sitagliptin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
dipeptidyl aminopeptidase-IV inhibitors 2448 486460-32-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sitagliptin
  • sitagliptin phosphate
  • januvia
  • ristaben
  • sitagliptin phosphate hydrate
  • sitagliptin phosphate monohydrate
  • MK-0431
  • MK 0431
  • sitagliptin monophosphate monohydrate
  • sitagliptin phosphate anhydrous
  • sitagliptin hydrochloride monohydrate
A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES.
  • Molecular weight: 407.32
  • Formula: C16H15F6N5O
  • CLOGP: 0.69
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 77.04
  • ALOGS: -4.08
  • ROTB: 5

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
0.10 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 78 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.35 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 87 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 6 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.62 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 12 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 20, 2007 EMA MERCK SHARP DOHME
Oct. 16, 2006 FDA MERCK SHARP DOHME

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
Blood glucose increased 823.17 11.24 660 55382 70664 50478418
Pancreatitis 595.38 11.24 442 55600 42172 50506910
Hypoglycaemia 563.51 11.24 470 55572 53111 50495971
Diabetes mellitus inadequate control 484.46 11.24 253 55789 12892 50536190
Pancreatic carcinoma 464.31 11.24 195 55847 6019 50543063
Glycosylated haemoglobin increased 290.93 11.24 168 55874 10438 50538644
Carotid artery thrombosis 263.13 11.24 88 55954 1411 50547671
Pancreatic carcinoma metastatic 258.70 11.24 94 55948 1948 50547134
Neurologic neglect syndrome 253.58 11.24 85 55957 1373 50547709
Lactic acidosis 250.20 11.24 242 55800 33113 50515969
Personality disorder 217.93 11.24 103 55939 4221 50544861
Adjustment disorder 215.66 11.24 82 55960 1937 50547145
Diabetic ketoacidosis 211.29 11.24 168 55874 17704 50531378
Hemiplegia 197.33 11.24 115 55927 7266 50541816
Pemphigoid 195.87 11.24 106 55936 5801 50543281
Acute kidney injury 178.07 11.24 606 55436 227452 50321630
Pancreatitis acute 173.36 11.24 170 55872 23642 50525440
Blood glucose abnormal 173.22 11.24 102 55940 6570 50542512
Affect lability 149.96 11.24 104 55938 8894 50540188
Contraindicated product administered 142.71 11.24 5 56037 148953 50400129
Sensory loss 125.59 11.24 88 55954 7650 50541432
Motor dysfunction 124.94 11.24 89 55953 7942 50541140
Systemic lupus erythematosus 124.18 11.24 8 56034 140614 50408468
Hyperglycaemia 123.86 11.24 176 55866 36229 50512853
No adverse event 118.19 11.24 165 55877 33413 50515669
Product dose omission issue 115.06 11.24 455 55587 183383 50365699
Drug intolerance 114.00 11.24 50 55992 219054 50330028
Treatment failure 112.69 11.24 11 56031 137626 50411456
Off label use 112.11 11.24 223 55819 474203 50074879
Ketoacidosis 107.60 11.24 62 55980 3833 50545249
Coordination abnormal 102.48 11.24 92 55950 11442 50537640
Bile duct stent insertion 98.92 11.24 21 56021 42 50549040
Maternal exposure during pregnancy 97.52 11.24 28 56014 159750 50389332
Blood glucose decreased 96.84 11.24 110 55932 18101 50530981
Synovitis 96.08 11.24 12 56030 123853 50425229
Muscle spasticity 93.43 11.24 105 55937 17079 50532003
Adenocarcinoma pancreas 93.17 11.24 37 56005 985 50548097
Glossodynia 92.62 11.24 10 56032 115559 50433523
Product residue present 92.34 11.24 55 55987 3617 50545465
Euglycaemic diabetic ketoacidosis 89.06 11.24 49 55993 2770 50546312
Blood glucose fluctuation 88.68 11.24 56 55986 4090 50544992
Therapeutic product effect decreased 88.44 11.24 21 56021 136029 50413053
Hemiparesis 86.71 11.24 109 55933 19939 50529143
Lipase increased 85.67 11.24 73 55969 8468 50540614
Eating disorder 85.22 11.24 95 55947 15314 50533768
Drug ineffective 84.19 11.24 548 55494 818785 49730297
Aphasia 82.88 11.24 128 55914 28366 50520716
Infusion related reaction 80.11 11.24 44 55998 169513 50379569
Pain 78.21 11.24 353 55689 578550 49970532
Pancreaticoduodenectomy 77.76 11.24 15 56027 13 50549069
Joint swelling 74.00 11.24 98 55944 245188 50303894
Arthropathy 73.12 11.24 42 56000 157864 50391218
Wrong technique in product usage process 72.84 11.24 178 55864 55332 50493750
Hyperkalaemia 69.37 11.24 160 55882 47929 50501153
Pericarditis 67.91 11.24 5 56037 78684 50470398
Product use issue 67.45 11.24 41 56001 149434 50399648
Lung diffusion test abnormal 59.84 11.24 17 56025 152 50548930
Hand deformity 58.51 11.24 19 56023 100180 50448902
Exposure during pregnancy 57.73 11.24 31 56011 120984 50428098
Cerebrovascular accident 55.66 11.24 230 55812 94450 50454632
Toxicity to various agents 55.25 11.24 94 55948 212405 50336677
Dysarthria 54.55 11.24 125 55917 37278 50511804
Muscular weakness 52.89 11.24 227 55815 94786 50454296
Metastases to liver 52.52 11.24 86 55956 20018 50529064
Dysphagia 51.76 11.24 196 55846 77322 50471760
Lower respiratory tract infection 50.61 11.24 21 56021 95180 50453902
Alopecia 48.89 11.24 126 55916 244921 50304161
Gangrene 46.85 11.24 40 56002 4652 50544430
Hypoglycaemic coma 46.15 11.24 30 56012 2303 50546779
Arterial occlusive disease 43.99 11.24 39 56003 4769 50544313
Drug abuse 43.57 11.24 7 56035 59839 50489243
