dexlansoprazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antiulcer, benzimidazole derivatives | 4162 | 138530-94-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 30 | mg | O |
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 30, 2009 | FDA | TAKEDA PHARMS USA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 815.32 | 13.97 | 439 | 35636 | 41617 | 56214375 |
| Tenosynovitis | 232.53 | 13.97 | 127 | 35948 | 12334 | 56243658 |
| End stage renal disease | 231.30 | 13.97 | 101 | 35974 | 6010 | 56249982 |
| Renal injury | 227.49 | 13.97 | 112 | 35963 | 8775 | 56247217 |
| Enthesopathy | 207.53 | 13.97 | 102 | 35973 | 7961 | 56248031 |
| Tongue disorder | 172.75 | 13.97 | 97 | 35978 | 9939 | 56246053 |
| Blood parathyroid hormone decreased | 172.16 | 13.97 | 91 | 35984 | 8273 | 56247719 |
| Rheumatoid nodule | 166.38 | 13.97 | 109 | 35966 | 14748 | 56241244 |
| Blood pressure systolic increased | 165.26 | 13.97 | 165 | 35910 | 40671 | 56215321 |
| Panniculitis | 160.98 | 13.97 | 92 | 35983 | 9750 | 56246242 |
| Red blood cell sedimentation rate | 149.49 | 13.97 | 67 | 36008 | 4241 | 56251751 |
| Granuloma skin | 145.93 | 13.97 | 77 | 35998 | 6974 | 56249018 |
| Tendonitis | 144.71 | 13.97 | 108 | 35967 | 17989 | 56238003 |
| Skin necrosis | 144.08 | 13.97 | 93 | 35982 | 12268 | 56243724 |
| Ulcer | 130.16 | 13.97 | 111 | 35964 | 22374 | 56233618 |
| Skin ulcer | 120.68 | 13.97 | 136 | 35939 | 38472 | 56217520 |
| Fear of injection | 106.81 | 13.97 | 61 | 36014 | 6454 | 56249538 |
| Alanine aminotransferase abnormal | 106.32 | 13.97 | 53 | 36022 | 4262 | 56251730 |
| Inflammation | 97.89 | 13.97 | 166 | 35909 | 68905 | 56187087 |
| Hypercalcaemia | 96.06 | 13.97 | 99 | 35976 | 25312 | 56230680 |
| Rash pruritic | 94.65 | 13.97 | 141 | 35934 | 52453 | 56203539 |
| Maternal exposure during pregnancy | 91.89 | 13.97 | 8 | 36067 | 189545 | 56066447 |
| Incorrect product administration duration | 90.17 | 13.97 | 65 | 36010 | 10261 | 56245731 |
| Drug eruption | 87.84 | 13.97 | 95 | 35980 | 25668 | 56230324 |
| Basal cell carcinoma | 85.98 | 13.97 | 93 | 35982 | 25128 | 56230864 |
| Pemphigus | 75.21 | 13.97 | 7 | 36068 | 157205 | 56098787 |
| Gastrooesophageal reflux disease | 73.68 | 13.97 | 164 | 35911 | 83093 | 56172899 |
| Exposure during pregnancy | 71.14 | 13.97 | 4 | 36071 | 136338 | 56119654 |
| Glossodynia | 69.80 | 13.97 | 8 | 36067 | 152450 | 56103542 |
| C-reactive protein abnormal | 69.56 | 13.97 | 101 | 35974 | 36708 | 56219284 |
| Total lung capacity increased | 68.27 | 13.97 | 25 | 36050 | 934 | 56255058 |
| Rebound acid hypersecretion | 62.98 | 13.97 | 18 | 36057 | 298 | 56255694 |
| Completed suicide | 61.31 | 13.97 | 7 | 36068 | 133826 | 56122166 |
| Forced expiratory volume decreased | 59.13 | 13.97 | 37 | 36038 | 4623 | 56251369 |
| Arthritis | 58.30 | 13.97 | 168 | 35907 | 99684 | 56156308 |
| Drug specific antibody | 55.57 | 13.97 | 27 | 36048 | 2053 | 56253939 |
| Peak expiratory flow rate decreased | 55.06 | 13.97 | 19 | 36056 | 595 | 56255397 |
| Erythema | 54.54 | 13.97 | 221 | 35854 | 155718 | 56100274 |
| Faeces soft | 52.92 | 13.97 | 35 | 36040 | 4807 | 56251185 |
| Granuloma | 51.27 | 13.97 | 36 | 36039 | 5451 | 56250541 |
| Drug interaction | 51.13 | 13.97 | 36 | 36039 | 209719 | 56046273 |
| Psoriatic arthropathy | 49.62 | 13.97 | 131 | 35944 | 73877 | 56182115 |
| Blood pressure fluctuation | 49.40 | 13.97 | 91 | 35984 | 40269 | 56215723 |
| Sputum discoloured | 49.23 | 13.97 | 53 | 36022 | 14239 | 56241753 |
| Endometriosis | 49.01 | 13.97 | 33 | 36042 | 4669 | 56251323 |
| Allergy to chemicals | 48.73 | 13.97 | 26 | 36049 | 2407 | 56253585 |
| Drug tolerance | 48.41 | 13.97 | 36 | 36039 | 5958 | 56250034 |
| Cervix neoplasm | 46.25 | 13.97 | 13 | 36062 | 202 | 56255790 |
| Toxicity to various agents | 45.58 | 13.97 | 46 | 36029 | 224518 | 56031474 |
| Swelling | 45.46 | 13.97 | 52 | 36023 | 239719 | 56016273 |
| Systemic lupus erythematosus | 45.09 | 13.97 | 30 | 36045 | 180048 | 56075944 |
| Red blood cell sedimentation rate increased | 44.10 | 13.97 | 82 | 35993 | 36541 | 56219451 |
| Loss of personal independence in daily activities | 43.77 | 13.97 | 133 | 35942 | 81236 | 56174756 |
| Arteriovenous fistula occlusion | 43.01 | 13.97 | 14 | 36061 | 365 | 56255627 |
| Obstructive airways disorder | 42.65 | 13.97 | 54 | 36021 | 17228 | 56238764 |
| Frustration tolerance decreased | 42.25 | 13.97 | 34 | 36041 | 6319 | 56249673 |
| Body temperature decreased | 42.21 | 13.97 | 55 | 36020 | 18053 | 56237939 |
