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

Stem definitionDrug idCAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives 4830 864070-44-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • empagliflozin
  • BI 10773
  • jardiance
Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
  • Molecular weight: 450.91
  • Formula: C23H27ClO7
  • CLOGP: 2.58
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 4
  • TPSA: 108.61
  • ALOGS: -3.61
  • ROTB: 6

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
17.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ
S (Water solubility) 0.11 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Aug. 1, 2014 FDA BOEHRINGER INGELHEIM
March 20, 2014 EMA
Dec. 26, 2014 PMDA Nippon Boehringer Ingelheim Co., Ltd

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 4944.94 14.67 1180 19869 19325 63448648
Euglycaemic diabetic ketoacidosis 2395.44 14.67 480 20569 3194 63464779
Ketoacidosis 2109.00 14.67 445 20604 3933 63464040
Fungal infection 1085.20 14.67 421 20628 36453 63431520
Blood ketone body increased 267.39 14.67 51 20998 249 63467724
Glycosylated haemoglobin increased 213.95 14.67 97 20952 12301 63455672
Blood glucose increased 211.56 14.67 194 20855 83562 63384411
Metabolic acidosis 188.56 14.67 140 20909 44929 63423044
Malignant mediastinal neoplasm 159.91 14.67 45 21004 1401 63466572
Urine ketone body present 143.60 14.67 47 21002 2456 63465517
Urinary tract infection 137.04 14.67 283 20766 264401 63203572
Ketosis 130.12 14.67 32 21017 581 63467392
Necrotising fasciitis 126.99 14.67 45 21004 2996 63464977
Lactic acidosis 125.53 14.67 103 20946 38184 63429789
Blood immunoglobulin E increased 113.10 14.67 44 21005 3805 63464168
Vomiting 105.89 14.67 415 20634 559202 62908771
Dehydration 102.38 14.67 196 20853 173158 63294815
Emphysematous pyelonephritis 98.64 14.67 22 21027 255 63467718
Glomerular filtration rate decreased 95.36 14.67 58 20991 13383 63454590
Eosinophilic myocarditis 95.24 14.67 25 21024 595 63467378
Hypoglycaemia 93.01 14.67 107 20942 59958 63408015
Blood glucose abnormal 91.41 14.67 47 21002 7845 63460128
Ketonuria 89.23 14.67 24 21025 629 63467344
Urosepsis 87.57 14.67 62 20987 18462 63449511
Bronchiectasis 85.63 14.67 58 20991 16084 63451889
Acetonaemia 83.78 14.67 17 21032 120 63467853
Hyperglycaemia 83.04 14.67 85 20964 41782 63426191
Vulvovaginal pruritus 77.68 14.67 32 21017 3211 63464762
Acute kidney injury 73.82 14.67 223 20826 263192 63204781
Pancreatitis 71.94 14.67 85 20964 48970 63419003
Pollakiuria 69.04 14.67 64 20985 27873 63440100
Polyuria 58.39 14.67 36 21013 8506 63459467
Toxicity to various agents 57.88 14.67 7 21042 247243 63220730
Diabetic ketosis 56.52 14.67 14 21035 262 63467711
Perinephric abscess 55.12 14.67 13 21036 196 63467777
Pruritus genital 52.95 14.67 23 21026 2631 63465342
Glycosylated haemoglobin abnormal 52.89 14.67 12 21037 151 63467822
Pyelonephritis 52.40 14.67 45 21004 17733 63450240
Nausea 52.08 14.67 470 20579 854001 62613972
Arthropathy 49.54 14.67 9 21040 234783 63233190
Urine ketone body 49.12 14.67 11 21038 130 63467843
Contraindicated product administered 48.93 14.67 7 21042 217641 63250332
Swelling 47.57 14.67 16 21033 275362 63192611
Glossodynia 47.43 14.67 3 21046 178873 63289100
COVID-19 47.09 14.67 111 20938 112992 63354981
Blood ketone body 46.67 14.67 9 21040 47 63467926
Pemphigus 46.10 14.67 4 21045 183722 63284251
Genital infection fungal 46.03 14.67 11 21038 176 63467797
Toe amputation 45.73 14.67 19 21030 1948 63466025
Infusion related reaction 44.66 14.67 13 21036 245508 63222465
Crush syndrome 44.59 14.67 10 21039 119 63467854
Drug hypersensitivity 44.19 14.67 24 21025 310663 63157310
Weight decreased 44 14.67 195 20854 276603 63191370
Glycosuria 43.96 14.67 16 21033 1150 63466823
Pyelonephritis fungal 43.22 14.67 10 21039 138 63467835
Genitourinary tract infection 43.17 14.67 11 21038 232 63467741
Joint swelling 42.83 14.67 28 21021 327638 63140335
Drug intolerance 42.24 14.67 25 21024 308636 63159337
Vulvovaginal mycotic infection 42.01 14.67 25 21024 5541 63462432
Genital infection 41.39 14.67 10 21039 168 63467805
Altered state of consciousness 40.81 14.67 46 21003 25184 63442789
Rheumatoid arthritis 40.07 14.67 17 21032 253802 63214171
Synovitis 39.78 14.67 7 21042 186911 63281062
Vulvovaginitis 39.60 14.67 11 21038 326 63467647
Glucose urine present 39.00 14.67 13 21036 719 63467254
Prerenal failure 38.14 14.67 16 21033 1680 63466293
Candida sepsis 37.81 14.67 15 21034 1365 63466608
Therapeutic product effect decreased 37.46 14.67 9 21040 193178 63274795
Full blood count abnormal 36.96 14.67 49 21000 31668 63436305
Sensorimotor disorder 35.62 14.67 11 21038 475 63467498
Cardiac failure 35.49 14.67 86 20963 89056 63378917
Pain 35.15 14.67 127 20922 740501 62727472
Exposure during pregnancy 34.95 14.67 5 21044 155542 63312431
Neutropenia 34.23 14.67 8 21041 174997 63292976
Catarrh 32.79 14.67 14 21035 1535 63466438
Diabetes mellitus inadequate control 32.34 14.67 32 21017 15094 63452879
Hyperglycaemic hyperosmolar nonketotic syndrome 31.53 14.67 12 21037 977 63466996
Necrotising soft tissue infection 31.16 14.67 7 21042 84 63467889
Steroid dependence 31.05 14.67 14 21035 1750 63466223
Haematochezia 30.87 14.67 60 20989 53484 63414489
Sepsis 30.73 14.67 116 20933 153007 63314966
Drug ineffective 30.24 14.67 213 20836 1044552 62423421
Acidosis 30.22 14.67 27 21022 11206 63456767
Sinusitis 30.10 14.67 19 21030 226634 63241339
Glycosylated haemoglobin decreased 29.95 14.67 10 21039 556 63467417
Failure to suspend medication 29.74 14.67 6 21043 41 63467932
Burns second degree 29.51 14.67 14 21035 1964 63466009
