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

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:

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	808.63	13.54	426	31452	39345	50533901
Renal injury	232.69	13.54	112	31766	8499	50564747
End stage renal disease	229.17	13.54	98	31780	5639	50567607
Enthesopathy	192.67	13.54	93	31785	7100	50566146
Tenosynovitis	185.95	13.54	103	31775	10462	50562784
Blood parathyroid hormone decreased	160.93	13.54	82	31796	7032	50566214
Tongue disorder	154.43	13.54	87	31791	9129	50564117
Panniculitis	149.92	13.54	83	31795	8420	50564826
Red blood cell sedimentation rate	149.00	13.54	63	31815	3523	50569723
Blood pressure systolic increased	146.96	13.54	144	31734	35305	50537941
Rheumatoid nodule	140.57	13.54	92	31786	12643	50560603
Granuloma skin	134.34	13.54	68	31810	5750	50567496
Tendonitis	131.32	13.54	98	31780	16607	50556639
Skin necrosis	131.04	13.54	83	31795	10784	50562462
Ulcer	110.83	13.54	96	31782	20104	50553142
Alanine aminotransferase abnormal	103.10	13.54	51	31827	4105	50569141
Fear of injection	100.58	13.54	57	31821	6046	50567200
Skin ulcer	89.78	13.54	111	31767	35207	50538039
Hypercalcaemia	84.21	13.54	88	31790	23264	50549982
Incorrect product administration duration	83.32	13.54	59	31819	9216	50564030
Inflammation	82.68	13.54	137	31741	56775	50516471
Drug eruption	78.13	13.54	85	31793	23521	50549725
Basal cell carcinoma	77.13	13.54	84	31794	23272	50549974
Psoriatic arthropathy	76.21	13.54	119	31759	46913	50526333
Total lung capacity increased	75.46	13.54	25	31853	702	50572544
C-reactive protein abnormal	73.26	13.54	89	31789	27720	50545526
Maternal exposure during pregnancy	72.53	13.54	8	31870	159770	50413476
Rash pruritic	66.58	13.54	113	31765	47733	50525513
Forced expiratory volume decreased	61.72	13.54	37	31841	4357	50568889
Exposure during pregnancy	60.52	13.54	4	31874	121011	50452235
Rebound acid hypersecretion	59.08	13.54	17	31861	294	50572952
Completed suicide	58.86	13.54	7	31871	131882	50441364
Peak expiratory flow rate decreased	56.19	13.54	19	31859	569	50572677
Pemphigus	54.56	13.54	6	31872	120160	50453086
Asthma	51.52	13.54	148	31730	89189	50484057
Glossodynia	47.20	13.54	8	31870	115561	50457685
Cervix neoplasm	46.53	13.54	13	31865	201	50573045
Frustration tolerance decreased	46.18	13.54	34	31844	5640	50567606
Drug interaction	46.12	13.54	35	31843	199586	50373660
Headache	45.09	13.54	502	31376	506033	50067213
Obstructive airways disorder	44.35	13.54	52	31826	15600	50557646
Red blood cell sedimentation rate increased	44.30	13.54	72	31806	29344	50543902
Loss of personal independence in daily activities	43.27	13.54	119	31759	69931	50503315
Arteriovenous fistula occlusion	43.24	13.54	14	31864	365	50572881
Arthritis	42.78	13.54	136	31742	86585	50486661
Blue toe syndrome	42.30	13.54	14	31864	392	50572854
Tubulointerstitial nephritis	42.22	13.54	50	31828	15161	50558085
Sputum discoloured	42.18	13.54	47	31831	13348	50559898
Renal failure	41.90	13.54	155	31723	106478	50466768
Somatic delusion	41.45	13.54	15	31863	551	50572695
Peripheral swelling	41.36	13.54	246	31632	205690	50367556
Blood pressure fluctuation	41.35	13.54	78	31800	35745	50537501
Erythema	39.70	13.54	190	31688	146224	50427022
