dexlansoprazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antiulcer, benzimidazole derivatives 4162 138530-94-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dexlansoprazole sesquihydrate
  • R-Lansoprazole
  • (R)-Lansoprazole
  • dexlansoprazole
  • kapidex
  • dexilant
  • TAK-390
  • TAK-390MR
Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+, K+)-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.
  • 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
S (Water solubility) 0.21 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Jan. 30, 2009 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 799.95 13.43 444 39981 44954 63403643
Tenosynovitis 251.09 13.43 138 40287 13657 63434940
Renal injury 224.69 13.43 113 40312 9326 63439271
End stage renal disease 223.09 13.43 101 40324 6592 63442005
Enthesopathy 210.57 13.43 105 40320 8509 63440088
Tongue disorder 184.75 13.43 103 40322 10477 63438120
Rheumatoid nodule 181.07 13.43 121 40304 17034 63431563
Blood pressure systolic increased 175.49 13.43 182 40243 47215 63401382
Blood parathyroid hormone decreased 167.38 13.43 94 40331 9697 63438900
Panniculitis 156.78 13.43 95 40330 11290 63437307
Ulcer 154.16 13.43 130 40295 25977 63422620
Tendonitis 148.50 13.43 113 40312 19502 63429095
Red blood cell sedimentation rate 148.44 13.43 69 40356 4785 63443812
Granuloma skin 144.22 13.43 81 40344 8356 63440241
Skin necrosis 141.48 13.43 96 40329 13854 63434743
Skin ulcer 130.87 13.43 149 40276 42896 63405701
Incorrect product administration duration 116.00 13.43 79 40346 11467 63437130
Alanine aminotransferase abnormal 104.49 13.43 53 40372 4451 63444146
Rash pruritic 102.25 13.43 156 40269 59643 63388954
Fear of injection 101.79 13.43 61 40364 7103 63441494
Maternal exposure during pregnancy 101.34 13.43 11 40414 220051 63228546
Inflammation 96.01 13.43 181 40244 82092 63366505
Hypercalcaemia 94.60 13.43 103 40322 28219 63420378
Sputum discoloured 91.59 13.43 79 40346 16268 63432329
Basal cell carcinoma 85.24 13.43 97 40328 27894 63420703
Drug eruption 84.96 13.43 98 40327 28596 63420001
Pemphigus 82.53 13.43 10 40415 183716 63264881
Exposure during pregnancy 82.32 13.43 4 40421 155543 63293054
Glossodynia 82.19 13.43 9 40416 178867 63269730
Completed suicide 67.76 13.43 7 40418 145666 63302931
Total lung capacity decreased 66.65 13.43 31 40394 2152 63446445
Arthritis 66.50 13.43 193 40232 115728 63332869
Allergy to chemicals 65.37 13.43 34 40391 3008 63445589
Rebound acid hypersecretion 62.32 13.43 18 40407 312 63448285
Blood pressure fluctuation 61.76 13.43 108 40317 46209 63402388
Bronchopulmonary aspergillosis allergic 59.57 13.43 29 40396 2229 63446368
C-reactive protein abnormal 58.26 13.43 105 40320 45991 63402606
Erythema 57.54 13.43 243 40182 175508 63273089
Forced expiratory volume decreased 57.17 13.43 37 40388 4931 63443666
Drug interaction 55.58 13.43 39 40386 229092 63219505
Drug specific antibody 55.47 13.43 28 40397 2327 63446270
Obstructive airways disorder 55.16 13.43 67 40358 20632 63427965
Toxicity to various agents 54.99 13.43 46 40379 247204 63201393
Faeces soft 54.94 13.43 38 40387 5654 63442943
Endometriosis 54.86 13.43 37 40388 5283 63443314
Peak expiratory flow rate decreased 54.74 13.43 19 40406 610 63447987
Systemic lupus erythematosus 54.15 13.43 33 40392 208885 63239712
Lung opacity 53.01 13.43 30 40395 3138 63445459
Granuloma 52.20 13.43 37 40388 5724 63442873
Drug tolerance 50.32 13.43 39 40386 6910 63441687
Joint injury 50.32 13.43 77 40348 29495 63419102
Body temperature decreased 49.70 13.43 63 40362 20256 63428341
Crepitations 49.44 13.43 41 40384 7999 63440598
Asthma 47.82 13.43 184 40241 127377 63321220
Rheumatoid lung 47.61 13.43 30 40395 3818 63444779
Total lung capacity increased 47.30 13.43 25 40400 2285 63446312
Helicobacter infection 47.18 13.43 3 40422 92782 63355815
Hepatic enzyme increased 47.04 13.43 36 40389 202292 63246305
Cervix neoplasm 46.22 13.43 13 40412 204 63448393
Tenosynovitis stenosans 46.12 13.43 28 40397 3336 63445261
Cough 45.15 13.43 330 40095 292413 63156184
Thrombocytopenia 44.89 13.43 20 40405 151137 63297460
Somatic delusion 44.35 13.43 16 40409 576 63448021
Defaecation disorder 43.54 13.43 17 40408 764 63447833
Antinuclear antibody positive 43.48 13.43 38 40387 7961 63440636
Synovial fluid analysis 43.32 13.43 24 40401 2409 63446188
Arteriovenous fistula occlusion 43.09 13.43 14 40411 365 63448232
Blood pressure diastolic decreased 42.75 13.43 62 40363 22644 63425953
Extra dose administered 42.45 13.43 34 40391 6316 63442281
Neutropenia 42.15 13.43 30 40395 174975 63273622
Blue toe syndrome 42.11 13.43 14 40411 393 63448204
Gastric disorder 42.06 13.43 81 40344 37288 63411309
Hyponatraemia 41.66 13.43 10 40415 111890 63336707
Pericarditis 41.35 13.43 16 40409 131563 63317034
Swelling 40.29 13.43 71 40354 275307 63173290
Psoriatic arthropathy 40.19 13.43 139 40286 91381 63357216
Echocardiogram abnormal 40.05 13.43 19 40406 1379 63447218
Frustration tolerance decreased 39.60 13.43 34 40391 6954 63441643
Rheumatoid factor positive 39.38 13.43 4 40421 84402 63364195
Scleritis 39.11 13.43 28 40397 4400 63444197
