site reaction 37.72 9.39 68 168487 49964 50386605
Lower respiratory tract infection 37.43 9.39 483 168072 94718 50341851
Post-traumatic stress disorder 37.42 9.39 58 168497 4245 50432324
Basilar artery occlusion 37.37 9.39 14 168541 96 50436473
Therapy interrupted 36.24 9.39 11 168544 20141 50416428
Crohn's disease 35.97 9.39 60 168495 4673 50431896
Renal tubular acidosis 35.55 9.39 34 168521 1500 50435069
Injection site erythema 35.50 9.39 129 168426 74807 50361762
Hepatic ischaemia 35.02 9.39 23 168532 582 50435987
Disseminated intravascular coagulation 34.93 9.39 131 168424 17004 50419565
Erythema multiforme 34.31 9.39 86 168469 8964 50427605
Coronary artery disease 34.19 9.39 192 168363 29534 50407035
Knee arthroplasty 33.53 9.39 42 168513 35804 50400765
Adrenal insufficiency 33.40 9.39 114 168441 14129 50422440
Syncope 33.00 9.39 504 168051 102498 50334071
Urine magnesium decreased 32.96 9.39 7 168548 0 50436569
Drug ineffective for unapproved indication 32.60 9.39 15 168540 21266 50415303
Product use in unapproved indication 32.41 9.39 239 168316 115580 50320989
Pemphigoid 32.36 9.39 65 168490 5842 50430727
Wrong technique in product usage process 32.33 9.39 87 168468 55423 50381146
Gastric polyps 32.30 9.39 42 168513 2612 50433957
Hepatorenal syndrome 31.90 9.39 34 168521 1709 50434860
Skin candida 31.89 9.39 30 168525 1296 50435273
Psoriasis 31.88 9.39 120 168435 68880 50367689
Somatic delusion 31.51 9.39 21 168534 545 50436024
Abortion spontaneous 31.29 9.39 57 168498 41715 50394854
Oesophagitis 31.28 9.39 107 168448 13276 50423293
Psoriatic arthropathy 31.10 9.39 69 168486 46963 50389606
Adverse drug reaction 31.08 9.39 88 168467 55134 50381435
Gastrooesophageal reflux disease 30.99 9.39 390 168165 76038 50360531
Hospitalisation 30.84 9.39 119 168436 67818 50368751
Hypergastrinaemia 30.67 9.39 12 168543 94 50436475
Therapeutic response decreased 30.66 9.39 70 168485 47161 50389408
Inappropriate schedule of product administration 30.61 9.39 129 168426 71702 50364867
Therapy cessation 30.58 9.39 25 168530 25986 50410583
Iron deficiency anaemia 30.50 9.39 124 168431 16710 50419859
Device dislocation 30.29 9.39 17 168538 21529 50415040
Hiatus hernia 30.03 9.39 131 168424 18213 50418356
Blood alkaline phosphatase increased 29.40 9.39 220 168335 37306 50399263
Urticaria 29.37 9.39 600 167955 128961 50307608
Post viral fatigue syndrome 29.27 9.39 16 168539 286 50436283
Red blood cell sedimentation rate abnormal 29.24 9.39 9 168546 16334 50420235
Demyelination 29.14 9.39 63 168492 5963 50430606
Altered state of consciousness 28.94 9.39 147 168408 21763 50414806
Deep vein thrombosis 28.85 9.39 372 168183 72932 50363637
Blood sodium decreased 28.72 9.39 143 168412 21004 50415565
Angina pectoris 28.71 9.39 167 168388 26021 50410548
Hyperchlorhydria 28.31 9.39 30 168525 1498 50435071
Pneumonia bacterial 28.28 9.39 70 168485 7239 50429330
Urine phosphorus decreased 28.25 9.39 6 168549 0 50436569
Temperature intolerance 27.91 9.39 71 168484 7468 50429101
Drug reaction with eosinophilia and systemic symptoms 27.82 9.39 176 168379 28248 50408321
Decreased appetite 27.34 9.39 869 167686 200054 50236515
Orthostatic hypotension 27.30 9.39 180 168375 29301 50407268
COVID-19 27.28 9.39 73 168482 46589 50389980
Urine potassium decreased 27.20 9.39 7 168548 9 50436560
Hyperkalaemia 26.64 9.39 261 168294 47828 50388741
Suicide attempt 26.57 9.39 86 168469 51646 50384923
Gastrointestinal haemorrhage 26.34 9.39 366 168189 72955 50363614
Rectal ulcer 26.23 9.39 25 168530 1098 50435471
Pituitary tumour benign 26.20 9.39 31 168524 1750 50434819
Intentional overdose 26.17 9.39 113 168442 62391 50374178
Platelet count decreased 26.06 9.39 476 168079 100250 50336319
Renal atrophy 25.70 9.39 26 168529 1229 50435340
Mobility decreased 25.33 9.39 159 168396 79789 50356780
Malaise 25.15 9.39 1362 167193 334170 50102399
Dermatitis exfoliative 25.14 9.39 54 168501 5088 50431481
Urine output decreased 24.96 9.39 84 168471 10337 50426232
Cerebral haemorrhage 24.94 9.39 165 168390 26887 50409682
Gallbladder disorder 24.74 9.39 116 168439 16626 50419943
Erythema dyschromicum perstans 24.63 9.39 9 168546 57 50436512
Upper gastrointestinal haemorrhage 24.36 9.39 112 168443 15923 50420646
Condition aggravated 24.29 9.39 779 167776 296279 50140290
Hypersensitivity pneumonitis 24.08 9.39 34 168521 2288 50434281
Premature delivery 23.99 9.39 26 168529 23637 50412932
Progressive multifocal leukoencephalopathy 23.70 9.39 88 168467 11369 50425200
Abnormal loss of weight 23.42 9.39 52 168503 5012 50431557
Asthma 23.40 9.39 423 168132 88914 50347655
Oropharyngeal oedema 23.27 9.39 13 168542 243 50436326
General physical health deterioration 23.26 9.39 334 168221 142100 50294469
Haemorrhage subcutaneous 22.92 9.39 36 168519 2665 50433904
Acne 22.83 9.39 19 168536 19576 50416993
Ill-defined disorder 22.76 9.39 99 168456 54555 50382014
Laryngeal pain 22.76 9.39 46 168509 4153 50432416
Liver disorder 22.60 9.39 206 168349 37016 50399553
Eosinophilia 22.47 9.39 122 168433 18530 50418039
Hyperparathyroidism secondary 22.39 9.39 25 168530 1325 50435244
Hip arthroplasty 22.36 9.39 42 168513 30387 50406182
Neuropathy, ataxia, retinitis pigmentosa syndrome 22.26 9.39 8 168547 48 50436521
Full blood count decreased 22.16 9.39 25 168530 22321 50414248
Hyperprolactinaemia 22.10 9.39 40 168515 3325 50433244
Toxic skin eruption 22.10 9.39 85 168470 11166 50425403
Cardiac failure 22.06 9.39 366 168189 75674 50360895
Impaired healing 22.00 9.39 139 168416 69647 50366922
Dermatitis bullous 21.98 9.39 63 168492 7110 50429459
Injection site bruising 21.89 9.39 57 168498 36711 50399858
Muscle relaxant therapy 21.84 9.39 11 168544 165 50436404
Aphasia 21.73 9.39 166 168389 28328 50408241
Flashback 21.26 9.39 10 168545 128 50436441
Pneumocystis jirovecii pneumonia 21.23 9.39 101 168454 14562 50422007
Disability 21.18 9.39 8 168547 12767 50423802
Haematuria 21.12 9.39 152 168403 25461 50411108
Rapid eye movement sleep behaviour disorder 21.04 9.39 11 168544 179 50436390
Nasal congestion 21.04 9.39 93 168462 51027 50385542
Subarachnoid haemorrhage 20.83 9.39 81 168474 10695 50425874
Oesophageal mucosal tear 20.78 9.39 6 168549 15 50436554
Blood lactic acid 20.75 9.39 9 168546 94 50436475
Gastric dysplasia 20.51 9.39 6 168549 16 50436553
Cholelithiasis 20.50 9.39 205 168350 37768 50398801
Red blood cell sedimentation rate increased 20.41 9.39 42 168513 29374 50407195
Pressure of speech 20.41 9.39 16 168539 538 50436031
Musculoskeletal stiffness 20.38 9.39 303 168252 128178 50308391
Multiple sclerosis relapse 20.32 9.39 74 168481 42890 50393679
Infection 20.09 9.39 431 168124 172523 50264046
Gastric cancer 19.98 9.39 36 168519 2982 50433587
Intentional product misuse 19.86 9.39 84 168471 46650 50389919
Superinfection 19.71 9.39 29 168526 2027 50434542
Pancreatitis 19.71 9.39 223 168332 42391 50394178
Product storage error 19.70 9.39 8 168547 12216 50424353
Carcinoid tumour of the stomach 19.62 9.39 10 168545 154 50436415
Enterocolitis 19.47 9.39 57 168498 6510 50430059
Gastrointestinal motility disorder 19.40 9.39 45 168510 4464 50432105
Dehydration 19.35 9.39 654 167901 151795 50284774
Blood pressure decreased 19.24 9.39 277 168278 55632 50380937
Rash erythematous 19.22 9.39 189 168366 34663 50401906
Product substitution issue 19.05 9.39 95 168460 13962 50422607
Dysuria 18.99 9.39 161 168394 28343 50408226
Cholecystitis 18.98 9.39 94 168461 13777 50422792
Alanine aminotransferase increased 18.97 9.39 406 168149 87953 50348616
Infusion site streaking 18.95 9.39 14 168541 430 50436139
Hypocalciuria 18.42 9.39 5 168550 9 50436560
Stoma site haemorrhage 18.37 9.39 19 168536 922 50435647
Anal prolapse 18.32 9.39 8 168547 85 50436484
Biliary sepsis 18.13 9.39 18 168537 832 50435737
Gastrointestinal stoma output decreased 18.08 9.39 5 168550 10 50436559
Injection site warmth 18.02 9.39 12 168543 13854 50422715
Genitourinary symptom 17.87 9.39 7 168548 55 50436514
Swollen joint count increased 17.85 9.39 14 168541 14859 50421710
Mediastinitis 17.80 9.39 10 168545 189 50436380
Pancreatitis acute 17.76 9.39 138 168417 23674 50412895
Hypophosphataemia 17.71 9.39 65 168490 8349 50428220
Enterochromaffin cell hyperplasia 17.65 9.39 7 168548 57 50436512
Intestinal ischaemia 17.56 9.39 56 168499 6701 50429868
Stress 17.55 9.39 106 168449 53687 50382882
Activated partial thromboplastin time prolonged 17.50 9.39 54 168501 6348 50430221
Palpitations 17.41 9.39 425 168130 94081 50342488
Gastroenteritis 17.40 9.39 135 168420 23146 50413423
Aspiration 17.39 9.39 69 168486 9195 50427374
Ulcer 17.31 9.39 121 168434 20079 50416490
No adverse event 17.11 9.39 56 168499 33522 50403047
Sleep disorder due to general medical condition, insomnia type 17.05 9.39 51 168504 31396 50405173
Hypoglycaemic coma 16.96 9.39 29 168526 2304 50434265
Ileus 16.94 9.39 88 168467 13141 50423428
Enteritis infectious 16.91 9.39 26 168529 1889 50434680
Hypochloraemia 16.91 9.39 24 168531 1623 50434946
Bradycardia 16.85 9.39 305 168250 64121 50372448
Mouth swelling 16.76 9.39 39 168516 3877 50432692
Gastric ulcer 16.74 9.39 125 168430 21180 50415389
Device difficult to use 16.72 9.39 6 168549 9880 50426689
Macular degeneration 16.70 9.39 14 168541 14374 50422195
Dialysis 16.69 9.39 69 168486 9369 50427200
Gastrointestinal disorder 16.67 9.39 218 168337 94238 50342331
Mixed liver injury 16.60 9.39 36 168519 3415 50433154
Gallbladder injury 16.57 9.39 21 168534 1273 50435296
Inappropriate antidiuretic hormone secretion 16.54 9.39 87 168468 13056 50423513
Hyponatraemic syndrome 16.44 9.39 14 168541 530 50436039
Cardioactive drug level increased 16.22 9.39 26 168529 1958 50434611
Oesophageal carcinoma 16.19 9.39 19 168536 1063 50435506
Myocardial ischaemia 16.10 9.39 79 168476 11534 50425035
Product quality issue 16.05 9.39 51 168504 30807 50405762
Pulmonary embolism 16.01 9.39 448 168107 101256 50335313
Hemiparesis 15.97 9.39 118 168437 19930 50416639
Chromaturia 15.96 9.39 93 168462 14497 50422072
Face oedema 15.96 9.39 108 168447 17731 50418838
Diarrhoea 15.85 9.39 2213 166342 586263 49850306
Oedema peripheral 15.80 9.39 660 167895 157301 50279268