Joint injury	39.35	13.54	58	31820	21731	50551515
Toxicity to various agents	38.85	13.54	46	31832	212453	50360793
Drug specific antibody	38.28	13.54	20	31858	1805	50571441
Chromaturia	37.29	13.54	46	31832	14544	50558702
Endometriosis	36.78	13.54	26	31852	4049	50569197
Faeces soft	36.72	13.54	26	31852	4058	50569188
Hyponatraemia	36.41	13.54	8	31870	96131	50477115
Thrombocytopenia	35.54	13.54	18	31860	127655	50445591
Rhinorrhoea	35.26	13.54	91	31787	51492	50521754
Granuloma	34.86	13.54	27	31851	4831	50568415
Body temperature decreased	34.57	13.54	47	31831	16348	50556898
Cough	33.96	13.54	264	31614	241000	50332246
Respiration abnormal	33.69	13.54	27	31851	5075	50568171
Musculoskeletal stiffness	33.58	13.54	165	31713	128316	50444930
Systemic lupus erythematosus	33.31	13.54	24	31854	140598	50432648
Lung diffusion test decreased	33.19	13.54	13	31865	596	50572650
Swelling	33.09	13.54	47	31831	200825	50372421
Pancytopenia	31.81	13.54	7	31871	84023	50489223
Neutropenia	31.60	13.54	28	31850	147937	50425309
Blood pressure diastolic decreased	30.77	13.54	45	31833	16736	50556510
Drug tolerance	30.05	13.54	25	31853	4951	50568295
Pulmonary thrombosis	30.05	13.54	30	31848	7511	50565735
Bradycardia	29.79	13.54	3	31875	64423	50508823
Central obesity	29.76	13.54	14	31864	1008	50572238
Total lung capacity decreased	29.54	13.54	15	31863	1276	50571970
Confusional state	29.16	13.54	45	31833	185883	50387363
Hypertensive nephropathy	28.49	13.54	11	31867	485	50572761
Gastrooesophageal reflux disease	28.27	13.54	109	31769	76319	50496927
Hand deformity	28.07	13.54	14	31864	100185	50473061
Bronchopulmonary aspergillosis allergic	27.72	13.54	14	31864	1177	50572069
Dysphonia	26.98	13.54	69	31809	38823	50534423
Therapeutic reaction time decreased	26.05	13.54	14	31864	1338	50571908
Gastritis fungal	25.77	13.54	7	31871	97	50573149
Death	25.42	13.54	112	31766	325267	50247979
Forced vital capacity decreased	24.69	13.54	12	31866	929	50572317
Aspartate aminotransferase increased	24.69	13.54	106	31772	77892	50495354
Connective tissue inflammation	24.54	13.54	6	31872	53	50573193
Cardiac arrest	24.49	13.54	11	31867	83640	50489606
Defaecation disorder	24.06	13.54	10	31868	535	50572711
Parotid gland enlargement	24.03	13.54	11	31867	744	50572502
Gastrointestinal motility disorder	23.86	13.54	21	31857	4488	50568758
Hepatic enzyme increased	23.76	13.54	31	31847	137349	50435897
No adverse event	23.73	13.54	60	31818	33518	50539728
Lung opacity	23.61	13.54	15	31863	1958	50571288
Renal pain	23.59	13.54	23	31855	5596	50567650
Urine odour abnormal	22.57	13.54	22	31856	5351	50567895
Echocardiogram abnormal	22.46	13.54	12	31866	1133	50572113
Peak expiratory flow rate abnormal	22.44	13.54	6	31872	78	50573168
Gastric disorder	22.15	13.54	54	31824	29494	50543752
Drug tolerance decreased	22.00	13.54	28	31850	9132	50564114
Renal haemangioma	22.00	13.54	5	31873	31	50573215
Crepitations	21.63	13.54	23	31855	6196	50567050
Cardio-respiratory arrest	21.41	13.54	4	31874	53888	50519358
Bladder disorder	21.27	13.54	25	31853	7518	50565728
Abnormal faeces	21.12	13.54	19	31859	4177	50569069
Abdominal pain	20.85	13.54	234	31644	235994	50337252
Allergy to chemicals	20.77	13.54	12	31866	1320	50571926