Loss of personal independence in daily activities 38.66 13.43 143 40282 97147 63351450
Musculoskeletal disorder 38.33 13.43 56 40369 20588 63428009
Confusional state 38.27 13.43 57 40368 236323 63212274
Musculoskeletal stiffness 38.12 13.43 224 40201 184394 63264203
Gastrooesophageal reflux disease 37.52 13.43 140 40285 95499 63353098
Red blood cell sedimentation rate increased 37.42 13.43 85 40340 43897 63404700
Upper respiratory tract infection 37.24 13.43 126 40299 81921 63366676
Renal failure 37.18 13.43 161 40264 117491 63331106
Peripheral swelling 37.18 13.43 293 40132 265649 63182948
Headache 37.10 13.43 587 39838 632654 62815943
Drug tolerance decreased 36.28 13.43 50 40375 17423 63431174
No adverse event 35.20 13.43 80 40345 41325 63407272
Drug abuse 35.00 13.43 3 40422 72515 63376082
Death 34.16 13.43 123 40302 374258 63074339
Tubulointerstitial nephritis 34.11 13.43 52 40373 19851 63428746
Folliculitis 33.69 13.43 3 40422 70314 63378283
Pleuritic pain 33.66 13.43 33 40392 7996 63440601
Chromaturia 33.46 13.43 47 40378 16670 63431927
Wound 32.02 13.43 34 40391 163229 63285368
Lung diffusion test decreased 31.33 13.43 13 40412 685 63447912
Blood calcium increased 31.21 13.43 34 40391 9316 63439281
Abdominal pain 30.50 13.43 303 40122 293153 63155444
Bradycardia 30.48 13.43 5 40420 73222 63375375
C-reactive protein increased 30.22 13.43 130 40295 94577 63354020
Blood test abnormal 29.90 13.43 43 40382 15586 63433011
Impaired healing 29.77 13.43 14 40411 102528 63346069
Disease progression 29.60 13.43 21 40404 122737 63325860
Cardiac arrest 29.49 13.43 11 40414 92534 63356063
Hand deformity 29.31 13.43 35 40390 159422 63289175
Hypertensive nephropathy 28.79 13.43 12 40413 640 63447957
Pancytopenia 28.50 13.43 13 40412 96920 63351677
Blood pressure systolic decreased 28.43 13.43 29 40396 7368 63441229
Rhinorrhoea 28.26 13.43 99 40326 65478 63383119
Respiration abnormal 28.08 13.43 27 40398 6390 63442207
Dysphonia 27.97 13.43 80 40345 47534 63401063
Pulmonary thrombosis 27.93 13.43 31 40394 8671 63439926
Pulmonary toxicity 27.49 13.43 32 40393 9423 63439174
Central obesity 27.25 13.43 14 40411 1207 63447390
Aspiration 27.10 13.43 34 40391 10817 63437780
Cushingoid 26.84 13.43 30 40395 8455 63440142
Depressed level of consciousness 26.38 13.43 4 40421 62074 63386523
Heart rate decreased 26.23 13.43 76 40349 45484 63403113
Aspartate aminotransferase increased 25.85 13.43 120 40305 90157 63358440
Therapeutic reaction time decreased 25.68 13.43 17 40408 2353 63446244
Gastritis fungal 25.18 13.43 7 40418 105 63448492
Deformity 25.11 13.43 34 40391 11650 63436947
Connective tissue inflammation 24.48 13.43 6 40419 53 63448544
Blood pressure diastolic abnormal 23.53 13.43 37 40388 14505 63434092
Coma 23.47 13.43 6 40419 64358 63384239
Synovial cyst 23.40 13.43 31 40394 10402 63438195
Bone density decreased 23.39 13.43 37 40388 14575 63434022
Gastrointestinal motility disorder 23.27 13.43 22 40403 5097 63443500
Type 2 diabetes mellitus 23.20 13.43 6 40419 63862 63384735
Cardio-respiratory arrest 23.03 13.43 5 40420 59954 63388643
Forced vital capacity decreased 23.01 13.43 12 40413 1067 63447530
Electrocardiogram QT prolonged 22.79 13.43 5 40420 59525 63389072
Blood cholesterol increased 22.78 13.43 16 40409 94016 63354581
Parotid gland enlargement 22.58 13.43 11 40414 847 63447750
Thoracic operation 22.21 13.43 7 40418 165 63448432
Pulmonary embolism 22.10 13.43 25 40400 116659 63331938
Renal pain 22.03 13.43 24 40401 6575 63442022
Abnormal faeces 22.00 13.43 22 40403 5458 63443139
Flail chest 21.96 13.43 6 40419 84 63448513
Cardiac failure 21.82 13.43 15 40410 89127 63359470
Joint effusion 21.72 13.43 39 40386 17021 63431576
Rales 21.51 13.43 33 40392 12664 63435933
Lung perforation 21.46 13.43 6 40419 92 63448505
Conjunctival haemorrhage 21.45 13.43 18 40407 3569 63445028
Renal haemangioma 21.42 13.43 5 40420 35 63448562
Respiratory failure 21.35 13.43 20 40405 101838 63346759
Peak expiratory flow rate abnormal 21.05 13.43 6 40419 99 63448498
Oropharyngeal pain 21.02 13.43 117 40308 94370 63354227
Urine odour abnormal 20.92 13.43 23 40402 6366 63442231
Abdominal pain upper 20.86 13.43 212 40213 206232 63242365
Nasal congestion 20.84 13.43 90 40335 65570 63383027
Platelet count decreased 20.79 13.43 26 40399 116096 63332501
Osteomyelitis 20.72 13.43 49 40376 25971 63422626
Pulmonary fibrosis 20.64 13.43 64 40361 39745 63408852
Regurgitation 20.30 13.43 13 40412 1701 63446896
Feeling jittery 20.17 13.43 33 40392 13370 63435227
Parapsoriasis 20.11 13.43 6 40419 117 63448480
Carcinoid tumour 20.01 13.43 8 40417 383 63448214
Pharyngitis streptococcal 19.88 13.43 29 40396 10643 63437954
Hyperkalaemia 19.86 13.43 5 40420 54198 63394399
Nephrogenic anaemia 19.85 13.43 14 40411 2148 63446449
Red blood cell count decreased 19.85 13.43 64 40361 40581 63408016
Injection site oedema 19.84 13.43 12 40413 1420 63447177
Dry mouth 19.77 13.43 100 40325 77763 63370834
Blood creatinine increased 19.69 13.43 109 40316 87735 63360862
Nocturia 19.52 13.43 25 40400 8116 63440481
Thrombosis 19.22 13.43 87 40338 64668 63383929
