dexlansoprazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,JAK3,MAP3K1,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK8,MAPK9,MAPKAPK2,MARK4,MELK,MET,MTOR,NTRK2,PDK1,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ZAP70 50
kinase-selectivity-class AXL 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 4.436 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 1
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 Moderate 0.73
rat-kpuu-brain Rat brain Kpuu 0.216 % High 1

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 789.19 12.25 429 47954 49762 90530302
Tenosynovitis 258.25 12.25 135 48248 14432 90565632
End stage renal disease 247.65 12.25 111 48272 8460 90571604
Renal injury 225.75 12.25 110 48273 10133 90569931
Enthesopathy 201.29 12.25 99 48284 9305 90570759
Blood pressure systolic increased 195.94 12.25 196 48187 58149 90521915
Tongue disorder 182.16 12.25 97 48286 10763 90569301
Rheumatoid nodule 173.02 12.25 117 48266 20049 90560015
Sputum discoloured 169.47 12.25 116 48267 20275 90559789
Bronchopulmonary aspergillosis allergic 162.99 12.25 65 48318 3701 90576363
Ulcer 154.02 12.25 133 48250 32749 90547315
Blood parathyroid hormone decreased 150.19 12.25 89 48294 12127 90567937
Tendonitis 148.51 12.25 109 48274 21263 90558801
Red blood cell sedimentation rate 146.39 12.25 64 48319 4594 90575470
Total lung capacity decreased 145.36 12.25 60 48323 3735 90576329
Lung opacity 141.92 12.25 68 48315 6034 90574030
Panniculitis 141.31 12.25 91 48292 14367 90565697
Maternal exposure during pregnancy 136.77 12.25 16 48367 360047 90220017
Blood calcium increased 130.61 12.25 81 48302 11977 90568087
Pemphigus 128.01 12.25 13 48370 326851 90253213
Granuloma skin 126.59 12.25 76 48307 10604 90569460
Incorrect product administration duration 126.31 12.25 95 48288 19227 90560837
Skin necrosis 125.90 12.25 90 48293 16851 90563213
Skin ulcer 125.36 12.25 144 48239 49931 90530133
Pleuritic pain 120.27 12.25 73 48310 10388 90569676
Obstructive airways disorder 117.85 12.25 103 48280 25766 90554298
Blood test abnormal 115.23 12.25 93 48290 20859 90559205
Glossodynia 104.80 12.25 22 48361 321757 90258307
Exposure during pregnancy 103.10 12.25 6 48377 238404 90341660
Alanine aminotransferase abnormal 101.08 12.25 52 48331 5374 90574690
Fear of injection 99.39 12.25 60 48323 8455 90571609
Cough 95.51 12.25 420 47963 368542 90211522
Hypercalcaemia 86.59 12.25 99 48284 34141 90545923
Aspiration 84.90 12.25 69 48314 15624 90564440
Pericarditis 84.87 12.25 20 48363 270131 90309933
Rales 82.29 12.25 68 48315 15759 90564305
Rash pruritic 82.07 12.25 153 48230 82061 90498003
Basal cell carcinoma 81.85 12.25 95 48288 33294 90546770
Body temperature decreased 81.75 12.25 81 48302 23735 90556329
Muscle injury 77.75 12.25 4 48379 176650 90403414
Blood pressure fluctuation 75.60 12.25 115 48268 52298 90527766
Helicobacter infection 74.89 12.25 15 48368 226835 90353229
Drug eruption 74.14 12.25 93 48290 35314 90544750
Hepatic enzyme increased 74.03 12.25 51 48332 360685 90219379
Allergy to chemicals 72.90 12.25 37 48346 3717 90576347
Duodenal ulcer perforation 72.29 12.25 15 48368 221273 90358791
Systemic lupus erythematosus 69.30 12.25 55 48328 361841 90218223
Joint injury 67.13 12.25 85 48298 32579 90547485
Wound 66.02 12.25 40 48343 302940 90277124
Forced expiratory volume decreased 65.41 12.25 40 48343 5768 90574296
Endometriosis 65.22 12.25 41 48342 6207 90573857
Hand deformity 64.75 12.25 39 48344 296323 90283741
Rheumatoid factor positive 64.20 12.25 8 48375 171642 90408422
Bronchiectasis 64.11 12.25 69 48314 22261 90557803
Rebound acid hypersecretion 63.91 12.25 18 48365 342 90579722
Faeces soft 63.04 12.25 43 48340 7468 90572596
Folliculitis 62.47 12.25 16 48367 204337 90375727
Haemoptysis 61.14 12.25 82 48301 33238 90546826
Impaired healing 59.89 12.25 25 48358 234174 90345890
Arthritis 59.85 12.25 211 48172 167104 90412960
Blood creatinine increased 59.18 12.25 152 48231 101234 90478830
Peak expiratory flow rate decreased 57.64 12.25 19 48364 623 90579441
Crepitations 56.69 12.25 43 48340 8809 90571255
Confusional state 56.53 12.25 74 48309 386131 90193933
Erythema 55.50 12.25 256 48127 228990 90351074
Antinuclear antibody positive 55.05 12.25 43 48340 9198 90570866
Type 2 diabetes mellitus 54.76 12.25 20 48363 203224 90376840
Pulmonary mass 54.63 12.25 72 48311 28700 90551364
Swelling 53.80 12.25 88 48295 418970 90161094
Completed suicide 53.67 12.25 7 48376 145051 90435013
Synovial fluid analysis 52.47 12.25 27 48356 2791 90577273
Blood pressure diastolic decreased 52.28 12.25 68 48315 26758 90553306
Tenosynovitis stenosans 51.75 12.25 30 48353 3923 90576141
Asthma 51.12 12.25 260 48123 241900 90338164
Granuloma 50.94 12.25 35 48348 6150 90573914
Thrombocytopenia 50.66 12.25 24 48359 208701 90371363
Somatic delusion 50.46 12.25 17 48366 597 90579467
Upper respiratory tract infection 50.42 12.25 167 48216 128151 90451913
Drug interaction 49.25 12.25 45 48338 276408 90303656
Irritable bowel syndrome 48.62 12.25 25 48358 207423 90372641
Cervix neoplasm 48.54 12.25 13 48370 203 90579861
Blister 48.48 12.25 39 48344 254959 90325105
Toxicity to various agents 47.64 12.25 50 48333 287796 90292268
Headache 47.60 12.25 684 47699 862062 89718002
Injury 47.42 12.25 23 48360 197326 90382738
Defaecation disorder 47.15 12.25 18 48365 911 90579153
Drug specific antibody 46.58 12.25 24 48359 2488 90577576
Scleritis 46.54 12.25 31 48352 5177 90574887
Transaminases increased 45.90 12.25 76 48307 37116 90542948
Arteriovenous fistula occlusion 45.82 12.25 14 48369 357 90579707
Heart rate decreased 45.39 12.25 93 48290 53412 90526652
Stomatitis 45.14 12.25 48 48335 274650 90305414
Gastric disorder 44.99 12.25 71 48312 33313 90546751
Extra dose administered 44.97 12.25 38 48345 9080 90570984
Rhinorrhoea 44.09 12.25 125 48258 88191 90491873
Echocardiogram abnormal 43.94 12.25 20 48363 1579 90578485
Gut fermentation syndrome 43.51 12.25 8 48375 16 90580048
Abdominal pain 43.38 12.25 360 48023 395361 90184703
Lip dry 42.26 12.25 3 48380 100952 90479112
Blue toe syndrome 42.10 12.25 14 48369 472 90579592
Sleep disorder due to general medical condition, insomnia type 41.45 12.25 9 48374 128685 90451379
Frustration tolerance decreased 41.20 12.25 34 48349 7862 90572202
