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 911.70 9.14 921 206207 44477 63237417
Drug ineffective 725.08 9.14 1454 205674 1043311 62238583
Colitis microscopic 425.96 9.14 304 206824 9035 63272859
Hyponatraemia 400.34 9.14 1026 206102 110874 63171020
Renal injury 398.05 9.14 293 206835 9146 63272748
Acute kidney injury 318.06 9.14 1696 205432 261719 63020175
Completed suicide 304.23 9.14 54 207074 145619 63136275
End stage renal disease 298.65 9.14 215 206913 6478 63275416
Product dose omission issue 211.95 9.14 272 206856 234041 63047853
Therapeutic product effect incomplete 207.93 9.14 74 207054 124982 63156912
Drug intolerance 203.47 9.14 440 206688 308221 62973673
Hypomagnesaemia 202.33 9.14 348 206780 28389 63253505
Fatigue 191.25 9.14 1916 205212 886112 62395782
Contraindicated product administered 182.38 9.14 267 206861 217381 63064513
Death 171.20 9.14 636 206492 373745 62908149
Pain 171.10 9.14 1570 205558 739058 62542836
Off label use 159.50 9.14 1421 205707 673041 62608853
Subacute cutaneous lupus erythematosus 158.64 9.14 102 207026 2541 63279353
Renal failure 148.17 9.14 767 206361 116885 63165009
Arthropathy 147.04 9.14 344 206784 234448 63047446
Treatment failure 135.85 9.14 278 206850 198765 63083129
Neutropenic sepsis 130.35 9.14 210 206918 16228 63265666
Synovitis 126.76 9.14 262 206866 186656 63095238
Joint swelling 125.33 9.14 596 206532 327070 62954824
Pemphigus 124.19 9.14 258 206870 183468 63098426
Hypertensive nephropathy 122.78 9.14 54 207074 598 63281296
Alopecia 122.74 9.14 625 206503 336911 62944983
Maternal exposure during pregnancy 113.95 9.14 354 206774 219708 63062186
Toxicity to various agents 112.90 9.14 420 206708 246830 63035064
Chest pain 111.68 9.14 1136 205992 214823 63067071
Therapeutic product effect decreased 109.31 9.14 298 206830 192889 63089005
Interstitial lung disease 107.85 9.14 444 206684 61464 63220430
Systemic lupus erythematosus 106.80 9.14 338 206790 208580 63073314
Swollen tongue 104.15 9.14 299 206829 34501 63247393
Angioedema 103.28 9.14 368 206760 47597 63234297
Cerebral infarction 101.24 9.14 234 206894 23659 63258235
Hepatic function abnormal 100.59 9.14 308 206820 36834 63245060
Electric shock 99.74 9.14 59 207069 1261 63280633
Exposure during pregnancy 98.84 9.14 226 206902 155321 63126573
Injection site pain 98.46 9.14 170 206958 129630 63152264
Tubulointerstitial nephritis 95.66 9.14 205 206923 19698 63262196
Product use issue 95.25 9.14 383 206745 220137 63061757
Melaena 91.95 9.14 262 206866 30103 63251791
Subarachnoid haemorrhage 91.53 9.14 166 206962 14117 63267777
Lip swelling 91.14 9.14 265 206863 30798 63251096
Haematemesis 88.79 9.14 259 206869 30153 63251741
Device expulsion 84.71 9.14 8 207120 34914 63246980
Glossodynia 84.15 9.14 300 206828 178576 63103318
Hand deformity 81.45 9.14 258 206870 159199 63122695
Abdominal pain 80.20 9.14 1374 205754 292082 62989812
Renal impairment 78.16 9.14 525 206603 87830 63194064
Swelling 77.34 9.14 553 206575 274825 63007069
Hypokalaemia 76.90 9.14 591 206537 103213 63178681
Cardiospasm 75.49 9.14 57 207071 1850 63280044
Diabetic nephropathy 74.88 9.14 51 207077 1403 63280491
Nephrogenic anaemia 73.38 9.14 59 207069 2103 63279791
Palmoplantar keratoderma 72.90 9.14 57 207071 1950 63279944
Pruritus genital 70.70 9.14 63 207065 2591 63279303
Cholecystitis chronic 68.41 9.14 122 207006 10239 63271655
Reaction to excipient 67.54 9.14 48 207080 1416 63280478
Arthralgia 66.50 9.14 1386 205742 568324 62713570
Sinusitis 66.15 9.14 450 206678 226203 63055691
Hypocalcaemia 62.95 9.14 237 206891 31476 63250418
Confusional state 62.46 9.14 1101 206027 235279 63046615
Sleep terror 62.40 9.14 59 207069 2621 63279273
Abdominal discomfort 62.24 9.14 708 206420 320177 62961717
Intervertebral discitis 62.03 9.14 64 207064 3164 63278730
Deep vein thrombosis postoperative 61.56 9.14 123 207005 11246 63270648
Lower respiratory tract infection 61.31 9.14 681 206447 131626 63150268
Labile blood pressure 61.10 9.14 49 207079 1740 63280154
Electrocardiogram QT prolonged 60.85 9.14 367 206761 59163 63222731
Drug abuse 60.62 9.14 89 207039 72429 63209465
Nephropathy 60.11 9.14 88 207040 6253 63275641
Hepatic enzyme increased 58.89 9.14 402 206726 201926 63079968
Loss of personal independence in daily activities 58.88 9.14 145 206983 97145 63184749
Infective pulmonary exacerbation of cystic fibrosis 58.44 9.14 104 207024 8713 63273181
Rebound acid hypersecretion 57.87 9.14 26 207102 304 63281590
Infusion related reaction 57.84 9.14 517 206611 245004 63036890
Sopor 55.59 9.14 179 206949 21985 63259909
Urticaria 54.55 9.14 801 206327 165001 63116893
Lip dry 54.35 9.14 141 206987 15329 63266565
Agranulocytosis 54.24 9.14 193 206935 24941 63256953
Atrial tachycardia 54.13 9.14 68 207060 4172 63277722
Weight increased 53.90 9.14 567 206561 260225 63021669
Hepatocellular injury 53.82 9.14 204 206924 27177 63254717
Swelling face 53.06 9.14 372 206756 63103 63218791
Cholestasis 51.96 9.14 212 206916 29222 63252672
Accidental exposure to product 51.35 9.14 13 207115 27392 63254502
Therapy interrupted 50.93 9.14 21 207107 32434 63249460
Psoriasis 50.76 9.14 132 206996 86825 63195069
Facet joint syndrome 50.46 9.14 118 207010 12020 63269874
Tension headache 49.20 9.14 72 207056 5114 63276780
Faeces discoloured 48.72 9.14 152 206976 18357 63263537
Rectal haemorrhage 48.67 9.14 300 206828 48730 63233164
Dry mouth 48.34 9.14 426 206702 77437 63204457
Foetal exposure during pregnancy 48.06 9.14 22 207106 31940 63249954
Hyperglycaemia 47.93 9.14 266 206862 41601 63240293
Wound 46.69 9.14 326 206802 162937 63118957
International normalised ratio increased 46.67 9.14 285 206843 46140 63235754
Injection site pruritus 46.56 9.14 47 207081 45069 63236825
Brain stem glioma 46.46 9.14 19 207109 173 63281721
Anti-cyclic citrullinated peptide antibody positive 46.33 9.14 208 206920 116004 63165890
Injection site reaction 45.88 9.14 75 207053 58449 63223445
Drug hypersensitivity 45.86 9.14 725 206403 309962 62971932
Vomiting 45.47 9.14 2246 204882 557371 62724523
Peripheral venous disease 45.36 9.14 132 206996 15345 63266549
Pemphigoid 45.34 9.14 84 207044 7260 63274634
Post-traumatic stress disorder 44.27 9.14 69 207059 5182 63276712
Gastritis 44.04 9.14 239 206889 37064 63244830
Immunisation 43.59 9.14 34 207094 1159 63280735
Injection site erythema 43.56 9.14 133 206995 83041 63198853
Lethargy 43.21 9.14 322 206806 55685 63226209
Dysphagia 42.88 9.14 460 206668 88125 63193769
Carotid artery occlusion 42.85 9.14 64 207064 4630 63277264
Coordination abnormal 42.82 9.14 120 207008 13653 63268241
Asthma 42.63 9.14 618 206510 126943 63154951
Injection site swelling 42.14 9.14 56 207072 47516 63234378
Jaundice 41.97 9.14 198 206930 29053 63252841
Liver function test abnormal 41.82 9.14 285 206843 47896 63233998
Autoimmune disorder 41.52 9.14 137 206991 17040 63264854
Macular degeneration 41.22 9.14 14 207114 24362 63257532
Inappropriate schedule of product administration 40.30 9.14 188 206940 103777 63178117
Biliary dyskinesia 40.10 9.14 47 207081 2682 63279212
Wrong technique in product usage process 40.04 9.14 90 207038 62250 63219644
Transient ischaemic attack 40.02 9.14 235 206893 37518 63244376
Upper respiratory tract inflammation 39.68 9.14 45 207083 2478 63279416
Post cholecystectomy syndrome 39.53 9.14 22 207106 417 63281477
Peripheral swelling 39.43 9.14 620 206508 265322 63016572
Liver disorder 39.37 9.14 305 206823 53382 63228512
Coma scale abnormal 38.37 9.14 64 207064 5089 63276805
Hepatic ischaemia 38.31 9.14 25 207103 639 63281255
Red blood cell sedimentation rate abnormal 37.82 9.14 9 207119 19773 63262121
Skin candida 37.70 9.14 36 207092 1619 63280275
Abdominal pain upper 37.20 9.14 909 206219 205535 63076359
Blood alkaline phosphatase increased 37.19 9.14 254 206874 42713 63239181
Circulatory collapse 37.14 9.14 156 206972 21782 63260112
Facial pain 36.84 9.14 96 207032 10465 63271429
Basilar artery occlusion 36.81 9.14 14 207114 103 63281791
Drug reaction with eosinophilia and systemic symptoms 36.76 9.14 212 206916 33624 63248270
Suicide attempt 36.69 9.14 91 207037 60827 63221067
Anaphylactic reaction 36.66 9.14 353 206775 65747 63216147
Discomfort 36.57 9.14 359 206769 167015 63114879
Demyelination 36.43 9.14 74 207054 6846 63275048
Nasopharyngitis 35.94 9.14 598 206530 253659 63028235
Therapy cessation 35.91 9.14 28 207100 30429 63251465
Anaemia 35.79 9.14 1230 205898 292200 62989694
Neutrophil count decreased 35.73 9.14 310 206818 56096 63225798
Nephrocalcinosis 35.70 9.14 29 207099 1049 63280845
Oesophagitis 35.66 9.14 119 207009 14889 63267005
Rheumatoid arthritis 35.54 9.14 598 206530 253221 63028673
Mixed liver injury 35.52 9.14 59 207069 4676 63277218
Hospitalisation 35.29 9.14 150 206978 84931 63196963
Crohn's disease 35.23 9.14 60 207068 4853 63277041
Hypersensitivity 35.23 9.14 708 206420 291977 62989917
Device dislocation 35.20 9.14 20 207108 25685 63256209
Reflux gastritis 35.12 9.14 30 207098 1165 63280729
Hepatorenal syndrome 34.79 9.14 37 207091 1895 63279999
Abortion spontaneous 34.69 9.14 63 207065 47132 63234762
Gastrooesophageal reflux disease 34.63 9.14 470 206658 95169 63186725
Hypophosphataemic osteomalacia 34.39 9.14 16 207112 204 63281690
Decreased appetite 34.12 9.14 1066 206062 249986 63031908
Hallucination 34.07 9.14 300 206828 54517 63227377
Somatic delusion 33.45 9.14 22 207106 570 63281324
Muscle twitching 33.40 9.14 140 206988 19528 63262366
Renal tubular acidosis 33.33 9.14 34 207094 1658 63280236
Urine magnesium decreased 33.10 9.14 7 207121 0 63281894
Condition aggravated 32.98 9.14 1030 206098 401187 62880707
Disseminated intravascular coagulation 32.66 9.14 136 206992 18915 63262979
Deep vein thrombosis 32.49 9.14 417 206711 83383 63198511
Cholecystitis acute 31.85 9.14 78 207050 8182 63273712
Temperature intolerance 31.80 9.14 82 207046 8882 63273012
Adrenal insufficiency 31.59 9.14 129 206999 17786 63264108
Hepatotoxicity 31.41 9.14 45 207083 36996 63244898
COVID-19 31.27 9.14 228 206900 112875 63169019
Drug interaction 31.15 9.14 973 206155 228158 63053736
Erythema multiforme 31.03 9.14 88 207040 10081 63271813
Progressive multifocal leukoencephalopathy 30.95 9.14 103 207025 12868 63269026
Coronary artery disease 30.81 9.14 196 206932 32181 63249713
Mobility decreased 30.80 9.14 250 206878 120909 63160985
Palpitations 30.72 9.14 528 206600 112242 63169652
Hyperkalaemia 30.32 9.14 290 206838 53913 63227981
Altered state of consciousness 30.02 9.14 162 206966 25068 63256826
Anosmia 29.96 9.14 68 207060 6792 63275102
Hypergastrinaemia 29.66 9.14 12 207116 106 63281788
Post viral fatigue syndrome 28.86 9.14 16 207112 301 63281593
Injury 28.61 9.14 365 206763 72882 63209012
Urine phosphorus decreased 28.37 9.14 6 207122 0 63281894
Blood sodium decreased 28.37 9.14 155 206973 24097 63257797
Dehydration 27.91 9.14 752 206376 172602 63109292
Total lung capacity decreased 27.85 9.14 35 207093 2148 63279746
Haemorrhage subcutaneous 27.70 9.14 41 207087 2942 63278952
Sedation 27.47 9.14 53 207075 38756 63243138
Urine potassium decreased 27.34 9.14 7 207121 9 63281885
No adverse event 27.22 9.14 59 207069 41346 63240548
Drug resistance 27.14 9.14 21 207107 22912 63258982
Pituitary tumour benign 27.08 9.14 33 207095 1962 63279932
Pneumonia bacterial 27.04 9.14 80 207048 9385 63272509
Rectal ulcer 26.33 9.14 26 207102 1219 63280675
Gastric polyps 26.31 9.14 43 207085 3362 63278532
Blood immunoglobulin A increased 25.91 9.14 21 207107 757 63281137
Hyperchlorhydria 25.84 9.14 31 207097 1813 63280081
Lung opacity 25.84 9.14 41 207087 3127 63278767
Influenza 25.54 9.14 229 206899 108493 63173401
Granulocyte count increased 25.50 9.14 22 207106 866 63281028
Syncope 25.23 9.14 530 206598 116855 63165039
Urine output decreased 25.12 9.14 88 207040 11282 63270612
Multiple sclerosis relapse 25.04 9.14 78 207050 48400 63233494
Aspiration 24.86 9.14 85 207043 10766 63271128