Regurgitation	20.65	13.54	12	31866	1334	50571912
Rheumatoid lung	20.58	13.54	15	31863	2450	50570796
Pericarditis	20.57	13.54	12	31866	78677	50494569
Nephrogenic anaemia	20.49	13.54	13	31865	1692	50571554
Parapsoriasis	20.47	13.54	6	31872	111	50573135
Hyperkalaemia	20.37	13.54	3	31875	48086	50525160
Depressed level of consciousness	20.33	13.54	4	31874	51949	50521297
Acute kidney injury	20.16	13.54	226	31652	227832	50345414
Respiratory failure	19.77	13.54	17	31861	91164	50482082
Oropharyngeal pain	19.66	13.54	99	31779	77702	50495544
Patella fracture	19.57	13.54	13	31865	1829	50571417
Blood pressure systolic decreased	19.57	13.54	21	31857	5718	50567528
Coma	19.12	13.54	6	31872	56873	50516373
Musculoskeletal disorder	19.06	13.54	37	31841	17312	50555934
Lung diffusion disorder	18.92	13.54	5	31873	62	50573184
Nausea	18.89	13.54	579	31299	704819	49868427
Brain hypoxia	18.74	13.54	8	31870	458	50572788
Nocturia	18.47	13.54	22	31856	6708	50566538
Electrocardiogram QT prolonged	18.31	13.54	5	31873	51881	50521365
Carcinoid tumour	18.30	13.54	7	31871	301	50572945
Dry throat	18.28	13.54	20	31858	5564	50567682
Platelet count decreased	18.18	13.54	22	31856	100704	50472542
Wound	18.16	13.54	24	31854	105770	50467476
Antinuclear antibody positive	18.04	13.54	21	31857	6251	50566995
Abdominal pain upper	17.97	13.54	166	31712	159143	50414103
Cardiac failure	17.97	13.54	13	31865	76027	50497219
Nephropathy	17.51	13.54	19	31859	5239	50568007
Nasopharyngitis	17.42	13.54	192	31686	192735	50380511
Alanine aminotransferase increased	17.34	13.54	105	31773	88254	50484992
Disease progression	17.23	13.54	21	31857	95845	50477401
Insomnia	17.17	13.54	177	31701	174688	50398558
Neutrophil count decreased	17.08	13.54	4	31874	46022	50527224
Blood pressure diastolic abnormal	17.01	13.54	25	31853	9336	50563910
Influenza	16.69	13.54	105	31773	89433	50483813
Pulmonary embolism	16.53	13.54	24	31854	101680	50471566
Upper respiratory tract infection	16.05	13.54	83	31795	65815	50507431
Dry mouth	16	13.54	74	31804	56104	50517142
Therapy non-responder	15.88	13.54	69	31809	50953	50522293
Nasal congestion	15.81	13.54	69	31809	51051	50522195
Migraine	15.76	13.54	91	31787	75189	50498057
Thoracic operation	15.68	13.54	5	31873	124	50573122
Malignant neoplasm progression	15.64	13.54	12	31866	68112	50505134
Knee deformity	15.34	13.54	9	31869	1018	50572228
Impaired healing	15.14	13.54	13	31865	69773	50503473
Pyrexia	15.06	13.54	160	31718	380043	50193203
C-reactive protein increased	15.01	13.54	82	31796	66392	50506854
Humidity intolerance	14.92	13.54	6	31872	295	50572951
Suicide attempt	14.83	13.54	7	31871	51725	50521521
Injection site oedema	14.79	13.54	9	31869	1089	50572157
Blood test abnormal	14.77	13.54	26	31852	11293	50561953
Mononeuropathy	14.59	13.54	5	31873	156	50573090
Flail chest	14.56	13.54	4	31874	58	50573188
Urinary tract disorder	14.46	13.54	12	31866	2368	50570878
Muscle strain	14.46	13.54	20	31858	7068	50566178
Hyperchlorhydria	14.37	13.54	10	31868	1518	50571728
Heart rate decreased	14.27	13.54	53	31825	36444	50536802
Lung perforation	14.08	13.54	4	31874	66	50573180
Oral discomfort	13.98	13.54	21	31857	7996	50565250
Mucosal inflammation	13.92	13.54	4	31874	40138	50533108
