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

Stem definitionDrug idCAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives 4304 461432-26-8

Description:

MoleculeDescription

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:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
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:

DateAgencyCompanyOrphan
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 11.62 acidic
pKa2 13.26 acidic
pKa3 13.7 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium/glucose cotransporter 2 Transporter INHIBITOR IC50 9.30 IUPHAR IUPHAR
Sodium/glucose cotransporter 1 Transporter IC50 8.49 CHEMBL
Sodium/myo-inositol cotransporter 2 Transporter IC50 6.42 CHEMBL
Low affinity sodium-glucose cotransporter Transporter IC50 8.87 CHEMBL
Sodium/glucose cotransporter 2 Transporter EC50 8.52 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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