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 948.67 9.36 908 182282 41148 56067729
Drug ineffective 663.90 9.36 1244 181946 917745 55191132
Hyponatraemia 414.25 9.36 981 182209 101158 56007719
Renal injury 409.96 9.36 291 182899 8596 56100281
Colitis microscopic 358.96 9.36 256 182934 7619 56101258
Acute kidney injury 337.82 9.36 1614 181576 239149 55869728
End stage renal disease 309.69 9.36 212 182978 5899 56102978
Rheumatoid arthritis 292.28 9.36 498 182692 382106 55726771
Completed suicide 269.20 9.36 54 183136 133779 55975098
Drug intolerance 233.62 9.36 312 182878 264506 55844371
Contraindicated product administered 210.59 9.36 178 183012 186108 55922769
Hypomagnesaemia 191.44 9.36 314 182876 24701 56084176
Fatigue 185.79 9.36 1659 181531 786893 55321984
Therapeutic product effect incomplete 185.64 9.36 57 183133 105974 56002903
Product dose omission issue 176.68 9.36 245 182945 204508 55904369
Pain 170.06 9.36 1364 181826 661820 55447057
Off label use 162.05 9.36 1103 182087 555077 55553800
Renal failure 160.59 9.36 749 182441 109751 55999126
Arthropathy 159.78 9.36 253 182937 200022 55908855
Alopecia 155.29 9.36 466 182724 292992 55815885
Subacute cutaneous lupus erythematosus 154.58 9.36 96 183094 2253 56106624
Death 150.94 9.36 586 182604 340840 55768037
Pemphigus 149.19 9.36 175 183015 157037 55951840
Treatment failure 143.87 9.36 207 182983 170185 55938692
Maternal exposure during pregnancy 140.53 9.36 251 182939 189302 55919575
Synovitis 140.13 9.36 192 182998 161113 55947764
Systemic lupus erythematosus 133.90 9.36 238 182952 179840 55929037
Joint swelling 125.08 9.36 502 182688 289298 55819579
Therapeutic product effect decreased 120.60 9.36 230 182960 169222 55939655
Hypertensive nephropathy 119.72 9.36 50 183140 484 56108393
Hepatic function abnormal 107.89 9.36 301 182889 34257 56074620
Neutropenic sepsis 107.36 9.36 184 183006 15001 56093876
Cerebral infarction 104.23 9.36 228 182962 22277 56086600
Interstitial lung disease 102.96 9.36 413 182777 56650 56052227
Gastrooesophageal reflux disease 101.49 9.36 537 182653 82720 56026157
Abdominal discomfort 100.62 9.36 512 182678 276762 55832115
Melaena 98.97 9.36 257 182933 28033 56080844
Hand deformity 98.82 9.36 179 183011 134313 55974564
Toxicity to various agents 98.74 9.36 386 182804 224178 55884699
Product use issue 98.60 9.36 295 182895 185746 55923131
Exposure during pregnancy 97.92 9.36 184 183006 136158 55972719
Glossodynia 94.22 9.36 224 182966 152234 55956643
Renal impairment 91.90 9.36 511 182679 80202 56028675
Hypokalaemia 91.49 9.36 573 182617 93864 56015013
Abdominal pain 89.45 9.36 1258 181932 257547 55851330
Haematemesis 89.30 9.36 250 182940 28508 56080369
Chest pain 86.73 9.36 972 182218 188825 55920052
Electric shock 85.63 9.36 50 183140 1045 56107832
Injection site pain 80.67 9.36 162 183028 116956 55991921
Swollen tongue 80.21 9.36 249 182941 30075 56078802
Arthralgia 76.43 9.36 1161 182029 500508 55608369
Tubulointerstitial nephritis 76.22 9.36 168 183022 16497 56092380
Swelling 75.38 9.36 464 182726 239307 55869570
Device expulsion 73.56 9.36 7 183183 30442 56078435
Nephrogenic anaemia 73.48 9.36 56 183134 1848 56107029
Diabetic nephropathy 73.11 9.36 49 183141 1315 56107562
Cholecystitis chronic 72.73 9.36 121 183069 9627 56099250
Electrocardiogram QT prolonged 69.20 9.36 356 182834 54232 56054645
Loss of personal independence in daily activities 67.49 9.36 100 183090 81269 56027608
Nephropathy 67.12 9.36 87 183103 5522 56103355
Psoriasis 65.74 9.36 126 183064 92566 56016311
Sinusitis 64.91 9.36 377 182813 197204 55911673
Peripheral swelling 64.87 9.36 472 182718 234254 55874623
Anti-cyclic citrullinated peptide antibody positive 64.85 9.36 140 183050 98460 56010417
Hypocalcaemia 63.38 9.36 222 182968 28538 56080339
Infective pulmonary exacerbation of cystic fibrosis 60.52 9.36 101 183089 8056 56100821
Labile blood pressure 59.27 9.36 47 183143 1646 56107231
Rebound acid hypersecretion 59.01 9.36 26 183164 290 56108587
Drug hypersensitivity 58.77 9.36 592 182598 274613 55834264
Infusion related reaction 58.75 9.36 418 182772 208513 55900364
Drug abuse 58.13 9.36 81 183109 67529 56041348
Wound 57.55 9.36 244 182946 138560 55970317
Hepatic enzyme increased 57.36 9.36 325 182865 171059 55937818
Gastritis 56.19 9.36 243 182947 34459 56074418
Cholestasis 56.11 9.36 204 182986 26709 56082168
Confusional state 55.54 9.36 969 182221 207186 55901691
Faeces discoloured 53.99 9.36 149 183041 16847 56092030
Angioedema 53.00 9.36 271 182919 41182 56067695
Weight increased 52.89 9.36 485 182705 229218 55879659
Intervertebral discitis 52.88 9.36 55 183135 2752 56106125
Hepatocellular injury 52.78 9.36 198 182992 26316 56082561
Agranulocytosis 51.75 9.36 177 183013 22482 56086395
COVID-19 51.51 9.36 104 183086 74954 56033923
Foetal exposure during pregnancy 51.08 9.36 23 183167 33800 56075077
Sopor 50.95 9.36 167 183023 20755 56088122
International normalised ratio increased 50.89 9.36 280 182910 43761 56065116
Lip swelling 50.49 9.36 194 182996 26078 56082799
Vomiting 50.40 9.36 2040 181150 496188 55612689
Swelling face 48.66 9.36 331 182859 55738 56053139
Lethargy 48.47 9.36 310 182880 51131 56057746
Rectal haemorrhage 48.16 9.36 264 182926 41203 56067674
Discomfort 47.87 9.36 268 182922 141493 55967384
Anaemia 46.69 9.36 1170 182020 266341 55842536
Accidental exposure to product 45.42 9.36 12 183178 24635 56084242
Dysphagia 45.09 9.36 436 182754 81511 56027366
Urticaria 45.07 9.36 691 182499 143985 55964892
Lower respiratory tract infection 44.94 9.36 571 182619 114223 55994654
Liver function test abnormal 44.75 9.36 278 182912 45393 56063484
Hyperglycaemia 43.97 9.36 243 182947 38038 56070839
Brain stem glioma 42.73 9.36 19 183171 217 56108660
Biliary dyskinesia 42.61 9.36 47 183143 2516 56106361
Neutrophil count decreased 42.56 9.36 293 182897 49529 56059348
Drug interaction 41.96 9.36 935 182255 208820 55900057
Jaundice 41.81 9.36 188 183002 27106 56081771
Injection site pruritus 41.56 9.36 45 183145 41886 56066991
Circulatory collapse 41.12 9.36 155 183035 20648 56088229
Injection site reaction 40.78 9.36 69 183121 53178 56055699
Upper respiratory tract inflammation 40.45 9.36 45 183145 2432 56106445
Coordination abnormal 40.44 9.36 111 183079 12510 56096367
Coma scale abnormal 39.87 9.36 63 183127 4800 56104077
Injection site swelling 39.71 9.36 50 183140 43528 56065349
Therapy interrupted 39.37 9.36 17 183173 25608 56083269
Anaphylactic reaction 39.18 9.36 327 182863 58668 56050209
Rheumatoid factor positive 39.12 9.36 106 183084 68954 56039923
Post-traumatic stress disorder 38.89 9.36 60 183130 4478 56104399
Hypophosphataemic osteomalacia 38.21 9.36 16 183174 156 56108721
Basilar artery occlusion 37.69 9.36 14 183176 96 56108781
Nasopharyngitis 37.52 9.36 500 182690 220459 55888418
Hepatic ischaemia 37.52 9.36 24 183166 594 56108283
Nephrocalcinosis 37.31 9.36 29 183161 986 56107891
Reflux gastritis 37.12 9.36 30 183160 1080 56107797
Pericarditis 36.72 9.36 206 182984 108717 56000160
Injection site erythema 36.01 9.36 130 183060 77318 56031559
Hypersensitivity 35.70 9.36 603 182587 255805 55853072
Renal tubular acidosis 35.10 9.36 34 183156 1561 56107316
Blood alkaline phosphatase increased 35.04 9.36 232 182958 38713 56070164
Hepatorenal syndrome 34.90 9.36 36 183154 1784 56107093
Red blood cell sedimentation rate abnormal 34.59 9.36 9 183181 18664 56090213
Facet joint syndrome 34.51 9.36 71 183119 6646 56102231
Coronary artery disease 34.38 9.36 194 182996 30602 56078275
Disseminated intravascular coagulation 34.31 9.36 132 183058 17753 56091124
Oesophagitis 34.04 9.36 112 183078 13945 56094932
Deep vein thrombosis postoperative 34.03 9.36 53 183137 3988 56104889
Wrong technique in product usage process 33.92 9.36 88 183102 58080 56050797
Inappropriate schedule of product administration 33.68 9.36 148 183042 83239 56025638
Urine magnesium decreased 33.12 9.36 7 183183 0 56108877
Skin candida 33.08 9.36 31 183159 1365 56107512
Erythema multiforme 32.60 9.36 86 183104 9468 56099409
Lip dry 32.55 9.36 87 183103 9653 56099224
Mobility decreased 32.41 9.36 189 183001 98802 56010075
Hyperkalaemia 32.22 9.36 279 182911 50586 56058291
Therapeutic response decreased 32.17 9.36 78 183112 52680 56056197
Therapy cessation 32.07 9.36 25 183165 27239 56081638
Adrenal insufficiency 31.89 9.36 118 183072 15579 56093298
Suicide attempt 31.84 9.36 90 183100 57746 56051131
Somatic delusion 31.75 9.36 21 183169 551 56108326
Syncope 31.49 9.36 511 182679 107688 56001189
Blood sodium decreased 31.38 9.36 150 183040 22184 56086693
Demyelination 30.78 9.36 65 183125 6197 56102680
Hypergastrinaemia 30.72 9.36 12 183178 96 56108781
Intentional overdose 30.58 9.36 116 183074 68001 56040876
Abortion spontaneous 30.55 9.36 60 183130 43693 56065184
Pemphigoid 30.51 9.36 65 183125 6235 56102642
Hospitalisation 30.36 9.36 133 183057 74867 56034010
Device dislocation 30.23 9.36 18 183172 22588 56086289
Decreased appetite 30.10 9.36 930 182260 218301 55890576
Altered state of consciousness 29.77 9.36 151 183039 22870 56086007
Haemorrhage subcutaneous 29.66 9.36 41 183149 2769 56106108
Drug resistance 29.44 9.36 15 183175 20527 56088350
Drug reaction with eosinophilia and systemic symptoms 29.40 9.36 184 183006 30120 56078757
Intentional product use issue 29.25 9.36 197 182993 99536 56009341
Post viral fatigue syndrome 29.18 9.36 16 183174 295 56108582
Pneumonia bacterial 29.18 9.36 74 183116 7954 56100923
Hiatus hernia 29.09 9.36 134 183056 19518 56089359
Liver disorder 28.96 9.36 245 182945 44125 56064752
Subarachnoid haemorrhage 28.92 9.36 92 183098 11255 56097622
Psoriatic arthropathy 28.90 9.36 133 183057 73875 56035002
Dry mouth 28.90 9.36 328 182862 63877 56045000
Iron deficiency anaemia 28.64 9.36 125 183065 17794 56091083
Deep vein thrombosis 28.48 9.36 379 182811 76598 56032279
Urine phosphorus decreased 28.39 9.36 6 183184 0 56108877
Temperature intolerance 28.07 9.36 73 183117 7967 56100910
Pituitary tumour benign 28.06 9.36 33 183157 1895 56106982
Platelet count decreased 27.89 9.36 494 182696 105889 56002988
Progressive multifocal leukoencephalopathy 27.57 9.36 94 183096 11919 56096958
Hyperchlorhydria 27.51 9.36 30 183160 1585 56107292
Cardiac failure 27.46 9.36 397 182793 81696 56027181
Urine potassium decreased 27.36 9.36 7 183183 9 56108868
Gastrointestinal haemorrhage 27.30 9.36 372 182818 75579 56033298
Urine output decreased 27.12 9.36 87 183103 10690 56098187
Gastric polyps 27.01 9.36 42 183148 3156 56105721
Macular degeneration 26.81 9.36 14 183176 18894 56089983
Condition aggravated 26.30 9.36 889 182301 344009 55764868
Haematuria 26.26 9.36 164 183026 26823 56082054
Peripheral venous disease 25.94 9.36 82 183108 9997 56098880
Rectal ulcer 25.93 9.36 25 183165 1141 56107736
