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

Stem definitionDrug idCAS RN
antiulcer, benzimidazole derivatives 2350 117976-89-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sodium rabeprazole
  • rabeprazole
  • rabeprazole sodium
  • habeprazole
  • aciphex
  • rabeprazole sodium salt
A 4-(3-methoxypropoxy)-3-methylpyridinyl 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.
  • Molecular weight: 359.44
  • Formula: C18H21N3O3S
  • CLOGP: 2.08
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 77.10
  • ALOGS: -3.03
  • ROTB: 8

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 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) 1.50 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 52 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 19, 1999 FDA EISAI INC

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
Obstructive airways disorder 228.73 9.95 177 61328 20522 63406995
Eosinophilic bronchitis 221.56 9.95 60 61445 513 63427004
Eosinophil count increased 216.84 9.95 134 61371 10794 63416723
Pemphigus 159.05 9.95 4 61501 183722 63243795
Reversible airways obstruction 145.73 9.95 58 61447 1784 63425733
Vital capacity decreased 142.27 9.95 56 61449 1672 63425845
Sputum culture positive 136.62 9.95 58 61447 2109 63425408
Maternal exposure during pregnancy 134.89 9.95 25 61480 220037 63207480
Bronchial secretion retention 125.98 9.95 59 61446 2714 63424803
Neutrophilia 116.30 9.95 65 61440 4341 63423176
Oral discomfort 111.15 9.95 83 61422 9118 63418399
Full blood count abnormal 104.66 9.95 141 61364 31576 63395941
Gastrooesophageal reflux disease 103.24 9.95 262 61243 95377 63332140
Synovitis 102.89 9.95 27 61478 186891 63240626
Polyp 102.32 9.95 69 61436 6452 63421065
Glossodynia 100.06 9.95 25 61480 178851 63248666
Hand deformity 97.93 9.95 18 61487 159439 63268078
Pericarditis 97.44 9.95 8 61497 131571 63295946
Loss of employment 96.59 9.95 46 61459 2198 63425319
Alopecia 93.23 9.95 114 61391 337422 63090095
Wound 92.92 9.95 22 61483 163241 63264276
Completed suicide 90.42 9.95 16 61489 145657 63281860
Anti-cyclic citrullinated peptide antibody positive 83.52 9.95 8 61497 116204 63311313
Systemic lupus erythematosus 82.67 9.95 50 61455 208868 63218649
Multiple allergies 81.95 9.95 83 61422 13719 63413798
Hepatic function abnormal 75.63 9.95 132 61373 37010 63390507
Nasal disorder 72.20 9.95 41 61464 2823 63424694
Upper-airway cough syndrome 72.10 9.95 71 61434 11347 63416170
Discomfort 66.28 9.95 40 61465 167334 63260183
Duodenal ulcer perforation 65.40 9.95 5 61500 87204 63340313
Interstitial lung disease 65.12 9.95 168 61337 61740 63365777
Gastric disorder 62.48 9.95 122 61383 37247 63390270
Toxicity to various agents 61.61 9.95 90 61415 247160 63180357
Rheumatoid factor positive 60.14 9.95 6 61499 84400 63343117
Hepatic steatosis 59.56 9.95 103 61402 28666 63398851
Sputum purulent 58.43 9.95 26 61479 1061 63426456
Nicotine dependence 58.20 9.95 23 61482 694 63426823
Hypomagnesaemia 57.04 9.95 101 61404 28636 63398881
Tonsillar disorder 56.96 9.95 26 61479 1127 63426390
Product dose omission issue 56.72 9.95 87 61418 234226 63193291
Exposure during pregnancy 56.42 9.95 41 61464 155506 63272011
Secondary immunodeficiency 55.44 9.95 27 61478 1356 63426161
Drug abuse 54.82 9.95 4 61501 72514 63355003
Death 54.08 9.95 184 61321 374197 63053320
Pulmonary mass 53.60 9.95 86 61419 22510 63405007
Gastric polyps 53.35 9.95 36 61469 3369 63424148
Asthma 52.72 9.95 254 61251 127307 63300210
Helicobacter infection 49.90 9.95 14 61491 92771 63334746
Colitis microscopic 49.76 9.95 53 61452 9286 63418231
Hiatus hernia 46.92 9.95 79 61426 21515 63406002
Bacterial infection 45.96 9.95 74 61431 19425 63408092
Cough 45.37 9.95 458 61047 292285 63135232
Cestode infection 45.10 9.95 15 61490 272 63427245
Cholecystitis chronic 43.59 9.95 52 61453 10309 63417208
Lichen sclerosus 39.56 9.95 20 61485 1089 63426428
Rheumatoid arthritis 39.26 9.95 397 61108 253422 63174095
Pneumothorax spontaneous 38.68 9.95 18 61487 816 63426701
Drug eruption 37.83 9.95 85 61420 28609 63398908
Platelet count decreased 37.50 9.95 216 61289 115906 63311611
Respiratory tract infection 36.07 9.95 105 61400 41378 63386139
Hypertonic bladder 36.00 9.95 29 61476 3559 63423958
Lung diffusion test decreased 35.30 9.95 16 61489 682 63426835
Arthropathy 34.81 9.95 114 61391 234678 63192839
Erythema multiforme 34.75 9.95 46 61459 10123 63417394
Magnesium deficiency 34.54 9.95 15 61490 577 63426940
Fatigue 34.45 9.95 630 60875 887398 62540119
Myocardial infarction 32.37 9.95 186 61319 99707 63327810
Tubulointerstitial nephritis 32.08 9.95 64 61441 19839 63407678
Blood pressure fluctuation 31.77 9.95 108 61397 46209 63381308
Premenstrual syndrome 31.74 9.95 15 61490 704 63426813
Enterocolitis haemorrhagic 31.70 9.95 19 61486 1447 63426070
Neutrophil count decreased 31.48 9.95 123 61382 56283 63371234
Polymyalgia rheumatica 30.54 9.95 27 61478 3764 63423753
Sputum culture 30.23 9.95 11 61494 263 63427254
Malignant polyp 30.08 9.95 10 61495 181 63427336
Treatment failure 29.25 9.95 97 61408 198946 63228571
Drug intolerance 28.80 9.95 178 61327 308483 63119034
Liver disorder 28.30 9.95 115 61390 53572 63373945
Lip pruritus 27.83 9.95 15 61490 932 63426585
Tubulointerstitial nephritis and uveitis syndrome 27.65 9.95 10 61495 235 63427282
Hypertension 27.47 9.95 401 61104 278902 63148615
C-reactive protein abnormal 26.62 9.95 6 61499 46090 63381427
Limb mass 26.00 9.95 23 61482 3209 63424308
Hypokalaemia 25.99 9.95 181 61324 103623 63323894
Hypereosinophilic syndrome 25.81 9.95 10 61495 286 63427231
Adenocarcinoma 25.76 9.95 22 61483 2928 63424589
Cardiac failure 25.69 9.95 161 61344 88981 63338536
Product use issue 25.66 9.95 118 61387 220402 63207115
Hepatic enzyme increased 25.53 9.95 105 61400 202223 63225294
Abdominal distension 25.32 9.95 157 61348 86458 63341059
Intra-abdominal fluid collection 25.16 9.95 20 61485 2409 63425108
Renal impairment 25.11 9.95 159 61346 88196 63339321
Malaise 24.55 9.95 551 60954 415403 63012114
Hyponatraemia 24.52 9.95 189 61316 111711 63315806
