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

Stem definition	Drug id	CAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives	4304	461432-26-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dapagliflozin propanediol monohydrate dapagliflozin propanediol BMS 512148 forxiga dapaglifozin dapagliflozin farxiga dapagliflozin propylene glycolate hydrate	an Sodium-glucose cotransporter 2 (SGLT2) inhibitor, SGLT2 expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen, by inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion Molecular weight: 408.88 Formula: C21H25ClO6 CLOGP: 3.37 LIPINSKI: 0 HAC: 6 HDO: 4 TPSA: 99.38 ALOGS: -3.37 ROTB: 6 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dapagliflozin propanediol monohydrate
dapagliflozin propanediol
BMS 512148
forxiga
dapaglifozin
dapagliflozin
farxiga
dapagliflozin propylene glycolate hydrate

an Sodium-glucose cotransporter 2 (SGLT2) inhibitor, SGLT2 expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen, by inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion

Molecular weight: 408.88
Formula: C21H25ClO6
CLOGP: 3.37
LIPINSKI: 0
HAC: 6
HDO: 4
TPSA: 99.38
ALOGS: -3.37
ROTB: 6

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
10	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution)	1.70 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.09 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	12.20 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	1.60 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company
March 24, 2014	PMDA	BRISTOL-MYERS
Jan. 8, 2014	FDA	ASTRAZENECA AB
Nov. 12, 2012	EMA

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
Diabetic ketoacidosis	2955.92	18.32	773	18999	19732	63449518
Ketoacidosis	1348.86	18.32	305	19467	4073	63465177
Euglycaemic diabetic ketoacidosis	907.79	18.32	214	19558	3460	63465790
Fungal infection	347.03	18.32	187	19585	36687	63432563
Pruritus genital	237.24	18.32	69	19703	2585	63466665
Ketosis	223.09	18.32	49	19723	564	63468686
Blood glucose increased	184.76	18.32	175	19597	83581	63385669
Cardiospasm	181.22	18.32	52	19720	1855	63467395
Palmoplantar keratoderma	178.59	18.32	52	19720	1955	63467295
Diabetes mellitus inadequate control	165.77	18.32	85	19687	15041	63454209
Sleep terror	163.77	18.32	52	19720	2628	63466622
Glycosylated haemoglobin increased	154.46	18.32	76	19696	12322	63456928
Atrial tachycardia	140.40	18.32	52	19720	4188	63465062
Carotid artery occlusion	138.83	18.32	53	19719	4641	63464609
Tension headache	133.70	18.32	53	19719	5133	63464117
Acute kidney injury	127.45	18.32	264	19508	263151	63206099
Metabolic acidosis	126.64	18.32	108	19664	44961	63424289
Dehydration	120.42	18.32	203	19569	173151	63296099
Ketonuria	120.05	18.32	30	19742	623	63468627
Hypoglycaemia	116.45	18.32	117	19655	59948	63409302
Anosmia	116.19	18.32	52	19720	6808	63462442
Immunisation	115.46	18.32	33	19739	1160	63468090
Glomerular filtration rate decreased	106.70	18.32	61	19711	13380	63455870
Urinary tract infection	104.99	18.32	245	19527	264439	63204811
Blood ketone body increased	98.26	18.32	22	19750	278	63468972
Facial pain	97.68	18.32	53	19719	10508	63458742
Pain of skin	92.88	18.32	53	19719	11581	63457669
Urine ketone body present	91.41	18.32	33	19739	2470	63466780
Subarachnoid haemorrhage	87.83	18.32	55	19717	14228	63455022
Ventricular tachycardia	86.84	18.32	62	19710	19917	63449333
Weight decreased	86.44	18.32	234	19538	276564	63192686
Lactic acidosis	86.24	18.32	81	19691	38206	63431044
Necrotising fasciitis	85.15	18.32	33	19739	3008	63466242
Diabetic metabolic decompensation	83.50	18.32	28	19744	1682	63467568
Tinnitus	83.38	18.32	77	19695	35551	63433699
Vasculitis	75.69	18.32	55	19717	18154	63451096
COVID-19	73.90	18.32	129	19643	112974	63356276
Diabetic ketosis	72.98	18.32	17	19755	259	63468991
Palpitations	72.88	18.32	128	19644	112642	63356608
Eye pruritus	72.22	18.32	54	19718	18617	63450633
Muscle twitching	71.91	18.32	55	19717	19613	63449637
Lip swelling	68.57	18.32	65	19707	30998	63438252
Blindness	67.13	18.32	55	19717	21644	63447606
Vulvovaginal pruritus	66.05	18.32	28	19744	3215	63466035
Genital infection female	64.97	18.32	13	19759	91	63469159
Drug ineffective	64.83	18.32	144	19628	1044621	62424629
Genital infection	63.50	18.32	14	19758	164	63469086
Diplopia	62.85	18.32	55	19717	23673	63445577
Catarrh	58.74	18.32	21	19751	1528	63467722
Hypoglycaemic coma	58.39	18.32	24	19748	2551	63466699
Steroid dependence	56.07	18.32	21	19751	1743	63467507
Burns second degree	53.74	18.32	21	19751	1957	63467293
Angioedema	53.14	18.32	70	19702	47895	63421355
Transient ischaemic attack	52.91	18.32	62	19710	37691	63431559
Intentional product misuse	52.76	18.32	79	19693	60838	63408412
Arthropathy	49.81	18.32	7	19765	234785	63234465
Joint swelling	49.62	18.32	20	19752	327646	63141604
Rheumatoid arthritis	48.49	18.32	10	19762	253809	63215441
Glucose urine present	48.03	18.32	15	19757	717	63468533
Hyperglycaemia	47.77	18.32	62	19710	41805	63427445
Temperature perception test abnormal	47.49	18.32	8	19764	17	63469233
Contraindicated product administered	47.33	18.32	6	19766	217642	63251608
Pyelonephritis	46.66	18.32	41	19731	17737	63451513
Pollakiuria	46.18	18.32	50	19722	27887	63441363
Disturbance in attention	45.85	18.32	58	19714	38131	63431119
Swelling	44.73	18.32	15	19757	275363	63193887
Cardiac failure	43.72	18.32	90	19682	89052	63380198
Polyuria	42.96	18.32	29	19743	8513	63460737
