metformin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antihyperglycaemics, phenformin derivatives 1725 657-24-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • metformin
  • metformin hydrochloride
  • glucophage
  • LA-6023
  • LA 6023
  • N,N-dimethylguanylguanidine
  • metformin HCl
A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
  • Molecular weight: 129.17
  • Formula: C4H11N5
  • CLOGP: -1.43
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 4
  • TPSA: 88.99
  • ALOGS: -1.97
  • ROTB: 0

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
2 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 99 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 387.10 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 52 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.64 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.70 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 3, 1995 FDA BRISTOL MYERS SQUIBB

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Lactic acidosis 18748.23 29.38 3367 13538 1963 2339217
Acute kidney injury 8952.19 29.38 2497 14408 25625 2315555
Hypoglycaemia 5112.64 29.38 1258 15647 7149 2334031
Metabolic acidosis 3957.01 29.38 960 15945 5038 2336142
Diarrhoea 3112.95 29.38 1540 15365 82024 2259156
Completed suicide 2497.01 29.38 890 16015 20144 2321036
Vomiting 2461.14 29.38 1253 15652 70349 2270831
Toxicity to various agents 2338.51 29.38 956 15949 31798 2309382
Hyperkalaemia 1984.29 29.38 554 16351 5339 2335841
Blood glucose increased 1813.65 29.38 613 16292 11677 2329503
Renal failure 1553.15 29.38 598 16307 16751 2324429
Nausea 1543.39 29.38 1091 15814 111098 2230082
Hypotension 1444.77 29.38 681 16224 31755 2309425
Intentional overdose 1379.92 29.38 490 16415 10831 2330349
Diabetes mellitus inadequate control 1269.52 29.38 308 16597 1579 2339601
Exposure during pregnancy 1200.49 29.38 555 16350 24664 2316516
Shock 1190.38 29.38 342 16563 3662 2337518
Dehydration 1058.39 29.38 490 16415 21805 2319375
Overdose 1021.64 29.38 462 16443 19445 2321735
Haemodialysis 994.07 29.38 258 16647 1811 2339369
Anuria 927.58 29.38 238 16667 1586 2339594
Diabetic ketoacidosis 907.20 29.38 270 16635 3294 2337886
Hypothermia 898.45 29.38 240 16665 1908 2339272
Hyperglycaemia 835.50 29.38 273 16632 4612 2336568
Cardiac arrest 776.26 29.38 350 16555 14580 2326600
Pancreatitis acute 768.20 29.38 242 16663 3611 2337569
Blood creatinine increased 721.17 29.38 300 16605 10233 2330947
Drug level increased 708.47 29.38 211 16694 2576 2338604
Glycosylated haemoglobin increased 701.43 29.38 191 16714 1643 2339537
Suicide attempt 701.29 29.38 300 16605 10982 2330198
Hyperlactacidaemia 697.20 29.38 143 16762 266 2340914
Abdominal pain 677.08 29.38 421 16484 33953 2307227
Hypoglycaemic coma 673.16 29.38 147 16758 419 2340761
Maternal exposure during pregnancy 582.92 29.38 287 16618 14576 2326604
Drug interaction 570.87 29.38 356 16549 28807 2312373
Ketoacidosis 564.96 29.38 140 16765 791 2340389
Drug hypersensitivity 562.67 29.38 422 16483 46221 2294959
Renal impairment 544.47 29.38 243 16662 9849 2331331
Multiple organ dysfunction syndrome 517.17 29.38 216 16689 7425 2333755
Confusional state 516.56 29.38 313 16592 24031 2317149
Asthenia 511.92 29.38 400 16505 46526 2294654
Tachypnoea 481.73 29.38 149 16756 2080 2339100
Blood lactic acid increased 461.65 29.38 117 16788 734 2340446
Malaise 458.59 29.38 403 16502 55182 2285998
Pancreatitis 456.45 29.38 201 16704 7878 2333302
Blood glucose decreased 453.53 29.38 156 16749 3096 2338084
Acidosis 422.50 29.38 125 16780 1485 2339695
Coma 422.00 29.38 197 16708 8859 2332321
Somnolence 417.52 29.38 270 16635 23215 2317965
Continuous haemodiafiltration 417.47 29.38 90 16815 236 2340944
Weight decreased 403.51 29.38 284 16621 28087 2313093
Dyspnoea 390.01 29.38 432 16473 78301 2262879
Decreased appetite 389.64 29.38 280 16625 28611 2312569
Drug ineffective 372.37 29.38 478 16427 101146 2240034
Diabetic metabolic decompensation 362.58 29.38 72 16833 103 2341077
Bradycardia 353.42 29.38 180 16725 9801 2331379
Abdominal pain upper 336.95 29.38 231 16674 21869 2319311
Cardio-respiratory arrest 332.73 29.38 168 16737 8978 2332202
Pemphigoid 332.52 29.38 93 16812 889 2340291
Gastrointestinal disorder 324.98 29.38 164 16741 8753 2332427
Vitamin B12 deficiency 324.35 29.38 82 16823 508 2340672
Sopor 304.33 29.38 123 16782 3872 2337308
Poisoning 293.74 29.38 109 16796 2711 2338469
Headache 281.89 29.38 370 16535 79809 2261371
Abdominal discomfort 279.13 29.38 188 16717 17268 2323912
Product complaint 275.99 29.38 119 16786 4419 2336761
Dialysis 275.27 29.38 97 16808 2070 2339110
Tachycardia 265.41 29.38 178 16727 16231 2324949
Condition aggravated 265.25 29.38 233 16672 31746 2309434
Blood potassium increased 258.87 29.38 93 16812 2103 2339077
Foetal exposure during pregnancy 256.16 29.38 118 16787 5134 2336046
Unresponsive to stimuli 254.98 29.38 115 16790 4761 2336419
Dizziness 252.80 29.38 300 16605 58365 2282815
Gastroenteritis 249.64 29.38 99 16806 2961 2338219
Hyperhidrosis 241.51 29.38 164 16741 15258 2325922
Circulatory collapse 240.89 29.38 102 16803 3618 2337562
Depressed level of consciousness 237.15 29.38 126 16779 7478 2333702
Weight increased 233.26 29.38 186 16719 22151 2319029
Loss of consciousness 230.29 29.38 172 16733 18595 2322585
Premature delivery 228.23 29.38 94 16811 3106 2338074
Fall 226.51 29.38 255 16650 46844 2294336
Oliguria 216.26 29.38 72 16833 1285 2339895
Anaemia 212.58 29.38 214 16691 34578 2306602
Hepatic steatosis 211.03 29.38 89 16816 3124 2338056
Blood pressure decreased 209.01 29.38 124 16781 9112 2332068
Diabetes mellitus 208.12 29.38 115 16790 7380 2333800
Intentional product misuse 205.91 29.38 124 16781 9365 2331815
Rhabdomyolysis 200.36 29.38 108 16797 6596 2334584
Urinary tract infection 197.39 29.38 192 16713 29750 2311430
Respiratory failure 193.27 29.38 136 16769 13392 2327788
Pancreatic carcinoma 193.11 29.38 67 16838 1362 2339818
Amylase increased 187.24 29.38 62 16843 1087 2340093
Body temperature decreased 186.42 29.38 64 16841 1259 2339921
Fatigue 184.57 29.38 313 16592 84560 2256620
Exposure via ingestion 184.28 29.38 56 16849 732 2340448
Product residue present 183.92 29.38 61 16844 1075 2340105
Haemodynamic instability 177.74 29.38 60 16845 1119 2340061
Hypomagnesaemia 175.00 29.38 73 16832 2491 2338689
Pharyngitis 174.26 29.38 70 16835 2165 2339015
Medication error 172.75 29.38 95 16810 6036 2335144
General physical health deterioration 169.84 29.38 128 16777 14011 2327169
Anion gap increased 168.82 29.38 42 16863 241 2340939
Blood glucose abnormal 168.25 29.38 59 16846 1239 2339941
Sepsis 167.87 29.38 142 16763 18346 2322834
Electrocardiogram QT prolonged 164.06 29.38 100 16805 7714 2333466
Hypertension 162.82 29.38 166 16739 27195 2313985
Hepatic failure 162.62 29.38 89 16816 5600 2335580
Hepatitis 161.68 29.38 92 16813 6245 2334935
Death 160.83 29.38 288 16617 81180 2260000
Lower respiratory tract infection 158.21 29.38 86 16819 5338 2335842
Pruritus 157.98 29.38 204 16701 43136 2298044
Disorientation 155.86 29.38 90 16815 6282 2334898
Hypovolaemia 153.32 29.38 54 16851 1149 2340031
Toothache 153.08 29.38 67 16838 2577 2338603
Septic shock 152.53 29.38 92 16813 6962 2334218
Caesarean section 151.32 29.38 76 16829 4005 2337175
Pneumonia 150.72 29.38 213 16692 49083 2292097
Blood glucose fluctuation 149.59 29.38 48 16857 758 2340422
Blood bicarbonate decreased 149.33 29.38 43 16862 460 2340720
Blood urea increased 148.13 29.38 72 16833 3533 2337647
Dyspepsia 147.65 29.38 102 16803 9742 2331438
Hypokalaemia 147.26 29.38 105 16800 10549 2330631
Drug intolerance 146.87 29.38 116 16789 13601 2327579
Polyuria 146.62 29.38 52 16853 1130 2340050
Chest pain 146.53 29.38 159 16746 27978 2313202
Poisoning deliberate 146.23 29.38 52 16853 1139 2340041
Live birth 145.86 29.38 53 16852 1238 2339942
Renal tubular necrosis 145.76 29.38 56 16849 1534 2339646
Product substitution issue 144.05 29.38 79 16826 4990 2336190
Respiratory arrest 142.49 29.38 84 16821 6094 2335086
Drug abuse 142.48 29.38 108 16797 11918 2329262
Gait inability 140.05 29.38 82 16823 5873 2335307