Product packaging quantity issue 43.27 11.24 22 56020 1058 50548024
Temperature perception test abnormal 43.09 11.24 9 56033 16 50549066
Pancreatitis chronic 42.58 11.24 28 56014 2192 50546890
Wound 42.41 11.24 33 56009 105761 50443321
MELAS syndrome 42.07 11.24 12 56030 109 50548973
Pneumobilia 41.88 11.24 12 56030 111 50548971
Rhinorrhoea 41.79 11.24 139 55903 51444 50497638
Adverse event 41.01 11.24 124 55918 43639 50505443
Product use in unapproved indication 40.57 11.24 41 56001 115778 50433304
Musculoskeletal stiffness 39.03 11.24 51 55991 128430 50420652
Skin haemorrhage 38.85 11.24 43 55999 6875 50542207
Pancreatectomy 37.36 11.24 8 56034 17 50549065
Sinus congestion 36.81 11.24 60 55982 13911 50535171
Hypersensitivity 36.78 11.24 119 55923 215042 50334040
Metabolic acidosis 35.43 11.24 109 55933 38716 50510366
Swelling 35.10 11.24 110 55932 200762 50348320
Seronegative arthritis 34.75 11.24 24 56018 2037 50547045
Completed suicide 34.56 11.24 58 55984 131831 50417251
Diabetic metabolic decompensation 34.20 11.24 21 56021 1459 50547623
Haemoglobin increased 34.09 11.24 28 56014 3087 50545995
Neutropenia 32.73 11.24 72 55970 147893 50401189
Nausea 32.71 11.24 1016 55026 704382 49844700
Renal cyst 32.53 11.24 44 55998 8643 50540439
Bursitis infective 32.38 11.24 19 56023 1215 50547867
Injection site erythema 31.81 11.24 22 56020 74914 50474168
Radiotherapy 30.99 11.24 12 56030 298 50548784
Discomfort 30.93 11.24 45 55997 108335 50440747
Renal disorder 30.69 11.24 83 55959 27422 50521660
Genital infection female 30.60 11.24 9 56033 92 50548990
Cerebral infarction 30.18 11.24 71 55971 21533 50527549
Abdominal discomfort 30.08 11.24 143 55899 231498 50317584
Tubulointerstitial nephritis and uveitis syndrome 29.57 11.24 10 56032 166 50548916
Pancreatic mass 28.72 11.24 15 56027 763 50548319
Diabetic neuropathy 28.70 11.24 27 56015 3564 50545518
Anuria 27.89 11.24 47 55995 11197 50537885
Urine ketone body present 27.71 11.24 22 56020 2311 50546771
Mixed liver injury 27.68 11.24 26 56016 3425 50545657
Drug hypersensitivity 27.56 11.24 164 55878 250846 50298236
Diabetes mellitus 27.15 11.24 117 55925 48916 50500166
Multiple drug therapy 26.80 11.24 20 56022 1917 50547165
Decreased vibratory sense 26.38 11.24 10 56032 234 50548848
Helicobacter infection 26.35 11.24 11 56031 49691 50499391
Tonsillectomy 25.95 11.24 14 56028 761 50548321
Oedema peripheral 25.80 11.24 278 55764 157683 50391399
Tubulointerstitial nephritis 25.76 11.24 54 55988 15157 50533925
Hepatic enzyme increased 25.59 11.24 73 55969 137307 50411775
Circumstance or information capable of leading to medication error 25.53 11.24 24 56018 3164 50545918
Diarrhoea 25.49 11.24 841 55201 587635 49961447
Hypoglycaemic encephalopathy 25.12 11.24 10 56032 268 50548814
Pancreatic stent placement 25.10 11.24 5 56037 6 50549076
Arthralgia 24.67 11.24 340 55702 438362 50110720
Insulin-requiring type 2 diabetes mellitus 24.41 11.24 7 56035 65 50549017
Abdominal pain 24.35 11.24 382 55660 235846 50313236
Product prescribing error 24.14 11.24 64 55978 20897 50528185
Explorative laparotomy 23.96 11.24 6 56036 31 50549051
General physical health deterioration 23.41 11.24 251 55791 142183 50406899
Irritable bowel syndrome 23.34 11.24 14 56028 51427 50497655
Splenic vein occlusion 23.23 11.24 4 56038 0 50549082
Dizziness 23.22 11.24 524 55518 345845 50203237
Prevertebral soft tissue swelling of cervical space 23.21 11.24 6 56036 36 50549046
Joint noise 23.14 11.24 24 56018 3563 50545519
Intentional product use issue 22.87 11.24 31 56011 76887 50472195
Anaemia vitamin B12 deficiency 22.81 11.24 10 56032 343 50548739
Peripheral artery haematoma 22.80 11.24 6 56036 39 50549043
Hepatic steatosis 22.75 11.24 69 55973 24315 50524767
Amylase increased 22.64 11.24 29 56013 5401 50543681
Blood pressure inadequately controlled 22.51 11.24 26 56016 4354 50544728
Impaired healing 21.91 11.24 27 56015 69759 50479323
Sinus disorder 21.91 11.24 57 55985 18401 50530681
Flatulence 21.77 11.24 77 55965 29381 50519701
Pancreatic pseudocyst 21.52 11.24 11 56031 535 50548547
Respiratory tract congestion 21.30 11.24 48 55994 14151 50534931
Aortic arteriosclerosis 21.28 11.24 28 56014 5354 50543728
Bladder trabeculation 21.09 11.24 6 56036 54 50549028
Metastases to lymph nodes 21.04 11.24 32 56010 6992 50542090
Hysterectomy 20.94 11.24 34 56008 7856 50541226
Migraine 20.75 11.24 32 56010 75248 50473834
Tri-iodothyronine free decreased 20.74 11.24 9 56033 301 50548781
Internal haemorrhage 20.68 11.24 25 56017 4392 50544690
Pancreatic duct dilatation 20.58 11.24 8 56034 201 50548881
Asthenia 20.54 11.24 480 55562 318562 50230520
Sneezing 20.54 11.24 47 55995 13997 50535085
Multiple sclerosis relapse 20.48 11.24 11 56031 42953 50506129
Glomerular filtration rate decreased 20.48 11.24 42 56000 11610 50537472
Febrile neutropenia 20.39 11.24 49 55993 97618 50451464
Abdominal pain upper 20.13 11.24 267 55775 159042 50390040
Infection 20.04 11.24 111 55931 172843 50376239
Intestinal transit time abnormal 19.76 11.24 6 56036 69 50549013
Dehydration 19.47 11.24 256 55786 152193 50396889
Condition aggravated 19.37 11.24 223 55819 296835 50252247
Splenectomy 19.29 11.24 10 56032 501 50548581
Incisional hernia repair 19.19 11.24 4 56038 7 50549075
Intensive care unit acquired weakness 19.00 11.24 11 56031 686 50548396