Upper gastrointestinal haemorrhage 25.77 9.36 117 183073 16937 56091940
Premature delivery 25.77 9.36 30 183160 27030 56081847
Red blood cell sedimentation rate increased 25.76 9.36 50 183140 36573 56072304
Renal atrophy 25.71 9.36 27 183163 1366 56107511
Angina pectoris 25.37 9.36 167 183023 27809 56081068
Toxic skin eruption 25.33 9.36 90 183100 11649 56097228
Gastric ulcer 25.10 9.36 142 183048 22421 56086456
Drug ineffective for unapproved indication 24.99 9.36 28 183162 25665 56083212
Dermatitis exfoliative 24.89 9.36 54 183136 5245 56103632
Erythema dyschromicum perstans 24.83 9.36 9 183181 57 56108820
Injury 24.39 9.36 300 182890 59551 56049326
Mixed liver injury 24.29 9.36 45 183145 3899 56104978
Crohn's disease 24.15 9.36 60 183130 6367 56102510
Dysuria 24.08 9.36 177 183013 30552 56078325
Gallbladder disorder 24.05 9.36 116 183074 17218 56091659
Adverse drug reaction 23.71 9.36 120 183070 65012 56043865
Cerebral haemorrhage 23.70 9.36 167 183023 28439 56080438
Hypersensitivity pneumonitis 23.42 9.36 34 183156 2403 56106474
Pancreatitis 23.40 9.36 237 182953 44843 56064034
Laryngeal pain 23.34 9.36 46 183144 4174 56104703
Dyspepsia 23.09 9.36 391 182799 83080 56025797
Product use in unapproved indication 23.04 9.36 321 182869 140501 55968376
Hyperprolactinaemia 22.84 9.36 42 183148 3619 56105258
Dermatitis bullous 22.69 9.36 65 183125 7508 56101369
Dehydration 22.65 9.36 677 182513 158148 55950729
Infection 22.57 9.36 488 182702 199718 55909159
Orthostatic hypotension 22.56 9.36 185 183005 33014 56075863
Abnormal loss of weight 22.53 9.36 52 183138 5264 56103613
Neuropathy, ataxia, retinitis pigmentosa syndrome 22.44 9.36 8 183182 48 56108829
Hyperparathyroidism secondary 22.43 9.36 25 183165 1354 56107523
Foot deformity 22.06 9.36 27 183163 23798 56085079
Muscle relaxant therapy 22.02 9.36 11 183179 166 56108711
Injection site bruising 21.91 9.36 59 183131 38462 56070415
Bradycardia 21.61 9.36 324 182866 67180 56041697
Nasal congestion 21.59 9.36 102 183088 56268 56052609
Product storage error 21.55 9.36 8 183182 13205 56095672
Inappropriate antidiuretic hormone secretion 21.25 9.36 95 183095 13661 56095216
Joint stiffness 21.11 9.36 53 183137 35372 56073505
Flashback 21.07 9.36 10 183180 134 56108743
Oropharyngeal oedema 21.05 9.36 13 183177 302 56108575
Oedema peripheral 21.03 9.36 717 182473 170537 55938340
Blood lactic acid 20.95 9.36 9 183181 94 56108783
Oesophageal mucosal tear 20.92 9.36 6 183184 15 56108862
Sedation 20.88 9.36 52 183138 34802 56074075
Hepatotoxicity 20.66 9.36 44 183146 31109 56077768
Rapid eye movement sleep behaviour disorder 20.65 9.36 11 183179 191 56108686
Gastric dysplasia 20.64 9.36 6 183184 16 56108861
Acne 20.59 9.36 23 183167 21113 56087764
Multiple sclerosis relapse 20.46 9.36 76 183114 44827 56064050
Cholecystitis 20.32 9.36 97 183093 14338 56094539
Pneumocystis jirovecii pneumonia 20.31 9.36 103 183087 15598 56093279
Pressure of speech 20.31 9.36 16 183174 555 56108322
Eosinophilia 20.16 9.36 123 183067 19954 56088923
Malaise 20.05 9.36 1422 181768 366438 55742439
Blood pressure decreased 19.91 9.36 286 182904 58764 56050113
Aphasia 19.87 9.36 168 183022 30247 56078630
Carcinoid tumour of the stomach 19.84 9.36 10 183180 154 56108723
Cholelithiasis 19.78 9.36 206 182984 39258 56069619
Dialysis 19.76 9.36 73 183117 9629 56099248
Rheumatoid nodule 19.63 9.36 12 183178 14845 56094032
Chromaturia 19.45 9.36 100 183090 15225 56093652
Aspiration 19.27 9.36 72 183118 9549 56099328
Diarrhoea 19.21 9.36 2365 180825 636142 55472735
Alanine aminotransferase increased 19.17 9.36 419 182771 93243 56015634
Activated partial thromboplastin time prolonged 19.08 9.36 56 183134 6556 56102321
Full blood count decreased 19.06 9.36 29 183161 23320 56085557
Product substitution issue 19.04 9.36 96 183094 14503 56094374
No adverse event 19.01 9.36 58 183132 36316 56072561
Stress 19.00 9.36 113 183077 58797 56050080
Superinfection 18.85 9.36 29 183161 2159 56106718
Gastrointestinal motility disorder 18.82 9.36 45 183145 4661 56104216
Purpura 18.68 9.36 75 183115 10287 56098590
Hypocalciuria 18.54 9.36 5 183185 9 56108868
Anal prolapse 18.50 9.36 8 183182 85 56108792
Hypoglycaemic coma 18.49 9.36 30 183160 2337 56106540
Enterocolitis 18.47 9.36 58 183132 7046 56101831
Device difficult to use 18.44 9.36 6 183184 10755 56098122
Infusion site streaking 18.42 9.36 14 183176 460 56108417
Abdominal pain upper 18.37 9.36 732 182458 177581 55931296
Neoplasm progression 18.23 9.36 49 183141 31967 56076910
Injection site warmth 18.14 9.36 12 183178 14231 56094646
Stoma site haemorrhage 18.13 9.36 19 183171 959 56107918
Poisoning deliberate 18.05 9.36 5 183185 9948 56098929
Gastric cancer 18.04 9.36 40 183150 3943 56104934
Enteritis infectious 17.88 9.36 27 183163 1977 56106900
Mediastinitis 17.88 9.36 10 183180 192 56108685
Cholecystitis acute 17.88 9.36 59 183131 7357 56101520
Face oedema 17.87 9.36 112 183078 18340 56090537
Enterochromaffin cell hyperplasia 17.81 9.36 7 183183 57 56108820
Wheezing 17.78 9.36 343 182847 74683 56034194
Biliary sepsis 17.71 9.36 18 183172 876 56108001
Autoimmune disorder 17.70 9.36 67 183123 8942 56099935
Rash erythematous 17.59 9.36 192 182998 37029 56071848
Intestinal ischaemia 17.37 9.36 56 183134 6899 56101978
Genitourinary symptom 17.20 9.36 7 183183 63 56108814
Deformity 17.08 9.36 6 183184 10249 56098628
Pancreatitis acute 17.07 9.36 140 183050 24984 56083893
Vulvovaginal candidiasis 17.07 9.36 33 183157 2953 56105924
Palpitations 17.06 9.36 435 182755 99237 56009640
Excessive eye blinking 17.03 9.36 19 183171 1030 56107847
Haemoptysis 16.98 9.36 146 183044 26414 56082463
Azotaemia 16.89 9.36 40 183150 4118 56104759
Gallbladder injury 16.88 9.36 21 183169 1279 56107598
Blood triglycerides increased 16.82 9.36 79 183111 11598 56097279
Eye haemorrhage 16.79 9.36 60 183130 7787 56101090
Musculoskeletal stiffness 16.79 9.36 383 182807 155624 55953253
Non-economic loss 16.77 9.36 5 183185 15 56108862
Enthesopathy 16.74 9.36 3 183187 8060 56100817
Hyponatraemic syndrome 16.72 9.36 14 183176 530 56108347
Influenza 16.72 9.36 214 182976 95047 56013830
Generalised bullous fixed drug eruption 16.65 9.36 7 183183 69 56108808
Hypochloraemia 16.62 9.36 24 183166 1688 56107189
Gastroenteritis 16.57 9.36 136 183054 24276 56084601
Ileus 16.53 9.36 89 183101 13793 56095084
Hypophosphataemia 16.52 9.36 69 183121 9633 56099244
Musculoskeletal disorder 16.39 9.36 23 183167 19124 56089753
Blood pressure increased 16.31 9.36 354 182836 144822 55964055
Acute coronary syndrome 16.27 9.36 69 183121 9699 56099178
Nightmare 16.21 9.36 102 183088 16724 56092153
Ulcer 16.20 9.36 127 183063 22358 56086519
Mouth swelling 16.20 9.36 39 183151 4058 56104819
Foetal death 16.17 9.36 4 183186 8583 56100294
Neuropathy peripheral 16.16 9.36 444 182746 102449 56006428
Total lung capacity decreased 16.13 9.36 22 183168 1467 56107410
Inflammatory bowel disease 16.13 9.36 37 183153 3731 56105146
Myocardial ischaemia 16.04 9.36 80 183110 12036 56096841
Panniculitis 15.98 9.36 6 183184 9836 56099041
Pulmonary embolism 15.91 9.36 459 182731 106665 56002212
Cardioactive drug level increased 15.86 9.36 26 183164 2043 56106834
Knee arthroplasty 15.85 9.36 82 183108 44177 56064700
Narrow anterior chamber angle 15.69 9.36 6 183184 45 56108832
Genital ulceration 15.64 9.36 13 183177 487 56108390
Product quality issue 15.60 9.36 52 183138 31684 56077193
Secondary adrenocortical insufficiency 15.54 9.36 20 183170 1260 56107617
Sinus bradycardia 15.44 9.36 86 183104 13500 56095377
Transient ischaemic attack 15.31 9.36 172 183018 33405 56075472
Dizziness 15.31 9.36 1422 181768 374718 55734159
Emotional distress 15.22 9.36 156 183034 29607 56079270
Pain in extremity 15.19 9.36 802 182388 296629 55812248
Respiratory arrest 15.18 9.36 50 183140 30575 56078302
Oral mucosal discolouration 15.03 9.36 11 183179 341 56108536
Hallucination 15.00 9.36 234 182956 48915 56059962
Erythema annulare 14.94 9.36 7 183183 91 56108786
Vascular skin disorder 14.90 9.36 4 183186 7 56108870
Lung opacity 14.78 9.36 27 183163 2314 56106563
Hemiparesis 14.73 9.36 120 183070 21370 56087507
Rhinorrhoea 14.63 9.36 117 183073 56920 56051957
Palmar erythema 14.63 9.36 22 183168 1605 56107272
Hypophagia 14.60 9.36 151 183039 28725 56080152
Asthma 14.56 9.36 475 182715 112295 55996582
Paramnesia 14.56 9.36 4 183186 8 56108869
Gastrointestinal stoma output decreased 14.56 9.36 6 183184 56 56108821
Haemodialysis 14.55 9.36 61 183129 8530 56100347
Immune thrombocytopenia 14.52 9.36 66 183124 9559 56099318
Intentional self-injury 14.42 9.36 38 183152 24954 56083923
Oesophageal carcinoma recurrent 14.31 9.36 5 183185 28 56108849
Pleuritic pain 14.29 9.36 53 183137 7004 56101873
Aortic valve calcification 14.27 9.36 12 183178 457 56108420
Nervous system disorder 14.23 9.36 99 183091 16790 56092087
Urine output 14.19 9.36 3 183187 0 56108877
Renal cyst 14.17 9.36 64 183126 9245 56099632
Hip fracture 14.10 9.36 43 183147 26930 56081947
Sleep disorder due to a general medical condition 14.01 9.36 6 183184 9084 56099793
Colon cancer 14.00 9.36 65 183125 9496 56099381
White blood cell count increased 14 9.36 214 182976 44545 56064332
Renal haemangioma 13.89 9.36 5 183185 31 56108846
Blood urea increased 13.84 9.36 131 183059 24342 56084535
Dermatitis psoriasiform 13.81 9.36 23 183167 1831 56107046
Multiple organ dysfunction syndrome 13.80 9.36 245 182945 52525 56056352
Tooth hypoplasia 13.77 9.36 6 183184 65 56108812
Phyllodes tumour 13.75 9.36 5 183185 32 56108845
Pleural effusion 13.74 9.36 370 182820 85110 56023767
Hepatic cytolysis 13.73 9.36 71 183119 10835 56098042
Coagulopathy 13.65 9.36 106 183084 18610 56090267
Bronchopulmonary aspergillosis allergic 13.65 9.36 20 183170 1426 56107451
Bradyphrenia 13.64 9.36 50 183140 6570 56102307
Pyrexia 13.60 9.36 1559 181631 417214 55691663
Urine calcium/creatinine ratio increased 13.59 9.36 7 183183 113 56108764
Atypical fracture 13.53 9.36 13 183177 591 56108286
Osteonecrosis 13.50 9.36 125 183065 23090 56085787
Cholangitis 13.42 9.36 41 183149 4908 56103969
Device dependence 13.42 9.36 4 183186 12 56108865
Fluid retention 13.38 9.36 112 183078 53966 56054911
Spleen congestion 13.38 9.36 7 183183 117 56108760
Laryngotracheal oedema 13.37 9.36 5 183185 35 56108842
Rhabdomyolysis 13.34 9.36 196 182994 40462 56068415
Multiple injuries 13.28 9.36 22 183168 1744 56107133
Immunodeficiency 13.25 9.36 20 183170 16137 56092740
Gastrointestinal perforation 13.24 9.36 31 183159 3168 56105709
General physical health deterioration 13.21 9.36 437 182753 169573 55939304
Maternal exposure before pregnancy 13.20 9.36 3 183187 6820 56102057
Ill-defined disorder 13.16 9.36 151 183039 68392 56040485
Eosinophilic pneumonia chronic 13.14 9.36 8 183182 181 56108696
Hepatitis acute 13.13 9.36 58 183132 8299 56100578