Oropharyngeal pain 40.09 12.25 144 48239 115043 90465021
Chromaturia 39.53 12.25 50 48333 19137 90560927
Musculoskeletal disorder 39.06 12.25 53 48330 21716 90558348
Blood pressure diastolic abnormal 38.12 12.25 50 48333 19831 90560233
Blood cholesterol increased 38.07 12.25 33 48350 207979 90372085
Analgesic therapy 37.66 12.25 14 48369 658 90579406
Inflammation 37.14 12.25 191 48192 178401 90401663
Aphonia 37.01 12.25 39 48344 12280 90567784
Aspartate aminotransferase increased 36.95 12.25 130 48253 102807 90477257
Gout 36.44 12.25 45 48338 16814 90563250
Antacid therapy 36.09 12.25 14 48369 740 90579324
Renal failure 36.00 12.25 152 48231 130855 90449209
Appendicolith 35.97 12.25 14 48369 747 90579317
Poor venous access 35.74 12.25 48 48335 19479 90560585
Rheumatoid lung 35.65 12.25 24 48359 4079 90575985
Drug therapy 35.14 12.25 14 48369 795 90579269
Neutropenia 35.08 12.25 41 48342 224863 90355201
Heart rate increased 35.00 12.25 136 48247 112766 90467298
Anticoagulant therapy 35.00 12.25 14 48369 803 90579261
Delirium 34.22 12.25 7 48376 104352 90475712
Central obesity 33.88 12.25 16 48367 1374 90578690
Peripheral venous disease 33.71 12.25 3 48380 83918 90496146
Total lung capacity increased 33.51 12.25 25 48358 4996 90575068
Cushingoid 33.19 12.25 34 48349 10361 90569703
Drug abuse 32.93 12.25 3 48380 82344 90497720
No adverse event 32.74 12.25 95 48288 67887 90512177
Gait inability 32.35 12.25 19 48364 146437 90433627
Dysphonia 32.18 12.25 90 48293 62994 90517070
Thrombosis 32.10 12.25 99 48284 73152 90506912
Musculoskeletal stiffness 32.05 12.25 269 48114 296263 90283801
Loss of personal independence in daily activities 31.45 12.25 150 48233 135955 90444109
Synovial disorder 31.39 12.25 20 48363 3098 90576966
Lung diffusion test decreased 31.36 12.25 13 48370 818 90579246
Blood pressure systolic decreased 30.84 12.25 31 48352 9239 90570825
Deformity 30.45 12.25 35 48348 12135 90567929
Pulmonary toxicity 30.27 12.25 34 48349 11497 90568567
Disease progression 29.69 12.25 24 48359 156591 90423473
Nasal congestion 29.64 12.25 105 48278 83309 90496755
Wound infection 29.46 12.25 10 48373 106392 90473672
Pulmonary thrombosis 29.44 12.25 31 48352 9751 90570313
Pneumococcal infection 29.33 12.25 14 48369 1231 90578833
Pharyngitis streptococcal 29.14 12.25 35 48348 12707 90567357
Synovial cyst 28.07 12.25 33 48350 11719 90568345
Bone density decreased 27.80 12.25 40 48343 17305 90562759
Liver injury 27.79 12.25 30 48353 170537 90409527
Tubulointerstitial nephritis 27.60 12.25 49 48334 25294 90554770
Respiration abnormal 27.17 12.25 27 48356 7936 90572128
Grip strength decreased 26.87 12.25 8 48375 92568 90487496
Gastrooesophageal reflux disease 26.71 12.25 166 48217 166171 90413893
Red blood cell count decreased 26.52 12.25 69 48314 46282 90533782
Productive cough 26.52 12.25 96 48287 76967 90503097
Serum amyloid A protein increased 26.32 12.25 11 48372 706 90579358
Therapeutic reaction time decreased 26.18 12.25 19 48364 3639 90576425
Hypoaldosteronism 25.84 12.25 9 48374 350 90579714
Depressed level of consciousness 25.78 12.25 4 48379 72780 90507284
Hypercholesterolaemia 25.41 12.25 11 48372 100881 90479183
Red blood cell sedimentation rate decreased 25.35 12.25 12 48371 1036 90579028
Joint effusion 25.30 12.25 41 48342 19669 90560395
Gastrointestinal motility disorder 25.25 12.25 23 48360 6068 90573996
Connective tissue inflammation 25.23 12.25 6 48377 56 90580008
Drug specific antibody present 25.20 12.25 22 48361 5492 90574572
Alanine aminotransferase increased 24.90 12.25 127 48256 118211 90461853
Bradycardia 24.79 12.25 7 48376 83840 90496224
Injection site oedema 24.74 12.25 14 48369 1749 90578315
Conjunctival haemorrhage 24.74 12.25 19 48364 3965 90576099
Impaired work ability 24.53 12.25 40 48343 19286 90560778
Renal pain 24.09 12.25 25 48358 7734 90572330
Thoracic operation 24.06 12.25 7 48376 150 90579914
Forced vital capacity decreased 24.02 12.25 12 48371 1166 90578898
Heart rate irregular 24.00 12.25 45 48338 24223 90555841
Feeling jittery 23.98 12.25 35 48348 15336 90564728
Urine odour abnormal 23.68 12.25 24 48359 7220 90572844
Hypertensive nephropathy 23.55 12.25 10 48373 668 90579396
Abnormal faeces 23.44 12.25 23 48360 6659 90573405
Parotid gland enlargement 23.43 12.25 11 48372 932 90579132
Discomfort 23.39 12.25 72 48311 274263 90305801
Hepatic enzyme decreased 23.27 12.25 11 48372 947 90579117
Acute kidney injury 23.04 12.25 267 48116 320120 90259944
Blood pressure increased 22.96 12.25 182 48201 197035 90383029
Tremor 22.82 12.25 150 48233 153023 90427041
Ill-defined disorder 22.61 12.25 40 48343 184851 90395213
Flail chest 22.57 12.25 6 48377 91 90579973
Patella fracture 22.39 12.25 15 48368 2528 90577536
Blood immunoglobulin E decreased 22.32 12.25 7 48376 195 90579869
Renal haemangioma 22.30 12.25 5 48378 35 90580029
Hyponatraemia 22.30 12.25 23 48360 133515 90446549
Oedema 22.17 12.25 46 48337 200249 90379815
Lung perforation 22.15 12.25 6 48377 98 90579966
Alopecia 22.14 12.25 164 48219 494907 90085157
Neoplasm malignant 22.08 12.25 53 48330 33827 90546237
Bladder disorder 22.08 12.25 28 48355 10744 90569320
Flank pain 22.02 12.25 38 48345 19184 90560880
Osteomyelitis 21.98 12.25 47 48336 27799 90552265
Peak expiratory flow rate abnormal 21.87 12.25 6 48377 103 90579961
Heart rate abnormal 21.78 12.25 21 48362 5950 90574114
Cardiac arrest 21.27 12.25 15 48368 104920 90475144
Fatigue 20.86 12.25 782 47601 1153241 89426823
Parapsoriasis 20.78 12.25 6 48377 125 90579939
Hyperaesthesia 20.65 12.25 27 48356 10675 90569389
Diarrhoea 20.62 12.25 651 47732 938539 89641525
Adjustment disorder with depressed mood 20.37 12.25 3 48380 56750 90523314
Drug tolerance 19.98 12.25 35 48348 17881 90562183
Skin irritation 19.82 12.25 30 48353 13573 90566491
Coma 19.80 12.25 7 48376 72625 90507439
Regurgitation 19.61 12.25 13 48370 2153 90577911
Injection site extravasation 19.37 12.25 24 48359 8995 90571069
Prescribed underdose 19.18 12.25 8 48375 75011 90505053
Epilepsy 19.11 12.25 10 48373 82196 90497868
Respiratory failure 19.09 12.25 21 48362 118397 90461667
Ocular hyperaemia 19.02 12.25 50 48333 33748 90546316
Aortic stenosis 18.93 12.25 20 48363 6316 90573748
Gastritis fungal 18.87 12.25 6 48377 175 90579889