Musculoskeletal stiffness	42.91	18.32	4	19768	184614	63284636
Toxicity to various agents	40.98	18.32	13	19759	247237	63222013
Hypopnoea	40.56	18.32	21	19751	3785	63465465
Dizziness	40.35	18.32	250	19522	429675	63039575
Urosepsis	39.43	18.32	38	19734	18486	63450764
Pancreatitis	38.79	18.32	61	19711	48994	63420256
Therapeutic product effect decreased	38.18	18.32	7	19765	193180	63276070
Leukocyturia	38.01	18.32	15	19757	1434	63467816
Hyperhidrosis	37.47	18.32	95	19677	107741	63361509
Wound	36.73	18.32	4	19768	163259	63305991
Hypersensitivity	36.60	18.32	23	19749	292662	63176588
Hallucination	36.39	18.32	63	19709	54754	63414496
Dry skin	35.97	18.32	64	19708	56823	63412427
Rash papular	34.92	18.32	33	19739	15669	63453581
Cerebral infarction	34.74	18.32	40	19732	23853	63445397
Nasopharyngitis	34.61	18.32	18	19754	254239	63215011
Vomiting	34.39	18.32	294	19478	559323	62909927
Hyperkalaemia	34.30	18.32	61	19711	54142	63415108
Candida infection	33.93	18.32	43	19729	28308	63440942
Drug intolerance	32.49	18.32	29	19743	308632	63160618
Hyperglycaemic hyperosmolar nonketotic syndrome	32.26	18.32	12	19760	977	63468273
Left ventricular dysfunction	32.17	18.32	28	19744	11960	63457290
Pneumonia	31.50	18.32	59	19713	456708	63012542
Genital infection fungal	31.44	18.32	8	19764	179	63469071
Vulvovaginitis	31.17	18.32	9	19763	328	63468922
Visual impairment	29.96	18.32	75	19697	84371	63384879
Exposure during pregnancy	29.96	18.32	6	19766	155541	63313709
Renal impairment	29.81	18.32	77	19695	88278	63380972
Acidosis	29.66	18.32	26	19746	11207	63458043
Hypernatraemia	29.40	18.32	22	19750	7587	63461663
Cardiac murmur	29.38	18.32	29	19743	14523	63454727
Parosmia	28.68	18.32	20	19752	6186	63463064
Bladder trabeculation	28.65	18.32	6	19766	54	63469196
Urinary tract infection fungal	28.55	18.32	10	19762	685	63468565
Amnesia	28.28	18.32	57	19715	55528	63413722
Peripartum cardiomyopathy	27.89	18.32	7	19765	148	63469102
Ischaemic stroke	27.70	18.32	31	19741	17926	63451324
Cardiac failure chronic	27.12	18.32	17	19755	4401	63464849
Aortic valve calcification	27.01	18.32	9	19763	530	63468720
Impaired quality of life	26.96	18.32	27	19745	13756	63455494
Cognitive disorder	26.94	18.32	56	19716	55759	63413491
Glycosuria	26.89	18.32	11	19761	1155	63468095
Decreased vibratory sense	26.73	18.32	8	19764	331	63468919
Blood glucose abnormal	26.52	18.32	21	19751	7871	63461379
Neutropenia	25.95	18.32	11	19761	174994	63294256
Gingival pain	25.90	18.32	21	19751	8141	63461109
Vulvovaginal mycotic infection	25.87	18.32	18	19754	5548	63463702
Heart rate increased	25.72	18.32	76	19696	94162	63375088
Sinusitis	25.43	18.32	20	19752	226633	63242617
Dysuria	25.35	18.32	41	19731	33697	63435553
Hepatic enzyme increased	25.14	18.32	16	19756	202312	63266938
Toe amputation	24.32	18.32	12	19760	1955	63467295
Haematuria	24.08	18.32	37	19735	29120	63440130
Myocardial infarction	23.95	18.32	77	19695	99816	63369434
Lower respiratory tract infection	23.67	18.32	6	19766	132301	63336949
Perineal pain	23.50	18.32	7	19765	285	63468965
Drug hypersensitivity	23.33	18.32	38	19734	310649	63158601
Blood ketone body	23.31	18.32	5	19767	51	63469199
Glomerular filtration rate abnormal	23.12	18.32	9	19763	830	63468420
Blood ketone body present	22.88	18.32	5	19767	56	63469194
Glycosylated haemoglobin abnormal	22.69	18.32	6	19766	157	63469093
Eczema	22.59	18.32	38	19734	32253	63436997
Impaired healing	21.86	18.32	3	19769	102539	63366711
Migraine	21.54	18.32	76	19696	103270	63365980
Latent autoimmune diabetes in adults	20.67	18.32	4	19768	23	63469227
Tubulointerstitial nephritis	20.43	18.32	28	19744	19875	63449375
Sarcopenia	20.43	18.32	5	19767	95	63469155
White blood cell count decreased	20.21	18.32	9	19763	139095	63330155
Conjunctival discolouration	19.95	18.32	5	19767	105	63469145
Rhinitis	19.94	18.32	21	19751	11345	63457905
Contusion	19.85	18.32	11	19761	150033	63319217
Compartment syndrome	19.84	18.32	11	19761	2273	63466977
Thirst	19.56	18.32	23	19749	14018	63455232
Marasmus	19.46	18.32	7	19765	518	63468732
Swollen tongue	19.29	18.32	37	19735	34763	63434487
Systemic lupus erythematosus	19.25	18.32	22	19750	208896	63260354
Portal fibrosis	19.21	18.32	6	19766	287	63468963
Tachycardia	18.97	18.32	80	19692	118076	63351174
Vulvovaginal candidiasis	18.95	18.32	12	19760	3163	63466087
Thrombotic cerebral infarction	18.62	18.32	5	19767	139	63469111
Aspartate aminotransferase increased	18.42	18.32	3	19769	90274	63378976

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
Diabetic ketoacidosis	1995.35	16.73	655	22270	17377	34916629
Ketoacidosis	771.63	16.73	226	22699	4017	34929989
Euglycaemic diabetic ketoacidosis	726.71	16.73	203	22722	3019	34930987
Pruritus genital	234.66	16.73	78	22847	2126	34931880
Cardiospasm	208.97	16.73	66	22859	1522	34932484
Ketosis	206.98	16.73	51	22874	447	34933559
Palmoplantar keratoderma	191.62	16.73	65	22860	1888	34932118
Glycosylated haemoglobin increased	188.45	16.73	108	22817	11252	34922754
Metabolic acidosis	179.98	16.73	180	22745	43500	34890506
Sleep terror	176.97	16.73	64	22861	2254	34931752
Atrial tachycardia	165.51	16.73	69	22856	3576	34930430
Blood glucose increased	163.75	16.73	210	22715	66508	34867498
Tension headache	163.53	16.73	65	22860	2977	34931029
Phimosis	161.06	16.73	47	22878	821	34933185
Facial pain	151.16	16.73	65	22860	3639	34930367
Carotid artery occlusion	150.61	16.73	65	22860	3672	34930334
Anosmia	149.20	16.73	66	22859	3958	34930048
Ketonuria	144.57	16.73	40	22885	571	34933435