Erythema dyschromicum perstans 24.81 9.14 9 207119 57 63281837
Genital ulceration 24.65 9.14 19 207109 636 63281258
Product storage error 24.58 9.14 9 207119 14947 63266947
Toxic skin eruption 24.50 9.14 95 207033 12790 63269104
Wrong patient received product 24.44 9.14 33 207095 2174 63279720
Wheezing 24.40 9.14 443 206685 95152 63186742
Iron deficiency anaemia 24.29 9.14 129 206999 19840 63262054
Renal atrophy 24.28 9.14 27 207101 1455 63280439
Aspartate aminotransferase 24.11 9.14 16 207112 421 63281473
Nightmare 24.03 9.14 125 207003 19069 63262825
Inappropriate antidiuretic hormone secretion 23.91 9.14 107 207021 15355 63266539
Rheumatoid factor positive 23.89 9.14 169 206959 84237 63197657
Bronchopulmonary aspergillosis allergic 23.85 9.14 33 207095 2225 63279669
Dermatitis exfoliative 23.71 9.14 54 207074 5405 63276489
Full blood count decreased 23.70 9.14 30 207098 25994 63255900
Medication error 23.69 9.14 268 206860 52016 63229878
Diarrhoea 23.54 9.14 2671 204457 712695 62569199
Pancreatitis 23.39 9.14 254 206874 48801 63233093
Cerebral haemorrhage 23.32 9.14 176 206952 30553 63251341
Blood lactic acid decreased 23.18 9.14 11 207117 147 63281747
Chromaturia 23.14 9.14 112 207016 16605 63265289
Vasculitis 23.09 9.14 119 207009 18090 63263804
Foetal death 23.06 9.14 4 207124 10976 63270918
Blood pressure increased 22.93 9.14 381 206747 161681 63120213
Hyperparathyroidism secondary 22.79 9.14 26 207102 1441 63280453
Haematuria 22.69 9.14 168 206960 28989 63252905
Injection site bruising 22.67 9.14 66 207062 41844 63240050
Hypersensitivity pneumonitis 22.59 9.14 35 207093 2615 63279279
Dermatitis bullous 22.51 9.14 70 207058 8438 63273456
Neuropathy, ataxia, retinitis pigmentosa syndrome 22.42 9.14 8 207120 48 63281846
Deja vu 22.39 9.14 9 207119 78 63281816
Rhinorrhoea 22.33 9.14 124 207004 65453 63216441
Neoplasm progression 22.26 9.14 54 207074 36374 63245520
Device difficult to use 22.25 9.14 7 207121 12789 63269105
Excessive eye blinking 22.15 9.14 24 207104 1256 63280638
C-reactive protein 22.00 9.14 49 207079 4833 63277061
Hiatus hernia 21.98 9.14 133 206995 21461 63260433
Joint stiffness 21.88 9.14 67 207061 41802 63240092
Muscle relaxant therapy 21.88 9.14 11 207117 168 63281726
Foot deformity 21.54 9.14 36 207092 27817 63254077
Laryngeal pain 21.23 9.14 46 207082 4452 63277442
Rheumatoid nodule 21.22 9.14 15 207113 17140 63264754
Bursitis 21.12 9.14 199 206929 36842 63245052
Platelet count decreased 21.10 9.14 512 206616 115610 63166284
Blood uric acid increased 21.04 9.14 51 207077 5316 63276578
Deformity 21.03 9.14 6 207122 11678 63270216
Cardiac failure 20.99 9.14 408 206720 88734 63193160
Pain in extremity 20.99 9.14 876 206252 330610 62951284
Oesophageal mucosal tear 20.90 9.14 6 207122 15 63281879
Hyperprolactinaemia 20.88 9.14 42 207086 3858 63278036
Nasal congestion 20.84 9.14 127 207001 65533 63216361
Fluid retention 20.79 9.14 112 207016 59574 63222320
Gastrointestinal haemorrhage 20.65 9.14 376 206752 80800 63201094
Dysuria 20.63 9.14 184 206944 33554 63248340
Abnormal loss of weight 20.62 9.14 53 207075 5729 63276165
Sleep disorder due to a general medical condition 20.61 9.14 7 207121 12181 63269713
Blood lactic acid 20.60 9.14 9 207119 98 63281796
Injection site warmth 20.55 9.14 12 207116 15183 63266711
Amnesia 20.46 9.14 274 206854 55311 63226583
Gallbladder disorder 20.43 9.14 118 207010 18724 63263170
Hypoxic-ischaemic encephalopathy 20.42 9.14 44 207084 4243 63277651
Upper gastrointestinal haemorrhage 20.40 9.14 118 207010 18734 63263160
Haemoptysis 20.39 9.14 162 206966 28564 63253330
Gastric ulcer 20.15 9.14 141 206987 23896 63257998
Lung disorder 20.14 9.14 300 206828 61961 63219933
Vitamin B1 decreased 20.12 9.14 11 207117 201 63281693
Angina pectoris 19.94 9.14 167 206961 29911 63251983
Oedema peripheral 19.82 9.14 781 206347 188730 63093164
Oropharyngeal oedema 19.80 9.14 13 207115 336 63281558
Carcinoid tumour of the stomach 19.64 9.14 10 207118 157 63281737
Gastric dysplasia 19.64 9.14 6 207122 20 63281874
Glomerular filtration rate increased 19.45 9.14 19 207109 879 63281015
Premature delivery 19.21 9.14 44 207084 30237 63251657
Cholecystitis 19.16 9.14 100 207028 15277 63266617
Pneumocystis jirovecii pneumonia 19.04 9.14 107 207021 16807 63265087
Ventricular tachycardia 19.04 9.14 121 207007 19858 63262036
Genital pain 19.01 9.14 14 207114 437 63281457
Flashback 18.99 9.14 10 207118 169 63281725
Human herpesvirus 6 infection reactivation 18.98 9.14 13 207115 361 63281533
Infection 18.96 9.14 586 206542 228587 63053307
Blood urea increased 18.86 9.14 149 206979 26230 63255664
Immunodeficiency 18.81 9.14 23 207105 20231 63261663
Obesity 18.65 9.14 164 206964 29788 63252106
Musculoskeletal disorder 18.59 9.14 24 207104 20620 63261274
Red blood cell sedimentation rate increased 18.57 9.14 77 207051 43905 63237989
Hypocalciuria 18.52 9.14 5 207123 9 63281885
Anal prolapse 18.48 9.14 8 207120 85 63281809
Panniculitis 18.46 9.14 7 207121 11378 63270516
Malaise 18.44 9.14 1586 205542 414368 62867526
Intestinal ischaemia 18.44 9.14 60 207068 7408 63274486
Face oedema 18.40 9.14 121 207007 20091 63261803
Enthesopathy 18.39 9.14 3 207125 8611 63273283
Stoma site haemorrhage 18.39 9.14 20 207108 1051 63280843
Pain of skin 18.36 9.14 81 207047 11553 63270341
Dopamine transporter scintigraphy abnormal 18.32 9.14 8 207120 87 63281807
Seasonal allergy 18.21 9.14 25 207103 20925 63260969
Tinnitus 18.17 9.14 187 206941 35441 63246453
Device issue 18.15 9.14 31 207097 23750 63258144
Acne 18.11 9.14 30 207098 23263 63258631
Rheumatoid factor increased 18.02 9.14 26 207102 1823 63280071
Therapeutic response decreased 17.99 9.14 122 207006 61403 63220491
Respiratory arrest 17.96 9.14 51 207077 32594 63249300
Hypoglycaemic coma 17.88 9.14 31 207097 2544 63279350
Bradycardia 17.87 9.14 337 206791 72890 63209004
Enterochromaffin cell hyperplasia 17.80 9.14 7 207121 57 63281837
Hypochloraemia 17.78 9.14 27 207101 1982 63279912
Chronic kidney disease-mineral and bone disorder 17.70 9.14 8 207120 95 63281799
Activated partial thromboplastin time prolonged 17.58 9.14 56 207072 6837 63275057
Dialysis 17.53 9.14 74 207054 10353 63271541
Nervous system disorder 17.48 9.14 113 207015 18653 63263241
Mediastinitis 17.41 9.14 10 207118 202 63281692
Genitourinary symptom 17.38 9.14 7 207121 61 63281833
Stress 17.33 9.14 138 206990 67029 63214865
Gastrointestinal motility disorder 17.31 9.14 46 207082 5073 63276821
Aphasia 17.20 9.14 174 206954 32826 63249068
Single functional kidney 17.19 9.14 12 207116 344 63281550
Infusion site streaking 17.13 9.14 14 207114 511 63281383
Generalised bullous fixed drug eruption 17.12 9.14 8 207120 103 63281791
Biliary sepsis 17.07 9.14 18 207110 913 63280981
Intentional overdose 17.06 9.14 157 206971 73995 63207899
Pancreatitis acute 17.04 9.14 149 206979 27017 63254877
Hip fracture 16.99 9.14 45 207083 29429 63252465
Pressure of speech 16.93 9.14 16 207112 710 63281184
Hypophosphataemia 16.87 9.14 78 207050 11348 63270546
Protein-losing gastroenteropathy 16.85 9.14 10 207118 215 63281679
Vulvovaginal candidiasis 16.77 9.14 34 207094 3141 63278753
Non-economic loss 16.76 9.14 5 207123 15 63281879
Device dependence 16.76 9.14 5 207123 15 63281879
Orthostatic hypotension 16.67 9.14 186 206942 35974 63245920
Enterocolitis 16.66 9.14 60 207068 7798 63274096
Product use in unapproved indication 16.54 9.14 451 206677 178629 63103265
Colon cancer 16.53 9.14 70 207058 9808 63272086
Eosinophilia 16.52 9.14 129 206999 22627 63259267
Hyponatraemic syndrome 16.45 9.14 14 207114 541 63281353
Parosmia 16.37 9.14 51 207077 6155 63275739
Alanine aminotransferase increased 16.36 9.14 449 206679 103321 63178573
Purpura 16.28 9.14 77 207051 11308 63270586
Hyperhidrosis 16.27 9.14 464 206664 107372 63174522
Skin necrosis 16.22 9.14 13 207115 13937 63267957
Pneumonia aspiration 16.08 9.14 178 206950 34362 63247532
Azotaemia 15.96 9.14 41 207087 4430 63277464
Limb discomfort 15.92 9.14 47 207081 29669 63252225
Blood parathyroid hormone decreased 15.91 9.14 6 207122 9785 63272109
Multiple allergies 15.88 9.14 13 207115 13789 63268105
Vitamin B12 increased 15.87 9.14 19 207109 1109 63280785
Infusion site pain 15.83 9.14 19 207109 16850 63265044
Respiratory tract congestion 15.78 9.14 21 207107 17811 63264083
Rapid eye movement sleep behaviour disorder 15.76 9.14 11 207117 315 63281579
Intentional self-injury 15.75 9.14 38 207090 25649 63256245
Hepatic cytolysis 15.75 9.14 95 207033 15312 63266582
Joint injury 15.68 9.14 47 207081 29525 63252369
Product quality issue 15.64 9.14 62 207066 35803 63246091
Acute coronary syndrome 15.60 9.14 70 207058 10056 63271838
Neuropathy peripheral 15.50 9.14 483 206645 113184 63168710
Maternal exposure before pregnancy 15.47 9.14 3 207125 7600 63274294
Pyrexia 15.47 9.14 1757 205371 468721 62813173
Narrow anterior chamber angle 15.45 9.14 6 207122 47 63281847
Pulmonary embolism 15.44 9.14 494 206634 116190 63165704
Psoriatic arthropathy 15.41 9.14 208 206920 91312 63190582
Complication of device insertion 15.36 9.14 3 207125 7561 63274333
Eosinophilic pneumonia chronic 15.35 9.14 9 207119 189 63281705
Gallbladder injury 15.34 9.14 21 207107 1402 63280492
Product substitution issue 15.32 9.14 97 207031 15899 63265995
White blood cell count increased 15.32 9.14 233 206895 48328 63233566
Enteritis infectious 15.31 9.14 26 207102 2098 63279796
Stevens-Johnson syndrome 15.22 9.14 136 206992 24814 63257080
Bone pain 15.17 9.14 110 207018 54531 63227363
Superinfection 15.08 9.14 29 207099 2578 63279316
Unevaluable event 14.97 9.14 102 207026 51284 63230610
Cholangitis 14.94 9.14 46 207082 5515 63276379
Myocardial ischaemia 14.91 9.14 82 207046 12777 63269117
Vascular skin disorder 14.89 9.14 4 207124 7 63281887
Injection site rash 14.84 9.14 24 207104 18785 63263109
Diplopia 14.81 9.14 130 206998 23598 63258296
Drug ineffective for unapproved indication 14.78 9.14 59 207069 34004 63247890
Inflammatory bowel disease 14.77 9.14 37 207091 3936 63277958
Oral mucosal discolouration 14.76 9.14 11 207117 350 63281544
Blood triglycerides increased 14.73 9.14 80 207048 12408 63269486
Cardioactive drug level increased 14.65 9.14 26 207102 2174 63279720
Oesophageal food impaction 14.59 9.14 9 207119 208 63281686
Palmar erythema 14.59 9.14 23 207105 1744 63280150
Musculoskeletal stiffness 14.56 9.14 475 206653 184143 63097751
Paramnesia 14.55 9.14 4 207124 8 63281886
Gastrointestinal stoma output decreased 14.54 9.14 6 207122 56 63281838
Gastric cancer 14.54 9.14 41 207087 4682 63277212
Injection site mass 14.53 9.14 24 207104 18632 63263262
Phyllodes tumour 14.45 9.14 5 207123 27 63281867
Blood pressure decreased 14.43 9.14 295 206833 64727 63217167
Muscle spasticity 14.37 9.14 31 207097 21763 63260131
Bronchiectasis 14.31 9.14 96 207032 16046 63265848
Oesophageal carcinoma recurrent 14.30 9.14 5 207123 28 63281866
Gastroenteritis 14.25 9.14 141 206987 26449 63255445
Renal cyst 14.24 9.14 69 207059 10233 63271661
Erythema annulare 14.22 9.14 7 207121 102 63281792
Urine output 14.19 9.14 3 207125 0 63281894
Pre-eclampsia 14.18 9.14 6 207122 9127 63272767
Cardiac output increased 14.11 9.14 9 207119 221 63281673
Eye haemorrhage 14.06 9.14 60 207068 8436 63273458
Hypophagia 14.05 9.14 160 206968 31099 63250795
Dizziness 14.05 9.14 1605 205523 428320 62853574
Abortion induced 13.98 9.14 8 207120 10234 63271660
Catarrh 13.97 9.14 21 207107 1528 63280366
Femoral neck fracture 13.96 9.14 60 207068 8463 63273431
Ileus 13.92 9.14 89 207039 14636 63267258
Rhabdomyolysis 13.91 9.14 211 206917 43740 63238154
Haemodialysis 13.90 9.14 62 207066 8885 63273009
Finger deformity 13.90 9.14 4 207124 7741 63274153
Device malfunction 13.89 9.14 23 207105 17834 63264060
Oesophageal achalasia 13.87 9.14 12 207116 474 63281420
Blood creatinine increased 13.82 9.14 380 206748 87464 63194430
Secondary adrenocortical insufficiency 13.80 9.14 20 207108 1408 63280486
Lactic acidosis 13.78 9.14 188 206940 38099 63243795