Bile duct stone 13.09 9.36 32 183158 3362 56105515
Cystitis noninfective 13.07 9.36 16 183174 958 56107919
Device issue 13.03 9.36 31 183159 21075 56087802
Femoral neck fracture 13.02 9.36 55 183135 7716 56101161
Lung disorder 12.99 9.36 242 182948 52355 56056522
Oesophageal food impaction 12.99 9.36 8 183182 185 56108692
Chronic gastritis 12.95 9.36 27 183163 2551 56106326
Hypoxic-ischaemic encephalopathy 12.94 9.36 35 183155 3910 56104967
Hyperlipidaemia 12.89 9.36 102 183088 18007 56090870
Gastrointestinal disorder 12.89 9.36 274 182916 112428 55996449
Inadequate diet 12.87 9.36 7 183183 127 56108750
Oesophageal achalasia 12.86 9.36 11 183179 429 56108448
Hepatic failure 12.85 9.36 166 183024 33320 56075557
Oropharyngeal swelling 12.83 9.36 15 183175 856 56108021
Urinary straining 12.80 9.36 5 183185 40 56108837
Tongue discolouration 12.73 9.36 29 183161 2910 56105967
Pancreatic carcinoma recurrent 12.67 9.36 6 183184 80 56108797
Injection site mass 12.63 9.36 22 183168 16771 56092106
Unevaluable event 12.61 9.36 97 183093 47590 56061287
Discoloured vomit 12.55 9.36 14 183176 759 56108118
Skin necrosis 12.54 9.36 13 183177 12348 56096529
Vulval haemorrhage 12.54 9.36 4 183186 16 56108861
Finger deformity 12.51 9.36 3 183187 6574 56102303
Joint dislocation 12.48 9.36 20 183170 15753 56093124
Pre-eclampsia 12.46 9.36 6 183184 8480 56100397
Abortion induced 12.45 9.36 8 183182 9637 56099240
Wrong patient received product 12.42 9.36 24 183166 2147 56106730
Illness 12.32 9.36 64 183126 34447 56074430
Occult blood positive 12.29 9.36 31 183159 3320 56105557
Dilatation atrial 12.25 9.36 22 183168 1861 56107016
Stevens-Johnson syndrome 12.17 9.36 120 183070 22543 56086334
Morbid thoughts 12.15 9.36 12 183178 564 56108313
Blood parathyroid hormone decreased 12.15 9.36 6 183184 8358 56100519
Obstructive nephropathy 12.12 9.36 3 183187 3 56108874
Respiratory tract congestion 12.12 9.36 20 183170 15571 56093306
Complication of device insertion 12.08 9.36 3 183187 6421 56102456
Injection site rash 12.06 9.36 23 183167 16935 56091942
Gingival bleeding 12.05 9.36 72 183118 11594 56097283
Rash papulosquamous 11.99 9.36 6 183184 91 56108786
Subdural haematoma 11.89 9.36 80 183110 13419 56095458
Hypoproteinaemia 11.88 9.36 22 183168 1906 56106971
Bone erosion 11.84 9.36 19 183171 14955 56093922
Physical deconditioning 11.79 9.36 12 183178 585 56108292
Muscle spasticity 11.78 9.36 30 183160 19930 56088947
Photodermatosis 11.74 9.36 10 183180 388 56108489
Autonomic neuropathy 11.71 9.36 16 183174 1069 56107808
Nocturia 11.68 9.36 50 183140 7056 56101821
Degenerative mitral valve disease 11.66 9.36 4 183186 21 56108856
Anxiety disorder 11.65 9.36 33 183157 3787 56105090
Presyncope 11.64 9.36 131 183059 25451 56083426
Gamma-glutamyltransferase increased 11.60 9.36 153 183037 30852 56078025
Cold sweat 11.60 9.36 68 183122 10875 56098002
Drug tolerance decreased 11.59 9.36 16 183174 13395 56095482
Blood albumin decreased 11.55 9.36 80 183110 13548 56095329
Limb discomfort 11.52 9.36 46 183144 26576 56082301
Bone pain 11.51 9.36 106 183084 50079 56058798
Rectocele 11.50 9.36 15 183175 958 56107919
Lip blister 11.50 9.36 23 183167 2110 56106767
Seasonal allergy 11.48 9.36 24 183166 17084 56091793
Breast cancer female 11.40 9.36 14 183176 12324 56096553
Hiccups 11.40 9.36 22 183168 1966 56106911
Device malfunction 11.37 9.36 22 183168 16114 56092763
Single functional kidney 11.36 9.36 7 183183 162 56108715
Pharyngotonsillitis 11.36 9.36 7 183183 162 56108715
Blood electrolytes abnormal 11.34 9.36 15 183175 971 56107906
Bradyarrhythmia 11.34 9.36 22 183168 1974 56106903
Pneumonia aspiration 11.33 9.36 158 183032 32253 56076624
Renal cyst haemorrhage 11.33 9.36 5 183185 56 56108821
Splenic vein thrombosis 11.33 9.36 9 183181 316 56108561
Cardiomegaly 11.32 9.36 92 183098 16375 56092502
Tetany 11.30 9.36 20 183170 1672 56107205
Gambling 11.30 9.36 8 183182 235 56108642
Bleeding time prolonged 11.30 9.36 12 183178 615 56108262
Erythema 11.28 9.36 618 182572 155321 55953556
Enterocolitis haemorrhagic 11.28 9.36 18 183172 1383 56107494
Cytomegalovirus test positive 11.28 9.36 27 183163 2799 56106078
Post cardiac arrest syndrome 11.22 9.36 4 183186 24 56108853
Hypoglycaemia 11.19 9.36 249 182941 55566 56053311
Infusion site vesicles 11.17 9.36 10 183180 415 56108462
Atypical femur fracture 11.15 9.36 39 183151 5008 56103869
Gallbladder hypofunction 11.14 9.36 11 183179 517 56108360
Laboratory test abnormal 11.12 9.36 42 183148 24653 56084224
Apraxia 11.08 9.36 20 183170 1699 56107178
Aortic aneurysm rupture 11.05 9.36 11 183179 522 56108355
Hyperphosphataemia 11.04 9.36 22 183168 2013 56106864
Osteonecrosis of jaw 11.02 9.36 161 183029 33197 56075680
Metastases to bone 11 9.36 30 183160 19478 56089399
Impaired quality of life 10.98 9.36 7 183183 8467 56100410
Bronchogenic cyst 10.92 9.36 3 183187 6 56108871
Oligohydramnios 10.89 9.36 3 183187 5991 56102886
Blood cholinesterase decreased 10.88 9.36 6 183184 112 56108765
Adrenal suppression 10.83 9.36 14 183176 886 56107991
Staphylococcus test positive 10.81 9.36 31 183159 3582 56105295
Hyperhidrosis 10.81 9.36 391 182799 93697 56015180
Uraemic encephalopathy 10.79 9.36 8 183182 253 56108624
Chronic kidney disease-mineral and bone disorder 10.79 9.36 8 183182 253 56108624
Regurgitation 10.78 9.36 18 183172 1436 56107441
Haematotoxicity 10.76 9.36 7 183183 8376 56100501
Duodenal ulcer 10.74 9.36 49 183141 7106 56101771
Prothrombin time ratio increased 10.69 9.36 6 183184 116 56108761
Abnormal faeces 10.67 9.36 37 183153 4731 56104146
Fasciitis 10.66 9.36 11 183179 545 56108332
Optic neuritis 10.66 9.36 52 183138 7752 56101125
Ejection fraction decreased 10.63 9.36 105 183085 19736 56089141
Hypercapnic coma 10.61 9.36 7 183183 183 56108694
Heparin-induced thrombocytopenia 10.59 9.36 34 183156 4180 56104697
Loss of consciousness 10.58 9.36 446 182744 108903 55999974
Renal hypertrophy 10.58 9.36 4 183186 29 56108848
Acute myocardial infarction 10.56 9.36 148 183042 30245 56078632
Product complaint 10.54 9.36 70 183120 11690 56097187
Abdominal rigidity 10.54 9.36 20 183170 1765 56107112
Medication error 10.53 9.36 195 182995 42140 56066737
Macroglossia 10.46 9.36 12 183178 671 56108206
Blood uric acid increased 10.45 9.36 34 183156 4208 56104669
Nasal mucosal erosion 10.41 9.36 5 183185 69 56108808
Gastrointestinal amyloidosis 10.34 9.36 5 183185 70 56108807
Protein-losing gastroenteropathy 10.34 9.36 7 183183 191 56108686
Nephrectomy 10.34 9.36 16 183174 1197 56107680
Bradykinesia 10.29 9.36 37 183153 4817 56104060
Flat affect 10.29 9.36 17 183173 1345 56107532
Blood pressure fluctuation 10.26 9.36 83 183107 40277 56068600
Osteoporosis 10.25 9.36 114 183076 51938 56056939
Femoral hernia 10.24 9.36 4 183186 32 56108845
Hyperuricaemia 10.19 9.36 38 183152 5035 56103842
Mouth ulceration 10.17 9.36 144 183046 29496 56079381
Blood creatinine increased 10.15 9.36 337 182853 79854 56029023
Pharyngeal oedema 10.11 9.36 76 183114 13209 56095668
Small intestinal haemorrhage 10.06 9.36 21 183169 1986 56106891
Herpes zoster 10.05 9.36 180 183010 75709 56033168
Arthritis 9.95 9.36 248 182942 99604 56009273
Cerebral mass effect 9.94 9.36 13 183177 832 56108045
Depressed mood 9.94 9.36 170 183020 36189 56072688
Ventricular dysfunction 9.94 9.36 25 183165 2674 56106203
Coagulation test abnormal 9.92 9.36 12 183178 710 56108167
Ventricular hypertrophy 9.90 9.36 28 183162 3210 56105667
Haemorrhoids 9.90 9.36 105 183085 20101 56088776
Disability 9.88 9.36 23 183167 15757 56093120
Chorea 9.84 9.36 17 183173 1395 56107482
Balance disorder 9.80 9.36 322 182868 76198 56032679
Glycosuria 9.75 9.36 15 183175 1117 56107760
Rash maculo-papular 9.74 9.36 140 183050 28767 56080110
Loose tooth 9.69 9.36 28 183162 3250 56105627
Gastrointestinal stoma output increased 9.68 9.36 7 183183 213 56108664
Fanconi syndrome 9.67 9.36 16 183174 1267 56107610
Scleroderma 9.66 9.36 37 183153 4964 56103913
Gingival erosion 9.65 9.36 7 183183 214 56108663
Gingival hypertrophy 9.59 9.36 17 183173 1423 56107454
Drug eruption 9.59 9.36 127 183063 25636 56083241
Arteriosclerosis 9.55 9.36 58 183132 9395 56099482
Post cholecystectomy syndrome 9.53 9.36 5 183185 84 56108793
Infusion site pain 9.50 9.36 19 183171 13743 56095134
Adverse event 9.49 9.36 125 183065 55251 56053626
Joint injury 9.49 9.36 47 183143 25607 56083270
Transplant rejection 9.47 9.36 11 183179 9923 56098954
Wheelchair user 9.45 9.36 3 183187 5463 56103414
Hepatitis 9.43 9.36 165 183025 35276 56073601
Muscle tension dysphonia 9.43 9.36 5 183185 86 56108791
Pulmonary venous thrombosis 9.40 9.36 3 183187 12 56108865
Documented hypersensitivity to administered product 9.39 9.36 10 183180 514 56108363
Renal hypertension 9.36 9.36 6 183184 149 56108728

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 593.71 10.08 739 123860 37236 31535509
Drug ineffective 336.95 10.08 655 123944 394918 31177827
Death 268.56 10.08 643 123956 359926 31212819
End stage renal disease 262.52 10.08 233 124366 7876 31564869
Completed suicide 241.29 10.08 36 124563 91478 31481267
Hyponatraemia 191.70 10.08 682 123917 73117 31499628
Colitis microscopic 177.16 10.08 106 124493 1904 31570841
Renal injury 175.26 10.08 213 124386 10452 31562293
Interstitial lung disease 171.20 10.08 581 124018 60822 31511923
Toxicity to various agents 136.67 10.08 321 124278 181166 31391579
Product dose omission issue 127.62 10.08 136 124463 105450 31467295
Drug dispensed to wrong patient 122.45 10.08 52 124547 427 31572318
Off label use 120.30 10.08 836 123763 346438 31226307
Drug abuse 120.15 10.08 101 124498 87657 31485088
Acute kidney injury 116.01 10.08 1639 122960 278075 31294670
Appendicolith 93.41 10.08 114 124485 5617 31567128
Fatigue 91.56 10.08 860 123739 334346 31238399
Cerebral infarction 88.04 10.08 263 124336 25714 31547031
Treatment failure 87.12 10.08 26 124573 40766 31531979
Nephrogenic anaemia 83.58 10.08 68 124531 2035 31570710
Foetal exposure during pregnancy 80.40 10.08 30 124569 40846 31531899
Neutropenic sepsis 76.79 10.08 158 124441 12221 31560524
Hepatic function abnormal 74.14 10.08 340 124259 40882 31531863
Lower respiratory tract infection 74.11 10.08 262 124337 27975 31544770
Hypertensive nephropathy 73.42 10.08 36 124563 425 31572320
Hypomagnesaemia 69.42 10.08 198 124401 18860 31553885
Product use in unapproved indication 66.36 10.08 186 124413 98985 31473760
Venous pressure jugular increased 66.05 10.08 40 124559 735 31572010
Drug resistance 64.66 10.08 8 124591 23445 31549300
Appendicitis 63.79 10.08 140 124459 11325 31561420
Gastrooesophageal reflux disease 62.87 10.08 282 124317 33589 31539156
Intentional product use issue 59.08 10.08 64 124535 49283 31523462
Renal impairment 57.02 10.08 554 124045 85795 31486950
COVID-19 56.30 10.08 80 124519 54741 31518004