Blood pressure increased 24.32 9.95 252 61253 161810 63265707
Polymenorrhoea 24.29 9.95 15 61490 1206 63426311
Blood pressure diastolic decreased 24.26 9.95 62 61443 22644 63404873
Cerebral infarction 24.25 9.95 64 61441 23829 63403688
Body temperature fluctuation 24.06 9.95 19 61486 2266 63425251
Cardiac failure congestive 23.63 9.95 162 61343 92271 63335246
Biliary dyskinesia 23.12 9.95 20 61485 2709 63424808
Non-economic loss 22.79 9.95 5 61500 15 63427502
Barotrauma 22.44 9.95 8 61497 180 63427337
Upper respiratory tract inflammation 22.41 9.95 19 61486 2504 63425013
Abdominal pain 22.38 9.95 404 61101 293052 63134465
Red cell distribution width increased 22.20 9.95 38 61467 10486 63417031
Chronic kidney disease 22.17 9.95 95 61410 45303 63382214
Menstruation delayed 21.79 9.95 16 61489 1713 63425804
Focal segmental glomerulosclerosis 21.76 9.95 15 61490 1453 63426064
Hepatitis chronic active 21.59 9.95 6 61499 57 63427460
Neutropenia 21.35 9.95 92 61413 174913 63252604
Abdominal pain upper 21.32 9.95 299 61206 206145 63221372
Retinal toxicity 21.23 9.95 14 61491 1261 63426256
Lip infection 21.10 9.95 7 61498 126 63427391
Hepatotoxicity 21.04 9.95 5 61500 37036 63390481
Adverse event 20.59 9.95 21 61484 67538 63359979
Akathisia 20.59 9.95 34 61471 9112 63418405
Eosinophil count decreased 20.50 9.95 17 61488 2173 63425344
Irritable bowel syndrome 20.49 9.95 30 61475 82382 63345135
Blood alkaline phosphatase increased 20.28 9.95 89 61416 42878 63384639
Blister 19.94 9.95 62 61443 129752 63297765
Infection 19.92 9.95 135 61370 229038 63198479
Gamma-glutamyltransferase increased 19.63 9.95 75 61430 33956 63393561
Aortic dissection 19.59 9.95 16 61489 2002 63425515
Blood pressure systolic increased 19.28 9.95 94 61411 47303 63380214
Hypocalcaemia 19.21 9.95 71 61434 31642 63395875
Intervertebral disc degeneration 18.97 9.95 45 61460 15687 63411830
Foetal exposure during pregnancy 18.78 9.95 4 61501 31958 63395559
Inflammation 18.60 9.95 140 61365 82133 63345384
Radioallergosorbent test positive 18.54 9.95 5 61500 42 63427475
Clitoris abscess 18.49 9.95 4 61501 11 63427506
Aspartate aminotransferase increased 18.41 9.95 150 61355 90127 63337390
Condition aggravated 18.23 9.95 277 61228 401940 63025577
Fall 18.15 9.95 503 61002 391831 63035686
Multiple fractures 18.02 9.95 31 61474 8587 63418930
Arthralgia 18 9.95 698 60807 569012 62858505
Peripheral swelling 17.87 9.95 168 61337 265774 63161743
Coeliac artery occlusion 17.82 9.95 3 61502 0 63427517
Intentional product use issue 17.65 9.95 64 61441 127828 63299689
Lower respiratory tract infection viral 17.52 9.95 11 61494 910 63426607
Premature delivery 17.37 9.95 4 61501 30277 63397240
Blood pressure decreased 17.24 9.95 115 61390 64907 63362610
Dysstasia 16.90 9.95 52 61453 21114 63406403
Prescribed overdose 16.85 9.95 6 61499 34147 63393370
Hip arthroplasty 16.69 9.95 13 61492 47633 63379884
Therapy non-responder 16.65 9.95 30 61475 75871 63351646
Abdominal tenderness 16.59 9.95 29 61476 8137 63419380
Swelling 16.41 9.95 179 61326 275199 63152318
Heart rate increased 16.31 9.95 151 61354 94087 63333430
Dysphonia 16.30 9.95 90 61415 47524 63379993
Q fever 16.20 9.95 6 61499 151 63427366
Oral discharge 15.84 9.95 6 61499 161 63427356
Rib fracture 15.76 9.95 53 61452 22544 63404973
Sedation 15.74 9.95 9 61496 38800 63388717
Impaired healing 15.73 9.95 49 61456 102493 63325024
Therapy cessation 15.63 9.95 5 61500 30452 63397065
Overdose 15.61 9.95 58 61447 115020 63312497
Abdominal discomfort 15.57 9.95 218 61287 320667 63106850
Rubella 15.50 9.95 6 61499 171 63427346
Gallbladder injury 15.35 9.95 12 61493 1411 63426106
Lower limb fracture 15.33 9.95 55 61450 24166 63403351
Intentional product misuse 15.32 9.95 22 61483 60895 63366622
Infusion related reaction 15.27 9.95 158 61347 245363 63182154
Spinal compression fracture 15.26 9.95 39 61466 14244 63413273
Erosive oesophagitis 15.18 9.95 13 61492 1737 63425780
Emphysema 15.09 9.95 33 61472 10905 63416612
Iron deficiency anaemia 14.97 9.95 48 61457 19921 63407596
No adverse event 14.89 9.95 11 61494 41394 63386123
Gastric mucosal lesion 14.86 9.95 8 61497 496 63427021
Hypercholesterolaemia 14.85 9.95 50 61455 21284 63406233
Serum sickness 14.83 9.95 16 61489 2844 63424673
Pulmonary function test abnormal 14.68 9.95 13 61492 1817 63425700
Hepatocellular carcinoma 14.52 9.95 14 61491 2180 63425337
Knee arthroplasty 14.21 9.95 19 61486 54187 63373330
Chorioretinal disorder 14.17 9.95 5 61500 109 63427408
Disease progression 14.08 9.95 66 61439 122692 63304825
Microcytic anaemia 14.08 9.95 17 61488 3412 63424105
Gastric cancer 14.08 9.95 20 61485 4703 63422814
Alanine aminotransferase increased 14.00 9.95 158 61347 103612 63323905
Gastric volvulus 13.93 9.95 3 61502 8 63427509
Off label use 13.89 9.95 524 60981 673938 62753579
Hyperthyroidism 13.59 9.95 38 61467 14635 63412882
Disseminated intravascular coagulation 13.57 9.95 45 61460 19006 63408511
Macule 13.53 9.95 13 61492 2015 63425502
Suicide attempt 13.43 9.95 24 61481 60894 63366623
Heat stroke 13.37 9.95 9 61496 839 63426678
Gastric antral vascular ectasia 13.23 9.95 8 61497 619 63426898
Intentional overdose 13.18 9.95 33 61472 74119 63353398
Uveitis 13.12 9.95 34 61471 12519 63414998
Gastritis 13.10 9.95 71 61434 37232 63390285
Pneumonia aspiration 12.99 9.95 67 61438 34473 63393044
Giardiasis 12.98 9.95 4 61501 56 63427461
Product use in unapproved indication 12.95 9.95 111 61394 178969 63248548
Restrictive pulmonary disease 12.92 9.95 12 61493 1783 63425734
Melaena 12.91 9.95 61 61444 30304 63397213
Productive cough 12.87 9.95 105 61400 63103 63364414
Gingival pain 12.86 9.95 26 61479 8136 63419381
Liver iron concentration abnormal 12.86 9.95 4 61501 58 63427459
Tibia fracture 12.85 9.95 20 61485 5100 63422417
Mucosal inflammation 12.76 9.95 16 61489 46912 63380605
Cystitis 12.67 9.95 94 61411 54897 63372620
Tooth fracture 12.56 9.95 31 61474 11079 63416438
Auricular swelling 12.55 9.95 4 61501 63 63427454
Haemoglobin decreased 12.41 9.95 204 61301 145281 63282236