Metastases to bone 13.78 9.14 30 207098 20989 63260905
Oropharyngeal swelling 13.76 9.14 16 207112 905 63280989
Tooth hypoplasia 13.76 9.14 6 207122 65 63281829
Lower limb fracture 13.75 9.14 130 206998 24091 63257803
Arthritis 13.74 9.14 281 206847 115640 63166254
Urine calcium/creatinine ratio increased 13.58 9.14 7 207121 113 63281781
Bile duct stone 13.54 9.14 34 207094 3622 63278272
Mouth swelling 13.48 9.14 40 207088 4700 63277194
Laryngotracheal oedema 13.36 9.14 5 207123 35 63281859
Renal haemangioma 13.36 9.14 5 207123 35 63281859
Spleen congestion 13.31 9.14 7 207121 118 63281776
Haematotoxicity 13.27 9.14 7 207121 9369 63272525
Ejection fraction decreased 13.25 9.14 121 207007 22211 63259683
General physical health deterioration 13.20 9.14 530 206598 200872 63081022
Aplastic anaemia 13.17 9.14 64 207064 9505 63272389
Morbid thoughts 13.16 9.14 13 207115 610 63281284
Basal cell carcinoma 13.11 9.14 47 207081 27944 63253950
Illness 13.03 9.14 100 207028 48959 63232935
Multiple injuries 12.95 9.14 22 207106 1776 63280118
Multiple sclerosis 12.94 9.14 129 206999 24243 63257651
Atypical fracture 12.93 9.14 13 207115 623 63281271
Dermatitis psoriasiform 12.91 9.14 25 207103 2234 63279660
Bradyphrenia 12.90 9.14 51 207077 6929 63274965
Throat clearing 12.89 9.14 26 207102 2393 63279501
Mucosal inflammation 12.87 9.14 220 206908 46708 63235186
Ulcer 12.82 9.14 136 206992 25971 63255923
Delirium 12.81 9.14 234 206894 50307 63231587
Cholelithiasis 12.81 9.14 208 206920 43717 63238177
Aortic valve calcification 12.80 9.14 12 207116 527 63281367
Food allergy 12.80 9.14 11 207117 11390 63270504
Urinary straining 12.79 9.14 5 207123 40 63281854
Pleuritic pain 12.75 9.14 56 207072 7973 63273921
Laboratory test abnormal 12.73 9.14 45 207083 26867 63255027
Immune thrombocytopenia 12.70 9.14 68 207060 10488 63271406
Cystitis noninfective 12.67 9.14 16 207112 987 63280907
Sinus bradycardia 12.58 9.14 86 207042 14465 63267429
Vulval haemorrhage 12.53 9.14 4 207124 16 63281878
Mouth ulceration 12.30 9.14 163 206965 32821 63249073
Herpes zoster 12.28 9.14 192 206936 82270 63199624
Drug tolerance decreased 12.25 9.14 24 207104 17449 63264445
Muscle tension dysphonia 12.21 9.14 8 207120 206 63281688
Disability 12.18 9.14 26 207102 18321 63263573
Osteonecrosis 12.15 9.14 128 207000 24402 63257492
Obstructive nephropathy 12.12 9.14 3 207125 3 63281891
Hepatic failure 12.00 9.14 173 206955 35483 63246411
Subdural haematoma 11.98 9.14 84 207044 14244 63267650
Pancreatic carcinoma recurrent 11.97 9.14 6 207122 91 63281803
Breast cancer female 11.97 9.14 16 207112 13543 63268351
Oligohydramnios 11.97 9.14 3 207125 6363 63275531
Rash erythematous 11.92 9.14 200 206928 42310 63239584
Hiccups 11.91 9.14 24 207104 2207 63279687
Vaginal cellulitis 11.86 9.14 6 207122 93 63281801
Wheelchair user 11.83 9.14 3 207125 6316 63275578
Emotional distress 11.79 9.14 160 206968 32389 63249505
Hydronephrosis 11.71 9.14 67 207061 10595 63271299
Degenerative mitral valve disease 11.65 9.14 4 207124 21 63281873
Joint destruction 11.65 9.14 3 207125 6249 63275645
Myelosuppression 11.64 9.14 39 207089 23664 63258230
Rash papulosquamous 11.63 9.14 6 207122 97 63281797
Pharyngotonsillitis 11.53 9.14 7 207121 157 63281737
Dactylitis 11.53 9.14 26 207102 2586 63279308
Physical deconditioning 11.45 9.14 14 207114 835 63281059
Unintended pregnancy 11.44 9.14 3 207125 6176 63275718
Bronchitis 11.44 9.14 315 206813 124620 63157274
Gastrointestinal perforation 11.43 9.14 31 207097 3460 63278434
Tongue discolouration 11.40 9.14 29 207099 3114 63278780
Transplant rejection 11.39 9.14 11 207117 10769 63271125
Multiple fractures 11.38 9.14 7 207121 8611 63273283
Overdose 11.36 9.14 287 206841 114791 63167103
Anxiety disorder 11.35 9.14 34 207094 4016 63277878
Dilatation atrial 11.34 9.14 22 207106 1969 63279925
Renal cyst haemorrhage 11.32 9.14 5 207123 56 63281838
Secretion discharge 11.24 9.14 14 207114 12217 63269677
Poisoning deliberate 11.22 9.14 12 207116 11206 63270688
Post cardiac arrest syndrome 11.21 9.14 4 207124 24 63281870
Gambling 11.20 9.14 8 207120 238 63281656
Blood phosphorus decreased 11.20 9.14 36 207092 4417 63277477
Staphylococcus test positive 11.20 9.14 33 207095 3863 63278031
Splenic vein thrombosis 11.16 9.14 9 207119 322 63281572
Multiple organ dysfunction syndrome 11.15 9.14 253 206875 56499 63225395
Large intestine perforation 11.15 9.14 56 207072 8426 63273468
Hepatitis acute 11.15 9.14 59 207069 9061 63272833
Chronic gastritis 11.14 9.14 27 207101 2814 63279080
Adjustment disorder with depressed mood 11.13 9.14 64 207064 10140 63271754
Cytomegalovirus test positive 11.11 9.14 28 207100 2990 63278904
Knee arthroplasty 11.11 9.14 118 207010 54088 63227806
Hospice care 11.11 9.14 6 207122 7926 63273968
Tachypnoea 11.09 9.14 25 207103 17277 63264617
Abdominal rigidity 11.08 9.14 22 207106 2002 63279892
Presyncope 11.08 9.14 139 206989 27646 63254248
Nasal polyps 11.06 9.14 3 207125 6036 63275858
Depression 10.97 9.14 763 206365 195729 63086165
Sinus congestion 10.96 9.14 27 207101 18096 63263798
Photodermatosis 10.95 9.14 10 207118 425 63281469
Cardiotoxicity 10.94 9.14 7 207121 8431 63273463
Dyspnoea 10.93 9.14 2377 204751 658936 62622958
Creatinine renal clearance decreased 10.92 9.14 23 207105 16285 63265609
Bronchogenic cyst 10.91 9.14 3 207125 6 63281888
Pleural effusion 10.90 9.14 389 206739 92821 63189073
Cold sweat 10.89 9.14 72 207056 11975 63269919
Hypoproteinaemia 10.89 9.14 22 207106 2027 63279867
Blood albumin decreased 10.88 9.14 84 207044 14682 63267212
Discoloured vomit 10.88 9.14 14 207114 880 63281014
Autonomic neuropathy 10.86 9.14 16 207112 1143 63280751
Hemiparesis 10.84 9.14 120 207008 23162 63258732
Aortic aneurysm rupture 10.81 9.14 11 207117 535 63281359
Prothrombin time ratio increased 10.68 9.14 6 207122 116 63281778
Inadequate diet 10.66 9.14 7 207121 181 63281713
Gingival bleeding 10.65 9.14 74 207054 12513 63269381
Enterocolitis haemorrhagic 10.64 9.14 18 207110 1448 63280446
Joint dislocation 10.61 9.14 29 207099 18771 63263123
Lacunar infarction 10.61 9.14 29 207099 3251 63278643
Optic neuritis 10.61 9.14 55 207073 8380 63273514
Gastrointestinal amyloidosis 10.59 9.14 5 207123 66 63281828
Joint noise 10.59 9.14 35 207093 4357 63277537
Small intestinal haemorrhage 10.58 9.14 22 207106 2070 63279824
Coagulopathy 10.55 9.14 108 207020 20436 63261458
Hyperuricaemia 10.54 9.14 40 207088 5330 63276564
Bleeding time prolonged 10.53 9.14 12 207116 664 63281230
Adrenal suppression 10.51 9.14 14 207114 910 63280984
Road traffic accident 10.51 9.14 173 206955 36459 63245435
Blood cholinesterase decreased 10.50 9.14 6 207122 120 63281774
Occult blood positive 10.47 9.14 31 207097 3639 63278255
Rectocele 10.46 9.14 15 207113 1046 63280848
Blood electrolytes abnormal 10.46 9.14 15 207113 1046 63280848
Bradyarrhythmia 10.41 9.14 22 207106 2093 63279801
Nasal mucosal erosion 10.40 9.14 5 207123 69 63281825
Hypoglycaemia 10.36 9.14 263 206865 59802 63222092
Uraemic encephalopathy 10.35 9.14 8 207120 269 63281625
Poisoning 10.33 9.14 18 207110 13682 63268212
Product dose omission in error 10.31 9.14 6 207122 7606 63274288
Hypercapnic coma 10.30 9.14 7 207121 192 63281702
Gallbladder hypofunction 10.29 9.14 11 207117 567 63281327
Pathogen resistance 10.27 9.14 4 207124 6394 63275500
Fasciitis 10.22 9.14 11 207117 571 63281323
Apraxia 10.22 9.14 20 207108 1801 63280093
Blood pressure systolic increased 10.20 9.14 102 207026 47295 63234599
Nocturia 10.18 9.14 53 207075 8088 63273806
Dyslalia 10.16 9.14 10 207118 467 63281427
Depressed mood 10.16 9.14 186 206942 40005 63241889
Macroglossia 10.12 9.14 12 207116 693 63281201
Surgery 10.11 9.14 72 207056 35840 63246054
Hyperlipidaemia 10.11 9.14 103 207025 19468 63262426
Cross sensitivity reaction 10.08 9.14 22 207106 2140 63279754
Intentional dose omission 10.07 9.14 7 207121 8068 63273826
Prescribed overdose 10.06 9.14 162 206966 33991 63247903
Central nervous system lesion 9.96 9.14 12 207116 10623 63271271
Skin haemorrhage 9.87 9.14 11 207117 10083 63271811
Fall 9.84 9.14 1125 206003 391209 62890685
Regurgitation 9.83 9.14 19 207109 1695 63280199
Caesarean section 9.82 9.14 26 207102 17006 63264888
Rash papular 9.79 9.14 86 207042 15616 63266278
Toxic epidermal necrolysis 9.78 9.14 126 207002 25208 63256686
Osteoporosis 9.76 9.14 130 206998 57208 63224686
Gastrointestinal tract irritation 9.75 9.14 10 207118 491 63281403
Disturbance in attention 9.75 9.14 177 206951 38012 63243882
Sinus disorder 9.74 9.14 44 207084 24509 63257385
Atypical femur fracture 9.72 9.14 39 207089 5333 63276561
Red cell distribution width increased 9.72 9.14 12 207116 10512 63271382
Femoral hernia 9.63 9.14 4 207124 38 63281856
Gestational diabetes 9.55 9.14 8 207120 8388 63273506
Disease recurrence 9.54 9.14 53 207075 27977 63253917
Bone erosion 9.51 9.14 28 207100 17689 63264205
Hyperphosphataemia 9.50 9.14 22 207106 2226 63279668
Adverse event 9.49 9.14 159 206969 67400 63214494
Flat affect 9.48 9.14 17 207111 1433 63280461
Gingival erosion 9.46 9.14 7 207121 220 63281674
Product preparation error 9.46 9.14 4 207124 6088 63275806
Neuroendocrine tumour 9.43 9.14 12 207116 746 63281148
Pulmonary venous thrombosis 9.40 9.14 3 207125 12 63281882
Injection site haemorrhage 9.40 9.14 44 207084 24270 63257624
Intentional product use issue 9.39 9.14 332 206796 127560 63154334
Glycosuria 9.38 9.14 15 207113 1151 63280743
Lip blister 9.36 9.14 23 207105 2417 63279477
Subendocardial ischaemia 9.31 9.14 5 207123 88 63281806
Spinal compression fracture 9.30 9.14 79 207049 14204 63267690
Abnormal faeces 9.30 9.14 39 207089 5441 63276453
Adenocarcinoma gastric 9.28 9.14 10 207118 520 63281374
Rash 9.22 9.14 1650 205478 559221 62722673
Renal hypertension 9.21 9.14 6 207122 153 63281741
Nail dystrophy 9.21 9.14 14 207114 1029 63280865
Pleurisy viral 9.21 9.14 3 207125 13 63281881
Ventricular dysfunction 9.15 9.14 25 207103 2803 63279091

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 560.35 10.11 748 136483 40462 34779238
Drug ineffective 415.78 10.11 725 136506 456026 34363674
Death 296.80 10.11 708 136523 397341 34422359
Completed suicide 264.48 10.11 36 137195 98132 34721568
End stage renal disease 254.63 10.11 238 136993 8623 34811077
Hyponatraemia 198.32 10.11 744 136487 81947 34737753
Colitis microscopic 184.99 10.11 115 137116 2222 34817478
Interstitial lung disease 182.74 10.11 618 136613 64664 34755036
Renal injury 175.18 10.11 218 137013 10977 34808723
Toxicity to various agents 172.45 10.11 328 136903 200034 34619666
Drug abuse 172.05 10.11 87 137144 99009 34720691
Product dose omission issue 140.08 10.11 158 137073 119553 34700147
Drug dispensed to wrong patient 134.41 10.11 57 137174 467 34819233
Off label use 123.80 10.11 1054 136177 418470 34401230
Appendicolith 106.01 10.11 149 137082 8452 34811248
Treatment failure 102.79 10.11 28 137203 46669 34773031
Acute kidney injury 101.75 10.11 1721 135510 303267 34516433
Cardiospasm 98.35 10.11 67 137164 1521 34818179
Palmoplantar keratoderma 88.10 10.11 68 137163 1885 34817815
Fatigue 87.36 10.11 983 136248 369670 34450030
Pruritus genital 87.11 10.11 71 137160 2133 34817567
Lip swelling 87.00 10.11 194 137037 15886 34803814
Cerebral infarction 86.75 10.11 271 136960 27184 34792516
Tension headache 86.03 10.11 81 137150 2961 34816739
Nephrogenic anaemia 84.82 10.11 70 137161 2141 34817559
Lower respiratory tract infection 80.22 10.11 290 136941 31347 34788353
Neutropenic sepsis 77.77 10.11 169 137062 13598 34806102
Appendicitis 77.16 10.11 176 137055 14631 34805069
Foetal exposure during pregnancy 74.71 10.11 28 137203 38073 34781627
Hepatic function abnormal 74.25 10.11 358 136873 44005 34775695
Hypertensive nephropathy 71.31 10.11 36 137195 455 34819245
Drug resistance 70.98 10.11 9 137222 25918 34793782
Product use in unapproved indication 70.02 10.11 232 136999 117267 34702433
Sleep terror 69.95 10.11 64 137167 2254 34817446