Immunisation	142.70	16.73	45	22880	1032	34932974
Glomerular filtration rate decreased	140.56	16.73	94	22831	12867	34921139
Balanoposthitis	133.87	16.73	44	22881	1156	34932850
Eye pruritus	123.66	16.73	71	22854	7418	34926588
Pain of skin	123.01	16.73	66	22859	6043	34927963
Ventricular tachycardia	115.85	16.73	113	22812	26466	34907540
Lip swelling	109.38	16.73	88	22837	15992	34918014
Fungal infection	107.96	16.73	87	22838	15848	34918158
Vasculitis	101.52	16.73	73	22852	11223	34922783
Diabetic ketosis	98.49	16.73	22	22903	119	34933887
Glomerular filtration rate abnormal	97.71	16.73	32	22893	831	34933175
Dehydration	94.22	16.73	240	22685	129729	34804277
Migraine	90.92	16.73	82	22843	17396	34916610
Diabetes mellitus inadequate control	90.12	16.73	73	22852	13391	34920615
Muscle twitching	89.01	16.73	65	22860	10233	34923773
Polyuria	87.74	16.73	60	22865	8514	34925492
Pericarditis	84.05	16.73	66	22859	11579	34922427
N-terminal prohormone brain natriuretic peptide increased	83.19	16.73	39	22886	2676	34931330
Toxicity to various agents	82	16.73	16	22909	200346	34733660
Rash papular	80.17	16.73	61	22864	10217	34923789
Subarachnoid haemorrhage	79.31	16.73	66	22859	12569	34921437
Hyperglycaemia	78.09	16.73	112	22813	39368	34894638
Blood ketone body increased	77.85	16.73	23	22902	420	34933586
Drug ineffective	76.17	16.73	114	22811	456637	34477369
Diplopia	75.98	16.73	73	22852	16770	34917236
Tinnitus	75.68	16.73	79	22846	20039	34913967
Hypoglycaemia	74.85	16.73	131	22794	54509	34879497
Necrotising fasciitis	71.55	16.73	39	22886	3683	34930323
Blindness	71.50	16.73	67	22858	14919	34919087
Palpitations	68.42	16.73	106	22819	39880	34894126
Lactic acidosis	67.82	16.73	98	22827	34674	34899332
Transient ischaemic attack	67.76	16.73	87	22838	27526	34906480
Urine ketone body present	66.86	16.73	26	22899	1122	34932884
Cardiac failure	66.56	16.73	169	22756	91079	34842927
Pollakiuria	66.49	16.73	73	22852	19601	34914405
Ejection fraction decreased	66.35	16.73	72	22853	19082	34914924
Toe amputation	64.45	16.73	32	22893	2492	34931514
Disturbance in attention	64.06	16.73	82	22843	25863	34908143
Neutropenia	63.11	16.73	13	22912	156765	34777241
Urinary tract infection	59.52	16.73	154	22771	83927	34850079
Acquired phimosis	57.20	16.73	13	22912	77	34933929
Type V hyperlipidaemia	56.91	16.73	21	22904	783	34933223
Dry skin	55.01	16.73	84	22841	31203	34902803
Urosepsis	54.96	16.73	54	22871	12745	34921261
COVID-19	53.82	16.73	141	22784	77409	34856597
Febrile neutropenia	53.73	16.73	12	22913	136837	34797169
Alopecia	52.46	16.73	72	22853	24283	34909723
Amnesia	50.53	16.73	74	22851	26489	34907517
Pneumonia	48.19	16.73	104	22821	362523	34571483
Abdominal discomfort	48.02	16.73	115	22810	59720	34874286
Epididymitis	47.91	16.73	26	22899	2433	34931573
Disease progression	47.76	16.73	7	22918	108070	34825936
Hyperglycaemic hyperosmolar nonketotic syndrome	47.46	16.73	21	22904	1259	34932747
Visual impairment	46.63	16.73	84	22841	35718	34898288
Weight decreased	46.19	16.73	233	22692	176068	34757938
Completed suicide	44.22	16.73	6	22919	98162	34835844
Cerebral infarction	43.11	16.73	70	22855	27385	34906621
Angioedema	42.82	16.73	83	22842	37291	34896715
Intentional product misuse	42.49	16.73	93	22832	45518	34888488
Bladder cancer	41.05	16.73	52	22873	16226	34917780
Cardiac failure chronic	41.03	16.73	37	22888	7842	34926164
Glomerular filtration rate increased	40.61	16.73	14	22911	427	34933579
Acute kidney injury	40.30	16.73	339	22586	304649	34629357
Drug abuse	38.26	16.73	9	22916	99087	34834919
Cognitive disorder	38.23	16.73	68	22857	28625	34905381
Heart rate increased	38.18	16.73	90	22835	46253	34887753
Blood pressure decreased	38.13	16.73	96	22829	51419	34882587
Glucose urine present	37.97	16.73	17	22908	1048	34932958
White blood cell count decreased	36.20	16.73	9	22916	95436	34838570
Blood glucose abnormal	35.10	16.73	30	22895	5922	34928084
Genital rash	33.34	16.73	13	22912	565	34933441
Ventricular internal diameter abnormal	33.33	16.73	10	22915	193	34933813
Genital infection fungal	33.04	16.73	10	22915	199	34933807
Glycosuria	32.53	16.73	16	22909	1221	34932785
Hypoglycaemic coma	32.19	16.73	20	22905	2411	34931595
Thrombocytopenia	32.18	16.73	33	22892	156214	34777792
Malignant neoplasm progression	32.06	16.73	9	22916	88037	34845969
Mitral valve incompetence	31.91	16.73	44	22881	14899	34919107
Atrial enlargement	31.44	16.73	13	22912	659	34933347
Congestive cardiomyopathy	30.97	16.73	31	22894	7479	34926527
Microalbuminuria	30.89	16.73	13	22912	689	34933317
Anaemia	30.85	16.73	67	22858	233268	34700738
Pancytopenia	30.68	16.73	12	22913	95145	34838861
Testicular swelling	30.58	16.73	17	22908	1668	34932338
Mitral valve thickening	30.52	16.73	11	22914	383	34933623
Pyelonephritis	30.05	16.73	28	22897	6187	34927819
Respiratory failure	29.92	16.73	17	22908	108555	34825451
Mitral valve calcification	29.86	16.73	12	22913	565	34933441
Gangrene	28.86	16.73	24	22901	4562	34929444
Inferior vena cava syndrome	28.44	16.73	7	22918	61	34933945
Renal impairment	28.37	16.73	130	22795	94383	34839623
Polycythaemia	27.99	16.73	17	22908	1968	34932038
Perineal abscess	27.67	16.73	10	22915	351	34933655
Thrombotic cerebral infarction	27.17	16.73	10	22915	370	34933636
Foot amputation	26.66	16.73	12	22913	749	34933257
Malaise	26.32	16.73	210	22715	185615	34748391
Thirst	26.16	16.73	29	22896	7866	34926140
Leukopenia	25.70	16.73	5	22920	62851	34871155
Feeling abnormal	25.28	16.73	95	22830	63140	34870866