Folliculitis 15.76 9.39 72 168483 39153 50397416
Colon cancer 15.73 9.39 64 168491 8627 50427942
Eye haemorrhage 15.72 9.39 57 168498 7278 50429291
Blood triglycerides increased 15.72 9.39 77 168478 11235 50425334
Purpura 15.63 9.39 70 168485 9841 50426728
Hepatotoxicity 15.61 9.39 43 168512 27183 50409386
Foetal death 15.57 9.39 4 168551 8176 50428393
Narrow anterior chamber angle 15.56 9.39 6 168549 45 50436524
Acute coronary syndrome 15.38 9.39 67 168488 9307 50427262
Secondary adrenocortical insufficiency 15.35 9.39 19 168536 1124 50435445
Respiratory arrest 15.33 9.39 50 168505 29959 50406610
Influenza 15.31 9.39 208 168347 89330 50347239
Pregnancy 15.30 9.39 49 168506 29528 50407041
Rheumatoid nodule 15.27 9.39 12 168543 12723 50423846
Deep vein thrombosis postoperative 15.26 9.39 23 168532 1642 50434927
Immune thrombocytopenia 15.22 9.39 65 168490 8952 50427617
Erythema annulare 15.21 9.39 7 168548 85 50436484
Injury 15.12 9.39 238 168317 48687 50387882
Azotaemia 15.10 9.39 38 168517 3970 50432599
Bradyphrenia 15.10 9.39 50 168505 6102 50430467
Dry mouth 15.06 9.39 267 168288 55911 50380658
Sedation 14.95 9.39 52 168503 30558 50406011
Dermatitis psoriasiform 14.84 9.39 23 168532 1683 50434886
Vascular skin disorder 14.81 9.39 4 168551 7 50436562
Excessive eye blinking 14.81 9.39 17 168538 929 50435640
Panniculitis 14.65 9.39 5 168550 8498 50428071
Neoplasm progression 14.60 9.39 49 168506 29108 50407461
Coagulopathy 14.51 9.39 106 168449 17838 50418731
Paramnesia 14.46 9.39 4 168551 8 50436561
Joint stiffness 14.46 9.39 52 168503 30256 50406313
Hallucination 14.43 9.39 227 168328 46430 50390139
Chronic gastritis 14.39 9.39 27 168528 2307 50434262
Phyllodes tumour 14.35 9.39 5 168550 27 50436542
Duodenal ulcer perforation 14.29 9.39 91 168464 45520 50391049
Discoloured vomit 14.28 9.39 14 168541 637 50435932
Immunodeficiency 14.26 9.39 17 168538 14811 50421758
Cholecystitis acute 14.21 9.39 54 168501 7052 50429517
Oesophageal carcinoma recurrent 14.20 9.39 5 168550 28 50436541
Urine output 14.12 9.39 3 168552 0 50436569
Blood pressure increased 13.97 9.39 337 168218 132795 50303774
Fibromyalgia 13.96 9.39 90 168465 44888 50391681
Hepatitis acute 13.92 9.39 58 168497 7903 50428666
Haemodialysis 13.90 9.39 60 168495 8302 50428267
Unevaluable event 13.88 9.39 93 168462 45973 50390596
Adverse event 13.88 9.39 87 168468 43676 50392893
Laboratory test abnormal 13.80 9.39 36 168519 23172 50413397
Renal haemangioma 13.77 9.39 5 168550 31 50436538
Pleural effusion 13.73 9.39 362 168193 81092 50355477
Foot deformity 13.69 9.39 27 168528 19183 50417386
Hypophagia 13.69 9.39 147 168408 27581 50408988
Lung opacity 13.66 9.39 24 168531 1949 50434620
Tooth hypoplasia 13.64 9.39 6 168549 65 50436504
Musculoskeletal disorder 13.60 9.39 23 168532 17326 50419243
Dyspepsia 13.58 9.39 333 168222 73764 50362805
Blood urea increased 13.55 9.39 129 168426 23456 50413113
Eosinophilic pneumonia chronic 13.54 9.39 8 168547 167 50436402
Total lung capacity decreased 13.53 9.39 19 168536 1272 50435297
Wrong patient received product 13.52 9.39 22 168533 1678 50434891
Urinary straining 13.51 9.39 5 168550 33 50436536
Oropharyngeal swelling 13.49 9.39 15 168540 791 50435778
Fluid retention 13.46 9.39 106 168449 50543 50386026
Urine calcium/creatinine ratio increased 13.44 9.39 7 168548 113 50436456
Paraesthesia oral 13.44 9.39 78 168477 12143 50424426
Femoral neck fracture 13.43 9.39 55 168500 7435 50429134
Hip fracture 13.39 9.39 43 168512 25888 50410681
Atypical fracture 13.36 9.39 13 168542 586 50435983
Device dependence 13.33 9.39 4 168551 12 50436557
Haemoptysis 13.29 9.39 137 168418 25436 50411133
Muscle spasticity 13.27 9.39 23 168532 17161 50419408
Laryngotracheal oedema 13.26 9.39 5 168550 35 50436534
Oesophageal food impaction 13.25 9.39 8 168547 174 50436395
Oesophageal achalasia 13.25 9.39 11 168544 402 50436167
Spleen congestion 13.22 9.39 7 168548 117 50436452
Nervous system disorder 13.21 9.39 96 168459 16127 50420442
Helicobacter infection 13.21 9.39 104 168451 49598 50386971
Bronchopulmonary aspergillosis allergic 13.19 9.39 18 168537 1173 50435396
Sinus bradycardia 13.13 9.39 82 168473 13101 50423468
Tongue discolouration 13.06 9.39 29 168526 2795 50433774
Poisoning deliberate 13.04 9.39 5 168550 7907 50428662
Injection site mass 13.03 9.39 20 168535 15660 50420909
Hypoxic-ischaemic encephalopathy 13.01 9.39 35 168520 3807 50432762
Abnormal faeces 13 9.39 37 168518 4159 50432410
Pancreatic carcinoma recurrent 12.74 9.39 6 168549 77 50436492
Inadequate diet 12.72 9.39 7 168548 127 50436442
Rheumatic fever 12.64 9.39 23 168532 16844 50419725
Device issue 12.64 9.39 30 168525 19942 50416627
Morbid thoughts 12.54 9.39 12 168543 530 50436039
Hepatitis 12.53 9.39 160 168395 31293 50405276
Neuropathy peripheral 12.50 9.39 416 168139 96341 50340228
Transient ischaemic attack 12.47 9.39 163 168392 32047 50404522
Vulval haemorrhage 12.45 9.39 4 168551 16 50436553
Bradykinesia 12.44 9.39 35 168520 3908 50432661
Cytomegalovirus test positive 12.42 9.39 27 168528 2565 50434004
Chronic kidney disease-mineral and bone disorder 12.41 9.39 6 168549 82 50436487
Emotional distress 12.36 9.39 148 168407 28515 50408054
Rectocele 12.30 9.39 15 168540 874 50435695
Hyperlipidaemia 12.29 9.39 100 168455 17390 50419179
Presyncope 12.28 9.39 129 168426 24069 50412500
Balance disorder 12.27 9.39 315 168240 70275 50366294
Inflammatory bowel disease 12.27 9.39 32 168523 3418 50433151
Abortion induced 12.26 9.39 8 168547 9336 50427233
Dilatation atrial 12.24 9.39 22 168533 1819 50434750
Occult blood positive 12.19 9.39 31 168524 3260 50433309
Intentional self-injury 12.16 9.39 38 168517 23074 50413495
White blood cell count increased 12.13 9.39 203 168352 42037 50394532
Palmar erythema 12.13 9.39 20 168535 1543 50435026
Bile duct stone 12.09 9.39 31 168524 3276 50433293
Obstructive nephropathy 12.05 9.39 3 168552 3 50436566
Pneumonia aspiration 12.05 9.39 157 168398 30847 50405722
Pleuritic pain 12.01 9.39 48 168507 6418 50430151
Renal cyst 11.98 9.39 59 168496 8628 50427941
Hepatic failure 11.93 9.39 162 168393 32121 50404448
Nightmare 11.87 9.39 93 168462 15993 50420576
Rash papulosquamous 11.85 9.39 6 168549 91 50436478
Bradyarrhythmia 11.82 9.39 22 168533 1868 50434701
Pre-eclampsia 11.82 9.39 6 168549 8038 50428531
Cold sweat 11.75 9.39 68 168487 10576 50425993
Erythema 11.67 9.39 598 167957 145816 50290753
Cardiomegaly 11.66 9.39 92 168463 15853 50420716
Stomatitis 11.63 9.39 253 168302 101091 50335478
Tetany 11.59 9.39 20 168535 1601 50434968
Pain in extremity 11.59 9.39 768 167787 272097 50164472
Degenerative mitral valve disease 11.57 9.39 4 168551 21 50436548
Deformity 11.55 9.39 6 168549 7934 50428635
Grip strength decreased 11.55 9.39 14 168541 12107 50424462
Gingival bleeding 11.55 9.39 71 168484 11282 50425287
Photodermatosis 11.53 9.39 10 168545 388 50436181
Infusion site vesicles 11.53 9.39 10 168545 388 50436181
Stevens-Johnson syndrome 11.53 9.39 117 168438 21635 50414934
Staphylococcus test positive 11.51 9.39 31 168524 3375 50433194
Gamma-glutamyltransferase increased 11.51 9.39 150 168405 29473 50407096
Haematotoxicity 11.43 9.39 6 168549 7889 50428680
Hypoglycaemia 11.43 9.39 246 168309 53335 50383234
Hyperhidrosis 11.43 9.39 384 168171 89042 50347527
Complication of device insertion 11.41 9.39 3 168552 6038 50430531
Metastases to bone 11.41 9.39 27 168528 17968 50418601
Nephrectomy 11.41 9.39 14 168541 821 50435748
Pharyngotonsillitis 11.40 9.39 7 168548 157 50436412
Enterocolitis haemorrhagic 11.39 9.39 18 168537 1339 50435230
Bleeding time prolonged 11.39 9.39 12 168543 595 50435974
Heparin-induced thrombocytopenia 11.36 9.39 34 168521 3931 50432638
Pyrexia 11.35 9.39 1439 167116 378764 50057805
Gambling 11.35 9.39 8 168547 228 50436341
Injection site rash 11.31 9.39 23 168532 16154 50420415
Splenic vein thrombosis 11.24 9.39 9 168546 312 50436257
Blood electrolytes abnormal 11.22 9.39 15 168540 958 50435611
Atypical femur fracture 11.22 9.39 39 168516 4877 50431692
Renal cyst haemorrhage 11.22 9.39 5 168550 56 50436513
Muscle injury 11.14 9.39 75 168480 37036 50399533
Post cardiac arrest syndrome 11.13 9.39 4 168551 24 50436545
Wheezing 11.11 9.39 278 168277 61769 50374800
Blood uric acid increased 11.10 9.39 33 168522 3801 50432768
Hypoproteinaemia 11.07 9.39 21 168534 1810 50434759
Cholangitis 11.04 9.39 37 168518 4542 50432027
Multiple injuries 11.02 9.39 20 168535 1666 50434903
Anxiety disorder 11.00 9.39 32 168523 3641 50432928
Dizziness 11.00 9.39 1316 167239 345053 50091516
Blood cholinesterase decreased 10.99 9.39 6 168549 107 50436462
Gallbladder hypofunction 10.98 9.39 11 168544 514 50436055
Respiratory tract congestion 10.97 9.39 19 168536 14180 50422389
Aortic aneurysm rupture 10.96 9.39 11 168544 515 50436054
Osteonecrosis 10.94 9.39 119 168436 22398 50414171
Adrenal suppression 10.92 9.39 14 168541 858 50435711
Hypercapnic coma 10.91 9.39 7 168548 170 50436399
Macroglossia 10.90 9.39 12 168543 626 50435943
Fanconi syndrome 10.85 9.39 16 168539 1120 50435449
Bronchogenic cyst 10.85 9.39 3 168552 6 50436563
Multiple sclerosis 10.75 9.39 110 168445 20383 50416186
Autonomic neuropathy 10.75 9.39 15 168540 998 50435571
Hyperphosphataemia 10.74 9.39 21 168534 1850 50434719
Vulvovaginal candidiasis 10.65 9.39 26 168529 2666 50433903
Rhabdomyolysis 10.64 9.39 186 168369 38841 50397728
Product complaint 10.61 9.39 70 168485 11396 50425173
Blood albumin decreased 10.59 9.39 78 168477 13158 50423411
Oligohydramnios 10.59 9.39 3 168552 5747 50430822
Flat affect 10.53 9.39 17 168538 1288 50435281
Gastrointestinal amyloidosis 10.49 9.39 5 168550 66 50436503
Illness 10.49 9.39 44 168511 24496 50412073
Gastrointestinal perforation 10.48 9.39 28 168527 3033 50433536
Neuroendocrine tumour 10.42 9.39 11 168544 547 50436022
Pustule 10.41 9.39 16 168539 1162 50435407
Finger deformity 10.40 9.39 3 168552 5679 50430890
Drug-induced liver injury 10.39 9.39 141 168414 27954 50408615
Haemorrhoids 10.35 9.39 103 168452 18950 50417619
Small intestinal haemorrhage 10.34 9.39 21 168534 1902 50434667
Nasal mucosal erosion 10.30 9.39 5 168550 69 50436500
