empagliflozin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| sodium glucose co-transporter inhibitors, phlorizin derivatives | 4830 | 864070-44-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 17.50 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diabetic ketoacidosis | 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diabetic ketoacidosis | 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Diabetic ketoacidosis | 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:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.62 | acidic |
| pKa2 | 13.26 | acidic |
| pKa3 | 13.7 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG;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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |