All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

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:

Dose	Unit	Route
30	mg	O

ADMET properties:

Property	Value	Reference
S (Water solubility)	0.21 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ

Approvals:

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

FDA Adverse Event Reporting System (Male)

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

FDA Adverse Event Reporting System (Geriatric)

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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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	P20648 P51164	ATP4A_HUMAN ATP4B_HUMAN	INHIBITOR				CHEMBL	CHEMBL
Cytosolic endo-beta-N-acetylglucosaminidase	Enzyme	Q8NFI3	ENASE_HUMAN		IC50	4.60		CHEMBL
Sterile alpha and TIR motif-containing protein 1	Unclassified	Q6SZW1	SARM1_HUMAN		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	24979-001	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	32 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	24979-002	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	32 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	24979-703	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	24979-703	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	24979-703	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	24979-704	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	24979-704	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	24979-704	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA AUTHORIZED GENERIC	33 sections
Dexlansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	49884-147	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	28 sections
Dexlansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	49884-148	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	28 sections
Dexlansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	49884-148	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	28 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4374	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA	32 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5944	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA AUTHORIZED GENERIC	32 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5956	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA AUTHORIZED GENERIC	32 sections
Dexlansoprazole delayed release	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6514	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	32 sections
Dexlansoprazoledelayed release	HUMAN PRESCRIPTION DRUG LABEL	1	51407-746	CAPSULE, DELAYED RELEASE	30 mg	ORAL	ANDA	32 sections
Dexlansoprazoledelayed release	HUMAN PRESCRIPTION DRUG LABEL	1	51407-747	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	32 sections
Kapidex	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5998	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA	16 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6152	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA	31 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	55154-5154	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA	31 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	55154-5154	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA	31 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	64764-171	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA	33 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	64764-171	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA	33 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	64764-171	CAPSULE, DELAYED RELEASE	30 mg	ORAL	NDA	33 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	64764-175	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA	33 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	64764-175	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA	33 sections
Dexilant	HUMAN PRESCRIPTION DRUG LABEL	1	64764-175	CAPSULE, DELAYED RELEASE	60 mg	ORAL	NDA	33 sections
Dexlansoprazole	HUMAN PRESCRIPTION DRUG LABEL	1	70518-3693	CAPSULE, DELAYED RELEASE	60 mg	ORAL	ANDA	28 sections