Wound 29.03 14.67 9 21040 163254 63304719
Hypersensitivity 28.54 14.67 33 21016 292652 63175321
Diabetic ketoacidotic hyperglycaemic coma 28.48 14.67 6 21043 52 63467921
Maternal exposure during pregnancy 28.47 14.67 19 21030 220043 63247930
Systemic lupus erythematosus 28.45 14.67 17 21032 208901 63259072
Diabetic metabolic decompensation 28.29 14.67 13 21036 1697 63466276
Blood ketone body present 28.18 14.67 6 21043 55 63467918
Blood pH abnormal 28.14 14.67 5 21044 15 63467958
Stoma site ulcer 28.00 14.67 8 21041 263 63467710
Stomatitis 27.81 14.67 6 21043 138719 63329254
Perineal infection 27.59 14.67 7 21042 145 63467828
Impaired quality of life 27.34 14.67 28 21021 13755 63454218
Embolic cerebellar infarction 27.02 14.67 5 21044 20 63467953
Pemphigoid 26.69 14.67 21 21028 7323 63460650
Coagulation test abnormal 26.59 14.67 10 21039 788 63467185
pH body fluid abnormal 26.12 14.67 6 21043 80 63467893
Candida infection 25.91 14.67 39 21010 28312 63439661
Vulval abscess 25.65 14.67 10 21039 869 63467104
Systemic candida 25.61 14.67 15 21034 3230 63464743
Urinary tract candidiasis 25.58 14.67 9 21040 586 63467387
Chest wall haematoma 25.35 14.67 7 21042 203 63467770
Hypocapnia 25.11 14.67 8 21041 383 63467590
Vesicoureteric reflux 24.90 14.67 7 21042 217 63467756
Creatinine renal clearance 24.81 14.67 4 21045 5 63467968
Diarrhoea 24.48 14.67 352 20697 715014 62752959
Hypophagia 24.41 14.67 40 21009 31219 63436754
Vulvovaginal discomfort 24.23 14.67 13 21036 2365 63465608
Anion gap increased 24.11 14.67 12 21037 1870 63466103
Insomnia 23.53 14.67 22 21027 215230 63252743
Vulvovaginal candidiasis 23.29 14.67 14 21035 3161 63464812
Hypertension 22.66 14.67 36 21013 279267 63188706
Blood glucose normal 22.27 14.67 4 21045 13 63467960
Emphysematous cystitis 22.03 14.67 6 21043 165 63467808
Genital candidiasis 21.82 14.67 6 21043 171 63467802
Thirst 21.69 14.67 25 21024 14016 63453957
Rhinorrhoea 21.68 14.67 59 20990 65518 63402455
Glucose urine 21.62 14.67 4 21045 16 63467957
Pancreatitis acute 21.53 14.67 35 21014 27131 63440842
Genital discomfort 21.48 14.67 5 21044 71 63467902
Impaired healing 21.46 14.67 4 21045 102538 63365435
Arthralgia 21.23 14.67 107 20942 569603 62898370
Blood lactic acid increased 21.01 14.67 18 21031 7068 63460905
Hypopnoea 20.96 14.67 14 21035 3792 63464181
Starvation ketoacidosis 20.86 14.67 5 21044 81 63467892
Hyperparathyroidism secondary 20.72 14.67 10 21039 1457 63466516
Musculoskeletal pain 20.65 14.67 3 21046 92274 63375699
Female reproductive tract disorder 20.40 14.67 7 21042 423 63467550
Product use issue 20.28 14.67 26 21023 220494 63247479
Musculoskeletal stiffness 20.02 14.67 19 21030 184599 63283374
Limb amputation 20.00 14.67 4 21045 26 63467947
Hypovolaemia 19.94 14.67 21 21028 10652 63457321
Pancreatic carcinoma 19.86 14.67 18 21031 7610 63460363
Language disorder 19.77 14.67 11 21038 2149 63465824
Leg amputation 19.75 14.67 11 21038 2153 63465820
Nasopharyngitis 19.49 14.67 34 21015 254223 63213750
Papilloma 19.48 14.67 6 21043 257 63467716
Alopecia 19.38 14.67 53 20996 337483 63130490
Hyperphosphataemia 19.36 14.67 11 21038 2237 63465736
Hyperventilation 19.08 14.67 16 21033 6100 63461873
Haematocrit increased 19.01 14.67 11 21038 2315 63465658
Perineal pain 18.86 14.67 6 21043 286 63467687
Blood bicarbonate abnormal 18.75 14.67 4 21045 37 63467936
Genital erythema 18.75 14.67 4 21045 37 63467936
Hepatic enzyme increased 18.46 14.67 24 21025 202304 63265669
Haematuria 18.44 14.67 34 21015 29123 63438850
Incorrect product formulation administered 18.41 14.67 5 21044 136 63467837
Hypernatraemia 17.96 14.67 17 21032 7592 63460381
Pancytopenia 17.85 14.67 5 21044 96928 63371045
Abnormal loss of weight 17.78 14.67 15 21034 5767 63462206
Fungal cystitis 17.74 14.67 3 21046 6 63467967
Irritable bowel syndrome 17.71 14.67 3 21046 82409 63385564
Peripheral swelling 17.42 14.67 39 21010 265903 63202070
Fatigue 17.30 14.67 200 20849 887828 62580145
Discomfort 17.26 14.67 18 21031 167356 63300617
Polydipsia 17.00 14.67 12 21037 3552 63464421
Microalbuminuria 16.92 14.67 6 21043 400 63467573
Anxiety 16.75 14.67 29 21020 217512 63250461
Pyelonephritis acute 16.28 14.67 13 21036 4628 63463345
Renal abscess 16.26 14.67 7 21042 783 63467190
Vaginal infection 16.25 14.67 16 21033 7502 63460471
Periorbital haematoma 16.23 14.67 7 21042 787 63467186
Glomerular filtration rate abnormal 15.86 14.67 7 21042 832 63467141
Inflammatory bowel disease 15.83 14.67 12 21037 3961 63464012
Glycosylated haemoglobin 15.76 14.67 4 21045 83 63467890
Blister 15.74 14.67 12 21037 129802 63338171
Contusion 15.62 14.67 16 21033 150028 63317945
Body mass index abnormal 15.58 14.67 4 21045 87 63467886
Abdominal pain 15.51 14.67 157 20892 293299 63174674
White blood cell count decreased 15.45 14.67 14 21035 139090 63328883
Blood insulin decreased 15.35 14.67 3 21046 17 63467956
Disease progression 15.33 14.67 11 21038 122747 63345226
Urine output increased 15.28 14.67 8 21041 1385 63466588
Death 15.28 14.67 68 20981 374313 63093660
Polycythaemia 15.28 14.67 7 21042 908 63467065
Injury 15.02 14.67 3 21046 73244 63394729
Mobility decreased 14.94 14.67 11 21038 121148 63346825
Parosmia 14.91 14.67 14 21035 6192 63461781
Ventricular asystole 14.76 14.67 4 21045 108 63467865

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 4539.75 14.73 1294 27295 16738 34911604
Euglycaemic diabetic ketoacidosis 2395.47 14.73 550 28039 2672 34925670
Ketoacidosis 1938.28 14.73 489 28100 3754 34924588
Fungal infection 357.09 14.73 199 28390 15736 34912606
Pollakiuria 310.64 14.73 196 28393 19478 34908864
Metabolic acidosis 242.22 14.73 234 28355 43446 34884896