Hypophagia 138.13 29.38 71 16834 3929 2337251
Heart rate increased 134.37 29.38 101 16804 11004 2330176
Hyponatraemia 132.68 29.38 108 16797 13217 2327963
Mental status changes 131.63 29.38 77 16828 5505 2335675
Product use in unapproved indication 131.39 29.38 100 16805 11100 2330080
Leukocytosis 127.91 29.38 65 16840 3511 2337669
Pulseless electrical activity 127.21 29.38 45 16860 970 2340210
Hemiplegia 127.06 29.38 49 16856 1356 2339824
Vasoplegia syndrome 126.27 29.38 30 16875 137 2341043
Syncope 125.94 29.38 116 16789 16759 2324421
Dysarthria 125.52 29.38 78 16827 6224 2334956
Adverse drug reaction 124.62 29.38 86 16819 8197 2332983
Agitation 123.79 29.38 96 16809 10955 2330225
Electrolyte imbalance 122.42 29.38 53 16852 1984 2339196
Inappropriate schedule of product administration 121.68 29.38 99 16806 12105 2329075
Atrial fibrillation 121.35 29.38 104 16801 13664 2327516
Personality disorder 120.40 29.38 34 16871 337 2340843
Persistent cloaca 115.63 29.38 20 16885 3 2341177
Abortion spontaneous 115.33 29.38 100 16805 13345 2327835
Blood pH decreased 115.26 29.38 35 16870 456 2340724
Eosinophilia 115.09 29.38 57 16848 2913 2338267
Acute myocardial infarction 114.64 29.38 68 16837 4987 2336193
Pancytopenia 114.38 29.38 93 16812 11359 2329821
Thrombocytopenia 113.60 29.38 116 16789 19015 2322165
Abdominal distension 113.48 29.38 89 16816 10322 2330858
Arthralgia 113.48 29.38 197 16708 54088 2287092
Type 2 diabetes mellitus 112.28 29.38 51 16854 2143 2339037
Drug-induced liver injury 111.62 29.38 60 16845 3639 2337541
Vitamin B12 decreased 110.89 29.38 32 16873 345 2340835
Myocardial infarction 110.57 29.38 114 16791 18899 2322281
Glomerular filtration rate decreased 110.32 29.38 45 16860 1448 2339732
Myalgia 109.63 29.38 125 16780 23208 2317972
Euglycaemic diabetic ketoacidosis 109.56 29.38 27 16878 148 2341032
Electrocardiogram QRS complex prolonged 108.89 29.38 41 16864 1061 2340119
Alanine aminotransferase increased 107.69 29.38 98 16807 13934 2327246
Angioedema 107.46 29.38 79 16826 8317 2332863
Tubulointerstitial nephritis 107.14 29.38 51 16854 2387 2338793
Respiratory rate increased 106.15 29.38 44 16861 1476 2339704
Cold sweat 105.85 29.38 48 16857 2009 2339171
Urticaria 105.67 29.38 125 16780 24136 2317044
Accidental overdose 104.90 29.38 59 16846 3913 2337267
Oedema peripheral 104.43 29.38 123 16782 23640 2317540
Blood pressure systolic increased 103.01 29.38 49 16856 2290 2338890
Postprandial hypoglycaemia 102.97 29.38 18 16887 4 2341176
Aspartate aminotransferase increased 102.54 29.38 91 16814 12521 2328659
Cardiac failure 101.80 29.38 89 16816 12005 2329175
Product prescribing error 100.64 29.38 52 16853 2908 2338272
Hypoaesthesia 99.56 29.38 111 16794 20104 2321076
Intestinal malrotation 98.96 29.38 20 16885 33 2341147
Hypersensitivity vasculitis 98.79 29.38 40 16865 1262 2339918
Conjoined twins 98.63 29.38 18 16887 10 2341170
Respiratory distress 98.40 29.38 62 16843 5067 2336113
Blood creatine phosphokinase increased 98.33 29.38 62 16843 5074 2336106
Cholestasis 97.53 29.38 55 16850 3666 2337514
Encephalopathy 97.32 29.38 59 16846 4502 2336678
Off label use 96.85 29.38 220 16685 73378 2267802
Anhidrosis 96.82 29.38 20 16885 39 2341141
Hepatocellular injury 95.76 29.38 56 16849 3999 2337181
Pancreatic carcinoma metastatic 95.09 29.38 30 16875 447 2340733
Hypovolaemic shock 94.13 29.38 34 16871 780 2340400
Cholelithiasis 93.80 29.38 63 16842 5740 2335440
Pulmonary oedema 93.59 29.38 69 16836 7294 2333886
Gastrooesophageal reflux disease 93.22 29.38 75 16830 9020 2332160
Blood sodium decreased 92.74 29.38 50 16855 3050 2338130
Blood pressure increased 91.88 29.38 98 16807 16888 2324292
Blood pressure diastolic decreased 91.28 29.38 36 16869 1059 2340121
Hyperventilation 90.66 29.38 37 16868 1192 2339988
Coma scale abnormal 90.24 29.38 33 16872 785 2340395
Muscular weakness 89.64 29.38 91 16814 14806 2326374
Cough 89.32 29.38 135 16770 32982 2308198
Pyrexia 88.48 29.38 176 16729 53532 2287648
Renal injury 88.08 29.38 34 16871 943 2340237
Altered state of consciousness 87.72 29.38 52 16853 3808 2337372
Mitral valve incompetence 87.27 29.38 45 16860 2505 2338675
Dysphagia 85.89 29.38 83 16822 12722 2328458
Premature baby 85.71 29.38 48 16857 3156 2338024
Aphasia 85.70 29.38 56 16849 4872 2336308
White blood cell count increased 84.76 29.38 64 16841 7014 2334166
Sinus tachycardia 84.05 29.38 48 16857 3277 2337903
Toxic epidermal necrolysis 83.83 29.38 47 16858 3097 2338083
Lethargy 83.18 29.38 69 16836 8661 2332519
Respiratory disorder 80.84 29.38 50 16855 3954 2337226
Jaundice 80.04 29.38 56 16849 5452 2335728
Vision blurred 79.98 29.38 85 16820 14583 2326597
Urosepsis 79.67 29.38 39 16866 1942 2339238
Diabetic nephropathy 79.60 29.38 22 16883 200 2340980
Renal cyst 79.54 29.38 33 16872 1109 2340071
Presyncope 78.07 29.38 48 16857 3755 2337425
Delirium 78.00 29.38 54 16851 5169 2336011
Urine output decreased 76.75 29.38 35 16870 1484 2339696
Kussmaul respiration 75.61 29.38 16 16889 37 2341143
Haematemesis 74.95 29.38 48 16857 4034 2337146
Incorrect dose administered 74.93 29.38 68 16837 9627 2331553
Hyperthyroidism 74.64 29.38 38 16867 2059 2339121
Anal incontinence 74.61 29.38 36 16869 1736 2339444
Diabetic retinopathy 74.02 29.38 23 16882 325 2340855
Patent ductus arteriosus 73.64 29.38 27 16878 647 2340533
Erythema 72.75 29.38 106 16799 25053 2316127
Urachal abnormality 72.74 29.38 13 16892 5 2341175
Rash 72.74 29.38 173 16732 59385 2281795
Left ventricular hypertrophy 72.23 29.38 27 16878 684 2340496
Chronic kidney disease 72.11 29.38 47 16858 4071 2337109
Product odour abnormal 72.09 29.38 23 16882 356 2340824
Tremor 71.62 29.38 95 16810 20566 2320614
Asthma 71.51 29.38 71 16834 11243 2329937
Systemic infection 70.78 29.38 17 16888 82 2341098
Polyhydramnios 70.66 29.38 22 16883 313 2340867
Gastrointestinal sounds abnormal 70.18 29.38 25 16880 550 2340630
Microalbuminuria 70.11 29.38 17 16888 86 2341094
PCO2 decreased 69.76 29.38 21 16884 265 2340915
Low birth weight baby 68.20 29.38 27 16878 802 2340378
Rectal haemorrhage 68.01 29.38 52 16853 5804 2335376
Blindness transient 67.18 29.38 27 16878 835 2340345
Congenital bladder anomaly 67.01 29.38 13 16892 15 2341165
Swelling face 66.43 29.38 63 16842 9430 2331750
Treatment noncompliance 66.16 29.38 50 16855 5484 2335696
Electrocardiogram T wave peaked 65.97 29.38 15 16890 54 2341126
Muscle spasms 65.47 29.38 93 16812 21473 2319707
Colitis microscopic 65.03 29.38 27 16878 909 2340271
Ischaemic stroke 64.99 29.38 41 16864 3356 2337824
Anaemia megaloblastic 64.72 29.38 16 16889 89 2341091
Pregnancy 63.88 29.38 57 16848 7892 2333288
Anaemia vitamin B12 deficiency 63.58 29.38 15 16890 66 2341114
Anaemia macrocytic 63.14 29.38 21 16884 373 2340807
Hypoxia 63.06 29.38 51 16854 6176 2335004
Product quality issue 63.04 29.38 65 16840 10764 2330416
Hepatic enzyme increased 62.85 29.38 62 16843 9740 2331440
Therapeutic response unexpected 62.61 29.38 42 16863 3817 2337363
Left atrial dilatation 62.60 29.38 19 16886 247 2340933
Hepatic cirrhosis 62.25 29.38 35 16870 2318 2338862
Blood chloride decreased 61.62 29.38 24 16881 682 2340498
Adenocarcinoma pancreas 61.56 29.38 18 16887 204 2340976
Hepatitis acute 61.07 29.38 30 16875 1505 2339675
Haemoglobin decreased 60.67 29.38 82 16823 18069 2323111
Deep vein thrombosis 60.21 29.38 69 16836 12863 2328317
Retching 60.18 29.38 33 16872 2081 2339099
Pain in extremity 60.15 29.38 131 16774 42409 2298771
Hypocalcaemia 59.99 29.38 41 16864 3842 2337338
Chest discomfort 59.89 29.38 73 16832 14522 2326658
Blood phosphorus increased 59.73 29.38 20 16885 363 2340817
Drug reaction with eosinophilia and systemic symptoms 59.73 29.38 47 16858 5471 2335709
Hemiparesis 59.48 29.38 39 16866 3411 2337769
Nephropathy toxic 58.84 29.38 27 16878 1161 2340019
Flatulence 58.83 29.38 43 16862 4482 2336698
Self-medication 58.14 29.38 22 16883 577 2340603
Azotaemia 57.93 29.38 22 16883 583 2340597
Coagulopathy 57.89 29.38 36 16869 2873 2338307
Bradyphrenia 57.66 29.38 26 16879 1073 2340107
Hypoperfusion 57.10 29.38 17 16888 206 2340974
Creatinine renal clearance abnormal 56.92 29.38 14 16891 76 2341104