Nodule 18.76 12.25 43 48340 26643 90553421
Facet joint syndrome 18.74 12.25 15 48368 98374 90481690
Eye pain 18.71 12.25 59 48324 44109 90535955
Pancytopenia 18.66 12.25 22 48361 120241 90459823
Drug tolerance decreased 18.56 12.25 48 48335 32082 90547982
Brain hypoxia 18.47 12.25 8 48375 561 90579503
Dry throat 18.43 12.25 22 48361 7938 90572126
Autoimmune disorder 18.34 12.25 9 48374 76735 90503329
Malignant neoplasm progression 18.30 12.25 18 48365 106852 90473212
Platelet count decreased 18.27 12.25 28 48355 136941 90443123
Electrocardiogram QT prolonged 18.08 12.25 8 48375 72448 90507616
Photophobia 18.07 12.25 37 48346 21232 90558832
Knee arthroplasty 18.07 12.25 11 48372 83171 90496893
Oral discomfort 18.02 12.25 25 48358 10458 90569606
Multiple organ dysfunction syndrome 17.94 12.25 7 48376 68329 90511735
Suicide attempt 17.78 12.25 9 48374 75390 90504674
Neutrophil count decreased 17.69 12.25 8 48375 71524 90508540
Feeling abnormal 17.67 12.25 151 48232 167084 90412980
Conjunctivitis 17.64 12.25 42 48341 26664 90553400
Hypoxia 17.60 12.25 81 48302 72318 90507746
Sleep disorder 17.57 12.25 51 48332 197979 90382085
Product dose omission issue 17.49 12.25 235 48148 291452 90288612
Pleural effusion 17.49 12.25 111 48272 111880 90468184
Pneumonia 17.49 12.25 455 47928 637604 89942460
Arthralgia 17.42 12.25 541 47842 777981 89802083
Peripheral swelling 17.22 12.25 313 48070 412793 90167271
Carcinoid tumour 17.20 12.25 7 48376 420 90579644
Eye haemorrhage 17.08 12.25 24 48359 10156 90569908
Abortion spontaneous 16.96 12.25 4 48379 54052 90526012
Nocturia 16.95 12.25 24 48359 10231 90569833
Eye irritation 16.86 12.25 48 48335 33930 90546134
White coat hypertension 16.75 12.25 9 48374 1016 90579048
Lung diffusion disorder 16.69 12.25 5 48378 119 90579945
Weight decreased 16.59 12.25 290 48093 379620 90200444
Arthropathy 16.51 12.25 121 48262 366121 90213943
Mononeuropathy 16.46 12.25 5 48378 125 90579939
Contraindicated product administered 16.31 12.25 102 48281 320037 90260027
Pain in extremity 16.28 12.25 334 48049 450195 90129869
AST/ALT ratio abnormal 16.27 12.25 5 48378 130 90579934
Stress 16.18 12.25 86 48297 81309 90498755
Contusion 16.15 12.25 74 48309 251142 90328922
Death 16.04 12.25 161 48222 456390 90123674
Hyperchlorhydria 16.02 12.25 11 48372 1930 90578134
Undifferentiated connective tissue disease 15.88 12.25 5 48378 141 90579923
Skin cancer 15.84 12.25 27 48356 13492 90566572
Drug-induced liver injury 15.71 12.25 15 48368 90303 90489761
Knee deformity 15.68 12.25 10 48373 1552 90578512
Obesity 15.63 12.25 20 48363 105487 90474577
Back injury 15.55 12.25 3 48380 46619 90533445
Mobility decreased 15.45 12.25 75 48308 250659 90329405
Blood pressure diastolic increased 15.42 12.25 26 48357 12880 90567184
Urinary tract disorder 15.36 12.25 14 48369 3697 90576367
Hyperphosphataemia 15.36 12.25 14 48369 3697 90576367
Lactic acidosis 15.32 12.25 4 48379 50459 90529605
Gastrointestinal disorder 15.12 12.25 78 48305 256609 90323455
Iodine allergy 15.10 12.25 8 48375 878 90579186
Groin infection 15.07 12.25 7 48376 579 90579485
Muscle strain 15.03 12.25 22 48361 9665 90570399
Myalgia 14.92 12.25 151 48232 174974 90405090
Influenza 14.84 12.25 126 48257 139138 90440926
Lupus vulgaris 14.82 12.25 3 48380 45056 90535008
Nausea 14.77 12.25 729 47654 1109587 89470477
Keratomileusis 14.70 12.25 5 48378 181 90579883
Amnesia 14.64 12.25 22 48361 108483 90471581
Foot fracture 14.60 12.25 39 48344 26567 90553497
Hypokalaemia 14.60 12.25 30 48353 131086 90448978
Bronchitis 14.57 12.25 135 48248 152792 90427272
Cardio-respiratory arrest 14.21 12.25 8 48375 63132 90516932
Skin sensitisation 14.08 12.25 8 48375 1007 90579057
Hip arthroplasty 14.04 12.25 12 48371 76196 90503868
Hypoprothrombinaemia 14.02 12.25 6 48377 409 90579655
Cardiac failure 14.02 12.25 23 48360 109473 90470591
Humidity intolerance 13.95 12.25 6 48377 414 90579650
Musculoskeletal discomfort 13.85 12.25 33 48350 20958 90559106
Abdominal pain upper 13.83 12.25 252 48131 332422 90247642
Nephrogenic anaemia 13.67 12.25 11 48372 2455 90577609
Atelectasis 13.62 12.25 36 48347 24373 90555691
Eye ulcer 13.57 12.25 6 48377 442 90579622
Blood phosphorus increased 13.56 12.25 14 48369 4304 90575760
Pulmonary fibrosis 13.50 12.25 101 48282 107402 90472662
Mucosal inflammation 13.41 12.25 7 48376 57618 90522446
Pituitary tumour recurrent 13.40 12.25 4 48379 94 90579970
Tonsillitis fungal 13.38 12.25 3 48380 21 90580043
Energy increased 13.33 12.25 12 48371 3118 90576946
Abdominal distension 13.31 12.25 117 48266 130484 90449580
Klebsiella bacteraemia 13.19 12.25 11 48372 2581 90577483
Red blood cell sedimentation rate increased 12.98 12.25 82 48301 82513 90497551
Quality of life decreased 12.96 12.25 23 48360 11866 90568198
Nephropathy 12.94 12.25 20 48363 9215 90570849
Lupus-like syndrome 12.82 12.25 5 48378 48841 90531223
Spirometry abnormal 12.79 12.25 5 48378 270 90579794
Arthroscopic surgery 12.77 12.25 4 48379 111 90579953
Secretion discharge 12.74 12.25 27 48356 15869 90564195
Mental status changes 12.71 12.25 4 48379 44675 90535389
Hallucination 12.63 12.25 10 48373 65949 90514115
Liver function test increased 12.57 12.25 83 48300 84772 90495292
Drug hypersensitivity 12.51 12.25 330 48053 463279 90116785
Vomiting 12.47 12.25 323 48060 787970 89792094
Hepatic failure 12.35 12.25 3 48380 39725 90540339
Seizure 12.34 12.25 41 48342 152588 90427476
Night sweats 12.29 12.25 32 48351 128734 90451330
Rhabdomyolysis 12.26 12.25 6 48377 51250 90528814

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 353.82 19.04 250 22102 46991 42551992
End stage renal disease 297.99 19.04 154 22198 16404 42582579
Hyperphosphataemia 197.38 19.04 108 22244 12896 42586087
Myasthenia gravis 185.98 19.04 112 22240 16025 42582958
Sleep disorder therapy 174.60 19.04 81 22271 6813 42592170
Analgesic therapy 169.43 19.04 78 22274 6446 42592537
Synovitis 166.47 19.04 103 22249 15464 42583519
Appendicolith 161.83 19.04 96 22256 13360 42585623
Blood phosphorus increased 160.22 19.04 93 22259 12432 42586551
Drug therapy 146.30 19.04 70 22282 6310 42592673
Ulcer 144.15 19.04 96 22256 16345 42582638
Stress 142.50 19.04 144 22208 44068 42554915
Incorrect route of product administration 142.20 19.04 111 22241 24194 42574789
Neuralgia 139.05 19.04 112 22240 25535 42573448