Immunisation 68.03 10.11 46 137185 1031 34818669
Atrial tachycardia 66.91 10.11 77 137154 3568 34816132
Venous pressure jugular increased 64.88 10.11 40 137191 761 34818939
Facial pain 64.24 10.11 76 137155 3628 34816072
Hypomagnesaemia 63.85 10.11 210 137021 21641 34798059
Intentional overdose 62.40 10.11 48 137183 43626 34776074
Antimicrobial susceptibility test resistant 61.99 10.11 30 137201 344 34819356
Wrong patient received product 60.80 10.11 63 137168 2591 34817109
Malaise 59.37 10.11 1042 136189 184783 34634917
Minimum inhibitory concentration 57.57 10.11 23 137208 159 34819541
Carotid artery occlusion 57.22 10.11 72 137159 3665 34816035
Suicide attempt 54.61 10.11 44 137187 39072 34780628
Anosmia 54.55 10.11 73 137158 3951 34815749
Toxic epidermal necrolysis 54.51 10.11 198 137033 21448 34798252
Disease progression 54.20 10.11 229 137002 107848 34711852
Pain of skin 51.71 10.11 89 137142 6020 34813680
Cholestasis 50.64 10.11 225 137006 26723 34792977
Hypoparathyroidism secondary 50.34 10.11 20 137211 136 34819564
Transient ischaemic attack 49.23 10.11 227 137004 27386 34792314
Liver function test abnormal 48.59 10.11 246 136985 30828 34788872
Adrenal suppression 46.61 10.11 30 137201 617 34819083
Renal impairment 46.34 10.11 571 136660 93942 34725758
Therapeutic response delayed 44.53 10.11 29 137202 609 34819091
Nephropathy 43.42 10.11 81 137150 5836 34813864
Full blood count abnormal 43.38 10.11 10 137221 18658 34801042
Hypergastrinaemia 43.31 10.11 15 137216 65 34819635
Diabetic nephropathy 42.55 10.11 47 137184 2081 34817619
Hospitalisation 41.48 10.11 102 137129 56800 34762900
Subarachnoid haemorrhage 41.09 10.11 126 137105 12509 34807191
Stress 40.48 10.11 230 137001 30117 34789583
Ventricular fibrillation 40.40 10.11 188 137043 22766 34796934
Pericarditis 39.63 10.11 118 137113 11527 34808173
Subacute cutaneous lupus erythematosus 39.01 10.11 32 137199 970 34818730
Muscle twitching 38.57 10.11 108 137123 10190 34809510
Weight increased 38.00 10.11 212 137019 92821 34726879
Abdominal distension 37.66 10.11 373 136858 58119 34761581
Therapeutic product effect incomplete 37.31 10.11 90 137141 50451 34769249
Gingival disorder 37.17 10.11 37 137194 1450 34818250
Nasopharyngitis 36.47 10.11 146 137085 69822 34749878
Occupational dermatitis 36.30 10.11 14 137217 87 34819613
Vomiting 35.68 10.11 1246 135985 246375 34573325
Haematemesis 35.64 10.11 208 137023 27503 34792197
Neutrophil count decreased 35.42 10.11 331 136900 50773 34768927
Blood phosphorus increased 35.06 10.11 87 137144 7634 34812066
Chronic kidney disease-mineral and bone disorder 34.98 10.11 21 137210 380 34819320
Overdose 34.79 10.11 212 137019 90847 34728853
Melaena 34.71 10.11 248 136983 35132 34784568
Tubulointerstitial nephritis 34.68 10.11 169 137062 20855 34798845
Tetanus 34.11 10.11 12 137219 55 34819645
Poisoning 34.06 10.11 4 137227 12222 34807478
Rash vesicular 34.06 10.11 48 137183 2729 34816971
Ascites 33.97 10.11 305 136926 46266 34773434
Rash papular 33.89 10.11 103 137128 10175 34809525
Hepatocellular injury 33.44 10.11 174 137057 22037 34797663
Device dependence 33.27 10.11 11 137220 40 34819660
Angioedema 33.27 10.11 256 136975 37118 34782582
Hypocalcaemia 33.00 10.11 185 137046 24104 34795596
Jaundice 32.75 10.11 226 137005 31656 34788044
Vasculitis 32.49 10.11 108 137123 11188 34808512
Agranulocytosis 32.07 10.11 181 137050 23640 34796060
Drug intolerance 31.87 10.11 123 137108 59447 34760253
Abdominal pain 31.74 10.11 854 136377 162764 34656936
Injection site pain 31.61 10.11 66 137165 38939 34780761
Tetany 31.37 10.11 26 137205 800 34818900
Inappropriate schedule of product administration 31.21 10.11 132 137099 62164 34757536
Drug eruption 30.74 10.11 157 137074 19741 34799959
Therapeutic product effect decreased 30.57 10.11 56 137175 34687 34785013
Tinnitus 30.56 10.11 158 137073 19960 34799740
Gastric cancer 30.55 10.11 74 137157 6395 34813305
Diplopia 29.68 10.11 138 137093 16705 34802995
Ventricular tachycardia 29.46 10.11 192 137039 26387 34793313
Hyperchlorhydria 29.00 10.11 23 137208 664 34819036
Weight decreased 28.39 10.11 504 136727 175797 34643903
Palpitations 28.21 10.11 260 136971 39726 34779974
Synovitis 28.14 10.11 10 137221 14056 34805644
Drug hypersensitivity 27.95 10.11 193 137038 80336 34739364
Gait disturbance 27.64 10.11 208 137023 84932 34734768
Eye pruritus 27.52 10.11 78 137153 7411 34812289
Pancreatitis acute 27.45 10.11 197 137034 27944 34791756
Unevaluable event 27.38 10.11 54 137177 32536 34787164
Haemorrhage subcutaneous 26.78 10.11 39 137192 2285 34817415
Blood pressure fluctuation 26.67 10.11 36 137195 25213 34794487
COVID-19 26.35 10.11 187 137044 77363 34742337
Gastric polyps 26.12 10.11 28 137203 1198 34818502
Cytokine release syndrome 25.85 10.11 31 137200 22846 34796854
Accidental exposure to product 25.78 10.11 9 137222 12793 34806907
Liver disorder 25.04 10.11 218 137013 32779 34786921
Pneumonia aspiration 24.95 10.11 263 136968 41640 34778060
Therapy partial responder 24.78 10.11 4 137227 9612 34810088
Intentional product use issue 24.58 10.11 136 137095 59680 34760020
Aplastic anaemia 24.56 10.11 89 137142 9627 34810073
Femoral neck fracture 23.92 10.11 45 137186 3262 34816438
Rheumatoid arthritis 23.79 10.11 74 137157 38164 34781536
Occupational exposure to air contaminants 23.75 10.11 12 137219 152 34819548
Melanoderma 23.68 10.11 12 137219 153 34819547
Pulmonary fibrosis 23.60 10.11 138 137093 18258 34801442
Blood uric acid increased 23.36 10.11 87 137144 9537 34810163
Orthostatic hypotension 23.32 10.11 178 137053 25741 34793959
Asthenia 23.19 10.11 760 136471 244491 34575209
Marasmus 23.08 10.11 19 137212 579 34819121
Hepatitis acute 23.06 10.11 74 137157 7527 34812173
Hepatic cytolysis 22.82 10.11 115 137116 14381 34805319
Therapy non-responder 22.80 10.11 78 137153 39068 34780632
Rectal haemorrhage 22.74 10.11 250 136981 39999 34779701
Amnesia 22.56 10.11 180 137051 26383 34793317
Enteritis infectious 22.52 10.11 27 137204 1307 34818393
Cardiogenic shock 22.40 10.11 180 137051 26438 34793262
Cystitis escherichia 22.26 10.11 12 137219 175 34819525
Protein-losing gastroenteropathy 22.08 10.11 15 137216 339 34819361
Haematotoxicity 22.05 10.11 3 137228 8191 34811509
Disseminated intravascular coagulation 22.02 10.11 154 137077 21662 34798038
Idiopathic pulmonary fibrosis 21.83 10.11 45 137186 3489 34816211
Chest pain 21.61 10.11 651 136580 126111 34693589
Pneumonia bacterial 21.45 10.11 98 137133 11774 34807926
Drug dependence 21.33 10.11 39 137192 24178 34795522
Renal failure 21.33 10.11 667 136564 129890 34689810
Prostatic specific antigen increased 21.13 10.11 16 137215 14664 34805036
Coma 20.94 10.11 100 137131 45578 34774122
Cardio-respiratory arrest 20.93 10.11 129 137102 55144 34764556
Hypoacusis 20.74 10.11 20 137211 16281 34803419
Pain 20.60 10.11 629 136602 204046 34615654
Pathogen resistance 20.28 10.11 6 137225 9476 34810224
Therapy cessation 20.26 10.11 22 137209 16951 34802749
Dehydration 19.93 10.11 659 136572 129310 34690390
Neurotoxicity 19.72 10.11 25 137206 17985 34801715
Neutrophil count increased 19.70 10.11 125 137106 17021 34802679
Gastric varices 19.66 10.11 17 137214 555 34819145
Laboratory test abnormal 19.65 10.11 31 137200 20360 34799340
Therapy interrupted 19.63 10.11 15 137216 13682 34806018
Infusion related reaction 19.49 10.11 125 137106 52932 34766768
Wrong technique in product usage process 19.44 10.11 74 137157 35912 34783788
Blood alkaline phosphatase increased 19.18 10.11 197 137034 30978 34788722
Hypotension 19.06 10.11 695 136536 220954 34598746
Gastrooesophageal reflux disease 18.94 10.11 230 137001 37694 34782006
Product use issue 18.86 10.11 158 137073 63058 34756642
Neuroendocrine tumour 18.85 10.11 19 137212 756 34818944
Hypozincaemia 18.80 10.11 5 137226 6 34819694
Sinobronchitis 18.80 10.11 5 137226 6 34819694
Enterochromaffin cell hyperplasia 18.78 10.11 6 137225 19 34819681
Drug reaction with eosinophilia and systemic symptoms 18.63 10.11 205 137026 32807 34786893
Platelet count decreased 18.60 10.11 608 136623 119109 34700591
Rebound acid hypersecretion 18.53 10.11 9 137222 104 34819596
Renal disorder 18.13 10.11 166 137065 25314 34794386
Failure to anastomose 18.09 10.11 11 137220 204 34819496
Loss of personal independence in daily activities 18.07 10.11 68 137163 33111 34786589
Dissociation 17.92 10.11 27 137204 1631 34818069
Immune reconstitution inflammatory syndrome 17.91 10.11 6 137225 8753 34810947
Hiatus hernia 17.64 10.11 68 137163 7577 34812123
Renal hypertension 17.36 10.11 10 137221 167 34819533
Duodenal polyp 17.32 10.11 11 137220 221 34819479
Bulbospinal muscular atrophy congenital 17.27 10.11 5 137226 10 34819690
Vasculitic rash 17.17 10.11 20 137211 939 34818761
Wrong product administered 17.16 10.11 53 137178 5281 34814419
Neuropathy peripheral 17.14 10.11 227 137004 83036 34736664
Nephrosclerosis 17.13 10.11 20 137211 941 34818759
Haemorrhagic cerebral infarction 17.01 10.11 19 137212 852 34818848
Dialysis 17.01 10.11 88 137143 11120 34808580
Constipation 16.95 10.11 678 136553 136304 34683396
Upper respiratory tract inflammation 16.90 10.11 27 137204 1717 34817983
Alcoholic liver disease 16.83 10.11 16 137215 592 34819108
Aspergillus infection 16.83 10.11 14 137217 12240 34807460
Biliary sepsis 16.79 10.11 17 137214 680 34819020
Poisoning deliberate 16.71 10.11 5 137226 7839 34811861
Localised infection 16.70 10.11 27 137204 17560 34802140
Paraesthesia oral 16.69 10.11 45 137186 4152 34815548
Respiratory muscle weakness 16.66 10.11 8 137223 90 34819610
Renal artery stenosis 16.65 10.11 31 137200 2230 34817470
Contraindication to medical treatment 16.49 10.11 17 137214 695 34819005
Renal cyst 16.39 10.11 75 137156 9018 34810682
Influenza 16.27 10.11 121 137110 49545 34770155
Sopor 16.19 10.11 92 137139 12044 34807656
Immune thrombocytopenia 16.13 10.11 75 137156 9077 34810623
Glomerulosclerosis 15.97 10.11 18 137213 815 34818885
Confusional state 15.91 10.11 705 136526 143455 34676245
Sedation 15.82 10.11 37 137194 20969 34798731
Psoriatic arthropathy 15.62 10.11 34 137197 19764 34799936
Gastrointestinal polyp haemorrhage 15.57 10.11 12 137219 332 34819368
Device malfunction 15.47 10.11 11 137220 10410 34809290
Myasthenia gravis 15.42 10.11 61 137170 6879 34812821
White blood cell count increased 15.40 10.11 237 136994 40914 34778786
Drug ineffective for unapproved indication 15.39 10.11 45 137186 23670 34796030
Terminal insomnia 15.38 10.11 15 137216 573 34819127
Oral disorder 15.36 10.11 44 137187 4205 34815495
Pulmonary thrombosis 15.28 10.11 5 137226 7402 34812298
Periprosthetic fracture 15.23 10.11 9 137222 158 34819542
Cholangitis 15.16 10.11 71 137160 8618 34811082
Incorrect dose administered 15.11 10.11 95 137136 40420 34779280
Mouth ulceration 15.05 10.11 89 137142 11821 34807879
Subdural haematoma 15.02 10.11 134 137097 20287 34799413
Toxic skin eruption 14.99 10.11 86 137145 11299 34808401
Hyperuricaemia 14.99 10.11 67 137164 7976 34811724
Mobility decreased 14.98 10.11 64 137167 30064 34789636
Follicular mucinosis 14.95 10.11 5 137226 19 34819681
Device issue 14.94 10.11 10 137221 9767 34809933
Faecal vomiting 14.92 10.11 13 137218 429 34819271
Renal haemangioma 14.75 10.11 5 137226 20 34819680
Central nervous system mass 14.65 10.11 9 137222 170 34819530
Gastric ulcer haemorrhage 14.61 10.11 51 137180 5415 34814285
Gastrointestinal ulcer 14.57 10.11 25 137206 1686 34818014
Wall motion score index abnormal 14.52 10.11 9 137222 173 34819527
Thrombotic cerebral infarction 14.51 10.11 12 137219 368 34819332
Respiratory depression 14.45 10.11 26 137205 16219 34803481
Joint swelling 14.33 10.11 158 137073 59732 34759968
Oesophagitis 14.21 10.11 95 137136 13166 34806534
Diffuse vasculitis 14.11 10.11 7 137224 85 34819615
Blindness 14.09 10.11 104 137127 14882 34804818
Migraine 14.06 10.11 117 137114 17361 34802339
Blood magnesium decreased 13.90 10.11 56 137175 6367 34813333