Rhinorrhoea 10.26 9.39 116 168439 51467 50385102
Abdominal pain upper 10.23 9.39 638 167917 158671 50277898
Drug eruption 10.23 9.39 122 168433 23484 50413085
Protein-losing gastroenteropathy 10.23 9.39 7 168548 190 50436379
Hyperleukocytosis 10.22 9.39 10 168545 454 50436115
Chorea 10.20 9.39 17 168538 1323 50435246
Loss of consciousness 10.20 9.39 435 168120 103918 50332651
Hallucination, visual 10.18 9.39 92 168463 16490 50420079
Maternal exposure before pregnancy 10.16 9.39 3 168552 5594 50430975
Femoral hernia 10.15 9.39 4 168551 32 50436537
Device malfunction 10.15 9.39 22 168533 15099 50421470
Seasonal allergy 10.14 9.39 21 168534 14655 50421914
Regurgitation 10.14 9.39 17 168538 1329 50435240
Sleep disorder due to a general medical condition 10.10 9.39 6 168549 7365 50429204
Cystitis noninfective 10.09 9.39 13 168542 801 50435768
Scleroderma 10.03 9.39 37 168518 4764 50431805
Cerebral mass effect 9.99 9.39 13 168542 809 50435760
Blood blister 9.98 9.39 19 168536 1641 50434928
Rash maculo-papular 9.97 9.39 134 168421 26507 50410062
Gastrointestinal stoma output increased 9.94 9.39 7 168548 199 50436370
Skin necrosis 9.89 9.39 13 168542 10854 50425715
Wrong drug 9.79 9.39 6 168549 134 50436435
Gingival hypertrophy 9.78 9.39 17 168538 1369 50435200
Hyperuricaemia 9.72 9.39 36 168519 4644 50431925
Pharyngeal oedema 9.65 9.39 76 168479 13089 50423480
Abdominal rigidity 9.63 9.39 19 168536 1685 50434884
Ventricular hypertrophy 9.62 9.39 28 168527 3187 50433382
Osteonecrosis of jaw 9.59 9.39 157 168398 32369 50404200
Gingival erosion 9.59 9.39 7 168548 211 50436358
Sinus node dysfunction 9.58 9.39 32 168523 3923 50432646
Underdose 9.54 9.39 35 168520 20243 50416326
Cholestasis of pregnancy 9.49 9.39 15 168540 1116 50435453
Caesarean section 9.49 9.39 24 168531 15615 50420954
Tracheal haemorrhage 9.49 9.39 6 168549 142 50436427
Blood phosphorus decreased 9.48 9.39 31 168524 3758 50432811
Bone pain 9.47 9.39 106 168449 47123 50389446
Blood parathyroid hormone decreased 9.46 9.39 6 168549 7108 50429461
Large intestinal ulcer 9.45 9.39 27 168528 3042 50433527
Loose tooth 9.44 9.39 28 168527 3222 50433347
Aortic valve calcification 9.39 9.39 9 168546 398 50436171

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Chronic kidney disease 566.60 9.96 716 118534 35700 29419577
Drug ineffective 313.66 9.96 621 118629 362549 29092728
Death 293.51 9.96 587 118663 341497 29113780
End stage renal disease 256.73 9.96 227 119023 7437 29447840
Completed suicide 245.06 9.96 36 119214 90210 29365067
Colitis microscopic 176.84 9.96 102 119148 1661 29453616
Renal injury 170.35 9.96 208 119042 9994 29445283
Interstitial lung disease 166.66 9.96 562 118688 57156 29398121
Hyponatraemia 163.26 9.96 621 118629 67012 29388265
Toxicity to various agents 139.92 9.96 308 118942 173353 29281924
Drug abuse 136.60 9.96 76 119174 79807 29375470
Product dose omission issue 132.70 9.96 116 119134 96267 29359010
Off label use 114.27 9.96 728 118522 300072 29155205
Acute kidney injury 106.34 9.96 1578 117672 263689 29191588
Fatigue 87.40 9.96 837 118413 315984 29139293
Cerebral infarction 86.49 9.96 257 118993 24418 29430859
Drug dispensed to wrong patient 83.50 9.96 34 119216 241 29455036
Treatment failure 77.63 9.96 26 119224 36913 29418364
Nephrogenic anaemia 77.07 9.96 64 119186 1921 29453356
Appendicolith 73.31 9.96 80 119170 3400 29451877
Hepatic function abnormal 72.32 9.96 332 118918 38927 29416350
Neutropenic sepsis 71.65 9.96 151 119099 11576 29443701
Lower respiratory tract infection 71.14 9.96 252 118998 26250 29429027
Venous pressure jugular increased 67.37 9.96 40 119210 689 29454588
Foetal exposure during pregnancy 65.84 9.96 27 119223 33840 29421437
Hypertensive nephropathy 65.82 9.96 33 119217 399 29454878
Drug resistance 59.80 9.96 8 119242 21532 29433745
Hypomagnesaemia 59.38 9.96 180 119070 17288 29437989
Product use in unapproved indication 55.38 9.96 173 119077 86702 29368575
Hypoparathyroidism secondary 52.48 9.96 20 119230 116 29455161
Renal impairment 51.57 9.96 528 118722 80805 29374472
Intentional overdose 51.03 9.96 48 119202 38480 29416797
Liver function test abnormal 49.92 9.96 240 119010 28678 29426599
Intentional product use issue 48.45 9.96 60 119190 42438 29412839
Cholestasis 47.41 9.96 204 119046 23258 29432019
Suicide attempt 46.95 9.96 41 119209 34069 29421208
Wrong patient received product 43.84 9.96 50 119200 2232 29453045
Appendicitis 42.43 9.96 103 119147 8676 29446601
Neutrophil count decreased 41.25 9.96 309 118941 43258 29412019
COVID-19 40.89 9.96 51 119199 35963 29419314
Toxic epidermal necrolysis 40.73 9.96 163 119087 17990 29437287
Nephropathy 39.66 9.96 74 119176 5189 29450088
Drug intolerance 38.69 9.96 86 119164 48293 29406984
Subacute cutaneous lupus erythematosus 38.23 9.96 30 119220 829 29454448
Gastric cancer 38.14 9.96 69 119181 4725 29450552
Hypergastrinaemia 37.63 9.96 13 119237 54 29455223
Full blood count abnormal 36.36 9.96 8 119242 15005 29440272
Malaise 36.07 9.96 870 118380 158732 29296545
Tetany 35.86 9.96 26 119224 636 29454641
Tetanus 35.69 9.96 12 119238 45 29455232
Diabetic nephropathy 35.53 9.96 41 119209 1854 29453423
Occupational dermatitis 35.06 9.96 13 119237 69 29455208
Hospitalisation 34.96 9.96 84 119166 45904 29409373
Hepatocellular injury 34.30 9.96 173 119077 21070 29434207
Intentional product misuse 33.50 9.96 55 119195 34606 29420671
Haematemesis 33.28 9.96 191 119059 24435 29430842
Antimicrobial susceptibility test resistant 32.85 9.96 18 119232 264 29455013
Peripheral swelling 32.63 9.96 139 119111 63600 29391677
Jaundice 31.93 9.96 215 119035 29081 29426196
Tubulointerstitial nephritis 30.85 9.96 147 119103 17496 29437781
Chronic kidney disease-mineral and bone disorder 30.46 9.96 19 119231 359 29454918
Drug eruption 30.39 9.96 141 119109 16600 29438677
Hyperchlorhydria 30.38 9.96 23 119227 602 29454675
Melaena 30.00 9.96 222 119028 30954 29424323
Adverse drug reaction 29.43 9.96 32 119218 23988 29431289
Rash vesicular 29.09 9.96 42 119208 2376 29452901
Inappropriate schedule of product administration 28.71 9.96 88 119162 44384 29410893
Gastrooesophageal reflux disease 28.47 9.96 221 119029 31275 29424002
Hypocalcaemia 28.39 9.96 161 119089 20504 29434773
Drug hypersensitivity 28.20 9.96 161 119089 68245 29387032
Weight increased 28.20 9.96 187 119063 76480 29378797
Therapeutic product effect incomplete 28.16 9.96 74 119176 39231 29416046
Liver disorder 28.08 9.96 200 119050 27549 29427728
Device dependence 27.14 9.96 9 119241 32 29455245
Poisoning 27.06 9.96 4 119246 9989 29445288
Blood pressure fluctuation 26.08 9.96 25 119225 19869 29435408
Haemorrhage subcutaneous 25.70 9.96 37 119213 2088 29453189
Abdominal pain 25.65 9.96 721 118529 134636 29320641
Dissociation 25.62 9.96 27 119223 1102 29454175
Overdose 25.35 9.96 203 119047 79616 29375661
Disease progression 25.25 9.96 210 119040 81706 29373571
Therapeutic response delayed 25.05 9.96 18 119232 434 29454843
Injection site pain 24.87 9.96 59 119191 32387 29422890
Platelet count decreased 24.65 9.96 574 118676 104098 29351179
Idiopathic pulmonary fibrosis 24.45 9.96 45 119205 3123 29452154
Nasopharyngitis 24.29 9.96 141 119109 59524 29395753
Unevaluable event 23.91 9.96 53 119197 29798 29425479
Pulmonary fibrosis 23.83 9.96 125 119125 15457 29439820
Therapeutic product effect decreased 23.83 9.96 52 119198 29399 29425878
Protein-losing gastroenteropathy 23.66 9.96 15 119235 292 29454985
Pain 23.63 9.96 519 118731 170913 29284364
Melanoderma 23.38 9.96 12 119238 153 29455124
Agranulocytosis 23.20 9.96 151 119099 20189 29435088
Loss of personal independence in daily activities 23.09 9.96 42 119208 25398 29429879
Neutrophil count increased 23.06 9.96 119 119131 14623 29440654
Cystitis escherichia 22.97 9.96 12 119238 159 29455118
Contraindication to medical treatment 22.85 9.96 17 119233 433 29454844
Renal failure 22.82 9.96 633 118617 117966 29337311
Pneumonia bacterial 22.67 9.96 86 119164 9257 29446020
Disseminated intravascular coagulation 22.59 9.96 148 119102 19832 29435445
Enteritis infectious 21.88 9.96 26 119224 1213 29454064
Hiatus hernia 21.48 9.96 68 119182 6684 29448593
Lip swelling 21.41 9.96 103 119147 12307 29442970
Weight decreased 21.33 9.96 455 118795 150450 29304827
Toxic skin eruption 20.61 9.96 86 119164 9671 29445606
Abdominal distension 20.60 9.96 279 118971 45632 29409645
Pancreatitis acute 20.34 9.96 168 119082 24217 29431060
Hypozincaemia 20.25 9.96 5 119245 3 29455274
Accidental exposure to product 20.21 9.96 9 119241 10744 29444533
Occupational exposure to air contaminants 20.01 9.96 10 119240 120 29455157
Gait disturbance 20.00 9.96 194 119056 73155 29382122
Pneumonia aspiration 19.80 9.96 231 119019 36506 29418771
Neurotoxicity 19.58 9.96 18 119232 14595 29440682
Hepatitis acute 19.58 9.96 64 119186 6398 29448879
Immune thrombocytopenia 19.52 9.96 73 119177 7804 29447473
Nephrosclerosis 19.43 9.96 20 119230 794 29454483
Femoral neck fracture 19.38 9.96 38 119212 2765 29452512
Marasmus 19.30 9.96 16 119234 479 29454798
Rebound acid hypersecretion 19.27 9.96 9 119241 92 29455185
Blood alkaline phosphatase increased 19.23 9.96 187 119063 28219 29427058
Confusional state 19.14 9.96 662 118588 127215 29328062
Synovitis 19.12 9.96 10 119240 10880 29444397
Biliary sepsis 19.06 9.96 17 119233 563 29454714
Rectal haemorrhage 18.96 9.96 218 119032 34331 29420946
Cardio-respiratory arrest 18.81 9.96 123 119127 50478 29404799
Joint swelling 18.78 9.96 120 119130 49510 29405767
Therapy non-responder 18.67 9.96 63 119187 30848 29424429
Sinobronchitis 18.67 9.96 5 119245 6 29455271
Enterochromaffin cell hyperplasia 18.62 9.96 6 119244 19 29455258
Cholangitis 17.98 9.96 69 119181 7468 29447809
Renal disorder 17.96 9.96 154 119096 22441 29432836
Renal artery stenosis 17.91 9.96 30 119220 1931 29453346
Hypoacusis 17.91 9.96 19 119231 14404 29440873
Failure to anastomose 17.82 9.96 11 119239 204 29455073
Glomerulosclerosis 17.75 9.96 18 119232 702 29454575
Hypotension 17.61 9.96 624 118626 193730 29261547
Alcoholic liver disease 17.59 9.96 16 119234 544 29454733
Haematotoxicity 17.42 9.96 3 119247 6696 29448581