Tenosynovitis 137.34 19.04 61 22291 4634 42594349
Blood uric acid increased 134.43 19.04 90 22262 15457 42583526
Hypophosphataemia 134.25 19.04 101 22251 20844 42578139
Drug intolerance 132.64 19.04 186 22166 80238 42518745
Enthesopathy 132.53 19.04 60 22292 4768 42594215
Appendicitis 131.23 19.04 99 22253 20514 42578469
Iron deficiency 125.44 19.04 76 22276 10985 42587998
Renal injury 123.10 19.04 78 22274 12202 42586781
Psoriatic arthropathy 122.72 19.04 103 22249 24864 42574119
Ventricular fibrillation 121.42 19.04 111 22241 30012 42568971
C-reactive protein abnormal 119.06 19.04 69 22283 9192 42589791
Bacterial infection 116.81 19.04 105 22247 27774 42571209
Abdominal distension 109.58 19.04 160 22192 71575 42527408
Tongue disorder 108.25 19.04 54 22298 5329 42593654
Anticoagulant therapy 107.77 19.04 51 22301 4484 42594499
Terminal insomnia 106.98 19.04 33 22319 886 42598097
Antacid therapy 105.86 19.04 51 22301 4666 42594317
Drug hypersensitivity 104.43 19.04 187 22165 99202 42499781
Blood cholesterol increased 102.84 19.04 96 22256 26645 42572338
Alanine aminotransferase abnormal 100.61 19.04 50 22302 4894 42594089
Activated partial thromboplastin time prolonged 98.17 19.04 75 22277 15828 42583155
Drug interaction 96.49 19.04 13 22339 266986 42331997
Chronic obstructive pulmonary disease 90.95 19.04 137 22215 62977 42536006
Dry mouth 90.39 19.04 108 22244 39771 42559212
Swelling 81.73 19.04 121 22231 54764 42544219
Tendonitis 80.09 19.04 55 22297 9839 42589144
Blood test abnormal 77.76 19.04 60 22292 12846 42586137
Micturition urgency 75.39 19.04 57 22295 11841 42587142
Diabetes mellitus 73.49 19.04 121 22231 59966 42539017
Blood calcium increased 73.21 19.04 49 22303 8405 42590578
Bronchopulmonary aspergillosis allergic 71.99 19.04 39 22313 4559 42594424
Cardiogenic shock 70.27 19.04 90 22262 35550 42563433
Asthma 70.25 19.04 121 22231 62193 42536790
Injection site warmth 69.40 19.04 32 22320 2651 42596332
Congenital hiatus hernia 68.91 19.04 42 22310 6132 42592851
Incorrect product administration duration 68.20 19.04 41 22311 5839 42593144
Hyperlipidaemia 67.30 19.04 69 22283 21447 42577536
Red blood cell sedimentation rate 66.50 19.04 24 22328 1056 42597927
Thrombocytopenia 64.71 19.04 11 22341 190268 42408715
Granuloma skin 64.52 19.04 24 22328 1151 42597832
Sleep disorder 64.48 19.04 101 22251 47994 42550989
Pelvic pain 63.53 19.04 32 22320 3222 42595761
Thrombosis 60.80 19.04 120 22232 68391 42530592
Device dislocation 59.79 19.04 42 22310 7789 42591194
Pleuritic pain 58.84 19.04 40 22312 7037 42591946
Lower respiratory tract infection 58.69 19.04 89 22263 41117 42557866
Aortic stenosis 57.86 19.04 43 22309 8702 42590281
Blood parathyroid hormone decreased 56.72 19.04 24 22328 1619 42597364
Mobility decreased 55.67 19.04 80 22272 35226 42563757
General physical health deterioration 54.69 19.04 189 22163 151057 42447926
Troponin increased 54.02 19.04 58 22294 19004 42579979
Full blood count abnormal 53.54 19.04 72 22280 29804 42569179
Intentional product misuse 53.21 19.04 107 22245 61793 42537190
Gout 52.41 19.04 69 22283 27986 42570997
Ascites 51.16 19.04 100 22252 56578 42542405
Device malfunction 50.77 19.04 46 22306 12281 42586702
Panniculitis 50.21 19.04 24 22328 2157 42596826
Injection site mass 49.77 19.04 39 22313 8536 42590447
Joint injury 47.59 19.04 48 22304 14628 42584355
Occupational dermatitis 47.22 19.04 11 22341 95 42598888
Total lung capacity decreased 46.94 19.04 27 22325 3543 42595440
Inspiratory capacity abnormal 46.82 19.04 11 22341 99 42598884
Kidney infection 46.39 19.04 34 22318 6736 42592247
Rheumatoid nodule 45.77 19.04 25 22327 2970 42596013
Abdominal pain 45.46 19.04 209 22143 190262 42408721
Oral herpes 45.28 19.04 35 22317 7509 42591474
Toxicity to various agents 44.69 19.04 33 22319 229103 42369880
Stiff person syndrome 44.52 19.04 12 22340 196 42598787
Musculoskeletal stiffness 43.97 19.04 95 22257 57670 42541313
Bacteroides infection 43.47 19.04 23 22329 2564 42596419
Drug abuse 43.28 19.04 3 22349 104768 42494215
Neck pain 42.98 19.04 65 22287 29949 42569034
Occupational exposure to air contaminants 41.93 19.04 11 22341 161 42598822
Oesophageal polyp 41.50 19.04 9 22343 54 42598929
Nerve degeneration 40.02 19.04 11 22341 194 42598789
Neutropenia 39.82 19.04 28 22324 199403 42399580
Loss of personal independence in daily activities 39.14 19.04 83 22269 49733 42549250
Headache 38.79 19.04 236 22116 239133 42359850
Lung opacity 37.05 19.04 28 22324 5809 42593174
Disease progression 36.21 19.04 15 22337 143641 42455342
Respiratory failure 34.59 19.04 12 22340 128120 42470863
Orthostatic hypertension 34.58 19.04 12 22340 470 42598513
Hyponatraemia 34.23 19.04 124 22228 101338 42497645
Tender joint count decreased 32.72 19.04 10 22342 260 42598723
Swollen joint count decreased 32.72 19.04 10 22342 260 42598723
Sputum discoloured 32.60 19.04 33 22319 10099 42588884
Somnolence 32.28 19.04 153 22199 140952 42458031
Benign prostatic hyperplasia 32.15 19.04 47 22305 21005 42577978
Dry eye 31.88 19.04 40 22312 15466 42583517
Pancytopenia 31.83 19.04 11 22341 117732 42481251
Bone hypertrophy 31.61 19.04 10 22342 292 42598691
Multiple organ dysfunction syndrome 31.39 19.04 117 22235 96918 42502065
Seizure 31.34 19.04 12 22340 120549 42478434
Therapeutic response shortened 31.17 19.04 37 22315 13517 42585466
Respiratory symptom 30.08 19.04 33 22319 11073 42587910
Cardiovascular disorder 29.94 19.04 36 22316 13329 42585654
Breath sounds abnormal 29.45 19.04 34 22318 12059 42586924
Blood immunoglobulin E increased 28.98 19.04 20 22332 3605 42595378
Aspiration 28.88 19.04 41 22311 17845 42581138
Aspartate aminotransferase increased 28.34 19.04 97 22255 77066 42521917
Cardiac arrest 28.22 19.04 11 22341 109309 42489674
SAPHO syndrome 28.17 19.04 10 22342 419 42598564
Ocular hyperaemia 27.88 19.04 38 22314 15925 42583058
Nephrogenic anaemia 27.35 19.04 17 22335 2569 42596414
Platelet count decreased 26.93 19.04 20 22332 138561 42460422
Skin necrosis 26.86 19.04 24 22328 6290 42592693
Injection site reaction 26.81 19.04 37 22315 15684 42583299
Hypercholesterolaemia 26.18 19.04 33 22319 12816 42586167
Leukopenia 26.10 19.04 4 22348 74742 42524241
Condition aggravated 26.01 19.04 229 22123 260525 42338458