Rheumatoid arthritis 18.86 11.24 139 55903 202411 50346671
Pancreatic cyst 18.79 11.24 14 56028 1339 50547743
Exercise tolerance decreased 18.72 11.24 25 56017 4849 50544233
Blood creatinine increased 18.49 11.24 146 55896 76014 50473068
Leukopenia 18.33 11.24 29 56013 67499 50481583
Haematochezia 18.25 11.24 90 55952 39792 50509290
Peripheral vascular disorder 17.95 11.24 26 56016 5441 50543641
Therapy non-responder 17.93 11.24 18 56024 51004 50498078
Cholelithiasis 17.60 11.24 86 55956 37887 50511195
Seizure 17.58 11.24 69 55973 117805 50431277
Injury 17.49 11.24 17 56025 48908 50500174
Radiotherapy to pancreas 17.42 11.24 3 56039 0 50549082
Biliary obstruction 17.25 11.24 17 56025 2376 50546706
Weight decreased 17.15 11.24 342 55700 220903 50328179
Muscle atrophy 17.10 11.24 27 56015 6094 50542988
Flushing 17.06 11.24 30 56012 66985 50482097
Endometrial disorder 16.98 11.24 10 56032 644 50548438
Increased appetite 16.95 11.24 32 56010 8329 50540753
Infusion site scar 16.92 11.24 8 56034 328 50548754
Altered state of consciousness 16.82 11.24 58 55984 21852 50527230
Micturition disorder 16.77 11.24 15 56027 1856 50547226
Mucosal inflammation 16.75 11.24 12 56030 40130 50508952
Urine albumin/creatinine ratio increased 16.69 11.24 7 56035 215 50548867
Fear-related avoidance of activities 16.66 11.24 6 56036 121 50548961
Dysuria 16.54 11.24 69 55973 28435 50520647
Myalgia 16.39 11.24 210 55832 124109 50424973
Ill-defined disorder 16.28 11.24 22 56020 54632 50494450
Injection site reaction 16.08 11.24 19 56023 50013 50499069
Psoriatic arthropathy 16.06 11.24 17 56025 47015 50502067
Impaired work ability 16.06 11.24 42 56000 13598 50535484
Vision blurred 16.04 11.24 145 55897 78502 50470580
Angina pectoris 15.67 11.24 64 55978 26124 50522958
Skin exfoliation 15.49 11.24 76 55966 33536 50515546
Stomatitis 15.32 11.24 59 55983 101285 50447797
Gastric disorder 15.21 11.24 69 55973 29479 50519603
Renal impairment 15.17 11.24 139 55903 75522 50473560
Cataract 15.17 11.24 97 55945 47203 50501879
Diabetic complication 15.15 11.24 10 56032 788 50548294
Sinusitis 14.95 11.24 119 55923 170439 50378643
Pancreatic neuroendocrine tumour 14.94 11.24 7 56035 281 50548801
Peripheral swelling 14.85 11.24 151 55891 205785 50343297
Acidosis 14.71 11.24 34 56008 10193 50538889
Injection site pain 14.70 11.24 68 55974 110956 50438126
Pancreatitis necrotising 14.47 11.24 12 56030 1341 50547741
Bile duct stone 14.33 11.24 18 56024 3289 50545793
Radioallergosorbent test positive 14.26 11.24 4 56038 34 50549048
Glycosylated haemoglobin decreased 14.19 11.24 8 56034 474 50548608
Glycosylated haemoglobin abnormal 14.16 11.24 5 56037 95 50548987
Hyperlipidaemia 14.04 11.24 47 55995 17443 50531639
Meibomianitis 13.96 11.24 4 56038 37 50549045
Hyperthermia 13.83 11.24 28 56014 7668 50541414
Pancreatic neoplasm 13.73 11.24 9 56033 701 50548381
Tongue oedema 13.70 11.24 19 56023 3820 50545262
Hunger 13.60 11.24 20 56022 4243 50544839
Rash pruritic 13.47 11.24 95 55947 47751 50501331
Coma acidotic 13.40 11.24 5 56037 112 50548970
Blister 13.38 11.24 49 55993 85369 50463713
Acquired mitochondrial DNA mutation 13.27 11.24 3 56039 9 50549073
Disease recurrence 13.23 11.24 3 56039 20078 50529004
Vomiting 13.19 11.24 630 55412 460128 50088954
Carcinoid crisis 13.19 11.24 6 56036 225 50548857
Oedema 13.11 11.24 127 55915 70054 50479028
Peripheral sensorimotor neuropathy 13.09 11.24 11 56031 1251 50547831
Fatigue 13.03 11.24 646 55396 706955 49842127
Palpitations 13.03 11.24 161 55881 94345 50454737
Sedation 12.97 11.24 9 56033 30601 50518481
Product colour issue 12.96 11.24 8 56034 561 50548521
Adverse drug reaction 12.93 11.24 26 56016 55196 50493886
Hepatic cancer 12.89 11.24 17 56025 3258 50545824
Pulmonary haematoma 12.87 11.24 4 56038 50 50549032
Diabetic retinopathy 12.87 11.24 14 56028 2196 50546886
Adrenal mass 12.83 11.24 9 56033 783 50548299
Hip arthroplasty 12.82 11.24 9 56033 30420 50518662
Renal failure 12.75 11.24 177 55865 106456 50442626
Device dislocation 12.72 11.24 4 56038 21542 50527540
Nephroangiosclerosis 12.59 11.24 5 56037 133 50548949
Pancreatic carcinoma stage IV 12.53 11.24 6 56036 253 50548829
Infusion site rash 12.51 11.24 11 56031 1331 50547751
Rhabdomyolysis 12.49 11.24 80 55962 38947 50510135
Enterococcus test positive 12.48 11.24 10 56032 1064 50548018
Loss of personal independence in daily activities 12.47 11.24 38 56004 70012 50479070
Reperfusion injury 12.39 11.24 4 56038 57 50549025
Portal fibrosis 12.29 11.24 6 56036 264 50548818
Gout 12.18 11.24 34 56008 11436 50537646
Pancreatic atrophy 12.09 11.24 5 56037 148 50548934
Renal cancer metastatic 12.07 11.24 6 56036 275 50548807
Infrequent bowel movements 11.97 11.24 10 56032 1128 50547954
Angioedema 11.92 11.24 77 55965 37599 50511483
Splenic granuloma 11.90 11.24 3 56039 16 50549066
Oral mucosal discolouration 11.87 11.24 6 56036 285 50548797
Pancreatic enzymes increased 11.79 11.24 8 56034 660 50548422
Vitamin B12 decreased 11.68 11.24 15 56027 2800 50546282
Metastases to peritoneum 11.61 11.24 15 56027 2818 50546264
Oesophageal mucosal tear 11.60 11.24 3 56039 18 50549064
Fibromyalgia 11.57 11.24 20 56022 44958 50504124
Cardiac failure 11.56 11.24 132 55910 75908 50473174
Product size issue 11.49 11.24 6 56036 305 50548777
Intraductal papillary mucinous neoplasm 11.47 11.24 6 56036 306 50548776