Prostatic specific antigen increased 17.41 9.96 15 119235 12549 29442728
Subdural haematoma 17.19 9.96 129 119121 18064 29437213
Hepatic cytolysis 17.18 9.96 73 119177 8274 29447003
Therapy cessation 16.92 9.96 20 119230 14442 29440835
Orthostatic hypotension 16.83 9.96 152 119098 22477 29432800
Vasculitic rash 16.77 9.96 19 119231 842 29454435
Dry skin 16.60 9.96 44 119206 23263 29432014
Pathogen resistance 16.55 9.96 6 119244 8110 29447167
Rheumatoid arthritis 16.52 9.96 70 119180 32082 29423195
Mouth ulceration 16.48 9.96 84 119166 10271 29445006
Respiratory muscle weakness 16.46 9.96 8 119242 90 29455187
Upper respiratory tract inflammation 16.45 9.96 26 119224 1594 29453683
Oesophagitis 16.45 9.96 93 119157 11830 29443447
Dialysis 16.38 9.96 83 119167 10125 29445152
Hyperuricaemia 16.37 9.96 63 119187 6826 29448451
Stress 16.32 9.96 145 119105 21345 29433932
Dermatitis acneiform 16.29 9.96 54 119196 5437 29449840
Retinal vascular occlusion 16.25 9.96 9 119241 135 29455142
Ischaemic nephropathy 16.24 9.96 5 119245 13 29455264
Sopor 16.23 9.96 87 119163 10847 29444430
Ascites 16.21 9.96 222 119028 36397 29418880
Gastric polyps 16.16 9.96 20 119230 974 29454303
Gastric varices 16.09 9.96 13 119237 375 29454902
Vomiting 16.01 9.96 1026 118224 211234 29244043
Full blood count decreased 15.80 9.96 25 119225 15967 29439310
Faecal vomiting 15.80 9.96 13 119237 385 29454892
Wrong technique in product usage process 15.79 9.96 69 119181 31359 29423918
Transient ischaemic attack 15.66 9.96 153 119097 23117 29432160
Laboratory test abnormal 15.64 9.96 31 119219 18154 29437123
Immune reconstitution inflammatory syndrome 15.52 9.96 6 119244 7796 29447481
Paraesthesia oral 15.52 9.96 40 119210 3497 29451780
Periprosthetic fracture 15.47 9.96 9 119241 149 29455128
Underdose 15.46 9.96 15 119235 11854 29443423
Electrocardiogram ST-T segment abnormal 15.45 9.96 10 119240 202 29455075
Drug dependence 15.41 9.96 39 119211 20942 29434335
Neuroendocrine tumour 15.24 9.96 16 119234 650 29454627
White blood cell count increased 15.23 9.96 224 119026 37292 29417985
Serotonin syndrome 14.94 9.96 30 119220 17482 29437795
Gastrointestinal ulcer 14.87 9.96 25 119225 1614 29453663
Thrombosis 14.83 9.96 107 119143 42938 29412339
Follicular mucinosis 14.82 9.96 5 119245 19 29455258
Renal hypertension 14.71 9.96 9 119241 164 29455113
Renal cyst 14.64 9.96 67 119183 7840 29447437
Gastrointestinal tract irritation 14.63 9.96 10 119240 222 29455055
Renal haemangioma 14.62 9.96 5 119245 20 29455257
Coma 14.61 9.96 96 119154 39354 29415923
Minimum inhibitory concentration 14.56 9.96 6 119244 44 29455233
Asthenia 14.44 9.96 715 118535 214535 29240742
Adrenal suppression 14.41 9.96 14 119236 518 29454759
Drug ineffective for unapproved indication 14.25 9.96 22 119228 14192 29441085
Ventricular fibrillation 14.25 9.96 111 119139 15722 29439555
Burning feet syndrome 14.23 9.96 7 119243 81 29455196
Aspergillus infection 14.22 9.96 13 119237 10568 29444709
Macroglossia 14.20 9.96 12 119238 369 29454908
Inhibitory drug interaction 14.12 9.96 23 119227 1447 29453830
Blood albumin decreased 14.06 9.96 88 119162 11607 29443670
Product use issue 14.04 9.96 136 119114 51308 29403969
Radiation pneumonitis 13.96 9.96 29 119221 2200 29453077
Haemoptysis 13.85 9.96 186 119064 30364 29424913
Haemorrhagic cerebral infarction 13.80 9.96 16 119234 727 29454550
Thrombotic cerebral infarction 13.74 9.96 11 119239 313 29454964
Eosinophilia 13.61 9.96 143 119107 22018 29433259
Enterocolitis 13.49 9.96 58 119192 6608 29448669
Faeces discoloured 13.37 9.96 96 119154 13255 29442022
Drug reaction with eosinophilia and systemic symptoms 13.34 9.96 172 119078 27820 29427457
Gingival disorder 13.32 9.96 21 119229 1285 29453992
Device malfunction 13.26 9.96 9 119241 8498 29446779
Hyponatraemic seizure 13.23 9.96 6 119244 57 29455220
Crohn's disease 13.17 9.96 34 119216 2975 29452302
Pulmonary thrombosis 13.14 9.96 5 119245 6560 29448717
Multiple sclerosis relapse 13.14 9.96 16 119234 11403 29443874
Lymphocyte stimulation test positive 12.86 9.96 15 119235 686 29454591
Circulatory collapse 12.67 9.96 123 119127 18550 29436727
Lymphocyte count decreased 12.62 9.96 126 119124 19145 29436132
Oesophagogastric fundoplasty 12.57 9.96 4 119246 12 29455265
Erythema multiforme 12.56 9.96 63 119187 7654 29447623
Blood magnesium decreased 12.55 9.96 49 119201 5345 29449932
Embolic cerebral infarction 12.45 9.96 14 119236 615 29454662
Chondrocalcinosis 12.45 9.96 10 119240 286 29454991
Barrett's oesophagus 12.39 9.96 12 119238 442 29454835
Procedural failure 12.38 9.96 6 119244 67 29455210
Intracranial haematoma 12.37 9.96 11 119239 363 29454914
Pelvic cyst 12.33 9.96 5 119245 35 29455242
Dyspepsia 12.28 9.96 180 119070 29945 29425332
Sterile pyuria 12.21 9.96 5 119245 36 29455241
Therapy partial responder 12.13 9.96 3 119247 5196 29450081
Enterocolitis haemorrhagic 12.08 9.96 16 119234 834 29454443
Nocturia 12.05 9.96 66 119184 8296 29446981
Gastric varices haemorrhage 12.01 9.96 9 119241 232 29455045
N-telopeptide urine increased 11.98 9.96 5 119245 38 29455239
Helicobacter test positive 11.87 9.96 14 119236 648 29454629
Diffuse vasculitis 11.86 9.96 6 119244 74 29455203
Iron deficiency anaemia 11.84 9.96 69 119181 8873 29446404
Peptic ulcer 11.84 9.96 29 119221 2456 29452821
Spinal cord haemorrhage 11.82 9.96 10 119240 308 29454969
Discharge 11.81 9.96 8 119242 175 29455102
Brain stem haemorrhage 11.79 9.96 16 119234 854 29454423
Tendon pain 11.73 9.96 29 119221 2471 29452806
Sexually inappropriate behaviour 11.69 9.96 11 119239 391 29454886
Hirsutism 11.65 9.96 8 119242 179 29455098
Infusion related reaction 11.57 9.96 117 119133 43769 29411508
Aortic dissection 11.55 9.96 28 119222 2356 29452921
Mobility decreased 11.54 9.96 59 119191 25721 29429556
Carotid bruit 11.50 9.96 8 119242 183 29455094
Gastric pH increased 11.49 9.96 3 119247 3 29455274
Hypersensitivity vasculitis 11.48 9.96 34 119216 3223 29452054
Mesothelioma 11.43 9.96 11 119239 402 29454875
Cerebral hyperperfusion syndrome 11.39 9.96 6 119244 81 29455196
Cerebral haemorrhage 11.36 9.96 184 119066 31242 29424035
Exposed bone in jaw 11.33 9.96 21 119229 1465 29453812
Osteonecrosis of jaw 11.32 9.96 109 119141 16401 29438876
Pancreatic carcinoma recurrent 11.32 9.96 4 119246 18 29455259
Meniere's disease 11.26 9.96 5 119245 45 29455232
Drug-induced liver injury 11.15 9.96 135 119115 21520 29433757
Lichenoid keratosis 11.07 9.96 26 119224 2144 29453133
Central nervous system mass 11.01 9.96 6 119244 87 29455190
Neuropathic ulcer 10.98 9.96 4 119246 20 29455257
Hepatic encephalopathy 10.97 9.96 90 119160 12945 29442332
Ventricular hypertrophy 10.97 9.96 40 119210 4224 29451053
Neuropathy peripheral 10.96 9.96 211 119039 70816 29384461
Gastric ulcer haemorrhage 10.92 9.96 44 119206 4870 29450407
Coronary artery disease 10.91 9.96 244 119006 43946 29411331
Incorrect dose administered 10.87 9.96 83 119167 32901 29422376
Blood creatine phosphokinase increased 10.86 9.96 227 119023 40417 29414860
Blood folate decreased 10.84 9.96 12 119238 518 29454759
Sedation 10.84 9.96 35 119215 17370 29437907
Cerebellar infarction 10.81 9.96 23 119227 1774 29453503
Gastrostomy tube site complication 10.80 9.96 5 119245 50 29455227
Hip fracture 10.75 9.96 16 119234 10476 29444801
Localised infection 10.68 9.96 25 119225 13791 29441486
Upper gastrointestinal haemorrhage 10.59 9.96 135 119115 21779 29433498
Premature baby 10.58 9.96 35 119215 17245 29438032
Memory impairment 10.56 9.96 95 119155 36375 29418902
Eosinophil count increased 10.51 9.96 58 119192 7311 29447966
Influenza 10.49 9.96 113 119137 41768 29413509
Poisoning deliberate 10.46 9.96 5 119245 5726 29449551
Wall motion score index abnormal 10.44 9.96 6 119244 97 29455180
Cirrhosis alcoholic 10.29 9.96 14 119236 749 29454528
Ammonia decreased 10.28 9.96 3 119247 6 29455271
Psoriatic arthropathy 10.26 9.96 28 119222 14663 29440614
Dressler's syndrome 10.25 9.96 4 119246 25 29455252
Infective pulmonary exacerbation of cystic fibrosis 10.21 9.96 51 119199 6185 29449092
Gastritis 10.19 9.96 122 119128 19395 29435882
Anaphylactic reaction 10.18 9.96 162 119088 27411 29427866
Putamen haemorrhage 10.17 9.96 8 119242 222 29455055
Transverse sinus thrombosis 10.12 9.96 4 119246 26 29455251
Myocardial ischaemia 10.11 9.96 104 119146 15924 29439353
Chest pain 10.08 9.96 550 118700 111423 29343854
Large intestinal polypectomy 10.08 9.96 5 119245 59 29455218
Cardiac murmur 10.08 9.96 53 119197 6560 29448717
Therapeutic response unexpected 10.05 9.96 12 119238 8626 29446651
Electrocardiogram QT prolonged 10.04 9.96 203 119047 35934 29419343
Inappropriate antidiuretic hormone secretion 10.04 9.96 77 119173 10855 29444422
Occupational exposure to product 9.99 9.96 9 119241 302 29454975
Aplastic anaemia 9.98 9.96 58 119192 7452 29447825
Dialysis hypotension 9.97 9.96 3 119247 7 29455270

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
Drug ineffective 755.23 9.34 1276 243956 838971 63414529
Completed suicide 592.28 9.34 77 245155 224337 64029163
Chronic kidney disease 575.52 9.34 891 244341 57028 64196472
Hyponatraemia 495.25 9.34 1461 243771 146878 64106622
Colitis microscopic 492.36 9.34 323 244909 7109 64246391
Death 349.54 9.34 829 244403 481876 63771624
Toxicity to various agents 261.49 9.34 626 244606 362887 63890613
Acute kidney injury 261.37 9.34 2732 242500 446508 63806992
End stage renal disease 245.48 9.34 248 244984 10227 64243273
Interstitial lung disease 229.55 9.34 855 244377 96877 64156623
Hypomagnesaemia 225.00 9.34 462 244770 36914 64216586
Product dose omission issue 218.41 9.34 251 244981 194496 64059004
Off label use 212.54 9.34 1472 243760 631334 63622166
Drug intolerance 205.76 9.34 247 244985 187745 64065755
Drug abuse 197.61 9.34 130 245102 132244 64121256
Treatment failure 189.40 9.34 104 245128 116712 64136788
Subacute cutaneous lupus erythematosus 187.15 9.34 126 245106 2899 64250601
Synovitis 184.14 9.34 73 245159 99017 64154483
Fatigue 176.33 9.34 1910 243322 746820 63506680
Neutropenic sepsis 169.77 9.34 312 244920 22960 64230540