Intentional overdose 56.16 10.08 48 124551 41341 31531404
Hypoparathyroidism secondary 52.98 10.08 20 124579 116 31572629
Wrong patient received product 51.94 10.08 57 124542 2502 31570243
Liver function test abnormal 51.24 10.08 242 124357 29450 31543295
Suicide attempt 50.78 10.08 43 124556 37205 31535540
Antimicrobial susceptibility test resistant 47.61 10.08 24 124575 302 31572443
Rheumatoid arthritis 46.91 10.08 72 124527 47737 31525008
Toxic epidermal necrolysis 46.86 10.08 176 124423 19348 31553397
Cholestasis 46.70 10.08 209 124390 24866 31547879
Nephropathy 46.53 10.08 80 124519 5399 31567346
Malaise 45.56 10.08 922 123677 167589 31405156
Diabetic nephropathy 44.50 10.08 47 124552 1974 31570771
Hypergastrinaemia 44.44 10.08 15 124584 59 31572686
Subacute cutaneous lupus erythematosus 41.27 10.08 32 124567 892 31571853
Minimum inhibitory concentration 40.60 10.08 16 124583 106 31572639
Full blood count abnormal 39.60 10.08 8 124591 16339 31556406
Neutrophil count decreased 39.05 10.08 314 124285 46080 31526665
Drug intolerance 37.51 10.08 94 124505 51939 31520806
Melaena 37.36 10.08 238 124361 32416 31540329
Haematemesis 37.15 10.08 199 124400 25454 31547291
Therapeutic response delayed 36.78 10.08 24 124575 505 31572240
Tetany 36.10 10.08 26 124573 646 31572099
Hypocalcaemia 35.66 10.08 176 124423 21802 31550943
Occupational dermatitis 35.39 10.08 13 124586 69 31572676
Chronic kidney disease-mineral and bone disorder 35.30 10.08 21 124578 373 31572372
Hepatocellular injury 35.30 10.08 173 124426 21371 31551374
Inappropriate schedule of product administration 34.96 10.08 94 124505 50729 31522016
Tetanus 34.45 10.08 12 124587 53 31572692
Hospitalisation 34.35 10.08 92 124507 49715 31523030
Tubulointerstitial nephritis 34.31 10.08 154 124445 18342 31554403
Abdominal pain 34.09 10.08 782 123817 145170 31427575
Device dependence 33.91 10.08 11 124588 37 31572708
Peripheral swelling 33.43 10.08 145 124454 67720 31505025
Disease progression 32.00 10.08 216 124383 90248 31482497
Weight increased 31.92 10.08 193 124406 82754 31489991
Jaundice 31.76 10.08 216 124383 30071 31542674
Therapeutic product effect incomplete 31.44 10.08 79 124520 43617 31529128
Rash vesicular 31.42 10.08 44 124555 2483 31570262
Pain 30.97 10.08 532 124067 186227 31386518
Abdominal distension 30.92 10.08 320 124279 50364 31522381
Gastric cancer 30.49 10.08 71 124528 5974 31566771
Drug eruption 30.48 10.08 147 124452 18040 31554705
Hyperchlorhydria 30.41 10.08 23 124576 617 31572128
Drug hypersensitivity 30.04 10.08 165 124434 72434 31500311
Agranulocytosis 29.54 10.08 163 124436 21084 31551661
Liver disorder 28.88 10.08 208 124391 29499 31543246
Overdose 28.54 10.08 205 124394 84459 31488286
Ventricular fibrillation 28.52 10.08 148 124451 18700 31554045
Stress 28.04 10.08 181 124418 24760 31547985
Poisoning 27.56 10.08 4 124595 10387 31562358
Nasopharyngitis 27.13 10.08 142 124457 63103 31509642
Haemorrhage subcutaneous 27.06 10.08 38 124561 2150 31570595
Injection site pain 27.00 10.08 60 124539 34574 31538171
Adverse drug reaction 26.64 10.08 36 124563 25165 31547580
Blood pressure fluctuation 26.64 10.08 30 124569 22706 31550039
Therapeutic product effect decreased 26.15 10.08 53 124546 31569 31541176
Ascites 25.52 10.08 260 124339 40753 31531992
Pancreatitis acute 25.33 10.08 180 124419 25420 31547325
Hepatic cytolysis 24.68 10.08 96 124503 10727 31562018
Loss of personal independence in daily activities 24.61 10.08 46 124553 28242 31544503
Renal failure 24.35 10.08 646 123953 122684 31450061
Platelet count decreased 24.32 10.08 587 124012 109848 31462897
Unevaluable event 23.81 10.08 53 124546 30522 31542223
Disseminated intravascular coagulation 23.68 10.08 150 124449 20387 31552358
Melanoderma 23.66 10.08 12 124587 153 31572592
Enteritis infectious 23.47 10.08 27 124572 1249 31571496
Neutrophil count increased 23.44 10.08 123 124476 15608 31557137
Lip swelling 23.28 10.08 109 124490 13214 31559531
Cystitis escherichia 23.26 10.08 12 124587 159 31572586
Pneumonia bacterial 23.21 10.08 91 124508 10205 31562540
Dissociation 22.86 10.08 27 124572 1285 31571460
Intentional product misuse 22.63 10.08 75 124524 37876 31534869
Synovitis 22.54 10.08 10 124589 12273 31560472
Protein-losing gastroenteropathy 22.41 10.08 15 124584 330 31572415
Vomiting 22.29 10.08 1085 123514 222888 31349857
Adrenal suppression 22.17 10.08 18 124581 537 31572208
Pulmonary fibrosis 21.96 10.08 126 124473 16534 31556211
Occupational exposure to air contaminants 21.85 10.08 11 124588 138 31572607
Gastric polyps 21.78 10.08 24 124575 1058 31571687
Pneumonia aspiration 21.52 10.08 240 124359 38486 31534259
Hiatus hernia 21.35 10.08 68 124531 6879 31565866
Orthostatic hypotension 21.25 10.08 165 124434 23954 31548791
Neurotoxicity 20.60 10.08 20 124579 16206 31556539
Gait disturbance 20.52 10.08 200 124399 77295 31495450
Confusional state 20.49 10.08 677 123922 132657 31440088
Accidental exposure to product 20.11 10.08 10 124589 11485 31561260
Hepatitis acute 20.01 10.08 65 124534 6644 31566101
Dry skin 19.98 10.08 44 124555 25437 31547308
Toxic skin eruption 19.82 10.08 86 124513 10094 31562651
Rectal haemorrhage 19.72 10.08 224 124375 36080 31536665
Blood alkaline phosphatase increased 19.42 10.08 189 124410 29264 31543481
Renal disorder 19.33 10.08 159 124440 23486 31549259
Prostatic specific antigen increased 19.23 10.08 15 124584 13523 31559222
Gastric varices 19.22 10.08 15 124584 422 31572323
Gingival disorder 19.00 10.08 25 124574 1329 31571416
Weight decreased 19.00 10.08 481 124118 159471 31413274
Rebound acid hypersecretion 18.99 10.08 9 124590 98 31572647
Marasmus 18.91 10.08 16 124583 506 31572239
Hypozincaemia 18.80 10.08 5 124594 6 31572739
Sinobronchitis 18.80 10.08 5 124594 6 31572739
Femoral neck fracture 18.79 10.08 38 124561 2902 31569843
Enterochromaffin cell hyperplasia 18.77 10.08 6 124593 19 31572726
Biliary sepsis 18.72 10.08 17 124582 592 31572153
Renal cyst 18.66 10.08 74 124525 8342 31564403
Contraindication to medical treatment 18.60 10.08 17 124582 597 31572148
Hypoacusis 18.45 10.08 19 124580 14980 31557765
Sopor 18.38 10.08 92 124507 11460 31561285
Haematotoxicity 18.35 10.08 3 124596 7134 31565611
Cholangitis 18.34 10.08 71 124528 7915 31564830
Immune thrombocytopenia 18.27 10.08 74 124525 8424 31564321
Vasculitic rash 18.18 10.08 20 124579 880 31571865
Failure to anastomose 18.07 10.08 11 124588 204 31572541
Dialysis 17.98 10.08 86 124513 10517 31562228
Glomerulosclerosis 17.92 10.08 18 124581 712 31572033
Alcoholic liver disease 17.89 10.08 16 124583 546 31572199
Nephrosclerosis 17.81 10.08 20 124579 901 31571844
Pathogen resistance 17.76 10.08 6 124593 8695 31564050
Drug dependence 17.70 10.08 39 124560 22540 31550205
Joint swelling 17.69 10.08 130 124469 53301 31519444
Psoriatic arthropathy 17.59 10.08 32 124567 19851 31552894
Upper respiratory tract inflammation 17.55 10.08 27 124572 1659 31571086
Cardio-respiratory arrest 17.54 10.08 125 124474 51601 31521144
White blood cell count increased 17.45 10.08 232 124367 38768 31533977
Subdural haematoma 17.39 10.08 131 124468 18840 31553905
Psoriasis 17.29 10.08 110 124489 46609 31526136
Idiopathic pulmonary fibrosis 17.12 10.08 45 124554 4085 31568660
Renal hypertension 17.09 10.08 10 124589 172 31572573
Oesophagitis 17.09 10.08 95 124504 12321 31560424
Paraesthesia oral 17.03 10.08 42 124557 3666 31569079
Mouth ulceration 16.98 10.08 86 124513 10762 31561983
Therapy non-responder 16.79 10.08 72 124527 33739 31539006
Transient ischaemic attack 16.67 10.08 156 124443 23900 31548845
Respiratory muscle weakness 16.65 10.08 8 124591 90 31572655
Renal artery stenosis 16.54 10.08 30 124569 2112 31570633
Barrett's oesophagus 16.49 10.08 14 124585 445 31572300
Blood albumin decreased 16.37 10.08 94 124505 12337 31560408
Therapy partial responder 16.34 10.08 3 124596 6559 31566186
Hyperuricaemia 16.17 10.08 65 124534 7373 31565372
Aspergillus infection 16.09 10.08 13 124586 11515 31561230
Immune reconstitution inflammatory syndrome 16.08 10.08 6 124593 8172 31564573
Faecal vomiting 16.03 10.08 13 124586 387 31572358
Laboratory test abnormal 16.01 10.08 31 124568 18783 31553962
Wrong technique in product usage process 15.95 10.08 72 124527 33271 31539474
Aplastic anaemia 15.86 10.08 75 124524 9128 31563617
Hypotension 15.74 10.08 651 123948 203967 31368778
Periprosthetic fracture 15.68 10.08 9 124590 149 31572596
Dermatitis acneiform 15.54 10.08 54 124545 5713 31567032
Constipation 15.48 10.08 615 123984 123376 31449369
Blood magnesium decreased 15.44 10.08 54 124545 5732 31567013
Therapy cessation 15.42 10.08 22 124577 15033 31557712
Duodenal polyp 15.26 10.08 10 124589 212 31572533
Asthenia 15.25 10.08 725 123874 224030 31348715
Gastrointestinal ulcer 15.05 10.08 25 124574 1640 31571105
Haemorrhagic cerebral infarction 15.04 10.08 17 124582 771 31571974
Follicular mucinosis 14.95 10.08 5 124594 19 31572726
Device malfunction 14.85 10.08 9 124590 9257 31563488
Blood phosphorus increased 14.82 10.08 45 124554 4437 31568308
Electrocardiogram ST-T segment abnormal 14.78 10.08 10 124589 224 31572521
Renal haemangioma 14.75 10.08 5 124594 20 31572725
Gastrointestinal tract irritation 14.67 10.08 10 124589 227 31572518
Haemoptysis 14.61 10.08 192 124407 31997 31540748
Enterocolitis 14.58 10.08 62 124537 7212 31565533
Thrombosis 14.40 10.08 111 124488 45040 31527705
Cardiogenic shock 14.39 10.08 143 124456 22265 31550480
Underdose 14.37 10.08 17 124582 12590 31560155
Gastrointestinal motility disorder 14.35 10.08 30 124569 2346 31570399
Macroglossia 14.25 10.08 12 124587 377 31572368
Coma 14.17 10.08 99 124500 41051 31531694
Infusion related reaction 14.02 10.08 121 124478 47934 31524811
Retinal vascular occlusion 13.94 10.08 9 124590 186 31572559
Dyspepsia 13.89 10.08 192 124407 32361 31540384
Ischaemic nephropathy 13.85 10.08 5 124594 25 31572720
Wrong product administered 13.81 10.08 47 124552 4921 31567824
Eosinophil count increased 13.80 10.08 64 124535 7727 31565018
Inhibitory drug interaction 13.73 10.08 23 124576 1519 31571226
Faeces discoloured 13.67 10.08 97 124502 13689 31559056
Pulmonary thrombosis 13.62 10.08 5 124594 6880 31565865
Drug reaction with eosinophilia and systemic symptoms 13.61 10.08 179 124420 29839 31542906
Drug-induced liver injury 13.54 10.08 151 124448 24212 31548533
Therapy interrupted 13.52 10.08 13 124586 10583 31562162
Thrombotic cerebral infarction 13.41 10.08 11 124588 333 31572412
Hyponatraemic seizure 13.37 10.08 6 124593 57 31572688
Gastritis 13.27 10.08 130 124469 20162 31552583
Lymphocyte stimulation test positive 13.16 10.08 15 124584 687 31572058
Localised infection 13.12 10.08 25 124574 15240 31557505
Neuroendocrine tumour 13.10 10.08 16 124583 789 31571956
Gastric ulcer haemorrhage 12.98 10.08 47 124552 5076 31567669
Nocturia 12.93 10.08 71 124528 9164 31563581