Ischaemic nephropathy 13.86 10.11 5 137226 25 34819675
Upper gastrointestinal haemorrhage 13.73 10.11 157 137074 25361 34794339
Macroglossia 13.69 10.11 12 137219 399 34819301
Premature baby 13.68 10.11 36 137195 19597 34800103
Multiple sclerosis relapse 13.59 10.11 19 137212 13114 34806586
Eosinophil count increased 13.49 10.11 68 137163 8504 34811196
Clostridium test positive 13.46 10.11 36 137195 3306 34816394
Dermatitis acneiform 13.43 10.11 54 137177 6135 34813565
Retinal vascular occlusion 13.42 10.11 9 137222 199 34819501
Electrocardiogram ST-T segment abnormal 13.28 10.11 10 137221 267 34819433
Blood albumin decreased 13.23 10.11 95 137136 13477 34806223
Crohn's disease 12.98 10.11 34 137197 3083 34816617
Burning feet syndrome 12.93 10.11 7 137224 103 34819597
Cardiac murmur 12.92 10.11 63 137168 7774 34811926
Pain in extremity 12.91 10.11 388 136843 126125 34693575
Lymphocyte stimulation test positive 12.86 10.11 15 137216 705 34818995
Septic embolus 12.83 10.11 20 137211 1245 34818455
Cardiac failure congestive 12.76 10.11 240 136991 83030 34736670
Oesophagogastric fundoplasty 12.68 10.11 4 137227 12 34819688
Gastrointestinal motility disorder 12.68 10.11 30 137201 2554 34817146
Hyponatraemic seizure 12.62 10.11 6 137225 66 34819634
Blood gastrin increased 12.58 10.11 5 137226 34 34819666
Procedural failure 12.54 10.11 6 137225 67 34819633
Pelvic cyst 12.46 10.11 5 137226 35 34819665
Abdominal pain upper 12.40 10.11 368 136863 71122 34748578
Therapeutic response decreased 12.39 10.11 66 137165 29247 34790453
Barrett's oesophagus 12.38 10.11 12 137219 455 34819245
Airway remodelling 12.29 10.11 9 137222 230 34819470
Inhibitory drug interaction 12.25 10.11 23 137208 1665 34818035
Product dispensing error 12.25 10.11 53 137178 6221 34813479
Bronchiectasis 12.23 10.11 73 137158 9728 34809972
Eosinophilia 12.22 10.11 157 137074 26065 34793635
Rash morbilliform 12.18 10.11 33 137198 3054 34816646
Hospice care 12.17 10.11 6 137225 6934 34812766
Enterocolitis 12.16 10.11 63 137168 7963 34811737
Haemoptysis 12.12 10.11 199 137032 34807 34784893
N-telopeptide urine increased 12.11 10.11 5 137226 38 34819662
Lymphocyte count decreased 12.09 10.11 139 137092 22483 34797217
Urinary retention 12.09 10.11 205 137026 36083 34783617
Gastrointestinal tract irritation 12.06 10.11 10 137221 308 34819392
Cardiac septal defect 12.03 10.11 10 137221 309 34819391
Oculocephalogyric reflex absent 12.00 10.11 4 137227 15 34819685
Full blood count decreased 11.97 10.11 34 137197 18054 34801646
Gastrostomy tube site complication 11.87 10.11 6 137225 76 34819624
Atopy 11.86 10.11 9 137222 243 34819457
Adrenocortical insufficiency acute 11.86 10.11 22 137209 1578 34818122
Erythema multiforme 11.83 10.11 66 137165 8583 34811117
Generalised onset non-motor seizure 11.80 10.11 4 137227 16 34819684
Hepatotoxicity 11.72 10.11 44 137187 21441 34798259
Carotid bruit 11.69 10.11 8 137223 183 34819517
Sterile pyuria 11.68 10.11 5 137226 42 34819658
Gastric varices haemorrhage 11.67 10.11 9 137222 249 34819451
Spinal cord haemorrhage 11.65 10.11 10 137221 323 34819377
Hip fracture 11.61 10.11 18 137213 11907 34807793
Skin irritation 11.58 10.11 48 137183 5529 34814171
Circulatory collapse 11.57 10.11 130 137101 20908 34798792
Gastric pH increased 11.57 10.11 3 137228 3 34819697
Metaplasia 11.55 10.11 9 137222 253 34819447
Hypersensitivity vasculitis 11.54 10.11 34 137197 3301 34816399
Hirsutism 11.54 10.11 8 137223 187 34819513
Putamen haemorrhage 11.40 10.11 9 137222 258 34819442
Aortic dissection 11.33 10.11 30 137201 2738 34816962
Blood cholesterol increased 11.33 10.11 127 137104 20416 34799284
Embolic cerebral infarction 11.32 10.11 14 137217 700 34819000
Rhinorrhoea 11.30 10.11 57 137174 25611 34794089
Adrenal insufficiency 11.28 10.11 94 137137 13953 34805747
Brain stem haemorrhage 11.27 10.11 16 137215 916 34818784
Radiation pneumonitis 11.21 10.11 29 137202 2611 34817089
Discoloured vomit 11.15 10.11 12 137219 516 34819184
Faeces discoloured 11.13 10.11 98 137133 14780 34804920
Renal atrophy 11.01 10.11 18 137213 1167 34818533
Mesothelioma 10.99 10.11 11 137220 434 34819266
Prostate cancer 10.98 10.11 101 137130 39548 34780152
Cerebral hyperperfusion syndrome 10.92 10.11 6 137225 91 34819609
Knee arthroplasty 10.86 10.11 8 137223 7436 34812264
Nocturia 10.85 10.11 73 137158 10137 34809563
Oral candidiasis 10.80 10.11 83 137148 12027 34807673
Cerebral haemorrhage 10.79 10.11 195 137036 34742 34784958
Exposed bone in jaw 10.76 10.11 21 137210 1565 34818135
Infective pulmonary exacerbation of cystic fibrosis 10.74 10.11 54 137177 6747 34812953
Adverse event 10.73 10.11 38 137193 18839 34800861
Electrocardiogram QRS complex prolonged 10.64 10.11 3 137228 4891 34814809
Intracranial haematoma 10.62 10.11 11 137220 452 34819248
Enterocolitis haemorrhagic 10.61 10.11 16 137215 967 34818733
Hepatic encephalopathy 10.61 10.11 96 137135 14589 34805111
Dyslalia 10.57 10.11 12 137219 548 34819152
Muscle strain 10.55 10.11 37 137194 3939 34815761
Osteonecrosis of jaw 10.51 10.11 112 137119 17777 34801923
Haematuria 10.46 10.11 264 136967 49802 34769898
Meniere's disease 10.43 10.11 5 137226 56 34819644
Treatment noncompliance 10.42 10.11 66 137165 28034 34791666
Ammonia decreased 10.36 10.11 3 137228 6 34819694
Dressler's syndrome 10.35 10.11 4 137227 25 34819675
Akathisia 10.26 10.11 10 137221 8099 34811601
Peptic ulcer 10.24 10.11 29 137202 2754 34816946
Cardiac disorder 10.23 10.11 114 137117 43012 34776688
Thrombosis 10.22 10.11 138 137093 50320 34769380
Therapeutic response unexpected 10.22 10.11 14 137217 9743 34809957
Cerebellar infarction 10.21 10.11 23 137208 1896 34817804
Mediastinal abscess 10.21 10.11 5 137226 59 34819641
Exposure during pregnancy 10.20 10.11 12 137219 8922 34810778
Amaurosis fugax 10.12 10.11 12 137219 574 34819126
Mental status changes 10.12 10.11 98 137133 37985 34781715

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 885.58 9.32 1677 294821 1079236 78368654
Completed suicide 647.49 9.32 77 296421 245690 79202200
Chronic kidney disease 564.34 9.32 938 295560 65216 79382674
Colitis microscopic 558.62 9.32 399 296099 10369 79437521
Hyponatraemia 534.56 9.32 1664 294834 176184 79271706
Death 364.22 9.32 999 295499 565515 78882375
Toxicity to various agents 314.18 9.32 688 295810 420852 79027038
Product dose omission issue 256.62 9.32 326 296172 247211 79200679
Interstitial lung disease 248.39 9.32 951 295547 111649 79336241
Acute kidney injury 245.30 9.32 2979 293519 516425 78931465
End stage renal disease 244.31 9.32 263 296235 11957 79435933
Hypomagnesaemia 240.39 9.32 536 295962 46375 79401515
Drug abuse 232.45 9.32 160 296338 162531 79285359
Off label use 219.58 9.32 2237 294261 904978 78542912
Therapeutic product effect incomplete 201.42 9.32 140 296358 141505 79306385
Neutropenic sepsis 194.55 9.32 356 296142 26708 79421182
Subacute cutaneous lupus erythematosus 189.42 9.32 134 296364 3427 79444463
Fatigue 182.64 9.32 2401 294097 927326 78520564
Cardiospasm 163.62 9.32 119 296379 3182 79444708
Treatment failure 161.05 9.32 240 296258 170246 79277644
Cerebral infarction 160.42 9.32 452 296046 45224 79402666
Pruritus genital 151.59 9.32 129 296369 4357 79443533
Drug intolerance 151.08 9.32 491 296007 263628 79184262
Palmoplantar keratoderma 151.07 9.32 119 296379 3597 79444293
Lip swelling 146.78 9.32 408 296090 40503 79407387
Synovitis 145.50 9.32 209 296289 150525 79297365
Hepatic function abnormal 145.49 9.32 598 295900 72509 79375381
Injection site pain 144.04 9.32 162 296336 129676 79318214
Renal injury 140.23 9.32 237 296261 16690 79431200
Pain 137.38 9.32 1819 294679 701983 78745907
Sleep terror 130.20 9.32 118 296380 4340 79443550
Subarachnoid haemorrhage 126.96 9.32 281 296217 24184 79423706
Tension headache 126.58 9.32 145 296353 7066 79440824
Atrial tachycardia 114.50 9.32 137 296361 6996 79440894
Nephrogenic anaemia 111.45 9.32 102 296396 3800 79444090
Appendicolith 111.43 9.32 148 296350 8403 79439487
Haematemesis 108.35 9.32 433 296065 51831 79396059
Joint swelling 105.83 9.32 634 295864 288012 79159878
Therapeutic product effect decreased 104.15 9.32 290 296208 163573 79284317
Immunisation 102.62 9.32 76 296422 2091 79445799
Melaena 102.01 9.32 473 296025 60417 79387473
Hypertensive nephropathy 101.58 9.32 57 296441 957 79446933
Lower respiratory tract infection 100.61 9.32 823 295675 128397 79319493
Angioedema 100.19 9.32 552 295946 75483 79372407
Loss of personal independence in daily activities 99.20 9.32 142 296356 102438 79345452
Cholestasis 94.95 9.32 415 296083 51694 79396196
Swollen tongue 94.18 9.32 360 296138 42210 79405680
Hypocalcaemia 92.03 9.32 399 296099 49525 79398365
Carotid artery occlusion 91.53 9.32 127 296371 7520 79440370
Weight increased 90.11 9.32 632 295866 276754 79171136
Arthropathy 90.01 9.32 346 296152 176765 79271125
Transient ischaemic attack 88.76 9.32 410 296088 52285 79395605
Confusional state 87.37 9.32 1664 294834 316333 79131557
Electric shock 87.26 9.32 58 296440 1336 79446554
Drug resistance 86.06 9.32 25 296473 42188 79405702
Drug dispensed to wrong patient 85.50 9.32 45 296453 661 79447229
Liver function test abnormal 84.89 9.32 468 296030 64007 79383883
Anosmia 84.36 9.32 132 296366 8712 79439178
Contraindicated product administered 83.82 9.32 302 296196 157236 79290654
Chest pain 83.73 9.32 1495 295003 280809 79167081
Appendicitis 83.27 9.32 216 296282 20578 79427312
Facial pain 83.18 9.32 158 296340 12192 79435698
Renal failure 81.15 9.32 1121 295377 199847 79248043
Abdominal pain 80.48 9.32 1956 294542 387613 79060277
Hepatocellular injury 79.93 9.32 370 296128 47223 79400667
Agranulocytosis 79.30 9.32 355 296143 44675 79403215
Jaundice 78.28 9.32 399 296099 52950 79394940
Tubulointerstitial nephritis 77.03 9.32 314 296184 37921 79409969
Suicide attempt 76.11 9.32 119 296379 82813 79365077
Sinusitis 73.95 9.32 425 296073 195076 79252814
Infusion related reaction 71.64 9.32 531 295967 229706 79218184
Device expulsion 70.83 9.32 7 296491 25854 79422036
Intentional overdose 70.72 9.32 183 296315 105777 79342113
Renal impairment 70.70 9.32 897 295601 156886 79291004
Drug hypersensitivity 66.64 9.32 750 295748 298166 79149724
Wrong patient received product 66.54 9.32 84 296414 4534 79443356
Hypergastrinaemia 66.41 9.32 26 296472 180 79447710
Product use issue 66.19 9.32 482 296016 209340 79238550
Nasopharyngitis 66.07 9.32 614 295884 253267 79194623
Vomiting 65.55 9.32 3064 293434 662764 78785126
Muscle twitching 65.48 9.32 222 296276 24542 79423348
Rectal haemorrhage 65.44 9.32 497 296001 75803 79372087
Electrocardiogram QT prolonged 64.68 9.32 565 295933 89821 79358069
Pain of skin 63.95 9.32 157 296341 14456 79433434
Product use in unapproved indication 63.64 9.32 609 295889 249750 79198140
Inappropriate schedule of product administration 63.50 9.32 268 296230 133360 79314530
Cholecystitis chronic 63.37 9.32 124 296374 9782 79438108
Sopor 63.29 9.32 267 296231 32743 79415147
Antimicrobial susceptibility test resistant 62.49 9.32 30 296468 358 79447532
Faeces discoloured 61.72 9.32 243 296255 28884 79419006
Diabetic nephropathy 61.69 9.32 65 296433 2882 79445008
Accidental exposure to product 61.24 9.32 20 296478 31302 79416588
Exposure during pregnancy 60.58 9.32 184 296314 100948 79346942
Neutrophil count decreased 60.46 9.32 574 295924 93385 79354505
Hypokalaemia 59.98 9.32 808 295690 143232 79304658
Minimum inhibitory concentration 59.02 9.32 23 296475 157 79447733
Hospitalisation 58.95 9.32 168 296330 94068 79353822
Wrong technique in product usage process 58.73 9.32 116 296382 73759 79374131
Malaise 58.16 9.32 2299 294199 487570 78960320
Therapy interrupted 56.22 9.32 23 296475 31318 79416572
Liver disorder 55.14 9.32 459 296039 71958 79375932
Injection site pruritus 54.70 9.32 46 296452 42237 79405653
Intervertebral discitis 53.08 9.32 77 296421 4751 79443139
Arthralgia 52.70 9.32 1672 294826 570131 78877759