Ketonuria 232.65 14.73 61 28528 550 34927792
Glycosylated haemoglobin increased 227.86 14.73 132 28457 11228 34917114
Urinary tract infection 225.10 14.73 309 28280 83772 34844570
Toe amputation 203.83 14.73 77 28512 2447 34925895
Blood ketone body increased 201.71 14.73 51 28538 392 34927950
Urine ketone body present 190.45 14.73 60 28529 1088 34927254
Ketosis 186.16 14.73 49 28540 449 34927893
Balanoposthitis 171.51 14.73 56 28533 1144 34927198
Hyperglycaemia 136.75 14.73 165 28424 39315 34889027
Blood glucose increased 119.98 14.73 204 28385 66514 34861828
Dehydration 115.11 14.73 297 28292 129672 34798670
Polyuria 114.60 14.73 77 28512 8497 34919845
Blood glucose abnormal 113.61 14.73 67 28522 5885 34922457
Lactic acidosis 113.41 14.73 141 28448 34631 34893711
Acidosis 110.89 14.73 83 28506 10862 34917480
Necrotising fasciitis 110.18 14.73 56 28533 3666 34924676
Product monitoring error 107.12 14.73 58 28531 4323 34924019
Urine ketone body 106.65 14.73 21 28568 38 34928304
Blood ketone body 92.85 14.73 20 28569 67 34928275
Acute kidney injury 87.25 14.73 484 28105 304504 34623838
Urosepsis 87.20 14.73 77 28512 12722 34915620
Hypovolaemia 86.87 14.73 67 28522 9167 34919175
Weight decreased 79.84 14.73 320 28269 175981 34752361
Pancreatitis 79.42 14.73 126 28463 38765 34889577
Genital infection fungal 75.42 14.73 20 28569 189 34928153
Diabetes mellitus inadequate control 74.27 14.73 72 28517 13392 34914950
Febrile neutropenia 73.30 14.73 12 28577 136837 34791505
Gangrene 73.09 14.73 46 28543 4540 34923802
Phimosis 71.96 14.73 27 28562 841 34927501
Thirst 71.47 14.73 56 28533 7839 34920503
Neutropenia 69.43 14.73 21 28568 156757 34771585
Glomerular filtration rate decreased 63.53 14.73 65 28524 12896 34915446
Vomiting 62.23 14.73 380 28209 247241 34681101
Dysuria 59.65 14.73 91 28498 27061 34901281
Drug ineffective 59.18 14.73 185 28404 456566 34471776
Thrombocytopenia 58.99 14.73 27 28562 156220 34772122
Drug interaction 57.57 14.73 60 28529 225886 34702456
Death 56.03 14.73 155 28434 397894 34530448
Genital rash 55.38 14.73 20 28569 558 34927784
Toxicity to various agents 54.74 14.73 50 28539 200312 34728030
Glomerular filtration rate abnormal 54.38 14.73 22 28567 841 34927501
Glycosylated haemoglobin abnormal 54.35 14.73 15 28574 167 34928175
pH body fluid abnormal 53.69 14.73 10 28579 11 34928331
Hypoglycaemia 52.57 14.73 129 28460 54511 34873831
Haematocrit increased 51.73 14.73 28 28561 2085 34926257
Haemoglobin increased 51.35 14.73 33 28556 3376 34924966
Anaemia 50.88 14.73 70 28519 233265 34695077
Polycythaemia 50.54 14.73 27 28562 1958 34926384
Drug abuse 50.21 14.73 10 28579 99086 34829256
Therapeutic drug monitoring analysis incorrectly performed 49.69 14.73 16 28573 312 34928030
Blood ketone body present 49.34 14.73 11 28578 45 34928297
Diabetic ketosis 48.54 14.73 13 28576 128 34928214
Perineal abscess 48.18 14.73 16 28573 345 34927997
Glycosuria 46.77 14.73 22 28567 1215 34927127
Acetonaemia 46.60 14.73 13 28576 151 34928191
Anion gap increased 46.07 14.73 25 28564 1871 34926471
Completed suicide 45.56 14.73 12 28577 98156 34830186
Disease progression 45.13 14.73 16 28573 108061 34820281
Balanitis candida 45.10 14.73 12 28577 115 34928227
Dizziness 44.89 14.73 319 28270 218202 34710140
Insulin C-peptide decreased 44.84 14.73 10 28579 41 34928301
Diabetic foot 44.52 14.73 28 28561 2760 34925582
Penile discomfort 44.41 14.73 8 28581 6 34928336
Scrotal abscess 43.41 14.73 17 28572 596 34927746
Cardiac failure chronic 43.20 14.73 42 28547 7837 34920505
Pruritus genital 42.55 14.73 25 28564 2179 34926163
Genital infection 42.29 14.73 9 28580 28 34928314
Pancytopenia 41.63 14.73 13 28576 95144 34833198
Cellulitis of male external genital organ 41.27 14.73 10 28579 63 34928279
Skin ulcer 39.96 14.73 68 28521 22148 34906194
Leg amputation 39.94 14.73 24 28565 2180 34926162
Foot amputation 39.85 14.73 17 28572 744 34927598
Prostatitis 39.25 14.73 34 28555 5473 34922869
Altered state of consciousness 38.47 14.73 68 28521 22825 34905517
Cystitis 37.40 14.73 43 28546 9722 34918620
Left atrial dilatation 36.86 14.73 22 28567 1974 34926368
Haematuria 36.80 14.73 107 28482 49959 34878383
Platelet count decreased 36.22 14.73 27 28562 119690 34808652
N-terminal prohormone brain natriuretic peptide increased 35.36 14.73 24 28565 2691 34925651
Seizure 35.28 14.73 21 28568 104836 34823506
Penile rash 34.77 14.73 7 28582 15 34928327
Hyperthyroidism 34.66 14.73 43 28546 10523 34917819
Acquired phimosis 34.33 14.73 9 28580 81 34928261
Genital discomfort 33.35 14.73 8 28581 48 34928294
Circumcision 33.08 14.73 7 28582 21 34928321
Kussmaul respiration 32.87 14.73 9 28580 97 34928245
Leukopenia 32.55 14.73 6 28583 62850 34865492
Glycosylated haemoglobin 32.51 14.73 6 28583 6 34928336
Genital infection male 32.03 14.73 6 28583 7 34928335
Testicular abscess 31.81 14.73 8 28581 60 34928282
Diabetic metabolic decompensation 31.41 14.73 19 28570 1747 34926595
COVID-19 31.26 14.73 136 28453 77414 34850928
Renal impairment 30.95 14.73 156 28433 94357 34833985
Mucosal dryness 30.82 14.73 17 28572 1314 34927028
Micturition urgency 30.67 14.73 32 28557 6493 34921849
Urinary hesitation 30.06 14.73 22 28567 2780 34925562
Gastroenteritis 29.85 14.73 47 28542 14353 34913989
Ejection fraction decreased 28.52 14.73 54 28535 19100 34909242
Penile erythema 27.88 14.73 9 28580 177 34928165
Cerebral infarction 27.65 14.73 66 28523 27389 34900953
Amputation 27.62 14.73 13 28576 719 34927623
Skin pressure mark 26.70 14.73 7 28582 63 34928279
Pancreatitis acute 26.58 14.73 66 28523 28075 34900267
Haemoglobin decreased 26.51 14.73 36 28553 120736 34807606