Muscular weakness	24.71	16.73	104	22821	72793	34861213
N-terminal prohormone brain natriuretic peptide abnormal	24.67	16.73	8	22917	201	34933805
Lung diffusion test abnormal	24.51	16.73	6	22919	51	34933955
Memory impairment	24.35	16.73	73	22852	43245	34890761
Tricuspid valve incompetence	24.32	16.73	31	22894	9729	34924277
Left ventricular false tendon	24.20	16.73	6	22919	54	34933952
Overdose	24.04	16.73	15	22910	91044	34842962
Suspected COVID-19	23.86	16.73	13	22912	1226	34932780
Dizziness	23.73	16.73	233	22692	218288	34715718
Anal abscess	23.58	16.73	25	22900	6448	34927558
Hyperhidrosis	23.37	16.73	105	22820	75587	34858419
Extremity necrosis	23.06	16.73	15	22910	1957	34932049
Epistaxis	23.06	16.73	5	22920	58246	34875760
Genital erythema	22.72	16.73	8	22917	260	34933746
Body mass index increased	22.72	16.73	12	22913	1063	34932943
Multiple organ dysfunction syndrome	22.54	16.73	11	22914	76555	34857451
Acetonaemia	22.34	16.73	7	22918	157	34933849
Pancreatitis	22.29	16.73	66	22859	38825	34895181
Burns second degree	22.17	16.73	12	22913	1117	34932889
Peripheral arterial occlusive disease	21.96	16.73	23	22902	5851	34928155
Total cholesterol/HDL ratio increased	21.93	16.73	7	22918	167	34933839
Cough	21.62	16.73	41	22884	150099	34783907
Immune-mediated hepatitis	21.48	16.73	15	22910	2200	34931806
Neutrophil count decreased	21.03	16.73	4	22921	51100	34882906
Splinter haemorrhages	20.76	16.73	6	22919	101	34933905
Treatment failure	20.67	16.73	3	22922	46694	34887312
Catarrh	20.66	16.73	11	22914	991	34933015
Genital infection male	20.61	16.73	4	22921	9	34933997
Orchitis	20.41	16.73	13	22912	1636	34932370
Fall	20.18	16.73	67	22858	202818	34731188
Blood creatine increased	19.61	16.73	20	22905	4931	34929075
Cardiac pacemaker evaluation	19.61	16.73	6	22919	124	34933882
Seizure	19.55	16.73	24	22901	104833	34829173
Scrotal abscess	19.38	16.73	9	22916	604	34933402
Steroid dependence	18.88	16.73	12	22913	1505	34932501
Hypertrophy	18.51	16.73	8	22917	453	34933553
Abdominal pain upper	18.32	16.73	94	22831	71396	34862610
Myocardial infarction	18.31	16.73	139	22786	120946	34813060
Urine output increased	18.09	16.73	11	22914	1276	34932730
Obesity	17.77	16.73	31	22894	12847	34921159
Peripheral circulatory failure	17.69	16.73	6	22919	174	34933832
Vomiting	17.48	16.73	243	22682	247378	34686628
Electrocardiogram QT prolonged	17.29	16.73	3	22922	40949	34893057
Hallucination	17.08	16.73	73	22852	51425	34882581
Chills	16.80	16.73	17	22908	81026	34852980

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
Diabetic ketoacidosis	3818.17	15.54	1155	36332	32967	79673934
Ketoacidosis	1569.58	15.54	419	37068	7435	79699466
Euglycaemic diabetic ketoacidosis	1409.70	15.54	374	37113	6470	79700431
Pruritus genital	445.54	15.54	139	37348	4347	79702554
Cardiospasm	381.86	15.54	115	37372	3186	79703715
Palmoplantar keratoderma	364.25	15.54	114	37373	3602	79703299
Ketosis	352.41	15.54	86	37401	1040	79705861
Sleep terror	339.85	15.54	113	37374	4345	79702556
Atrial tachycardia	305.70	15.54	118	37369	7015	79699886
Metabolic acidosis	301.15	15.54	274	37213	82255	79624646
Tension headache	293.83	15.54	115	37372	7096	79699805
Carotid artery occlusion	287.29	15.54	115	37372	7532	79699369
Blood glucose increased	284.65	15.54	309	37178	114666	79592235
Anosmia	271.12	15.54	115	37372	8729	79698172
Glycosylated haemoglobin increased	258.16	15.54	142	37345	19118	79687783
Immunisation	252.82	15.54	76	37411	2091	79704810
Facial pain	234.37	15.54	115	37372	12235	79694666
Diabetes mellitus inadequate control	225.19	15.54	141	37346	24123	79682778
Pain of skin	213.26	15.54	114	37373	14499	79692402
Ventricular tachycardia	207.70	15.54	166	37321	41769	79665132
Dehydration	203.20	15.54	394	37093	247793	79459108
Ketonuria	197.13	15.54	55	37432	1153	79705748
Eye pruritus	197.11	15.54	122	37365	20448	79686453
Vasculitis	177.29	15.54	123	37364	24979	79681922
Glomerular filtration rate decreased	171.59	15.54	116	37371	22586	79684315
Hypoglycaemia	170.36	15.54	224	37263	101370	79605531
Subarachnoid haemorrhage	168.39	15.54	118	37369	24347	79682554
Lip swelling	163.33	15.54	143	37344	40768	79666133
Muscle twitching	162.47	15.54	116	37371	24648	79682253
Acute kidney injury	155.42	15.54	566	36921	518838	79188063
Tinnitus	153.45	15.54	143	37344	44190	79662711
Blindness	152.70	15.54	118	37369	28265	79678636
Diabetic ketosis	150.43	15.54	37	37450	463	79706438
Diplopia	147.90	15.54	124	37363	33342	79673559
Lactic acidosis	139.98	15.54	169	37318	70190	79636711
Hyperglycaemia	128.73	15.54	162	37325	70173	79636728
Urine ketone body present	128.33	15.54	52	37435	3513	79703388
Fungal infection	128.07	15.54	126	37361	41622	79665279
Drug ineffective	125.77	15.54	197	37290	1080716	78626185
Transient ischaemic attack	123.97	15.54	138	37349	52557	79654344
Blood ketone body increased	122.99	15.54	34	37453	688	79706213
Disturbance in attention	122.89	15.54	135	37352	50666	79656235
Necrotising fasciitis	116.76	15.54	57	37430	5993	79700908
COVID-19	116.48	15.54	240	37247	157434	79549467
Toxicity to various agents	115.76	15.54	28	37459	421512	79285389
Rash papular	113.29	15.54	89	37398	21827	79685074
Polyuria	111.74	15.54	76	37411	14938	79691963
Palpitations	110.82	15.54	207	37280	126403	79580498
Balanoposthitis	108.77	15.54	33	37454	937	79705964
Phimosis	101.17	15.54	28	37459	569	79706332
Cardiac failure	99.76	15.54	223	37264	154619	79552282
Completed suicide	95.00	15.54	5	37482	245762	79461139
Angioedema	93.96	15.54	145	37342	75890	79631011