Drug tolerance 25.94 19.04 18 22334 3272 42595711
Treatment failure 25.93 19.04 82 22270 62542 42536441
Feeling hot 25.65 19.04 45 22307 23437 42575546
Pyrexia 25.64 19.04 113 22239 393929 42205054
Pain 25.44 19.04 217 22135 244631 42354352
Injection site erythema 25.11 19.04 41 22311 20154 42578829
Constipation 24.98 19.04 158 22194 162133 42436850
Atrial fibrillation 24.82 19.04 22 22330 139571 42459412
Renal haemangioma 24.73 19.04 5 22347 20 42598963
Haemoglobin decreased 24.62 19.04 20 22332 132451 42466532
Hyperkalaemia 22.65 19.04 7 22345 80451 42518532
Burning sensation 22.61 19.04 40 22312 20973 42578010
Renal neoplasm 21.68 19.04 12 22340 1463 42597520
Erythema of eyelid 21.47 19.04 12 22340 1491 42597492
Dehydration 21.08 19.04 26 22326 141741 42457242
Sensory disturbance 21.01 19.04 22 22330 7001 42591982
Renal mass 20.76 19.04 13 22339 1989 42596994
Occupational exposure to product 20.65 19.04 8 22344 429 42598554
Fatigue 20.42 19.04 331 22021 435310 42163673
Serum amyloid A protein increased 20.40 19.04 7 22345 265 42598718
Restrictive pulmonary disease 19.79 19.04 11 22341 1352 42597631
Syncope 19.76 19.04 14 22338 99392 42499591
Hypertensive nephropathy 19.62 19.04 8 22344 491 42598492
Bone density decreased 19.61 19.04 13 22339 2193 42596790

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 555.18 13.36 410 62506 75881 110450502
Tenosynovitis 396.53 13.36 191 62725 16092 110510291
End stage renal disease 349.38 13.36 192 62724 21281 110505102
Enthesopathy 330.21 13.36 155 62761 12323 110514060
Tongue disorder 292.56 13.36 149 62767 14149 110512234
Ulcer 287.46 13.36 220 62696 42896 110483487
Tendonitis 235.47 13.36 160 62756 25923 110500460
Bronchopulmonary aspergillosis allergic 233.28 13.36 108 62808 8318 110518065
Rheumatoid nodule 223.51 13.36 141 62775 20155 110506228
Blood calcium increased 220.67 13.36 134 62782 17906 110508477
Red blood cell sedimentation rate 209.96 13.36 87 62829 5127 110521256
Blood test abnormal 208.77 13.36 154 62762 28400 110497983
Hyperphosphataemia 203.77 13.36 123 62793 16258 110510125
Sputum discoloured 202.70 13.36 150 62766 27795 110498588
Analgesic therapy 200.52 13.36 93 62823 7191 110519192
Blood parathyroid hormone decreased 199.14 13.36 112 62804 12977 110513406
Alanine aminotransferase abnormal 198.93 13.36 100 62816 9234 110517149
Total lung capacity decreased 196.37 13.36 91 62825 7023 110519360
Appendicolith 187.62 13.36 111 62805 14144 110512239
Panniculitis 186.12 13.36 114 62802 15468 110510915
Pleuritic pain 184.95 13.36 115 62801 16025 110510358
Sleep disorder therapy 179.95 13.36 87 62829 7384 110518999
Granuloma skin 178.34 13.36 99 62817 11184 110515199
Drug therapy 175.90 13.36 85 62831 7206 110519177
Lung opacity 175.36 13.36 99 62817 11553 110514830
Blood pressure systolic increased 173.78 13.36 225 62691 82766 110443617
Myasthenia gravis 168.57 13.36 121 62795 21390 110504993
Blood phosphorus increased 166.25 13.36 108 62808 16232 110510151
Skin necrosis 150.50 13.36 113 62803 21399 110504984
Drug interaction 144.61 13.36 52 62864 500131 110026252
Blood uric acid increased 137.24 13.36 107 62809 21422 110504961
Anticoagulant therapy 136.93 13.36 65 62851 5296 110521087
Antacid therapy 135.53 13.36 65 62851 5419 110520964
Toxicity to various agents 133.83 13.36 53 62863 480502 110045881
Skin ulcer 132.37 13.36 172 62744 63473 110462910
Appendicitis 126.71 13.36 115 62801 28349 110498034
Renal injury 121.44 13.36 94 62822 18619 110507764
Stress 118.49 13.36 214 62702 105134 110421249
Joint injury 117.67 13.36 129 62787 39865 110486518
Aspiration 114.18 13.36 112 62804 30421 110495962
Fear of injection 108.48 13.36 66 62850 8845 110517538
Thrombocytopenia 108.31 13.36 32 62884 348853 110177530
Hypophosphataemia 108.15 13.36 113 62803 33069 110493314
Asthma 106.60 13.36 349 62567 249942 110276441
Neuralgia 105.49 13.36 134 62782 48344 110478039
Iron deficiency 105.32 13.36 86 62830 18390 110507993
Thrombosis 105.15 13.36 207 62709 108455 110417928
Bacterial infection 104.55 13.36 130 62786 45906 110480477
Maternal exposure during pregnancy 103.25 13.36 12 62904 254871 110271512
Basal cell carcinoma 98.30 13.36 125 62791 45145 110481238
Gout 97.41 13.36 112 62804 36454 110489929
Activated partial thromboplastin time prolonged 96.88 13.36 89 62827 22279 110504104
Ventricular fibrillation 94.36 13.36 117 62799 41196 110485187
Incorrect route of product administration 90.39 13.36 144 62772 63917 110462466
Terminal insomnia 87.13 13.36 35 62881 1903 110524480
Rash pruritic 84.42 13.36 178 62738 97891 110428492
Drug abuse 84.09 13.36 4 62912 177407 110348976
Obstructive airways disorder 82.67 13.36 116 62800 46033 110480350
Hypercalcaemia 81.68 13.36 116 62800 46541 110479842
Headache 80.78 13.36 811 62105 881566 109644817
Rales 80.18 13.36 84 62832 24655 110501728
Pemphigus 80.05 13.36 13 62903 214557 110311826
Aortic stenosis 79.13 13.36 63 62853 12996 110513387
Drug hypersensitivity 77.35 13.36 482 62434 453608 110072775
Abdominal pain 77.33 13.36 528 62388 512461 110013922
Chronic obstructive pulmonary disease 76.99 13.36 183 62733 108975 110417408
Abdominal distension 75.26 13.36 245 62671 174858 110351525
Bronchiectasis 73.34 13.36 97 62819 36396 110489987
Drug eruption 72.13 13.36 118 62798 53541 110472842
Allergy to chemicals 71.96 13.36 36 62880 3289 110523094
Upper respiratory tract infection 71.77 13.36 200 62716 131128 110395255
Cough 71.25 13.36 478 62438 461163 110065220
Endometriosis 71.16 13.36 39 62877 4295 110522088
Loss of personal independence in daily activities 70.98 13.36 217 62699 149803 110376580
Neutropenia 69.93 13.36 66 62850 374554 110151829
Musculoskeletal stiffness 68.53 13.36 328 62588 279494 110246889
Pericarditis 68.15 13.36 20 62896 219094 110307289
Aspartate aminotransferase increased 68.03 13.36 223 62693 159713 110366670
Congenital hiatus hernia 67.70 13.36 43 62873 6216 110520167
Hyperlipidaemia 67.04 13.36 92 62824 35756 110490627
Glossodynia 65.94 13.36 22 62894 221982 110304401
Muscle injury 64.17 13.36 4 62912 140803 110385580
Diabetes mellitus 64.11 13.36 161 62755 99220 110427163
Blood creatinine increased 63.95 13.36 239 62677 182650 110343733
Erythema 63.15 13.36 330 62586 291117 110235266
Confusional state 62.14 13.36 107 62809 468573 110057810