Neutrophil count decreased 19.19 13.43 6 40419 56400 63392197
Bladder disorder 19.18 13.43 26 40399 8920 63439677
Hypokalaemia 18.84 13.43 23 40402 103781 63344816
Malignant neoplasm progression 18.58 13.43 15 40410 82106 63366491
Blister 18.48 13.43 34 40391 129780 63318817
Wheezing 18.44 13.43 114 40311 95481 63353116
Stomatitis 18.31 13.43 38 40387 138687 63309910
Lung diffusion disorder 18.30 13.43 5 40420 70 63448527
Heart rate abnormal 18.30 13.43 19 40406 4928 63443669
Synovial disorder 18.22 13.43 13 40412 2032 63446565
Suicide attempt 18.17 13.43 8 40417 60910 63387687
Delirium 17.88 13.43 5 40420 50536 63398061
Heart rate irregular 17.61 13.43 42 40383 22379 63426218
Patella fracture 17.55 13.43 13 40412 2153 63446444
Skin irritation 17.47 13.43 26 40399 9715 63438882
Brain hypoxia 17.44 13.43 8 40417 538 63448059
Impaired work ability 17.40 13.43 36 40389 17439 63431158
Alanine aminotransferase increased 17.12 13.43 119 40306 103651 63344946
Medication error 17.02 13.43 6 40419 52278 63396319
Bronchiectasis 16.96 13.43 34 40391 16108 63432489
Drug specific antibody present 16.92 13.43 17 40408 4242 63444355
Metabolic acidosis 16.82 13.43 4 40421 45065 63403532
Arthralgia 16.80 13.43 478 39947 569232 62879365
Flank pain 16.57 13.43 34 40391 16376 63432221
Gout 16.47 13.43 30 40395 13241 63435356
Heart rate increased 16.10 13.43 109 40316 94129 63354468
Nodule 16.10 13.43 39 40386 20987 63427610
Abortion spontaneous 16.09 13.43 5 40420 47190 63401407
Nephropathy 16.04 13.43 20 40405 6321 63442276
Eye irritation 16.02 13.43 40 40385 21931 63426666
Mental status changes 15.83 13.43 3 40422 39596 63409001
Eye haemorrhage 15.70 13.43 23 40402 8473 63440124
International normalised ratio increased 15.68 13.43 5 40420 46420 63402177
Pain in extremity 15.60 13.43 297 40128 331189 63117408
White coat hypertension 15.53 13.43 8 40417 694 63447903
Knee deformity 15.43 13.43 10 40415 1335 63447262
Sleep disorder due to general medical condition, insomnia type 15.35 13.43 7 40418 52210 63396387
Conjunctivitis 15.31 13.43 38 40387 20758 63427839
Dry throat 15.02 13.43 20 40405 6745 63441852
Photophobia 14.90 13.43 34 40391 17601 63430996
Sepsis 14.81 13.43 49 40376 153074 63295523
Hyperchlorhydria 14.79 13.43 11 40414 1833 63446764
Pyrexia 14.71 13.43 211 40214 470267 62978330
Mononeuropathy 14.48 13.43 5 40420 158 63448439
Mucosal inflammation 14.26 13.43 6 40419 46922 63401675
Irritable bowel syndrome 14.19 13.43 19 40406 82393 63366204
Hyperaesthesia 14.03 13.43 23 40402 9335 63439262
Blood alkaline phosphatase increased 13.87 13.43 5 40420 42962 63405635
Humidity intolerance 13.79 13.43 6 40419 356 63448241
Nausea 13.77 13.43 670 39755 853801 62594796
Skin sensitisation 13.76 13.43 8 40417 881 63447716
Gastrointestinal haemorrhage 13.69 13.43 19 40406 81157 63367440
Hepatic failure 13.64 13.43 3 40422 35653 63412944

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 466.66 18.24 258 13931 40952 34901790
End stage renal disease 210.12 18.24 92 14097 8769 34933973
Tenosynovitis 157.56 18.24 62 14127 4508 34938234
Renal injury 157.08 18.24 81 14108 11114 34931628
Enthesopathy 153.50 18.24 61 14128 4552 34938190
Synovitis 142.41 18.24 82 14107 13984 34928758
C-reactive protein abnormal 127.92 18.24 65 14124 8645 34934097
Tongue disorder 125.13 18.24 55 14134 5284 34937458
Psoriatic arthropathy 116.70 18.24 82 14107 19716 34923026
Tendonitis 102.54 18.24 57 14132 9083 34933659
Alanine aminotransferase abnormal 96.16 18.24 44 14145 4644 34938098
Red blood cell sedimentation rate 78.18 18.24 26 14163 1162 34941580
Blood phosphorus increased 78.09 18.24 45 14144 7676 34935066
Granuloma skin 76.30 18.24 26 14163 1253 34941489
Drug intolerance 73.60 18.24 105 14084 59465 34883277
Appendicolith 73.59 18.24 45 14144 8556 34934186
Loss of personal independence in daily activities 70.86 18.24 77 14112 33102 34909640
Stress 69.35 18.24 73 14116 30274 34912468
Blood parathyroid hormone decreased 68.83 18.24 25 14164 1455 34941287
Incorrect product administration duration 65.13 18.24 34 14155 4777 34937965
Panniculitis 65.04 18.24 26 14163 1968 34940774
Device dislocation 59.43 18.24 35 14154 6214 34936528
Rheumatoid nodule 58.37 18.24 27 14162 2920 34939822
Drug interaction 57.61 18.24 11 14178 225935 34716807
Abdominal distension 55.17 18.24 91 14098 58401 34884341
Device malfunction 54.14 18.24 40 14149 10381 34932361
Appendicitis 53.69 18.24 46 14143 14761 34927981
Inspiratory capacity abnormal 53.00 18.24 12 14177 120 34942622
Occupational dermatitis 50.56 18.24 11 14178 90 34942652
Oesophageal polyp 48.96 18.24 10 14179 58 34942684
Myasthenia gravis 48.61 18.24 32 14157 6908 34935834
Blood uric acid increased 47.90 18.24 36 14153 9588 34933154
Terminal insomnia 47.36 18.24 15 14174 573 34942169
Treatment failure 47.23 18.24 75 14114 46622 34896120
Drug hypersensitivity 46.93 18.24 102 14087 80427 34862315
Mobility decreased 46.16 18.24 59 14130 30069 34912673
Occupational exposure to air contaminants 45.25 18.24 11 14178 153 34942589
Headache 42.96 18.24 178 14011 200457 34742285
Nerve degeneration 42.66 18.24 11 14178 197 34942545
Dry mouth 39.94 18.24 55 14134 30110 34912632