Pharyngitis streptococcal	13.86	13.54	22	31856	8786	50564460
International normalised ratio increased	13.73	13.54	5	31873	43147	50530099
Diarrhoea	13.64	13.54	475	31403	588001	49985245

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	531.51	19.14	250	9200	36166	29528911
End stage renal disease	226.44	19.14	87	9363	7577	29557500
Renal injury	179.60	19.14	80	9370	10122	29554955
Tenosynovitis	149.42	19.14	53	9397	3680	29561397
Enthesopathy	145.49	19.14	52	9398	3691	29561386
C-reactive protein abnormal	114.18	19.14	51	9399	6485	29558592
Tongue disorder	113.63	19.14	46	9404	4590	29560487
Synovitis	100.44	19.14	55	9395	10835	29554242
Tendonitis	95.66	19.14	48	9402	7913	29557164
Alanine aminotransferase abnormal	92.43	19.14	35	9415	2922	29562155
Psoriatic arthropathy	85.18	19.14	55	9395	14636	29550441
Loss of personal independence in daily activities	78.43	19.14	65	9385	25375	29539702
Drug intolerance	52.86	19.14	71	9379	48308	29516769
Headache	50.99	19.14	146	9304	173861	29391216
Occupational dermatitis	49.48	19.14	10	9440	72	29565005
Treatment failure	44.67	19.14	57	9393	36882	29528195
Red blood cell sedimentation rate	43.04	19.14	13	9437	541	29564536
Inspiratory capacity abnormal	41.89	19.14	9	9441	90	29564987
Incorrect product administration duration	41.69	19.14	22	9428	4019	29561058
Oesophageal polyp	41.44	19.14	8	9442	44	29565033
Nerve degeneration	41.16	19.14	10	9440	179	29564898
Granuloma skin	41.03	19.14	13	9437	635	29564442
Nephrogenic anaemia	39.55	19.14	17	9433	1968	29563109
Occupational exposure to air contaminants	39.45	19.14	9	9441	121	29564956
Blood parathyroid hormone decreased	37.97	19.14	13	9437	811	29564266
Asthma	37.45	19.14	50	9400	33799	29531278
Stiff person syndrome	36.97	19.14	8	9442	83	29564994
Renal failure	36.12	19.14	101	9349	118498	29446579
Drug hypersensitivity	35.82	19.14	72	9378	68334	29496743
Mobility decreased	34.72	19.14	42	9408	25738	29539339
Blood immunoglobulin E increased	33.37	19.14	15	9435	1932	29563145
Airway remodelling	33.15	19.14	8	9442	139	29564938
Drug interaction	33.01	19.14	11	9439	197374	29367703
Panniculitis	32.98	19.14	13	9437	1208	29563869
Neck pain	32.29	19.14	37	9413	21410	29543667
Device dislocation	31.39	19.14	19	9431	4508	29560569
Erythema	29.82	19.14	71	9379	75535	29489542
Terminal insomnia	29.16	19.14	9	9441	403	29564674
Rheumatoid nodule	29.07	19.14	14	9436	2108	29562969
Micturition urgency	29.07	19.14	19	9431	5154	29559923
Device malfunction	28.86	19.14	23	9427	8484	29556593
Hypertensive nephropathy	28.74	19.14	9	9441	423	29564654
Erythema of eyelid	28.54	19.14	10	9440	668	29564409
Occupational exposure to product	27.21	19.14	8	9442	303	29564774
Renal haemangioma	27.21	19.14	5	9445	20	29565057
Renal neoplasm	26.92	19.14	11	9439	1122	29563955
Renal mass	26.83	19.14	12	9438	1528	29563549
Bone density decreased	25.83	19.14	12	9438	1668	29563409
Aspartate aminotransferase increased	25.64	19.14	58	9392	59667	29505410
Pain	25.26	19.14	115	9335	171317	29393760
Acute kidney injury	24.82	19.14	157	9293	265110	29299967
Dyspnoea at rest	23.61	19.14	14	9436	3200	29561877
Therapy non-responder	23.12	19.14	38	9412	30873	29534204
Abdominal rigidity	22.81	19.14	10	9440	1214	29563863