Premature delivery 11.36 11.24 6 56036 23657 50525425
Appendicectomy 11.36 11.24 14 56028 2508 50546574
Vitamin D deficiency 11.33 11.24 33 56009 11369 50537713
Cholecystectomy 11.32 11.24 29 56013 9274 50539808
Inability to afford medication 11.27 11.24 11 56031 1519 50547563

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
Pancreatitis 648.66 10.88 512 50794 34002 29489219
Hypoglycaemia 510.84 10.88 518 50788 47828 29475393
Pancreatic carcinoma 439.92 10.88 225 51081 6925 29516296
Blood glucose increased 411.53 10.88 509 50797 58475 29464746
Pancreatic carcinoma metastatic 336.08 10.88 139 51167 2582 29520639
Diabetes mellitus inadequate control 324.79 10.88 223 51083 11911 29511310
Pancreatitis acute 217.53 10.88 239 51067 24146 29499075
Glycosylated haemoglobin increased 214.66 10.88 157 51149 9269 29513952
Adenocarcinoma pancreas 176.47 10.88 70 51236 1161 29522060
Diabetic ketoacidosis 174.53 10.88 175 51131 15898 29507323
Pancreaticoduodenectomy 158.20 10.88 34 51272 35 29523186
Lactic acidosis 136.74 10.88 212 51094 30035 29493186
Drug abuse 124.26 10.88 3 51303 79880 29443341
Metastases to liver 121.25 10.88 125 51181 11731 29511490
Bile duct stent insertion 116.13 10.88 27 51279 51 29523170
No adverse event 110.80 10.88 144 51162 17334 29505887
Lipase increased 109.83 10.88 101 51205 8236 29514985
Pemphigoid 108.05 10.88 96 51210 7485 29515736
Toxicity to various agents 107.91 10.88 86 51220 173575 29349646
Hyperglycaemia 104.65 10.88 202 51104 34085 29489136
Pancreatectomy 101.83 10.88 21 51285 14 29523207
Radiotherapy 99.47 10.88 33 51273 317 29522904
Product monitoring error 96.30 10.88 59 51247 2586 29520635
Off label use 92.34 10.88 245 51061 300555 29222666
Blood glucose abnormal 90.16 10.88 73 51233 5010 29518211
General physical health deterioration 88.38 10.88 383 50923 102474 29420747
Bladder cancer 82.97 10.88 95 51211 10032 29513189
Interstitial lung disease 80.02 10.88 251 51055 57467 29465754
Ketoacidosis 76.97 10.88 58 51248 3581 29519640
Euglycaemic diabetic ketoacidosis 71.91 10.88 49 51257 2581 29520640
Pancreatitis chronic 70.69 10.88 44 51262 1984 29521237
Hyperlipidaemia 60.75 10.88 91 51215 12499 29510722
Product dose omission issue 60.46 10.88 328 50978 96055 29427166
Pancreatic stent placement 60.13 10.88 12 51294 5 29523216
Glycosylated haemoglobin abnormal 53.95 10.88 16 51290 102 29523119
Explorative laparotomy 53.75 10.88 12 51294 17 29523204
Renal cyst 53.01 10.88 67 51239 7840 29515381
Product use in unapproved indication 51.43 10.88 45 51261 86830 29436391
Blood glucose decreased 50.92 10.88 82 51224 11987 29511234
Cerebral infarction 49.70 10.88 123 51183 24552 29498669
Hyperkalaemia 48.43 10.88 223 51083 61169 29462052
Cholelithiasis 46.30 10.88 101 51205 18571 29504650
Biliary sphincterotomy 43.06 10.88 9 51297 7 29523214
Febrile neutropenia 42.80 10.88 81 51225 112159 29411062
Seronegative arthritis 42.56 10.88 24 51282 900 29522321
Prostatomegaly 42.07 10.88 46 51260 4615 29518606
Neutropenia 42 10.88 105 51201 131606 29391615
Diverticulum intestinal 41.67 10.88 39 51267 3251 29519970
Amylase increased 40.68 10.88 48 51258 5232 29517989
Diabetic foetopathy 40.59 10.88 15 51291 203 29523018
Blood glucose fluctuation 40.57 10.88 40 51266 3557 29519664
Insulin-requiring type 2 diabetes mellitus 39.84 10.88 13 51293 118 29523103
Cholecystectomy 39.28 10.88 33 51273 2384 29520837
Circumstance or information capable of leading to medication error 38.39 10.88 27 51279 1497 29521724
Product residue present 37.87 10.88 33 51273 2506 29520715
Therapeutic drug monitoring analysis not performed 37.80 10.88 18 51288 472 29522749
Pancreatic enzymes increased 37.71 10.88 19 51287 565 29522656
Metabolic acidosis 37.60 10.88 147 51159 37515 29485706
Diabetic nephropathy 35.27 10.88 28 51278 1867 29521354
Acute kidney injury 34.66 10.88 649 50657 264618 29258603
Pancreatic cyst 33.53 10.88 19 51287 719 29522502
Metastases to lymph nodes 33.43 10.88 38 51268 3979 29519242
Splenectomy 31.62 10.88 15 51291 390 29522831
Electrolyte imbalance 31.45 10.88 64 51242 11210 29512011
Thirst 31.43 10.88 47 51259 6444 29516777
Diabetes mellitus 30.89 10.88 144 51162 39687 29483534
Wrong technique in product usage process 30.83 10.88 122 51184 31306 29491915
Glycosylated haemoglobin decreased 30.81 10.88 14 51292 329 29522892
Dizziness 30.50 10.88 480 50826 189204 29334017
Large for dates baby 30.30 10.88 19 51287 868 29522353
Death 29.61 10.88 417 50889 341667 29181554
Dyslipidaemia 29.51 10.88 44 51262 6017 29517204
Autoimmune pancreatitis 29.48 10.88 13 51293 284 29522937
Pancreatic disorder 29.15 10.88 23 51283 1520 29521701
Gastroenterostomy 28.28 10.88 8 51298 42 29523179
Mucosal inflammation 27.82 10.88 10 51296 31585 29491636
Weight decreased 27.01 10.88 389 50917 150516 29372705
Pancreatitis necrotising 26.28 10.88 26 51280 2321 29520900
Hypoglycaemic coma 26.17 10.88 25 51281 2138 29521083
Drug ineffective 25.95 10.88 459 50847 362711 29160510
Gastrooesophageal reflux disease 25.26 10.88 115 51191 31381 29491840
Metastases to peritoneum 25.21 10.88 21 51285 1499 29521722
Pyrexia 25.07 10.88 350 50956 287272 29235949
Disease progression 24.79 10.88 67 51239 81849 29441372
Alcoholic ketoacidosis 24.66 10.88 6 51300 15 29523206
Pancreatic pseudocyst 24.51 10.88 16 51290 784 29522437