Stiff person syndrome 39.48 18.24 9 14180 93 34942649
Skin necrosis 38.61 18.24 26 14163 5827 34936915
Asthma 38.38 18.24 65 14124 42591 34900151
Blood immunoglobulin E increased 37.37 18.24 19 14170 2527 34940215
Ulcer 37.34 18.24 30 14159 8805 34933937
Nephrogenic anaemia 36.88 18.24 18 14171 2193 34940549
Airway remodelling 36.46 18.24 10 14179 229 34942513
Ventricular fibrillation 35.23 18.24 45 14144 22909 34919833
Thrombocytopenia 35.05 18.24 10 14179 156237 34786505
Blood cholesterol increased 34.28 18.24 42 14147 20501 34922241
Neck pain 33.22 18.24 46 14143 25303 34917439
Analgesic therapy 32.50 18.24 13 14176 985 34941757
Sleep disorder therapy 32.19 18.24 13 14176 1010 34941732
Iron deficiency 31.01 18.24 22 14167 5359 34937383
Drug therapy 30.82 18.24 13 14176 1128 34941614
Erythema 30.38 18.24 92 14097 88688 34854054
Erythema of eyelid 29.71 18.24 12 14177 933 34941809
Drug abuse 29.48 18.24 3 14186 99093 34843649
Injection site warmth 29.13 18.24 15 14174 2047 34940695
Pain 28.82 18.24 161 14028 204514 34738228
Abdominal pain 28.79 18.24 137 14052 163481 34779261
Drug tolerance 27.03 18.24 16 14173 2866 34939876
Restrictive pulmonary disease 26.90 18.24 12 14177 1192 34941550
General physical health deterioration 26.76 18.24 113 14076 128156 34814586
Pelvic pain 26.54 18.24 15 14174 2465 34940277
Renal neoplasm 26.05 18.24 12 14177 1285 34941457
Renal haemangioma 26.01 18.24 5 14184 20 34942722
Cardiogenic shock 25.86 18.24 42 14147 26576 34916166
Hypertensive nephropathy 25.49 18.24 9 14180 482 34942260
Micturition urgency 25.14 18.24 21 14168 6504 34936238
Renal mass 25.13 18.24 13 14176 1791 34940951
Bone density decreased 24.31 18.24 13 14176 1916 34940826
Neutropenia 24.27 18.24 17 14172 156761 34785981
Occupational exposure to product 23.85 18.24 8 14181 367 34942375
Therapy non-responder 23.25 18.24 50 14139 39096 34903646
Rheumatoid lung 23.03 18.24 10 14179 932 34941810
Hyperphosphataemia 22.97 18.24 17 14172 4420 34938322
Aspartate aminotransferase increased 22.95 18.24 70 14119 67713 34875029
Skin ulcer 22.88 18.24 36 14153 22180 34920562
Injection site mass 22.83 18.24 20 14169 6606 34936136
Blood pressure systolic decreased 22.75 18.24 17 14172 4486 34938256
Incorrect route of product administration 22.61 18.24 29 14160 14816 34927926
Abdominal rigidity 22.49 18.24 11 14178 1346 34941396
Contraindicated product administered 22.39 18.24 35 14154 21446 34921296
Disease progression 22.30 18.24 8 14181 108069 34834673
Coma scale abnormal 22.21 18.24 16 14173 3992 34938750
Oral herpes 21.68 18.24 18 14171 5529 34937213
Dermatitis contact 21.60 18.24 15 14174 3531 34939211
Toxicity to various agents 21.50 18.24 30 14159 200332 34742410
Hip surgery 21.35 18.24 10 14179 1112 34941630
Pyrexia 21.31 18.24 67 14122 332946 34609796
Swollen joint count decreased 21.15 18.24 6 14183 156 34942586
Tender joint count decreased 21.15 18.24 6 14183 156 34942586
Bone hypertrophy 20.76 18.24 6 14183 167 34942575
Renal failure 20.58 18.24 106 14083 130451 34812291
Basal cell carcinoma 20.44 18.24 32 14157 19626 34923116
Nausea 20.39 18.24 219 13970 339689 34603053
Off label use 20.18 18.24 259 13930 419265 34523477
Chronic kidney disease-mineral and bone disorder 19.49 18.24 7 14182 394 34942348
Neuralgia 19.16 18.24 27 14162 15086 34927656
Respiratory acidosis 18.93 18.24 16 14173 5034 34937708
Gastrooesophageal reflux disease 18.70 18.24 45 14144 37879 34904863
Hypercalcaemia 18.68 18.24 27 14162 15441 34927301
Rebound acid hypersecretion 18.50 18.24 5 14184 108 34942634
Dyspnoea at rest 18.34 18.24 14 14175 3814 34938928
Fatigue 18.30 18.24 230 13959 370423 34572319
Condition aggravated 18.28 18.24 137 14052 192059 34750683
Fear of injection 18.28 18.24 10 14179 1542 34941200

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
Chronic kidney disease 635.87 14.07 427 46542 65727 79631692
Tenosynovitis 413.91 14.07 196 46773 15358 79682061
Enthesopathy 361.03 14.07 163 46806 11445 79685974
Tongue disorder 314.35 14.07 157 46812 13818 79683601
Tendonitis 260.84 14.07 167 46802 23663 79673756
Rheumatoid nodule 257.32 14.07 148 46821 17290 79680129
Blood parathyroid hormone decreased 238.83 14.07 119 46850 10417 79687002
Red blood cell sedimentation rate 228.21 14.07 95 46874 5470 79691949
Panniculitis 226.41 14.07 121 46848 12250 79685169
End stage renal disease 224.98 14.07 120 46849 12100 79685319
Granuloma skin 217.99 14.07 107 46862 9067 79688352
Ulcer 195.25 14.07 153 46816 29819 79667600
Alanine aminotransferase abnormal 191.72 14.07 97 46872 8770 79688649
Skin necrosis 186.24 14.07 122 46847 17965 79679454
Blood pressure systolic increased 170.91 14.07 204 46765 66782 79630637
Skin ulcer 156.74 14.07 176 46793 53974 79643445
Psoriatic arthropathy 153.86 14.07 209 46760 77790 79619629
C-reactive protein abnormal 150.00 14.07 163 46806 48204 79649215
Renal injury 136.02 14.07 98 46871 16829 79680590
Fear of injection 128.10 14.07 70 46899 7404 79690015
Rash pruritic 127.92 14.07 183 46786 71446 79625973
Drug interaction 125.50 14.07 44 46925 415139 79282280
Toxicity to various agents 121.83 14.07 48 46921 421492 79275927