Hip surgery	22.70	19.14	9	9441	849	29564228
Contraindicated product administered	21.77	19.14	28	9422	18238	29546839
Chronic kidney disease-mineral and bone disorder	21.54	19.14	7	9443	371	29564706
Alanine aminotransferase increased	21.14	19.14	60	9390	70884	29494193
Restrictive pulmonary disease	20.57	19.14	9	9441	1087	29563990
Rebound acid hypersecretion	20.25	19.14	5	9445	96	29564981
Blood pressure diastolic increased	19.40	19.14	13	9437	3673	29561404
Dermatitis contact	19.32	19.14	12	9438	2980	29562097
Neutropenia	19.26	19.14	9	9441	131702	29433375

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	662.84	14.15	403	34197	57516	64406616
Tenosynovitis	337.37	14.15	152	34448	11681	64452451
Enthesopathy	333.87	14.15	142	34458	9496	64454636
Tongue disorder	272.56	14.15	132	34468	11948	64452184
Tendonitis	236.49	14.15	143	34457	20139	64443993
End stage renal disease	228.92	14.15	112	34488	10363	64453769
Blood parathyroid hormone decreased	211.15	14.15	95	34505	7271	64456861
Red blood cell sedimentation rate	202.82	14.15	76	34524	3638	64460494
Panniculitis	197.22	14.15	96	34504	8783	64455349
Rheumatoid nodule	192.27	14.15	106	34494	12545	64451587
Alanine aminotransferase abnormal	188.47	14.15	86	34514	6802	64457330
Granuloma skin	182.62	14.15	81	34519	5993	64458139
Psoriatic arthropathy	178.16	14.15	163	34437	43118	64421014
C-reactive protein abnormal	167.96	14.15	133	34467	28914	64435218
Skin necrosis	154.19	14.15	96	34504	14233	64449899
Renal injury	147.67	14.15	96	34504	15333	64448799
Blood pressure systolic increased	143.61	14.15	154	34446	49299	64414833
Ulcer	136.64	14.15	107	34493	22883	64441249
Loss of personal independence in daily activities	118.50	14.15	169	34431	72285	64391847
Fear of injection	113.78	14.15	58	34542	5854	64458278
Skin ulcer	103.85	14.15	123	34477	43851	64420281
Basal cell carcinoma	102.02	14.15	103	34497	30735	64433397
Headache	99.87	14.15	552	34048	528915	63935217
Inflammation	94.76	14.15	144	34456	65156	64398976
Hypercalcaemia	91.47	14.15	98	34502	31318	64432814
Drug interaction	89.80	14.15	41	34559	362042	64102090
Rash pruritic	89.61	14.15	131	34469	57273	64406859
Asthma	85.69	14.15	170	34430	95055	64369077
Toxicity to various agents	82.89	14.15	46	34554	363467	64100665
Total lung capacity increased	80.06	14.15	25	34575	683	64463449
Drug eruption	78.66	14.15	97	34503	36039	64428093
Erythema	74.34	14.15	245	34355	186825	64277307
Peripheral swelling	62.77	14.15	250	34350	208903	64255229
Peak expiratory flow rate decreased	57.96	14.15	19	34581	609	64463523
Thrombocytopenia	55.96	14.15	25	34575	223776	64240356
Drug abuse	55.57	14.15	4	34596	132370	64331762
Forced expiratory volume decreased	54.38	14.15	38	34562	6829	64457303
Synovitis	53.79	14.15	145	34455	98945	64365187
Hyponatraemia	53.27	14.15	8	34592	148331	64315801
Rhinorrhoea	51.45	14.15	105	34495	59864	64404268
Aspartate aminotransferase increased	51.27	14.15	161	34439	119627	64344505
Red blood cell sedimentation rate increased	51.24	14.15	73	34527	31162	64432970
Neutropenia	50.81	14.15	33	34567	239591	64224541
Cervix neoplasm	50.13	14.15	13	34587	177	64463955
Drug hypersensitivity	50.11	14.15	256	34344	237559	64226573
Drug intolerance	48.80	14.15	215	34385	187777	64276355