Cerebral infarction 161.03 9.34 429 244803 40615 64212885
Therapeutic product effect incomplete 148.60 9.34 106 245126 103376 64150124
Renal injury 141.60 9.34 229 245003 15200 64238300
Hepatic function abnormal 140.55 9.34 550 244682 63763 64189737
Contraindicated product administered 122.96 9.34 137 245095 107692 64145808
Pain 120.56 9.34 1436 243796 552075 63701425
Injection site pain 120.11 9.34 148 245084 111260 64142240
Therapeutic product effect decreased 116.39 9.34 161 245071 115190 64138310
Nephrogenic anaemia 109.26 9.34 95 245137 3230 64250270
Joint swelling 109.02 9.34 435 244797 214947 64038553
Arthropathy 108.44 9.34 183 245049 120784 64132716
Haematemesis 104.35 9.34 404 244828 46595 64206905
Melaena 99.72 9.34 436 244796 53112 64200388
Weight increased 95.70 9.34 451 244781 212897 64040603
Hypertensive nephropathy 93.44 9.34 51 245181 790 64252710
Liver function test abnormal 93.19 9.34 460 244772 58941 64194559
Drug resistance 92.59 9.34 12 245220 35090 64218410
Hand deformity 91.82 9.34 63 245169 62708 64190792
Maternal exposure during pregnancy 89.72 9.34 141 245091 95743 64157757
Cholestasis 88.67 9.34 372 244860 44500 64209000
Drug hypersensitivity 85.08 9.34 542 244690 237273 64016227
Loss of personal independence in daily activities 84.87 9.34 90 245142 72364 64181136
Pemphigus 84.76 9.34 64 245168 60637 64192863
Renal failure 84.09 9.34 1058 244174 180630 64072870
Peripheral swelling 82.56 9.34 462 244770 208691 64044809
Hypocalcaemia 82.39 9.34 346 244886 41407 64212093
Alopecia 82.32 9.34 337 244895 165353 64088147
Renal impairment 81.86 9.34 829 244403 134188 64119312
Confusional state 81.32 9.34 1420 243812 259724 63993776
Abdominal pain 79.27 9.34 1646 243586 310729 63942771
Appendicolith 77.41 9.34 80 245152 3389 64250111
Intentional overdose 77.03 9.34 140 245092 89804 64163696
Hepatocellular injury 76.51 9.34 358 244874 44877 64208623
Jaundice 76.32 9.34 376 244856 48136 64205364
Intentional product use issue 75.95 9.34 155 245077 95209 64158291
Product use in unapproved indication 75.91 9.34 379 244853 176239 64077261
Nasopharyngitis 75.28 9.34 437 244795 195636 64057864
Exposure during pregnancy 73.84 9.34 113 245119 77562 64175938
Electric shock 72.18 9.34 48 245184 1081 64252419
Anti-cyclic citrullinated peptide antibody positive 72.14 9.34 50 245182 49512 64203988
Neutrophil count decreased 71.59 9.34 521 244711 76675 64176825
Faeces discoloured 71.47 9.34 238 244994 25491 64228009
Rheumatoid arthritis 70.92 9.34 352 244880 163942 64089558
Product use issue 70.20 9.34 317 244915 151398 64102102
Electrocardiogram QT prolonged 70.15 9.34 530 244702 78918 64174582
Infusion related reaction 70.06 9.34 354 244878 164113 64089387
Hypokalaemia 68.93 9.34 738 244494 121165 64132335
Sinusitis 68.67 9.34 303 244929 145625 64107875
Lower respiratory tract infection 68.34 9.34 603 244629 94011 64159489
Cholecystitis chronic 67.08 9.34 124 245108 9163 64244337
Systemic lupus erythematosus 65.39 9.34 122 245110 77490 64176010
Swollen tongue 64.61 9.34 284 244948 34670 64218830
Agranulocytosis 64.25 9.34 302 244930 37927 64215573
Hypergastrinaemia 62.06 9.34 24 245208 156 64253344
Sopor 61.83 9.34 250 244982 29411 64224089
Suicide attempt 59.49 9.34 112 245120 70895 64182605
Device expulsion 58.80 9.34 6 245226 21130 64232370
Rectal haemorrhage 56.62 9.34 416 244816 61401 64192099
Tubulointerstitial nephritis 56.27 9.34 250 244982 30659 64222841
Lip swelling 55.79 9.34 255 244977 31652 64221848
Diabetic nephropathy 55.28 9.34 59 245173 2595 64250905
Inappropriate schedule of product administration 54.90 9.34 174 245058 92112 64161388
Platelet count decreased 54.70 9.34 919 244313 166792 64086708
Venous pressure jugular increased 53.89 9.34 42 245190 1221 64252279
Intentional product misuse 53.82 9.34 122 245110 72173 64181327
Abdominal discomfort 53.34 9.34 440 244792 181882 64071618
Swelling 52.83 9.34 374 244858 159844 64093656
Malaise 52.74 9.34 1921 243311 394326 63859174
COVID-19 52.61 9.34 105 245127 65035 64188465
Arthralgia 52.35 9.34 1281 243951 440979 63812521
Hepatic enzyme increased 51.80 9.34 286 244946 129657 64123843
Rheumatoid factor positive 51.18 9.34 35 245197 34903 64218597
Vomiting 50.56 9.34 2570 242662 548547 63704953
Hospitalisation 50.43 9.34 134 245098 75073 64178427
Gastrooesophageal reflux disease 50.12 9.34 510 244722 82633 64170867
Infective pulmonary exacerbation of cystic fibrosis 50.05 9.34 127 245105 11669 64241831
Injection site pruritus 48.92 9.34 43 245189 37783 64215717
Drug ineffective for unapproved indication 48.60 9.34 29 245203 31104 64222396
Nephropathy 48.51 9.34 102 245130 8284 64245216
Glossodynia 48.30 9.34 109 245123 64587 64188913
Accidental exposure to product 48.02 9.34 20 245212 26344 64227156
Gastritis 47.48 9.34 301 244931 42317 64211183
Gastric cancer 47.28 9.34 87 245145 6406 64247094
Wrong technique in product usage process 47.28 9.34 111 245121 64863 64188637
Pneumonia bacterial 47.15 9.34 145 245087 14890 64238610
Injection site erythema 46.83 9.34 127 245105 70673 64182827
Appendicitis 46.47 9.34 135 245097 13434 64240066
Hypoparathyroidism secondary 45.87 9.34 20 245212 183 64253317
Liver disorder 45.46 9.34 353 244879 52998 64200502
Discomfort 44.34 9.34 158 245074 80720 64172780
Disseminated intravascular coagulation 44.14 9.34 241 244991 32107 64221393
Intervertebral discitis 43.50 9.34 63 245169 3794 64249706
Circulatory collapse 43.16 9.34 247 244985 33485 64220015
Therapy cessation 43.16 9.34 36 245196 32453 64221047
Toxic skin eruption 42.99 9.34 166 245066 19118 64234382
Wound 42.87 9.34 148 245084 76329 64177171
Haemorrhage subcutaneous 41.76 9.34 66 245166 4295 64249205
Injection site swelling 41.41 9.34 58 245174 41295 64212205
Labile blood pressure 41.15 9.34 45 245187 2035 64251465
Device dependence 40.67 9.34 13 245219 43 64253457
Brain stem glioma 40.64 9.34 17 245215 139 64253361
Overdose 40.57 9.34 399 244833 159167 64094333
Wrong patient received product 40.34 9.34 60 245172 3702 64249798
Upper respiratory tract inflammation 40.10 9.34 60 245172 3722 64249778
Coronary artery disease 39.99 9.34 378 244854 60055 64193445
Reflux gastritis 39.97 9.34 32 245200 968 64252532
Injection site reaction 39.62 9.34 73 245159 46591 64206909
Tetany 39.56 9.34 45 245187 2127 64251373
Drug dispensed to wrong patient 39.52 9.34 22 245210 355 64253145
Chest pain 39.03 9.34 1174 244058 234806 64018694
Swelling face 38.61 9.34 369 244863 58797 64194703
International normalised ratio increased 37.86 9.34 464 244768 78703 64174797
Poisoning 37.64 9.34 18 245214 21861 64231639
Toxic epidermal necrolysis 36.87 9.34 255 244977 36911 64216589
Therapy interrupted 36.81 9.34 15 245217 20021 64233479
Urine magnesium decreased 36.61 9.34 8 245224 0 64253500
Orthostatic hypotension 36.42 9.34 303 244929 46435 64207065
Tetanus 36.39 9.34 12 245220 45 64253455
Biliary dyskinesia 36.35 9.34 45 245187 2327 64251173
Immune thrombocytopenia 36.33 9.34 133 245099 14933 64238567
Blood pressure fluctuation 35.86 9.34 91 245141 51780 64201720
Drug reaction with eosinophilia and systemic symptoms 35.81 9.34 339 244893 53878 64199622
Chronic kidney disease-mineral and bone disorder 35.78 9.34 23 245209 488 64253012
Blood alkaline phosphatase increased 35.75 9.34 349 244883 55930 64197570
Oesophagitis 35.70 9.34 170 245062 21460 64232040
Mobility decreased 35.27 9.34 187 245045 85653 64167847
Blood sodium decreased 34.58 9.34 211 245021 29271 64224229
Hyperkalaemia 34.37 9.34 558 244674 100571 64152929
Enterochromaffin cell hyperplasia 34.35 9.34 13 245219 79 64253421
Therapeutic response decreased 34.22 9.34 94 245138 52094 64201406
Erythema multiforme 34.06 9.34 134 245098 15567 64237933
Post-traumatic stress disorder 34.03 9.34 59 245173 4146 64249354
Cerebral haemorrhage 34.02 9.34 320 244912 50770 64202730
Influenza 33.98 9.34 251 244981 106280 64147220
Cardiac failure 33.98 9.34 699 244533 131674 64121826
Psoriatic arthropathy 33.90 9.34 71 245161 43210 64210290
Biliary sepsis 33.81 9.34 34 245198 1394 64252106
Antimicrobial susceptibility test resistant 33.79 9.34 18 245214 265 64253235
Red blood cell sedimentation rate abnormal 33.76 9.34 10 245222 16296 64237204
Nasal congestion 33.74 9.34 115 245117 59543 64193957
Pericarditis 33.69 9.34 123 245109 62393 64191107
Pancreatitis acute 33.49 9.34 278 244954 42577 64210923
Enteritis infectious 33.49 9.34 49 245183 2979 64250521
Sedation 33.33 9.34 67 245165 41395 64212105
Occupational dermatitis 33.10 9.34 14 245218 118 64253382
Eosinophilia 33.03 9.34 253 244979 37823 64215677
Anaemia 32.83 9.34 1757 243475 376923 63876577
Gastric polyps 32.82 9.34 48 245184 2917 64250583
Device dislocation 32.67 9.34 20 245212 21158 64232342
Hyperchlorhydria 32.30 9.34 37 245195 1762 64251738
Protein-losing gastroenteropathy 32.19 9.34 22 245210 519 64252981
Hiatus hernia 31.61 9.34 155 245077 19802 64233698
Hepatic ischaemia 31.18 9.34 28 245204 994 64252506
Enterocolitis 30.60 9.34 108 245124 11910 64241590
Idiopathic pulmonary fibrosis 30.34 9.34 53 245179 3747 64249753
Coma scale abnormal 30.22 9.34 81 245151 7693 64245807
Cholangitis 30.07 9.34 100 245132 10702 64242798
Injection site bruising 29.91 9.34 58 245174 36315 64217185
Hepatitis acute 29.63 9.34 115 245117 13274 64240226
Upper gastrointestinal haemorrhage 29.43 9.34 232 245000 34988 64218512
Diarrhoea 29.26 9.34 3156 242076 719548 63533952
Femoral neck fracture 29.11 9.34 86 245146 8638 64244862
Acne 28.94 9.34 27 245205 23054 64230446
Full blood count decreased 28.81 9.34 26 245206 22556 64230944
Abnormal loss of weight 28.66 9.34 77 245155 7323 64246177
Angioedema 28.55 9.34 360 244872 61461 64192039
Therapy partial responder 28.28 9.34 3 245229 10245 64243255
Adverse drug reaction 28.26 9.34 84 245148 45380 64208120
Syncope 28.17 9.34 792 244440 156843 64096657
Decreased appetite 28.05 9.34 1323 243909 279966 63973534
Coordination abnormal 27.97 9.34 122 245110 14842 64238658
Carcinoid tumour of the stomach 27.95 9.34 14 245218 180 64253320
Knee arthroplasty 27.91 9.34 37 245195 26962 64226538
Rectal ulcer 27.76 9.34 35 245197 1844 64251656
Anaphylactic reaction 27.63 9.34 390 244842 68274 64185226