Basal cell carcinoma 119.46 14.07 128 46841 37247 79660172
Inflammation 115.43 14.07 202 46767 93551 79603868
Hypercalcaemia 107.94 14.07 123 46846 38307 79659112
Loss of personal independence in daily activities 103.65 14.07 203 46766 102377 79595042
Drug eruption 93.16 14.07 122 46847 43813 79653606
Erythema 92.01 14.07 315 46654 222975 79474444
Sputum discoloured 90.64 14.07 86 46883 21657 79675762
Thrombocytopenia 82.02 14.07 27 46942 265232 79432187
Headache 81.50 14.07 660 46309 653112 79044307
Asthma 80.48 14.07 217 46752 134878 79562541
Drug abuse 79.21 14.07 4 46965 162687 79534732
Drug tolerance 76.11 14.07 53 46916 8622 79688797
Rheumatoid lung 73.41 14.07 40 46929 4205 79693214
Drug tolerance decreased 71.30 14.07 60 46909 12918 79684501
Allergy to chemicals 69.84 14.07 33 46936 2569 79694850
Total lung capacity decreased 69.36 14.07 34 46935 2871 79694548
Neutropenia 67.66 14.07 43 46926 287667 79409752
Bronchopulmonary aspergillosis allergic 64.75 14.07 33 46936 3028 79694391
Endometriosis 64.65 14.07 35 46934 3633 79693786
Granuloma 64.30 14.07 47 46922 8250 79689169
Arthritis 63.91 14.07 180 46789 114700 79582719
Joint injury 63.32 14.07 85 46884 31250 79666169
Peripheral swelling 60.50 14.07 316 46653 269301 79428118
Appendicolith 58.60 14.07 45 46924 8506 79688913
Drug hypersensitivity 57.49 14.07 336 46633 298580 79398839
Maternal exposure during pregnancy 56.39 14.07 7 46962 136531 79560888
Lung opacity 55.95 14.07 36 46933 5138 79692281
Drug intolerance 55.47 14.07 304 46665 263815 79433604
Peak expiratory flow rate decreased 54.65 14.07 19 46950 664 79696755
Musculoskeletal disorder 54.14 14.07 65 46904 21383 79676036
Crepitations 52.34 14.07 45 46924 9972 79687447
Blood pressure diastolic decreased 52.16 14.07 76 46893 30140 79667279
Drug specific antibody 51.75 14.07 27 46942 2601 79694818
Red blood cell sedimentation rate increased 51.41 14.07 95 46874 45847 79651572
Blood phosphorus increased 51.08 14.07 45 46924 10302 79687117
Gastrooesophageal reflux disease 50.96 14.07 156 46813 104090 79593329
Cardiac arrest 50.63 14.07 19 46950 172077 79525342
Blood pressure fluctuation 50.61 14.07 118 46851 67027 79630392
Tenosynovitis stenosans 50.46 14.07 28 46941 3050 79694369
Abdominal pain 50.40 14.07 397 46572 389172 79308247
Bone density decreased 50.38 14.07 50 46919 13297 79684122
Aspartate aminotransferase increased 49.72 14.07 187 46782 138454 79558965
Completed suicide 49.67 14.07 43 46926 245724 79451695
Total lung capacity increased 49.26 14.07 25 46944 2273 79695146
Cervix neoplasm 48.73 14.07 13 46956 180 79697239
Disease progression 48.44 14.07 24 46945 184338 79513081
Gastric disorder 47.79 14.07 82 46887 37351 79660068
Respiratory failure 46.85 14.07 24 46945 180887 79516532
Forced expiratory volume decreased 46.83 14.07 38 46931 7776 79689643
Faeces soft 46.80 14.07 39 46930 8284 79689135
Occupational dermatitis 46.64 14.07 12 46957 143 79697276
Defaecation disorder 46.62 14.07 17 46952 684 79696735
Blood pressure systolic decreased 46.52 14.07 44 46925 11032 79686387
Pancytopenia 45.98 14.07 20 46949 165725 79531694
Synovial fluid analysis 45.78 14.07 24 46945 2335 79695084
Dry mouth 45.17 14.07 134 46835 87885 79609534
Synovitis 44.99 14.07 192 46777 150542 79546877
Inspiratory capacity abnormal 44.24 14.07 11 46958 113 79697306
Musculoskeletal stiffness 43.36 14.07 211 46758 174797 79522622
Obstructive airways disorder 42.94 14.07 71 46898 31388 79666031
Death 42.83 14.07 180 46789 566334 79131085
Stress 42.57 14.07 123 46846 79489 79617930
Somatic delusion 42.56 14.07 16 46953 702 79696717
Cough 42.17 14.07 364 46605 366425 79330994
C-reactive protein increased 42.16 14.07 169 46800 128858 79568561
Blood test abnormal 41.99 14.07 52 46917 17658 79679761
Coma 41.95 14.07 5 46964 100644 79596775
Nephrogenic anaemia 41.82 14.07 27 46942 3875 79693544
Arthralgia 41.72 14.07 517 46452 571286 79126133
Scleritis 41.49 14.07 28 46941 4328 79693091
Cardio-respiratory arrest 41.47 14.07 7 46962 108503 79588916
Occupational exposure to air contaminants 41.18 14.07 11 46958 153 79697266
Rhinorrhoea 41.13 14.07 118 46851 75956 79621463
Rhabdomyolysis 40.89 14.07 6 46963 103125 79594294
Hyperkalaemia 40.30 14.07 9 46960 114389 79583030
Frustration tolerance decreased 39.81 14.07 34 46935 7468 79689951
Depressed level of consciousness 39.80 14.07 5 46964 96647 79600772
Platelet count decreased 39.40 14.07 34 46935 194630 79502789
Confusional state 39.37 14.07 80 46889 317917 79379502
Arteriovenous fistula occlusion 39.00 14.07 14 46955 538 79696881
Oesophageal polyp 38.10 14.07 9 46960 73 79697346
Blue toe syndrome 38.07 14.07 14 46955 577 79696842
Cardiac failure 37.97 14.07 22 46947 154820 79542599
Fatigue 37.53 14.07 761 46208 928966 78768453
Rebound acid hypersecretion 35.97 14.07 9 46960 95 79697324
Nerve degeneration 34.95 14.07 11 46958 280 79697139
Glossodynia 34.69 14.07 9 46960 103328 79594091
Pleuritic pain 34.62 14.07 36 46933 10116 79687303
Abdominal distension 34.61 14.07 151 46818 119499 79577920
Deformity 34.45 14.07 35 46934 9570 79687849
Neutrophil count decreased 33.89 14.07 7 46962 93952 79603467