Confusional state 12.40 9.95 158 61347 236222 63191295
Anaemia 12.39 9.95 372 61133 293058 63134459
Haemolytic anaemia 12.25 9.95 29 61476 10096 63417421
Vaccination site pain 12.15 9.95 5 61500 168 63427349
Hypochromic anaemia 12.12 9.95 12 61493 1930 63425587
Medication error 12.07 9.95 20 61485 52264 63375253
Hypercapnia 11.97 9.95 20 61485 5411 63422106
Forced expiratory volume decreased 11.91 9.95 19 61486 4949 63422568
Mean cell haemoglobin concentration decreased 11.82 9.95 16 61489 3596 63423921
Adenocarcinoma gastric 11.80 9.95 7 61498 523 63426994
Sinusitis 11.70 9.95 152 61353 226501 63201016
Wrong technique in product usage process 11.67 9.95 27 61478 62313 63365204
Accidental exposure to product 11.63 9.95 6 61499 27399 63400118
Adverse drug reaction 11.59 9.95 39 61466 79675 63347842
General physical health deterioration 11.56 9.95 132 61373 201270 63226247
Pseudocholinesterase deficiency 11.48 9.95 4 61501 84 63427433
Premature baby 11.39 9.95 3 61502 20732 63406785
Gastric dysplasia 11.37 9.95 3 61502 23 63427494
Pain in extremity 11.36 9.95 410 61095 331076 63096441
Skin injury 11.28 9.95 11 61494 1737 63425780
Gallbladder disorder 11.26 9.95 42 61463 18800 63408717
Injection site erythema 11.22 9.95 42 61463 83132 63344385
Contraindicated product administered 11.22 9.95 146 61359 217502 63210015
Enteritis infectious 11.22 9.95 12 61493 2112 63425405
Injection site swelling 11.17 9.95 18 61487 47554 63379963
Joint space narrowing 11.09 9.95 7 61498 585 63426932
Gastrointestinal polyp haemorrhage 11.01 9.95 5 61500 214 63427303
Blood pressure systolic decreased 10.99 9.95 23 61482 7374 63420143
Gastrointestinal bacterial infection 10.98 9.95 8 61497 846 63426671
Femoral neck fracture 10.96 9.95 25 61480 8498 63419019
Unresponsive to stimuli 10.90 9.95 10 61495 33806 63393711
Intertrigo 10.83 9.95 7 61498 609 63426908
Ascites 10.77 9.95 72 61433 40656 63386861
Sleep disorder due to a general medical condition 10.73 9.95 31 61474 12157 63415360
Pneumonia 10.72 9.95 543 60962 456224 62971293
Compression fracture 10.71 9.95 21 61484 6427 63421090
Liver injury 10.70 9.95 27 61478 60493 63367024
Overlap syndrome 10.64 9.95 8 61497 888 63426629
Colon cancer 10.58 9.95 27 61478 9851 63417666
Stress at work 10.54 9.95 9 61496 1198 63426319
Prescribed underdose 10.53 9.95 8 61497 29681 63397836
Inflammatory pain 10.51 9.95 8 61497 904 63426613
Idiopathic interstitial pneumonia 10.48 9.95 3 61502 32 63427485
Pancreatic neuroendocrine tumour 10.41 9.95 6 61499 425 63427092
Superficial injury of eye 10.40 9.95 5 61500 244 63427273
Catheter site hypersensitivity 10.37 9.95 4 61501 113 63427404
Alternaria infection 10.36 9.95 5 61500 246 63427271
Beta-N-acetyl-D-glucosaminidase increased 10.32 9.95 3 61502 34 63427483
Pharyngeal oedema 10.30 9.95 33 61472 13688 63413829
Swollen tongue 10.11 9.95 63 61442 34737 63392780
Generalised oedema 10.08 9.95 36 61469 15782 63411735
Enterocolitis 10.05 9.95 23 61482 7835 63419682
Neck pain 10.01 9.95 107 61398 69211 63358306
Aphthous ulcer 10.00 9.95 33 61472 13905 63413612
Leukaemia 9.96 9.95 16 61489 4192 63423325

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
Interstitial lung disease 135.80 10.76 249 37571 65033 34854078
Hepatic function abnormal 123.85 10.76 193 37627 44170 34874941
Coombs positive haemolytic anaemia 113.94 10.76 42 37778 930 34918181
Needle fatigue 99.35 10.76 37 37783 844 34918267
Toxicity to various agents 96.78 10.76 48 37772 200314 34718797
Relapsing-remitting multiple sclerosis 93.04 10.76 37 37783 1013 34918098
Gait spastic 91.50 10.76 37 37783 1059 34918052
Lymphadenitis 87.16 10.76 43 37777 1985 34917126
Hypertonic bladder 84.53 10.76 41 37779 1823 34917288
Completed suicide 75.12 10.76 9 37811 98159 34820952
Drug abuse 69.05 10.76 12 37808 99084 34820027
Death 67.62 10.76 214 37606 397835 34521276
Monoparesis 64.70 10.76 37 37783 2309 34916802
Oesophageal pain 61.85 10.76 26 37794 823 34918288
Cerebral infarction 58.63 10.76 106 37714 27349 34891762
Parathyroid gland enlargement 56.90 10.76 16 37804 141 34918970
Upper respiratory fungal infection 55.36 10.76 16 37804 157 34918954
Product dose omission issue 52.90 10.76 32 37788 119679 34799432
Tetanus 49.39 10.76 12 37808 55 34919056
Off label use 48.96 10.76 261 37559 419263 34499848
Hypoparathyroidism secondary 48.03 10.76 14 37806 142 34918969
Movement disorder 46.95 10.76 62 37758 12186 34906925
Forced expiratory volume 46.39 10.76 13 37807 113 34918998
Hepatic cancer 44.98 10.76 50 37770 8225 34910886
Anorectal discomfort 43.77 10.76 27 37793 1937 34917174
Muscle spasticity 43.60 10.76 42 37778 5846 34913265
Drug ineffective 42.46 10.76 305 37515 456446 34462665
Gastrointestinal motility disorder 41.64 10.76 29 37791 2555 34916556
Gastrooesophageal reflux disease 41.57 10.76 112 37708 37812 34881299
Haemolysis 40.75 10.76 47 37773 8047 34911064
Central nervous system lesion 40.31 10.76 42 37778 6421 34912690
Micturition urgency 39.97 10.76 42 37778 6483 34912628
Nipple inflammation 39.95 10.76 10 37810 53 34919058
Migraine 39.26 10.76 69 37751 17409 34901702
Clumsiness 39.08 10.76 24 37796 1708 34917403
Hypergastrinaemia 37.58 10.76 10 37810 70 34919041
Asthma 35.30 10.76 114 37706 42542 34876569
Nocturia 35.06 10.76 49 37771 10161 34908950
Mycobacterium test positive 34.38 10.76 14 37806 408 34918703
Lung diffusion test decreased 32.26 10.76 15 37805 606 34918505
Ocular discomfort 32.19 10.76 23 37797 2111 34917000
Nerve degeneration 32.01 10.76 11 37809 197 34918914
Liver disorder 31.79 10.76 93 37727 32904 34886207
Occupational dermatitis 30.81 10.76 9 37811 92 34919019
Erythema multiforme 30.44 10.76 42 37778 8607 34910504
Treatment failure 29.71 10.76 7 37813 46690 34872421
Bronchopulmonary aspergillosis allergic 29.29 10.76 16 37804 913 34918198
Chronic kidney disease 28.72 10.76 104 37716 41106 34878005
Hypomagnesaemia 28.58 10.76 69 37751 21782 34897329
Hospitalisation 28.38 10.76 13 37807 56889 34862222
Tetany 28.20 10.76 15 37805 811 34918300
Nipple disorder 28.07 10.76 10 37810 200 34918911
Bronchial disorder 28.04 10.76 18 37802 1385 34917726