| Renal failure | 42.16 | 13.97 | 161 | 35914 | 110339 | 56145653 |
| Blue toe syndrome | 42.03 | 13.97 | 14 | 36061 | 393 | 56255599 |
| Asthma | 41.96 | 13.97 | 163 | 35912 | 112607 | 56143385 |
| Somatic delusion | 41.04 | 13.97 | 15 | 36060 | 557 | 56255435 |
| Tubulointerstitial nephritis | 41.01 | 13.97 | 52 | 36023 | 16613 | 56239379 |
| Peripheral swelling | 40.95 | 13.97 | 274 | 35801 | 234452 | 56021540 |
| Headache | 40.70 | 13.97 | 541 | 35534 | 558503 | 55697489 |
| Rheumatoid lung | 40.01 | 13.97 | 25 | 36050 | 3115 | 56252877 |
| Joint injury | 39.46 | 13.97 | 64 | 36011 | 25590 | 56230402 |
| Blood pressure diastolic decreased | 39.41 | 13.97 | 55 | 36020 | 19268 | 56236724 |
| Thrombocytopenia | 39.39 | 13.97 | 19 | 36056 | 136205 | 56119787 |
| Hyponatraemia | 38.64 | 13.97 | 9 | 36066 | 102130 | 56153862 |
| Hepatic enzyme increased | 38.45 | 13.97 | 32 | 36043 | 171352 | 56084640 |
| Defaecation disorder | 38.06 | 13.97 | 15 | 36060 | 687 | 56255305 |
| Gastric disorder | 37.07 | 13.97 | 72 | 36003 | 33138 | 56222854 |
| Drug tolerance decreased | 36.47 | 13.97 | 44 | 36031 | 13367 | 56242625 |
| Cough | 36.45 | 13.97 | 288 | 35787 | 259673 | 55996319 |
| Neutropenia | 36.14 | 13.97 | 29 | 36046 | 158138 | 56097854 |
| Total lung capacity decreased | 35.83 | 13.97 | 18 | 36057 | 1471 | 56254521 |
| Echocardiogram abnormal | 35.39 | 13.97 | 17 | 36058 | 1260 | 56254732 |
| Chromaturia | 34.87 | 13.97 | 46 | 36029 | 15279 | 56240713 |
| Confusional state | 34.43 | 13.97 | 50 | 36025 | 208105 | 56047887 |
| Musculoskeletal disorder | 33.95 | 13.97 | 51 | 36024 | 19096 | 56236896 |
| Crepitations | 33.48 | 13.97 | 31 | 36044 | 6953 | 56249039 |
| Musculoskeletal stiffness | 32.73 | 13.97 | 191 | 35884 | 155816 | 56100176 |
| Dysphonia | 32.01 | 13.97 | 78 | 35997 | 41869 | 56214123 |
| Lung diffusion test decreased | 31.86 | 13.97 | 13 | 36062 | 652 | 56255340 |
| Pericarditis | 31.78 | 13.97 | 15 | 36060 | 108908 | 56147084 |
| Rhinorrhoea | 31.39 | 13.97 | 94 | 35981 | 56943 | 56199049 |
| Pancytopenia | 31.30 | 13.97 | 9 | 36066 | 88706 | 56167286 |
| Hypertensive nephropathy | 31.03 | 13.97 | 12 | 36063 | 522 | 56255470 |
| Respiration abnormal | 30.91 | 13.97 | 27 | 36048 | 5614 | 56250378 |
| Bronchopulmonary aspergillosis allergic | 30.51 | 13.97 | 16 | 36059 | 1430 | 56254562 |
| Death | 28.71 | 13.97 | 117 | 35958 | 341309 | 55914683 |
| Pulmonary thrombosis | 28.02 | 13.97 | 30 | 36045 | 8007 | 56247985 |
| Aspartate aminotransferase increased | 27.99 | 13.97 | 116 | 35959 | 82486 | 56173506 |
| Central obesity | 27.95 | 13.97 | 14 | 36061 | 1137 | 56254855 |
| Hand deformity | 27.90 | 13.97 | 27 | 36048 | 134465 | 56121527 |
| Bradycardia | 27.49 | 13.97 | 5 | 36070 | 67499 | 56188493 |
| Cardiac arrest | 26.58 | 13.97 | 11 | 36064 | 86303 | 56169689 |
| Antinuclear antibody positive | 26.47 | 13.97 | 27 | 36048 | 6814 | 56249178 |
| Tenosynovitis stenosans | 26.42 | 13.97 | 18 | 36057 | 2596 | 56253396 |
| Wound | 26.39 | 13.97 | 30 | 36045 | 138774 | 56117218 |
| Blood pressure systolic decreased | 26.32 | 13.97 | 26 | 36049 | 6317 | 56249675 |
| C-reactive protein increased | 26.27 | 13.97 | 110 | 35965 | 78574 | 56177418 |
| Abdominal pain | 26.13 | 13.97 | 267 | 35808 | 258538 | 55997454 |
| Lung opacity | 25.77 | 13.97 | 17 | 36058 | 2324 | 56253668 |
| Upper respiratory tract infection | 25.66 | 13.97 | 102 | 35973 | 71186 | 56184806 |
| Gastritis fungal | 25.65 | 13.97 | 7 | 36068 | 97 | 56255895 |
| Therapeutic reaction time decreased | 24.91 | 13.97 | 15 | 36060 | 1749 | 56254243 |
| Connective tissue inflammation | 24.34 | 13.97 | 6 | 36069 | 54 | 56255938 |
| Impaired healing | 23.77 | 13.97 | 13 | 36062 | 86828 | 56169164 |
| Renal pain | 23.76 | 13.97 | 24 | 36051 | 5989 | 56250003 |
| Forced vital capacity decreased | 23.73 | 13.97 | 12 | 36063 | 994 | 56254998 |
| Blood pressure diastolic abnormal | 23.63 | 13.97 | 33 | 36042 | 11565 | 56244427 |
| Synovial fluid analysis | 23.62 | 13.97 | 15 | 36060 | 1923 | 56254069 |
| Depressed level of consciousness | 23.37 | 13.97 | 4 | 36071 | 56429 | 56199563 |
| No adverse event | 22.97 | 13.97 | 63 | 36012 | 36311 | 56219681 |
| Parotid gland enlargement | 22.93 | 13.97 | 11 | 36064 | 813 | 56255179 |
| Gastrointestinal motility disorder | 22.77 | 13.97 | 21 | 36054 | 4685 | 56251307 |
| Abnormal faeces | 22.54 | 13.97 | 21 | 36054 | 4747 | 56251245 |
| Hyperkalaemia | 22.45 | 13.97 | 3 | 36072 | 50862 | 56205130 |
| Nocturia | 22.13 | 13.97 | 25 | 36050 | 7081 | 56248911 |