Pneumonia 26.43 14.73 181 28408 362446 34565896
Electrocardiogram abnormal 26.20 14.73 35 28554 9212 34919130
Genital candidiasis 26.04 14.73 7 28582 70 34928272
Penile discharge 25.86 14.73 7 28582 72 34928270
White blood cell count decreased 25.80 14.73 24 28565 95421 34832921
Spondylolysis 25.78 14.73 7 28582 73 34928269
Glucose urine present 25.75 14.73 14 28575 1051 34927291
International normalised ratio increased 25.65 14.73 4 28585 47323 34881019
Polydipsia 25.56 14.73 23 28566 3892 34924450
Lumbosacral radiculoplexus neuropathy 25.16 14.73 6 28583 35 34928307
Scrotal cellulitis 24.74 14.73 5 28584 11 34928331
Acute myocardial infarction 24.61 14.73 98 28491 53621 34874721
Anxiety 24.60 14.73 27 28562 99401 34828941
Perineal cellulitis 24.44 14.73 4 28585 0 34928342
Pleural effusion 23.87 14.73 19 28570 81527 34846815
Cardio-respiratory arrest 23.37 14.73 8 28581 55265 34873077
Creatinine renal clearance increased 23.31 14.73 10 28579 444 34927898
Ascites 22.95 14.73 5 28584 46566 34881776
Malignant neoplasm progression 22.80 14.73 23 28566 88023 34840319
Pericardial fibrosis 22.69 14.73 7 28582 118 34928224
Low density lipoprotein abnormal 22.25 14.73 9 28580 344 34927998
Overdose 22.23 14.73 25 28564 91034 34837308
Alanine aminotransferase increased 22.22 14.73 20 28569 80795 34847547
Decreased ventricular preload 22.14 14.73 5 28584 22 34928320
Mitral valve incompetence 22.09 14.73 42 28547 14901 34913441
Diabetic ketoacidotic hyperglycaemic coma 21.16 14.73 7 28582 149 34928193
Necrotising soft tissue infection 20.61 14.73 6 28583 82 34928260
Chronic coronary syndrome 20.14 14.73 7 28582 174 34928168
Orchitis 20.11 14.73 14 28575 1635 34926707
Pancreatic carcinoma 19.77 14.73 30 28559 8871 34919471
Plasma cell myeloma 19.75 14.73 5 28584 42032 34886310
Glucose urine 19.73 14.73 4 28585 9 34928333
Non-compaction cardiomyopathy 19.71 14.73 5 28584 39 34928303
Suicide attempt 19.69 14.73 4 28585 39112 34889230
Pancreatitis necrotising 19.60 14.73 17 28572 2741 34925601
Aspartate aminotransferase increased 19.58 14.73 16 28573 67767 34860575
Troponin increased 19.35 14.73 34 28555 11355 34916987
Diabetic coma 19.29 14.73 11 28578 906 34927436
Encephalopathy 19.10 14.73 3 28586 35316 34893026
Diabetic nephropathy 19.05 14.73 15 28574 2113 34926229
Application site haematoma 18.69 14.73 5 28584 49 34928293
Postprandial hypoglycaemia 18.66 14.73 4 28585 13 34928329
Cardiac failure 18.54 14.73 133 28456 91115 34837227
Starvation ketoacidosis 18.42 14.73 5 28584 52 34928290
Pyelonephritis 18.34 14.73 24 28565 6191 34922151
Scrotal gangrene 18.33 14.73 3 28586 0 34928342
Genital infection bacterial 18.33 14.73 3 28586 0 34928342
Genital discolouration 18.33 14.73 3 28586 0 34928342
Perineal necrosis 18.33 14.73 3 28586 0 34928342
Stomatitis 18.24 14.73 6 28583 42508 34885834
Albumin urine present 18.22 14.73 8 28581 376 34927966
Respiratory failure 17.75 14.73 39 28550 108533 34819809
Pterygium 17.62 14.73 6 28583 140 34928202
Pemphigoid 17.56 14.73 28 28561 8638 34919704
Blood lactic acid decreased 17.55 14.73 5 28584 63 34928279
Dysmetria 17.51 14.73 9 28580 603 34927739
Hypotension 17.41 14.73 266 28323 221383 34706959
Mucosal inflammation 17.38 14.73 5 28584 38617 34889725
Respiratory distress 17.23 14.73 4 28585 35661 34892681
Anion gap 17.18 14.73 10 28579 857 34927485
Neutrophilia 17.17 14.73 19 28570 4118 34924224
Groin infection 17.05 14.73 7 28582 278 34928064
Interstitial lung disease 16.96 14.73 17 28572 65265 34863077
Diabetic neuropathy 16.95 14.73 19 28570 4178 34924164
Diabetic foot infection 16.63 14.73 9 28580 670 34927672
Urinary incontinence 16.50 14.73 43 28546 18831 34909511
Urine odour abnormal 16.40 14.73 11 28578 1209 34927133
Hyperlactacidaemia 16.39 14.73 16 28573 3000 34925342
Genital tract inflammation 16.25 14.73 3 28586 3 34928339
Infusion related reaction 15.99 14.73 12 28577 53045 34875297
Hypoxia 15.92 14.73 13 28576 55082 34873260
Urine output increased 15.87 14.73 11 28578 1276 34927066
Aggression 15.86 14.73 6 28583 38958 34889384
Intentional overdose 15.76 14.73 8 28581 43666 34884676
Malaise 15.75 14.73 226 28363 185599 34742743
Electrocardiogram QT prolonged 15.55 14.73 7 28582 40945 34887397
Gait disturbance 15.26 14.73 29 28560 85111 34843231
Tachypnoea 15.22 14.73 41 28548 18311 34910031
Systemic infection 15.18 14.73 20 28569 5192 34923150
Sepsis 15.10 14.73 205 28384 166356 34761986
Limb injury 15.04 14.73 31 28558 11658 34916684
Glycosylated haemoglobin decreased 14.99 14.73 7 28582 380 34927962
Neutrophil count decreased 14.84 14.73 12 28577 51092 34877250

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 6914.92 12.55 1882 40490 32240 79669776
Euglycaemic diabetic ketoacidosis 4457.81 12.55 969 41403 5875 79696141
Ketoacidosis 3180.38 12.55 755 41617 7099 79694917
Metabolic acidosis 430.32 12.55 354 42018 82175 79619841
Fungal infection 397.88 12.55 258 42114 41490 79660526
Blood ketone body increased 369.13 12.55 84 42288 638 79701378
Pollakiuria 317.74 12.55 215 42157 37102 79664914
Glycosylated haemoglobin increased 295.93 12.55 162 42210 19098 79682918
Urine ketone body present 271.11 12.55 93 42279 3472 79698544
Ketonuria 268.55 12.55 72 42300 1136 79700880
Ketosis 254.51 12.55 68 42304 1058 79700958
Lactic acidosis 234.85 12.55 235 42137 70124 79631892
Urinary tract infection 225.87 12.55 469 41903 274043 79427973
Hyperglycaemia 225.76 12.55 230 42142 70105 79631911
Toe amputation 214.20 12.55 80 42292 3831 79698185
Blood glucose increased 214.07 12.55 284 42088 114691 79587325
Dehydration 208.79 12.55 428 41944 247759 79454257
Acute kidney injury 184.46 12.55 650 41722 518754 79183262