COVID-19 27.49 10.76 26 37794 77524 34841587
Drug eruption 27.28 10.76 64 37756 19834 34899277
Tendon disorder 26.13 10.76 23 37797 2852 34916259
Decreased appetite 26.10 10.76 285 37535 166107 34753004
Interstitial granulomatous dermatitis 25.60 10.76 9 37811 173 34918938
Hepatic encephalopathy 25.56 10.76 52 37768 14633 34904478
Lung disorder 25.41 10.76 89 37731 34607 34884504
Muscle strain 25.08 10.76 26 37794 3950 34915161
Intentional overdose 25.06 10.76 8 37812 43666 34875445
Renal cyst 24.57 10.76 39 37781 9054 34910057
Rhinitis 24.16 10.76 32 37788 6306 34912805
Ataxia 24.05 10.76 49 37771 13804 34905307
Product use in unapproved indication 23.67 10.76 58 37762 117441 34801670
Primary hypoparathyroidism 23.64 10.76 6 37814 34 34919077
Duodenal polyp 23.47 10.76 9 37811 223 34918888
Blood pressure increased 23.17 10.76 169 37651 87933 34831178
Enterocolitis haemorrhagic 23.15 10.76 14 37806 969 34918142
Nephrectomy 23.12 10.76 13 37807 785 34918326
Platelet count decreased 23.07 10.76 214 37606 119503 34799608
Chest discomfort 22.84 10.76 118 37702 54412 34864699
Gastric polyps 22.71 10.76 15 37805 1211 34917900
Occupational exposure to air contaminants 22.65 10.76 8 37812 156 34918955
Tubulointerstitial nephritis 21.94 10.76 61 37759 20963 34898148
Haemochromatosis 21.84 10.76 14 37806 1074 34918037
Infusion related reaction 21.66 10.76 114 37706 52943 34866168
IIIrd nerve paresis 21.52 10.76 7 37813 105 34919006
Disseminated intravascular coagulation 21.50 10.76 62 37758 21754 34897357
Carotid arteriosclerosis 21.31 10.76 17 37803 1841 34917270
Hypocalcaemia 21.08 10.76 66 37754 24223 34894888
Erectile dysfunction 20.68 10.76 59 37761 20578 34898533
Idiopathic pulmonary fibrosis 20.33 10.76 22 37798 3512 34915599
Hepatocellular carcinoma 20.00 10.76 32 37788 7477 34911634
Ear discomfort 19.85 10.76 19 37801 2623 34916488
Gastric adenoma 19.66 10.76 4 37816 6 34919105
Mycobacterial infection 19.62 10.76 18 37802 2356 34916755
Haemorrhagic cerebral infarction 19.48 10.76 12 37808 859 34918252
Pollakiuria 19.47 10.76 56 37764 19618 34899493
Nasopharyngitis 19.43 10.76 136 37684 69832 34849279
Anxiety 19.28 10.76 178 37642 99250 34819861
Gastric cancer 19.23 10.76 29 37791 6440 34912671
Fatigue 19.21 10.76 284 37536 370369 34548742
Dyslalia 18.64 10.76 10 37810 550 34918561
Bronchiectasis 18.62 10.76 36 37784 9765 34909346
Hypoaesthesia 18.59 10.76 122 37698 61322 34857789
Cardiac failure 18.53 10.76 165 37655 91083 34828028
Complex regional pain syndrome 18.53 10.76 10 37810 557 34918554
Eczema 17.79 10.76 52 37768 18384 34900727
Sneezing 17.76 10.76 25 37795 5217 34913894
Multiple sclerosis relapse 17.74 10.76 42 37778 13091 34906020
Polymyalgia rheumatica 17.71 10.76 14 37806 1496 34917615
Sitting disability 17.42 10.76 7 37813 197 34918914
Dysarthria 17.24 10.76 79 37741 34703 34884408
Benign prostatic hyperplasia 17.09 10.76 44 37776 14451 34904660
Bone density decreased 16.67 10.76 15 37805 1914 34917197
Device breakage 16.27 10.76 16 37804 2284 34916827
Delusion of replacement 16.19 10.76 6 37814 135 34918976
Hyperuricaemia 15.84 10.76 30 37790 8013 34911098
Metaplasia 15.73 10.76 7 37813 255 34918856
Thrombosis 15.55 10.76 19 37801 50439 34868672
Renal impairment 15.31 10.76 163 37657 94350 34824761
Hyperventilation 15.24 10.76 17 37803 2807 34916304
Sinus congestion 15.08 10.76 24 37796 5581 34913530
Abdominal rigidity 14.68 10.76 12 37808 1345 34917766
Sensory disturbance 14.67 10.76 25 37795 6152 34912959
Foetal exposure during pregnancy 14.42 10.76 12 37808 38089 34881022
Blood pressure diastolic decreased 14.42 10.76 31 37789 9063 34910048
Nephroangiosclerosis 14.27 10.76 6 37814 190 34918921
General physical health deterioration 14.21 10.76 81 37739 128188 34790923
Leukocyte adhesion deficiency type I 14.15 10.76 4 37816 36 34919075
Gastrointestinal polyp haemorrhage 13.91 10.76 7 37813 337 34918774
Erythema of eyelid 13.83 10.76 10 37810 935 34918176
Altered state of consciousness 13.66 10.76 55 37765 22838 34896273
Sedation 13.66 10.76 3 37817 21003 34898108
Pyomyositis 13.58 10.76 6 37814 215 34918896
Malaise 13.55 10.76 279 37541 185546 34733565
Occupational exposure to product 13.34 10.76 7 37813 368 34918743
Thalamus haemorrhage 13.28 10.76 10 37810 995 34918116
Asthma-chronic obstructive pulmonary disease overlap syndrome 13.13 10.76 11 37809 1276 34917835
Cholangitis 13.08 10.76 29 37791 8660 34910451
Renal neoplasm 13.06 10.76 11 37809 1286 34917825
Dermatitis allergic 12.86 10.76 25 37795 6805 34912306
Injection site pain 12.76 10.76 14 37806 38991 34880120
Oxygen consumption increased 12.56 10.76 11 37809 1355 34917756
Neuropathy peripheral 12.53 10.76 47 37773 83216 34835895
Dizziness 12.48 10.76 317 37503 218204 34700907
Balance disorder 12.46 10.76 81 37739 40573 34878538
Obstruction 12.38 10.76 15 37805 2704 34916407
Premature baby 12.37 10.76 3 37817 19630 34899481
Drug intolerance 12.31 10.76 29 37791 59541 34859570
Heart rate decreased 12.13 10.76 67 37753 31678 34887433
Dermatitis acneiform 12.08 10.76 23 37797 6166 34912945
Hepatic enzyme increased 12.06 10.76 78 37742 39002 34880109
Bronchiolitis 12.05 10.76 16 37804 3160 34915951
Electrocardiogram abnormal 11.87 10.76 29 37791 9218 34909893
Angina pectoris 11.86 10.76 66 37754 31297 34887814
Constipation 11.80 10.76 211 37609 136771 34782340
Renal mass 11.75 10.76 12 37808 1792 34917319
Hypotension 11.73 10.76 169 37651 221480 34697631
Disease progression 11.57 10.76 69 37751 108008 34811103
Eye movement disorder 11.56 10.76 18 37802 4109 34915002
Folliculitis 11.54 10.76 19 37801 4547 34914564
Allergy to vaccine 11.53 10.76 3 37817 19 34919092
Abdominal discomfort 11.53 10.76 107 37713 59728 34859383
Blood immunoglobulin E increased 11.52 10.76 14 37806 2532 34916579
Glaucoma 11.47 10.76 24 37796 6888 34912223
Neck injury 11.35 10.76 10 37810 1241 34917870
Intentional product misuse 11.30 10.76 20 37800 45591 34873520
Pulmonary function test abnormal 11.24 10.76 14 37806 2596 34916515
Tachypnoea 11.19 10.76 3 37817 18349 34900762