Dry skin	93.04	15.54	136	37351	67859	79639042
Cerebral infarction	89.66	15.54	109	37378	45567	79661334
Glomerular filtration rate abnormal	87.86	15.54	32	37455	1616	79705285
Hypoglycaemic coma	86.36	15.54	43	37444	4717	79702184
Amnesia	84.65	15.54	125	37362	62932	79643969
N-terminal prohormone brain natriuretic peptide increased	83.46	15.54	42	37445	4713	79702188
Migraine	82.79	15.54	148	37339	87345	79619556
Toe amputation	81.99	15.54	39	37448	3872	79703029
Weight decreased	81.74	15.54	357	37130	354841	79352060
Pollakiuria	79.74	15.54	93	37394	37224	79669677
Intentional product misuse	77.58	15.54	151	37336	95014	79611887
Visual impairment	77.32	15.54	148	37339	91983	79614918
Neutropenia	75.31	15.54	21	37466	287689	79419212
Urinary tract infection	75.03	15.54	291	37196	274221	79432680
Hyperglycaemic hyperosmolar nonketotic syndrome	74.09	15.54	31	37456	2272	79704629
Glucose urine present	71.51	15.54	28	37459	1728	79705173
Infusion related reaction	69.96	15.54	12	37475	230225	79476676
Diabetic metabolic decompensation	69.16	15.54	33	37454	3299	79703602
Congenital hydrocephalus	68.57	15.54	14	37473	68	79706833
Joint swelling	68.57	15.54	25	37462	288621	79418280
Arthropathy	67.20	15.54	4	37483	177107	79529794
Cognitive disorder	67.07	15.54	119	37368	69807	79637094
Hypersensitivity	67.05	15.54	20	37467	262219	79444682
Hallucination	65.01	15.54	132	37355	85613	79621288
Urosepsis	63.35	15.54	70	37417	26425	79680476
Type V hyperlipidaemia	62.18	15.54	22	37465	1021	79705880
Genital infection	61.33	15.54	15	37472	183	79706718
Hyperhidrosis	60.15	15.54	182	37305	151310	79555591
Catarrh	59.13	15.54	26	37461	2152	79704749
Pyelonephritis	57.85	15.54	59	37428	20329	79686572
Pneumonia	57.72	15.54	142	37345	660104	79046797
Burns second degree	57.52	15.54	27	37460	2601	79704300
Steroid dependence	57.51	15.54	27	37460	2603	79704298
Cardiac failure chronic	57.07	15.54	45	37442	11090	79695811
Heart rate increased	56.61	15.54	154	37333	120570	79586331
Treatment failure	56.15	15.54	7	37480	170479	79536422
Ejection fraction decreased	54.46	15.54	74	37413	34503	79672398
Vulvovaginal pruritus	54.41	15.54	26	37461	2607	79704294
Musculoskeletal stiffness	53.43	15.54	9	37478	174999	79531902
Blood glucose abnormal	52.65	15.54	42	37445	10524	79696377
White blood cell count decreased	52.61	15.54	12	37475	188276	79518625
Epididymitis	52.27	15.54	23	37464	1907	79704994
Genital infection female	52.21	15.54	11	37476	64	79706837
Therapeutic product effect decreased	50.98	15.54	8	37479	163855	79543046
Febrile neutropenia	49.99	15.54	23	37464	230976	79475925
Rheumatoid arthritis	49.58	15.54	18	37469	208452	79498449
Swelling	49.40	15.54	20	37467	216691	79490210
Myocardial infarction	49.28	15.54	194	37293	183935	79522966
Nasopharyngitis	48.03	15.54	30	37457	253851	79453050
Thrombotic cerebral infarction	45.59	15.54	15	37472	557	79706344
Left ventricular dysfunction	44.30	15.54	50	37437	19311	79687590
Temperature perception test abnormal	44.20	15.54	8	37479	17	79706884
Contraindicated product administered	44.09	15.54	10	37477	157528	79549373
Drug intolerance	43.69	15.54	36	37451	264083	79442818
Sinusitis	43.02	15.54	19	37468	195482	79511419
Renal impairment	42.83	15.54	167	37320	157616	79549285
Acquired phimosis	42.62	15.54	9	37478	53	79706848
Disease progression	42.04	15.54	17	37470	184345	79522556
Memory impairment	40.42	15.54	130	37357	111604	79595297
Hypopnoea	39.71	15.54	27	37460	5302	79701599
Vomiting	39.05	15.54	481	37006	665347	79041554
Drug hypersensitivity	38.96	15.54	50	37437	298866	79408035
Dizziness	38.89	15.54	398	37089	526043	79180858
Muscular weakness	38.76	15.54	164	37323	160565	79546336
Microalbuminuria	38.66	15.54	15	37472	903	79705998
Hyperkalaemia	38.60	15.54	130	37357	114268	79592633
Pericarditis	38.36	15.54	122	37365	104114	79602787
Pancreatitis	37.82	15.54	93	37394	68482	79638419
Glycosuria	37.44	15.54	19	37468	2169	79704732
Dysuria	36.91	15.54	77	37410	50874	79656027
Fall	36.48	15.54	113	37374	487516	79219385
Suspected COVID-19	36.28	15.54	21	37466	3112	79703789
Acetonaemia	35.65	15.54	11	37476	331	79706570
Wound	35.40	15.54	6	37481	116173	79590728
Parosmia	35.20	15.54	28	37459	6986	79699915
Glomerular filtration rate increased	34.64	15.54	15	37472	1196	79705705
Ventricular internal diameter abnormal	34.48	15.54	10	37477	242	79706659
Stomatitis	34.33	15.54	13	37474	146744	79560157
Therapeutic product effect incomplete	34.06	15.54	12	37475	141633	79565268
Exposure during pregnancy	33.67	15.54	4	37483	101128	79605773
Marasmus	33.61	15.54	14	37473	1014	79705887
Malignant neoplasm progression	33.61	15.54	11	37476	135979	79570922
Congestive cardiomyopathy	33.25	15.54	34	37453	11746	79695155
Mitral valve thickening	33.24	15.54	11	37476	416	79706485
Malaise	33.18	15.54	364	37123	489505	79217396
Chest pain	32.71	15.54	236	37251	282068	79424833
Thirst	32.64	15.54	42	37445	18577	79688324
Adverse drug reaction	32.42	15.54	86	37401	66306	79640595
Feeling abnormal	32.05	15.54	154	37333	159045	79547856
Thrombocytopenia	31.92	15.54	47	37440	265212	79441689
Genital infection fungal	31.59	15.54	9	37478	204	79706697
Drug abuse	31.06	15.54	19	37468	162672	79544229
Respiratory failure	30.73	15.54	24	37463	180887	79526014
Mitral valve incompetence	30.51	15.54	51	37436	28514	79678387
Leukocyturia	30.42	15.54	16	37471	1967	79704934
Testicular swelling	30.35	15.54	14	37473	1296	79705605
Condition aggravated	30.27	15.54	127	37360	500997	79205904
Anal abscess	30.11	15.54	29	37458	9326	79697575