Blood glucose abnormal 168.19 12.55 91 42281 10475 79691541
Polyuria 166.01 12.55 102 42270 14912 79687104
Urosepsis 155.66 12.55 122 42250 26373 79675643
Necrotising fasciitis 148.92 12.55 70 42302 5980 79696036
Balanoposthitis 138.97 12.55 41 42331 929 79701087
Vomiting 137.06 12.55 706 41666 665122 79036894
Malignant mediastinal neoplasm 135.83 12.55 44 42328 1371 79700645
Acidosis 129.25 12.55 97 42275 19665 79682351
Blood ketone body 125.62 12.55 26 42346 118 79701898
Hypoglycaemia 122.80 12.55 205 42167 101389 79600627
Acetonaemia 113.24 12.55 28 42344 314 79701702
Glomerular filtration rate decreased 113.20 12.55 95 42277 22607 79679409
Pancreatitis 103.13 12.55 153 42219 68422 79633594
Urine ketone body 100.79 12.55 23 42349 177 79701839
Hypovolaemia 100.76 12.55 80 42292 17611 79684405
Emphysematous pyelonephritis 97.65 12.55 25 42347 326 79701690
Product monitoring error 97.17 12.55 60 42312 8846 79693170
Diabetes mellitus inadequate control 93.98 12.55 88 42284 24176 79677840
Toxicity to various agents 93.51 12.55 54 42318 421486 79280530
Diabetic ketosis 93.45 12.55 26 42346 474 79701542
Glycosuria 92.21 12.55 37 42335 2151 79699865
Completed suicide 90.11 12.55 12 42360 245755 79456261
Weight decreased 88.96 12.55 399 41973 354799 79347217
Neutropenia 84.63 12.55 24 42348 287686 79414330
Thirst 78.87 12.55 71 42301 18548 79683468
Drug ineffective 77.81 12.55 304 42068 1080609 78621407
Altered state of consciousness 76.51 12.55 105 42267 43717 79658299
Blood immunoglobulin E increased 75.51 12.55 44 42328 5838 79696178
Pruritus genital 75.21 12.55 40 42332 4446 79697570
Anion gap increased 73.38 12.55 37 42335 3683 79698333
Genital infection fungal 73.36 12.55 18 42354 195 79701821
Phimosis 71.59 12.55 22 42350 575 79701441
Cardiac failure chronic 69.15 12.55 53 42319 11082 79690934
Haematocrit increased 67.72 12.55 36 42336 3998 79698018
Eosinophilic myocarditis 66.92 12.55 25 42347 1197 79700819
Glomerular filtration rate abnormal 66.46 12.55 27 42345 1621 79700395
Polycythaemia 64.26 12.55 29 42343 2255 79699761
Febrile neutropenia 63.04 12.55 22 42350 230977 79471039
Infusion related reaction 62.71 12.55 22 42350 230215 79471801
Dysuria 61.77 12.55 103 42269 50848 79651168
COVID-19 60.61 12.55 203 42169 157471 79544545
Rheumatoid arthritis 60.16 12.55 18 42354 208452 79493564
Diabetic foot 59.81 12.55 32 42340 3600 79698416
Drug intolerance 58.27 12.55 34 42338 264085 79437931
Therapeutic product effect decreased 57.72 12.55 9 42363 163854 79538162
Drug abuse 57.16 12.55 9 42363 162682 79539334
Glycosylated haemoglobin abnormal 56.77 12.55 15 42357 223 79701793
Drug hypersensitivity 55.98 12.55 46 42326 298870 79403146
Genital infection 54.58 12.55 14 42358 184 79701832
Bronchiectasis 53.95 12.55 63 42309 22323 79679693
Perineal abscess 53.43 12.55 18 42354 635 79701381
Blood ketone body present 52.86 12.55 12 42360 90 79701926
Cerebral infarction 52.27 12.55 90 42282 45586 79656430
N-terminal prohormone brain natriuretic peptide increased 51.78 12.55 32 42340 4723 79697293
White blood cell count decreased 51.25 12.55 18 42354 188270 79513746
Haematuria 51.11 12.55 113 42259 68723 79633293
Joint swelling 50.92 12.55 47 42325 288599 79413417
Perinephric abscess 50.64 12.55 14 42358 249 79701767
Insulin C-peptide decreased 50.58 12.55 11 42361 66 79701950
Balanitis candida 50.33 12.55 12 42360 114 79701902
Necrotising soft tissue infection 49.77 12.55 14 42358 266 79701750
Pancreatitis acute 49.41 12.55 92 42280 49512 79652504
Genital rash 48.98 12.55 19 42353 1009 79701007
Scrotal abscess 48.86 12.55 16 42356 516 79701500
Pyelonephritis 48.50 12.55 57 42315 20331 79681685
Glucose urine present 48.47 12.55 22 42350 1734 79700282
Pain 47.91 12.55 202 42170 703600 78998416
Penile discomfort 47.85 12.55 8 42364 6 79702010
Diabetic ketoacidotic hyperglycaemic coma 47.85 12.55 13 42359 216 79701800
Renal impairment 47.79 12.55 188 42184 157595 79544421
Stomatitis 47.50 12.55 10 42362 146747 79555269
Treatment failure 46.91 12.55 16 42356 170470 79531546
Polydipsia 46.73 12.55 34 42338 6571 79695445
Haemoglobin increased 46.67 12.55 33 42339 6099 79695917
Disease progression 46.26 12.55 20 42352 184342 79517674
Gangrene 45.69 12.55 38 42334 8926 79693090
Cardiac failure 45.69 12.55 183 42189 154659 79547357
Anxiety 44.38 12.55 40 42332 248472 79453544
Therapeutic drug monitoring analysis incorrectly performed 44.21 12.55 16 42356 700 79701316
Cellulitis of male external genital organ 44.20 12.55 9 42363 37 79701979
Sepsis 44.02 12.55 269 42103 269159 79432857
Genital candidiasis 43.50 12.55 11 42361 136 79701880
Glossodynia 43.22 12.55 3 42369 103334 79598682
Arthropathy 43.20 12.55 20 42352 177091 79524925
Pancytopenia 43.17 12.55 17 42355 165728 79536288
Foot amputation 42.99 12.55 17 42355 951 79701065
Exposure during pregnancy 42.11 12.55 3 42369 101129 79600887
Leukopenia 41.94 12.55 6 42366 116507 79585509
Sinusitis 41.94 12.55 26 42346 195475 79506541
Thrombocytopenia 41.34 12.55 48 42324 265211 79436805
Blood pH abnormal 41.25 12.55 8 42364 24 79701992
Swelling 40.99 12.55 33 42339 216678 79485338
Leg amputation 40.76 12.55 25 42347 3641 79698375
Prostatitis 40.07 12.55 26 42346 4176 79697840
Nausea 39.40 12.55 720 41652 956476 78745540
Hyperthyroidism 38.43 12.55 53 42319 22156 79679860
Synovitis 38.37 12.55 16 42356 150718 79551298
Hypersensitivity 38.19 12.55 50 42322 262189 79439827
Glucose urine 38.18 12.55 8 42364 39 79701977
Vulvovaginal pruritus 37.29 12.55 21 42351 2612 79699404
Hyperglycaemic hyperosmolar nonketotic syndrome 37.11 12.55 20 42352 2283 79699733
Acute myocardial infarction 36.80 12.55 107 42265 76929 79625087