Dehydration 27.59 9.34 1046 244186 215717 64037783
Altered state of consciousness 27.57 9.34 242 244990 37660 64215840
Pemphigoid 27.50 9.34 110 245122 12876 64240624
Basilar artery occlusion 27.48 9.34 14 245218 187 64253313
Dysphagia 27.40 9.34 564 244668 106248 64147252
Cystitis escherichia 27.30 9.34 19 245213 462 64253038
Red blood cell sedimentation rate increased 27.29 9.34 48 245184 31187 64222313
Post viral fatigue syndrome 27.20 9.34 16 245216 288 64253212
Neurotoxicity 26.88 9.34 39 245193 27365 64226135
Respiratory arrest 26.77 9.34 107 245125 52878 64200622
Neuroendocrine tumour 26.71 9.34 27 245205 1114 64252386
Gastric dysplasia 26.66 9.34 8 245224 20 64253480
Nephrocalcinosis 26.64 9.34 29 245203 1305 64252195
Haematotoxicity 26.53 9.34 8 245224 12888 64240612
Pneumonia aspiration 26.46 9.34 343 244889 58928 64194572
Urine potassium decreased 26.28 9.34 7 245225 9 64253491
Lethargy 25.96 9.34 404 244828 72190 64181310
Rheumatoid nodule 25.75 9.34 8 245224 12643 64240857
Multiple sclerosis relapse 25.57 9.34 76 245156 41059 64212441
Haemoptysis 25.44 9.34 292 244940 48756 64204744
Somatic delusion 25.31 9.34 21 245211 669 64252831
Mouth swelling 24.89 9.34 58 245174 5049 64248451
Poisoning deliberate 24.85 9.34 10 245222 13448 64240052
Hyperlipidaemia 24.80 9.34 161 245071 22815 64230685
Transient ischaemic attack 24.73 9.34 267 244965 43915 64209585
Hypophosphataemic osteomalacia 24.65 9.34 15 245217 288 64253212
Angina pectoris 24.57 9.34 271 244961 44810 64208690
Disability 24.24 9.34 8 245224 12164 64241336
Skin candida 24.02 9.34 31 245201 1672 64251828
Hyperglycaemia 24.02 9.34 345 244887 60623 64192877
Adrenal insufficiency 23.93 9.34 157 245075 22330 64231170
Weight decreased 23.92 9.34 867 244365 284872 63968628
Drug eruption 23.89 9.34 226 245006 35910 64217590
Rebound acid hypersecretion 23.78 9.34 10 245222 83 64253417
Blood pressure increased 23.70 9.34 488 244744 172064 64081436
Hepatic cytolysis 23.61 9.34 111 245121 13938 64239562
Constipation 23.57 9.34 1082 244150 228255 64025245
Subdural haematoma 23.55 9.34 185 245047 27869 64225631
Cardioactive drug level increased 23.45 9.34 45 245187 3420 64250080
Demyelination 23.41 9.34 68 245164 6766 64246734
Hepatotoxicity 23.30 9.34 76 245156 39886 64213614
Enterocolitis haemorrhagic 23.30 9.34 33 245199 1947 64251553
Urine output decreased 23.26 9.34 124 245108 16368 64237132
Musculoskeletal stiffness 23.23 9.34 329 244903 122877 64130623
Hypersensitivity pneumonitis 23.15 9.34 43 245189 3189 64250311
Erythema dyschromicum perstans 23.08 9.34 9 245223 60 64253440
Mouth ulceration 23.01 9.34 206 245026 32238 64221262
Gastrointestinal tract irritation 22.96 9.34 18 245214 528 64252972
Subarachnoid haemorrhage 22.93 9.34 134 245098 18304 64235196
Device malfunction 22.86 9.34 20 245212 17613 64235887
Drug interaction 22.81 9.34 1634 243598 360449 63893051
Iron deficiency anaemia 22.19 9.34 151 245081 21738 64231762
Haematuria 22.18 9.34 338 244894 60133 64193367
Myocardial ischaemia 22.16 9.34 158 245074 23093 64230407
Hyperuricaemia 22.12 9.34 87 245145 10104 64243396
Pathogen resistance 22.07 9.34 10 245222 12533 64240967
General physical health deterioration 22.01 9.34 600 244632 203825 64049675
Hyperparathyroidism secondary 21.95 9.34 35 245197 2295 64251205
Pancreatic carcinoma recurrent 21.90 9.34 10 245222 103 64253397
Gait disturbance 21.87 9.34 493 244739 171662 64081838
Immune reconstitution inflammatory syndrome 21.85 9.34 10 245222 12460 64241040
Renal tubular acidosis 21.80 9.34 40 245192 2939 64250561
Oropharyngeal oedema 21.72 9.34 13 245219 242 64253258
Fluid retention 21.71 9.34 135 245097 59471 64194029
Hip fracture 21.60 9.34 44 245188 27055 64226445
Paraesthesia oral 21.52 9.34 103 245129 13028 64240472
Renal atrophy 21.48 9.34 29 245203 1635 64251865
Red cell distribution width increased 21.37 9.34 10 245222 12299 64241201
Cardiac arrest 21.37 9.34 435 244797 153629 64099871
Blood creatine phosphokinase increased 21.36 9.34 327 244905 58231 64195269
Barrett's oesophagus 21.25 9.34 20 245212 755 64252745
Musculoskeletal disorder 21.23 9.34 22 245210 17884 64235616
Purpura 21.23 9.34 125 245107 17121 64236379
Neuropathy, ataxia, retinitis pigmentosa syndrome 21.22 9.34 8 245224 48 64253452
Gastrointestinal motility disorder 21.19 9.34 55 245177 5124 64248376
Marasmus 21.16 9.34 21 245211 847 64252653
Rhabdomyolysis 21.16 9.34 477 244755 91249 64162251
Cardio-respiratory arrest 21.02 9.34 256 244976 98137 64155363
Macroglossia 20.88 9.34 23 245209 1049 64252451
Gallbladder disorder 20.68 9.34 123 245109 16907 64236593
Occupational exposure to air contaminants 20.57 9.34 10 245222 120 64253380
Hypersensitivity 20.54 9.34 579 244653 195873 64057627
Device issue 20.52 9.34 34 245198 22614 64230886
Muscle relaxant therapy 20.47 9.34 11 245221 165 64253335
Device difficult to use 20.30 9.34 6 245226 9792 64243708
Abdominal distension 20.24 9.34 493 244739 95501 64157999
Hypoglycaemic coma 20.24 9.34 48 245184 4226 64249274
Unevaluable event 20.18 9.34 111 245121 50378 64203122
Osteonecrosis of jaw 20.17 9.34 236 244996 39589 64213911
Blood pressure decreased 19.80 9.34 448 244784 85751 64167749
Pain in extremity 19.78 9.34 946 244286 302139 63951361
Rhinorrhoea 19.74 9.34 140 245092 59829 64193671
Nephrosclerosis 19.71 9.34 27 245205 1544 64251956
Premature delivery 19.70 9.34 25 245207 18564 64234936
Ventricular hypertrophy 19.65 9.34 62 245170 6454 64247046
Pituitary tumour benign 19.65 9.34 33 245199 2260 64251240
Cholecystitis 19.63 9.34 135 245097 19501 64233999
Psoriasis 19.62 9.34 176 245056 71527 64181973
Hyponatraemic syndrome 19.61 9.34 19 245213 744 64252756
Coma 19.46 9.34 226 245006 87389 64166111
Mixed liver injury 19.22 9.34 55 245177 5426 64248074
Bradycardia 19.21 9.34 587 244645 117632 64135868
Gastric varices 19.17 9.34 16 245216 514 64252986
Contraindication to medical treatment 19.07 9.34 21 245211 957 64252543
Sleep disorder due to general medical condition, insomnia type 19.01 9.34 45 245187 26225 64227275
Extravasation blood 18.95 9.34 14 245218 375 64253125
Alanine aminotransferase increased 18.91 9.34 676 244556 138355 64115145
Ill-defined disorder 18.63 9.34 95 245137 43957 64209543
Anal prolapse 18.56 9.34 8 245224 71 64253429
Hip arthroplasty 18.48 9.34 33 245199 21318 64232182
Cardiac murmur 18.45 9.34 90 245142 11473 64242027
Joint stiffness 18.30 9.34 57 245175 30347 64223153
Underdose 18.09 9.34 45 245187 25784 64227716
Dyspepsia 18.01 9.34 416 244816 79896 64173604
Gastric ulcer 17.99 9.34 185 245047 30049 64223451
Face oedema 17.96 9.34 158 245074 24603 64228897
Gastrointestinal haemorrhage 17.91 9.34 643 244589 131669 64121831
Transplant rejection 17.83 9.34 24 245208 17377 64236123
Condition aggravated 17.81 9.34 1198 244034 371228 63882272
Dilatation atrial 17.72 9.34 40 245192 3410 64250090
Microcytic anaemia 17.70 9.34 48 245184 4590 64248910
Cold sweat 17.58 9.34 115 245117 16340 64237160
Dermatitis exfoliative 17.55 9.34 82 245150 10270 64243230
Melanoderma 17.50 9.34 13 245219 351 64253149
Pelvic cyst 17.42 9.34 7 245225 51 64253449
Renal cyst 17.38 9.34 94 245138 12476 64241024
Dialysis 17.32 9.34 117 245115 16803 64236697
Infusion site streaking 17.22 9.34 14 245218 433 64253067
Hepatic encephalopathy 17.18 9.34 138 245094 20928 64232572
Alcoholic liver disease 17.18 9.34 15 245217 513 64252987
Nocturia 17.17 9.34 86 245146 11079 64242421
Inappropriate antidiuretic hormone secretion 17.10 9.34 144 245088 22145 64231355
Peptic ulcer 17.07 9.34 52 245180 5311 64248189
White blood cell count increased 17.06 9.34 349 244883 65665 64187835
Eye haemorrhage 17.05 9.34 70 245162 8290 64245210
Limb discomfort 17.04 9.34 50 245182 27125 64226375
Neoplasm progression 16.95 9.34 89 245143 40875 64212625
Respiratory tract congestion 16.86 9.34 22 245210 16143 64237357
Ulcer 16.83 9.34 147 245085 22843 64230657
Embolic cerebral infarction 16.78 9.34 21 245211 1098 64252402
Blood albumin decreased 16.62 9.34 137 245095 20936 64232564
Infection 16.60 9.34 556 244676 184324 64069176
Aortic dissection 16.60 9.34 39 245193 3413 64250087
Drug-induced liver injury 16.60 9.34 264 244968 47379 64206121
Cerebral mass effect 16.59 9.34 26 245206 1680 64251820
Dermatitis bullous 16.57 9.34 90 245142 11964 64241536
Cerebellar infarction 16.51 9.34 38 245194 3281 64250219
Staphylococcus test positive 16.38 9.34 53 245179 5592 64247908
Illness 16.34 9.34 37 245195 21901 64231599
Stoma site haemorrhage 16.26 9.34 25 245207 1588 64251912
Oesophageal mucosal tear 16.26 9.34 5 245227 14 64253486
Laryngeal pain 16.25 9.34 53 245179 5615 64247885
Atypical fracture 16.23 9.34 16 245216 640 64252860
Flashback 16.23 9.34 11 245221 256 64253244
Hiccups 16.20 9.34 69 245163 8307 64245193
Unintentional medical device removal 16.17 9.34 3 245229 6731 64246769
Cholelithiasis 16.17 9.34 253 244979 45253 64208247
Acute coronary syndrome 16.02 9.34 127 245105 19183 64234317
Chronic gastritis 16.01 9.34 37 245195 3203 64250297
Penile curvature 16.01 9.34 5 245227 15 64253485
Hypophagia 15.99 9.34 225 245007 39362 64214138
Hypoacusis 15.92 9.34 48 245184 25819 64227681
Tachypnoea 15.86 9.34 50 245182 26521 64226979
Bleeding time prolonged 15.82 9.34 21 245211 1165 64252335
Urinary retention 15.79 9.34 269 244963 48932 64204568
C-reactive protein abnormal 15.75 9.34 57 245175 28990 64224510
Injection site haemorrhage 15.71 9.34 44 245188 24234 64229266
Foot deformity 15.69 9.34 24 245208 16480 64237020
Product substitution issue 15.67 9.34 119 245113 17742 64235758
Therapeutic response delayed 15.60 9.34 18 245214 864 64252636
Brain stem haemorrhage 15.58 9.34 24 245208 1527 64251973
Blood gastrin increased 15.52 9.34 6 245226 39 64253461
Hypozincaemia 15.52 9.34 6 245226 39 64253461
Sleep disorder due to a general medical condition 15.40 9.34 6 245226 8228 64245272
Minimum inhibitory concentration 15.39 9.34 6 245226 40 64253460
Radiation pneumonitis 15.36 9.34 37 245195 3291 64250209
Blood magnesium decreased 15.35 9.34 98 245134 13807 64239693
Electrocardiogram QRS complex prolonged 15.31 9.34 8 245224 9236 64244264