Cerebrovascular accident 56.82 29.38 84 16821 20102 2321078
Neurologic neglect syndrome 56.76 29.38 14 16891 77 2341103
Constipation 56.61 29.38 87 16818 21542 2319638
Acute respiratory distress syndrome 56.24 29.38 37 16868 3255 2337925
Pancreatitis chronic 56.15 29.38 18 16887 283 2340897
Back pain 56.01 29.38 107 16798 31552 2309628
Vertigo 55.84 29.38 57 16848 9327 2331853
Cholecystitis 55.71 29.38 32 16873 2208 2338972
Electrocardiogram abnormal 55.59 29.38 27 16878 1321 2339859
Allergic reaction to excipient 55.33 29.38 13 16892 56 2341124
Hypersensitivity 54.99 29.38 90 16815 23503 2317677
Product administration error 54.76 29.38 39 16866 3904 2337276
Hepatotoxicity 54.36 29.38 37 16868 3444 2337736
Malabsorption 54.31 29.38 21 16884 585 2340595
Insomnia 54.30 29.38 94 16811 25693 2315487
Restlessness 54.04 29.38 41 16864 4522 2336658
Carotid artery thrombosis 54.00 29.38 14 16891 97 2341083
Duodenal ulcer 53.78 29.38 25 16880 1108 2340072
Cholestatic liver injury 53.71 29.38 17 16888 256 2340924
Dyslipidaemia 53.43 29.38 22 16883 725 2340455
Coma acidotic 53.40 29.38 11 16894 21 2341159
Polydipsia 53.32 29.38 21 16884 615 2340565
Mydriasis 53.32 29.38 31 16874 2188 2338992
Muscle spasticity 53.21 29.38 28 16877 1625 2339555
Intentional self-injury 53.16 29.38 39 16866 4088 2337092
Palpitations 52.96 29.38 73 16832 16383 2324797
Alopecia 52.74 29.38 85 16820 21916 2319264
Prescription drug used without a prescription 52.64 29.38 16 16889 209 2340971
Premature rupture of membranes 52.56 29.38 23 16882 883 2340297
Dry mouth 52.53 29.38 52 16853 8201 2332979
Systemic inflammatory response syndrome 52.48 29.38 22 16883 759 2340421
Anaphylactic reaction 52.46 29.38 56 16849 9649 2331531
Dysentery 52.09 29.38 16 16889 217 2340963
Lipase increased 50.60 29.38 26 16879 1436 2339744
Bronchitis 50.53 29.38 65 16840 13649 2327531
Anxiety 50.42 29.38 98 16807 29261 2311919
Hypertensive heart disease 50.11 29.38 18 16887 406 2340774
Drug level above therapeutic 50.08 29.38 19 16886 502 2340678
Congenital uterine anomaly 49.67 29.38 10 16895 16 2341164
Affect lability 49.54 29.38 29 16876 2073 2339107
Pollakiuria 49.53 29.38 36 16869 3720 2337460
Maternal drugs affecting foetus 49.21 29.38 26 16879 1521 2339659
Gestational diabetes 48.97 29.38 25 16880 1362 2339818
Small for dates baby 48.92 29.38 20 16885 647 2340533
Hypoglycaemia neonatal 48.80 29.38 15 16890 204 2340976
Disseminated intravascular coagulation 48.53 29.38 34 16871 3316 2337864
Glycosylated haemoglobin decreased 48.29 29.38 13 16892 106 2341074
Prerenal failure 48.27 29.38 15 16890 212 2340968
Respiratory acidosis 48.14 29.38 21 16884 800 2340380
Nephropathy 47.92 29.38 21 16884 809 2340371
Normal newborn 47.56 29.38 24 16881 1276 2339904
Tricuspid valve incompetence 47.55 29.38 26 16879 1630 2339550
Blister 47.49 29.38 45 16860 6726 2334454
Cardiogenic shock 47.49 29.38 30 16875 2461 2338719
Interstitial lung disease 47.47 29.38 48 16857 7764 2333416
Pneumonia aspiration 47.38 29.38 35 16870 3707 2337473
Pallor 47.38 29.38 35 16870 3707 2337473
Head injury 47.23 29.38 36 16869 3998 2337182
Gait disturbance 47.22 29.38 82 16823 22463 2318717
Cardiometabolic syndrome 47.20 29.38 15 16890 229 2340951
Adjustment disorder 46.77 29.38 14 16891 173 2341007
Oedema 46.75 29.38 54 16851 10149 2331031
Aortic valve incompetence 46.40 29.38 21 16884 874 2340306
International normalised ratio increased 46.28 29.38 46 16859 7290 2333890
Proteinuria 46.19 29.38 31 16874 2819 2338361
Cerebral venous thrombosis 45.84 29.38 17 16888 421 2340759
Liver function test abnormal 45.47 29.38 46 16859 7444 2333736
Pyelonephritis acute 44.99 29.38 18 16887 550 2340630
Bezoar 44.98 29.38 14 16891 199 2340981
No adverse event 44.62 29.38 51 16854 9477 2331703
Feeling abnormal 44.56 29.38 82 16823 23499 2317681
Pre-eclampsia 44.26 29.38 24 16881 1480 2339700
Atrial septal defect 43.93 29.38 23 16882 1321 2339859
Latent autoimmune diabetes in adults 43.42 29.38 9 16896 18 2341162
Product dose omission 43.30 29.38 108 16797 38149 2303031
Fungal infection 43.18 29.38 37 16868 4852 2336328
Acid base balance abnormal 42.95 29.38 10 16895 41 2341139
Limb malformation 42.94 29.38 12 16893 114 2341066
Renal tubular disorder 42.91 29.38 17 16888 506 2340674
Adverse event 42.82 29.38 45 16860 7614 2333566
Acetonaemia 42.77 29.38 9 16896 20 2341160
Dermatitis exfoliative 42.75 29.38 22 16883 1219 2339961
Resuscitation 42.49 29.38 15 16890 321 2340859
Acute abdomen 42.49 29.38 15 16890 321 2340859
Bradypnoea 42.34 29.38 16 16889 418 2340762
Shock haemorrhagic 42.06 29.38 22 16883 1261 2339919
Liver injury 41.95 29.38 27 16878 2287 2338893
Congestive cardiomyopathy 41.86 29.38 20 16885 943 2340237
Foetal death 41.46 29.38 25 16880 1887 2339293
Congenital absence of bile ducts 41.34 29.38 8 16897 9 2341171
Cerebral haemorrhage 41.33 29.38 38 16867 5466 2335714
PO2 increased 41.20 29.38 12 16893 134 2341046
Diabetic neuropathy 41.17 29.38 16 16889 452 2340728
Obesity 41.04 29.38 23 16882 1513 2339667
Product use issue 40.69 29.38 55 16850 12114 2329066
Metastases to liver 40.63 29.38 29 16876 2912 2338268
Blood potassium decreased 40.57 29.38 37 16868 5268 2335912
Autoimmune haemolytic anaemia 40.54 29.38 18 16887 716 2340464
Hepatorenal syndrome 40.31 29.38 14 16891 285 2340895
Depression 40.14 29.38 87 16818 28045 2313135
Diabetic hyperosmolar coma 40.00 29.38 11 16894 98 2341082
Basilar artery thrombosis 39.67 29.38 9 16896 32 2341148
Cardiac failure congestive 39.66 29.38 63 16842 16038 2325142
Intestinal ischaemia 39.49 29.38 20 16885 1071 2340109
Pulmonary embolism 39.47 29.38 67 16838 18016 2323164
Psychomotor skills impaired 39.16 29.38 15 16890 407 2340773
Heart rate decreased 39.11 29.38 31 16874 3645 2337535
Prothrombin consumption time prolonged 38.95 29.38 7 16898 3 2341177
Thirst 38.95 29.38 23 16882 1671 2339509
HELLP syndrome 38.82 29.38 13 16892 236 2340944
Seizure 38.79 29.38 79 16826 24387 2316793
Blood magnesium decreased 38.78 29.38 21 16884 1291 2339889
Pemphigus 38.69 29.38 17 16888 659 2340521
Blood folate decreased 38.59 29.38 11 16894 113 2341067
Hepatitis cholestatic 38.38 29.38 20 16885 1137 2340043
Placental insufficiency 38.37 29.38 13 16892 245 2340935
Pulmonary hypoplasia 38.36 29.38 10 16895 71 2341109
Anal atresia 38.12 29.38 10 16895 73 2341107
Bundle branch block right 38.01 29.38 18 16887 832 2340348
Hyperphosphataemia 37.93 29.38 13 16892 254 2340926
Urine albumin/creatinine ratio abnormal 37.68 29.38 7 16898 5 2341175
Monoclonal B-cell lymphocytosis 37.68 29.38 7 16898 5 2341175
Impaired work ability 37.54 29.38 23 16882 1787 2339393
Atrioventricular block complete 37.31 29.38 21 16884 1393 2339787
Inappropriate antidiuretic hormone secretion 37.14 29.38 25 16880 2284 2338896
Bradykinesia 37.04 29.38 16 16889 595 2340585
Pancreatic atrophy 37.04 29.38 9 16896 46 2341134
Pancreatic failure 36.97 29.38 11 16894 133 2341047
Transient ischaemic attack 36.81 29.38 37 16868 5941 2335239
Skin turgor decreased 36.57 29.38 10 16895 87 2341093
Foetal hypokinesia 36.52 29.38 11 16894 139 2341041
Folate deficiency 36.46 29.38 12 16893 206 2340974
Pleural effusion 36.40 29.38 51 16854 11617 2329563
Acute hepatic failure 36.38 29.38 26 16879 2616 2338564
Hypoplastic left heart syndrome 35.83 29.38 9 16896 54 2341126
Ventricular fibrillation 35.81 29.38 24 16881 2177 2339003
Myopathy 35.61 29.38 21 16884 1522 2339658
Hyperglycaemic hyperosmolar nonketotic syndrome 35.60 29.38 10 16895 97 2341083
Hyperhomocysteinaemia 35.58 29.38 8 16897 27 2341153
Ventricular tachycardia 35.53 29.38 27 16878 2984 2338196
Aortitis 35.42 29.38 10 16895 99 2341081
Obstructive airways disorder 35.17 29.38 20 16885 1353 2339827
Pulse abnormal 35.16 29.38 13 16892 319 2340861
Gastritis 35.12 29.38 32 16873 4549 2336631
Insulin C-peptide decreased 34.84 29.38 7 16898 11 2341169
Urticarial vasculitis 34.76 29.38 9 16896 62 2341118
Liver disorder 34.64 29.38 37 16868 6377 2334803
Respiratory alkalosis 34.53 29.38 13 16892 336 2340844
Blood gases abnormal 34.47 29.38 10 16895 110 2341070
Sudden death 34.46 29.38 22 16883 1838 2339342
Abdominal tenderness 34.45 29.38 18 16887 1029 2340151