Polyuria 24.46 10.88 45 51261 7317 29515904
Pancreatic carcinoma recurrent 24.38 10.88 6 51300 16 29523205
Pancreatic mass 23.81 10.88 16 51290 823 29522398
Adverse event 23.51 10.88 69 51237 15222 29507999
Biliary dilatation 23.48 10.88 15 51291 708 29522513
Hyperlipasaemia 23.38 10.88 13 51293 474 29522747
Pyelitis 22.52 10.88 8 51298 96 29523125
Diabetic neuropathy 22.35 10.88 30 51276 3723 29519498
Angioedema 22.31 10.88 112 51194 31803 29491418
Completed suicide 22.24 10.88 81 51225 90165 29433056
Tonsillectomy 21.99 10.88 11 51295 322 29522899
Knee operation 21.69 10.88 19 51287 1453 29521768
Aortic arteriosclerosis 21.59 10.88 30 51276 3846 29519375
Food aversion 21.53 10.88 11 51295 337 29522884
Intestinal adhesion lysis 21.44 10.88 4 51302 0 29523221
Radiotherapy to pancreas 21.44 10.88 4 51302 0 29523221
Pemphigus 21.19 10.88 17 51289 1151 29522070
Pancreatolithiasis 21.03 10.88 7 51299 68 29523153
Vomiting projectile 20.87 10.88 13 51293 587 29522634
Alopecia universalis 20.85 10.88 7 51299 70 29523151
Malignant ascites 20.70 10.88 11 51295 366 29522855
Drug resistance 20.40 10.88 6 51300 21534 29501687
Diverticulum 20.15 10.88 38 51268 6294 29516927
Seizure 20.15 10.88 88 51218 93035 29430186
Rhabdomyolysis 20.14 10.88 177 51129 60631 29462590
Hyperlactacidaemia 20.06 10.88 24 51282 2654 29520567
Pneumobilia 19.87 10.88 6 51300 41 29523180
Vena cava filter insertion 19.65 10.88 5 51301 16 29523205
Cytomegalovirus infection 19.35 10.88 8 51298 23207 29500014
Urticaria chronic 19.34 10.88 7 51299 89 29523132
Lower respiratory tract infection 19.26 10.88 11 51295 26491 29496730
Phlebolith 19.20 10.88 4 51302 3 29523218
Ductal adenocarcinoma of pancreas 19.19 10.88 5 51301 18 29523203
Metastases to lung 18.91 10.88 42 51264 7813 29515408
Renal impairment 18.88 10.88 220 51086 81113 29442108
Prostatic calcification 18.79 10.88 7 51299 97 29523124
Staphylococcal infection 18.72 10.88 14 51292 29226 29493995
Eczema asteatotic 18.61 10.88 8 51298 164 29523057
Urine ketone body present 18.47 10.88 15 51291 1033 29522188
Diabetic metabolic decompensation 18.35 10.88 17 51289 1399 29521822
Drug intolerance 18.34 10.88 35 51271 48344 29474877
Insulin C-peptide increased 18.14 10.88 6 51300 57 29523164
Oedema peripheral 18.12 10.88 266 51040 103291 29419930
Bile duct cancer 18.07 10.88 12 51294 605 29522616
Weight increased 18.07 10.88 208 51098 76459 29446762
Product packaging quantity issue 17.99 10.88 13 51293 752 29522469
Type 2 diabetes mellitus 17.82 10.88 58 51248 13523 29509698
Product prescribing error 17.80 10.88 70 51236 17906 29505315
Therapeutic product effect decreased 17.72 10.88 15 51291 29436 29493785
Peripancreatic fluid collection 17.56 10.88 5 51301 27 29523194
Treatment failure 17.53 10.88 23 51283 36916 29486305
Renal failure 17.49 10.88 296 51010 118303 29404918
Colon cancer 17.39 10.88 40 51266 7615 29515606
Dysuria 17.30 10.88 81 51225 22359 29500862
Hypomagnesaemia 17.28 10.88 68 51238 17400 29505821
Foetal exposure during pregnancy 17.22 10.88 20 51286 33847 29489374
Pseudohyponatraemia 17.20 10.88 6 51300 68 29523153
Nephrolithiasis 17.07 10.88 88 51218 25246 29497975
Psychotic disorder 16.99 10.88 7 51299 20347 29502874
Pancreatic neoplasm 16.89 10.88 13 51293 828 29522393
Groin abscess 16.65 10.88 11 51295 550 29522671
Sprue-like enteropathy 16.49 10.88 10 51296 430 29522791
Stent placement 16.47 10.88 28 51278 4278 29518943
Spinal osteoarthritis 16.46 10.88 35 51271 6321 29516900
Suicide attempt 16.43 10.88 21 51285 34089 29489132
Biopsy pancreas 16.08 10.88 3 51303 0 29523221
Choledochoenterostomy 16.08 10.88 3 51303 0 29523221
Splenic vein occlusion 16.08 10.88 3 51303 0 29523221
Bile duct adenocarcinoma 16.08 10.88 3 51303 0 29523221
Duodenal sphincterotomy 16.08 10.88 3 51303 0 29523221
Biliary neoplasm 16.08 10.88 3 51303 0 29523221
Pancreatic sphincterotomy 16.08 10.88 3 51303 0 29523221
Pollakiuria 16.05 10.88 65 51241 16851 29506370
Pulmonary mass 16.04 10.88 48 51258 10700 29512521
Genital swelling 15.91 10.88 7 51299 152 29523069
Dependence on respirator 15.86 10.88 6 51300 87 29523134
Oscillopsia 15.77 10.88 5 51301 41 29523180
Respiratory arrest 15.74 10.88 13 51293 25820 29497401
Amaurosis 15.65 10.88 11 51295 609 29522612
Drug eruption 15.62 10.88 64 51242 16677 29506544
Vitamin B1 decreased 15.57 10.88 8 51298 248 29522973
Gastrointestinal mucosal necrosis 15.54 10.88 7 51299 161 29523060
Coma 15.43 10.88 28 51278 39422 29483799
Vitamin B1 deficiency 15.37 10.88 8 51298 255 29522966
Drug ineffective for unapproved indication 15.34 10.88 3 51303 14211 29509010
Renal mass 15.31 10.88 16 51290 1524 29521697
Bile duct stenosis 15.17 10.88 14 51292 1146 29522075
Nephroangiosclerosis 15.12 10.88 7 51299 172 29523049
Suicidal ideation 15.10 10.88 23 51283 34693 29488528
Romberg test positive 14.98 10.88 5 51301 49 29523172
Abdominal pain 14.88 10.88 323 50983 135034 29388187
Large intestine polyp 14.77 10.88 34 51272 6475 29516746
Thrombocytopenia 14.77 10.88 156 51150 134667 29388554
Adrenal mass 14.74 10.88 10 51296 523 29522698
Palindromic rheumatism 14.55 10.88 7 51299 188 29523033
Subdural hygroma 14.41 10.88 8 51298 291 29522930
Osteonecrosis 14.29 10.88 3 51303 13516 29509705
Thyroid neoplasm 14.24 10.88 9 51297 417 29522804
Pancreatic fistula 14.23 10.88 5 51301 58 29523163