| Disease progression | 21.94 | 13.97 | 21 | 36054 | 105152 | 56150840 |
| Renal haemangioma | 21.92 | 13.97 | 5 | 36070 | 31 | 56255961 |
| Extra dose administered | 21.91 | 13.97 | 22 | 36053 | 5451 | 56250541 |
| Cardiac failure | 21.46 | 13.97 | 13 | 36062 | 82080 | 56173912 |
| Nephrogenic anaemia | 21.38 | 13.97 | 14 | 36061 | 1890 | 56254102 |
| Bladder disorder | 21.28 | 13.97 | 26 | 36049 | 7998 | 56247994 |
| Coma | 21.13 | 13.97 | 6 | 36069 | 59649 | 56196343 |
| Peak expiratory flow rate abnormal | 21.01 | 13.97 | 6 | 36069 | 99 | 56255893 |
| Scleritis | 20.81 | 13.97 | 18 | 36057 | 3693 | 56252299 |
| Cardio-respiratory arrest | 20.67 | 13.97 | 5 | 36070 | 55316 | 56200676 |
| Urine odour abnormal | 20.61 | 13.97 | 22 | 36053 | 5852 | 56250140 |
| Oropharyngeal pain | 20.51 | 13.97 | 107 | 35968 | 83681 | 56172311 |
| Alanine aminotransferase increased | 20.49 | 13.97 | 116 | 35959 | 93546 | 56162446 |
| Abdominal pain upper | 20.45 | 13.97 | 189 | 35886 | 178124 | 56077868 |
| Electrocardiogram QT prolonged | 20.27 | 13.97 | 5 | 36070 | 54583 | 56201409 |
| Platelet count decreased | 20.21 | 13.97 | 23 | 36052 | 106360 | 56149632 |
| Parapsoriasis | 20.03 | 13.97 | 6 | 36069 | 118 | 56255874 |
| Heart rate decreased | 19.81 | 13.97 | 64 | 36011 | 40363 | 56215629 |
| Regurgitation | 19.60 | 13.97 | 12 | 36063 | 1442 | 56254550 |
| Pulmonary embolism | 19.46 | 13.97 | 24 | 36051 | 107100 | 56148892 |
| Pharyngitis streptococcal | 19.32 | 13.97 | 27 | 36048 | 9471 | 56246521 |
| Stomatitis | 19.01 | 13.97 | 30 | 36045 | 120780 | 56135212 |
| Thoracic operation | 18.98 | 13.97 | 6 | 36069 | 142 | 56255850 |
| Patella fracture | 18.85 | 13.97 | 13 | 36062 | 1912 | 56254080 |
| Conjunctival haemorrhage | 18.78 | 13.97 | 16 | 36059 | 3217 | 56252775 |
| Acute kidney injury | 18.68 | 13.97 | 236 | 35839 | 240527 | 56015465 |
| Respiratory failure | 18.67 | 13.97 | 20 | 36055 | 95042 | 56160950 |
| Pulmonary toxicity | 18.46 | 13.97 | 24 | 36051 | 7859 | 56248133 |
| Nausea | 18.43 | 13.97 | 629 | 35446 | 763549 | 55492443 |
| Lung diffusion disorder | 18.27 | 13.97 | 5 | 36070 | 70 | 56255922 |
| Flail chest | 18.21 | 13.97 | 5 | 36070 | 71 | 56255921 |
| Brain hypoxia | 18.19 | 13.97 | 8 | 36067 | 484 | 56255508 |
| Type 2 diabetes mellitus | 17.98 | 13.97 | 4 | 36071 | 46858 | 56209134 |
| Nephropathy | 17.93 | 13.97 | 20 | 36055 | 5589 | 56250403 |
| Lung perforation | 17.71 | 13.97 | 5 | 36070 | 79 | 56255913 |
| Neutrophil count decreased | 17.67 | 13.97 | 5 | 36070 | 49817 | 56206175 |
| Delirium | 17.64 | 13.97 | 3 | 36072 | 42514 | 56213478 |
| Knee deformity | 17.31 | 13.97 | 10 | 36065 | 1080 | 56254912 |
| Dry mouth | 17.12 | 13.97 | 84 | 35991 | 64121 | 56191871 |
| Diarrhoea | 17.03 | 13.97 | 532 | 35543 | 637975 | 55618017 |
| Heart rate increased | 16.83 | 13.97 | 101 | 35974 | 83172 | 56172820 |
| Suicide attempt | 16.81 | 13.97 | 8 | 36067 | 57828 | 56198164 |
| Carcinoid tumour | 16.67 | 13.97 | 7 | 36068 | 378 | 56255614 |
| Dry throat | 16.63 | 13.97 | 20 | 36055 | 6054 | 56249938 |
| Pyrexia | 16.59 | 13.97 | 180 | 35895 | 418593 | 55837399 |
| Pulmonary fibrosis | 16.32 | 13.97 | 49 | 36026 | 29709 | 56226283 |
| Injection site oedema | 16.27 | 13.97 | 10 | 36065 | 1210 | 56254782 |
| Heart rate abnormal | 16.04 | 13.97 | 17 | 36058 | 4486 | 56251506 |
| Bone density decreased | 15.90 | 13.97 | 29 | 36046 | 12731 | 56243261 |
| Blood test abnormal | 15.86 | 13.97 | 29 | 36046 | 12755 | 56243237 |
| Pleuritic pain | 15.77 | 13.97 | 21 | 36054 | 7036 | 56248956 |
| Gout | 15.51 | 13.97 | 28 | 36047 | 12193 | 56243799 |
| Migraine | 15.50 | 13.97 | 102 | 35973 | 86695 | 56169297 |
| Heart rate irregular | 15.29 | 13.97 | 38 | 36037 | 20641 | 56235351 |
| Hypokalaemia | 15.29 | 13.97 | 23 | 36052 | 94414 | 56161578 |
| Malignant neoplasm progression | 14.99 | 13.97 | 15 | 36060 | 73572 | 56182420 |
| Deformity | 14.98 | 13.97 | 25 | 36050 | 10230 | 56245762 |
| Mental status changes | 14.80 | 13.97 | 3 | 36072 | 37498 | 56218494 |
| Humidity intolerance | 14.63 | 13.97 | 6 | 36069 | 305 | 56255687 |
| Thrombosis | 14.62 | 13.97 | 76 | 35999 | 59351 | 56196641 |
| International normalised ratio increased | 14.58 | 13.97 | 5 | 36070 | 44036 | 56211956 |
| Mononeuropathy | 14.51 | 13.97 | 5 | 36070 | 156 | 56255836 |
| Nasal congestion | 14.50 | 13.97 | 73 | 36002 | 56297 | 56199695 |
| Metabolic acidosis | 14.46 | 13.97 | 4 | 36071 | 40450 | 56215542 |
| Abortion spontaneous | 14.43 | 13.97 | 5 | 36070 | 43748 | 56212244 |