Bladder cancer 34.44 29.38 16 16889 708 2340472
Overweight 34.29 29.38 14 16891 451 2340729
Staphylococcal sepsis 34.16 29.38 18 16887 1047 2340133
Pyelonephritis 34.00 29.38 23 16882 2118 2339062
Temperature perception test abnormal 33.80 29.38 6 16899 2 2341178
Metabolic disorder 33.63 29.38 15 16890 603 2340577
Urine albumin/creatinine ratio increased 33.58 29.38 8 16897 37 2341143
Gamma-glutamyltransferase increased 33.47 29.38 34 16871 5528 2335652
Congenital aortic valve stenosis 33.44 29.38 7 16898 15 2341165
Hypoglycaemic unconsciousness 33.36 29.38 11 16894 190 2340990
Blood cholesterol increased 33.31 29.38 33 16872 5208 2335972
Transaminases increased 33.15 29.38 31 16874 4556 2336624
Hypokinesia 33.12 29.38 21 16884 1733 2339447
Platelet count increased 33.09 29.38 23 16882 2214 2338966
Foetal growth restriction 33.01 29.38 18 16887 1122 2340058
Shock hypoglycaemic 32.75 29.38 8 16897 42 2341138
Sputum discoloured 32.63 29.38 18 16887 1148 2340032
Neutrophilia 32.60 29.38 14 16891 513 2340667
Paraesthesia 32.30 29.38 69 16836 22019 2319161
Hyperinsulinaemia 32.28 29.38 8 16897 45 2341135
Rheumatic fever 32.16 29.38 9 16896 86 2341094
Pulmonary hypertension 32.11 29.38 32 16873 5086 2336094
Stool analysis abnormal 31.84 29.38 8 16897 48 2341132
Abdominal pain lower 31.77 29.38 25 16880 2908 2338272
Fallot's tetralogy 31.70 29.38 9 16896 91 2341089
Pain 31.65 29.38 133 16772 61724 2279456
Neonatal respiratory distress syndrome 31.59 29.38 14 16891 554 2340626
Cardiovascular insufficiency 31.52 29.38 12 16893 320 2340860
Hallucination, visual 31.43 29.38 25 16880 2954 2338226
Diabetic ulcer 31.43 29.38 8 16897 51 2341129
Cellulitis 31.39 29.38 42 16863 9159 2332021
Spine malformation 31.30 29.38 8 16897 52 2341128
Autoimmune hepatitis 31.28 29.38 20 16885 1675 2339505
Blindness 31.17 29.38 27 16878 3591 2337589
Carotid arteriosclerosis 31.09 29.38 10 16895 159 2341021
Brain injury 30.81 29.38 16 16889 903 2340277
Blood pressure systolic decreased 30.76 29.38 15 16890 740 2340440
Cardiopulmonary failure 30.56 29.38 15 16890 751 2340429
Acute coronary syndrome 30.08 29.38 19 16886 1558 2339622
Cyanosis 29.96 29.38 25 16880 3160 2338020
Renal disorder 29.90 29.38 29 16876 4459 2336721
Cardiovascular disorder 29.75 29.38 22 16883 2333 2338847
Haemofiltration 29.65 29.38 6 16899 10 2341170
Klebsiella infection 29.64 29.38 15 16890 802 2340378
Toxic encephalopathy 29.62 29.38 15 16890 803 2340377
Escherichia test positive 29.52 29.38 11 16894 276 2340904
Sleep apnoea syndrome 29.45 29.38 21 16884 2105 2339075

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Lactic acidosis 15604.12 33.80 3035 11708 2094 1729944
Acute kidney injury 7470.29 33.80 2479 12264 32465 1699573
Hypoglycaemia 3985.13 33.80 1114 13629 7324 1724714
Metabolic acidosis 3377.01 33.80 891 13852 4511 1727527
Completed suicide 2821.68 33.80 1001 13742 15311 1716727
Toxicity to various agents 2323.14 33.80 1021 13722 28120 1703918
Hyperkalaemia 2082.59 33.80 680 14063 7867 1724171
Diarrhoea 1576.91 33.80 963 13780 52889 1679149
Hypotension 1449.11 33.80 744 13999 28910 1703128
Renal failure 1395.28 33.80 641 14102 19376 1712662
Intentional overdose 1327.22 33.80 473 14270 7197 1724841
Blood glucose increased 1291.29 33.80 505 14238 10079 1721959
Vomiting 1128.71 33.80 690 14053 37625 1694413
Shock 901.77 33.80 304 14439 3857 1728181
Overdose 887.94 33.80 445 14298 16256 1715782
Diabetes mellitus inadequate control 839.18 33.80 238 14505 1604 1730434
Suicide attempt 735.42 33.80 305 14438 7076 1724962
Dehydration 670.09 33.80 376 14367 17282 1714756
Diabetic ketoacidosis 664.43 33.80 228 14515 3055 1728983
Abdominal pain 660.50 33.80 399 14344 21091 1710947
Hyperglycaemia 630.05 33.80 247 14496 4918 1727120
Glycosylated haemoglobin increased 622.44 33.80 190 14553 1701 1730337
Nausea 591.01 33.80 525 14218 50671 1681367
Blood lactic acid increased 580.79 33.80 153 14590 746 1731292
Haemodialysis 565.74 33.80 191 14552 2425 1729613
Anuria 550.94 33.80 173 14570 1715 1730323
Drug interaction 520.74 33.80 380 14363 27578 1704460
Pancreatitis acute 514.33 33.80 200 14543 3887 1728151
Hyperlactacidaemia 513.46 33.80 118 14625 278 1731760
Blood creatinine increased 506.96 33.80 289 14454 13657 1718381
Renal impairment 501.51 33.80 275 14468 12039 1719999
Coma 501.47 33.80 232 14511 7030 1725008
Hypoglycaemic coma 492.23 33.80 121 14622 419 1731619
Pancreatitis 466.47 33.80 220 14523 6967 1725071
Multiple organ dysfunction syndrome 456.99 33.80 235 14508 9007 1723031
Drug level increased 451.58 33.80 164 14579 2613 1729425
Confusional state 443.60 33.80 310 14433 20968 1711070
Cardiac arrest 413.32 33.80 266 14477 15664 1716374
Bradycardia 403.34 33.80 226 14517 10308 1721730
Dyspnoea 386.37 33.80 420 14323 51639 1680399
Diabetic metabolic decompensation 356.98 33.80 76 14667 104 1731934
Malaise 323.39 33.80 295 14448 29270 1702768
Cardio-respiratory arrest 317.04 33.80 185 14558 9108 1722930
Acidosis 314.41 33.80 107 14636 1390 1730648
Hypothermia 301.95 33.80 108 14635 1640 1730398
Weight decreased 296.70 33.80 251 14492 22502 1709536
Vitamin B12 deficiency 283.27 33.80 72 14671 295 1731743
Continuous haemodiafiltration 271.11 33.80 67 14676 238 1731800
Asthenia 267.47 33.80 286 14457 34384 1697654
Pancreatic carcinoma 258.35 33.80 96 14647 1633 1730405
Somnolence 254.44 33.80 202 14541 16537 1715501
Haemodynamic instability 251.42 33.80 88 14655 1249 1730789
Anion gap increased 243.68 33.80 60 14683 209 1731829
Drug hypersensitivity 241.54 33.80 188 14555 14947 1717091
Pemphigoid 240.90 33.80 82 14661 1065 1730973
Cardiogenic shock 239.12 33.80 100 14643 2354 1729684
Rhabdomyolysis 238.57 33.80 165 14578 10925 1721113
Hypertension 231.96 33.80 204 14539 19244 1712794
Blood glucose decreased 230.76 33.80 96 14647 2229 1729809
Respiratory failure 224.57 33.80 177 14566 14328 1717710
Poisoning 222.87 33.80 96 14647 2436 1729602
Decreased appetite 220.23 33.80 217 14526 23654 1708384
Diabetes mellitus 215.80 33.80 130 14613 6778 1725260
Sepsis 214.18 33.80 195 14548 19243 1712795
Exposure via ingestion 213.69 33.80 66 14677 614 1731424
Tachypnoea 209.50 33.80 90 14653 2268 1729770
Drug ineffective 208.17 33.80 345 14398 63456 1668582
Loss of consciousness 203.76 33.80 169 14574 14706 1717332
Foetal exposure during pregnancy 202.06 33.80 121 14622 6238 1725800
Blood glucose fluctuation 201.68 33.80 62 14681 567 1731471
Ketoacidosis 199.48 33.80 65 14678 730 1731308
Leukocytosis 198.23 33.80 98 14645 3435 1728603
Depressed level of consciousness 198.04 33.80 121 14622 6471 1725567
Syncope 196.19 33.80 162 14581 14007 1718031
Weight increased 194.08 33.80 147 14596 11210 1720828
Hepatotoxicity 189.40 33.80 91 14652 2993 1729045
Body temperature decreased 187.56 33.80 67 14676 1012 1731026
Diabetic neuropathy 187.36 33.80 56 14687 461 1731577
Haemolytic anaemia 185.16 33.80 77 14666 1785 1730253
Blood glucose abnormal 178.18 33.80 63 14680 922 1731116
Abdominal discomfort 174.12 33.80 126 14617 8955 1723083
Sopor 169.97 33.80 74 14669 1927 1730111
Dizziness 169.65 33.80 226 14517 34135 1697903
Renal tubular necrosis 169.11 33.80 75 14668 2044 1729994
Tachycardia 163.64 33.80 139 14604 12489 1719549
Anaemia 162.96 33.80 205 14538 29252 1702786
Hepatic steatosis 157.91 33.80 76 14667 2508 1729530
Medication error 157.82 33.80 93 14650 4650 1727388
Pancreatic carcinoma metastatic 157.61 33.80 51 14692 559 1731479
Atrial fibrillation 157.40 33.80 147 14596 14964 1717074
Jaundice 153.80 33.80 100 14643 5962 1726076
Agitation 152.41 33.80 126 14617 10900 1721138
Bladder cancer 152.05 33.80 69 14674 1987 1730051
Dialysis 147.79 33.80 71 14672 2333 1729705
Abdominal pain upper 144.36 33.80 122 14621 10879 1721159
Blood pH decreased 143.58 33.80 45 14698 441 1731597
Fatigue 142.20 33.80 257 14486 50524 1681514
Fall 137.28 33.80 181 14562 27033 1705005
Hypokalaemia 134.98 33.80 94 14649 6280 1725758
Cardiac failure 133.92 33.80 124 14619 12478 1719560
Hepatitis 133.74 33.80 85 14658 4870 1727168
Euglycaemic diabetic ketoacidosis 131.34 33.80 34 14709 152 1731886
Blood pressure increased 130.41 33.80 114 14629 10639 1721399