Frustration tolerance decreased	48.75	14.15	34	34566	6091	64458041
Endometriosis	46.88	14.15	25	34575	2767	64461365
Blood pressure diastolic decreased	45.55	14.15	58	34542	22243	64441889
Occupational dermatitis	44.58	14.15	11	34589	121	64464011
Pancytopenia	44.55	14.15	11	34589	143298	64320834
Joint injury	44.24	14.15	58	34542	22889	64441243
Nephrogenic anaemia	42.80	14.15	25	34575	3300	64460832
Multiple organ dysfunction syndrome	42.75	14.15	3	34597	101410	64362722
Gastrooesophageal reflux disease	42.46	14.15	119	34481	83024	64381108
Somatic delusion	40.90	14.15	15	34585	675	64463457
Sputum discoloured	40.58	14.15	49	34551	17807	64446325
Arteriovenous fistula occlusion	40.36	14.15	14	34586	535	64463597
Blue toe syndrome	39.65	14.15	14	34586	564	64463568
Drug specific antibody	38.71	14.15	20	34580	2075	64462057
Alanine aminotransferase increased	38.36	14.15	162	34438	138869	64325263
Rebound acid hypersecretion	37.81	14.15	9	34591	84	64464048
Blood pressure fluctuation	37.79	14.15	85	34515	51786	64412346
Maternal exposure during pregnancy	37.25	14.15	4	34596	95880	64368252
Therapy non-responder	36.32	14.15	97	34503	65802	64398330
Death	36.24	14.15	135	34465	482570	63981562
Cardiac arrest	35.77	14.15	19	34581	154045	64310087
Cough	35.35	14.15	280	34320	301868	64162264
Fatigue	34.86	14.15	579	34021	748151	63715981
Obstructive airways disorder	34.85	14.15	52	34548	23133	64440999
Occupational exposure to air contaminants	34.81	14.15	9	34591	121	64464011
Respiration abnormal	34.53	14.15	28	34572	6287	64457845
Respiratory failure	34.41	14.15	22	34578	161161	64302971
Arthritis	34.34	14.15	111	34489	83703	64380429
Drug tolerance decreased	34.05	14.15	29	34571	6969	64457163
Nasopharyngitis	33.84	14.15	200	34400	195873	64268259
Cardio-respiratory arrest	33.77	14.15	6	34594	98387	64365745
Granuloma	33.30	14.15	28	34572	6613	64457519
Completed suicide	33.20	14.15	43	34557	224371	64239761
Hyperkalaemia	32.95	14.15	7	34593	101122	64363010
Inspiratory capacity abnormal	32.84	14.15	8	34592	83	64464049
Dysphonia	32.67	14.15	75	34525	46307	64417825
Nerve degeneration	32.46	14.15	10	34590	261	64463871
Sepsis	32.20	14.15	46	34554	230295	64233837
Faeces soft	32.10	14.15	26	34574	5829	64458303
Oesophageal polyp	30.83	14.15	7	34593	52	64464080
Coma	30.82	14.15	5	34595	87610	64376522
Rhabdomyolysis	30.61	14.15	6	34594	91720	64372412
Musculoskeletal stiffness	30.50	14.15	139	34461	123067	64341065
Arthralgia	30.16	14.15	366	34234	441894	64022238
Pulmonary thrombosis	29.19	14.15	32	34568	10486	64453646
Platelet count decreased	28.19	14.15	29	34571	167682	64296450
Neutrophil count decreased	28.08	14.15	4	34596	77192	64386940
Depressed level of consciousness	27.87	14.15	5	34595	81431	64382701
Hypertensive nephropathy	27.82	14.15	12	34588	829	64463303
Total lung capacity decreased	27.74	14.15	15	34585	1707	64462425
Nausea	27.32	14.15	581	34019	785219	63678913
C-reactive protein increased	27.27	14.15	112	34488	94797	64369335
Defaecation disorder	27.20	14.15	10	34590	453	64463679
Cardiac failure	27	14.15	19	34581	132354	64331778
Treatment failure	26.87	14.15	129	34471	116687	64347445
Lung diffusion test decreased	26.76	14.15	13	34587	1183	64462949