Overdose 52.55 9.32 435 296063 183771 79264119
Venous pressure jugular increased 52.52 9.32 42 296456 1298 79446592
Injection site erythema 52.22 9.32 135 296363 78062 79369828
Influenza 52.14 9.32 276 296222 129330 79318560
Maternal exposure during pregnancy 52.06 9.32 296 296202 136242 79311648
Sedation 52.00 9.32 70 296428 51825 79396065
Hand deformity 51.51 9.32 205 296293 103714 79344176
Swelling face 51.39 9.32 446 296052 70766 79377124
Therapy cessation 50.93 9.32 39 296459 37523 79410367
Hepatic enzyme increased 50.84 9.32 434 296064 182176 79265714
Vasculitis 50.45 9.32 206 296292 24896 79422994
Abdominal pain upper 48.95 9.32 1133 295365 222686 79225204
Infective pulmonary exacerbation of cystic fibrosis 48.92 9.32 131 296367 12720 79435170
Drug reaction with eosinophilia and systemic symptoms 48.81 9.32 407 296091 63837 79384053
Dehydration 48.45 9.32 1237 295261 246950 79200940
Ventricular tachycardia 48.42 9.32 294 296204 41641 79406249
Injection site reaction 48.03 9.32 81 296417 54704 79393186
Dry mouth 47.66 9.32 519 295979 87500 79360390
Toxic epidermal necrolysis 47.39 9.32 306 296192 44275 79403615
Diplopia 46.81 9.32 247 296251 33219 79414671
Deep vein thrombosis postoperative 46.50 9.32 115 296383 10637 79437253
Poisoning 46.23 9.32 18 296480 25254 79422636
Haemorrhage subcutaneous 46.18 9.32 72 296426 4737 79443153
Gastrooesophageal reflux disease 45.98 9.32 591 295907 103655 79344235
Tinnitus 45.72 9.32 302 296196 44031 79403859
Rheumatoid arthritis 45.67 9.32 525 295973 207945 79239945
Injection site swelling 44.81 9.32 66 296432 47066 79400824
Therapy partial responder 44.42 9.32 6 296492 17391 79430499
Mobility decreased 44.37 9.32 269 296229 121906 79325984
Labile blood pressure 44.17 9.32 48 296450 2205 79445685
Nephropathy 44.08 9.32 106 296392 9632 79438258
Hypoparathyroidism secondary 44.07 9.32 20 296478 208 79447682
COVID-19 43.77 9.32 375 296123 157299 79290591
Palpitations 43.52 9.32 687 295811 125923 79321967
Device dependence 43.50 9.32 14 296484 49 79447841
Red blood cell sedimentation rate abnormal 43.50 9.32 12 296486 20951 79426939
Platelet count decreased 43.36 9.32 988 295510 193676 79254214
Pneumonia bacterial 43.18 9.32 164 296334 19167 79428723
Hepatic cytolysis 42.61 9.32 207 296291 26944 79420946
Brain stem glioma 42.60 9.32 19 296479 189 79447701
Lip dry 42.34 9.32 140 296358 15278 79432612
Disseminated intravascular coagulation 41.84 9.32 252 296246 35590 79412300
Rash papular 41.80 9.32 177 296321 21739 79426151
Facet joint syndrome 41.80 9.32 114 296384 11188 79436702
Blood alkaline phosphatase increased 41.48 9.32 390 296108 63274 79384616
Amnesia 41.45 9.32 387 296111 62670 79385220
Hepatotoxicity 41.36 9.32 80 296418 51272 79396618
Post-traumatic stress disorder 41.31 9.32 69 296429 4812 79443078
Upper respiratory tract inflammation 40.98 9.32 62 296436 3973 79443917
Pemphigus 40.65 9.32 211 296287 99371 79348519
Device dislocation 40.57 9.32 23 296475 25947 79421943
Gastritis 40.24 9.32 311 296187 47682 79400208
Chronic kidney disease-mineral and bone disorder 40.01 9.32 25 296473 516 79447374
Circulatory collapse 39.70 9.32 258 296240 37410 79410480
Hallucination 39.47 9.32 490 296008 85255 79362635
Toxic skin eruption 39.43 9.32 176 296322 22117 79425773
Diarrhoea 39.32 9.32 3791 292707 876698 78571192
Blood pressure increased 38.97 9.32 552 295946 210808 79237082
Pancreatitis acute 38.61 9.32 316 296182 49288 79398602
Reflux gastritis 38.33 9.32 34 296464 1215 79446675
Blood uric acid increased 38.21 9.32 123 296375 13237 79434653
Swelling 37.86 9.32 572 295926 216139 79231751
Pemphigoid 37.63 9.32 134 296364 15181 79432709
Oesophagitis 37.28 9.32 184 296314 24105 79423785
Mixed liver injury 37.04 9.32 85 296413 7493 79440397
Urine magnesium decreased 36.79 9.32 8 296490 0 79447890
Nasal congestion 36.68 9.32 153 296345 76399 79371491
Protein-losing gastroenteropathy 36.54 9.32 25 296473 605 79447285
Rhinorrhoea 36.48 9.32 152 296346 75922 79371968
Ventricular fibrillation 36.33 9.32 223 296275 31703 79416187
Pneumonia aspiration 36.31 9.32 395 296103 66572 79381318
Hyperkalaemia 36.07 9.32 612 295886 113786 79334104
Blood sodium decreased 35.80 9.32 229 296269 33026 79414864
Decreased appetite 35.57 9.32 1585 294913 340833 79107057
Coronary artery disease 34.95 9.32 385 296113 65089 79382801
Tetanus 34.75 9.32 12 296486 55 79447835
International normalised ratio increased 34.74 9.32 474 296024 84247 79363643
Biliary dyskinesia 34.63 9.32 45 296453 2500 79445390
Enterochromaffin cell hyperplasia 34.63 9.32 13 296485 79 79447811
Occupational dermatitis 34.46 9.32 15 296483 140 79447750
Gastric polyps 34.46 9.32 55 296443 3692 79444198
Rheumatoid nodule 34.33 9.32 11 296487 17427 79430463
Post cholecystectomy syndrome 33.84 9.32 20 296478 372 79447518
Hepatic ischaemia 33.52 9.32 30 296468 1085 79446805
Femoral neck fracture 33.30 9.32 97 296401 9887 79438003
Pain in extremity 33.26 9.32 1067 295431 363471 79084419
Aplastic anaemia 32.91 9.32 143 296355 17762 79430128
Alopecia 32.84 9.32 634 295864 230721 79217169
Cerebral haemorrhage 32.58 9.32 343 296155 57330 79390560
Peripheral venous disease 32.32 9.32 131 296367 15778 79432112
Drug ineffective for unapproved indication 32.29 9.32 91 296407 51147 79396743
Tetany 32.19 9.32 45 296453 2683 79445207
Orthostatic hypotension 32.19 9.32 335 296163 55829 79392061
Psoriasis 32.13 9.32 198 296300 89389 79358501
Enteritis infectious 32.09 9.32 50 296448 3288 79444602
Injection site bruising 32.05 9.32 65 296433 40937 79406953
Haematotoxicity 31.98 9.32 9 296489 15510 79432380
Sleep disorder due to a general medical condition 31.91 9.32 7 296491 14270 79433620
Respiratory arrest 31.47 9.32 109 296389 57441 79390449
Therapeutic response decreased 31.18 9.32 135 296363 66718 79381172
Blood pressure fluctuation 31.07 9.32 136 296362 67009 79380881
Therapeutic response delayed 30.97 9.32 29 296469 1113 79446777
Erythema multiforme 30.95 9.32 139 296359 17512 79430378
Biliary sepsis 30.92 9.32 34 296464 1583 79446307
Cardiac failure 30.85 9.32 774 295724 154068 79293822
Anti-cyclic citrullinated peptide antibody positive 30.74 9.32 182 296316 82961 79364929
Cholangitis 30.72 9.32 111 296387 12665 79435225
Neuroendocrine tumour 30.58 9.32 31 296467 1313 79446577
Disease progression 30.38 9.32 492 296006 183870 79264020
Eye pruritus 30.28 9.32 154 296344 20416 79427474
Hyperchlorhydria 30.25 9.32 38 296460 2041 79445849
Haemoptysis 30.22 9.32 330 296168 55669 79392221
Systemic lupus erythematosus 30.20 9.32 296 296202 120853 79327037
Abdominal distension 30.06 9.32 618 295880 119032 79328858
Autoimmune disorder 30.02 9.32 132 296366 16480 79431410
Hepatitis acute 30.01 9.32 126 296372 15416 79432474
Altered state of consciousness 29.83 9.32 271 296227 43551 79404339
Immune thrombocytopenia 29.58 9.32 138 296360 17667 79430223
Fluid retention 29.58 9.32 146 296352 69663 79378227
Neoplasm progression 29.55 9.32 96 296402 51586 79396304
Device malfunction 29.42 9.32 22 296476 21426 79426464
Full blood count decreased 29.14 9.32 34 296464 26785 79421105
Multiple sclerosis relapse 29.06 9.32 83 296415 46450 79401440
Poisoning deliberate 28.95 9.32 17 296481 18811 79429079
Device issue 28.78 9.32 35 296463 27073 79420817
Red blood cell sedimentation rate increased 28.65 9.32 82 296416 45860 79402030
Skin candida 28.55 9.32 37 296461 2050 79445840
Coma 28.54 9.32 238 296260 100411 79347479
Rectal ulcer 28.32 9.32 37 296461 2067 79445823
Musculoskeletal disorder 28.15 9.32 23 296475 21425 79426465
Carcinoid tumour of the stomach 27.90 9.32 14 296484 185 79447705
Demyelination 27.77 9.32 79 296419 7944 79439946
Coma scale abnormal 27.69 9.32 83 296415 8595 79439295
Eosinophilia 27.67 9.32 274 296224 45071 79402819
Gastric cancer 27.57 9.32 92 296406 10087 79437803
Lethargy 27.51 9.32 440 296058 80852 79367038
Hyperglycaemia 27.41 9.32 390 296108 69945 79377945
Basilar artery occlusion 27.38 9.32 14 296484 193 79447697
Upper gastrointestinal haemorrhage 27.21 9.32 254 296244 41126 79406764
Coordination abnormal 27.18 9.32 132 296366 17180 79430710
Device difficult to use 27.15 9.32 8 296490 13377 79434513
Idiopathic pulmonary fibrosis 27.14 9.32 53 296445 4175 79443715
Somatic delusion 27.07 9.32 22 296476 696 79447194
Gastrointestinal motility disorder 27.03 9.32 66 296432 6056 79441834
Weight decreased 26.85 9.32 1064 295434 354134 79093756
Glossodynia 26.81 9.32 250 296248 103087 79344803
Enterocolitis 26.75 9.32 116 296382 14396 79433494
Pathogen resistance 26.59 9.32 10 296488 14332 79433558
Urine potassium decreased 26.44 9.32 7 296491 9 79447881
Peripheral swelling 26.33 9.32 782 295716 268835 79179055
Joint stiffness 26.11 9.32 72 296426 40758 79407132
Gait disturbance 26.09 9.32 580 295918 206926 79240964
Drug dependence 25.99 9.32 72 296426 40697 79407193
Mouth ulceration 25.91 9.32 237 296261 38157 79409733
Gastric dysplasia 25.79 9.32 8 296490 24 79447866
Marasmus 25.77 9.32 25 296473 1003 79446887
Hip fracture 25.58 9.32 47 296451 30714 79417176
Blindness 25.53 9.32 187 296311 28196 79419694
Post viral fatigue syndrome 25.49 9.32 16 296482 333 79447557
Immune reconstitution inflammatory syndrome 25.08 9.32 10 296488 13831 79434059
Dysphagia 25.07 9.32 613 295885 121523 79326367
Blood pressure systolic increased 24.57 9.32 147 296351 66839 79381051
Syncope 24.56 9.32 856 295642 178593 79269297
Total lung capacity decreased 24.49 9.32 41 296457 2864 79445026
Constipation 24.49 9.32 1287 295211 281763 79166127
Gastric varices 24.41 9.32 21 296477 720 79447170
Occupational exposure to air contaminants 24.37 9.32 12 296486 152 79447738
Nephrocalcinosis 24.36 9.32 29 296469 1473 79446417
Subdural haematoma 24.33 9.32 200 296298 31234 79416656
Anaemia 24.25 9.32 1945 294553 443070 79004820
Haematuria 24.21 9.32 375 296123 68461 79379429
Blood phosphorus increased 24.12 9.32 89 296409 10258 79437632
Adrenal insufficiency 24.10 9.32 185 296313 28302 79419588
Limb discomfort 24.07 9.32 54 296444 32796 79415094
Abnormal loss of weight 23.85 9.32 77 296421 8299 79439591
Unevaluable event 23.69 9.32 116 296382 55469 79392421
Nightmare 23.61 9.32 171 296327 25690 79422200
Foot deformity 23.59 9.32 33 296465 24041 79423849
Cardio-respiratory arrest 23.46 9.32 274 296224 108236 79339654
Inappropriate antidiuretic hormone secretion 23.46 9.32 173 296325 26140 79421750
Erythema dyschromicum perstans 23.28 9.32 9 296489 60 79447830
Anaphylactic reaction 23.20 9.32 439 296059 83304 79364586
Discomfort 23.16 9.32 328 296170 125289 79322601
Respiratory tract congestion 23.11 9.32 24 296474 19930 79427960
Cystitis escherichia 22.98 9.32 19 296479 616 79447274
Rebound acid hypersecretion 22.91 9.32 10 296488 94 79447796
Musculoskeletal stiffness 22.91 9.32 486 296012 174522 79273368
Renal atrophy 22.88 9.32 31 296467 1794 79446096
Wound 22.63 9.32 300 296198 115879 79332011
Hypophosphataemic osteomalacia 22.59 9.32 15 296483 345 79447545
Hypoacusis 22.56 9.32 49 296449 30101 79417789
Hiatus hernia 22.36 9.32 156 296342 23156 79424734
Mouth swelling 22.34 9.32 61 296437 5990 79441900
Incorrect dose administered 22.27 9.32 180 296318 76450 79371440
Illness 22.26 9.32 93 296405 46418 79401472
Condition aggravated 22.19 9.32 1584 294914 499540 78948350
Hypersensitivity 22.15 9.32 775 295723 261464 79186426
Intentional product use issue 22.14 9.32 415 296083 151697 79296193
Urticaria 22.09 9.32 870 295628 184331 79263559
Cardioactive drug level increased 22.01 9.32 45 296453 3664 79444226
Urine output decreased 21.86 9.32 128 296370 17894 79429996
Hyperparathyroidism secondary 21.71 9.32 37 296461 2623 79445267
Gastrointestinal tract irritation 21.71 9.32 19 296479 667 79447223
Multiple allergies 21.68 9.32 6 296492 10454 79437436
Hyperuricaemia 21.51 9.32 94 296404 11705 79436185
Cholecystitis acute 21.43 9.32 103 296395 13348 79434542
Neuropathy, ataxia, retinitis pigmentosa syndrome 21.40 9.32 8 296490 48 79447842