Unresponsive to stimuli 126.40 33.80 80 14663 4549 1727489
Drug-induced liver injury 125.12 33.80 70 14673 3167 1728871
Mental status changes 124.92 33.80 88 14655 5987 1726051
Pulmonary fibrosis 124.43 33.80 64 14679 2440 1729598
Poisoning deliberate 122.99 33.80 46 14697 796 1731242
Product residue present 122.37 33.80 45 14698 741 1731297
Lipase increased 121.65 33.80 55 14688 1569 1730469
Hypomagnesaemia 120.04 33.80 59 14684 2039 1729999
Blood bicarbonate decreased 120.02 33.80 38 14705 386 1731652
Anion gap 118.19 33.80 27 14716 61 1731977
Glomerular filtration rate decreased 117.63 33.80 52 14691 1405 1730633
Gastroenteritis 117.43 33.80 58 14685 2026 1730012
Inappropriate schedule of product administration 117.39 33.80 92 14651 7367 1724671
General physical health deterioration 116.58 33.80 117 14626 13001 1719037
Acute myocardial infarction 116.28 33.80 97 14646 8490 1723548
Hyponatraemia 112.31 33.80 97 14646 8903 1723135
Product prescribing error 112.31 33.80 59 14684 2351 1729687
Blood potassium increased 109.61 33.80 59 14684 2471 1729567
Chronic kidney disease 108.94 33.80 71 14672 4246 1727792
Sinus tachycardia 106.78 33.80 58 14685 2474 1729564
Accidental overdose 106.34 33.80 69 14674 4095 1727943
Lethargy 105.32 33.80 85 14658 7099 1724939
Respiratory distress 104.39 33.80 74 14669 5083 1726955
Diabetic nephropathy 104.32 33.80 32 14711 290 1731748
Hepatocellular injury 103.91 33.80 62 14681 3169 1728869
Blood lactic acid 103.69 33.80 20 14723 9 1732029
Coma scale abnormal 103.35 33.80 37 14706 562 1731476
Chest pain 102.73 33.80 134 14609 19780 1712258
Contraindicated product administered 102.16 33.80 47 14696 1397 1730641
Product complaint 102.13 33.80 56 14687 2434 1729604
Distributive shock 101.40 33.80 26 14717 111 1731927
Pruritus 101.24 33.80 144 14599 23078 1708960
Death 100.14 33.80 312 14431 87131 1644907
Pyrexia 99.48 33.80 210 14533 46190 1685848
Oliguria 97.49 33.80 43 14700 1155 1730883
Premature baby 96.03 33.80 57 14686 2885 1729153
Intentional product misuse 95.24 33.80 81 14662 7277 1724761
Condition aggravated 94.92 33.80 133 14610 21017 1711021
Disorientation 93.78 33.80 71 14672 5398 1726640
Myocardial infarction 93.61 33.80 151 14592 27023 1705015
Hyperventilation 92.22 33.80 34 14709 564 1731474
Diabetic foot infection 91.86 33.80 24 14719 112 1731926
Cholestasis 91.79 33.80 60 14683 3605 1728433
Thrombocytopenia 91.48 33.80 131 14612 21118 1710920
Encephalopathy 90.37 33.80 64 14679 4388 1727650
Ketonuria 88.75 33.80 24 14719 131 1731907
Acute respiratory distress syndrome 88.61 33.80 58 14685 3493 1728545
Blood pressure decreased 88.54 33.80 79 14664 7567 1724471
Arrhythmia 87.79 33.80 71 14672 5945 1726093
Polyuria 87.57 33.80 41 14702 1269 1730769
Adenocarcinoma pancreas 86.19 33.80 27 14716 264 1731774
Cardiopulmonary failure 86.11 33.80 36 14707 845 1731193
Hyperhidrosis 85.48 33.80 97 14646 12391 1719647
Alanine aminotransferase increased 85.11 33.80 96 14647 12182 1719856
Pulseless electrical activity 84.26 33.80 37 14706 983 1731055
Naevus flammeus 83.54 33.80 18 14725 27 1732011
Haematuria 83.38 33.80 76 14667 7484 1724554
Blood urea increased 82.63 33.80 62 14681 4649 1727389
Hepatic failure 82.63 33.80 68 14675 5835 1726203
Constipation 82.13 33.80 104 14639 14896 1717142
Myocardial ischaemia 81.74 33.80 53 14690 3140 1728898
Product administration error 80.51 33.80 51 14692 2902 1729136
Gamma-glutamyltransferase increased 80.44 33.80 63 14680 5035 1727003
Type 2 diabetes mellitus 79.13 33.80 43 14700 1835 1730203
Prerenal failure 78.94 33.80 25 14718 254 1731784
Back pain 78.30 33.80 107 14636 16506 1715532
Nephrolithiasis 77.83 33.80 56 14687 3936 1728102
Cardiovascular disorder 76.88 33.80 47 14696 2510 1729528
Pancreatitis chronic 76.59 33.80 25 14718 282 1731756
Coagulopathy 75.74 33.80 48 14695 2733 1729305
Hemiplegia 74.54 33.80 37 14706 1306 1730732
Blood pressure systolic increased 74.51 33.80 40 14703 1665 1730373
Hypovolaemia 74.31 33.80 36 14707 1204 1730834
Hepatitis acute 73.85 33.80 36 14707 1221 1730817
Hypocalcaemia 72.58 33.80 49 14694 3107 1728931
Metastases to liver 71.58 33.80 43 14700 2224 1729814
Atrioventricular block complete 71.35 33.80 37 14706 1434 1730604
Gastrointestinal disorder 71.32 33.80 57 14686 4691 1727347
Heart rate increased 70.92 33.80 65 14678 6445 1725593
Abdominal tenderness 70.38 33.80 28 14715 576 1731462
Acute lung injury 69.90 33.80 21 14722 176 1731862
Urosepsis 68.65 33.80 36 14707 1428 1730610
Altered state of consciousness 68.04 33.80 49 14694 3448 1728590
Myalgia 68.03 33.80 97 14646 15561 1716477
Septic shock 67.75 33.80 70 14673 8039 1723999
Ventricular tachycardia 66.64 33.80 50 14693 3748 1728290
Gait disturbance 66.44 33.80 86 14657 12584 1719454
Pneumonia aspiration 66.15 33.80 57 14686 5209 1726829
Interstitial lung disease 65.80 33.80 75 14668 9621 1722417
Blindness 65.71 33.80 44 14699 2752 1729286
Respiratory arrest 64.97 33.80 59 14684 5780 1726258
Vertigo 64.20 33.80 52 14691 4361 1727677
Dysarthria 64.19 33.80 56 14687 5203 1726835
Oedema peripheral 64.15 33.80 94 14649 15456 1716582
Product odour abnormal 64.09 33.80 21 14722 240 1731798
Respiratory rate increased 64.06 33.80 33 14710 1261 1730777
Circulatory collapse 63.87 33.80 47 14696 3420 1728618
Headache 63.83 33.80 147 14596 34229 1697809
Acetonaemia 62.74 33.80 13 14730 14 1732024
Treatment noncompliance 62.71 33.80 55 14688 5146 1726892
Latent autoimmune diabetes in adults 62.26 33.80 13 14730 15 1732023
Wrong product administered 61.57 33.80 31 14712 1128 1730910
Hypophagia 61.27 33.80 46 14697 3451 1728587
Aspartate aminotransferase increased 61.12 33.80 76 14667 10680 1721358
Nervous system disorder 61.01 33.80 40 14703 2414 1729624
Adverse drug reaction 60.97 33.80 52 14691 4686 1727352
Basilar artery thrombosis 60.87 33.80 14 14729 33 1732005
Pallor 60.05 33.80 45 14698 3366 1728672
Urinary tract infection 59.72 33.80 73 14670 10080 1721958
Metabolic disorder 59.69 33.80 24 14719 508 1731530
Muscle spasms 59.55 33.80 78 14665 11543 1720495
Diabetic retinopathy 58.59 33.80 21 14722 320 1731718
Polydipsia 58.54 33.80 26 14717 710 1731328
Foetal disorder 58.50 33.80 15 14728 64 1731974
Discomfort 58.41 33.80 40 14703 2596 1729442
Glycosuria 58.35 33.80 20 14723 265 1731773
Fournier's gangrene 58.29 33.80 18 14725 167 1731871
Renal aplasia 57.95 33.80 17 14726 130 1731908
Hepatitis cholestatic 57.75 33.80 31 14712 1290 1730748
Gastric ulcer 57.74 33.80 40 14703 2645 1729393
Cerebral ischaemia 57.25 33.80 29 14714 1069 1730969
Low birth weight baby 56.94 33.80 27 14716 860 1731178
Ventricular fibrillation 56.80 33.80 40 14703 2716 1729322
Vasoplegia syndrome 56.74 33.80 18 14725 184 1731854
Amylase increased 56.47 33.80 30 14713 1222 1730816
Urticaria 56.38 33.80 78 14665 12163 1719875
Neutropenia neonatal 55.56 33.80 13 14730 34 1732004
Diabetic ketoacidotic hyperglycaemic coma 55.29 33.80 13 14730 35 1732003
Obesity 54.81 33.80 28 14715 1051 1730987
Large for dates baby 54.47 33.80 16 14727 123 1731915
Neutrophilia 54.45 33.80 23 14720 554 1731484
Sinus bradycardia 54.23 33.80 34 14709 1899 1730139
Cholelithiasis 54.04 33.80 41 14702 3124 1728914
Hypovolaemic shock 53.32 33.80 26 14717 882 1731156
Urine albumin/creatinine ratio abnormal 52.93 33.80 10 14733 3 1732035
Cognitive disorder 52.62 33.80 46 14697 4284 1727754
Agranulocytosis 51.72 33.80 42 14701 3534 1728504
Incorrect dose administered 51.43 33.80 58 14685 7351 1724687
Ischaemic stroke 51.21 33.80 40 14703 3182 1728856
Product monitoring error 50.94 33.80 14 14729 82 1731956
Diabetic foetopathy 50.85 33.80 11 14732 17 1732021
Bundle branch block right 50.62 33.80 28 14715 1237 1730801
Transaminases increased 50.41 33.80 43 14700 3874 1728164
White blood cell count increased 50.35 33.80 57 14686 7255 1724783
Microalbuminuria 50.22 33.80 15 14728 123 1731915
Blood triglycerides increased 49.59 33.80 36 14707 2564 1729474
Superinfection 49.58 33.80 18 14725 285 1731753
Respiratory depression 49.56 33.80 34 14709 2213 1729825
Cough 49.52 33.80 94 14649 19103 1712935
Type I hypersensitivity 49.41 33.80 18 14725 288 1731750
Melaena 49.06 33.80 48 14695 5162 1726876