Helicobacter infection 59.57 13.36 15 62901 181862 110344521
Crepitations 58.76 13.36 49 62867 10786 110515597
Blister 58.59 13.36 28 62888 227348 110299035
Disease progression 58.51 13.36 33 62883 244001 110282382
Blood pressure diastolic decreased 58.12 13.36 86 62830 35799 110490584
Respiratory failure 57.85 13.36 25 62891 215307 110311076
Blood pressure fluctuation 56.65 13.36 129 62787 74695 110451688
Duodenal ulcer perforation 55.66 13.36 16 62900 177684 110348699
Faeces soft 55.28 13.36 48 62868 11162 110515221
Peak expiratory flow rate decreased 54.84 13.36 19 62897 681 110525702
Stomatitis 54.79 13.36 44 62872 270198 110256185
Cardiogenic shock 53.96 13.36 108 62808 57230 110469153
Body temperature decreased 53.44 13.36 84 62832 36851 110489532
Tenosynovitis stenosans 52.56 13.36 30 62886 3573 110522810
Drug intolerance 52.31 13.36 403 62513 406109 110120274
Synovial fluid analysis 52.12 13.36 27 62889 2654 110523729
Fatigue 51.67 13.36 974 61942 1214984 109311399
Rheumatoid factor positive 51.34 13.36 7 62909 131633 110394750
Micturition urgency 51.16 13.36 59 62857 19261 110507122
Cardiac arrest 51.04 13.36 24 62892 196729 110329654
Impaired healing 51.02 13.36 24 62892 196693 110329690
Type 2 diabetes mellitus 50.17 13.36 19 62897 177213 110349170
Rheumatoid lung 50.15 13.36 31 62885 4273 110522110
Rhinorrhoea 49.95 13.36 150 62766 102516 110423867
Ocular hyperaemia 49.59 13.36 84 62832 39202 110487181
Granuloma 49.57 13.36 42 62874 9448 110516935
Bone density decreased 49.37 13.36 53 62863 15989 110510394
Cervix neoplasm 49.17 13.36 13 62903 180 110526203
Rhabdomyolysis 47.92 13.36 6 62910 120395 110405988
Pancytopenia 47.91 13.36 30 62886 209583 110316800
Defaecation disorder 47.69 13.36 18 62898 827 110525556
Psoriatic arthropathy 47.68 13.36 230 62686 196531 110329852
Transaminases increased 47.67 13.36 109 62807 63281 110463102
Somatic delusion 46.73 13.36 17 62899 704 110525679
Occupational dermatitis 46.45 13.36 12 62904 151 110526232
Depressed level of consciousness 46.17 13.36 5 62911 112273 110414110
Systemic lupus erythematosus 46.06 13.36 46 62870 254292 110272091
Serum amyloid A protein increased 45.79 13.36 18 62898 924 110525459
Folliculitis 45.77 13.36 19 62897 167634 110358749
Inspiratory capacity abnormal 45.63 13.36 11 62905 102 110526281
Wound 45.27 13.36 40 62876 234397 110291986
Platelet count decreased 44.89 13.36 39 62877 230404 110295979
Completed suicide 44.86 13.36 43 62873 242338 110284045
Pulmonary mass 44.78 13.36 78 62838 37223 110489160
Blood pressure systolic decreased 44.20 13.36 46 62870 13395 110512988
Musculoskeletal disorder 43.64 13.36 59 62857 22605 110503778
C-reactive protein abnormal 43.27 13.36 167 62749 129528 110396855
Drug tolerance 42.83 13.36 50 62866 16535 110509848
Injury 42.44 13.36 24 62892 177241 110349142
Seizure 42.40 13.36 38 62878 221147 110305236
Neutrophil count decreased 41.53 13.36 9 62907 120932 110405451
Scleritis 41.34 13.36 30 62886 5390 110520993
Occupational exposure to air contaminants 41.04 13.36 11 62905 161 110526222
Arthritis 40.67 13.36 196 62720 167390 110358993
Hand deformity 40.16 13.36 39 62877 218467 110307916
Lip dry 39.80 13.36 5 62911 100078 110426305
Drug specific antibody 39.79 13.36 23 62893 2805 110523578
Arteriovenous fistula occlusion 39.55 13.36 14 62902 535 110525848
Liver injury 39.55 13.36 18 62898 150395 110375988
Pelvic pain 39.41 13.36 47 62869 15895 110510488
Heart rate decreased 39.40 13.36 120 62796 82636 110443747
Troponin increased 39.38 13.36 65 62851 29701 110496682
Hepatic function abnormal 39.33 13.36 3 62913 89292 110437091
Gut fermentation syndrome 39.33 13.36 8 62908 30 110526353
Bacteroides infection 39.12 13.36 23 62893 2896 110523487
Aphonia 38.72 13.36 42 62874 12818 110513565
Oropharyngeal pain 38.63 13.36 166 62750 135110 110391273
Hepatic enzyme increased 38.32 13.36 78 62838 320814 110205569
Irritable bowel syndrome 38.23 13.36 23 62893 164192 110362191
Coma 38.05 13.36 10 62906 117859 110408524
Full blood count abnormal 37.40 13.36 92 62824 55960 110470423
Delirium 37.35 13.36 15 62901 135010 110391373
Cardio-respiratory arrest 37.07 13.36 10 62906 115826 110410557
Injection site mass 37.03 13.36 57 62859 24556 110501827
Oesophageal polyp 36.63 13.36 9 62907 91 110526292
Gastric disorder 36.51 13.36 67 62849 33290 110493093
Blue toe syndrome 36.47 13.36 14 62902 674 110525709
Frustration tolerance decreased 36.37 13.36 34 62882 8697 110517686
Blood pressure diastolic abnormal 36.37 13.36 58 62858 25757 110500626
Forced expiratory volume decreased 36.17 13.36 41 62875 13135 110513248
Inflammation 35.93 13.36 210 62706 193028 110333355
Therapeutic response shortened 35.69 13.36 62 62854 29521 110496862
Deformity 35.63 13.36 36 62880 10124 110516259
Nerve degeneration 35.51 13.36 11 62905 275 110526108
Tender joint count decreased 35.11 13.36 11 62905 286 110526097
Gastrooesophageal reflux disease 35.04 13.36 198 62718 179778 110346605
Dry mouth 34.44 13.36 213 62703 199735 110326648
Rebound acid hypersecretion 34.43 13.36 9 62907 119 110526264
Kidney infection 34.00 13.36 56 62860 25543 110500840
Peripheral venous disease 33.94 13.36 4 62912 84113 110442270
Ascites 33.86 13.36 123 62793 92685 110433698
Dysphonia 33.28 13.36 107 62809 75822 110450561
Antinuclear antibody positive 33.10 13.36 33 62883 9135 110517248
Benign prostatic hyperplasia 32.90 13.36 46 62870 18188 110508195
Device malfunction 32.73 13.36 55 62861 25503 110500880
Swollen joint count decreased 32.64 13.36 11 62905 362 110526021
Sleep disorder due to general medical condition, insomnia type 32.19 13.36 10 62906 105633 110420750
Synovial cyst 32.12 13.36 36 62880 11394 110514989
Nephrogenic anaemia 31.91 13.36 24 62892 4553 110521830
Gait inability 31.88 13.36 19 62897 136357 110390026
Total lung capacity increased 31.70 13.36 25 62891 5087 110521296
Haemoptysis 31.68 13.36 101 62815 71253 110455130
Lactic acidosis 31.67 13.36 7 62909 92804 110433579
Epilepsy 31.42 13.36 9 62907 100200 110426183
Synovial disorder 30.89 13.36 20 62896 2987 110523396
Arthralgia 30.77 13.36 618 62298 779014 109747369
Constipation 30.74 13.36 325 62591 357461 110168922
Heart rate increased 30.52 13.36 162 62754 143672 110382711
Echocardiogram abnormal 30.50 13.36 19 62897 2655 110523728