Blood calcium increased 33.89 14.07 36 46933 10364 79687055
Pulmonary fibrosis 33.76 14.07 78 46891 44034 79653385
Dysphonia 33.48 14.07 91 46878 56781 79640638
Alanine aminotransferase increased 33.34 14.07 186 46783 162384 79535035
Therapeutic product effect incomplete 33.10 14.07 168 46801 141477 79555942
Body temperature decreased 32.91 14.07 64 46905 32081 79665338
Pyrexia 32.65 14.07 250 46719 678459 79018960
Myasthenia gravis 32.14 14.07 35 46934 10364 79687055
Electrocardiogram QT prolonged 32.06 14.07 7 46962 90379 79607040
Therapy non-responder 31.84 14.07 123 46846 92182 79605237
Seizure 31.41 14.07 39 46930 188795 79508624
Terminal insomnia 31.33 14.07 15 46954 1202 79696217
Synovial cyst 31.32 14.07 34 46935 10031 79687388
Blood uric acid increased 31.30 14.07 39 46930 13321 79684098
Pemphigus 30.99 14.07 10 46959 99572 79597847
Hypokalaemia 30.57 14.07 24 46945 144016 79553403
Echocardiogram abnormal 30.45 14.07 18 46951 2210 79695209
Device malfunction 30.07 14.07 49 46920 21399 79676020
Incorrect product administration duration 29.63 14.07 36 46933 11986 79685433
Rheumatoid arthritis 29.45 14.07 217 46752 208253 79489166
Appendicitis 28.47 14.07 47 46922 20747 79676672
Duodenal ulcer perforation 28.32 14.07 3 46966 66208 79631211
Pericarditis 28.24 14.07 13 46956 104223 79593196
Lactic acidosis 28.10 14.07 4 46965 70355 79627064
Oropharyngeal pain 27.90 14.07 133 46836 109220 79588199
Heart rate decreased 27.86 14.07 98 46871 70218 79627201
Analgesic therapy 27.71 14.07 13 46956 996 79696423
Hypertensive nephropathy 27.64 14.07 13 46956 1001 79696418
Sleep disorder therapy 27.52 14.07 13 46956 1011 79696408
International normalised ratio increased 27.27 14.07 8 46961 84713 79612706
Osteomyelitis 27.25 14.07 60 46909 32805 79664614
Respiration abnormal 27.24 14.07 28 46941 7760 79689659
Delirium 27.23 14.07 8 46961 84619 79612800
Medication error 27.19 14.07 4 46965 68638 79628781
Wheezing 26.99 14.07 138 46831 116526 79580893
Antinuclear antibody positive 26.94 14.07 28 46941 7862 79689557
Renal neoplasm 26.86 14.07 16 46953 1992 79695427
Airway remodelling 26.73 14.07 9 46960 285 79697134
Upper respiratory tract infection 26.32 14.07 115 46854 91053 79606366
Feeling jittery 26.19 14.07 35 46934 12806 79684613
Systemic lupus erythematosus 25.95 14.07 20 46949 121129 79576290
Stiff person syndrome 25.93 14.07 9 46960 313 79697106
Abdominal pain upper 25.62 14.07 222 46747 223597 79473822
Drug therapy 25.55 14.07 13 46956 1188 79696231
Nausea 25.38 14.07 740 46229 956456 78740963
Ocular hyperaemia 25.11 14.07 53 46916 28153 79669266
Rheumatoid factor positive 24.87 14.07 3 46966 59836 79637583
Bronchiectasis 24.68 14.07 46 46923 22340 79675079
Pulmonary thrombosis 24.56 14.07 33 46936 12138 79685281
Lung diffusion test decreased 24.49 14.07 13 46956 1297 79696122
Metabolic acidosis 24.45 14.07 9 46960 82520 79614899
Blood pressure diastolic abnormal 24.42 14.07 42 46927 19160 79678259
Thrombosis 24.21 14.07 106 46863 83994 79613425
Cushingoid 24.19 14.07 29 46940 9523 79687896
Pain in extremity 24.15 14.07 324 46645 364214 79333205
Heart rate irregular 24.15 14.07 57 46912 32622 79664797
Hypoglycaemia 24.11 14.07 15 46954 101579 79595840
Treatment failure 23.81 14.07 177 46792 170309 79527110
Hypotension 23.66 14.07 157 46812 440160 79257259
Nasopharyngitis 23.65 14.07 241 46728 253640 79443779
Respiratory arrest 23.63 14.07 3 46966 57547 79639872
Therapeutic reaction time decreased 23.07 14.07 18 46951 3483 79693936
Septic shock 23.00 14.07 23 46946 122778 79574641
Suicide attempt 23.00 14.07 10 46959 82922 79614497
Blood pressure diastolic increased 22.84 14.07 35 46934 14507 79682912
Nasal congestion 22.43 14.07 97 46872 76455 79620964
Joint effusion 22.39 14.07 39 46930 17975 79679444
Renal pain 22.35 14.07 26 46943 8270 79689149
Occupational exposure to product 22.30 14.07 10 46959 690 79696729
Impaired healing 22.14 14.07 12 46957 87643 79609776
Tender joint count decreased 22.10 14.07 7 46962 182 79697237
Gamma-glutamyltransferase increased 22.10 14.07 3 46966 54677 79642742
Swollen joint count decreased 22.03 14.07 7 46962 184 79697235
Therapeutic response shortened 21.91 14.07 36 46933 15827 79681592
Respiratory distress 21.77 14.07 4 46965 58335 79639084
Stomatitis 21.69 14.07 33 46936 146724 79550695
Blister 21.67 14.07 23 46946 119453 79577966
Pulmonary toxicity 21.59 14.07 32 46937 12882 79684537
Flail chest 21.51 14.07 6 46963 99 79697320
Peak expiratory flow rate abnormal 21.46 14.07 6 46963 100 79697319
Heart rate increased 21.43 14.07 133 46836 120591 79576828
Gastrointestinal motility disorder 21.40 14.07 22 46947 6100 79691319
Chronic kidney disease-mineral and bone disorder 21.39 14.07 9 46960 532 79696887
Injection site oedema 21.19 14.07 12 46957 1359 79696060
Photophobia 21.17 14.07 41 46928 20487 79676932
Carcinoid tumour 21.14 14.07 9 46960 548 79696871
Pain 21.12 14.07 553 46416 703249 78994170
Lung perforation 21.08 14.07 6 46963 107 79697312
Device dislocation 21.07 14.07 47 46922 25923 79671496
Central obesity 20.91 14.07 13 46956 1748 79695671
Thoracic operation 20.84 14.07 7 46962 220 79697199