Aggression 14.10 10.88 25 51281 35516 29487705
Psoriatic arthropathy 14.08 10.88 4 51302 14687 29508534
Toe amputation 14.03 10.88 18 51288 2137 29521084
Malignant neoplasm of ampulla of Vater 14.00 10.88 3 51303 3 29523218
Brain contusion 13.98 10.88 11 51295 724 29522497
Pancreatic duct dilatation 13.92 10.88 5 51301 62 29523159
Biliary obstruction 13.92 10.88 19 51287 2395 29520826
Respiratory failure 13.88 10.88 105 51201 97026 29426195
Generalised tonic-clonic seizure 13.82 10.88 8 51298 19131 29504090
Oedematous pancreatitis 13.80 10.88 9 51297 440 29522781
Unevaluable event 13.75 10.88 19 51287 29832 29493389
Unresponsive to stimuli 13.70 10.88 14 51292 25112 29498109
Umbilical hernia repair 13.69 10.88 4 51302 24 29523197
Pneumocystis jirovecii pneumonia 13.64 10.88 6 51300 16773 29506448
Nephrogenic anaemia 13.59 10.88 17 51289 1968 29521253
Gastrointestinal tube insertion 13.57 10.88 13 51293 1116 29522105
Superinfection 13.48 10.88 17 51289 1984 29521237
Bile duct stone 13.47 10.88 18 51288 2224 29520997
Bladder irrigation 13.44 10.88 5 51301 69 29523152
Intentional product use issue 13.43 10.88 34 51272 42464 29480757
Duodenitis 13.39 10.88 25 51281 4110 29519111
Pancytopenia 13.30 10.88 87 51219 83081 29440140
Infusion related reaction 13.19 10.88 36 51270 43850 29479371
Genital lesion 13.12 10.88 7 51299 235 29522986
Diabetic retinopathy 13.07 10.88 15 51291 1587 29521634
Fracture 13.06 10.88 31 51275 6022 29517199
Inability to afford medication 13.03 10.88 12 51294 980 29522241
Haematochezia 12.95 10.88 109 51197 36874 29486347
Musculoskeletal pain 12.74 10.88 90 51216 28863 29494358
Hypoxia 12.69 10.88 41 51265 47338 29475883
Metastases to spleen 12.63 10.88 8 51298 372 29522849
Blood ketone body increased 12.59 10.88 8 51298 374 29522847
Nephropathy 12.51 10.88 28 51278 5235 29517986
Intraductal papillary-mucinous carcinoma of pancreas 12.48 10.88 3 51303 7 29523214
Campylobacter infection 12.39 10.88 10 51296 683 29522538
Pseudocyst 12.31 10.88 6 51300 166 29523055
Hepatic steatosis 12.30 10.88 55 51251 14891 29508330
Renal stone removal 12.29 10.88 4 51302 36 29523185
Procedural headache 12.29 10.88 4 51302 36 29523185
Hypercapnic coma 12.27 10.88 6 51300 167 29523054
Arthroscopy 12.23 10.88 5 51301 90 29523131
Toxic skin eruption 12.21 10.88 41 51265 9716 29513505
Bladder transitional cell carcinoma 12.17 10.88 18 51288 2443 29520778
Encephalopathy 12.17 10.88 22 51284 31021 29492200
Cyst removal 12.10 10.88 4 51302 38 29523183
Gallbladder disorder 12.09 10.88 29 51277 5671 29517550
Intentional overdose 12.03 10.88 31 51275 38497 29484724
Agitation 12.01 10.88 47 51259 51257 29471964
Alanine aminotransferase increased 11.97 10.88 73 51233 70871 29452350
Flushing 11.86 10.88 20 51286 28972 29494249
Pneumonitis 11.80 10.88 19 51287 28025 29495196
Thrombosis 11.71 10.88 37 51269 43008 29480213
Nodular rash 11.52 10.88 5 51301 105 29523116
Pancreatic carcinoma stage III 11.18 10.88 4 51302 49 29523172
Abdominal hernia repair 11.18 10.88 4 51302 49 29523172
Acute respiratory distress syndrome 11.17 10.88 14 51292 22921 29500300
Discoloured vomit 11.15 10.88 8 51298 458 29522763
Pain 11.14 10.88 220 51086 171212 29352009
Hallucination 11.09 10.88 40 51266 44672 29478549
Chronic gastritis 11.05 10.88 12 51294 1194 29522027
Nasal neoplasm 11.02 10.88 5 51301 117 29523104
Tachycardia 10.95 10.88 77 51229 72333 29450888
Appendicectomy 10.95 10.88 10 51296 808 29522413

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Blood glucose increased 868.79 10.25 832 81879 97241 64318780
Hypoglycaemia 867.96 10.25 800 81911 89092 64326929
Pancreatitis 653.13 10.25 570 82141 59037 64356984
Diabetes mellitus inadequate control 567.76 10.25 349 82362 20972 64395049
Pancreatic carcinoma 394.05 10.25 214 82497 10159 64405862
Lactic acidosis 389.68 10.25 436 82275 60974 64355047
Diabetic ketoacidosis 373.01 10.25 308 82403 29537 64386484
Glycosylated haemoglobin increased 346.40 10.25 230 82481 15789 64400232
Pancreatitis acute 313.37 10.25 328 82383 42527 64373494
Pemphigoid 299.17 10.25 194 82517 12792 64403229
Carotid artery thrombosis 234.99 10.25 88 82623 1707 64414314
Neurologic neglect syndrome 232.70 10.25 85 82626 1533 64414488
Hyperglycaemia 209.50 10.25 320 82391 60648 64355373
Acute kidney injury 197.15 10.25 1112 81599 448128 63967893
Personality disorder 192.39 10.25 102 82609 4609 64411412
Lipase increased 186.96 10.25 152 82559 14250 64401771
Adjustment disorder 182.87 10.25 83 82628 2662 64413359
Blood glucose abnormal 178.38 10.25 122 82589 8791 64407230
Ketoacidosis 164.16 10.25 105 82606 6758 64409263
Euglycaemic diabetic ketoacidosis 163.22 10.25 96 82615 5314 64410707
General physical health deterioration 162.16 10.25 603 82108 203822 64212199
Hemiplegia 155.80 10.25 130 82581 12638 64403383
Drug abuse 147.29 10.25 5 82706 132369 64283652
Hyperkalaemia 137.57 10.25 360 82351 100769 64315252
Affect lability 131.95 10.25 102 82609 8888 64407133
Toxicity to various agents 129.30 10.25 166 82545 363347 64052674
Off label use 127.43 10.25 403 82308 632403 63783618
Product residue present 107.02 10.25 61 82650 3181 64412840
Blood glucose decreased 105.47 10.25 139 82572 22984 64393037
Product monitoring error 105.24 10.25 73 82638 5381 64410640
Interstitial lung disease 104.58 10.25 319 82392 97413 64318608