Cerebral hypoperfusion 11.16 10.76 7 37813 517 34918594
Neurotoxicity 10.88 10.76 3 37817 18007 34901104
Enteritis infectious 10.80 10.76 10 37810 1324 34917787
Fibrin degradation products increased 10.80 10.76 5 37815 200 34918911

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
Interstitial lung disease 182.41 9.71 384 84809 112216 79546979
Hepatic function abnormal 178.09 9.71 297 84896 72810 79586385
Completed suicide 169.99 9.71 29 85164 245738 79413457
Toxicity to various agents 164.47 9.71 126 85067 421414 79237781
Obstructive airways disorder 132.85 9.71 166 85027 31293 79627902
Vital capacity decreased 124.26 9.71 53 85140 1763 79657432
Reversible airways obstruction 121.35 9.71 55 85138 2121 79657074
Drug abuse 119.79 9.71 16 85177 162675 79496520
Hypertonic bladder 113.25 9.71 65 85128 4136 79655059
Coombs positive haemolytic anaemia 108.29 9.71 42 85151 1088 79658107
Eosinophil count increased 105.78 9.71 110 85083 16995 79642200
Synovitis 97.37 9.71 21 85172 150713 79508482
Sputum culture positive 95.29 9.71 56 85137 3725 79655470
Maternal exposure during pregnancy 94.60 9.71 16 85177 136522 79522673
Needle fatigue 91.70 9.71 35 85158 867 79658328
Bronchial secretion retention 91.05 9.71 56 85137 4048 79655147
Full blood count abnormal 90.06 9.71 158 85035 40316 79618879
Pemphigus 89.32 9.71 4 85189 99578 79559617
Death 88.34 9.71 310 84883 566204 79092991
Loss of employment 86.13 9.71 46 85147 2541 79656654
Hypomagnesaemia 84.21 9.71 167 85026 46744 79612451
Gastrooesophageal reflux disease 84.20 9.71 274 84919 103972 79555223
Gait spastic 82.12 9.71 35 85158 1162 79658033
Cerebral infarction 78.87 9.71 160 85033 45516 79613679
Multiple allergies 77.09 9.71 74 85119 10386 79648809
Relapsing-remitting multiple sclerosis 74.12 9.71 35 85158 1484 79657711
Product dose omission issue 69.33 9.71 98 85095 247439 79411756
Pericarditis 68.38 9.71 14 85179 104222 79554973
Eosinophilic bronchitis 68.24 9.71 24 85169 468 79658727
Hand deformity 64.08 9.71 16 85177 103903 79555292
Lung diffusion test decreased 63.36 9.71 30 85163 1280 79657915
Anti-cyclic citrullinated peptide antibody positive 61.60 9.71 8 85185 83135 79576060
Treatment failure 61.37 9.71 55 85138 170431 79488764
Lymphadenitis 61.32 9.71 46 85147 4609 79654586
Gastric polyps 58.40 9.71 41 85152 3706 79655489
Nasal disorder 58.18 9.71 41 85152 3728 79655467
Platelet count decreased 57.81 9.71 381 84812 194283 79464912
Upper-airway cough syndrome 56.37 9.71 66 85127 11627 79647568
Liver disorder 56.36 9.71 188 85005 72229 79586966
Drug eruption 55.67 9.71 136 85057 43799 79615396
Duodenal ulcer perforation 55.27 9.71 4 85189 66207 79592988
Glossodynia 54.59 9.71 21 85172 103316 79555879
Erythema multiforme 54.49 9.71 80 85113 17571 79641624
Asthma 53.36 9.71 285 84908 134810 79524385
Tonsillar disorder 52.22 9.71 26 85167 1240 79657955
Wound 51.57 9.71 30 85163 116149 79543046
Alopecia 51.54 9.71 106 85087 231249 79427946
Blood pressure increased 51.31 9.71 394 84799 210966 79448229
Pulmonary mass 50.47 9.71 102 85091 28932 79630263
Rheumatoid arthritis 49.71 9.71 387 84806 208083 79451112
Tetanus 49.54 9.71 12 85181 55 79659140
Monoparesis 49.17 9.71 36 85157 3475 79655720
Enterocolitis haemorrhagic 48.83 9.71 30 85163 2164 79657031
Parathyroid gland enlargement 46.77 9.71 14 85179 159 79659036
Nicotine dependence 46.59 9.71 22 85171 933 79658262
Rheumatoid factor positive 46.21 9.71 5 85188 59834 79599361
Sputum purulent 44.95 9.71 24 85169 1325 79657870
Systemic lupus erythematosus 44.91 9.71 38 85155 121111 79538084
Cestode infection 44.13 9.71 15 85178 263 79658932
Forced expiratory volume 43.74 9.71 12 85181 97 79659098
Oral discomfort 43.61 9.71 53 85140 9707 79649488
Hypoparathyroidism secondary 42.96 9.71 14 85179 214 79658981
Colitis microscopic 42.57 9.71 55 85138 10713 79648482
Cardiac failure 41.17 9.71 295 84898 154547 79504648
Polymyalgia rheumatica 41.04 9.71 36 85157 4501 79654694
Hypocalcaemia 40.99 9.71 132 85061 49792 79609403
Nipple inflammation 40.56 9.71 10 85183 50 79659145
Tubulointerstitial nephritis 39.85 9.71 110 85083 38125 79621070
Lichen sclerosus 39.78 9.71 20 85173 974 79658221
Off label use 39.27 9.71 708 84485 906507 78752688
Hepatic cancer 38.87 9.71 52 85141 10477 79648718
Upper respiratory fungal infection 36.90 9.71 14 85179 341 79658854
Discomfort 36.89 9.71 48 85145 125569 79533626
Hypergastrinaemia 36.21 9.71 12 85181 194 79659001
Helicobacter infection 35.45 9.71 15 85178 69689 79589506
Oesophageal pain 34.85 9.71 32 85161 4247 79654948
Hiatus hernia 34.83 9.71 77 85116 23235 79635960
Premenstrual syndrome 33.77 9.71 15 85178 551 79658644
Anorectal discomfort 33.36 9.71 29 85164 3582 79655613
Clumsiness 32.77 9.71 27 85166 3100 79656095
Overdose 32.67 9.71 95 85098 184111 79475084
Decreased appetite 32.47 9.71 530 84663 341888 79317307
Magnesium deficiency 32.37 9.71 15 85178 609 79658586
Cholecystitis chronic 32.18 9.71 46 85147 9860 79649335
Hepatic encephalopathy 31.89 9.71 76 85117 24090 79635105
Intentional overdose 31.62 9.71 40 85153 105920 79553275
Blood pressure diastolic decreased 31.55 9.71 87 85106 30129 79629066
Exposure during pregnancy 31.42 9.71 37 85156 101095 79558100
Occupational dermatitis 31.17 9.71 10 85183 145 79659050
Movement disorder 31.00 9.71 81 85112 27178 79632017
Hepatocellular carcinoma 30.95 9.71 43 85150 8978 79650217
Renal cyst 30.83 9.71 56 85137 14676 79644519
Fatigue 30.69 9.71 758 84435 928969 78730226
Cough 30.55 9.71 556 84637 366233 79292962
Malaise 30.43 9.71 711 84482 489158 79170037
Mycobacterium test positive 30.38 9.71 13 85180 436 79658759
Sedation 30.09 9.71 9 85184 51886 79607309
Secondary immunodeficiency 29.93 9.71 26 85167 3208 79655987
Nocturia 29.90 9.71 53 85140 13628 79645567
Haemolysis 29.78 9.71 51 85142 12761 79646434
Renal impairment 29.72 9.71 278 84915 157505 79501690
Product use in unapproved indication 29.65 9.71 152 85041 250207 79408988
Neutrophil count decreased 29.15 9.71 186 85007 93773 79565422
Gastric disorder 28.96 9.71 97 85096 37336 79621859
C-reactive protein abnormal 28.76 9.71 8 85185 48359 79610836