| Pain in extremity | 14.36 | 13.97 | 269 | 35806 | 297162 | 55958830 |
| Skin irritation | 14.25 | 13.97 | 22 | 36053 | 8433 | 56247559 |
| Sleep disorder due to general medical condition, insomnia type | 14.21 | 13.97 | 5 | 36070 | 43333 | 56212659 |
| Arthralgia | 14.16 | 13.97 | 421 | 35654 | 501248 | 55754744 |
| Eye haemorrhage | 14.05 | 13.97 | 21 | 36054 | 7826 | 56248166 |
| Insomnia | 14.00 | 13.97 | 186 | 35889 | 191674 | 56064318 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 514.97 | 18.75 | 255 | 10807 | 37720 | 31648562 |
| End stage renal disease | 221.07 | 18.75 | 89 | 10973 | 8020 | 31678262 |
| Renal injury | 169.41 | 18.75 | 80 | 10982 | 10585 | 31675697 |
| Tenosynovitis | 160.49 | 18.75 | 59 | 11003 | 4151 | 31682131 |
| Enthesopathy | 155.78 | 18.75 | 58 | 11004 | 4229 | 31682053 |
| Tongue disorder | 126.20 | 18.75 | 52 | 11010 | 4965 | 31681317 |
| C-reactive protein abnormal | 119.45 | 18.75 | 57 | 11005 | 7712 | 31678570 |
| Tendonitis | 105.43 | 18.75 | 54 | 11008 | 8504 | 31677778 |
| Synovitis | 105.41 | 18.75 | 61 | 11001 | 12222 | 31674060 |
| Alanine aminotransferase abnormal | 99.38 | 18.75 | 41 | 11021 | 3926 | 31682356 |
| Loss of personal independence in daily activities | 81.11 | 18.75 | 72 | 10990 | 28216 | 31658066 |
| Psoriatic arthropathy | 78.67 | 18.75 | 61 | 11001 | 19822 | 31666460 |
| Red blood cell sedimentation rate | 72.90 | 18.75 | 23 | 11039 | 1013 | 31685269 |
| Granuloma skin | 70.92 | 18.75 | 23 | 11039 | 1108 | 31685174 |
| Blood parathyroid hormone decreased | 67.39 | 18.75 | 23 | 11039 | 1299 | 31684983 |
| Panniculitis | 60.51 | 18.75 | 23 | 11039 | 1773 | 31684509 |
| Drug intolerance | 58.46 | 18.75 | 81 | 10981 | 51952 | 31634330 |
| Incorrect product administration duration | 55.46 | 18.75 | 28 | 11034 | 4274 | 31682008 |
| Rheumatoid nodule | 54.83 | 18.75 | 24 | 11038 | 2657 | 31683625 |
| Device dislocation | 53.34 | 18.75 | 29 | 11033 | 5147 | 31681135 |
| Occupational dermatitis | 48.60 | 18.75 | 10 | 11052 | 72 | 31686210 |
| Mobility decreased | 47.30 | 18.75 | 53 | 11009 | 27416 | 31658866 |
| Headache | 47.24 | 18.75 | 156 | 10906 | 183496 | 31502786 |
| Device malfunction | 46.93 | 18.75 | 33 | 11029 | 9233 | 31677049 |
| Treatment failure | 46.55 | 18.75 | 64 | 10998 | 40728 | 31645554 |
| Oesophageal polyp | 45.90 | 18.75 | 9 | 11053 | 49 | 31686233 |
| Occupational exposure to air contaminants | 42.65 | 18.75 | 10 | 11052 | 139 | 31686143 |
| Drug interaction | 41.17 | 18.75 | 11 | 11051 | 208532 | 31477750 |
| Inspiratory capacity abnormal | 41.10 | 18.75 | 9 | 11053 | 90 | 31686192 |
| Nerve degeneration | 40.28 | 18.75 | 10 | 11052 | 179 | 31686103 |
| Blood immunoglobulin E increased | 39.32 | 18.75 | 18 | 11044 | 2213 | 31684069 |
| Drug hypersensitivity | 37.46 | 18.75 | 80 | 10982 | 72519 | 31613763 |
| Nephrogenic anaemia | 37.17 | 18.75 | 17 | 11045 | 2086 | 31684196 |
| Airway remodelling | 36.26 | 18.75 | 9 | 11053 | 161 | 31686121 |
| Skin necrosis | 35.69 | 18.75 | 23 | 11039 | 5575 | 31680707 |
| Gastrooesophageal reflux disease | 35.45 | 18.75 | 51 | 11011 | 33820 | 31652462 |
| Stiff person syndrome | 34.90 | 18.75 | 8 | 11054 | 100 | 31686182 |
| Ulcer | 33.12 | 18.75 | 25 | 11037 | 7796 | 31678486 |
| Erythema | 33.06 | 18.75 | 81 | 10981 | 80324 | 31605958 |
| Renal failure | 31.86 | 18.75 | 105 | 10957 | 123225 | 31563057 |
| Asthma | 30.58 | 18.75 | 54 | 11008 | 42557 | 31643725 |
| Therapy non-responder | 29.81 | 18.75 | 47 | 11015 | 33764 | 31652518 |
| Erythema of eyelid | 29.76 | 18.75 | 11 | 11051 | 784 | 31685498 |
| Occupational exposure to product | 29.40 | 18.75 | 9 | 11053 | 358 | 31685924 |
| Micturition urgency | 27.98 | 18.75 | 20 | 11042 | 5740 | 31680542 |
| Aspartate aminotransferase increased | 27.72 | 18.75 | 65 | 10997 | 62654 | 31623628 |
| Neck pain | 27.72 | 18.75 | 37 | 11025 | 22873 | 31663409 |
| Terminal insomnia | 27.58 | 18.75 | 9 | 11053 | 442 | 31685840 |
| Hypertensive nephropathy | 27.38 | 18.75 | 9 | 11053 | 452 | 31685830 |
| Renal haemangioma | 26.77 | 18.75 | 5 | 11057 | 20 | 31686262 |
| Pain | 26.53 | 18.75 | 132 | 10930 | 186627 | 31499655 |
| Contraindicated product administered | 25.58 | 18.75 | 33 | 11029 | 19739 | 31666543 |
| Renal neoplasm | 25.26 | 18.75 | 11 | 11051 | 1202 | 31685080 |
| Renal mass | 25.07 | 18.75 | 12 | 11050 | 1631 | 31684651 |
| Bone density decreased | 24.45 | 18.75 | 12 | 11050 | 1723 | 31684559 |
| Stress | 23.85 | 18.75 | 36 | 11026 | 24905 | 31661377 |