Drug intolerance 103.54 10.25 56 82655 187936 64228085
Bladder cancer 98.62 10.25 94 82617 10880 64405141
Sensory loss 95.01 10.25 89 82622 10080 64405941
Synovitis 94.33 10.25 9 82702 99081 64316940
Motor dysfunction 93.92 10.25 93 82618 11280 64404741
Cerebral infarction 89.18 10.25 176 82535 40868 64375153
Muscle spasticity 83.55 10.25 105 82606 16564 64399457
Systemic lupus erythematosus 82.73 10.25 4 82707 77608 64338413
Coordination abnormal 82.66 10.25 99 82612 14865 64401156
Metabolic acidosis 81.96 10.25 238 82473 70720 64345301
Therapeutic product effect decreased 80.37 10.25 24 82687 115327 64300694
Treatment failure 80.13 10.25 25 82686 116791 64299230
Drug ineffective 79.98 10.25 692 82019 839555 63576466
Seronegative arthritis 75.79 10.25 46 82665 2697 64413324
Hypoglycaemic coma 75.03 10.25 54 82657 4220 64411801
Eating disorder 70.50 10.25 97 82614 16708 64399313
Product use in unapproved indication 69.85 10.25 74 82637 176544 64239477
Arthropathy 63.76 10.25 38 82673 120929 64295092
Blood glucose fluctuation 63.23 10.25 56 82655 5899 64410122
Maternal exposure during pregnancy 61.46 10.25 23 82688 95861 64320160
Diabetes mellitus 61.10 10.25 206 82505 66268 64349753
Hemiparesis 60.14 10.25 124 82587 29703 64386318
Infusion related reaction 59.52 10.25 74 82637 164393 64251628
Pain 58.88 10.25 442 82269 553069 63862952
Product use issue 58.40 10.25 65 82646 151650 64264371
Amylase increased 56.68 10.25 66 82645 9619 64406402
Glossodynia 56.29 10.25 8 82703 64688 64351333
Lung diffusion test abnormal 53.81 10.25 16 82695 145 64415876
Product dose omission issue 53.59 10.25 430 82281 194317 64221704
Gangrene 53.30 10.25 56 82655 7282 64408739
Dizziness 53.21 10.25 810 81901 429353 63986668
Contraindicated product administered 52.56 10.25 37 82674 107792 64308229
Lower respiratory tract infection 50.88 10.25 29 82682 94585 64321436
Wrong technique in product usage process 50.01 10.25 190 82521 64784 64351237
Joint swelling 49.12 10.25 129 82582 215253 64200768
Aphasia 48.96 10.25 139 82572 40767 64375254
Neutropenia 48.44 10.25 152 82559 239472 64176549
Product prescribing error 48.36 10.25 126 82585 35143 64380878
Completed suicide 47.76 10.25 139 82572 224275 64191746
Glycosylated haemoglobin abnormal 46.69 10.25 14 82697 131 64415890
Diabetic metabolic decompensation 44.56 10.25 33 82678 2695 64413326
Febrile neutropenia 43.86 10.25 111 82600 187546 64228475
Urine ketone body present 43.12 10.25 35 82676 3272 64412749
Haematochezia 42.26 10.25 183 82528 66190 64349831
Temperature perception test abnormal 41.77 10.25 9 82702 16 64416005
Rhabdomyolysis 40.60 10.25 228 82483 91498 64324523
Therapeutic drug monitoring analysis not performed 40.53 10.25 23 82688 1189 64414832
Muscular weakness 40.52 10.25 291 82420 127047 64288974
Mucosal inflammation 40.12 10.25 15 82696 62569 64353452
Pancreatic carcinoma metastatic 39.53 10.25 34 82677 3444 64412577
Serotonin syndrome 38.93 10.25 3 82708 39279 64376742
Exposure during pregnancy 38.72 10.25 26 82685 77649 64338372
Adenocarcinoma pancreas 38.33 10.25 26 82685 1847 64414174
Pemphigus 38.17 10.25 15 82696 60686 64355335
No adverse event 38.10 10.25 101 82610 28460 64387561
Thirst 37.43 10.25 66 82645 14071 64401950
Hypersensitivity 37.35 10.25 128 82583 196324 64219697
MELAS syndrome 37.18 10.25 12 82699 146 64415875
Hand deformity 37.09 10.25 17 82694 62754 64353267
Renal impairment 37.05 10.25 298 82413 134719 64281302
Pericarditis 36.83 10.25 17 82694 62499 64353522
Diarrhoea 36.75 10.25 1198 81513 721506 63694515
Pancreatitis chronic 36.64 10.25 33 82678 3553 64412468
Dysuria 35.73 10.25 127 82584 41930 64374091
Drug hypersensitivity 35.73 10.25 170 82541 237645 64178376
Dysphagia 35.68 10.25 247 82464 106565 64309456
Pancreatitis necrotising 35.65 10.25 31 82680 3186 64412835
Injection site erythema 34.89 10.25 24 82687 70776 64345245
Oedema peripheral 34.55 10.25 417 82294 209900 64206121
Dysarthria 34.21 10.25 159 82552 59247 64356774
Duodenal ulcer perforation 33.33 10.25 3 82708 34622 64381399
Hypoglycaemic encephalopathy 33.03 10.25 16 82695 596 64415425
Pancreatic enzymes increased 32.82 10.25 20 82691 1181 64414840
Weight decreased 32.58 10.25 531 82180 285208 64130813
Cardiac failure 32.51 10.25 285 82426 132088 64283933
Genital infection female 32.19 10.25 9 82702 64 64415957
Alopecia 32.14 10.25 107 82604 165583 64250438
Abdominal pain 31.81 10.25 570 82141 311805 64104216
Renal failure 31.50 10.25 364 82347 181324 64234697
Autoimmune pancreatitis 30.47 10.25 15 82696 579 64415442
Musculoskeletal stiffness 30.25 10.25 71 82640 123135 64292886
Arterial occlusive disease 30.11 10.25 41 82670 6992 64409029
Sinus congestion 29.73 10.25 63 82648 15376 64400645
Skin haemorrhage 29.37 10.25 45 82666 8540 64407481
Sneezing 29.10 10.25 62 82649 15189 64400832
Nephroangiosclerosis 29.10 10.25 12 82699 303 64415718
Polyuria 28.41 10.25 55 82656 12588 64403433
Cerebrovascular accident 28.18 10.25 285 82426 137298 64278723
Rhinorrhoea 27.82 10.25 151 82560 59818 64356203
Flushing 27.80 10.25 36 82675 78612 64337409
Pancreatic pseudocyst 26.74 10.25 18 82693 1263 64414758
Hyperlactacidaemia 26.67 10.25 32 82679 4812 64411209
Micturition disorder 26.47 10.25 26 82685 3122 64412899
Alcoholic ketoacidosis 26.47 10.25 6 82705 15 64416006
Wound 26.02 10.25 36 82675 76441 64339580