Neuropathy peripheral 20.67 14.07 32 46937 141273 79556146
Unresponsive to stimuli 20.44 14.07 4 46965 55784 79641635
Mental status changes 20.35 14.07 7 46962 66952 79630467
Folliculitis 20.23 14.07 4 46965 55376 79642043
Bone marrow failure 20.19 14.07 3 46966 51104 79646315
Pharyngitis streptococcal 20.04 14.07 28 46941 10686 79686733
Impaired work ability 19.92 14.07 39 46930 19642 79677777
Blood pressure increased 19.85 14.07 201 46768 211159 79486260
Device dependence 19.55 14.07 5 46964 58 79697361
Synovial disorder 19.50 14.07 13 46956 1970 79695449
Rales 19.48 14.07 39 46930 19962 79677457
Gastrointestinal haemorrhage 19.27 14.07 36 46933 147683 79549736
Renal impairment 19.24 14.07 40 46929 157743 79539676
Cardiac failure congestive 19.20 14.07 34 46935 142368 79555051
Abnormal faeces 19.20 14.07 23 46946 7548 79689871
Urine odour abnormal 19.19 14.07 21 46948 6252 79691167
Type 2 diabetes mellitus 19.12 14.07 5 46964 57117 79640302
Pulmonary embolism 18.91 14.07 46 46923 171608 79525811
Acute myocardial infarction 18.80 14.07 11 46958 77025 79620394
Incorrect route of product administration 18.70 14.07 54 46915 34875 79662544
Iron deficiency 18.68 14.07 27 46942 10627 79686792
Erythema of eyelid 18.66 14.07 14 46955 2556 79694863
Eye irritation 18.57 14.07 39 46930 20642 79676777
Forced vital capacity decreased 18.53 14.07 12 46957 1731 79695688
Atelectasis 18.37 14.07 51 46918 32206 79665213
Drug specific antibody present 18.18 14.07 21 46948 6631 79690788
Deep vein thrombosis 18.05 14.07 27 46942 120892 79576527
Dry eye 17.78 14.07 55 46914 36876 79660543
Gastritis fungal 17.76 14.07 6 46963 192 79697227
Syncope 17.56 14.07 51 46918 179398 79518021
Intentional overdose 17.49 14.07 22 46947 105938 79591481
Patella fracture 17.47 14.07 12 46957 1909 79695510
White coat hypertension 17.40 14.07 9 46960 851 79696568
Bladder disorder 17.21 14.07 24 46945 9141 79688278
Blood alkaline phosphatase increased 17.15 14.07 8 46961 63656 79633763
Malignant neoplasm progression 16.99 14.07 34 46935 135956 79561463
SAPHO syndrome 16.63 14.07 7 46962 414 79697005
Neck pain 16.60 14.07 88 46881 75329 79622090
Knee deformity 16.57 14.07 10 46959 1275 79696144
Generalised tonic-clonic seizure 16.41 14.07 3 46966 43907 79653512
Drug ineffective 16.32 14.07 785 46184 1080128 78617291
Skin irritation 16.19 14.07 26 46943 11214 79686205
Therapeutic response decreased 16.10 14.07 80 46889 66773 79630646
Anaemia 16.09 14.07 176 46793 444839 79252580
Hyperparathyroidism secondary 16.08 14.07 13 46956 2647 79694772
Haematocrit decreased 16.06 14.07 8 46961 61304 79636115
Back pain 16.05 14.07 260 46709 303920 79393499
Chromaturia 15.96 14.07 42 46927 25704 79671715
Melaena 15.87 14.07 8 46961 60882 79636537
Pulmonary function test decreased 15.86 14.07 21 46948 7616 79689803
Hyperglycaemia 15.85 14.07 11 46958 70324 79627095
Aspiration 15.81 14.07 36 46933 20122 79677297
Pneumonia aspiration 15.73 14.07 10 46959 66957 79630462
Fall 15.65 14.07 198 46771 487431 79209988
Drug resistance 15.52 14.07 3 46966 42210 79655209
Mobility decreased 15.47 14.07 124 46845 122051 79575368
Renal mass 15.44 14.07 14 46955 3326 79694093
Ear infection 15.41 14.07 50 46919 34382 79663037
Cerebral infarction 15.29 14.07 4 46965 45672 79651747
Orthostatic hypotension 15.22 14.07 7 46962 56157 79641262
Conjunctival haemorrhage 15.17 14.07 18 46951 5847 79691572
Eosinophilia 15.12 14.07 4 46965 45341 79652078
Flank pain 15.08 14.07 35 46934 19809 79677610
Blood urea increased 15.00 14.07 5 46964 48785 79648634
Hyponatraemia 15.00 14.07 54 46915 177794 79519625
Nodule 14.75 14.07 38 46931 22956 79674463
Heart rate abnormal 14.70 14.07 18 46951 6039 79691380
Eye haemorrhage 14.65 14.07 23 46946 9734 79687685
Liver function test abnormal 14.64 14.07 10 46959 64465 79632954
Hepatic failure 14.57 14.07 9 46960 61203 79636216
Off label use 14.56 14.07 663 46306 906552 78790867
Bone hypertrophy 14.52 14.07 7 46962 570 79696849
Bradycardia 14.40 14.07 37 46932 135520 79561899
Renal failure 14.28 14.07 181 46788 200787 79496632
Colitis ulcerative 14.26 14.07 49 46920 34693 79662726
Accidental overdose 14.17 14.07 3 46966 39578 79657841
Infusion related reaction 14.15 14.07 202 46767 230035 79467384

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BC06 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
FDA MoA N0000000147 Proton Pump Inhibitors
FDA EPC N0000175525 Proton Pump Inhibitor
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D054328 Proton Pump Inhibitors

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

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Erosive esophagitis indication 40719004
Gastroesophageal reflux disease indication 235595009 DOID:8534
Maintenance of Healing Erosive Esophagitis indication
Duodenal ulcer disease off-label use 51868009 DOID:1724
Zollinger-Ellison syndrome off-label use 53132006 DOID:0050782
Gastric ulcer off-label use 397825006 DOID:10808
Duodenal Ulcer due to H. Pylori off-label use
Maintenance of Healing Duodenal Ulcer off-label use
NSAID-Induced Gastric Ulcer off-label use
Prevention of NSAID-Induced Gastric Ulcer off-label use