| Thrombocytopenia | 23.83 | 18.75 | 10 | 11052 | 142737 | 31543545 |
| Neutropenia | 23.17 | 18.75 | 10 | 11052 | 140354 | 31545928 |
| Basal cell carcinoma | 22.98 | 18.75 | 30 | 11032 | 18149 | 31668133 |
| Alanine aminotransferase increased | 22.41 | 18.75 | 67 | 10995 | 74589 | 31611693 |
| Abdominal rigidity | 21.89 | 18.75 | 10 | 11052 | 1223 | 31685059 |
| Dyspnoea at rest | 21.26 | 18.75 | 14 | 11048 | 3517 | 31682765 |
| Hip surgery | 20.91 | 18.75 | 9 | 11053 | 956 | 31685326 |
| Skin ulcer | 20.77 | 18.75 | 30 | 11032 | 19955 | 31666327 |
| Drug abuse | 20.69 | 18.75 | 3 | 11059 | 87755 | 31598527 |
| Chronic kidney disease-mineral and bone disorder | 20.65 | 18.75 | 7 | 11055 | 387 | 31685895 |
| Dermatitis contact | 20.37 | 18.75 | 13 | 11049 | 3097 | 31683185 |
| Fatigue | 19.87 | 18.75 | 191 | 10871 | 335015 | 31351267 |
| Restrictive pulmonary disease | 19.54 | 18.75 | 9 | 11053 | 1122 | 31685160 |
| Rebound acid hypersecretion | 19.52 | 18.75 | 5 | 11057 | 102 | 31686180 |
| Rheumatoid lung | 19.42 | 18.75 | 8 | 11054 | 762 | 31685520 |
| Rash pruritic | 19.36 | 18.75 | 32 | 11030 | 23906 | 31662376 |
| Hypercalcaemia | 19.10 | 18.75 | 24 | 11038 | 13976 | 31672306 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 662.90 | 14.56 | 418 | 39468 | 60639 | 70827919 |
| Tenosynovitis | 398.14 | 14.56 | 182 | 39704 | 13794 | 70874764 |
| Enthesopathy | 359.02 | 14.56 | 157 | 39729 | 10712 | 70877846 |
| Tongue disorder | 302.30 | 14.56 | 148 | 39738 | 13079 | 70875479 |
| Tendonitis | 258.84 | 14.56 | 159 | 39727 | 21963 | 70866595 |
| Blood parathyroid hormone decreased | 245.99 | 14.56 | 114 | 39772 | 8910 | 70879648 |
| Rheumatoid nodule | 241.88 | 14.56 | 133 | 39753 | 14934 | 70873624 |
| End stage renal disease | 231.98 | 14.56 | 117 | 39769 | 11016 | 70877542 |
| Panniculitis | 230.70 | 14.56 | 115 | 39771 | 10561 | 70877997 |
| Red blood cell sedimentation rate | 226.43 | 14.56 | 90 | 39796 | 4820 | 70883738 |
| Granuloma skin | 218.63 | 14.56 | 100 | 39786 | 7582 | 70880976 |
| Alanine aminotransferase abnormal | 195.66 | 14.56 | 94 | 39792 | 7965 | 70880593 |
| Skin necrosis | 187.79 | 14.56 | 116 | 39770 | 16175 | 70872383 |
| Ulcer | 169.95 | 14.56 | 130 | 39756 | 25624 | 70862934 |
| Blood pressure systolic increased | 165.72 | 14.56 | 182 | 39704 | 57077 | 70831481 |
| C-reactive protein abnormal | 161.94 | 14.56 | 150 | 39736 | 38429 | 70850129 |
| Skin ulcer | 148.01 | 14.56 | 158 | 39728 | 47987 | 70840571 |
| Psoriatic arthropathy | 144.28 | 14.56 | 180 | 39706 | 64591 | 70823967 |
| Renal injury | 139.85 | 14.56 | 96 | 39790 | 15998 | 70872560 |
| Fear of injection | 132.82 | 14.56 | 68 | 39818 | 6604 | 70881954 |
| Rash pruritic | 129.16 | 14.56 | 168 | 39718 | 62823 | 70825735 |
| Basal cell carcinoma | 124.28 | 14.56 | 122 | 39764 | 33576 | 70854982 |
| Loss of personal independence in daily activities | 119.03 | 14.56 | 189 | 39697 | 84721 | 70803837 |
| Inflammation | 118.49 | 14.56 | 181 | 39705 | 78484 | 70810074 |
| Hypercalcaemia | 113.08 | 14.56 | 117 | 39769 | 34268 | 70854290 |
| Drug interaction | 104.39 | 14.56 | 42 | 39844 | 381399 | 70507159 |
| Drug eruption | 99.73 | 14.56 | 117 | 39769 | 39379 | 70849179 |
| Toxicity to various agents | 96.82 | 14.56 | 47 | 39839 | 382125 | 70506433 |
| Erythema | 93.22 | 14.56 | 285 | 39601 | 199278 | 70689280 |
| Headache | 90.19 | 14.56 | 596 | 39290 | 579809 | 70308749 |
| Gastrooesophageal reflux disease | 84.46 | 14.56 | 169 | 39717 | 90670 | 70797888 |
| Total lung capacity increased | 71.82 | 14.56 | 25 | 39861 | 920 | 70887638 |
| Peripheral swelling | 70.91 | 14.56 | 292 | 39594 | 236271 | 70652287 |
| Drug tolerance decreased | 70.10 | 14.56 | 52 | 39834 | 9781 | 70878777 |
| Asthma | 69.46 | 14.56 | 186 | 39700 | 120607 | 70767951 |
| Drug abuse | 66.77 | 14.56 | 4 | 39882 | 147252 | 70741306 |
| Thrombocytopenia | 65.89 | 14.56 | 26 | 39860 | 239084 | 70649474 |
| Granuloma | 62.40 | 14.56 | 44 | 39842 | 7651 | 70880907 |
| Rheumatoid lung | 62.39 | 14.56 | 33 | 39853 | 3426 | 70885132 |
| Neutropenia | 61.54 | 14.56 | 34 | 39852 | 257122 | 70631436 |
| Red blood cell sedimentation rate increased | 59.69 | 14.56 | 90 | 39796 | 38552 | 70850006 |
| Endometriosis | 58.73 | 14.56 | 31 | 39855 | 3205 | 70885353 |
| Drug tolerance | 56.84 | 14.56 | 41 | 39845 | 7387 | 70881171 |
| Arthritis | 56.45 | 14.56 | 151 | 39735 | 97829 | 70790729 |
| Aspartate aminotransferase increased | 56.14 | 14.56 | 178 | 39708 | 126800 | 70761758 |
| Peak expiratory flow rate decreased | 56.07 | 14.56 | 19 | 39867 | 644 | 70887914 |