Cardiac arrest 21.35 9.32 482 296016 171614 79276276
White blood cell count increased 21.29 9.32 393 296105 74240 79373650
Enterocolitis haemorrhagic 21.28 9.32 33 296465 2161 79445729
Rhabdomyolysis 21.28 9.32 518 295980 102613 79345277
Cytokine release syndrome 21.19 9.32 66 296432 35932 79411958
Myocardial ischaemia 21.19 9.32 165 296333 25354 79422536
Blood immunoglobulin A increased 21.15 9.32 22 296476 961 79446929
Tachypnoea 20.91 9.32 56 296442 32007 79415883
Barrett's oesophagus 20.90 9.32 20 296478 789 79447101
Medication error 20.83 9.32 365 296133 68277 79379613
Arthritis 20.82 9.32 301 296197 114579 79333311
Genital ulceration 20.81 9.32 23 296475 1077 79446813
Sinus congestion 20.79 9.32 26 296472 19870 79428020
Panniculitis 20.74 9.32 10 296488 12361 79435529
Transplant rejection 20.74 9.32 25 296473 19412 79428478
Hyperlipidaemia 20.73 9.32 167 296331 25926 79421964
Asthma 20.67 9.32 653 295845 134442 79313448
Muscle relaxant therapy 20.58 9.32 11 296487 167 79447723
Red cell distribution width increased 20.44 9.32 16 296482 15226 79432664
Gastric ulcer 20.27 9.32 204 296294 33701 79414189
Cardiac murmur 20.25 9.32 114 296384 15710 79432180
Immunodeficiency 20.19 9.32 31 296467 21737 79426153
Drug eruption 20.18 9.32 251 296247 43684 79404206
Foetal death 20.01 9.32 3 296495 8041 79439849
Pituitary tumour benign 19.94 9.32 35 296463 2541 79445349
Cystitis 19.72 9.32 115 296383 52617 79395273
Acne 19.68 9.32 45 296453 27145 79420745
Hypoglycaemic coma 19.63 9.32 50 296448 4710 79443180
Hyponatraemic syndrome 19.62 9.32 19 296479 761 79447129
Mental status changes 19.59 9.32 157 296341 66802 79381088
Purpura 19.52 9.32 132 296366 19395 79428495
Macroglossia 19.48 9.32 23 296475 1158 79446732
Hypersensitivity pneumonitis 19.46 9.32 43 296455 3696 79444194
Renal cyst 19.43 9.32 107 296391 14625 79433265
Angina pectoris 19.42 9.32 285 296213 51447 79396443
Electrocardiogram QRS complex prolonged 19.35 9.32 8 296490 10825 79437065
Food allergy 19.32 9.32 8 296490 10816 79437074
Cholecystitis 19.21 9.32 145 296353 22067 79425823
Ascites 19.21 9.32 391 296107 75171 79372719
Face oedema 19.15 9.32 174 296324 27962 79419928
Osteonecrosis of jaw 19.02 9.32 245 296253 42981 79404909
Basal cell carcinoma 18.98 9.32 73 296425 37302 79410588
Chromaturia 18.96 9.32 162 296336 25584 79422306
Lung opacity 18.95 9.32 52 296446 5122 79442768
Genital pain 18.93 9.32 19 296479 795 79447095
Unintentional medical device removal 18.90 9.32 3 296495 7709 79440181
Abortion spontaneous 18.89 9.32 52 296446 29455 79418435
Anal prolapse 18.73 9.32 8 296490 71 79447819
Bradycardia 18.63 9.32 647 295851 134910 79312980
Neutrophil count increased 18.61 9.32 179 296319 29217 79418673
Infection 18.47 9.32 723 295775 240989 79206901
Therapeutic response shortened 18.46 9.32 19 296479 15844 79432046
Psoriatic arthropathy 18.43 9.32 193 296305 77806 79370084
Myelosuppression 18.41 9.32 82 296416 40214 79407676
Bulbospinal muscular atrophy congenital 18.24 9.32 5 296493 8 79447882
Ventricular hypertrophy 18.17 9.32 62 296436 6876 79441014
Aspartate aminotransferase 18.15 9.32 16 296482 567 79447323
Extravasation blood 18.15 9.32 14 296484 410 79447480
Joint injury 18.06 9.32 58 296440 31277 79416613
Fall 18.05 9.32 1564 294934 486065 78961825
Vulvovaginal candidiasis 17.98 9.32 33 296465 2481 79445409
Drug use disorder 17.86 9.32 5 296493 8646 79439244
Urinary retention 17.86 9.32 303 296195 56327 79391563
Dermatitis bullous 17.81 9.32 102 296396 14143 79433747
Bone pain 17.58 9.32 128 296370 55614 79392276
Blood gastrin increased 17.58 9.32 7 296491 51 79447839
Cardiotoxicity 17.51 9.32 12 296486 12227 79435663
Temperature intolerance 17.45 9.32 77 296421 9628 79438262
Dialysis 17.39 9.32 123 296375 18339 79429551
Pancreatic carcinoma recurrent 17.36 9.32 10 296488 177 79447713
Pelvic cyst 17.35 9.32 7 296491 53 79447837
Pulmonary thrombosis 17.33 9.32 12 296486 12159 79435731
Dermatitis exfoliative 17.31 9.32 83 296415 10746 79437144
C-reactive protein 17.21 9.32 49 296449 4930 79442960
Disturbance in attention 17.20 9.32 275 296223 50526 79397364
Iron deficiency anaemia 17.09 9.32 158 296340 25514 79422376
Renal tubular acidosis 17.07 9.32 40 296458 3574 79444316
Nephrosclerosis 17.02 9.32 27 296471 1803 79446087
Pulmonary fibrosis 16.95 9.32 244 296254 43868 79404022
Lymphadenopathy 16.92 9.32 122 296376 53125 79394765
Product monitoring error 16.87 9.32 6 296492 8900 79438990
Haemorrhagic cerebral infarction 16.86 9.32 24 296474 1455 79446435
Neurotoxicity 16.84 9.32 63 296435 32455 79415435
Bronchopulmonary aspergillosis allergic 16.84 9.32 36 296462 3025 79444865
Cerebellar infarction 16.83 9.32 40 296458 3607 79444283
Drug interaction 16.76 9.32 1776 294722 413407 79034483
Alanine aminotransferase abnormal 16.75 9.32 6 296492 8861 79439029
Skin oedema 16.63 9.32 26 296472 1715 79446175
Hypervolaemia 16.56 9.32 92 296406 42598 79405292
Skin necrosis 16.54 9.32 26 296472 18061 79429829
Blood albumin decreased 16.54 9.32 150 296348 24093 79423797
Dilatation atrial 16.42 9.32 40 296458 3664 79444226
Melanoderma 16.39 9.32 13 296485 397 79447493
Oesophageal mucosal tear 16.37 9.32 5 296493 14 79447876
Aortic dissection 16.34 9.32 43 296455 4132 79443758
Hospice care 16.33 9.32 9 296489 10315 79437575
Disability 16.25 9.32 24 296474 17096 79430794
Staphylococcus test positive 16.17 9.32 57 296441 6424 79441466
Alcoholic liver disease 16.16 9.32 15 296483 569 79447321
Renal hypertension 16.15 9.32 10 296488 203 79447687
Hiccups 16.12 9.32 77 296421 9954 79437936
Penile curvature 16.12 9.32 5 296493 15 79447875
Acute coronary syndrome 16.11 9.32 134 296364 20999 79426891
Stoma site haemorrhage 16.10 9.32 27 296471 1889 79446001
Catarrh 16.09 9.32 29 296469 2149 79445741
Epstein-Barr virus infection 15.96 9.32 18 296480 14398 79433492
Rheumatoid factor positive 15.85 9.32 144 296354 59695 79388195
Heart rate decreased 15.81 9.32 176 296322 70140 79377750
Injection site haemorrhage 15.77 9.32 52 296446 27818 79420072
Hydronephrosis 15.70 9.32 115 296383 17339 79430551
Sinus disorder 15.60 9.32 38 296460 22426 79425464
Disease recurrence 15.55 9.32 98 296400 44011 79403879
Atypical fracture 15.55 9.32 16 296482 690 79447200
Blood pressure decreased 15.54 9.32 482 296016 98984 79348906
Single functional kidney 15.52 9.32 11 296487 282 79447608
Blood creatine phosphokinase increased 15.50 9.32 338 296160 65752 79382138
Gallbladder disorder 15.48 9.32 124 296374 19216 79428674
Infusion site streaking 15.47 9.32 14 296484 514 79447376
Oropharyngeal oedema 15.43 9.32 13 296485 433 79447457
Post transplant lymphoproliferative disorder 15.42 9.32 12 296486 11452 79436438
Alanine aminotransferase increased 15.24 9.32 745 295753 161825 79286065
Spleen congestion 15.23 9.32 13 296485 441 79447449
Nocturia 15.21 9.32 95 296403 13586 79434304
Failure to anastomose 15.21 9.32 10 296488 226 79447664
Flashback 15.16 9.32 11 296487 293 79447597
Bone erosion 15.08 9.32 27 296471 17820 79430070
Skin toxicity 15.08 9.32 6 296492 8308 79439582
No adverse event 15.06 9.32 79 296419 37113 79410777
Embolic cerebral infarction 15.05 9.32 21 296477 1250 79446640
Cold sweat 15.03 9.32 120 296378 18579 79429311
Chronic gastritis 15.01 9.32 41 296457 4027 79443863
Macular degeneration 14.97 9.32 12 296486 11284 79436606
Wall motion score index abnormal 14.97 9.32 9 296489 173 79447717
Central nervous system mass 14.92 9.32 9 296489 174 79447716
Bleeding time prolonged 14.92 9.32 21 296477 1260 79446630
Hypoaesthesia 14.92 9.32 531 295967 178821 79269069
Cerebral mass effect 14.88 9.32 26 296472 1880 79446010
Brain stem haemorrhage 14.87 9.32 24 296474 1626 79446264
Device use error 14.85 9.32 4 296494 7097 79440793
Chills 14.83 9.32 468 296030 159766 79288124
Vasculitic rash 14.78 9.32 28 296470 2156 79445734
Embolic stroke 14.77 9.32 63 296435 7763 79440127
Hypotension 14.74 9.32 1423 295075 438894 79008996
Follicular mucinosis 14.64 9.32 5 296493 22 79447868
Uveitis 14.64 9.32 25 296473 16805 79431085
Clostridium test positive 14.62 9.32 55 296443 6399 79441491
Contraindication to medical treatment 14.61 9.32 21 296477 1285 79446605
Laryngeal pain 14.60 9.32 53 296445 6061 79441829
Urine phosphorus decreased 14.59 9.32 6 296492 48 79447842
Microcytic anaemia 14.58 9.32 48 296450 5226 79442664
Hypozincaemia 14.48 9.32 6 296492 49 79447841
Central nervous system lesion 14.47 9.32 17 296481 13351 79434539
Gastrointestinal toxicity 14.47 9.32 6 296492 8103 79439787
Hypocalciuria 14.46 9.32 5 296493 23 79447867
Parosmia 14.44 9.32 58 296440 6956 79440934
Complication of device insertion 14.42 9.32 3 296495 6347 79441543
Polyneuropathy 14.41 9.32 44 296454 24107 79423783
Colon cancer 14.41 9.32 98 296400 14425 79433465
Hypophagia 14.40 9.32 243 296255 45124 79402766
Product quality issue 14.36 9.32 71 296427 33869 79414021
Multiple organ dysfunction syndrome 14.36 9.32 565 295933 119681 79328209
Infusion site pain 14.32 9.32 19 296479 14157 79433733
Hepatic encephalopathy 14.25 9.32 145 296353 24021 79423869
Finger deformity 14.21 9.32 5 296493 7469 79440421
Blood parathyroid hormone decreased 14.20 9.32 11 296487 10525 79437365
Gallbladder injury 14.20 9.32 20 296478 1201 79446689
Breast cancer female 14.18 9.32 13 296485 11448 79436442
Substance abuse 14.18 9.32 11 296487 10515 79437375
Dermatitis acneiform 14.14 9.32 74 296424 9919 79437971
Heart rate irregular 14.04 9.32 68 296430 32611 79415279
Myasthenia gravis 14.03 9.32 76 296422 10323 79437567
Poor venous access 13.99 9.32 29 296469 18120 79429770
Pharyngeal oedema 13.95 9.32 106 296392 16166 79431724
Hepatorenal syndrome 13.90 9.32 41 296457 4208 79443682
Sedation complication 13.89 9.32 23 296475 15646 79432244
Tongue disorder 13.85 9.32 19 296479 13956 79433934
Premature delivery 13.83 9.32 43 296455 23424 79424466
Bile duct stone 13.81 9.32 49 296449 5540 79442350
Oesophageal anastomosis 13.80 9.32 3 296495 0 79447890
Putamen haemorrhage 13.77 9.32 13 296485 504 79447386
Autonomic neuropathy 13.71 9.32 25 296473 1870 79446020
Malignant melanoma 13.67 9.32 21 296477 14720 79433170
Bursitis 13.66 9.32 198 296300 35646 79412244
Phyllodes tumour 13.66 9.32 5 296493 28 79447862
Eye haemorrhage 13.63 9.32 72 296426 9685 79438205
Blood cholinesterase decreased 13.63 9.32 10 296488 271 79447619
Product prescribing error 13.61 9.32 104 296394 44709 79403181
Surgery 13.61 9.32 69 296429 32697 79415193
Rash morbilliform 13.59 9.32 52 296446 6098 79441792
Injury 13.59 9.32 381 296117 77115 79370775
Activated partial thromboplastin time prolonged 13.52 9.32 95 296403 14133 79433757
Blood lactic acid decreased 13.48 9.32 10 296488 276 79447614
Laboratory test abnormal 13.47 9.32 56 296442 27992 79419898
Blood glucose increased 13.44 9.32 539 295959 114436 79333454
Blood cholesterol increased 13.42 9.32 407 296091 83313 79364577
Granulocyte count increased 13.41 9.32 20 296478 1265 79446625
Fasciitis 13.40 9.32 16 296482 815 79447075
Secretion discharge 13.36 9.32 22 296476 15000 79432890
Regurgitation 13.33 9.32 31 296467 2756 79445134
Knee arthroplasty 13.31 9.32 100 296398 43148 79404742
Blood magnesium decreased 13.29 9.32 106 296392 16406 79431484
Peptic ulcer 13.25 9.32 52 296446 6171 79441719
Hypochloraemia 13.17 9.32 29 296469 2486 79445404
Rheumatoid factor increased 13.14 9.32 24 296474 1797 79446093
Drug tolerance 13.10 9.32 8 296490 8667 79439223
Underdose 13.10 9.32 71 296427 33080 79414810
Cerebral ventricular rupture 13.09 9.32 12 296486 448 79447442
Joint destruction 13.05 9.32 3 296495 5922 79441968
Sinus node dysfunction 13.02 9.32 60 296438 7641 79440249
Radiation pneumonitis 12.91 9.32 38 296460 3895 79443995
Cognitive disorder 12.89 9.32 346 296152 69580 79378310
Gastric ulcer haemorrhage 12.88 9.32 67 296431 8960 79438930
Cutaneous lupus erythematosus 12.86 9.32 32 296466 2971 79444919
Glomerular filtration rate increased 12.86 9.32 19 296479 1192 79446698