Gastrointestinal motility disorder 28.59 9.71 34 85159 6088 79653107
Nerve degeneration 28.54 9.71 11 85182 280 79658915
Intentional product misuse 28.32 9.71 36 85157 95129 79564066
Nipple disorder 28.01 9.71 10 85183 204 79658991
Pneumothorax spontaneous 27.65 9.71 18 85175 1436 79657759
Hepatic steatosis 27.62 9.71 96 85097 37642 79621553
Respiratory tract infection 27.49 9.71 114 85079 48575 79610620
Erectile dysfunction 27.27 9.71 53 85140 14611 79644584
Lip pruritus 26.99 9.71 15 85178 897 79658298
Polyp 26.86 9.71 38 85155 8069 79651126
General physical health deterioration 26.78 9.71 178 85015 275060 79384135
Blood pressure fluctuation 26.73 9.71 142 85051 67003 79592192
Mucosal inflammation 26.45 9.71 25 85168 75555 79583640
Pulmonary function test abnormal 26.25 9.71 27 85166 4117 79655078
Malignant polyp 25.91 9.71 9 85184 169 79659026
Polymenorrhoea 25.67 9.71 15 85178 987 79658208
Hypokalaemia 25.26 9.71 250 84943 143790 79515405
Lip infection 24.84 9.71 9 85184 192 79659003
Hypereosinophilic syndrome 24.83 9.71 12 85181 536 79658659
Idiopathic pulmonary fibrosis 24.03 9.71 26 85167 4202 79654993
Sputum culture 23.81 9.71 9 85184 217 79658978
Tubulointerstitial nephritis and uveitis syndrome 23.66 9.71 10 85183 325 79658870
Abdominal distension 23.63 9.71 213 84980 119437 79539758
Primary hypoparathyroidism 23.28 9.71 6 85187 37 79659158
Interstitial granulomatous dermatitis 23.21 9.71 9 85184 233 79658962
Hepatotoxicity 23.15 9.71 13 85180 51339 79607856
Menstruation delayed 23.15 9.71 16 85177 1410 79657785
Gastric cancer 22.98 9.71 40 85153 10139 79649056
Occupational exposure to air contaminants 22.75 9.71 8 85185 156 79659039
Micturition urgency 22.67 9.71 45 85148 12596 79646599
Abdominal pain upper 22.54 9.71 350 84843 223469 79435726
Gastrointestinal polyp haemorrhage 22.50 9.71 11 85182 504 79658691
Chronic kidney disease 22.43 9.71 134 85059 66020 79593175
Heart rate increased 22.37 9.71 212 84981 120512 79538683
Blood pressure systolic increased 22.27 9.71 135 85058 66851 79592344
Adenocarcinoma 22.26 9.71 24 85169 3862 79655333
Dyslalia 22.19 9.71 14 85179 1058 79658137
Enteritis infectious 21.60 9.71 22 85171 3316 79655879
Upper respiratory tract inflammation 21.52 9.71 24 85169 4011 79655184
Hypotension 21.45 9.71 336 84857 439981 79219214
Barotrauma 21.20 9.71 8 85185 192 79659003
Iron deficiency anaemia 21.18 9.71 68 85125 25604 79633591
Folliculitis 20.97 9.71 17 85176 55363 79603832
Biliary dyskinesia 20.66 9.71 19 85174 2526 79656669
Neutropenia 20.64 9.71 202 84991 287508 79371687
Drug intolerance 20.42 9.71 182 85011 263937 79395258
Duodenal polyp 20.30 9.71 9 85184 329 79658866
Disseminated intravascular coagulation 20.29 9.71 84 85109 35758 79623437
Limb mass 20.22 9.71 22 85171 3577 79655618
Lung disorder 19.98 9.71 151 85042 80406 79578789
Adverse event 19.83 9.71 21 85172 60193 79599002
Central nervous system lesion 19.80 9.71 44 85149 13324 79645871
Hypertension 19.78 9.71 478 84715 330514 79328681
Respiratory depression 19.66 9.71 3 85190 27627 79631568
Muscle strain 19.59 9.71 36 85157 9519 79649676
Suicide attempt 19.31 9.71 37 85156 82895 79576300
Haemochromatosis 19.26 9.71 14 85179 1336 79657859
Therapy cessation 19.23 9.71 8 85185 37554 79621641
Aortic dissection 19.19 9.71 23 85170 4152 79655043
Uveitis 19.12 9.71 50 85143 16780 79642415
Disease progression 19.06 9.71 117 85076 184245 79474950
Intra-abdominal fluid collection 18.90 9.71 20 85173 3152 79656043
Retinal toxicity 18.71 9.71 14 85179 1397 79657798
Therapy non-responder 18.33 9.71 45 85148 92260 79566935
Macule 18.25 9.71 19 85174 2938 79656257
Neurotoxicity 18.21 9.71 6 85187 32512 79626683
Radioallergosorbent test positive 18.16 9.71 5 85188 41 79659154
Clitoris abscess 18.10 9.71 4 85189 11 79659184
Benign prostatic hyperplasia 18.08 9.71 39 85154 11573 79647622
Irritable bowel syndrome 18.05 9.71 24 85169 62217 79596978
Product prescribing error 17.94 9.71 13 85180 44800 79614395
Somnolence 17.90 9.71 166 85027 238815 79420380
Hospitalisation 17.89 9.71 47 85146 94189 79565006
Spinal compression fracture 17.88 9.71 49 85144 16909 79642286
Multiple organ dysfunction syndrome 17.87 9.71 67 85126 120179 79539016
Rhinitis 17.87 9.71 45 85148 14762 79644433
Unresponsive to stimuli 17.77 9.71 20 85173 55768 79603427
IIIrd nerve paresis 17.71 9.71 7 85186 191 79659004
Bronchopulmonary aspergillosis allergic 17.70 9.71 19 85174 3042 79656153
Fall 17.69 9.71 662 84531 486967 79172228
Poisoning 17.41 9.71 3 85190 25269 79633926
Product use issue 17.37 9.71 142 85051 209680 79449515
Oesophageal varices haemorrhage 17.32 9.71 22 85171 4214 79654981
Bronchial disorder 17.20 9.71 17 85176 2472 79656723
Condition aggravated 17.17 9.71 406 84787 500718 79158477
Device issue 17.05 9.71 4 85189 27104 79632091
Cardiac failure chronic 16.89 9.71 37 85156 11098 79648097
Knee arthroplasty 16.72 9.71 13 85180 43235 79615960
Thrombocytopenia 16.69 9.71 192 85001 265067 79394128
Hyperuricaemia 16.54 9.71 38 85155 11761 79647434
Neutrophilia 16.35 9.71 30 85163 7921 79651274
Posterior reversible encephalopathy syndrome 16.29 9.71 4 85189 26277 79632918
Multiple fractures 16.15 9.71 30 85163 7996 79651199
Acute kidney injury 16.12 9.71 427 84766 518977 79140218
Body temperature fluctuation 15.93 9.71 20 85173 3787 79655408
Thalamus haemorrhage 15.84 9.71 14 85179 1768 79657427
Injection site pain 15.83 9.71 78 85115 129760 79529435
Tachycardia 15.79 9.71 118 85075 177650 79481545
Premature delivery 15.70 9.71 3 85190 23464 79635731
Blister 15.61 9.71 70 85123 119406 79539789
Rubella 15.31 9.71 6 85187 160 79659035
Dysarthria 15.25 9.71 124 85069 67498 79591697
Blood pressure decreased 15.24 9.71 168 85025 99298 79559897
Delusion of replacement 15.20 9.71 6 85187 163 79659032
Balance disorder 15.16 9.71 167 85026 98690 79560505
Prescribed overdose 15.15 9.71 11 85182 37872 79621323
Peripheral swelling 15.13 9.71 200 84993 269417 79389778
Chest discomfort 15.10 9.71 219 84974 137825 79521370
Red cell distribution width increased 15.04 9.71 43 85150 15199 79643996