| Allergy to chemicals | 53.71 | 14.56 | 25 | 39861 | 1971 | 70886587 |
| Drug specific antibody | 52.91 | 14.56 | 26 | 39860 | 2313 | 70886245 |
| Joint injury | 52.34 | 14.56 | 70 | 39816 | 26862 | 70861696 |
| Drug intolerance | 51.46 | 14.56 | 257 | 39629 | 225430 | 70663128 |
| Forced expiratory volume decreased | 50.62 | 14.56 | 38 | 39848 | 7276 | 70881282 |
| Blood pressure diastolic decreased | 50.09 | 14.56 | 67 | 39819 | 25713 | 70862845 |
| Maternal exposure during pregnancy | 49.77 | 14.56 | 4 | 39882 | 115341 | 70773217 |
| Pancytopenia | 49.55 | 14.56 | 12 | 39874 | 151095 | 70737463 |
| Cervix neoplasm | 49.53 | 14.56 | 13 | 39873 | 177 | 70888381 |
| Musculoskeletal disorder | 48.48 | 14.56 | 58 | 39828 | 19913 | 70868645 |
| Drug hypersensitivity | 47.11 | 14.56 | 280 | 39606 | 262179 | 70626379 |
| Rhinorrhoea | 46.29 | 14.56 | 110 | 39776 | 66261 | 70822297 |
| Sputum discoloured | 44.54 | 14.56 | 54 | 39832 | 18797 | 70869761 |
| Frustration tolerance decreased | 44.28 | 14.56 | 34 | 39852 | 6731 | 70881827 |
| Occupational dermatitis | 44.06 | 14.56 | 11 | 39875 | 121 | 70888437 |
| Faeces soft | 43.64 | 14.56 | 34 | 39852 | 6876 | 70881682 |
| Alanine aminotransferase increased | 42.54 | 14.56 | 180 | 39706 | 147300 | 70741258 |
| Nephrogenic anaemia | 42.29 | 14.56 | 26 | 39860 | 3592 | 70884966 |
| C-reactive protein increased | 41.79 | 14.56 | 147 | 39739 | 110370 | 70778188 |
| Defaecation disorder | 41.61 | 14.56 | 15 | 39871 | 612 | 70887946 |
| Hyponatraemia | 41.53 | 14.56 | 19 | 39867 | 160068 | 70728490 |
| Cardiac arrest | 41.42 | 14.56 | 19 | 39867 | 159815 | 70728743 |
| Bone density decreased | 41.28 | 14.56 | 41 | 39845 | 11433 | 70877125 |
| Synovitis | 40.64 | 14.56 | 162 | 39724 | 129066 | 70759492 |
| Blood pressure fluctuation | 40.28 | 14.56 | 97 | 39789 | 58915 | 70829643 |
| Somatic delusion | 40.00 | 14.56 | 15 | 39871 | 685 | 70887873 |
| Gastric disorder | 39.71 | 14.56 | 69 | 39817 | 33253 | 70855305 |
| Arteriovenous fistula occlusion | 39.71 | 14.56 | 14 | 39872 | 535 | 70888023 |
| Death | 39.18 | 14.56 | 151 | 39735 | 509910 | 70378648 |
| Blue toe syndrome | 38.89 | 14.56 | 14 | 39872 | 569 | 70887989 |
| Completed suicide | 38.00 | 14.56 | 43 | 39843 | 227092 | 70661466 |
| Respiratory failure | 37.96 | 14.56 | 24 | 39862 | 168711 | 70719847 |
| Fatigue | 37.96 | 14.56 | 662 | 39224 | 823657 | 70064901 |
| Hyperkalaemia | 37.94 | 14.56 | 7 | 39879 | 106584 | 70781974 |
| Occupational exposure to air contaminants | 37.91 | 14.56 | 10 | 39876 | 139 | 70888419 |
| Therapy non-responder | 36.93 | 14.56 | 111 | 39775 | 76804 | 70811754 |
| Rebound acid hypersecretion | 36.83 | 14.56 | 9 | 39877 | 90 | 70888468 |
| Blood pressure systolic decreased | 35.62 | 14.56 | 35 | 39851 | 9636 | 70878922 |
| Musculoskeletal stiffness | 35.60 | 14.56 | 171 | 39715 | 147589 | 70740969 |
| Oesophageal polyp | 35.02 | 14.56 | 8 | 39878 | 58 | 70888500 |
| Cardio-respiratory arrest | 35.01 | 14.56 | 7 | 39879 | 100670 | 70787888 |
| Coma | 35 | 14.56 | 5 | 39881 | 91839 | 70796719 |
| Dysphonia | 34.89 | 14.56 | 83 | 39803 | 50017 | 70838541 |
| Crepitations | 34.85 | 14.56 | 33 | 39853 | 8681 | 70879877 |
| Arthralgia | 34.82 | 14.56 | 434 | 39452 | 502956 | 70385602 |
| Rhabdomyolysis | 34.71 | 14.56 | 6 | 39880 | 95754 | 70792804 |
| Cough | 34.52 | 14.56 | 306 | 39580 | 325071 | 70563487 |
| Cardiac failure | 34.28 | 14.56 | 19 | 39867 | 143522 | 70745036 |
| Abdominal pain | 33.89 | 14.56 | 317 | 39569 | 341810 | 70546748 |
| Total lung capacity decreased | 33.30 | 14.56 | 18 | 39868 | 1951 | 70886607 |
| Disease progression | 32.94 | 14.56 | 24 | 39862 | 156648 | 70731910 |
| Depressed level of consciousness | 32.76 | 14.56 | 5 | 39881 | 87426 | 70801132 |
| Inspiratory capacity abnormal | 32.47 | 14.56 | 8 | 39878 | 83 | 70888475 |
| Obstructive airways disorder | 32.34 | 14.56 | 55 | 39831 | 26058 | 70862500 |
| Therapeutic product effect incomplete | 32.02 | 14.56 | 143 | 39743 | 119739 | 70768819 |
| Nerve degeneration | 31.99 | 14.56 | 10 | 39876 | 261 | 70888297 |
| Platelet count decreased | 31.75 | 14.56 | 32 | 39854 | 178190 | 70710368 |
| Respiration abnormal | 31.35 | 14.56 | 28 | 39858 | 6836 | 70881722 |
| Neutrophil count decreased | 30.81 | 14.56 | 5 | 39881 | 83551 | 70805007 |
| Confusional state | 30.57 | 14.56 | 72 | 39814 | 284326 | 70604232 |
| Bronchopulmonary aspergillosis allergic | 30.54 | 14.56 | 17 | 39869 | 1952 | 70886606 |
| Pyrexia | 30.52 | 14.56 | 208 | 39678 | 606744 | 70281814 |