Burning feet syndrome 12.92 10.08 7 124592 103 31572642
Hepatic encephalopathy 12.87 10.08 95 124504 13576 31559169
Eosinophilia 12.87 10.08 144 124455 23109 31549636
Cytokine release syndrome 12.83 10.08 29 124570 16613 31556132
Clostridium test positive 12.81 10.08 29 124570 2395 31570350
Product use issue 12.80 10.08 152 124447 56607 31516138
Peptic ulcer 12.71 10.08 30 124569 2546 31570199
Circulatory collapse 12.68 10.08 126 124473 19618 31553127
Oesophagogastric fundoplasty 12.67 10.08 4 124595 12 31572733
Radiation pneumonitis 12.65 10.08 29 124570 2415 31570330
Erythema multiforme 12.64 10.08 64 124535 8007 31564738
Cerebral haemorrhage 12.59 10.08 190 124409 32622 31540123
Embolic cerebral infarction 12.53 10.08 14 124585 627 31572118
Procedural failure 12.53 10.08 6 124593 67 31572678
Central nervous system mass 12.46 10.08 7 124592 111 31572634
Pelvic cyst 12.46 10.08 5 124594 35 31572710
Wall motion score index abnormal 12.41 10.08 7 124592 112 31572633
Neuropathy peripheral 12.34 10.08 216 124383 75433 31497312
Incorrect dose administered 12.31 10.08 86 124513 35666 31537079
Sterile pyuria 12.22 10.08 5 124594 37 31572708
Henoch-Schonlein purpura 12.19 10.08 22 124577 1543 31571202
Granulomatous dermatitis 12.18 10.08 9 124590 233 31572512
Drug ineffective for unapproved indication 12.15 10.08 33 124566 17757 31554988
N-telopeptide urine increased 12.11 10.08 5 124594 38 31572707
Chondrocalcinosis 12.07 10.08 10 124589 307 31572438
Oculocephalogyric reflex absent 12.00 10.08 4 124595 15 31572730
Poisoning deliberate 11.95 10.08 7 124592 7337 31565408
Multiple sclerosis relapse 11.95 10.08 18 124581 12029 31560716
Gastric varices haemorrhage 11.95 10.08 9 124590 240 31572505
Lymphocyte count decreased 11.94 10.08 129 124470 20520 31552225
Hypersensitivity vasculitis 11.90 10.08 34 124565 3241 31569504
Brain stem haemorrhage 11.88 10.08 16 124583 870 31571875
Intracranial haematoma 11.85 10.08 11 124588 394 31572351
Spinal cord haemorrhage 11.83 10.08 10 124589 316 31572429
Inappropriate antidiuretic hormone secretion 11.81 10.08 81 124518 11306 31561439
Dehydration 11.81 10.08 577 124022 118534 31454211
Diffuse vasculitis 11.80 10.08 6 124593 77 31572668
Generalised onset non-motor seizure 11.80 10.08 4 124595 16 31572729
Enterocolitis haemorrhagic 11.77 10.08 16 124583 878 31571867
Putamen haemorrhage 11.76 10.08 9 124590 246 31572499
Prostate cancer 11.73 10.08 93 124506 37508 31535237
Hirsutism 11.72 10.08 8 124591 182 31572563
Carotid bruit 11.68 10.08 8 124591 183 31572562
Sedation 11.64 10.08 37 124562 18928 31553817
Metaplasia 11.63 10.08 9 124590 250 31572495
Exposed bone in jaw 11.60 10.08 21 124578 1476 31571269
Mobility decreased 11.59 10.08 62 124537 27407 31545338
Gastric pH increased 11.56 10.08 3 124596 3 31572742
Discharge 11.54 10.08 9 124590 253 31572492
Cerebral hyperperfusion syndrome 11.53 10.08 6 124593 81 31572664
Osteonecrosis of jaw 11.48 10.08 110 124489 16961 31555784
Influenza 11.47 10.08 115 124484 44210 31528535
Blood creatine phosphokinase increased 11.41 10.08 230 124369 41744 31531001
Mesothelioma 11.40 10.08 11 124588 414 31572331
Meniere's disease 11.38 10.08 5 124594 45 31572700
Device issue 11.31 10.08 10 124589 8474 31564271
Ventricular hypertrophy 11.28 10.08 40 124559 4276 31568469
Product dispensing error 11.27 10.08 49 124550 5755 31566990
Premature baby 11.26 10.08 35 124564 18031 31554714
Iron deficiency anaemia 11.19 10.08 69 124530 9290 31563455
Neuropathic ulcer 11.08 10.08 4 124595 20 31572725
Full blood count decreased 11.06 10.08 31 124568 16509 31556236
Chest pain 11.06 10.08 564 124035 116393 31456352
Plasma cell myeloma 11.04 10.08 156 124443 56375 31516370
Aortic dissection 10.99 10.08 28 124571 2494 31570251
Gastrostomy tube site complication 10.92 10.08 5 124594 50 31572695
Cerebellar infarction 10.85 10.08 23 124576 1816 31570929
Rhabdomyolysis 10.85 10.08 327 124272 63254 31509491
Upper gastrointestinal haemorrhage 10.82 10.08 139 124460 23044 31549701
Occupational exposure to product 10.80 10.08 10 124589 357 31572388
Muscle injury 10.77 10.08 19 124580 1309 31571436
Coronary artery disease 10.75 10.08 247 124352 45840 31526905
Hyperkalaemia 10.72 10.08 330 124269 64021 31508724
Sexually inappropriate behaviour 10.69 10.08 11 124588 448 31572297
Alanine aminotransferase increased 10.68 10.08 376 124223 74280 31498465
Respiratory depression 10.62 10.08 26 124573 14484 31558261
Electrocardiogram QT prolonged 10.61 10.08 209 124390 37778 31534967
Rash morbilliform 10.56 10.08 29 124570 2702 31570043
Myocardial ischaemia 10.52 10.08 106 124493 16561 31556184
Therapeutic response unexpected 10.47 10.08 12 124587 9012 31563733
Amaurosis fugax 10.43 10.08 12 124587 555 31572190
Ammonia decreased 10.36 10.08 3 124596 6 31572739
Dressler's syndrome 10.35 10.08 4 124595 25 31572720
Hip fracture 10.34 10.08 17 124582 10969 31561776
Renal infarct 10.26 10.08 18 124581 1234 31571511
Urinary retention 10.26 10.08 188 124411 33537 31539208
Cirrhosis alcoholic 10.23 10.08 14 124585 773 31571972
Transverse sinus thrombosis 10.21 10.08 4 124595 26 31572719
Renal atrophy 10.20 10.08 17 124582 1118 31571627
Helicobacter test positive 10.18 10.08 14 124585 777 31571968
Cardiac murmur 10.16 10.08 53 124546 6709 31566036
Lichenoid keratosis 10.16 10.08 26 124573 2322 31570423
Haematuria 10.12 10.08 246 124353 46068 31526677
Airway remodelling 10.11 10.08 7 124592 163 31572582

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 787.09 9.46 1434 261776 938318 69726916
Chronic kidney disease 600.89 9.46 923 262287 60134 70605100
Completed suicide 582.74 9.46 77 263133 227058 70438176
Hyponatraemia 539.04 9.46 1557 261653 158530 70506704
Colitis microscopic 487.00 9.46 342 262868 8663 70656571
Death 328.60 9.46 896 262314 509165 70156069
Acute kidney injury 274.11 9.46 2827 260383 471797 70193437
Toxicity to various agents 265.37 9.46 646 262564 381526 70283708
End stage renal disease 257.83 9.46 259 262951 10874 70654360
Rheumatoid arthritis 248.30 9.46 439 262771 291366 70373868
Hypomagnesaemia 242.12 9.46 494 262716 40270 70624964
Interstitial lung disease 235.92 9.46 889 262321 103796 70561438
Product dose omission issue 220.72 9.46 290 262920 217178 70448056
Off label use 219.23 9.46 1738 261472 741322 69923912
Fatigue 188.43 9.46 2055 261155 822264 69842970
Subacute cutaneous lupus erythematosus 187.76 9.46 128 263082 3085 70662149
Drug intolerance 183.46 9.46 349 262861 225338 70439896
Drug abuse 180.57 9.46 168 263042 147088 70518146
Therapeutic product effect incomplete 174.50 9.46 115 263095 119767 70545467
Neutropenic sepsis 171.88 9.46 321 262889 24509 70640725
Cerebral infarction 164.94 9.46 439 262771 42570 70622664
Treatment failure 160.19 9.46 179 263031 143963 70521271
Synovitis 154.27 9.46 151 263059 129077 70536157
Pain 151.78 9.46 1547 261663 627269 70037965
Hepatic function abnormal 149.47 9.46 573 262637 67423 70597811
Renal injury 143.97 9.46 233 262977 15861 70649373
Gastrooesophageal reflux disease 126.85 9.46 669 262541 90170 70575064
Injection site pain 124.29 9.46 152 263058 117467 70547767
Haematemesis 112.86 9.46 418 262792 48379 70616855
Nephrogenic anaemia 112.23 9.46 99 263111 3519 70661715
Melaena 110.28 9.46 458 262752 55897 70609337
Therapeutic product effect decreased 107.75 9.46 231 262979 142787 70522447
Joint swelling 107.63 9.46 528 262682 252683 70412551
Contraindicated product administered 104.28 9.46 214 262996 134398 70530836
Loss of personal independence in daily activities 103.90 9.46 97 263113 84813 70580421
Hypertensive nephropathy 101.12 9.46 54 263156 820 70664414
Appendicolith 97.84 9.46 113 263097 5567 70659667
Arthropathy 97.48 9.46 262 262948 149795 70515439
Hypocalcaemia 96.91 9.46 376 262834 44483 70620751
Cholestasis 95.19 9.46 391 262819 47481 70617753
Liver function test abnormal 94.93 9.46 464 262746 60682 70604552
Abdominal pain 92.94 9.46 1784 261426 340343 70324891
Confusional state 91.04 9.46 1522 261688 282876 70382358
COVID-19 90.81 9.46 158 263052 105599 70559635
Renal failure 90.33 9.46 1086 262124 187984 70477250
Intentional overdose 89.21 9.46 142 263068 98293 70566941
Renal impairment 87.80 9.46 868 262342 143069 70522165
Drug resistance 86.61 9.46 18 263192 38172 70627062
Weight increased 83.09 9.46 542 262668 241789 70423445
Drug hypersensitivity 82.60 9.46 602 262608 261857 70403377
Hepatocellular injury 81.27 9.46 363 262847 45728 70619506
Lower respiratory tract infection 80.39 9.46 699 262511 111214 70554020
Drug dispensed to wrong patient 79.18 9.46 40 263170 538 70664696
Alopecia 76.95 9.46 427 262783 198063 70467171
Jaundice 76.18 9.46 378 262832 49730 70615504
Hypokalaemia 75.62 9.46 782 262428 130406 70534828
Electric shock 75.57 9.46 50 263160 1145 70664089
Electrocardiogram QT prolonged 74.93 9.46 549 262661 82968 70582266
Agranulocytosis 73.80 9.46 321 262889 39977 70625257
Product use in unapproved indication 73.70 9.46 459 262751 207019 70458215
Swollen tongue 72.41 9.46 301 262909 36745 70628489
Faeces discoloured 71.76 9.46 241 262969 26568 70638666
Maternal exposure during pregnancy 70.75 9.46 207 263003 115138 70550096
Suicide attempt 69.89 9.46 117 263093 79393 70585841
Neutrophil count decreased 69.19 9.46 539 262671 83017 70582217
Arthralgia 69.11 9.46 1385 261825 502005 70163229
Hypergastrinaemia 68.64 9.46 26 263184 163 70665071
Appendicitis 68.44 9.46 175 263035 16558 70648676
Cholecystitis chronic 68.39 9.46 124 263086 9252 70655982
Sinusitis 67.76 9.46 360 262850 168835 70496399
Infusion related reaction 67.60 9.46 442 262768 197092 70468142
Peripheral swelling 65.86 9.46 561 262649 236002 70429232
Intentional product use issue 65.70 9.46 227 262983 119915 70545319
Hand deformity 64.85 9.46 140 263070 86342 70578892
Tubulointerstitial nephritis 63.28 9.46 267 262943 32809 70632425
Diabetic nephropathy 63.27 9.46 64 263146 2709 70662525
Inappropriate schedule of product administration 63.11 9.46 197 263013 107358 70557876
Rectal haemorrhage 62.68 9.46 439 262771 65392 70599842
Product use issue 61.88 9.46 402 262808 179535 70485699
Sopor 61.86 9.46 255 262955 31012 70634222
Exposure during pregnancy 61.71 9.46 147 263063 87570 70577664
Device expulsion 60.83 9.46 6 263204 22240 70642994
Lip swelling 60.64 9.46 269 262941 33785 70631449
Vomiting 59.34 9.46 2729 260481 590382 70074852
Nasopharyngitis 58.30 9.46 535 262675 221671 70443563
Psoriasis 57.96 9.46 180 263030 98253 70566981
Pemphigus 56.96 9.46 141 263069 82895 70582339
Platelet count decreased 55.21 9.46 949 262261 177273 70487961
Chest pain 54.13 9.46 1267 261943 249993 70415241
Venous pressure jugular increased 53.37 9.46 42 263168 1270 70663964
Gastritis 53.30 9.46 315 262895 44276 70620958
Hospitalisation 52.22 9.46 146 263064 82422 70582812
Liver disorder 51.99 9.46 399 262811 61169 70604065