Toe amputation 48.90 33.80 20 14723 443 1731595
Aphasia 48.69 33.80 40 14703 3421 1728617
Rash 48.66 33.80 143 14600 38550 1693488
Antipsychotic drug level decreased 48.50 33.80 15 14728 140 1731898
Product substitution issue 48.38 33.80 39 14704 3247 1728791
Muscular weakness 48.23 33.80 66 14677 10183 1721855
PCO2 decreased 48.10 33.80 17 14726 248 1731790
Cerebrovascular accident 47.97 33.80 89 14654 17777 1714261
Flatulence 47.88 33.80 37 14706 2897 1729141
Anion gap abnormal 47.80 33.80 11 14732 26 1732012
Actinic elastosis 47.68 33.80 10 14733 12 1732026
Brain injury 47.34 33.80 25 14718 1006 1731032
Paraesthesia 47.23 33.80 66 14677 10385 1721653
Dysstasia 47.07 33.80 30 14713 1724 1730314
Drug level above therapeutic 47.03 33.80 20 14723 490 1731548
Bile duct stent insertion 46.84 33.80 12 14731 51 1731987
Drug intolerance 46.48 33.80 50 14693 6012 1726026
Presyncope 46.17 33.80 35 14708 2663 1729375
Anaemia vitamin B12 deficiency 45.18 33.80 11 14732 36 1732002
Pancreaticoduodenectomy 45.18 33.80 11 14732 36 1732002
Azotaemia 44.93 33.80 22 14721 753 1731285
Speech disorder 44.89 33.80 43 14700 4505 1727533
Blood sodium decreased 44.17 33.80 32 14711 2272 1729766
Dyspepsia 43.38 33.80 44 14699 4941 1727097
Vitamin B12 decreased 43.04 33.80 14 14729 156 1731882
Electrocardiogram QT prolonged 42.97 33.80 46 14697 5499 1726539
Toxic encephalopathy 42.83 33.80 21 14722 721 1731317
Hyperlipidaemia 42.82 33.80 31 14712 2198 1729840
Accidental exposure to product 42.81 33.80 40 14703 4061 1727977
Liver injury 42.74 33.80 29 14714 1853 1730185
Toxic skin eruption 42.73 33.80 29 14714 1854 1730184
Neuropathy peripheral 42.65 33.80 59 14684 9194 1722844
Genital infection fungal 42.55 33.80 13 14730 116 1731922
Erythema 42.32 33.80 74 14669 14114 1717924
Eosinophilia 41.92 33.80 37 14706 3490 1728548
Gastritis 41.72 33.80 35 14708 3082 1728956
Oesophageal perforation 41.41 33.80 13 14730 128 1731910
Intestinal ischaemia 41.29 33.80 23 14720 1030 1731008
Pneumonia 41.28 33.80 152 14591 46030 1686008
Product quality issue 41.10 33.80 47 14696 6046 1725992
Hyperoxaluria 40.78 33.80 10 14733 34 1732004
Dyslipidaemia 40.72 33.80 21 14722 804 1731234
Dysuria 40.63 33.80 37 14706 3635 1728403
Potentiating drug interaction 40.51 33.80 20 14723 697 1731341
Benign prostatic hyperplasia 40.25 33.80 25 14718 1373 1730665
Blood creatine phosphokinase increased 40.12 33.80 56 14687 8800 1723238
Rash erythematous 40.10 33.80 38 14705 3927 1728111
Intentional self-injury 39.94 33.80 32 14711 2641 1729397
Abnormal loss of weight 39.91 33.80 18 14725 510 1731528
Hypernatraemia 39.77 33.80 22 14721 972 1731066
Haemoglobin decreased 39.52 33.80 80 14663 17034 1715004
Base excess decreased 39.51 33.80 10 14733 40 1731998
Haemolysis 39.31 33.80 23 14720 1132 1730906
Hypoventilation 39.30 33.80 18 14725 529 1731509
Pollakiuria 39.26 33.80 33 14710 2913 1729125
Wernicke's encephalopathy 38.70 33.80 12 14731 113 1731925
Visual impairment 38.66 33.80 46 14697 6172 1725866
Renal injury 38.60 33.80 23 14720 1171 1730867
Fixed eruption 38.49 33.80 14 14729 223 1731815
Atrial septal defect 38.38 33.80 24 14719 1334 1730704
Cardiorenal syndrome 37.86 33.80 11 14732 81 1731957
Polyneuropathy 37.39 33.80 26 14717 1729 1730309
Blindness cortical 37.28 33.80 11 14732 86 1731952
Metastases to peritoneum 36.89 33.80 15 14728 327 1731711
Cerebral haematoma 36.88 33.80 19 14724 726 1731312
Palpitations 36.87 33.80 47 14696 6767 1725271
Gastrooesophageal reflux disease 36.80 33.80 39 14704 4608 1727430
Plasmapheresis 36.32 33.80 10 14733 59 1731979
Gout 36.31 33.80 30 14713 2586 1729452
Coordination abnormal 36.23 33.80 24 14719 1473 1730565
Polymerase chain reaction 36.01 33.80 8 14735 15 1732023
Diarrhoea haemorrhagic 35.81 33.80 21 14722 1038 1731000
Abdominal distension 35.74 33.80 45 14698 6399 1725639
Osteomyelitis 35.41 33.80 28 14715 2267 1729771
Pseudomonal sepsis 35.18 33.80 15 14728 370 1731668
Hypoperfusion 35.12 33.80 13 14730 218 1731820
Acute coronary syndrome 34.77 33.80 28 14715 2327 1729711
Hypoglycaemia neonatal 34.66 33.80 14 14729 300 1731738
Leukaemoid reaction 34.27 33.80 9 14734 43 1731995
Metastases to the mediastinum 34.27 33.80 9 14734 43 1731995
Proteinuria 34.12 33.80 30 14713 2814 1729224
Urine leukocyte esterase positive 34.10 33.80 9 14734 44 1731994
Aortic aneurysm 34.02 33.80 20 14723 993 1731045
Hepatic cirrhosis 33.88 33.80 29 14714 2624 1729414

Pharmacologic Action:

SourceCodeDescription
ATC A10BA02 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Biguanides
ATC A10BD02 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD03 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD05 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD07 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD08 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD10 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD11 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD13 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD14 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD15 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD16 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD17 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD18 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 A10BD22 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD23 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD25 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
CHEBI has role CHEBI:35526 hypoglycemic agent
FDA EPC N0000175565 Biguanide
FDA CS M0002471 Biguanides
MeSH PA D007004 Hypoglycemic Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Treatment Refractory Type 2 Diabetes Mellitus indication
Gestational diabetes mellitus off-label use 11687002 DOID:11714
Polycystic ovaries off-label use 69878008
Weight loss off-label use 89362005
Prevention of Type 2 Diabetes Mellitus off-label use
Alcoholism contraindication 7200002
Weight gain finding contraindication 8943002
Asthenia contraindication 13791008
Pulmonary edema contraindication 19242006 DOID:11396
Myocardial infarction contraindication 22298006 DOID:5844
Acute vomiting contraindication 23971007
Severe adrenal insufficiency contraindication 24867002
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Dehydration contraindication 34095006
Macular retinal edema contraindication 37231002 DOID:4449
Infectious disease contraindication 40733004
Body fluid retention contraindication 43498006
End stage renal disease contraindication 46177005 DOID:784
Chronic heart failure contraindication 48447003
Lymphocytopenia contraindication 48813009 DOID:614
Hepatic porphyria contraindication 55056006 DOID:3133
Ketoacidosis contraindication 56051008
Acute nephropathy contraindication 58574008
Metabolic acidosis contraindication 59455009
Hepatic failure contraindication 59927004
Hemolytic anemia contraindication 61261009 DOID:583
Glucose-6-phosphate dehydrogenase deficiency anemia contraindication 62403005
Acute infectious disease contraindication 63171007
Osteoporosis contraindication 64859006 DOID:11476
Hypopituitarism contraindication 74728003 DOID:9406
Cardiogenic shock contraindication 89138009
Kidney disease contraindication 90708001 DOID:557
Lactic acidosis contraindication 91273001 DOID:3650
Fracture of bone contraindication 125605004
Liver function tests abnormal contraindication 166603001
Cobalamin deficiency contraindication 190634004
Angina pectoris contraindication 194828000
Decompensated cardiac failure contraindication 195111005
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Hypoglycemic disorder contraindication 237630007
Sepsis syndrome contraindication 238150007
Edema contraindication 267038008
Osteopenia contraindication 312894000
Primary adrenocortical insufficiency contraindication 373662000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Fever contraindication 386661006
Surgical procedure contraindication 387713003
Malignant tumor of urinary bladder contraindication 399326009 DOID:11054
Severe diarrhea contraindication 409587002
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Traumatic injury contraindication 417746004