| Tenosynovitis stenosans | 30.46 | 14.56 | 18 | 39868 | 2315 | 70886243 |
| Hypertensive nephropathy | 30.07 | 14.56 | 13 | 39873 | 861 | 70887697 |
| Body temperature decreased | 29.87 | 14.56 | 56 | 39830 | 28616 | 70859942 |
| Oropharyngeal pain | 28.89 | 14.56 | 119 | 39767 | 96191 | 70792367 |
| Nausea | 28.36 | 14.56 | 652 | 39234 | 851436 | 70037122 |
| Sepsis | 27.83 | 14.56 | 60 | 39826 | 244485 | 70644073 |
| Echocardiogram abnormal | 27.77 | 14.56 | 16 | 39870 | 1963 | 70886595 |
| Pulmonary embolism | 27.74 | 14.56 | 28 | 39858 | 155839 | 70732719 |
| Anaemia | 27.49 | 14.56 | 125 | 39761 | 403298 | 70485260 |
| Incorrect product administration duration | 27.20 | 14.56 | 32 | 39854 | 10792 | 70877766 |
| Blood pressure diastolic abnormal | 26.67 | 14.56 | 38 | 39848 | 15466 | 70873092 |
| Electrocardiogram QT prolonged | 26.66 | 14.56 | 7 | 39879 | 83510 | 70805048 |
| Renal neoplasm | 26.50 | 14.56 | 15 | 39871 | 1779 | 70886779 |
| Multiple organ dysfunction syndrome | 26.44 | 14.56 | 14 | 39872 | 108501 | 70780057 |
| Pemphigus | 26.43 | 14.56 | 7 | 39879 | 83029 | 70805529 |
| Pulmonary thrombosis | 26.30 | 14.56 | 32 | 39854 | 11176 | 70877382 |
| Glossodynia | 26.22 | 14.56 | 8 | 39878 | 86479 | 70802079 |
| Device malfunction | 26.05 | 14.56 | 42 | 39844 | 19042 | 70869516 |
| Synovial fluid analysis | 25.93 | 14.56 | 15 | 39871 | 1854 | 70886704 |
| Airway remodelling | 25.88 | 14.56 | 8 | 39878 | 201 | 70888357 |
| Lung diffusion test decreased | 25.68 | 14.56 | 13 | 39873 | 1232 | 70887326 |
| Nasopharyngitis | 25.65 | 14.56 | 213 | 39673 | 221993 | 70666565 |
| Pain in extremity | 25.34 | 14.56 | 289 | 39597 | 327793 | 70560765 |
| Treatment failure | 25.32 | 14.56 | 153 | 39733 | 143989 | 70744569 |
| Occupational exposure to product | 25.23 | 14.56 | 11 | 39875 | 744 | 70887814 |
| Hypokalaemia | 25.19 | 14.56 | 22 | 39864 | 131166 | 70757392 |
| Renal pain | 25.14 | 14.56 | 26 | 39860 | 7604 | 70880954 |
| Lung opacity | 25.05 | 14.56 | 19 | 39867 | 3694 | 70884864 |
| Seizure | 24.37 | 14.56 | 39 | 39847 | 177923 | 70710635 |
| Delirium | 24.31 | 14.56 | 6 | 39880 | 74608 | 70813950 |
| Pulmonary fibrosis | 24.06 | 14.56 | 57 | 39829 | 34253 | 70854305 |
| Blood test abnormal | 23.99 | 14.56 | 35 | 39851 | 14555 | 70874003 |
| Lactic acidosis | 23.73 | 14.56 | 4 | 39882 | 65020 | 70823538 |
| International normalised ratio increased | 23.53 | 14.56 | 8 | 39878 | 80718 | 70807840 |
| Deformity | 23.34 | 14.56 | 26 | 39860 | 8271 | 70880287 |
| Scleritis | 23.26 | 14.56 | 18 | 39868 | 3604 | 70884954 |
| Abdominal pain upper | 23.11 | 14.56 | 187 | 39699 | 193415 | 70695143 |
| Heart rate decreased | 23.01 | 14.56 | 82 | 39804 | 61933 | 70826625 |
| Central obesity | 22.60 | 14.56 | 13 | 39873 | 1590 | 70886968 |
| Metabolic acidosis | 22.31 | 14.56 | 7 | 39879 | 74339 | 70814219 |
| Blood pressure diastolic increased | 22.25 | 14.56 | 31 | 39855 | 12360 | 70876198 |
| Medication error | 21.91 | 14.56 | 3 | 39883 | 56909 | 70831649 |
| Peak expiratory flow rate abnormal | 21.84 | 14.56 | 6 | 39880 | 98 | 70888460 |
| Stomatitis | 21.84 | 14.56 | 24 | 39862 | 128487 | 70760071 |
| Hypoglycaemia | 21.80 | 14.56 | 13 | 39873 | 94351 | 70794207 |
| Stiff person syndrome | 21.68 | 14.56 | 8 | 39878 | 349 | 70888209 |
| Hypotension | 21.59 | 14.56 | 136 | 39750 | 404245 | 70484313 |
| Heart rate increased | 21.47 | 14.56 | 117 | 39769 | 106031 | 70782527 |
| Therapeutic reaction time decreased | 21.40 | 14.56 | 15 | 39871 | 2582 | 70885976 |
| Abnormal faeces | 20.94 | 14.56 | 22 | 39864 | 6551 | 70882007 |
| Renal failure | 20.63 | 14.56 | 179 | 39707 | 188891 | 70699667 |
| Pharyngitis streptococcal | 20.61 | 14.56 | 26 | 39860 | 9422 | 70879136 |
| Heart rate irregular | 20.41 | 14.56 | 49 | 39837 | 29694 | 70858864 |
| Respiratory arrest | 20.40 | 14.56 | 3 | 39883 | 53930 | 70834628 |
| Device dependence | 20.37 | 14.56 | 5 | 39881 | 51 | 70888507 |
| Gastrointestinal motility disorder | 20.23 | 14.56 | 20 | 39866 | 5546 | 70883012 |
| Infusion related reaction | 20.01 | 14.56 | 184 | 39702 | 197350 | 70691208 |
| Urine odour abnormal | 20.00 | 14.56 | 20 | 39866 | 5623 | 70882935 |
| Chronic kidney disease-mineral and bone disorder | 19.94 | 14.56 | 9 | 39877 | 661 | 70887897 |
| Forced vital capacity decreased | 19.93 | 14.56 | 12 | 39874 | 1597 | 70886961 |
| Device dislocation | 19.86 | 14.56 | 41 | 39845 | 22466 | 70866092 |
| Blood pressure increased | 19.81 | 14.56 | 177 | 39709 | 188340 | 70700218 |