Intentional product use issue 14.97 9.71 98 85095 152014 79507181
Somnambulism 14.94 9.71 24 85169 5697 79653498
Injection site swelling 14.90 9.71 17 85176 47115 79612080
Pneumonia bacterial 14.87 9.71 50 85143 19281 79639914
Injection site erythema 14.84 9.71 39 85154 78158 79581037
Hip arthroplasty 14.80 9.71 10 85183 35746 79623449
Sleep disorder due to a general medical condition 14.80 9.71 41 85152 14236 79644959
Sleep attacks 14.68 9.71 6 85187 179 79659016
Mental status changes 14.62 9.71 31 85162 66928 79592267
No adverse event 14.61 9.71 11 85182 37181 79622014
Cholangitis 14.56 9.71 38 85155 12738 79646457
Carotid arteriosclerosis 14.51 9.71 16 85177 2640 79656555
Productive cough 14.37 9.71 151 85042 88180 79571015
COVID-19 14.32 9.71 104 85089 157570 79501625
Coeliac artery occlusion 14.24 9.71 3 85190 6 79659189
Tetany 14.16 9.71 16 85177 2712 79656483
Constipation 14.07 9.71 399 84794 282651 79376544
Blood alkaline phosphatase increased 13.96 9.71 116 85077 63548 79595647
Hepatitis chronic active 13.94 9.71 6 85187 204 79658991
Neck injury 13.91 9.71 16 85177 2765 79656430
Haemorrhagic cerebral infarction 13.91 9.71 12 85181 1467 79657728
Gastric antral vascular ectasia 13.82 9.71 10 85183 948 79658247
Dermatitis acneiform 13.81 9.71 32 85161 9961 79649234
Drug ineffective 13.80 9.71 982 84211 1079931 78579264
Hypercholesterolaemia 13.77 9.71 55 85138 23040 79636155
Gallbladder injury 13.76 9.71 11 85182 1210 79657985
Inappropriate antidiuretic hormone secretion 13.61 9.71 60 85133 26253 79632942
Neutropenic sepsis 13.48 9.71 6 85187 27058 79632137
Renal disorder 13.45 9.71 84 85109 42021 79617174
Erosive oesophagitis 13.45 9.71 16 85177 2866 79656329
Injection site reaction 13.14 9.71 24 85169 54761 79604434
Renal mass 13.11 9.71 17 85176 3323 79655872
Sitting disability 13.05 9.71 7 85186 390 79658805
Red blood cell sedimentation rate increased 13.03 9.71 18 85175 45924 79613271
Nasopharyngitis 12.92 9.71 359 84834 253522 79405673
Concomitant disease aggravated 12.85 9.71 37 85156 13130 79646065
Lower limb fracture 12.82 9.71 54 85139 23161 79636034
Blood gastrin increased 12.73 9.71 4 85189 54 79659141
Gamma-glutamyltransferase increased 12.73 9.71 101 85092 54579 79604616
Accidental exposure to product 12.65 9.71 9 85184 31313 79627882
Device dislocation 12.56 9.71 6 85187 25964 79633231
Oral discharge 12.54 9.71 6 85187 262 79658933
Liver iron concentration abnormal 12.47 9.71 4 85189 58 79659137
Colon cancer 12.47 9.71 39 85154 14484 79644711
Medication error 12.45 9.71 35 85158 68607 79590588
Neuropathy peripheral 12.45 9.71 94 85099 141211 79517984
Ear discomfort 12.43 9.71 28 85165 8555 79650640
Pneumonia 12.39 9.71 841 84352 659405 78999790
Gallbladder disorder 12.29 9.71 47 85146 19293 79639902
Intervertebral disc degeneration 12.29 9.71 41 85152 15744 79643451
Infection 12.24 9.71 183 85010 241529 79417666
Stress at work 12.19 9.71 10 85183 1141 79658054
Coronary artery disease 12.14 9.71 115 85078 65359 79593836
Pancreatic neuroendocrine tumour 11.97 9.71 8 85185 667 79658528
Forced expiratory volume decreased 11.89 9.71 26 85167 7788 79651407
Mycobacterial infection 11.87 9.71 17 85176 3651 79655544
Acute myocardial infarction 11.75 9.71 130 85063 76906 79582289
Accidental overdose 11.74 9.71 15 85178 39566 79619629
Arthralgia 11.74 9.71 734 84459 571069 79088126
Occupational exposure to product 11.71 9.71 8 85185 692 79658503
Chorioretinal disorder 11.70 9.71 5 85188 167 79659028
Lower respiratory tract infection viral 11.68 9.71 10 85183 1210 79657985
Compression fracture 11.59 9.71 23 85170 6437 79652758
Blood albumin decreased 11.58 9.71 54 85139 24189 79635006
Postmenopausal haemorrhage 11.47 9.71 11 85182 1541 79657654
Therapy interrupted 11.40 9.71 10 85183 31331 79627864
Coma 11.40 9.71 62 85131 100587 79558608
Cytokine release syndrome 11.36 9.71 13 85180 35985 79623210
Respiratory failure 11.35 9.71 131 85062 180780 79478415
Myocardial infarction 11.31 9.71 267 84926 183862 79475333
Anticoagulation drug level decreased 11.25 9.71 5 85188 184 79659011
Arthropathy 11.21 9.71 128 85065 176983 79482212
Intramedullary rod insertion 11.17 9.71 5 85188 187 79659008
Dyspnoea exertional 11.10 9.71 142 85051 86931 79572264
Confusional state 11.05 9.71 257 84936 317740 79341455
Nephroangiosclerosis 11.04 9.71 6 85187 343 79658852
Cardiac arrest 11.04 9.71 124 85069 171972 79487223
Blood iron increased 11.02 9.71 11 85182 1619 79657576
Cataract 10.97 9.71 108 85085 62012 79597183
Helicobacter test positive 10.88 9.71 10 85183 1328 79657867
Vaccination site pain 10.88 9.71 5 85188 199 79658996
Abdominal mass 10.84 9.71 16 85177 3529 79655666
Metaplasia 10.79 9.71 7 85186 555 79658640
Aggression 10.79 9.71 24 85169 50934 79608261
Dermatitis contact 10.77 9.71 31 85162 11002 79648193
Tachypnoea 10.76 9.71 11 85182 32052 79627143
Enterocolitis 10.69 9.71 37 85156 14475 79644720
Ataxia 10.69 9.71 54 85139 24985 79634210
Emphysema 10.68 9.71 40 85153 16260 79642935
Pneumonia aspiration 10.67 9.71 114 85079 66853 79592342
End stage renal disease 10.66 9.71 33 85160 12187 79647008
Drug resistance 10.57 9.71 18 85175 42195 79617000
Abdominal tenderness 10.56 9.71 30 85163 10564 79648631
Serotonin syndrome 10.56 9.71 20 85173 45007 79614188
Flatulence 10.54 9.71 80 85113 42644 79616551
Ocular discomfort 10.50 9.71 19 85174 4964 79654231
Gastric dysplasia 10.46 9.71 3 85190 29 79659166
Full blood count decreased 10.45 9.71 8 85185 26811 79632384
Heart rate decreased 10.42 9.71 118 85075 70198 79588997
Device malfunction 10.30 9.71 5 85188 21443 79637752
Nephrectomy 10.30 9.71 12 85181 2103 79657092
Diverticulum 10.13 9.71 37 85156 14859 79644336
Catheter site hypersensitivity 10.12 9.71 4 85189 109 79659086
Therapy partial responder 10.12 9.71 3 85190 17394 79641801
Tooth disorder 10.11 9.71 55 85138 26178 79633017
Cholelithiasis 10.01 9.71 93 85100 52571 79606624
Akathisia 9.94 9.71 34 85159 13225 79645970
Vocal cord paralysis 9.89 9.71 13 85180 2574 79656621
Hypoalbuminaemia 9.85 9.71 47 85146 21250 79637945