Fever greater than 100.4 Fahrenheit contraindication 426000000
Radiography with IV Iodinated Contrast Agent contraindication
Prolonged-Severe Nausea and Vomiting contraindication
Severe Hypoxemia contraindication
Severe Autonomic Insufficiency contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.63 Basic
pKa2 3.34 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1GM XIGDUO XR ASTRAZENECA AB N205649 July 28, 2017 RX TABLET, EXTENDED RELEASE ORAL 6414126 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM XIGDUO XR ASTRAZENECA AB N205649 July 28, 2017 RX TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 6936590 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 9198925 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 6414126 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 6936590 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 9198925 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 RX TABLET, EXTENDED RELEASE ORAL 6414126 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 RX TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 RX TABLET, EXTENDED RELEASE ORAL 6936590 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 RX TABLET, EXTENDED RELEASE ORAL 9198925 Oct. 4, 2020 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FORTAMET ANDRX LABS LLC N021574 April 27, 2004 DISCN TABLET, EXTENDED RELEASE ORAL 6790459 March 17, 2021 METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FORTAMET ANDRX LABS LLC N021574 April 27, 2004 DISCN TABLET, EXTENDED RELEASE ORAL 6790459 March 17, 2021 METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
1GM ACTOPLUS MET XR TAKEDA PHARMS USA N022024 May 12, 2009 DISCN TABLET, EXTENDED RELEASE ORAL 6790459 March 17, 2021 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
1GM JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
1GM JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
1GM JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
500MG JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
500MG JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
500MG JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
500MG JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
1GM JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
500MG JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
500MG JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM KOMBIGLYZE XR ASTRAZENECA AB N200678 Nov. 5, 2010 RX TABLET, EXTENDED RELEASE ORAL RE44186 July 31, 2023 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH SAXAGLIPTIN AND METFORMIN IS APPROPRIATE
1GM KOMBIGLYZE XR ASTRAZENECA AB N200678 Nov. 5, 2010 RX TABLET, EXTENDED RELEASE ORAL RE44186 July 31, 2023 METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN IN COMBINATION WITH METFORMIN
500MG KOMBIGLYZE XR ASTRAZENECA AB N200678 Nov. 5, 2010 RX TABLET, EXTENDED RELEASE ORAL RE44186 July 31, 2023 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH SAXAGLIPTIN AND METFORMIN IS APPROPRIATE
500MG KOMBIGLYZE XR ASTRAZENECA AB N200678 Nov. 5, 2010 RX TABLET, EXTENDED RELEASE ORAL RE44186 July 31, 2023 METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN IN COMBINATION WITH METFORMIN
1GM QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 RX TABLET, EXTENDED RELEASE ORAL RE44186 July 31, 2023 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND, OPTIONALLY, A SULFONYLUREA
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
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
1GM KAZANO TAKEDA PHARMS USA N203414 Jan. 25, 2013 RX TABLET ORAL 8173663 March 15, 2025 METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
500MG KAZANO TAKEDA PHARMS USA N203414 Jan. 25, 2013 RX TABLET ORAL 8173663 March 15, 2025 METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
1GM INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8222219 April 11, 2025 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8222219 April 11, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8222219 April 11, 2025 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8222219 April 11, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8222219 April 11, 2025 REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8222219 April 11, 2025 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8222219 April 11, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8222219 April 11, 2025 REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8222219 April 11, 2025 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8222219 April 11, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 7326708 Nov. 24, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
500MG JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 7326708 Nov. 24, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL 7326708 Nov. 24, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
500MG JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL 7326708 Nov. 24, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
1GM XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 RX TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8513202 Dec. 3, 2027 REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8513202 Dec. 3, 2027 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8513202 Dec. 3, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8513202 Dec. 3, 2027 REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8513202 Dec. 3, 2027 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 8513202 Dec. 3, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8513202 Dec. 3, 2027 REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8513202 Dec. 3, 2027 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8513202 Dec. 3, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8513202 Dec. 3, 2027 REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8513202 Dec. 3, 2027 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 8513202 Dec. 3, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM KAZANO TAKEDA PHARMS USA N203414 Jan. 25, 2013 RX TABLET ORAL 7807689 June 27, 2028 METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
500MG KAZANO TAKEDA PHARMS USA N203414 Jan. 25, 2013 RX TABLET ORAL 7807689 June 27, 2028 METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
1GM JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 8414921 July 21, 2028 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
500MG JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL 8414921 July 21, 2028 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
1GM INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 7943582 Feb. 26, 2029 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 7943582 Feb. 26, 2029 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 7943582 Feb. 26, 2029 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL 7943582 Feb. 26, 2029 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 7943582 Feb. 26, 2029 REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 7943582 Feb. 26, 2029 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 7943582 Feb. 26, 2029 TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 7943582 Feb. 26, 2029 REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 7943582 Feb. 26, 2029 REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL 7943582 Feb. 26, 2029 TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 10022379 April 2, 2029 USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 10022379 April 2, 2029 USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 10022379 April 2, 2029 USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 10022379 April 2, 2029 USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
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
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
1GM XIGDUO XR ASTRAZENECA AB N205649 July 28, 2017 RX TABLET, EXTENDED RELEASE ORAL 8685934 May 26, 2030 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
500MG XIGDUO XR ASTRAZENECA AB N205649 Oct. 29, 2014 RX TABLET, EXTENDED RELEASE ORAL 8685934 May 26, 2030 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