Malaise 51.80 9.46 2030 261180 430902 70234332
Nephropathy 51.26 9.46 106 263104 8719 70656515
Systemic lupus erythematosus 50.18 9.46 201 263009 101701 70563533
Infective pulmonary exacerbation of cystic fibrosis 49.57 9.46 127 263083 12031 70653203
Accidental exposure to product 49.49 9.46 21 263189 28030 70637204
Wrong technique in product usage process 49.22 9.46 114 263096 68584 70596650
Injection site pruritus 48.90 9.46 44 263166 39166 70626068
Haemorrhage subcutaneous 48.36 9.46 71 263139 4438 70660796
Antimicrobial susceptibility test resistant 48.02 9.46 24 263186 315 70664919
Pneumonia bacterial 47.58 9.46 153 263057 16488 70648746
Injection site erythema 47.58 9.46 127 263083 72797 70592437
Hypoparathyroidism secondary 46.24 9.46 20 263190 184 70665050
Wrong patient received product 45.83 9.46 69 263141 4411 70660823
Intervertebral discitis 45.32 9.46 66 263144 4095 70661139
Abdominal discomfort 45.23 9.46 544 262666 214114 70451120
Swelling 45.19 9.46 464 262746 188075 70477159
Toxic skin eruption 45.18 9.46 171 263039 19991 70645243
Hepatic enzyme increased 45.16 9.46 369 262841 156621 70508613
Therapy interrupted 44.68 9.46 18 263192 24784 70640450
Swelling face 44.55 9.46 393 262817 62771 70602463
Disseminated intravascular coagulation 44.53 9.46 244 262966 33354 70631880
Injection site reaction 44.14 9.46 73 263137 49779 70615455
Hepatic cytolysis 44.03 9.46 164 263046 19028 70646206
Mobility decreased 43.57 9.46 215 262995 102784 70562450
Circulatory collapse 43.31 9.46 252 262958 35222 70630012
Toxic epidermal necrolysis 43.21 9.46 273 262937 39284 70625950
Anti-cyclic citrullinated peptide antibody positive 42.99 9.46 126 263084 70059 70595175
Labile blood pressure 42.89 9.46 46 263164 2086 70663148
Upper respiratory tract inflammation 42.17 9.46 62 263148 3880 70661354
Minimum inhibitory concentration 41.75 9.46 16 263194 104 70665130
Therapy cessation 41.75 9.46 38 263172 33638 70631596
Device dependence 40.98 9.46 13 263197 43 70665191
Sedation 40.85 9.46 69 263141 46662 70618572
Blood alkaline phosphatase increased 40.69 9.46 363 262847 58158 70607076
Overdose 40.58 9.46 418 262792 169327 70495907
Drug ineffective for unapproved indication 40.48 9.46 50 263160 38488 70626746
International normalised ratio increased 40.41 9.46 468 262742 80258 70584976
Reflux gastritis 40.27 9.46 34 263176 1138 70664096
Brain stem glioma 40.04 9.46 19 263191 221 70665013
Red blood cell sedimentation rate abnormal 40.03 9.46 11 263199 19292 70645942
Coronary artery disease 40.02 9.46 382 262828 62354 70602880
Injection site swelling 39.33 9.46 62 263148 43095 70622139
Hyperkalaemia 39.16 9.46 584 262626 106007 70559227
Tetany 39.09 9.46 45 263165 2209 70663025
Oesophagitis 38.87 9.46 177 263033 22475 70642759
Blood sodium decreased 38.36 9.46 221 262989 30777 70634457
Blood pressure fluctuation 38.32 9.46 103 263107 58909 70606325
Poisoning 38.24 9.46 18 263192 22604 70642630
Pancreatitis acute 37.58 9.46 292 262918 44932 70620302
Drug reaction with eosinophilia and systemic symptoms 37.38 9.46 354 262856 57659 70607575
Nasal congestion 37.32 9.46 122 263088 65550 70599684
Therapeutic response decreased 37.23 9.46 103 263107 58350 70606884
Biliary dyskinesia 36.82 9.46 45 263165 2354 70662880
Urine magnesium decreased 36.80 9.46 8 263202 0 70665234
Cardiac failure 36.69 9.46 742 262468 142799 70522435
Influenza 36.59 9.46 259 262951 113441 70551793
Orthostatic hypotension 36.00 9.46 321 262889 51422 70613812
Enteritis infectious 35.67 9.46 51 263159 3111 70662123
Post-traumatic stress disorder 35.66 9.46 61 263149 4346 70660888
Chronic kidney disease-mineral and bone disorder 35.19 9.46 25 263185 645 70664589
Therapy partial responder 35.09 9.46 3 263207 12471 70652763
Tetanus 34.95 9.46 12 263198 54 70665180
Device dislocation 34.94 9.46 20 263190 22487 70642747
Cerebral haemorrhage 34.86 9.46 329 262881 53535 70611699
Red blood cell sedimentation rate increased 34.76 9.46 56 263154 38586 70626648
Enterochromaffin cell hyperplasia 34.66 9.46 13 263197 79 70665155
Immune thrombocytopenia 33.77 9.46 135 263075 16189 70649045
Angioedema 33.71 9.46 387 262823 66223 70599011
Dehydration 33.56 9.46 1087 262123 225055 70440179
Discomfort 33.52 9.46 241 262969 105195 70560039
Glossodynia 33.51 9.46 186 263024 86301 70578933
Occupational dermatitis 33.43 9.46 14 263196 118 70665116
Hepatic ischaemia 33.37 9.46 29 263181 1010 70664224
Biliary sepsis 33.13 9.46 34 263176 1464 70663770
Anaemia 32.96 9.46 1821 261389 401602 70263632
Decreased appetite 32.92 9.46 1414 261796 303366 70361868
Gastric cancer 32.91 9.46 90 263120 8865 70656369
Cholangitis 32.85 9.46 106 263104 11443 70653791
Lethargy 32.78 9.46 425 262785 74825 70590409
Erythema multiforme 32.69 9.46 135 263075 16429 70648805
Hyperchlorhydria 32.26 9.46 37 263173 1809 70663425
Psoriatic arthropathy 31.73 9.46 128 263082 64643 70600591
Diarrhoea 31.41 9.46 3342 259868 779999 69885235
Poisoning deliberate 31.36 9.46 12 263198 17048 70648186
Gastric polyps 31.24 9.46 50 263160 3371 70661863
Enterocolitis 31.10 9.46 113 263097 12953 70652281
Protein-losing gastroenteropathy 31.05 9.46 22 263188 565 70664669
Eosinophilia 30.60 9.46 255 262955 40064 70625170
Upper gastrointestinal haemorrhage 30.59 9.46 241 262969 37236 70627998
Rheumatoid nodule 30.48 9.46 9 263201 15058 70650176
Facet joint syndrome 30.45 9.46 69 263141 6044 70659190
Hiatus hernia 30.41 9.46 157 263053 20977 70644257
Coma scale abnormal 30.25 9.46 82 263128 8034 70657200
Gastrointestinal motility disorder 30.18 9.46 65 263145 5501 70659733
Injection site bruising 29.82 9.46 60 263150 37972 70627262
Haemoptysis 29.76 9.46 307 262903 51145 70614089
Wound 29.33 9.46 230 262980 98502 70566732
Hepatitis acute 29.31 9.46 116 263094 13846 70651388
Neurotoxicity 28.98 9.46 41 263169 29785 70635449
Dysphagia 28.74 9.46 583 262627 112251 70552983
Altered state of consciousness 28.73 9.46 250 262960 39772 70625462
Transient ischaemic attack 28.44 9.46 278 262932 45666 70619568
Femoral neck fracture 28.32 9.46 86 263124 8987 70656247
Carcinoid tumour of the stomach 28.27 9.46 14 263196 180 70665054
Subarachnoid haemorrhage 28.14 9.46 145 263065 19359 70645875
Blood pressure increased 28.14 9.46 511 262699 188006 70477228
Lip dry 28.01 9.46 90 263120 9695 70655539
Syncope 27.90 9.46 809 262401 164900 70500334
Dyspepsia 27.80 9.46 475 262735 88602 70576632
Hepatotoxicity 27.64 9.46 78 263132 43908 70621326
Pneumonia aspiration 27.64 9.46 353 262857 61936 70603298
Basilar artery occlusion 27.60 9.46 14 263196 190 70665044
Pemphigoid 27.45 9.46 114 263096 13908 70651326
Abnormal loss of weight 27.39 9.46 77 263133 7707 70657527
Abdominal distension 27.38 9.46 543 262667 104126 70561108
Intentional product misuse 27.25 9.46 178 263032 79417 70585817
Constipation 27.21 9.46 1171 262039 251267 70413967
Subdural haematoma 27.07 9.46 194 263016 29104 70636130
Rectal ulcer 26.90 9.46 35 263175 1951 70663283
Gastric dysplasia 26.85 9.46 8 263202 20 70665214
Post viral fatigue syndrome 26.85 9.46 16 263194 303 70664931
Rheumatoid factor positive 26.75 9.46 91 263119 48309 70616925
Ventricular fibrillation 26.51 9.46 182 263028 26929 70638305
Rhabdomyolysis 26.48 9.46 501 262709 95259 70569975
Anaphylactic reaction 26.46 9.46 408 262802 74566 70590668
Urine potassium decreased 26.45 9.46 7 263203 9 70665225
Coordination abnormal 26.43 9.46 124 263086 15942 70649292
Hyperglycaemia 26.41 9.46 361 262849 64311 70600923
Gastric ulcer 26.26 9.46 205 263005 31585 70633649
Mixed liver injury 26.23 9.46 66 263144 6183 70659051
Haematotoxicity 26.18 9.46 9 263201 13665 70651569
Respiratory arrest 26.16 9.46 107 263103 53826 70611408
Nephrocalcinosis 26.05 9.46 29 263181 1372 70663862
Cystitis escherichia 25.77 9.46 19 263191 520 70664714
Adrenal insufficiency 25.75 9.46 171 263039 25024 70640210
Acne 25.64 9.46 33 263177 24956 70640278
Haematuria 25.60 9.46 354 262856 63219 70602015
Rhinorrhoea 25.57 9.46 143 263067 66228 70599006
Device malfunction 25.54 9.46 20 263190 19064 70646170
Somatic delusion 25.49 9.46 21 263189 679 70664555
Deep vein thrombosis postoperative 25.42 9.46 47 263163 3560 70661674
Musculoskeletal disorder 25.40 9.46 22 263188 19949 70645285
Barrett's oesophagus 25.39 9.46 22 263188 763 70664471
Drug interaction 25.19 9.46 1690 261520 379751 70285483
Dry mouth 25.08 9.46 384 262826 70073 70595161
Urine output decreased 25.07 9.46 127 263083 16843 70648391
Skin candida 25.03 9.46 32 263178 1753 70663481
Mouth ulceration 24.88 9.46 215 262995 34134 70631100
Hypophosphataemic osteomalacia 24.81 9.46 15 263195 292 70664942
Foot deformity 24.79 9.46 24 263186 20631 70644603
Joint stiffness 24.69 9.46 59 263151 35117 70630117
Therapeutic response delayed 24.51 9.46 24 263186 976 70664258
Hyperlipidaemia 24.41 9.46 162 263048 23701 70641533
Multiple sclerosis relapse 24.38 9.46 80 263130 42937 70622297
Full blood count decreased 24.12 9.46 32 263178 23886 70641348
Mouth swelling 24.04 9.46 58 263152 5291 70659943
Demyelination 23.93 9.46 70 263140 7166 70658068
Gastric varices 23.88 9.46 19 263191 584 70664650
Pain in extremity 23.87 9.46 985 262225 327097 70338137
Drug eruption 23.48 9.46 237 262973 39259 70625975
Purpura 23.46 9.46 130 263080 17845 70647389
Rebound acid hypersecretion 23.41 9.46 10 263200 89 70665145
Neuroendocrine tumour 23.38 9.46 27 263183 1330 70663904
Cardioactive drug level increased 23.35 9.46 45 263165 3517 70661717
Pathogen resistance 23.33 9.46 10 263200 13269 70651965
Erythema dyschromicum perstans 23.29 9.46 9 263201 60 70665174
Gastrointestinal tract irritation 22.94 9.46 18 263192 542 70664692
Renal atrophy 22.85 9.46 30 263180 1687 70663547
Enterocolitis haemorrhagic 22.81 9.46 33 263177 2035 70663199
Myocardial ischaemia 22.80 9.46 161 263049 24039 70641195
Inappropriate antidiuretic hormone secretion 22.60 9.46 156 263054 23120 70642114
Pericarditis 22.60 9.46 203 263007 84502 70580732
Immune reconstitution inflammatory syndrome 22.48 9.46 10 263200 12980 70652254
Occupational exposure to air contaminants 22.45 9.46 11 263199 138 70665096
Bradycardia 22.26 9.46 613 262597 124002 70541232
Marasmus 22.24 9.46 22 263188 906 70664328
Idiopathic pulmonary fibrosis 22.24 9.46 53 263157 4798 70660436
Hypersensitivity pneumonitis 22.15 9.46 43 263167 3379 70661855
Hyperuricaemia 22.13 9.46 90 263120 10876 70654358
Osteonecrosis of jaw 22.01 9.46 241 262969 40761 70624473
Aplastic anaemia 21.88 9.46 121 263089 16595 70648639
Hip fracture 21.81 9.46 45 263165 28218 70637016
Angina pectoris 21.81 9.46 275 262935 48108 70617126
Sleep disorder due to a general medical condition 21.67 9.46 6 263204 10470 70654764
Hyperparathyroidism secondary 21.48 9.46 36 263174 2522 70662712
Hypoglycaemic coma 21.47 9.46 49 263161 4312 70660922