| Osteomyelitis | 19.79 | 14.56 | 49 | 39837 | 30269 | 70858289 |
| Suicide attempt | 19.75 | 14.56 | 10 | 39876 | 79500 | 70809058 |
| Patella fracture | 19.67 | 14.56 | 12 | 39874 | 1634 | 70886924 |
| Systemic lupus erythematosus | 19.67 | 14.56 | 17 | 39869 | 101885 | 70786673 |
| Stress | 19.61 | 14.56 | 83 | 39803 | 67883 | 70820675 |
| Knee deformity | 19.37 | 14.56 | 10 | 39876 | 988 | 70887570 |
| Pericarditis | 19.11 | 14.56 | 12 | 39874 | 84693 | 70803865 |
| Terminal insomnia | 19.07 | 14.56 | 10 | 39876 | 1020 | 70887538 |
| Pain | 18.98 | 14.56 | 475 | 39411 | 628341 | 70260217 |
| Gamma-glutamyltransferase increased | 18.76 | 14.56 | 3 | 39883 | 50682 | 70837876 |
| Drug ineffective | 18.69 | 14.56 | 674 | 39212 | 939078 | 69949480 |
| Erythema of eyelid | 18.68 | 14.56 | 13 | 39873 | 2212 | 70886346 |
| Chromaturia | 18.61 | 14.56 | 41 | 39845 | 23487 | 70865071 |
| Respiratory distress | 18.59 | 14.56 | 4 | 39882 | 54646 | 70833912 |
| Dyspepsia | 18.57 | 14.56 | 99 | 39787 | 88978 | 70799580 |
| Wheezing | 18.51 | 14.56 | 103 | 39783 | 94067 | 70794491 |
| Mobility decreased | 18.51 | 14.56 | 110 | 39776 | 102889 | 70785669 |
| Product use issue | 18.42 | 14.56 | 168 | 39718 | 179769 | 70708789 |
| Intentional overdose | 18.30 | 14.56 | 17 | 39869 | 98418 | 70790140 |
| Cardiac failure congestive | 18.25 | 14.56 | 30 | 39856 | 135427 | 70753131 |
| Gastritis fungal | 18.18 | 14.56 | 6 | 39880 | 187 | 70888371 |
| Thoracic operation | 18.06 | 14.56 | 6 | 39880 | 191 | 70888367 |
| Dry mouth | 18.02 | 14.56 | 83 | 39803 | 70374 | 70818184 |
| Flail chest | 17.96 | 14.56 | 5 | 39881 | 86 | 70888472 |
| Carcinoid tumour | 17.85 | 14.56 | 8 | 39878 | 578 | 70887980 |
| Injection site oedema | 17.84 | 14.56 | 10 | 39876 | 1164 | 70887394 |
| Lung perforation | 17.70 | 14.56 | 5 | 39881 | 91 | 70888467 |
| Bradycardia | 17.35 | 14.56 | 27 | 39859 | 124588 | 70763970 |
| Unresponsive to stimuli | 17.26 | 14.56 | 4 | 39882 | 51927 | 70836631 |
| Mental status changes | 17.13 | 14.56 | 7 | 39879 | 63094 | 70825464 |
| Hyperparathyroidism secondary | 17.06 | 14.56 | 13 | 39873 | 2545 | 70886013 |
| Plasma cell myeloma | 17.03 | 14.56 | 10 | 39876 | 73191 | 70815367 |
| Septic shock | 16.93 | 14.56 | 23 | 39863 | 112235 | 70776323 |
| Bladder disorder | 16.80 | 14.56 | 22 | 39864 | 8267 | 70880291 |
| Back pain | 16.69 | 14.56 | 229 | 39657 | 270923 | 70617635 |
| Ear infection | 16.64 | 14.56 | 44 | 39842 | 28292 | 70860266 |
| Therapeutic response decreased | 16.57 | 14.56 | 71 | 39815 | 58382 | 70830176 |
| Upper respiratory tract infection | 16.45 | 14.56 | 88 | 39798 | 79186 | 70809372 |
| Neuropathy peripheral | 16.27 | 14.56 | 29 | 39857 | 126867 | 70761691 |
| Impaired healing | 16.14 | 14.56 | 11 | 39875 | 74363 | 70814195 |
| Muscle strain | 15.95 | 14.56 | 22 | 39864 | 8688 | 70879870 |
| Synovial cyst | 15.89 | 14.56 | 22 | 39864 | 8720 | 70879838 |
| Therapeutic response shortened | 15.84 | 14.56 | 27 | 39859 | 12811 | 70875747 |
| Blister | 15.77 | 14.56 | 20 | 39866 | 100506 | 70788052 |
| Pleuritic pain | 15.59 | 14.56 | 22 | 39864 | 8875 | 70879683 |
| Lung diffusion disorder | 15.56 | 14.56 | 5 | 39881 | 143 | 70888415 |
| Migraine | 15.54 | 14.56 | 81 | 39805 | 72157 | 70816401 |
| Hepatotoxicity | 15.41 | 14.56 | 3 | 39883 | 43983 | 70844575 |
| Blood immunoglobulin E increased | 15.33 | 14.56 | 16 | 39870 | 4728 | 70883830 |
| Pneumonia aspiration | 15.22 | 14.56 | 8 | 39878 | 62281 | 70826277 |
| Feeling jittery | 15.21 | 14.56 | 25 | 39861 | 11518 | 70877040 |
| Nasal congestion | 15.08 | 14.56 | 75 | 39811 | 65597 | 70822961 |
| Blood alkaline phosphatase increased | 15.08 | 14.56 | 7 | 39879 | 58514 | 70830044 |
| Pulmonary toxicity | 15.06 | 14.56 | 24 | 39862 | 10774 | 70877784 |
| Fall | 14.82 | 14.56 | 169 | 39717 | 443927 | 70444631 |
| Hyperglycaemia | 14.81 | 14.56 | 9 | 39877 | 64663 | 70823895 |
| Impaired work ability | 14.69 | 14.56 | 30 | 39856 | 16310 | 70872248 |
| Joint effusion | 14.61 | 14.56 | 29 | 39857 | 15448 | 70873110 |
| Humidity intolerance | 14.60 | 14.56 | 6 | 39880 | 350 | 70888208 |
| Gastrointestinal haemorrhage | 14.57 | 14.56 | 35 | 39851 | 137373 | 70751185 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.23 | acidic |
| pKa2 | 3.35 | Basic |
| pKa3 | 2.72 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 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 |
| 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 | 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 |