Body temperature decreased	26.63	14.15	49	34551	25879	64438253
Oropharyngeal pain	26.43	14.15	106	34494	88761	64375371
Renal pain	26.24	14.15	25	34575	6949	64457183
Bronchopulmonary aspergillosis allergic	25.77	14.15	14	34586	1608	64462524
Confusional state	25.26	14.15	65	34535	261079	64203053
Drug tolerance	25.18	14.15	23	34577	6062	64458070
Rheumatoid lung	25.13	14.15	16	34584	2463	64461669
Pyrexia	24.68	14.15	187	34413	558457	63905675
Stiff person syndrome	24.48	14.15	8	34592	254	64463878
Drug ineffective	24.46	14.15	606	33994	839641	63624491
Occupational exposure to product	24.40	14.15	10	34590	608	64463524
Disease progression	24.38	14.15	24	34576	141656	64322476
Central obesity	24.35	14.15	13	34587	1442	64462690
Abdominal pain upper	24.30	14.15	169	34431	174861	64289271
Incorrect product administration duration	24.20	14.15	28	34572	9730	64454402
Rheumatoid arthritis	23.62	14.15	160	34440	164134	64299998
Crepitations	23.58	14.15	25	34575	7890	64456242
Therapeutic reaction time decreased	23.49	14.15	14	34586	1918	64462214
Pain in extremity	23.39	14.15	257	34343	302828	64161304
Peak expiratory flow rate abnormal	23.32	14.15	6	34594	79	64464053
Abdominal pain	23.25	14.15	263	34337	312112	64152020
Airway remodelling	23.24	14.15	7	34593	169	64463963
Pain	23.14	14.15	421	34179	553090	63911042
Electrocardiogram QT prolonged	22.99	14.15	7	34593	79441	64384691
Lactic acidosis	22.77	14.15	3	34597	61407	64402725
Musculoskeletal disorder	22.51	14.15	37	34563	17869	64446263
Urine odour abnormal	22.40	14.15	20	34580	5116	64459016
Allergy to chemicals	22.39	14.15	11	34589	1026	64463106
Blood test abnormal	22.34	14.15	31	34569	12912	64451220
Gastrointestinal motility disorder	22.26	14.15	20	34580	5159	64458973
Renal failure	22.11	14.15	170	34430	181518	64282614
Delirium	22.11	14.15	5	34595	69189	64394943
Pulmonary embolism	21.68	14.15	28	34572	146328	64317804
Lung opacity	21.44	14.15	16	34584	3183	64460949
Blood pressure systolic decreased	21.35	14.15	25	34575	8795	64455337
Blood pressure diastolic abnormal	21.25	14.15	29	34571	11888	64452244
International normalised ratio increased	21.13	14.15	8	34592	79159	64384973
Forced vital capacity decreased	21.12	14.15	12	34588	1504	64462628
Chromaturia	21.08	14.15	41	34559	22570	64441562
Patella fracture	20.67	14.15	12	34588	1566	64462566
Infusion related reaction	20.64	14.15	155	34445	164312	64299820
Device dependence	20.60	14.15	5	34595	51	64464081
Blood pressure diastolic increased	20.45	14.15	27	34573	10725	64453407
Bradycardia	20.37	14.15	20	34580	118199	64345933
Carcinoid tumour	20.28	14.15	8	34592	440	64463692
Abnormal faeces	20.16	14.15	20	34580	5839	64458293
Terminal insomnia	20.14	14.15	10	34590	954	64463178
Hypotension	20.05	14.15	121	34479	380853	64083279
Renal neoplasm	19.96	14.15	12	34588	1669	64462463
Heart rate decreased	19.96	14.15	70	34530	54997	64409135
Intentional overdose	19.57	14.15	12	34588	89932	64374200
Anaemia	19.55	14.15	121	34479	378559	64085573
Hypokalaemia	19.46	14.15	22	34578	121881	64342251
Chronic kidney disease-mineral and bone disorder	19.26	14.15	8	34592	503	64463629
Metabolic acidosis	19.23	14.15	7	34593	70951	64393181
Heart rate increased	19.21	14.15	104	34496	98571	64365561