Spleen congestion 15.28 9.34 13 245219 429 64253071
Chromaturia 15.24 9.34 142 245090 22469 64231031
Abortion spontaneous 15.23 9.34 47 245185 25096 64228404
Temperature intolerance 15.20 9.34 67 245165 8188 64245312
Therapeutic response shortened 15.15 9.34 10 245222 10160 64243340
Adverse event 15.14 9.34 88 245144 39401 64214099
Blood cholinesterase decreased 15.12 9.34 10 245222 223 64253277
Pulmonary fibrosis 15.10 9.34 177 245055 29701 64223799
Renal disorder 15.09 9.34 203 245029 35162 64218338
Mental status changes 15.09 9.34 154 245078 61008 64192492
Pharyngeal oedema 15.07 9.34 106 245126 15425 64238075
Failure to anastomose 15.01 9.34 10 245222 226 64253274
Helicobacter infection 14.97 9.34 85 245147 38277 64215223
Neutrophil count increased 14.96 9.34 154 245078 25020 64228480
Hypocalciuria 14.91 9.34 5 245227 20 64253480
Gallbladder injury 14.81 9.34 20 245212 1128 64252372
Renal artery stenosis 14.78 9.34 34 245198 2935 64250565
Burning feet syndrome 14.77 9.34 8 245224 122 64253378
Central nervous system lesion 14.69 9.34 14 245218 11835 64241665
Injection site mass 14.67 9.34 27 245205 17243 64236257
Impaired healing 14.62 9.34 153 245079 60320 64193180
Sinus node dysfunction 14.59 9.34 58 245174 6770 64246730
Product quality issue 14.54 9.34 61 245171 29738 64223762
Follicular mucinosis 14.53 9.34 5 245227 22 64253478
Urine phosphorus decreased 14.46 9.34 6 245226 48 64253452
Autonomic neuropathy 14.45 9.34 24 245208 1628 64251872
Blood loss anaemia 14.40 9.34 19 245213 13873 64239627
Abnormal faeces 14.36 9.34 52 245180 5807 64247693
Ischaemic nephropathy 14.35 9.34 5 245227 23 64253477
Embolic stroke 14.33 9.34 57 245175 6654 64246846
Oral candidiasis 14.28 9.34 143 245089 23069 64230431
Therapy non-responder 14.24 9.34 171 245061 65728 64187772
Panniculitis 14.24 9.34 8 245224 8871 64244629
Ventricular fibrillation 14.20 9.34 146 245086 23714 64229786
Sinus congestion 14.15 9.34 23 245209 15416 64238084
Haemorrhagic cerebral infarction 14.15 9.34 21 245211 1293 64252207
Blood pressure systolic increased 14.15 9.34 120 245112 49333 64204167
Hallucination, visual 14.12 9.34 165 245067 27669 64225831
Lymphangiosis carcinomatosa 14.02 9.34 25 245207 1796 64251704
Renal hypertension 14 9.34 9 245223 191 64253309
Drug dependence 14.00 9.34 72 245160 33240 64220260
Skin oedema 13.98 9.34 22 245210 1426 64252074
Activated partial thromboplastin time prolonged 13.90 9.34 90 245142 12741 64240759
Immunodeficiency 13.88 9.34 25 245207 16099 64237401
Rapid eye movement sleep behaviour disorder 13.82 9.34 11 245221 330 64253170
Pressure of speech 13.78 9.34 18 245214 983 64252517
Intestinal ischaemia 13.76 9.34 83 245149 11466 64242034
Oesophageal anastomosis 13.73 9.34 3 245229 0 64253500
Nightmare 13.73 9.34 131 245101 20862 64232638
Gastroenteritis 13.71 9.34 173 245059 29538 64223962
Dermatitis acneiform 13.67 9.34 66 245166 8377 64245123
Vasculitic rash 13.65 9.34 26 245206 1965 64251535
Colon cancer 13.59 9.34 89 245143 12650 64240850
Phyllodes tumour 13.55 9.34 5 245227 28 64253472
Pulmonary thrombosis 13.55 9.34 12 245220 10506 64242994
Hepatorenal syndrome 13.54 9.34 38 245194 3708 64249792
Rash erythematous 13.53 9.34 260 244972 48373 64205127
Acute myocardial infarction 13.50 9.34 354 244878 69364 64184136
Foetal death 13.50 9.34 3 245229 5927 64247573
Hyperprolactinaemia 13.49 9.34 40 245192 4025 64249475
Hypoalbuminaemia 13.46 9.34 114 245118 17560 64235940
Dissociation 13.39 9.34 33 245199 2978 64250522
Hepatic cancer 13.37 9.34 60 245172 7388 64246112
Abdominal pain upper 13.36 9.34 803 244429 174227 64079273
Injection site warmth 13.36 9.34 19 245213 13443 64240057
Device use error 13.34 9.34 4 245228 6467 64247033
Erythema 13.31 9.34 853 244379 186217 64067283
Mouth haemorrhage 13.29 9.34 73 245159 9746 64243754
Rash maculo-papular 13.29 9.34 252 244980 46774 64206726
Respiratory muscle weakness 13.24 9.34 10 245222 277 64253223
Palpitations 13.22 9.34 504 244728 103984 64149516
Hypoglycaemia 13.20 9.34 441 244791 89451 64164049
Discoloured vomit 13.20 9.34 19 245213 1138 64252362
Laboratory test abnormal 13.19 9.34 47 245185 24016 64229484
Malignant melanoma 13.16 9.34 18 245214 12946 64240554
Hypotension 13.05 9.34 1259 243973 379715 63873785
Helicobacter test positive 13.05 9.34 18 245214 1036 64252464
Hypochloraemia 13.02 9.34 26 245206 2035 64251465
Ileus 12.95 9.34 139 245093 22827 64230673
Alanine aminotransferase abnormal 12.91 9.34 5 245227 6883 64246617
Cardiotoxicity 12.90 9.34 12 245220 10262 64243238
Aphasia 12.89 9.34 223 245009 40683 64212817
Glossitis 12.79 9.34 34 245198 3213 64250287
Pneumocystis jirovecii pneumonia 12.79 9.34 161 245071 27473 64226027
Hypervolaemia 12.78 9.34 89 245143 38196 64215304
Basal cell carcinoma 12.76 9.34 67 245165 30771 64222729
Glomerulosclerosis 12.74 9.34 17 245215 948 64252552
Cutaneous lupus erythematosus 12.57 9.34 30 245202 2652 64250848
Dialysis hypotension 12.57 9.34 4 245228 13 64253487
Skin necrosis 12.53 9.34 22 245210 14307 64239193
Cholecystitis acute 12.50 9.34 80 245152 11280 64242220
Memory impairment 12.45 9.34 240 244992 85442 64168058
Oesophageal carcinoma recurrent 12.38 9.34 5 245227 37 64253463
Haemoglobin decreased 12.38 9.34 881 244351 194182 64059318
Discharge 12.32 9.34 17 245215 979 64252521
Incorrect dose administered 12.26 9.34 160 245072 60605 64192895
Oculomucocutaneous syndrome 12.25 9.34 10 245222 311 64253189
Diabetic metabolic decompensation 12.24 9.34 30 245202 2698 64250802
Coagulation test abnormal 12.22 9.34 18 245214 1101 64252399
Post transplant lymphoproliferative disorder 12.16 9.34 11 245221 9533 64243967
Rectal ulcer haemorrhage 12.15 9.34 9 245223 242 64253258
Acanthosis 12.15 9.34 11 245221 395 64253105
Strangury 12.08 9.34 8 245224 179 64253321
Rash morbilliform 12.07 9.34 45 245187 5096 64248404
Mesenteric artery embolism 12.06 9.34 6 245226 76 64253424
Bile duct stone 12.05 9.34 44 245188 4934 64248566
Hospice care 12.05 9.34 7 245225 7618 64245882
Epstein-Barr virus infection 12.02 9.34 18 245214 12470 64241030
Tongue discolouration 12.01 9.34 34 245198 3334 64250166
Blood uric acid increased 11.94 9.34 62 245170 8101 64245399
Vascular skin disorder 11.93 9.34 4 245228 16 64253484
Vulval haemorrhage 11.93 9.34 4 245228 16 64253484
Poor venous access 11.86 9.34 18 245214 12399 64241101
N-telopeptide urine increased 11.84 9.34 5 245227 42 64253458
Hypoperfusion 11.83 9.34 27 245205 2319 64251181
Cerebral ventricular rupture 11.83 9.34 11 245221 409 64253091
Lymphocyte count decreased 11.81 9.34 219 245013 40480 64213020
Procedural failure 11.79 9.34 6 245226 80 64253420
Hydronephrosis 11.77 9.34 93 245139 14032 64239468
Fasciitis 11.73 9.34 14 245218 697 64252803
Rash papulosquamous 11.66 9.34 7 245225 131 64253369
Erythema annulare 11.66 9.34 7 245225 131 64253369
Anti A antibody 11.66 9.34 3 245229 3 64253497
Bone pain 11.65 9.34 120 245112 47452 64206048
Sinobronchitis 11.64 9.34 5 245227 44 64253456
Incision site complication 11.59 9.34 14 245218 706 64252794
Laryngotracheal oedema 11.54 9.34 5 245227 45 64253455
Substance abuse 11.50 9.34 11 245221 9281 64244219
Fibromyalgia 11.48 9.34 84 245148 35647 64217853
Respiratory tract oedema 11.43 9.34 14 245218 716 64252784
Parakeratosis 11.38 9.34 10 245222 345 64253155
Gastrointestinal disorder 11.35 9.34 257 244975 89452 64164048
Pharyngotonsillitis 11.33 9.34 9 245223 269 64253231
Presyncope 11.32 9.34 192 245040 34897 64218603
Food allergy 11.32 9.34 8 245224 7843 64245657
Duodenal ulcer perforation 11.31 9.34 81 245151 34544 64218956
Surgery 11.29 9.34 62 245170 28151 64225349
Papule 11.28 9.34 51 245181 6299 64247201
Vulvovaginal candidiasis 11.28 9.34 25 245207 2105 64251395
Gastroenteritis staphylococcal 11.28 9.34 9 245223 271 64253229
Pregnancy 11.27 9.34 41 245191 20824 64232676
Product complaint 11.26 9.34 81 245151 11873 64241627
Tumour haemorrhage 11.24 9.34 34 245198 3459 64250041
Aortic aneurysm rupture 11.22 9.34 18 245214 1186 64252314
Congenital bowing of long bones 11.21 9.34 4 245228 20 64253480
Total lung capacity decreased 11.21 9.34 22 245210 1700 64251800
Urine calcium/creatinine ratio increased 11.21 9.34 7 245225 141 64253359
Urinary straining 11.17 9.34 5 245227 49 64253451
Putamen haemorrhage 11.16 9.34 11 245221 440 64253060
Central nervous system mass 11.10 9.34 6 245226 91 64253409
Gingivitis 11.08 9.34 58 245174 7601 64245899
Dysuria 11.08 9.34 223 245009 41834 64211666
Urticaria 11.08 9.34 675 244557 146642 64106858
Lymphocyte stimulation test positive 10.95 9.34 17 245215 1089 64252411
Gallbladder hypofunction 10.94 9.34 11 245221 451 64253049
Hepatic cancer metastatic 10.94 9.34 14 245218 749 64252751
Gastrostomy tube site complication 10.93 9.34 6 245226 94 64253406
Atypical femur fracture 10.93 9.34 41 245191 4657 64248843
Lymphadenopathy 10.93 9.34 119 245113 46567 64206933
Gastrointestinal stoma output decreased 10.91 9.34 5 245227 52 64253448
Sedation complication 10.89 9.34 14 245218 10340 64243160
Transplant dysfunction 10.82 9.34 6 245226 6702 64246798
Gamma-glutamyltransferase increased 10.79 9.34 251 244981 48259 64205241
Rectocele 10.77 9.34 12 245220 554 64252946
Wall motion score index abnormal 10.77 9.34 6 245226 97 64253403
Ear pain 10.75 9.34 54 245178 25082 64228418
Oesophageal carcinoma 10.71 9.34 41 245191 4702 64248798
Dysentery 10.69 9.34 15 245217 877 64252623
Hemiparesis 10.66 9.34 166 245066 29661 64223839
Gastric ulcer haemorrhage 10.66 9.34 60 245172 8083 64245417
Post cardiac arrest syndrome 10.61 9.34 4 245228 24 64253476
Thrombotic cerebral infarction 10.55 9.34 11 245221 471 64253029
Skin toxicity 10.52 9.34 6 245226 6596 64246904
Complication of device insertion 10.51 9.34 3 245229 5009 64248491
Disease progression 10.50 9.34 436 244796 141244 64112256
Paramnesia 10.48 9.34 4 245228 25 64253475
Gastrointestinal stoma output increased 10.46 9.34 8 245224 226 64253274
Platelet transfusion 10.44 9.34 22 245210 1789 64251711
Cytomegalovirus test positive 10.44 9.34 43 245189 5101 64248399
Periprosthetic fracture 10.43 9.34 12 245220 574 64252926
Pancreatic carcinoma metastatic 10.40 9.34 33 245199 3445 64250055