Seizure 36.66 12.55 28 42344 188806 79513210
Contraindicated product administered 36.58 12.55 19 42353 157519 79544497
Hypophagia 36.56 12.55 77 42295 45290 79656726
Genitourinary tract infection 36.29 12.55 11 42361 274 79701742
Acquired phimosis 35.97 12.55 8 42364 54 79701962
Kussmaul respiration 35.85 12.55 12 42360 415 79701601
Testicular abscess 35.72 12.55 8 42364 56 79701960
Vulvovaginitis 35.56 12.55 11 42361 294 79701722
Diabetic metabolic decompensation 35.21 12.55 22 42350 3310 79698706
Crush syndrome 35.16 12.55 10 42362 198 79701818
Pemphigoid 35.08 12.55 42 42330 15273 79686743
Drug interaction 34.91 12.55 109 42263 415074 79286942
Nasopharyngitis 34.38 12.55 51 42321 253830 79448186
Pemphigus 33.88 12.55 6 42366 99576 79602440
Pyelonephritis fungal 33.79 12.55 10 42362 229 79701787
Left atrial dilatation 33.78 12.55 21 42351 3132 79698884
Language disorder 33.41 12.55 21 42351 3193 79698823
Platelet count decreased 32.79 12.55 33 42339 194631 79507385
Catarrh 32.56 12.55 18 42354 2160 79699856
Gastroenteritis 32.44 12.55 62 42310 34020 79667996
Pancreatic carcinoma 32.36 12.55 38 42334 13539 79688477
Urinary tract candidiasis 32.26 12.55 13 42359 764 79701252
Burns second degree 32.00 12.55 19 42353 2609 79699407
Steroid dependence 31.99 12.55 19 42353 2611 79699405
Penile rash 31.74 12.55 6 42366 15 79702001
Penile discharge 31.64 12.55 7 42365 46 79701970
Mucosal dryness 31.45 12.55 21 42351 3538 79698478
Hyperkalaemia 31.21 12.55 132 42240 114266 79587750
Genital infection male 30.36 12.55 5 42367 3 79702013
Urinary hesitation 30.27 12.55 22 42350 4244 79697772
Death 30.21 12.55 177 42195 566337 79135679
Overdose 30.15 12.55 32 42340 184174 79517842
pH body fluid abnormal 30.03 12.55 8 42364 123 79701893
Emphysematous cystitis 29.90 12.55 10 42362 345 79701671
Product use issue 29.53 12.55 41 42331 209781 79492235
Maternal exposure during pregnancy 29.49 12.55 18 42354 136520 79565496
Haematochezia 29.46 12.55 108 42264 87537 79614479
Hypertension 29.17 12.55 85 42287 330907 79371109
Starvation ketoacidosis 29.06 12.55 8 42364 140 79701876
Impaired quality of life 29.00 12.55 37 42335 14349 79687667
Contusion 28.95 12.55 22 42350 148754 79553262
Pericarditis 28.29 12.55 10 42362 104226 79597790
Dizziness 27.86 12.55 413 41959 526028 79175988
Tachypnoea 27.69 12.55 56 42316 32007 79670009
Skin pressure mark 27.50 12.55 7 42365 89 79701927
Failure to suspend medication 27.07 12.55 10 42362 464 79701552
Insomnia 27.06 12.55 56 42316 245114 79456902
Anaemia 27.05 12.55 133 42239 444882 79257134
Diabetic neuropathy 26.91 12.55 24 42348 6192 79695824
Haemoglobin decreased 26.90 12.55 48 42324 222071 79479945
Scrotal cellulitis 26.89 12.55 5 42367 11 79702005
Angina pectoris 26.80 12.55 74 42298 51658 79650358
Glycosylated haemoglobin decreased 26.60 12.55 11 42361 691 79701325
Lower respiratory tract infection 26.59 12.55 18 42354 129202 79572814
Aspartate aminotransferase increased 26.34 12.55 21 42351 138620 79563396
Chronic coronary syndrome 26.25 12.55 7 42365 108 79701908
Product prescribing error 26.15 12.55 67 42305 44746 79657270
Blood lactic acid increased 26.05 12.55 33 42339 12711 79689305
Alopecia 25.40 12.55 53 42319 231302 79470714
Cardio-respiratory arrest 25.32 12.55 13 42359 108497 79593519
Genital discomfort 25.29 12.55 7 42365 125 79701891
Candida sepsis 25.07 12.55 16 42356 2497 79699519
Vesicoureteric reflux 24.79 12.55 7 42365 135 79701881
Spondylolysis 24.79 12.55 7 42365 135 79701881
Blood glucose normal 24.67 12.55 5 42367 20 79701996
Embolic cerebellar infarction 24.67 12.55 5 42367 20 79701996
Electrocardiogram abnormal 24.65 12.55 37 42335 16700 79685316
Stoma site ulcer 24.34 12.55 8 42364 261 79701755
Arthralgia 24.32 12.55 191 42181 571612 79130404
Hypernatraemia 24.28 12.55 34 42338 14417 79687599
Lumbosacral radiculoplexus neuropathy 24.13 12.55 6 42366 69 79701947
Urine output increased 24.10 12.55 15 42357 2241 79699775
Sensorimotor disorder 24.04 12.55 11 42361 883 79701133
Pericardial fibrosis 23.67 12.55 7 42365 160 79701856
Blood glucose fluctuation 23.53 12.55 23 42349 6659 79695357
Systemic candida 23.46 12.55 23 42349 6683 79695333
Postprandial hypoglycaemia 23.24 12.55 6 42366 81 79701935
International normalised ratio increased 23.21 12.55 8 42364 84713 79617303
Micturition urgency 23.14 12.55 31 42341 12610 79689406
Mucosal inflammation 22.77 12.55 6 42366 75574 79626442
Diabetic nephropathy 22.76 12.55 16 42356 2931 79699085
Ejection fraction decreased 22.61 12.55 54 42318 34523 79667493
Vulvovaginal mycotic infection 22.53 12.55 19 42353 4547 79697469
Blood creatinine increased 22.32 12.55 150 42222 154907 79547109
Amputation 22.12 12.55 10 42362 781 79701235
Decreased ventricular preload 21.97 12.55 5 42367 38 79701978
Skin ulcer 21.93 12.55 71 42301 54079 79647937
Diabetic foot infection 21.92 12.55 10 42362 797 79701219
Non-compaction cardiomyopathy 21.85 12.55 5 42367 39 79701977
Rheumatoid factor positive 21.72 12.55 3 42369 59836 79642180
Headache 21.48 12.55 233 42139 653539 79048477
Candida infection 21.13 12.55 56 42316 38158 79663858
Full blood count abnormal 21.07 12.55 58 42314 40416 79661600
Neutrophil count decreased 20.84 12.55 12 42360 93947 79608069
Hypocapnia 20.78 12.55 9 42363 634 79701382
Alanine aminotransferase increased 20.71 12.55 34 42338 162536 79539480
Left ventricular dysfunction 20.66 12.55 37 42335 19324 79682692
Perineal necrosis 20.63 12.55 6 42366 129 79701887
Fungal cystitis 20.62 12.55 4 42368 12 79702004
Diabetic coma 20.54 12.55 11 42361 1240 79700776
Therapy non-responder 20.17 12.55 12 42360 92293 79609723