Blood creatine phosphokinase increased 21.47 9.46 333 262877 60930 70604304
Device issue 21.44 9.46 35 263175 23990 70641244
Neuropathy, ataxia, retinitis pigmentosa syndrome 21.41 9.46 8 263202 48 70665186
Musculoskeletal stiffness 21.27 9.46 403 262807 147357 70517877
Renal cyst 21.23 9.46 102 263108 13243 70651991
Weight decreased 21.16 9.46 939 262271 309549 70355685
Neoplasm progression 21.14 9.46 91 263119 45137 70620097
Fluid retention 21.07 9.46 143 263067 63242 70601992
Device difficult to use 21.02 9.46 7 263203 10842 70654392
Premature delivery 20.98 9.46 29 263181 21275 70643959
Pituitary tumour benign 20.97 9.46 35 263175 2444 70662790
Iron deficiency anaemia 20.87 9.46 152 263058 22920 70642314
Unevaluable event 20.70 9.46 111 263099 51952 70613282
Muscle relaxant therapy 20.66 9.46 11 263199 166 70665068
White blood cell count increased 20.63 9.46 368 262842 69205 70596029
Abdominal pain upper 20.61 9.46 897 262313 192705 70472529
Gait disturbance 20.57 9.46 526 262684 184580 70480654
Alanine aminotransferase increased 20.35 9.46 703 262507 146777 70518457
Macroglossia 20.32 9.46 23 263187 1108 70664126
Cholecystitis 20.26 9.46 139 263071 20562 70644672
Ventricular hypertrophy 20.17 9.46 62 263148 6522 70658712
Blood albumin decreased 20.15 9.46 146 263064 21981 70643253
Blood pressure decreased 20.14 9.46 463 262747 91052 70574182
Condition aggravated 20.07 9.46 1342 261868 426293 70238941
Hyponatraemic syndrome 20.00 9.46 19 263191 744 70664490
Gastrointestinal haemorrhage 19.98 9.46 659 262551 136749 70528485
Adverse drug reaction 19.97 9.46 116 263094 53228 70612006
Gallbladder disorder 19.81 9.46 123 263087 17589 70647645
Dialysis 19.56 9.46 121 263089 17281 70647953
Illness 19.52 9.46 57 263153 31734 70633500
Drug dependence 19.40 9.46 72 263138 37249 70627985
Cardio-respiratory arrest 19.38 9.46 260 262950 100417 70564817
Face oedema 19.37 9.46 162 263048 25477 70639757
Extravasation blood 19.22 9.46 14 263196 376 70664858
Nocturia 19.21 9.46 93 263117 12111 70653123
Limb discomfort 19.17 9.46 52 263158 29653 70635581
Hypersensitivity 19.11 9.46 679 262531 229133 70436101
Renal tubular acidosis 18.89 9.46 40 263170 3346 70661888
Urticaria 18.84 9.46 762 262448 162287 70502947
Anal prolapse 18.75 9.46 8 263202 71 70665163
Transplant rejection 18.64 9.46 24 263186 18147 70647087
Pancreatic carcinoma recurrent 18.54 9.46 10 263200 155 70665079
Hepatic encephalopathy 18.48 9.46 143 263067 21975 70643259
Nephrosclerosis 18.31 9.46 27 263183 1694 70663540
Vulvovaginal candidiasis 18.17 9.46 32 263178 2334 70662900
Blood pressure systolic increased 18.14 9.46 131 263079 57128 70608106
Coma 18.11 9.46 236 262974 91608 70573626
Peripheral venous disease 17.96 9.46 83 263127 10604 70654630
Infection 17.94 9.46 621 262589 210164 70455070
Dilatation atrial 17.89 9.46 40 263170 3472 70661762
Cardiac murmur 17.86 9.46 91 263119 12095 70653139
Tachypnoea 17.84 9.46 51 263159 28587 70636647
Bone erosion 17.78 9.46 18 263192 15155 70650079
Dermatitis exfoliative 17.77 9.46 82 263128 10469 70654765
Peptic ulcer 17.69 9.46 54 263156 5659 70659575
Cardiac arrest 17.54 9.46 455 262755 159379 70505855
Microcytic anaemia 17.47 9.46 48 263162 4741 70660493
Oropharyngeal oedema 17.44 9.46 13 263197 362 70664872
Chromaturia 17.42 9.46 148 263062 23380 70641854
Red cell distribution width increased 17.42 9.46 15 263195 13642 70651592
Respiratory tract congestion 17.41 9.46 24 263186 17629 70647605
Hypoacusis 17.40 9.46 48 263162 27221 70638013
Alcoholic liver disease 17.37 9.46 15 263195 518 70664716
Pelvic cyst 17.36 9.46 7 263203 53 70665181
Panniculitis 17.28 9.46 9 263201 10667 70654567
Hiccups 17.26 9.46 73 263137 8979 70656255
Chronic gastritis 17.13 9.46 40 263170 3573 70661661
Cold sweat 17.09 9.46 115 263095 16901 70648333
Melanoderma 17.08 9.46 13 263197 374 70664860
Stoma site haemorrhage 17.03 9.46 26 263184 1683 70663551
Unintentional medical device removal 16.91 9.46 3 263207 7121 70658113
Acute coronary syndrome 16.87 9.46 130 263080 19949 70645285
Sinus congestion 16.76 9.46 24 263186 17349 70647885
Urinary retention 16.72 9.46 281 262929 52239 70612995
Infusion site streaking 16.72 9.46 14 263196 463 70664771
Laryngeal pain 16.68 9.46 53 263157 5675 70659559
Blood magnesium decreased 16.56 9.46 103 263107 14738 70650496
Hypophagia 16.54 9.46 231 262979 41339 70623895
Aortic dissection 16.53 9.46 41 263169 3806 70661428
Dermatitis bullous 16.47 9.46 92 263118 12665 70652569
Atypical fracture 16.46 9.46 16 263194 645 70664589
Cerebral mass effect 16.45 9.46 26 263184 1734 70663500
Arthritis 16.42 9.46 260 262950 97720 70567514
Embolic cerebral infarction 16.42 9.46 21 263189 1151 70664083
Oesophageal mucosal tear 16.38 9.46 5 263205 14 70665220
Renal hypertension 16.30 9.46 10 263200 200 70665034
Electrocardiogram QRS complex prolonged 16.27 9.46 8 263202 9798 70655436
Drug use disorder 16.25 9.46 5 263205 8146 70657088
Contraindication to medical treatment 16.23 9.46 21 263189 1164 70664070
Nightmare 16.21 9.46 139 263071 22017 70643217
Flashback 16.21 9.46 11 263199 263 70664971
Cerebellar infarction 16.20 9.46 38 263172 3404 70661830
Eye haemorrhage 16.16 9.46 71 263139 8878 70656356
Penile curvature 16.13 9.46 5 263205 15 70665219
Cholelithiasis 16.08 9.46 256 262954 47084 70618150
Knee arthroplasty 16.04 9.46 69 263141 34232 70631002
Neutrophil count increased 16.03 9.46 161 263049 26634 70638600
Paraesthesia oral 15.97 9.46 105 263105 15312 70649922
Alanine aminotransferase abnormal 15.96 9.46 5 263205 8054 70657180
Oral candidiasis 15.94 9.46 152 263058 24800 70640434
Sepsis 15.86 9.46 1082 262128 243463 70421771
Pharyngeal oedema 15.72 9.46 106 263104 15590 70649644
Bleeding time prolonged 15.64 9.46 21 263189 1207 70664027
Product substitution issue 15.63 9.46 120 263090 18393 70646841
Basal cell carcinoma 15.63 9.46 68 263142 33630 70631604
Temperature intolerance 15.60 9.46 69 263141 8654 70656580
Brain stem haemorrhage 15.54 9.46 24 263186 1569 70663665
Spleen congestion 15.48 9.46 13 263197 432 70664802
Staphylococcus test positive 15.47 9.46 53 263157 5901 70659333
Sinus node dysfunction 15.40 9.46 60 263150 7109 70658125
Blood gastrin increased 15.40 9.46 6 263204 41 70665193
Autonomic neuropathy 15.35 9.46 25 263185 1710 70663524
Therapeutic response shortened 15.31 9.46 15 263195 12823 70652411
Incorrect dose administered 15.24 9.46 166 263044 66553 70598681
Failure to anastomose 15.23 9.46 10 263200 226 70665008
Injection site mass 15.20 9.46 28 263182 18315 70646919
Gallbladder injury 15.13 9.46 20 263190 1132 70664102
Haemorrhagic cerebral infarction 15.06 9.46 22 263188 1369 70663865
Vasculitic rash 15.04 9.46 27 263183 1999 70663235
Mental status changes 14.81 9.46 156 263054 62945 70602289
Hepatorenal syndrome 14.77 9.46 40 263170 3917 70661317
Dermatitis acneiform 14.69 9.46 69 263141 8876 70656358
Pulmonary thrombosis 14.68 9.46 12 263198 11196 70654038
Follicular mucinosis 14.65 9.46 5 263205 22 70665212
Malignant melanoma 14.63 9.46 18 263192 13882 70651352
Ascites 14.63 9.46 341 262869 67206 70598028
Activated partial thromboplastin time prolonged 14.62 9.46 93 263117 13412 70651822
Urine phosphorus decreased 14.60 9.46 6 263204 48 70665186
Product quality issue 14.59 9.46 61 263149 30500 70634734
Rash maculo-papular 14.51 9.46 266 262944 50279 70614955
Sedation complication 14.51 9.46 17 263193 13393 70651841
Cholecystitis acute 14.50 9.46 85 263125 11909 70653325
Abortion spontaneous 14.49 9.46 50 263160 26429 70638805
Hypocalciuria 14.47 9.46 5 263205 23 70665211
Radiation pneumonitis 14.46 9.46 38 263172 3655 70661579
Coagulation test abnormal 14.37 9.46 20 263190 1190 70664044
Central nervous system lesion 14.34 9.46 15 263195 12438 70652796
Cardiotoxicity 14.31 9.46 12 263198 11058 70654176
Drug-induced liver injury 14.30 9.46 290 262920 55823 70609411
Fasciitis 14.29 9.46 16 263194 762 70664472
Post transplant lymphoproliferative disorder 14.17 9.46 11 263199 10534 70654700
Injection site haemorrhage 14.10 9.46 48 263162 25479 70639755
Joint dislocation 14.09 9.46 20 263190 14511 70650723
Foetal death 14.02 9.46 3 263207 6236 70658998
Blood cholinesterase decreased 13.94 9.46 10 263200 262 70664972
Hyperprolactinaemia 13.94 9.46 42 263168 4371 70660863
Bone pain 13.90 9.46 121 263089 50701 70614533
Dysuria 13.85 9.46 243 262967 45551 70619683
Renal disorder 13.85 9.46 208 263002 37801 70627433
Palpitations 13.82 9.46 522 262688 110231 70555003
Underdose 13.81 9.46 59 263151 29324 70635910
Oesophageal anastomosis 13.80 9.46 3 263207 0 70665234
Lip blister 13.80 9.46 29 263181 2413 70662821
Cerebral ventricular rupture 13.78 9.46 12 263198 419 70664815
Impaired quality of life 13.73 9.46 8 263202 8908 70656326
Disease progression 13.69 9.46 460 262750 156212 70509022
Lymphangiosis carcinomatosa 13.69 9.46 25 263185 1876 70663358
Pressure of speech 13.65 9.46 18 263192 1017 70664217
Intestinal ischaemia 13.63 9.46 84 263126 11980 70653254
Diabetic metabolic decompensation 13.62 9.46 33 263177 3019 70662215
Device use error 13.54 9.46 4 263206 6692 70658542
Muscle atrophy 13.53 9.46 75 263135 10295 70654939
Lymphocyte count decreased 13.52 9.46 232 262978 43307 70621927
Immunodeficiency 13.50 9.46 28 263182 17527 70647707
Heart rate decreased 13.49 9.46 156 263054 61859 70603375
Dissociation 13.49 9.46 35 263175 3341 70661893
Injection site warmth 13.43 9.46 19 263191 13806 70651428
Acute myocardial infarction 13.42 9.46 360 262850 72527 70592707
Rapid eye movement sleep behaviour disorder 13.39 9.46 11 263199 354 70664880
Multiple allergies 13.39 9.46 6 263204 7754 70657480
Respiratory muscle weakness 13.37 9.46 10 263200 280 70664954
Hypozincaemia 13.35 9.46 6 263204 61 70665173
Embolic stroke 13.29 9.46 58 263152 7231 70658003
Blood uric acid increased 13.26 9.46 68 263142 9061 70656173
Phyllodes tumour 13.25 9.46 5 263205 31 70665203
Disability 13.21 9.46 22 263188 14961 70650273
Ulcer 13.19 9.46 150 263060 25604 70639630
Cystitis 13.18 9.46 111 263099 46830 70618404
Osteoporosis 13.13 9.46 117 263093 48790 70616444
Skin oedema 13.10 9.46 22 263188 1544 70663690
Renal artery stenosis 13.07 9.46 34 263176 3250 70661984
Total lung capacity decreased 13.06 9.46 25 263185 1944 70663290
Gastroenteritis 13.05 9.46 175 263035 31038 70634196
Hypervolaemia 12.99 9.46 90 263120 39616 70625618
Hydronephrosis 12.98 9.46 99 263111 15143 70650091
Epstein-Barr virus infection 12.96 9.46 18 263192 13180 70652054
Cutaneous lupus erythematosus 12.93 9.46 31 263179 2817 70662417
Blood loss anaemia 12.92 9.46 21 263189 14420 70650814
Hallucination, visual 12.90 9.46 166 263044 29171 70636063
Glomerulosclerosis 12.89 9.46 17 263193 960 70664274
Breast cancer female 12.80 9.46 12 263198 10474 70654760
Wall motion score index abnormal 12.79 9.46 7 263203 112 70665122