Breast pain 9.85 9.71 25 85168 8240 79650955
Cholangitis acute 9.74 9.71 10 85183 1522 79657673
Microcytic anaemia 9.73 9.71 19 85174 5255 79653940

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BC04 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BC54 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BD12 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 A02BD13 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
FDA MoA N0000000147 Proton Pump Inhibitors
FDA EPC N0000175525 Proton Pump Inhibitor
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
Duodenal ulcer disease indication 51868009 DOID:1724
Zollinger-Ellison syndrome indication 53132006 DOID:0050782
Multiple endocrine adenomas indication 60549007
Gastroesophageal reflux disease indication 235595009 DOID:8534
Systemic mast cell disease indication 397016004 DOID:349
Duodenal Ulcer due to H. Pylori indication
Maintenance of Healing Gastroesophageal Reflux indication
Pathological Gastric Hypersecretory Condition indication
Upper gastrointestinal hemorrhage off-label use 37372002
Prevention of NSAID-Induced Gastric Ulcer off-label use
Osteoporosis contraindication 64859006 DOID:11476
Fracture of bone contraindication 125605004
Hypomagnesemia contraindication 190855004
Disease of liver contraindication 235856003 DOID:409




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 3.9 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
D(3) dopamine receptor GPCR Ki 6.10 DRUG MATRIX
5-hydroxytryptamine receptor 1D GPCR Ki 5.12 WOMBAT-PK
Sodium/potassium-transporting ATPase subunit alpha-1 Transporter WOMBAT-PK
Adenosine receptor A3 GPCR Ki 5.74 DRUG MATRIX
ATP-binding cassette sub-family G member 2 Transporter IC50 5.07 CHEMBL
Fatty acid synthase Enzyme Ki 5.23 CHEMBL
Insulin-degrading enzyme Enzyme IC50 4.96 CHEMBL
N(G),N(G)-dimethylarginine dimethylaminohydrolase 1 Enzyme IC50 4.28 CHEMBL
Cytosolic endo-beta-N-acetylglucosaminidase Enzyme IC50 5.35 CHEMBL
Alpha-2B adrenergic receptor GPCR Ki 6.10 DRUG MATRIX
Sterile alpha and TIR motif-containing protein 1 Unclassified IC50 5.50 CHEMBL

External reference:

IDSource
4021174 VUID
N0000148623 NUI
D00724 KEGG_DRUG
117976-90-6 SECONDARY_CAS_RN
4021174 VANDF
4021175 VANDF
C0378482 UMLSCUI
CHEBI:8768 CHEBI
RZX PDB_CHEM_ID
CHEMBL1219 ChEMBL_ID
CHEMBL1200930 ChEMBL_ID
DB01129 DRUGBANK_ID
D064750 MESH_DESCRIPTOR_UI
5029 PUBCHEM_CID
7290 IUPHAR_LIGAND_ID
7112 INN_ID
32828355LL UNII
114979 RXNORM
206957 MMSL
31277 MMSL
8292 MMSL
d04448 MMSL
007680 NDDF
007681 NDDF
387013009 SNOMEDCT_US
421279008 SNOMEDCT_US
422225001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Rabeprazole sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-107 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Rabeprazole sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-107 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Rabeprazole sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-107 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Rabeprazole sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-107 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 42291-722 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 31 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 45865-123 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
RABEPRAZOLE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 45865-802 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
RABEPRAZOLE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 50090-1424 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-3145 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 29 sections
Rabeprazole sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-3182 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 29 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-3430 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 30 sections
Rabeprazole Sodium Human Prescription Drug Label 1 50090-4751 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Rabeprazole Sodium Human Prescription Drug Label 1 50090-4751 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50436-0302 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50436-0724 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 20 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 51407-184 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 29 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 51407-184 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 29 sections
Aciphex HUMAN PRESCRIPTION DRUG LABEL 1 54868-4185 TABLET, DELAYED RELEASE 20 mg ORAL NDA 28 sections
Rabeprazole Sodium Human Prescription Drug Label 1 55700-767 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
Rabeprazole Sodium Human Prescription Drug Label 1 55700-767 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 60760-560 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 27 sections
RABEPRAZOLE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 60760-972 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 26 sections
RABERPRAZOLE SODIUM D/R HUMAN PRESCRIPTION DRUG LABEL 1 61919-225 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
RABERPRAZOLE SODIUM D/R HUMAN PRESCRIPTION DRUG LABEL 1 61919-225 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
RABERPRAZOLE SODIUM D/R HUMAN PRESCRIPTION DRUG LABEL 1 61919-225 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
RABERPRAZOLE SODIUM D/R HUMAN PRESCRIPTION DRUG LABEL 1 61919-225 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
RABEPRAZOLE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 61919-467 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 17 sections
RABEPRAZOLE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 61919-467 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 17 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 62135-503 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 20 sections
Rabeprazole Sodium HUMAN PRESCRIPTION DRUG LABEL 1 62175-302 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 29 sections