Blood bicarbonate abnormal 20.17 12.55 6 42366 140 79701876
Hypopnoea 20.00 12.55 19 42353 5310 79696706
Fatigue 19.98 12.55 361 42011 929366 78772650
Blood lactic acid decreased 19.96 12.55 7 42365 279 79701737
Systemic lupus erythematosus 19.87 12.55 21 42351 121128 79580888
Orchitis 19.82 12.55 11 42361 1330 79700686
Coagulation test abnormal 19.79 12.55 11 42361 1334 79700682
Penile erythema 19.70 12.55 6 42366 152 79701864
Genital discolouration 19.62 12.55 3 42369 0 79702016
Scrotal gangrene 19.62 12.55 3 42369 0 79702016
Troponin increased 19.53 12.55 36 42336 19219 79682797
Prerenal failure 19.52 12.55 16 42356 3682 79698334
Blood glucose decreased 19.39 12.55 43 42329 26191 79675825
Blood insulin decreased 19.35 12.55 4 42368 18 79701998
Genital erythema 19.11 12.55 7 42365 317 79701699
Encephalopathy 19.10 12.55 6 42366 67391 79634625
Vulval abscess 19.01 12.55 9 42363 781 79701235
Application site haematoma 19.01 12.55 5 42367 73 79701943
Pleural effusion 18.86 12.55 30 42342 145232 79556784
Musculoskeletal pain 18.83 12.55 16 42356 102338 79599678
Anal abscess 18.76 12.55 24 42348 9331 79692685
Hyperventilation 18.65 12.55 22 42350 7877 79694139
Intentional product misuse 18.60 12.55 14 42358 95151 79606865
Leukocyturia 18.25 12.55 12 42360 1971 79700045
Bladder cancer 17.94 12.55 35 42337 19491 79682525
Vulvovaginal candidiasis 17.92 12.55 13 42359 2501 79699515
Creatinine renal clearance 17.86 12.55 4 42368 28 79701988
Orchidectomy 17.62 12.55 4 42368 30 79701986
Perineal rash 17.54 12.55 3 42369 3 79702013
Prostatic abscess 17.54 12.55 7 42365 401 79701615
Hepatic enzyme increased 17.49 12.55 45 42327 182565 79519451
Parosmia 17.33 12.55 20 42352 6994 79695022
Debridement 17.14 12.55 11 42361 1734 79700282
Perineal cellulitis 16.97 12.55 4 42368 36 79701980
Chest wall haematoma 16.89 12.55 7 42365 442 79701574
Paraesthesia 16.46 12.55 44 42328 176279 79525737
Pyelonephritis acute 16.29 12.55 18 42354 6005 79696011
Ascites 16.26 12.55 10 42362 75552 79626464
Hypotension 16.21 12.55 326 42046 439991 79262025
Blister 16.16 12.55 24 42348 119452 79582564
Musculoskeletal stiffness 16.09 12.55 44 42328 174964 79527052
Ejection fraction abnormal 16.00 12.55 12 42360 2428 79699588
Incorrect product formulation administered 15.94 12.55 5 42367 140 79701876
Perineal infection 15.84 12.55 8 42364 799 79701217
Gait disturbance 15.68 12.55 57 42315 207449 79494567
Neutrophilia 15.32 12.55 20 42352 7931 79694085
Mitral valve incompetence 14.93 12.55 41 42331 28524 79673492
Gingival pain 14.86 12.55 21 42351 8977 79693039
Orthopaedic procedure 14.61 12.55 5 42367 185 79701831
Fibromyalgia 14.58 12.55 8 42364 64332 79637684
Abdominal pain 14.52 12.55 289 42083 389280 79312736
Coronary artery bypass 14.50 12.55 17 42355 6045 79695971
Electrocardiogram QT prolonged 14.45 12.55 16 42356 90370 79611646
Injury 14.39 12.55 12 42360 77484 79624532
Circumcision 14.26 12.55 3 42369 15 79702001
Rash maculo-papular 14.19 12.55 6 42366 56072 79645944
Generalised tonic-clonic seizure 14.18 12.55 3 42369 43907 79658109
Neuropathy peripheral 14.17 12.55 34 42338 141271 79560745
Albumin urine present 14.00 12.55 7 42365 684 79701332
Hypoxia 13.71 12.55 21 42351 103222 79598794
Perineal pain 13.64 12.55 8 42364 1074 79700942
Systemic infection 13.57 12.55 21 42351 9731 79692285
Renal abscess 13.56 12.55 8 42364 1085 79700931
Venous pressure jugular 13.52 12.55 3 42369 20 79701996
Sacroiliac joint dysfunction 13.42 12.55 4 42368 94 79701922
Glycosylated haemoglobin 13.40 12.55 3 42369 21 79701995
Peripheral artery occlusion 13.37 12.55 11 42361 2546 79699470
Arrhythmia 13.21 12.55 66 42306 61206 79640810
Red blood cell sedimentation rate increased 13.18 12.55 4 42368 45938 79656078
Abnormal loss of weight 13.03 12.55 19 42353 8357 79693659
Left atrial enlargement 12.86 12.55 8 42364 1195 79700821
Ischaemic cardiomyopathy 12.77 12.55 18 42354 7677 79694339
Pneumonia 12.72 12.55 261 42111 659985 79042031
Anion gap 12.71 12.55 10 42362 2171 79699845
Ventricular tachycardia 12.70 12.55 50 42322 41885 79660131
Blood creatine increased 12.66 12.55 20 42352 9435 79692581
Peripheral ischaemia 12.65 12.55 20 42352 9437 79692579
Pyrexia 12.58 12.55 270 42102 678439 79023577
Toxic epidermal necrolysis 12.58 12.55 4 42368 44577 79657439

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10BD19 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD20 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD27 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BK03 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
Chronic heart failure indication 48447003
Cardiovascular event reduce risk 405617006




🐶 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;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10406172 June 15, 2030 METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10406172 June 15, 2030 METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10406172 June 15, 2030 METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10406172 June 15, 2030 METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11564886 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11564886 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10596120 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11564886 March 7, 2032 TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
12.5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
12.5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR<30 ML/MIN/1.73 M2