Ischaemic nephropathy 12.73 9.46 5 263205 35 70665199
Hypotension 12.73 9.46 1310 261900 403071 70262163
Mouth haemorrhage 12.69 9.46 73 263137 10158 70655076
Hypochloraemia 12.69 9.46 26 263184 2125 70663109
Glossitis 12.67 9.46 34 263176 3312 70661922
Blood parathyroid hormone decreased 12.66 9.46 9 263201 9015 70656219
Food allergy 12.64 9.46 8 263202 8516 70656718
Central nervous system mass 12.62 9.46 7 263203 115 70665119
Bile duct stone 12.57 9.46 45 263165 5121 70660113
Hypoglycaemia 12.56 9.46 448 262762 93916 70571318
Putamen haemorrhage 12.53 9.46 12 263198 475 70664759
Abnormal faeces 12.52 9.46 53 263157 6520 70658714
Clostridium test positive 12.52 9.46 43 263167 4793 70660441
Skin necrosis 12.52 9.46 26 263184 16265 70648969
Injury 12.52 9.46 324 262886 64921 70600313
Hypoalbuminaemia 12.47 9.46 117 263093 19005 70646229
Gastrointestinal stoma output increased 12.41 9.46 9 263201 240 70664994
Substance abuse 12.31 9.46 11 263199 9826 70655408
Oculomucocutaneous syndrome 12.31 9.46 10 263200 317 70664917
Poor venous access 12.28 9.46 23 263187 14948 70650286
Multiple organ dysfunction syndrome 12.27 9.46 506 262704 108009 70557225
Hypoperfusion 12.26 9.46 28 263182 2465 70662769
Genital ulceration 12.20 9.46 14 263196 685 70664549
Rectal ulcer haemorrhage 12.16 9.46 9 263201 248 70664986
Adverse event 12.14 9.46 121 263089 49340 70615894
Myelosuppression 12.13 9.46 64 263146 30081 70635153
Autoimmune disorder 12.10 9.46 64 263146 8632 70656602
Product monitoring error 12.07 9.46 5 263205 6771 70658463
Gastric ulcer haemorrhage 12.06 9.46 63 263147 8455 70656779
Mesenteric artery embolism 12.06 9.46 6 263204 78 70665156
Tongue disorder 12.05 9.46 19 263191 13208 70652026
Heart rate irregular 12.05 9.46 63 263147 29680 70635554
Vascular skin disorder 12.02 9.46 4 263206 16 70665218
Vulval haemorrhage 12.02 9.46 4 263206 16 70665218
Burning feet syndrome 12.02 9.46 8 263202 185 70665049
Violence-related symptom 11.99 9.46 14 263196 698 70664536
Gamma-glutamyltransferase increased 11.96 9.46 259 262951 50426 70614808
N-telopeptide urine increased 11.95 9.46 5 263205 42 70665192
Strangury 11.95 9.46 8 263202 187 70665047
Generalised bullous fixed drug eruption 11.91 9.46 7 263203 129 70665105
Pneumocystis jirovecii pneumonia 11.90 9.46 167 263043 29915 70635319
Erythema 11.90 9.46 877 262333 198686 70466548
Ileus 11.89 9.46 140 263070 24097 70641137
Product complaint 11.89 9.46 82 263128 12149 70653085
Tongue discolouration 11.87 9.46 34 263176 3440 70661794
Discoloured vomit 11.86 9.46 19 263191 1282 70663952
Aphasia 11.86 9.46 226 262984 43023 70622211
Procedural failure 11.86 9.46 6 263204 81 70665153
Drug level below therapeutic 11.85 9.46 9 263201 8714 70656520
Sinus bradycardia 11.84 9.46 137 263073 23486 70641748
Rash papulosquamous 11.82 9.46 7 263203 131 70665103
Haemoglobin decreased 11.80 9.46 899 262311 204260 70460974
Rash erythematous 11.79 9.46 263 262947 51455 70613779
Skin toxicity 11.75 9.46 6 263204 7192 70658042
Sinobronchitis 11.75 9.46 5 263205 44 70665190
Anti A antibody 11.73 9.46 3 263207 3 70665231
Lymphadenopathy 11.71 9.46 120 263090 48671 70616563
Colon cancer 11.68 9.46 92 263118 14214 70651020
Oral mucosal discolouration 11.66 9.46 10 263200 342 70664892
Incision site complication 11.66 9.46 14 263196 719 70664515
Laryngotracheal oedema 11.66 9.46 5 263205 45 70665189
Discharge 11.63 9.46 18 263192 1179 70664055
Wheezing 11.55 9.46 443 262767 93727 70571507
Pharyngotonsillitis 11.53 9.46 9 263201 269 70664965
Immobilisation syndrome 11.51 9.46 11 263199 434 70664800
Inflammatory bowel disease 11.47 9.46 43 263167 5003 70660231
Laboratory test abnormal 11.44 9.46 53 263157 25770 70639464
Helicobacter test positive 11.38 9.46 18 263192 1201 70664033
Oesophageal carcinoma recurrent 11.38 9.46 5 263205 48 70665186
Urine calcium/creatinine ratio increased 11.37 9.46 7 263203 141 70665093
Dermatitis atopic 11.36 9.46 10 263200 8997 70656237
Prostatic specific antigen increased 11.36 9.46 11 263199 9455 70655779
Congenital bowing of long bones 11.31 9.46 4 263206 20 70665214
Urinary straining 11.29 9.46 5 263205 49 70665185
Lymphocyte stimulation test positive 11.25 9.46 17 263193 1090 70664144
Rash morbilliform 11.19 9.46 45 263165 5410 70659824
Aortic aneurysm rupture 11.16 9.46 18 263192 1221 70664013
Uveitis 11.15 9.46 24 263186 14821 70650413
Atrioventricular block 11.14 9.46 83 263127 12605 70652629
Gastroenteritis staphylococcal 11.14 9.46 9 263201 283 70664951
Complication of device insertion 11.13 9.46 3 263207 5329 70659905
Erythema annulare 11.07 9.46 7 263203 148 70665086
Gallbladder hypofunction 11.06 9.46 11 263199 456 70664778
Medication error 11.03 9.46 283 262927 56629 70608605
Product prescribing error 10.99 9.46 92 263118 38860 70626374
Joint injury 10.94 9.46 57 263153 26875 70638359
Parakeratosis 10.93 9.46 10 263200 373 70664861
Transplant dysfunction 10.93 9.46 6 263204 6903 70658331
Respiratory tract oedema 10.91 9.46 14 263196 770 70664464
Cardiomegaly 10.84 9.46 139 263071 24406 70640828
Acanthosis 10.81 9.46 11 263199 469 70664765
Atypical femur fracture 10.79 9.46 41 263169 4802 70660432
Gynaecomastia 10.74 9.46 52 263158 6771 70658463
Presyncope 10.74 9.46 197 263013 37241 70627993
Regurgitation 10.72 9.46 25 263185 2231 70663003
Pulmonary fibrosis 10.71 9.46 183 263027 34127 70631107
Post cardiac arrest syndrome 10.71 9.46 4 263206 24 70665210
Rectocele 10.67 9.46 12 263198 574 70664660
General physical health deterioration 10.67 9.46 743 262467 235288 70429946
Hypoaesthesia 10.65 9.46 464 262746 153275 70511959
Herpes zoster 10.62 9.46 238 262972 84997 70580237
Cystitis noninfective 10.62 9.46 18 263192 1273 70663961
Oedema 10.59 9.46 478 262732 103103 70562131
Rash vesicular 10.57 9.46 43 263167 5197 70660037
Paramnesia 10.57 9.46 4 263206 25 70665209
Papule 10.49 9.46 51 263159 6652 70658582
Lung opacity 10.49 9.46 34 263176 3679 70661555
Hospice care 10.48 9.46 9 263201 8196 70657038
Acute graft versus host disease 10.48 9.46 12 263198 9550 70655684
Fibrin degradation products increased 10.47 9.46 9 263201 309 70664925
Tumour haemorrhage 10.44 9.46 34 263176 3688 70661546
Myositis 10.42 9.46 105 263105 17384 70647850
Hyperlipasaemia 10.38 9.46 16 263194 1044 70664190
Surgery 10.29 9.46 67 263143 29922 70635312
Meniere's disease 10.29 9.46 7 263203 168 70665066
Thrombotic cerebral infarction 10.29 9.46 11 263199 497 70664737
Periprosthetic fracture 10.28 9.46 12 263198 598 70664636
Gingivitis 10.26 9.46 59 263151 8211 70657023
Hemiparesis 10.25 9.46 169 263041 31300 70633934
Diffuse vasculitis 10.24 9.46 6 263204 110 70665124
Narrow anterior chamber angle 10.22 9.46 7 263203 170 70665064
Finger deformity 10.19 9.46 5 263205 6131 70659103
Rash macular 10.18 9.46 142 263068 25402 70639832
Feeling of body temperature change 10.16 9.46 41 263169 4938 70660296
Paradoxical drug reaction 10.15 9.46 6 263204 6630 70658604
Cerebral hyperperfusion syndrome 10.14 9.46 6 263204 112 70665122
Pyelonephritis acute 10.14 9.46 44 263166 5473 70659761
Thrombosis 10.14 9.46 208 263002 75197 70590037
Hepatic cancer metastatic 10.13 9.46 14 263196 827 70664407
Dialysis hypotension 10.12 9.46 5 263205 64 70665170
Metaplasia 10.11 9.46 10 263200 412 70664822
Pleuritic pain 10.09 9.46 62 263148 8835 70656399
Drug tolerance decreased 10.07 9.46 13 263197 9820 70655414
Mucormycosis 9.98 9.46 9 263201 8005 70657229
Small intestinal haemorrhage 9.98 9.46 35 263175 3943 70661291
Fat redistribution 9.96 9.46 6 263204 116 70665118
Gamma-glutamyltransferase 9.95 9.46 4 263206 30 70665204
Hepatic atrophy 9.91 9.46 10 263200 422 70664812
Progressive multifocal leukoencephalopathy 9.88 9.46 112 263098 19102 70646132
Oesophageal ulcer 9.87 9.46 49 263161 6445 70658789
Blood electrolytes increased 9.85 9.46 5 263205 68 70665166
Physical deconditioning 9.83 9.46 19 263191 1488 70663746
Gastrointestinal stoma output decreased 9.82 9.46 6 263204 119 70665115
Sputum retention 9.80 9.46 15 263195 973 70664261
Sterile pyuria 9.78 9.46 5 263205 69 70665165
Nasal mucosal erosion 9.78 9.46 5 263205 69 70665165
Chondrocalcinosis 9.78 9.46 13 263197 740 70664494
Morbid thoughts 9.74 9.46 13 263197 743 70664491
Pre-eclampsia 9.73 9.46 6 263204 6479 70658755
Dysentery 9.73 9.46 15 263195 979 70664255
Periorbital discomfort 9.73 9.46 4 263206 32 70665202
Electrocardiogram ST-T segment abnormal 9.72 9.46 11 263199 530 70664704
Gastric varices haemorrhage 9.70 9.46 9 263201 342 70664892
Oropharyngeal swelling 9.70 9.46 17 263193 1235 70663999
Culture throat positive 9.68 9.46 3 263207 9 70665225
Drug tolerance 9.67 9.46 8 263202 7420 70657814
Sluggishness 9.63 9.46 5 263205 5938 70659296
Stevens-Johnson syndrome 9.63 9.46 187 263023 35720 70629514
Malignant neoplasm progression 9.61 9.46 548 262662 121191 70544043
Platelet transfusion 9.56 9.46 23 263187 2095 70663139
Large intestinal ulcer 9.54 9.46 37 263173 4375 70660859
Onychomycosis 9.53 9.46 7 263203 6894 70658340
Single functional kidney 9.52 9.46 6 263204 126 70665108
Gastrointestinal toxicity 9.51 9.46 6 263204 6399 70658835
Abdominal wound dehiscence 9.49 9.46 8 263202 267 70664967

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
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
Prevacid 24 HR HUMAN OTC DRUG LABEL 1 0113-6002 CAPSULE, DELAYED RELEASE 15 mg ORAL NDA 16 sections
Prevacid 24 HR HUMAN OTC DRUG LABEL 1 0113-6002 CAPSULE, DELAYED RELEASE 15 mg ORAL NDA 16 sections
Basic Care Lansoprazole HUMAN OTC DRUG LABEL 1 0113-7003 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 16 sections
basic care lansoprazole HUMAN OTC DRUG LABEL 1 0113-7116 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL NDA 16 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0363-0739 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 15 sections
lansoprazole HUMAN OTC DRUG LABEL 1 0363-1212 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 16 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0363-1419 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL NDA 16 sections
Lansoprazole HUMAN OTC DRUG LABEL 1 0363-4069 CAPSULE, DELAYED RELEASE 15 mg ORAL ANDA 16 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-6981 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-6981 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 15 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-6982 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 30 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-6982 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 30 mg ORAL ANDA 29 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-8015 CAPSULE, DELAYED RELEASE PELLETS 15 mg ORAL ANDA 30 sections
Lansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-8015 CAPSULE, DELAYED RELEASE PELLETS 15 mg ORAL ANDA 30 sections