Atrial enlargement	30.10	15.54	13	37474	1030	79705871
Acute myocardial infarction	30.03	15.54	92	37395	76944	79629957
Pancytopenia	29.43	15.54	21	37466	165724	79541177
Overdose	29.36	15.54	26	37461	184180	79522721
Blood pressure decreased	29.22	15.54	108	37379	99358	79607543
Contusion	28.93	15.54	17	37470	148759	79558142
Hepatic enzyme increased	28.84	15.54	26	37461	182584	79524317
Anaemia	28.62	15.54	110	37377	444905	79261996
Vulvovaginitis	28.40	15.54	9	37478	296	79706605
Body mass index increased	27.97	15.54	15	37472	1918	79704983
Leukopenia	27.79	15.54	10	37477	116503	79590398
Lower respiratory tract infection	27.73	15.54	13	37474	129207	79577694
Pancreatic carcinoma	27.61	15.54	33	37454	13544	79693357
Tachycardia	27.57	15.54	160	37327	177608	79529293
Abdominal discomfort	27.55	15.54	207	37280	250520	79456381
Gingival pain	27.29	15.54	27	37460	8971	79697930
Left ventricular false tendon	26.82	15.54	6	37481	48	79706853
Chronic kidney disease	26.72	15.54	80	37407	66074	79640827
Back pain	26.37	15.54	238	37249	303942	79402959
Pancreatitis acute	26.01	15.54	66	37421	49538	79657363
Productive cough	25.96	15.54	5	37482	88326	79618575
Bladder trabeculation	25.80	15.54	6	37481	58	79706843
Haematuria	25.71	15.54	81	37406	68755	79638146
Impaired healing	25.68	15.54	5	37482	87650	79619251
Bronchitis	25.30	15.54	15	37472	130629	79576272
Perineal abscess	25.14	15.54	10	37477	643	79706258
N-terminal prohormone brain natriuretic peptide abnormal	25.13	15.54	8	37479	267	79706634
Cardiac murmur	25.12	15.54	34	37453	15790	79691111
Hypernatraemia	24.40	15.54	32	37455	14419	79692482
Penile oedema	23.97	15.54	8	37479	311	79706590
Bladder cancer	23.77	15.54	37	37450	19489	79687412
Emphysematous cystitis	23.13	15.54	8	37479	347	79706554
Abdominal pain upper	23.03	15.54	182	37305	223637	79483264
Impaired quality of life	22.97	15.54	31	37456	14355	79692546
Mitral valve calcification	22.92	15.54	12	37475	1461	79705440
Hypoxia	22.76	15.54	10	37477	103233	79603668
Inferior vena cava syndrome	22.74	15.54	6	37481	101	79706800
Neutrophil count decreased	22.52	15.54	8	37479	93951	79612950
Injection site pain	22.33	15.54	17	37470	129821	79577080
Brain stem infarction	22.08	15.54	13	37474	1988	79704913
Gangrene	21.97	15.54	24	37463	8940	79697961
Peripheral arterial occlusive disease	21.81	15.54	23	37464	8235	79698666
Ischaemic stroke	21.62	15.54	48	37439	33083	79673818
Aspartate aminotransferase increased	21.57	15.54	20	37467	138621	79568280
Mental status changes	21.44	15.54	3	37484	66956	79639945
Immune-mediated hepatitis	21.42	15.54	16	37471	3640	79703261
Diabetic retinopathy	21.41	15.54	15	37472	3091	79703810
Foot amputation	21.36	15.54	10	37477	958	79705943
Ventricular hypokinesia	21.29	15.54	24	37463	9255	79697646
Cardiac pacemaker evaluation	21.27	15.54	6	37481	131	79706770
Total cholesterol/HDL ratio increased	21.12	15.54	7	37480	266	79706635
Splinter haemorrhages	21.10	15.54	6	37481	135	79706766
Orchitis	21.08	15.54	11	37476	1330	79705571
Tricuspid valve incompetence	20.79	15.54	35	37452	19677	79687224
Genital rash	20.78	15.54	10	37477	1018	79705883
Peripartum cardiomyopathy	20.77	15.54	6	37481	143	79706758
Chills	20.65	15.54	27	37460	160207	79546694
Urinary tract infection fungal	20.55	15.54	10	37477	1043	79705858
Polycythaemia	20.50	15.54	13	37474	2271	79704630
Intentional product use issue	20.47	15.54	132	37355	151980	79554921
Polydipsia	20.36	15.54	20	37467	6585	79700316
Alanine aminotransferase increased	20.34	15.54	28	37459	162542	79544359
Eczema	20.05	15.54	53	37434	40765	79666136
Scrotal abscess	19.97	15.54	8	37479	524	79706377
Mobility decreased	19.76	15.54	17	37470	122158	79584743
Discomfort	19.69	15.54	18	37469	125599	79581302
Heat illness	19.35	15.54	8	37479	569	79706332
Therapeutic response decreased	19.19	15.54	4	37483	66849	79640052
Wheezing	19.15	15.54	16	37471	116648	79590253
Testicular pain	19.15	15.54	12	37475	2053	79704848
Colitis ulcerative	19.03	15.54	47	37440	34695	79672206
International normalised ratio increased	19.00	15.54	8	37479	84713	79622188
Extremity necrosis	18.89	15.54	14	37473	3147	79703754
Shock	18.86	15.54	54	37433	43494	79663407
Coronary artery stenosis	18.58	15.54	26	37461	12458	79694443
Haemoglobin decreased	18.39	15.54	49	37438	222070	79484831
Exercise tolerance decreased	18.37	15.54	22	37465	9049	79697852
Blood ketone body present	18.28	15.54	5	37482	97	79706804
Fibromyalgia	18.16	15.54	4	37483	64336	79642565
Decreased vibratory sense	18.16	15.54	8	37479	665	79706236
Acidosis	18.13	15.54	33	37454	19729	79687172
Gait inability	18.04	15.54	3	37484	58914	79647987
Glycosylated haemoglobin abnormal	18.01	15.54	6	37481	232	79706669
Seizure	17.73	15.54	39	37448	188795	79518106
Cardio-respiratory arrest	17.67	15.54	15	37472	108495	79598406
Urticaria	17.59	15.54	38	37449	185163	79521738
Respiratory arrest	17.46	15.54	3	37484	57547	79649354
Perineal cellulitis	17.46	15.54	4	37483	36	79706865
Perineal pain	17.37	15.54	9	37478	1073	79705828
Gait disturbance	17.00	15.54	46	37441	207460	79499441
Conjunctival discolouration	16.97	15.54	5	37482	128	79706773
Hypertrophy	16.74	15.54	8	37479	802	79706099
Unevaluable event	16.64	15.54	3	37484	55582	79651319
Hospitalisation	16.64	15.54	12	37475	94224	79612677
Rhinitis	16.57	15.54	27	37460	14780	79692121
Adverse event	16.49	15.54	4	37483	60210	79646691
Cough	16.42	15.54	103	37384	366686	79340215
Injury	16.31	15.54	8	37479	77488	79629413