Pathological Gastric Hypersecretory Condition off-label use
Osteoporosis contraindication 64859006 DOID:11476
Fracture of bone contraindication 125605004
Hypomagnesemia contraindication 190855004
Disease of liver contraindication 235856003 DOID:409




🐶 Veterinary Drug Use

None

🐶 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT SOLUTAB TAKEDA PHARMS USA N208056 Jan. 26, 2016 DISCN TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT SOLUTAB TAKEDA PHARMS USA N208056 Jan. 26, 2016 DISCN TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 FOR HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE)
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 FOR THE TREATMENT OF HEARTBURN ASSOCIATED WITH SYMPTOMATIC NON-EROSIVE GASTROESOPHAGEAL DISEASE (GERD)
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 FOR HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE)
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 FOR THE TREATMENT OF HEARTBURN ASSOCIATED WITH SYMPTOMATIC NON-EROSIVE GASTROESOPHAGEAL DISEASE (GERD)
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 9233103 March 5, 2032 USE OF DEXLANSOPRAZOLE IN PATIENTS TAKING CLOPIDOGREL WITHOUT MEANINGFUL CYP2C19 INTERACTIONS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 9233103 March 5, 2032 USE OF DEXLANSOPRAZOLE IN PATIENTS TAKING CLOPIDOGREL WITHOUT MEANINGFUL CYP2C19 INTERACTIONS

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
Cytosolic endo-beta-N-acetylglucosaminidase Enzyme IC50 4.60 CHEMBL
Sterile alpha and TIR motif-containing protein 1 Unclassified IC50 5.48 CHEMBL

External reference:

IDSource
4028570 VUID
N0000189452 NUI
D08903 KEGG_DRUG
313640-86-7 SECONDARY_CAS_RN
4028570 VANDF
C2348248 UMLSCUI
CHEBI:135931 CHEBI
CHEMBL1201863 ChEMBL_ID
D064748 MESH_DESCRIPTOR_UI
DB05351 DRUGBANK_ID
5487 IUPHAR_LIGAND_ID
8524 INN_ID
UYE4T5I70X UNII
9578005 PUBCHEM_CID
816346 RXNORM
160770 MMSL
172755 MMSL
26184 MMSL
356045 MMSL
d07395 MMSL
012953 NDDF
441863009 SNOMEDCT_US
442540007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 24979-001 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 32 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 24979-002 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 32 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 24979-703 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 24979-703 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 24979-703 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 24979-704 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 24979-704 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 24979-704 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 49884-147 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 28 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 49884-148 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 28 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 49884-148 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 28 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 50090-4374 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 32 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 50090-5944 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA AUTHORIZED GENERIC 32 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 50090-5956 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA AUTHORIZED GENERIC 32 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 50090-6514 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 32 sections
Dexlansoprazoledelayed release HUMAN PRESCRIPTION DRUG LABEL 1 51407-746 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 32 sections
Dexlansoprazoledelayed release HUMAN PRESCRIPTION DRUG LABEL 1 51407-747 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 32 sections
Kapidex HUMAN PRESCRIPTION DRUG LABEL 1 54868-5998 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA 16 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 54868-6152 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 31 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 55154-5154 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 31 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 55154-5154 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 31 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-171 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA 33 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-171 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA 33 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-171 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA 33 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-175 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 33 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-175 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 33 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-175 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 33 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 70518-3693 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 28 sections