Electrocardiogram ST-T segment abnormal 10.40 9.34 11 245221 479 64253021
Drug use disorder 10.39 9.34 5 245227 6049 64247451
Vasomotor rhinitis 10.36 9.34 5 245227 59 64253441
Product prescribing error 10.35 9.34 85 245147 35184 64218316
Regurgitation 10.33 9.34 24 245208 2085 64251415
Meniere's disease 10.29 9.34 7 245225 164 64253336
Diffuse vasculitis 10.25 9.34 6 245226 107 64253393
Narrow anterior chamber angle 10.25 9.34 7 245225 165 64253335
Bradyphrenia 10.21 9.34 66 245166 9340 64244160
Aplastic anaemia 10.19 9.34 89 245143 13831 64239669
Lung opacity 10.17 9.34 31 245201 3168 64250332
Tongue disorder 10.16 9.34 19 245213 12061 64241439
Product monitoring error 10.16 9.34 4 245228 5450 64248050
Ammonia decreased 10.14 9.34 3 245229 7 64253493
Impaired quality of life 10.14 9.34 6 245226 6465 64247035
Sputum retention 10.13 9.34 15 245217 922 64252578
Rash macular 10.12 9.34 136 245096 23549 64229951
Prostatic specific antigen increased 10.12 9.34 11 245221 8749 64244751
Hypertransaminasaemia 10.10 9.34 54 245178 7137 64246363
Large intestinal ulcer 10.10 9.34 37 245195 4156 64249344
Full blood count abnormal 10.02 9.34 69 245163 29688 64223812
Oropharyngeal swelling 10.02 9.34 17 245215 1174 64252326
Cerebral hyperperfusion syndrome 10.01 9.34 6 245226 112 64253388
Sepsis 9.98 9.34 1011 244221 229330 64024170
Gamma-glutamyltransferase 9.97 9.34 4 245228 29 64253471
Bone erosion 9.96 9.34 18 245214 11577 64241923
Asthma 9.92 9.34 450 244782 94775 64158725
Morbid thoughts 9.91 9.34 13 245219 713 64252787
Hepatic atrophy 9.90 9.34 10 245222 412 64253088
Cystitis 9.90 9.34 109 245123 42566 64210934
Fat redistribution 9.87 9.34 6 245226 115 64253385
Acute graft versus host disease 9.85 9.34 12 245220 9072 64244428
Chondrocalcinosis 9.85 9.34 13 245219 717 64252783
Cystic fibrosis 9.74 9.34 32 245200 3402 64250098
Sterile pyuria 9.73 9.34 5 245227 68 64253432
Blood electrolytes increased 9.73 9.34 5 245227 68 64253432
Thalamus haemorrhage 9.72 9.34 20 245212 1599 64251901
Gynaecomastia 9.72 9.34 47 245185 5969 64247531
Pyelonephritis acute 9.70 9.34 42 245190 5092 64248408
Gastric varices haemorrhage 9.69 9.34 9 245223 334 64253166
Multiple allergies 9.67 9.34 5 245227 5809 64247691
Functional residual capacity decreased 9.67 9.34 5 245227 69 64253431
Nasal mucosal erosion 9.67 9.34 5 245227 69 64253431
Oesophageal ulcer 9.67 9.34 48 245184 6162 64247338
Periorbital discomfort 9.64 9.34 4 245228 32 64253468
Culture throat positive 9.60 9.34 3 245229 9 64253491
Blood lactate dehydrogenase increased 9.60 9.34 178 245054 32900 64220600
Deep vein thrombosis postoperative 9.52 9.34 18 245214 1353 64252147
Heart rate irregular 9.51 9.34 63 245169 27350 64226150
Muscle spasticity 9.51 9.34 32 245200 16637 64236863
Fibrin degradation products increased 9.50 9.34 8 245224 260 64253240
Lip oedema 9.46 9.34 42 245190 5147 64248353
Pre-eclampsia 9.45 9.34 6 245226 6225 64247275
Tracheostomy infection 9.42 9.34 5 245227 73 64253427
Atrioventricular block 9.41 9.34 78 245154 11937 64241563
Lichenoid keratosis 9.40 9.34 31 245201 3303 64250197
Small intestinal haemorrhage 9.38 9.34 34 245198 3799 64249701
Heart rate decreased 9.36 9.34 150 245082 54917 64198583

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BC03 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BC53 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BD02 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 A02BD03 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 A02BD07 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 A02BD09 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 A02BD10 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 PE N0000009724 Inhibition Gastric Acid Secretion
FDA EPC N0000175525 Proton Pump Inhibitor
CHEBI has role CHEBI:49200 proton pump inhibitors
CHEBI has role CHEBI:49201 anti-ulcer drugs
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D054328 Proton Pump Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Erosive esophagitis indication 40719004
Duodenal ulcer disease indication 51868009 DOID:1724
Zollinger-Ellison syndrome indication 53132006 DOID:0050782
Gastroesophageal reflux disease indication 235595009 DOID:8534
Gastric ulcer indication 397825006 DOID:10808
NSAID-Induced Gastric Ulcer indication
Gastric Hypersecretory Conditions indication
Duodenal Ulcer due to H. Pylori indication
Maintenance of Healing Duodenal Ulcer indication
Upper gastrointestinal hemorrhage off-label use 37372002
Pathological Gastric Hypersecretory Condition off-label use
Prevention of Stress Ulcer off-label use
Prevention of Acute Gastrointestinal Ulcer Re-Bleed off-label use
Alcoholism contraindication 7200002
Myocardial infarction contraindication 22298006 DOID:5844
Ventricular tachycardia contraindication 25569003
Obstruction of bile duct contraindication 30144000
Torsades de pointes contraindication 31722008
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Osteoporosis contraindication 64859006 DOID:11476
Gastrointestinal hemorrhage contraindication 74474003
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Cholestatic hepatitis contraindication 95556007
Prolonged QT interval contraindication 111975006
Fracture of bone contraindication 125605004
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Esophageal dysmotility contraindication 266434009 DOID:9192
Edema contraindication 267038008
Infectious mononucleosis contraindication 271558008 DOID:8568
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Pseudomembranous enterocolitis contraindication 397683000
Porphyria contraindication 418470004
Smokes tobacco daily contraindication 449868002




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.23 acidic
pKa2 3.35 Basic
pKa3 2.72 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Potassium-transporting ATPase Transporter INHIBITOR CHEMBL CHEMBL
Cytochrome P450 2C19 Enzyme IC50 6.47 DRUG MATRIX
Fatty acid synthase Enzyme Ki 5.28 CHEMBL
Phosphoethanolamine/phosphocholine phosphatase Enzyme IC50 6.36 CHEMBL
Microtubule-associated protein tau Structural Ki 8.60 CHEMBL
N(G),N(G)-dimethylarginine dimethylaminohydrolase 1 Enzyme IC50 4.29 CHEMBL
Cytochrome P450 2D6 Enzyme IC50 5.28 DRUG MATRIX
Cytosolic endo-beta-N-acetylglucosaminidase Enzyme IC50 4.61 CHEMBL
Indoleamine 2,3-dioxygenase 2 Enzyme IC50 5.09 CHEMBL
Indoleamine 2,3-dioxygenase 1 Enzyme IC50 4.03 CHEMBL

External reference:

IDSource
D00355 KEGG_DRUG
4020922 VANDF
C0050940 UMLSCUI
CHEBI:6375 CHEBI
CHEMBL480 ChEMBL_ID
DB00448 DRUGBANK_ID
D064747 MESH_DESCRIPTOR_UI
3883 PUBCHEM_CID
7208 IUPHAR_LIGAND_ID
6397 INN_ID
0K5C5T2QPG UNII
17128 RXNORM
169151 MMSL
330 MMSL
4958 MMSL
d03828 MMSL
004456 NDDF
108666007 SNOMEDCT_US
386888004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Prevacid24 HR HUMAN OTC DRUG LABEL 1 0067-6286 CAPSULE, DELAYED RELEASE 15 mg ORAL NDA 15 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-3008 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-3008 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-3009 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 30 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-3009 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 30 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-7350 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 27 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-7350 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 27 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-7351 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 27 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-7351 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 27 sections
Good Sense Lansoprazole HUMAN OTC DRUG LABEL 1 0113-0116 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL NDA 16 sections
Good Sense lansoprazole HUMAN OTC DRUG LABEL 1 0113-0117 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 16 sections
Good Sense Lansoprazole HUMAN OTC DRUG LABEL 1 0113-1114 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 16 sections
Prevacid 24 HR HUMAN OTC DRUG LABEL 1 0113-6002 CAPSULE, DELAYED RELEASE 15 mg ORAL NDA 16 sections
Prevacid 24 HR HUMAN OTC DRUG LABEL 1 0113-6002 CAPSULE, DELAYED RELEASE 15 mg ORAL NDA 16 sections
Basic Care Lansoprazole HUMAN OTC DRUG LABEL 1 0113-7003 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 16 sections
basic care lansoprazole HUMAN OTC DRUG LABEL 1 0113-7116 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL NDA 16 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0363-0739 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 15 sections
lansoprazole HUMAN OTC DRUG LABEL 1 0363-1212 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 16 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0363-1419 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL NDA 16 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0363-4069 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 16 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-6981 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-6982 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 30 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-8015 CAPSULE, DELAYED RELEASE PELLETS 15 mg ORAL ANDA 30 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-8030 CAPSULE, DELAYED RELEASE PELLETS 30 mg ORAL ANDA 30 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0536-1236 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 15 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0536-1324 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 15 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2147 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 28 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2148 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 28 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-6662 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 27 sections
up and up lansoprazole HUMAN OTC DRUG LABEL 1 11673-117 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 16 sections