Dry eye 30.49 13.36 85 62831 55708 110470675
Electrocardiogram QT prolonged 30.30 13.36 12 62904 108948 110417435
Hyperkalaemia 30.26 13.36 20 62896 135776 110390607
Lung diffusion test decreased 30.18 13.36 16 62900 1649 110524734
Stiff person syndrome 29.95 13.36 12 62904 648 110525735
Alanine aminotransferase increased 29.93 13.36 193 62723 183580 110342803
Renal impairment 29.83 13.36 38 62878 188407 110337976
Suicide attempt 29.40 13.36 11 62905 103383 110423000
Tremor 29.11 13.36 206 62710 202026 110324357
Drug tolerance decreased 28.50 13.36 54 62862 27486 110498897
Heart rate irregular 28.08 13.36 61 62855 34213 110492170
Wound infection 27.87 13.36 10 62906 96455 110429928
Feeling jittery 27.85 13.36 38 62878 14684 110511699
SAPHO syndrome 27.63 13.36 11 62905 584 110525799
Blood pressure diastolic increased 27.52 13.36 43 62873 18764 110507619
Cardiac failure 27.52 13.36 40 62876 187586 110338797
Hypoglycaemia 27.39 13.36 16 62900 116088 110410295
Blood pressure increased 27.23 13.36 245 62671 258128 110268255
Cushingoid 26.47 13.36 33 62883 11679 110514704
Intentional overdose 26.31 13.36 22 62894 132479 110393904
Grip strength decreased 25.50 13.36 7 62909 80167 110446216
Nasal congestion 25.33 13.36 117 62799 98165 110428218
Poor venous access 25.27 13.36 48 62868 24474 110501909
Death 25.23 13.36 265 62651 698604 109827779
Pulmonary fibrosis 25.22 13.36 120 62796 101922 110424461
Testicular mass 25.20 13.36 7 62909 118 110526265
Bone hypertrophy 25.08 13.36 11 62905 746 110525637
International normalised ratio increased 25.06 13.36 9 62907 86763 110439620
Obesity 24.84 13.36 17 62899 113334 110413049
Therapeutic reaction time decreased 24.82 13.36 22 62894 5257 110521126
Liver function test increased 24.77 13.36 108 62808 88440 110437943
Orthostatic hypertension 24.76 13.36 12 62904 1023 110525360
Renal neoplasm 24.71 13.36 16 62900 2390 110523993
Central obesity 24.58 13.36 15 62901 2021 110524362
Gamma-glutamyltransferase increased 24.53 13.36 3 62913 61306 110465077
Drug ineffective for unapproved indication 24.50 13.36 14 62902 102824 110423559
Peripheral swelling 24.25 13.36 343 62573 403691 110122692
Malignant neoplasm progression 23.89 13.36 39 62877 174528 110351855
Pneumococcal infection 23.50 13.36 14 62902 1805 110524578
Serotonin syndrome 23.41 13.36 3 62913 59150 110467233
Device dislocation 23.26 13.36 54 62862 31650 110494733
Injection site oedema 23.26 13.36 14 62902 1840 110524543
Pharyngitis streptococcal 23.22 13.36 33 62883 13244 110513139
Joint effusion 22.89 13.36 42 62874 20863 110505520
General physical health deterioration 22.77 13.36 354 62562 424941 110101442
Respiration abnormal 22.75 13.36 28 62888 9781 110516602
Drug specific antibody present 22.74 13.36 26 62890 8408 110517975
Klebsiella bacteraemia 22.31 13.36 20 62896 4849 110521534
Hepatic enzyme decreased 22.13 13.36 11 62905 991 110525392
Pulmonary thrombosis 22.13 13.36 33 62883 13830 110512553
Urine odour abnormal 21.95 13.36 24 62892 7391 110518992
Red blood cell sedimentation rate decreased 21.89 13.36 12 62904 1322 110525061
Mental status changes 21.81 13.36 8 62908 76114 110450269
Hypertensive nephropathy 21.76 13.36 11 62905 1027 110525356
Flail chest 21.72 13.36 6 62910 99 110526284
Drug-induced liver injury 21.40 13.36 22 62894 120045 110406338
Unresponsive to stimuli 21.39 13.36 5 62911 63785 110462598
Hypokalaemia 21.22 13.36 45 62871 182403 110343980
Blepharospasm 21.19 13.36 3 62913 54848 110471535
Peak expiratory flow rate abnormal 21.13 13.36 6 62910 110 110526273
Incorrect product administration duration 20.97 13.36 40 62876 20458 110505925
Occupational exposure to product 20.90 13.36 10 62906 829 110525554
Oral herpes 20.74 13.36 56 62860 36024 110490359
Respiratory arrest 20.71 13.36 4 62912 58295 110468088
Facet joint syndrome 20.59 13.36 15 62901 96813 110429570
Lung perforation 20.50 13.36 6 62910 123 110526260
Impaired work ability 20.49 13.36 46 62870 26373 110500010
Agranulocytosis 20.39 13.36 5 62911 61755 110464628
Injection site warmth 20.38 13.36 36 62880 17369 110509014
Medication error 20.30 13.36 18 62898 105348 110421035
Respiratory symptom 20.26 13.36 33 62883 14912 110511471
Atelectasis 20.13 13.36 56 62860 36656 110489727
Hypoaldosteronism 19.85 13.36 9 62907 660 110525723
Patella fracture 19.82 13.36 14 62902 2412 110523971
Drug resistance 19.75 13.36 4 62912 56370 110470013
Thoracic operation 19.66 13.36 7 62909 272 110526111
Renal pain 19.58 13.36 26 62890 9791 110516592
AST/ALT ratio abnormal 19.49 13.36 6 62910 147 110526236
Breath sounds abnormal 19.45 13.36 44 62872 25360 110501023
Metabolic acidosis 19.27 13.36 17 62899 99727 110426656
Osteomyelitis 19.25 13.36 55 62861 36545 110489838
Generalised tonic-clonic seizure 18.91 13.36 4 62912 54676 110471707
Gastrointestinal motility disorder 18.89 13.36 22 62894 7254 110519129
Abdominal pain upper 18.83 13.36 291 62625 348820 110177563
Hypotension 18.73 13.36 199 62717 523650 110002733
Pain 18.65 13.36 691 62225 954264 109572119
Taste disorder 18.51 13.36 7 62909 65380 110461003
Bone marrow failure 18.50 13.36 5 62911 57843 110468540
Melaena 18.43 13.36 8 62908 68749 110457634
Night sweats 18.27 13.36 30 62886 133953 110392430
Pneumonia aspiration 18.04 13.36 12 62904 81221 110445162
Photophobia 17.94 13.36 43 62873 25728 110500655
Blood alkaline phosphatase increased 17.86 13.36 9 62907 70926 110455457
Restlessness 17.73 13.36 5 62911 56254 110470129
Forced vital capacity decreased 17.57 13.36 12 62904 1958 110524425
Accidental overdose 17.50 13.36 4 62912 51830 110474553
Pulmonary toxicity 17.38 13.36 34 62882 17712 110508671
Lower respiratory tract infection 17.33 13.36 213 62703 242893 110283490
Back pain 17.33 13.36 302 62614 370694 110155689
Chromaturia 17.31 13.36 46 62870 29314 110497069
Pulmonary function test decreased 17.29 13.36 23 62893 8677 110517706
Red blood cell sedimentation rate increased 17.16 13.36 89 62827 78213 110448170
Blood immunoglobulin E decreased 17.11 13.36 6 62910 223 110526160
Chronic kidney disease-mineral and bone disorder 17.11 13.36 8 62908 630 110525753
Neuropathy peripheral 17.10 13.36 49 62867 179228 110347155
Hyperglycaemia 17.05 13.36 14 62902 85076 110441307
Bladder disorder 17.05 13.36 26 62890 11111 110515272