Seizure	19.00	14.15	38	34562	166854	64297278
Bone density decreased	18.94	14.15	25	34575	9927	64454205
Ear infection	18.92	14.15	40	34560	23364	64440768
Bladder disorder	18.78	14.15	22	34578	7745	64456387
Therapeutic product effect incomplete	18.77	14.15	107	34493	103375	64360757
Hyperparathyroidism secondary	18.70	14.15	13	34587	2317	64461815
Respiratory arrest	18.69	14.15	3	34597	52982	64411150
Wheezing	18.53	14.15	89	34511	80490	64383642
Gastritis fungal	18.46	14.15	6	34594	187	64463945
Erythema of eyelid	18.23	14.15	12	34588	1956	64462176
Hypoglycaemia	18.20	14.15	13	34587	89879	64374253
Gastric disorder	18.17	14.15	45	34555	29152	64434980
Blood pressure increased	18.05	14.15	156	34444	172396	64291736
Muscle strain	17.83	14.15	22	34578	8172	64455960
Knee deformity	17.74	14.15	9	34591	899	64463233
Systemic lupus erythematosus	17.39	14.15	10	34590	77602	64386530
Product use issue	17.38	14.15	140	34460	151575	64312557
Medication error	17.24	14.15	3	34597	49963	64414169
Therapeutic response shortened	17.01	14.15	24	34576	10146	64453986
Septic shock	16.86	14.15	19	34581	105418	64358714
Echocardiogram abnormal	16.79	14.15	11	34589	1778	64462354
Lung diffusion disorder	16.79	14.15	5	34595	116	64464016
Mental status changes	16.63	14.15	6	34594	61156	64402976
Dyspepsia	16.56	14.15	86	34514	80226	64383906
Gamma-glutamyltransferase increased	16.55	14.15	3	34597	48507	64415625
Pemphigus	16.42	14.15	6	34594	60695	64403437
Respiratory distress	16.29	14.15	4	34596	52327	64411805
Injection site oedema	16.27	14.15	9	34591	1071	64463061
Suicide attempt	16.12	14.15	9	34591	70998	64393134
Oral discomfort	15.82	14.15	21	34579	8385	64455747
Heart rate irregular	15.76	14.15	41	34559	27372	64436760
Migraine	15.71	14.15	71	34529	62606	64401526
Neck pain	15.65	14.15	70	34530	61463	64402669
Dry throat	15.65	14.15	18	34582	6214	64457918
Tubulointerstitial nephritis	15.53	14.15	44	34556	30865	64433267
Cardiac failure congestive	15.50	14.15	29	34571	130551	64333581
Haematocrit decreased	15.48	14.15	5	34595	54650	64409482
Influenza	15.45	14.15	104	34496	106427	64357705
Unresponsive to stimuli	15.40	14.15	4	34596	50389	64413743
Ascites	15.36	14.15	7	34593	61994	64402138
Pharyngitis streptococcal	15.32	14.15	21	34579	8647	64455485
Nasal congestion	15.27	14.15	68	34532	59590	64404542
Mobility decreased	15.07	14.15	88	34512	85752	64378380
Humidity intolerance	15.06	14.15	6	34594	339	64463793
Thoracic operation	15.00	14.15	5	34595	169	64463963
Glossodynia	14.98	14.15	8	34592	64688	64399444
Renal mass	14.64	14.15	12	34588	2735	64461397
Lung perforation	14.55	14.15	4	34596	69	64464063
Blood alkaline phosphatase increased	14.50	14.15	6	34594	56273	64407859
Renal haemangioma	14.40	14.15	3	34597	14	64464118
Flail chest	14.33	14.15	4	34596	73	64464059
Stomatitis	14.23	14.15	23	34577	109582	64354550
Acute myocardial infarction	14.22	14.15	10	34590	69708	64394424
Pneumonia aspiration	14.21	14.15	7	34593	59264	64404868

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 (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])	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	24979-703	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
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