1GM JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8846695 June 4, 2030 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
500MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8846695 June 4, 2030 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
850MG JENTADUETO BOEHRINGER INGELHEIM N201281 Jan. 30, 2012 RX TABLET ORAL 8846695 June 4, 2030 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
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
1GM SEGLUROMET MERCK SHARP DOHME N209806 Dec. 19, 2017 RX TABLET ORAL 8080580 July 13, 2030 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
500MG SEGLUROMET MERCK SHARP DOHME N209806 Dec. 19, 2017 RX TABLET ORAL 8080580 July 13, 2030 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
1GM SEGLUROMET MERCK SHARP DOHME N209806 Dec. 19, 2017 RX TABLET ORAL 9439902 Oct. 21, 2030 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
500MG SEGLUROMET MERCK SHARP DOHME N209806 Dec. 19, 2017 RX TABLET ORAL 9439902 Oct. 21, 2030 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 9555001 March 6, 2033 METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WHO HAVE NOT BEEN PREVIOUSLY TREATED WITH AN ANTIHYPERGLYCEMIC AGENT BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM JENTADUETO XR BOEHRINGER INGELHEIM N208026 May 27, 2016 RX TABLET, EXTENDED RELEASE ORAL 9555001 March 6, 2033 METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH ONE OR MORE CONVENTIONAL ANTIHYPERGLYCEMIC AGENTS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
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
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
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
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
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
1GM TRIJARDY XR BOEHRINGER INGELHEIM N212614 Jan. 27, 2020 RX TABLET, EXTENDED RELEASE ORAL 9949998 June 11, 2034 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1GM INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL Feb. 1, 2020 NEW CLINICAL DATA ADDED TO THE PRESCRIBING INFORMATION REGARDING CANAGLIFLOZIN ADD-ON COMBINATION THERAPY WITH METFORMIN AND A DIPEPTIDYL-PEPTIDASE-4 INHIBITOR
500MG INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL Feb. 1, 2020 NEW CLINICAL DATA ADDED TO THE PRESCRIBING INFORMATION REGARDING CANAGLIFLOZIN ADD-ON COMBINATION THERAPY WITH METFORMIN AND A DIPEPTIDYL-PEPTIDASE-4 INHIBITOR
1GM KOMBIGLYZE XR ASTRAZENECA AB N200678 Nov. 5, 2010 RX TABLET, EXTENDED RELEASE ORAL Feb. 27, 2020 PACKAGE INSERT UPDATED WITH RESULTS FROM STUDY CV181168, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF SAXAGLIPTIN ADDED TO DAPAGLIFLOZIN AND METFORMIN
500MG KOMBIGLYZE XR ASTRAZENECA AB N200678 Nov. 5, 2010 RX TABLET, EXTENDED RELEASE ORAL Feb. 27, 2020 PACKAGE INSERT UPDATED WITH RESULTS FROM STUDY CV181168, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF SAXAGLIPTIN ADDED TO DAPAGLIFLOZIN AND METFORMIN
1GM INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL Oct. 29, 2021 NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD)
500MG INVOKAMET JANSSEN PHARMS N204353 Aug. 8, 2014 RX TABLET ORAL Oct. 29, 2021 NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD)
1GM INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL Oct. 29, 2021 NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD)
500MG INVOKAMET XR JANSSEN PHARMS N205879 Sept. 20, 2016 RX TABLET, EXTENDED RELEASE ORAL Oct. 29, 2021 NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD)
1GM QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 RX TABLET, EXTENDED RELEASE ORAL May 2, 2022 NEW PRODUCT
1GM SEGLUROMET MERCK SHARP DOHME N209806 Dec. 19, 2017 RX TABLET ORAL Dec. 19, 2022 NEW CHEMICAL ENTITY
500MG SEGLUROMET MERCK SHARP DOHME N209806 Dec. 19, 2017 RX TABLET ORAL Dec. 19, 2022 NEW CHEMICAL ENTITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Mitochondrial complex I (NADH dehydrogenase) Enzyme INHIBITOR CHEMBL CHEMBL
Dipeptidyl peptidase 4 Enzyme IC50 4.54 CHEMBL
5'-AMP-activated protein kinase subunit beta-1 Kinase WOMBAT-PK
Solute carrier family 22 member 3 Transporter Km 2.50 WOMBAT-PK
Solute carrier family 22 member 2 Transporter IC50 3.40 WOMBAT-PK
Solute carrier family 22 member 1 Transporter IC50 2.70 WOMBAT-PK

External reference:

IDSource
4023979 VUID
N0000021984 NUI
C0025598 UMLSCUI
D00944 KEGG_DRUG
786Z46389E UNII
1115-70-4 SECONDARY_CAS_RN
109081006 SNOMEDCT_US
6809 RXNORM
372567009 SNOMEDCT_US
4023979 VANDF
004534 NDDF
d03807 MMSL
965 INN_ID
4091 PUBCHEM_CID
CHEBI:6801 CHEBI
CHEMBL1431 ChEMBL_ID
DB00331 DRUGBANK_ID
CHEMBL1703 ChEMBL_ID
MF8 PDB_CHEM_ID
D008687 MESH_DESCRIPTOR_UI
4779 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-0078 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL NDA 19 sections
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-0080 TABLET, FILM COATED, EXTENDED RELEASE 1000 mg ORAL NDA 19 sections
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-0081 TABLET, FILM COATED, EXTENDED RELEASE 1000 mg ORAL NDA 19 sections
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-0575 TABLET, FILM COATED 500 mg ORAL NDA 19 sections
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-0577 TABLET, FILM COATED 1000 mg ORAL NDA 19 sections
SEGLUROMET HUMAN PRESCRIPTION DRUG LABEL 1 0006-5369 TABLET, FILM COATED 500 mg ORAL NDA 20 sections
SEGLUROMET HUMAN PRESCRIPTION DRUG LABEL 1 0006-5370 TABLET, FILM COATED 500 mg ORAL NDA 20 sections
SEGLUROMET HUMAN PRESCRIPTION DRUG LABEL 1 0006-5373 TABLET, FILM COATED 1000 mg ORAL NDA 20 sections
SEGLUROMET HUMAN PRESCRIPTION DRUG LABEL 1 0006-5374 TABLET, FILM COATED 1000 mg ORAL NDA 20 sections
GLUCOPHAGE HUMAN PRESCRIPTION DRUG LABEL 1 0087-6060 TABLET, FILM COATED 500 mg ORAL NDA 18 sections
GLUCOPHAGE HUMAN PRESCRIPTION DRUG LABEL 1 0087-6063 TABLET, EXTENDED RELEASE 500 mg ORAL NDA 18 sections
GLUCOPHAGE HUMAN PRESCRIPTION DRUG LABEL 1 0087-6064 TABLET, EXTENDED RELEASE 750 mg ORAL NDA 18 sections
GLUCOPHAGE HUMAN PRESCRIPTION DRUG LABEL 1 0087-6070 TABLET, FILM COATED 850 mg ORAL NDA 18 sections
GLUCOPHAGE HUMAN PRESCRIPTION DRUG LABEL 1 0087-6071 TABLET, FILM COATED 1000 mg ORAL NDA 18 sections
Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-7212 TABLET, EXTENDED RELEASE 750 mg ORAL ANDA 13 sections
Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-7267 TABLET, EXTENDED RELEASE 500 mg ORAL ANDA 13 sections
Glipizide and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0093-7455 TABLET, FILM COATED 250 mg ORAL ANDA 13 sections
Glipizide and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0093-7456 TABLET, FILM COATED 500 mg ORAL ANDA 13 sections
Glipizide and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0093-7457 TABLET, FILM COATED 500 mg ORAL ANDA 13 sections
metformin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0185-4416 TABLET, EXTENDED RELEASE 500 mg ORAL ANDA 18 sections
Glyburide and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0228-2751 TABLET, FILM COATED 250 mg ORAL ANDA 14 sections
Glyburide and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0228-2752 TABLET, FILM COATED 500 mg ORAL ANDA 14 sections
Glyburide and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0228-2753 TABLET, FILM COATED 500 mg ORAL ANDA 14 sections
KOMBIGLYZE HUMAN PRESCRIPTION DRUG LABEL 2 0310-6125 TABLET, FILM COATED, EXTENDED RELEASE 1000 mg ORAL NDA 18 sections
KOMBIGLYZE HUMAN PRESCRIPTION DRUG LABEL 2 0310-6135 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL NDA 18 sections
KOMBIGLYZE HUMAN PRESCRIPTION DRUG LABEL 2 0310-6145 TABLET, FILM COATED, EXTENDED RELEASE 1000 mg ORAL NDA 18 sections
XIGDUO HUMAN PRESCRIPTION DRUG LABEL 2 0310-6225 TABLET, FILM COATED, EXTENDED RELEASE 1000 mg ORAL NDA 19 sections
XIGDUO HUMAN PRESCRIPTION DRUG LABEL 2 0310-6250 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL NDA 19 sections
XIGDUO HUMAN PRESCRIPTION DRUG LABEL 2 0310-6260 TABLET, FILM COATED, EXTENDED RELEASE 1000 mg ORAL NDA 19 sections
XIGDUO HUMAN PRESCRIPTION DRUG LABEL 2 0310-6270 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL NDA 19 sections