Airway remodelling 16.93 13.36 9 62907 933 110525450
Hepatic failure 16.89 13.36 9 62907 68730 110457653
Syncope 16.76 13.36 59 62857 202477 110323906
Nausea 16.76 13.36 861 62055 1234829 109291554
Gastrointestinal haemorrhage 16.71 13.36 44 62872 165474 110360909
Pyrexia 16.57 13.36 387 62529 897878 109628505
White coat hypertension 16.57 13.36 10 62906 1321 110525062
Flank pain 16.54 13.36 39 62877 23091 110503292
Productive cough 16.19 13.36 116 62800 114189 110412194
Bradycardia 15.96 13.36 41 62875 155476 110370907
Injection site extravasation 15.93 13.36 24 62892 10145 110516238
Treatment noncompliance 15.92 13.36 11 62905 72979 110453404
Cardiovascular disorder 15.86 13.36 38 62878 22722 110503661
Deep vein thrombosis 15.85 13.36 35 62881 139852 110386531
Erythema of eyelid 15.84 13.36 15 62901 3900 110522483
Heart rate abnormal 15.73 13.36 20 62896 7218 110519165
Defaecation urgency 15.68 13.36 22 62894 8725 110517658
Overdose 15.65 13.36 74 62842 233720 110292663
Inappropriate schedule of product administration 15.65 13.36 181 62735 203456 110322927
Cerebral infarction 15.62 13.36 5 62911 51833 110474550
Acute respiratory failure 15.56 13.36 12 62904 75248 110451135
Hepatitis 15.49 13.36 17 62899 90037 110436346
Conjunctival haemorrhage 15.49 13.36 19 62897 6614 110519769
Autoimmune disorder 15.48 13.36 9 62907 65474 110460909
Eye irritation 15.44 13.36 48 62868 33404 110492979
Leukopenia 15.44 13.36 39 62877 148752 110377631
Hepatic cytolysis 15.41 13.36 6 62910 55047 110471336
Cardiac failure congestive 15.35 13.36 40 62876 150960 110375423
Cerebral haemorrhage 15.25 13.36 9 62907 64959 110461424
Klebsiella test positive 15.25 13.36 12 62904 2434 110523949
Eosinophilia 15.12 13.36 7 62909 57929 110468454
Knee deformity 15.09 13.36 10 62906 1553 110524830
Septic shock 15.06 13.36 43 62873 157485 110368898
Pneumocystis jirovecii pneumonia 15.04 13.36 3 62913 42732 110483651
Contusion 14.96 13.36 75 62841 233286 110293097
Keratomileusis 14.91 13.36 5 62911 162 110526221
Renal mass 14.84 13.36 14 62902 3621 110522762
Abnormal faeces 14.76 13.36 22 62894 9214 110517169
Pancreatitis acute 14.65 13.36 8 62908 60266 110466117
Underdose 14.65 13.36 9 62907 63545 110462838
Toxic epidermal necrolysis 14.58 13.36 7 62909 56720 110469663
Carcinoid tumour 14.54 13.36 7 62909 588 110525795
Haematocrit decreased 14.37 13.36 10 62906 66107 110460276
Device dependence 14.37 13.36 4 62912 68 110526315
Eye ulcer 14.23 13.36 6 62910 369 110526014
Muscle strain 14.20 13.36 24 62892 11178 110515205
Stress at work 14.07 13.36 9 62907 1316 110525067
Hyperparathyroidism secondary 14.02 13.36 13 62903 3291 110523092
Intentional product misuse 13.98 13.36 126 62790 132778 110393605
Sinus tachycardia 13.94 13.36 4 62912 44489 110481894
Eye pain 13.93 13.36 61 62855 50038 110476345
Femur fracture 13.93 13.36 4 62912 44465 110481918
Blood lactate dehydrogenase increased 13.86 13.36 4 62912 44330 110482053
Skin cancer 13.83 13.36 31 62885 17753 110508630
Blood urea increased 13.79 13.36 7 62909 54950 110471433
Adjustment disorder with depressed mood 13.64 13.36 4 62912 43879 110482504
Renal haemangioma 13.59 13.36 3 62913 18 110526365
Appendix disorder 13.48 13.36 10 62906 1858 110524525

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

Related Drugs by ATC class:

A02BC Proton pump inhibitors 8 drugs
dexrabeprazoleesomeprazoleilaprazolelansoprazoleomeprazolepantoprazolerabeprazolevonoprazan

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 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 Enzyme IC50 5.48 CHEMBL

External reference:

IDSource
4028570 VUID
N0000189452 NUI
D08903 KEGG_DRUG
313640-86-7 SECONDARY_CAS_RN
4028570 VANDF
C2348248 UMLSCUI
CHEMBL1201863 ChEMBL_ID
D064748 MESH_DESCRIPTOR_UI
DB05351 DRUGBANK_ID
5487 IUPHAR_LIGAND_ID
8524 INN_ID
UYE4T5I70X UNII
9578005 PUBCHEM_CID
2673463 RXNORM
160770 MMSL
172755 MMSL
26184 MMSL
356045 MMSL
d07395 MMSL
012953 NDDF
441863009 SNOMEDCT_US
442540007 SNOMEDCT_US
CHEBI:135931 CHEBI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-2085 CAPSULE, DELAYED RELEASE PELLETS 30 mg ORAL ANDA 30 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-2086 CAPSULE, DELAYED RELEASE PELLETS 60 mg ORAL ANDA 30 sections
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 32 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 24979-704 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA AUTHORIZED GENERIC 32 sections
Dexlansoprazole Human Prescription Drug Label 1 46708-823 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 27 sections
Dexlansoprazole Human Prescription Drug Label 1 46708-824 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 27 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 49884-147 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 27 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 49884-148 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 27 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 50090-5944 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 50090-6514 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 32 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 50090-7451 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 27 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
Dexlansoprazole Human Prescription Drug Label 1 62332-823 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 27 sections
Dexlansoprazole Human Prescription Drug Label 1 62332-824 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 27 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-171 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA 32 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-175 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 32 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 71335-3071 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 31 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 72162-2214 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 28 sections
Dexlansoprazole delayed release HUMAN PRESCRIPTION DRUG LABEL 1 72162-2239 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 31 sections
Dexlansoprazole HUMAN PRESCRIPTION DRUG LABEL 1 72162-2244 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 28 sections