Feeling hot 12.85 9.32 151 296347 59583 79388307
Intestinal ischaemia 12.84 9.32 89 296409 13181 79434709
Lymphocyte count decreased 12.79 9.32 247 296251 47042 79400848
Renal artery stenosis 12.76 9.32 35 296463 3447 79444443
Coagulation test abnormal 12.72 9.32 20 296478 1325 79446565
Ischaemic nephropathy 12.72 9.32 5 296493 35 79447855
Sepsis 12.68 9.32 1165 295333 268263 79179627
Thrombotic cerebral infarction 12.66 9.32 13 296485 559 79447331
Product substitution issue 12.65 9.32 123 296375 20133 79427757
Discoloured vomit 12.65 9.32 21 296477 1457 79446433
Adverse event 12.65 9.32 153 296345 60061 79387829
Human herpesvirus 6 infection reactivation 12.61 9.32 13 296485 562 79447328
Injection site mass 12.60 9.32 36 296462 20148 79427742
Prostatic specific antigen increased 12.59 9.32 12 296486 10374 79437516
Drug tolerance decreased 12.51 9.32 18 296480 12960 79434930
Liver injury 12.48 9.32 287 296211 56327 79391563
Diffuse vasculitis 12.45 9.32 7 296491 118 79447772
Respiratory muscle weakness 12.45 9.32 10 296488 311 79447579
Hyperprolactinaemia 12.43 9.32 42 296456 4634 79443256
Joint dislocation 12.29 9.32 28 296470 16911 79430979
Restlessness 12.26 9.32 112 296386 46380 79401510
Drug dose omission by device 12.20 9.32 4 296494 6246 79441644
Drug level below therapeutic 12.19 9.32 11 296487 9759 79438131
Hypoalbuminaemia 12.18 9.32 127 296371 21170 79426720
Intentional dose omission 12.15 9.32 9 296489 8808 79439082
Wheezing 12.08 9.32 540 295958 116124 79331766
Product dose omission in error 12.02 9.32 7 296491 7781 79440109
Vulval haemorrhage 12.02 9.32 4 296494 16 79447874
Vascular skin disorder 12.02 9.32 4 296494 16 79447874
Upper limb fracture 12.01 9.32 31 296467 17936 79429954
Oculomucocutaneous syndrome 11.97 9.32 10 296488 329 79447561
Rash maculo-papular 11.97 9.32 283 296215 55795 79392095
N-telopeptide urine increased 11.94 9.32 5 296493 42 79447848
Gastrointestinal polyp haemorrhage 11.94 9.32 12 296486 503 79447387
Generalised bullous fixed drug eruption 11.93 9.32 8 296490 187 79447703
Strangury 11.93 9.32 8 296490 187 79447703
Cardiac septal defect 11.90 9.32 10 296488 332 79447558
Flushing 11.87 9.32 244 296254 88024 79359866
Transplant dysfunction 11.86 9.32 6 296492 7215 79440675
Inflammatory bowel disease 11.85 9.32 47 296451 5604 79442286
Gastrointestinal haemorrhage 11.83 9.32 667 295831 147052 79300838
Metabolic disorder 11.83 9.32 10 296488 9160 79438730
General physical health deterioration 11.83 9.32 872 295626 274366 79173524
Paradoxical drug reaction 11.76 9.32 6 296492 7179 79440711
Sinobronchitis 11.74 9.32 5 296493 44 79447846
Herpes zoster 11.74 9.32 260 296238 92823 79355067
Anti A antibody 11.73 9.32 3 296495 3 79447887
Diabetic metabolic decompensation 11.72 9.32 33 296465 3299 79444591
Mouth haemorrhage 11.70 9.32 75 296423 10824 79437066
Violence-related symptom 11.67 9.32 14 296484 717 79447173
Dialysis hypotension 11.65 9.32 6 296492 84 79447806
Procedural failure 11.65 9.32 6 296492 84 79447806
Laryngotracheal oedema 11.65 9.32 5 296493 45 79447845
Dyslalia 11.64 9.32 17 296481 1055 79446835
Aphasia 11.61 9.32 241 296257 46491 79401399
Burning feet syndrome 11.61 9.32 8 296490 196 79447694
Mesenteric artery embolism 11.59 9.32 6 296492 85 79447805
Cardiac output increased 11.57 9.32 9 296489 267 79447623
Oral mucosal discolouration 11.55 9.32 10 296488 346 79447544
Muscle spasticity 11.52 9.32 41 296457 21434 79426456
Bronchitis 11.51 9.32 384 296114 130260 79317630
Sluggishness 11.50 9.32 5 296493 6567 79441323
Immobilisation syndrome 11.50 9.32 12 296486 526 79447364
Lymphangiosis carcinomatosa 11.47 9.32 25 296473 2129 79445761
Pharyngotonsillitis 11.43 9.32 9 296489 272 79447618
Vitamin B12 increased 11.42 9.32 18 296480 1195 79446695
Progressive multifocal leukoencephalopathy 11.39 9.32 122 296376 20478 79427412
Hyperleukocytosis 11.38 9.32 28 296470 2582 79445308
Urine calcium/creatinine ratio increased 11.35 9.32 7 296491 141 79447749
Lip blister 11.34 9.32 29 296469 2738 79445152
Pre-eclampsia 11.34 9.32 6 296492 7035 79440855
Middle insomnia 11.30 9.32 27 296471 16042 79431848
Congenital bowing of long bones 11.30 9.32 4 296494 20 79447870
Incision site complication 11.29 9.32 14 296484 742 79447148
Urinary straining 11.28 9.32 5 296493 49 79447841
Lacunar infarction 11.27 9.32 48 296450 5909 79441981
Muscle atrophy 11.27 9.32 76 296422 11156 79436734
Pressure of speech 11.26 9.32 18 296480 1210 79446680
Cough 11.22 9.32 1193 295305 365596 79082294
Rectal ulcer haemorrhage 11.20 9.32 9 296489 280 79447610
Blood pressure abnormal 11.18 9.32 30 296468 17139 79430751
Osteoporosis 11.17 9.32 138 296360 53974 79393916
Hypoperfusion 11.17 9.32 28 296470 2611 79445279
Injection site warmth 11.13 9.32 24 296474 14783 79433107
X-ray abnormal 11.13 9.32 47 296451 5766 79442124
Vaginal cellulitis 11.12 9.32 6 296492 93 79447797
Gastritis bacterial 11.07 9.32 10 296488 366 79447524
Airway remodelling 11.07 9.32 9 296489 285 79447605
Rapid eye movement sleep behaviour disorder 11.06 9.32 11 296487 455 79447435
Glomerulosclerosis 11.06 9.32 17 296481 1105 79446785
Hypophosphataemia 11.04 9.32 118 296380 19795 79428095
Pneumocystis jirovecii pneumonia 11.01 9.32 176 296322 32332 79415558
Lymphocyte stimulation test positive 10.93 9.32 17 296481 1116 79446774
Rash papulosquamous 10.89 9.32 7 296491 152 79447738
Haemodynamic instability 10.86 9.32 31 296467 17351 79430539
Autoimmune hepatitis 10.81 9.32 78 296420 11705 79436185
Heat illness 10.81 9.32 12 296486 565 79447325
Product preparation error 10.81 9.32 4 296494 5789 79442101
Therapeutic response unexpected 10.76 9.32 38 296460 19908 79427982
Stevens-Johnson syndrome 10.74 9.32 205 296293 38961 79408929
Gastroenteritis staphylococcal 10.70 9.32 9 296489 299 79447591
Post cardiac arrest syndrome 10.70 9.32 4 296494 24 79447866
Coeliac disease 10.69 9.32 16 296482 11335 79436555
Parakeratosis 10.67 9.32 10 296488 384 79447506
Oral candidiasis 10.64 9.32 162 296336 29466 79418424
Morbid thoughts 10.63 9.32 14 296484 788 79447102
Gastroenteritis 10.61 9.32 182 296316 33900 79413990
Localised infection 10.58 9.32 89 296409 37486 79410404
Blood phosphorus decreased 10.58 9.32 51 296447 6617 79441273
Aortic aneurysm rupture 10.55 9.32 18 296480 1277 79446613
Procedural pain 10.53 9.32 47 296451 23037 79424853
Device leakage 10.52 9.32 15 296483 10841 79437049
Injection site rash 10.51 9.32 33 296465 17921 79429969
Respiratory depression 10.47 9.32 60 296438 27570 79420320
Acanthosis 10.43 9.32 11 296487 488 79447402
Acute myocardial infarction 10.41 9.32 367 296131 76669 79371221
Akathisia 10.38 9.32 21 296477 13238 79434652
Glossitis 10.36 9.32 34 296464 3696 79444194
Blood urea increased 10.34 9.32 246 296252 48544 79399346
Gingival pain 10.33 9.32 63 296435 8935 79438955
Oesophageal carcinoma recurrent 10.32 9.32 5 296493 61 79447829
Gastrointestinal stoma output increased 10.31 9.32 10 296488 401 79447489
Tongue discolouration 10.29 9.32 34 296464 3709 79444181
Hallucination, visual 10.27 9.32 175 296323 32554 79415336
Oedema 10.18 9.32 543 295955 119037 79328853
Blood loss anaemia 10.16 9.32 27 296471 15471 79432419
Abortion induced 10.13 9.32 7 296491 7102 79440788
Helicobacter test positive 10.12 9.32 18 296480 1320 79446570
Plasma cell myeloma recurrent 10.12 9.32 3 296495 4998 79442892
Oropharyngeal swelling 10.10 9.32 18 296480 1322 79446568
Cystitis noninfective 10.10 9.32 18 296480 1322 79446568
Meniere's disease 10.10 9.32 7 296491 173 79447717
Aspiration 10.06 9.32 117 296381 20041 79427849
Periprosthetic fracture 10.04 9.32 12 296486 612 79447278
Cardiogenic shock 10.03 9.32 215 296283 41699 79406191
Narrow anterior chamber angle 10.03 9.32 7 296491 175 79447715
Blood iron decreased 10.03 9.32 27 296471 15407 79432483
Rectocele 10.02 9.32 12 296486 613 79447277
Adenocarcinoma gastric 10.02 9.32 21 296477 1740 79446150
Mucormycosis 10.02 9.32 10 296488 8459 79439431
Gastrointestinal infection 9.99 9.32 17 296481 11444 79436446
Abnormal faeces 9.99 9.32 55 296443 7516 79440374
Duodenal polyp 9.98 9.32 9 296489 329 79447561
Tumour haemorrhage 9.96 9.32 36 296462 4108 79443782
Joint effusion 9.93 9.32 34 296464 17980 79429910
Fat redistribution 9.90 9.32 6 296492 117 79447773
Frustration tolerance decreased 9.90 9.32 8 296490 7494 79440396
Acute graft versus host disease 9.90 9.32 14 296484 10153 79437737
Abdominal discomfort 9.89 9.32 800 295698 249927 79197963
Small intestinal haemorrhage 9.87 9.32 36 296462 4127 79443763
Cholelithiasis 9.82 9.32 261 296237 52403 79395487
Rash vesicular 9.82 9.32 46 296452 5899 79441991
Cytomegalovirus test positive 9.81 9.32 46 296452 5901 79441989
Nasal mucosal erosion 9.78 9.32 5 296493 69 79447821
Hepatic cancer metastatic 9.77 9.32 14 296484 854 79447036
Renal disorder 9.77 9.32 215 296283 41890 79406000
Thrombosis 9.74 9.32 238 296260 83862 79364028
Paramnesia 9.72 9.32 4 296494 32 79447858
Dissociation 9.72 9.32 35 296463 3986 79443904
Hepatic atrophy 9.72 9.32 10 296488 431 79447459
Respiratory tract oedema 9.70 9.32 14 296484 860 79447030
Drug-induced liver injury 9.70 9.32 318 296180 65799 79382091
Multiple sclerosis 9.68 9.32 126 296372 22156 79425734
Ulcer 9.68 9.32 161 296337 29811 79418079
Culture throat positive 9.67 9.32 3 296495 9 79447881
Erythema annulare 9.66 9.32 7 296491 186 79447704
Body temperature increased 9.66 9.32 112 296386 44308 79403582
Dysuria 9.64 9.32 253 296245 50698 79397192
Dermatitis atopic 9.64 9.32 14 296484 10042 79437848
Gamma-glutamyltransferase increased 9.63 9.32 269 296229 54411 79393479
Gynaecomastia 9.61 9.32 55 296443 7626 79440264
Gallbladder hypofunction 9.60 9.32 11 296487 536 79447354
Deformity 9.58 9.32 13 296485 9592 79438298
Atrioventricular block second degree 9.57 9.32 53 296445 7259 79440631
Analgesic therapy 9.54 9.32 15 296483 994 79446896
Tenosynovitis 9.52 9.32 28 296470 15526 79432364
Cerebral hyperperfusion syndrome 9.51 9.32 6 296492 126 79447764
Migraine 9.50 9.32 407 296091 87086 79360804
Feeling jittery 9.50 9.32 21 296477 12820 79435070
Bronchiectasis 9.48 9.32 126 296372 22260 79425630
Injection site urticaria 9.47 9.32 21 296477 12805 79435085
Sterile pyuria 9.47 9.32 5 296493 74 79447816
Posterior reversible encephalopathy syndrome 9.46 9.32 58 296440 26223 79421667
Cushingoid 9.45 9.32 13 296485 9539 79438351
Hyperammonaemic encephalopathy 9.44 9.32 3 296495 4779 79443111
Adjustment disorder with depressed mood 9.43 9.32 62 296436 9024 79438866
Periorbital discomfort 9.41 9.32 4 296494 35 79447855
Blood electrolytes increased 9.41 9.32 5 296493 75 79447815
Hypoglycaemia 9.40 9.32 465 296033 101129 79346761
Pancreatic carcinoma metastatic 9.36 9.32 33 296465 3720 79444170
Excessive eye blinking 9.35 9.32 20 296478 1681 79446209
Vitamin B1 decreased 9.34 9.32 11 296487 552 79447338

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 | Suggest Off label Use Form| |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
ATP-binding cassette sub-family G member 2 Transporter IC50 4.84 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 0093-3008 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 0093-3009 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 0093-7350 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
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
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
Prevacid 24 HR HUMAN OTC DRUG LABEL 1 0113-6117 CAPSULE, DELAYED RELEASE 15 mg ORAL NDA 15 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 0363-0037 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 15 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0363-0739 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 15 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0363-0739 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 0363-1212 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 0363-1419 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