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 10258637 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 11090323 April 3, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR<60 ML/MIN/1.73 M2) BY INITIATION OF EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN HCL IF EGFR>=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR <30 ML/MIN/1.73 M2
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND HEART FAILURE BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH PLUS HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS, HEART FAILURE AND REDUCED EJECTION FRACTION BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949997 May 17, 2034 METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
12.5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
12.5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949997 May 17, 2034 METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
12.5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
25MG;5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
5MG;2.5MG;1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
25MG;5MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL March 30, 2023 ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Aug. 18, 2024 REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE AND REDUCED EJECTION FRACTION
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Feb. 24, 2025 LABELING REVISIONS RELATED TO CLINICAL STUDIES
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Aug. 24, 2025 PEDIATRIC EXCLUSIVITY
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL June 20, 2026 NEW PATIENT POPULATION
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL June 20, 2026 NEW PATIENT POPULATION
12.5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL June 20, 2026 NEW PATIENT POPULATION
12.5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL June 20, 2026 NEW PATIENT POPULATION
5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL June 20, 2026 NEW PATIENT POPULATION
5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL June 20, 2026 NEW PATIENT POPULATION
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL June 20, 2026 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL June 20, 2026 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL June 20, 2026 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL June 20, 2026 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY
12.5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY
12.5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY
5MG;1GM SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY
5MG;500MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY
10MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY
12.5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY
25MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY
5MG;1GM SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Dec. 20, 2026 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium/glucose cotransporter 2 Transporter INHIBITOR Kd 7.24 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 4 Transporter IC50 4.96 SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 5 Transporter IC50 5.96 SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 1 Transporter IC50 5.08 SCIENTIFIC LITERATURE
Sodium/myo-inositol cotransporter 2 Transporter IC50 5.70 SCIENTIFIC LITERATURE

External reference:

IDSource
HDC1R2M35U UNII
D10459 KEGG_DRUG
4033569 VUID
N0000190927 NUI
4033569 VANDF
C3490348 UMLSCUI
CHEBI:82720 CHEBI
7R3 PDB_CHEM_ID
CHEMBL2107830 ChEMBL_ID
11949646 PUBCHEM_CID
DB09038 DRUGBANK_ID
9398 INN_ID
C570240 MESH_SUPPLEMENTAL_RECORD_UI
4754 IUPHAR_LIGAND_ID
1545653 RXNORM
227183 MMSL
30461 MMSL
d08275 MMSL
015572 NDDF
703894008 SNOMEDCT_US
703895009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0152 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0152 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0152 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0152 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0153 TABLET, FILM COATED 25 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0153 TABLET, FILM COATED 25 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0153 TABLET, FILM COATED 25 mg ORAL NDA 30 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0153 TABLET, FILM COATED 25 mg ORAL NDA 30 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0159 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0159 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0159 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0159 TABLET 5 mg ORAL NDA 34 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 25 mg ORAL NDA 32 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 25 mg ORAL NDA 32 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 25 mg ORAL NDA 32 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0168 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0168 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0168 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0168 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0175 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0175 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0175 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0175 TABLET 5 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0180 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0180 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0180 TABLET 12.50 mg ORAL NDA 34 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0180 TABLET 12.50 mg ORAL NDA 34 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0182 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0182 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0182 TABLET, FILM COATED 10 mg ORAL NDA 32 sections