Genital tract inflammation	16.27	15.54	4	37483	50	79706851
Genital erythema	16.19	15.54	6	37481	318	79706583
Product use issue	16.10	15.54	48	37439	209774	79497127
Blood creatine increased	16.06	15.54	21	37466	9434	79697467
COVID-19 pneumonia	15.77	15.54	39	37448	28810	79678091
Respiratory distress	15.73	15.54	4	37483	58335	79648566
Depression	15.64	15.54	51	37436	216739	79490162
Mucosal inflammation	15.61	15.54	8	37479	75572	79631329
Prostatic haemorrhage	15.59	15.54	5	37482	171	79706730
Neck pain	15.55	15.54	8	37479	75409	79631492

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A10BD15	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD21	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD25	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BK01	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Sodium-glucose co-transporter 2 (SGLT2) inhibitors
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D000077203	Sodium-Glucose Transporter 2 Inhibitors
FDA MoA	N0000187058	Sodium-Glucose Transporter 2 Inhibitors
FDA EPC	N0000187059	Sodium-Glucose Cotransporter 2 Inhibitor
CHEBI has role	CHEBI:35526	antidiabetic
CHEBI has role	CHEBI:73273	sodium-glucose transport protein subtype 2 inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352
Diabetes mellitus type 1	indication	46635009	DOID:9744
Chronic heart failure	indication	48447003
Chronic kidney disease	indication	709044004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.62	acidic
pKa2	13.26	acidic
pKa3	13.7	acidic

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
10MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	Feb. 27, 2017	RX	TABLET	ORAL	RE44186	July 31, 2023	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	May 2, 2019	RX	TABLET	ORAL	RE44186	July 31, 2023	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM;EQ 5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	RE44186	July 31, 2023	TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM;EQ 2.5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	RE44186	July 31, 2023	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 2.5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	RE44186	July 31, 2023	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	RE44186	July 31, 2023	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	9238076	April 15, 2024	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	9238076	April 15, 2024	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8431685	April 13, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8461105	April 13, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8431685	April 13, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8461105	April 13, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	7456254	June 30, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	7456254	June 30, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	July 28, 2017	RX	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	Feb. 27, 2017	RX	TABLET	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	May 2, 2019	RX	TABLET	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM;EQ 5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM;EQ 2.5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 2.5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8329648	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8329648	Aug. 18, 2026	REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8329648	Aug. 18, 2026	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8906851	Aug. 18, 2026	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8329648	Aug. 18, 2026	REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8329648	Aug. 18, 2026	REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8329648	Aug. 18, 2026	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8906851	Aug. 18, 2026	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	July 28, 2017	RX	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	Feb. 27, 2017	RX	TABLET	ORAL	8501698	June 20, 2027	METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN
10MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	Feb. 27, 2017	RX	TABLET	ORAL	8501698	June 20, 2027	METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN
10MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	Feb. 27, 2017	RX	TABLET	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	May 2, 2019	RX	TABLET	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM;EQ 5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM;EQ 2.5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 2.5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 5MG BASE	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	DISCN	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8361972	March 21, 2028	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8361972	March 21, 2028	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8361972	March 21, 2028	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8361972	March 21, 2028	TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
10MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	Feb. 27, 2017	RX	TABLET	ORAL	8361972	March 21, 2028	METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN
10MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	Feb. 27, 2017	RX	TABLET	ORAL	8361972	March 21, 2028	METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN
10MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	Feb. 27, 2017	RX	TABLET	ORAL	8361972	March 21, 2028	TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE	QTERN	ASTRAZENECA AB	N209091	May 2, 2019	RX	TABLET	ORAL	8361972	March 21, 2028	TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8685934	May 26, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	8685934	May 26, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
10MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8685934	May 26, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
10MG;500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8685934	May 26, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
2.5MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	July 28, 2017	RX	TABLET, EXTENDED RELEASE	ORAL	8685934	May 26, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
5MG;1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8685934	May 26, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
5MG;500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8685934	May 26, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	10973836	March 9, 2040	REDUCTION OF THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE WITH REDUCED EJECTION FRACTION AND WITHOUT TYPE II DIABETES

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	May 5, 2023	TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE (NYHA CLASS II-IV) WITH REDUCED EJECTION FRACTION
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	May 5, 2023	TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE (NYHA CLASS II-IV) WITH REDUCED EJECTION FRACTION
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	April 30, 2024	TO REDUCE THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	April 30, 2024	TO REDUCE THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION
10MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	May 8, 2026	LABELING REVISIONS RELATED TO STUDY D1699CC00001
5MG	FARXIGA	ASTRAZENECA AB	N202293	Jan. 8, 2014	RX	TABLET	ORAL	May 8, 2026	LABELING REVISIONS RELATED TO STUDY D1699CC00001

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium/glucose cotransporter 2	Transporter	P31639	SC5A2_HUMAN	INHIBITOR	IC50	9.30	IUPHAR	IUPHAR
Sodium/glucose cotransporter 1	Transporter	P13866	SC5A1_HUMAN		IC50	8.49	CHEMBL
Sodium/myo-inositol cotransporter 2	Transporter	Q8WWX8	SC5AB_HUMAN		IC50	6.42	CHEMBL
Low affinity sodium-glucose cotransporter	Transporter	Q9NY91	SC5A4_HUMAN		IC50	8.87	CHEMBL
Sodium/glucose cotransporter 2	Transporter		SC5A2_RAT		EC50	8.52	CHEMBL

External reference:

ID	Source
D08897	KEGG_DRUG
960404-48-2	SECONDARY_CAS_RN
4033035	VANDF
CHEBI:85078	CHEBI
CHEMBL429910	ChEMBL_ID
CHEMBL2103802	ChEMBL_ID
C529054	MESH_SUPPLEMENTAL_RECORD_UI
4594	IUPHAR_LIGAND_ID
DB06292	DRUGBANK_ID
1486966	RXNORM
210769	MMSL
28989	MMSL
29986	MMSL
d07928	MMSL
014949	NDDF
014950	NDDF
703674001	SNOMEDCT_US
703675000	SNOMEDCT_US
703678003	SNOMEDCT_US
783086004	SNOMEDCT_US
C2353951	UMLSCUI
8886	INN_ID
9887712	PUBCHEM_CID
1ULL0QJ8UC	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6205	TABLET, FILM COATED	5 mg	ORAL	NDA	27 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6205	TABLET, FILM COATED	5 mg	ORAL	NDA	27 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6205	TABLET, FILM COATED	5 mg	ORAL	NDA	27 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6210	TABLET, FILM COATED	10 mg	ORAL	NDA	27 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6210	TABLET, FILM COATED	10 mg	ORAL	NDA	27 sections
FARXIGA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-6210	TABLET, FILM COATED	10 mg	ORAL	NDA	27 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6225	TABLET, FILM COATED, EXTENDED RELEASE	2.50 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6225	TABLET, FILM COATED, EXTENDED RELEASE	2.50 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6225	TABLET, FILM COATED, EXTENDED RELEASE	2.50 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6225	TABLET, FILM COATED, EXTENDED RELEASE	2.50 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6250	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6250	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6250	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6250	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6260	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6260	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6260	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6260	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6270	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6270	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6270	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6270	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6280	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6280	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6280	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
XIGDUOXR	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6280	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	30 sections
QTERN	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6770	TABLET, FILM COATED	5 mg	ORAL	NDA	28 sections
QTERN	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6770	TABLET, FILM COATED	5 mg	ORAL	NDA	28 sections
QTERN	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6770	TABLET, FILM COATED	5 mg	ORAL	NDA	28 sections
QTERN	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6780	TABLET, FILM COATED	10 mg	ORAL	NDA	28 sections