Pancreatic disorder 25.97 10.25 25 82686 2929 64413092
Angioedema 25.60 10.25 151 82560 61670 64354351
Swelling 25.56 10.25 112 82599 160106 64255915
Pollakiuria 24.91 10.25 93 82618 31437 64384584
Neurotoxicity 24.77 10.25 3 82708 27401 64388620
Altered state of consciousness 24.50 10.25 105 82606 37797 64378224
Diabetic nephropathy 24.35 10.25 23 82688 2631 64413390
Electrolyte imbalance 23.87 10.25 79 82632 25164 64390857
Gastric cancer 23.59 10.25 35 82676 6458 64409563
Tubulointerstitial nephritis and uveitis syndrome 23.49 10.25 10 82701 274 64415747
Flatulence 23.20 10.25 99 82612 35567 64380454
Pancreatic mass 23.19 10.25 17 82694 1367 64414654
Hyperlipasaemia 23.04 10.25 15 82696 995 64415026
Dyslipidaemia 23.00 10.25 42 82669 9200 64406821
Arthralgia 22.98 10.25 414 82297 441846 63974175
Food aversion 22.68 10.25 13 82698 685 64415336
Stomatitis 22.49 10.25 69 82642 109536 64306485
Prevertebral soft tissue swelling of cervical space 22.33 10.25 6 82705 36 64415985
Irritable bowel syndrome 22.26 10.25 10 82701 37359 64378662
C-reactive protein abnormal 22.21 10.25 5 82706 29042 64386979
Sedation 21.87 10.25 13 82698 41449 64374572
Dehydration 21.85 10.25 395 82316 216368 64199653
Helicobacter infection 21.73 10.25 11 82700 38351 64377670
Multiple drug therapy 21.58 10.25 20 82691 2234 64413787
Injury 21.52 10.25 24 82687 55968 64360053
Glycosylated haemoglobin decreased 21.44 10.25 12 82699 604 64415417
Folliculitis 21.41 10.25 6 82705 30071 64385950
Gastric disorder 21.33 10.25 84 82627 29113 64386908
Osteonecrosis 21.31 10.25 5 82706 28224 64387797
Peripheral artery haematoma 21.18 10.25 6 82705 45 64415976
Bladder transitional cell carcinoma 21.01 10.25 20 82691 2310 64413711
Blood pressure inadequately controlled 20.98 10.25 30 82681 5354 64410667
Hepatic function abnormal 20.46 10.25 147 82564 64166 64351855
Intentional product use issue 20.31 10.25 59 82652 95305 64320716
Haemoglobin increased 20.30 10.25 29 82682 5172 64410849
Seizure 20.27 10.25 128 82583 166764 64249257
Abdominal pain upper 20.19 10.25 326 82385 174704 64241317
Multiple sclerosis relapse 20.19 10.25 14 82697 41121 64374900
Respiratory depression 20.15 10.25 3 82708 23440 64392581
Insulin C-peptide increased 20.11 10.25 7 82704 109 64415912
Colon cancer 20.08 10.25 48 82663 12691 64403330
Respiratory arrest 20.04 10.25 23 82688 52962 64363059
Asthenia 19.99 10.25 703 82008 427341 63988680
Drug resistance 19.98 10.25 10 82701 35092 64380929
Infection 19.87 10.25 147 82564 184733 64231288
Migraine 19.86 10.25 31 82680 62646 64353375
Bladder trabeculation 19.83 10.25 6 82705 58 64415963
Nausea 19.70 10.25 1212 81499 784588 63631433
Psoriatic arthropathy 19.61 10.25 16 82695 43265 64372756
Depression 19.57 10.25 146 82565 183145 64232876
Groin abscess 19.20 10.25 15 82696 1327 64414694
Renal disorder 19.15 10.25 93 82618 35272 64380749
Exercise tolerance decreased 19.14 10.25 35 82676 7675 64408346
Gamma-glutamyltransferase increased 19.13 10.25 117 82594 48393 64367628
Mixed liver injury 19.13 10.25 29 82682 5452 64410569
Vitamin B1 decreased 19.07 10.25 9 82702 316 64415705
Intestinal transit time abnormal 18.90 10.25 6 82705 69 64415952
Sinus disorder 18.83 10.25 56 82655 16852 64399169
Discomfort 18.75 10.25 48 82663 80830 64335191
Angina pectoris 18.59 10.25 110 82601 44971 64371050
Urine albumin/creatinine ratio increased 18.48 10.25 9 82702 339 64415682
Bile duct stone 18.32 10.25 27 82684 4951 64411070
Glomerular filtration rate decreased 18.28 10.25 61 82650 19511 64396510
Tri-iodothyronine free decreased 18.17 10.25 9 82702 352 64415669
Blood creatinine increased 18.01 10.25 259 82452 135523 64280498
Vomiting 17.93 10.25 871 81840 550246 63865775
Endometrial disorder 17.91 10.25 10 82701 501 64415520
Infusion site scar 17.61 10.25 8 82703 257 64415764
Posterior reversible encephalopathy syndrome 17.45 10.25 4 82707 22942 64393079
Anaemia 17.44 10.25 621 82090 378059 64037962
Fear-related avoidance of activities 17.38 10.25 6 82705 91 64415930
Injection site pain 17.09 10.25 79 82632 111329 64304692
Alopecia universalis 16.97 10.25 7 82704 177 64415844
Pyelitis 16.95 10.25 8 82703 281 64415740
Multiple congenital abnormalities 16.92 10.25 6 82705 99 64415922
Injection site reaction 16.86 10.25 21 82690 46643 64369378
Increased appetite 16.83 10.25 39 82672 10107 64405914
Cytomegalovirus infection 16.55 10.25 14 82697 37185 64378836
Generalised tonic-clonic seizure 16.54 10.25 16 82695 39841 64376180
Gastrointestinal mucosal necrosis 16.37 10.25 7 82704 194 64415827
Red blood cell sedimentation rate increased 16.18 10.25 10 82701 31225 64384796
Adverse event 16.06 10.25 96 82615 39393 64376628
Death 16.04 10.25 484 82227 482221 63933800
Diabetic retinopathy 16.04 10.25 19 82692 2820 64413201
Blood ketone body increased 15.94 10.25 10 82701 622 64415399
Anuria 15.88 10.25 57 82654 18907 64397114
Basal cell carcinoma 15.80 10.25 10 82701 30828 64385193
Fall 15.76 10.25 669 82042 416157 63999864
Joint noise 15.73 10.25 20 82691 3191 64412830
Amaurosis 15.66 10.25 12 82699 1032 64414989
Pneumocystis jirovecii pneumonia 15.54 10.25 8 82703 27626 64388395
Pancreatectomy 15.50 10.25 4 82707 20 64416001
Bladder irrigation 15.41 10.25 5 82706 62 64415959
Blood ketone body present 15.41 10.25 5 82706 62 64415959
Psychotic disorder 15.40 10.25 13 82698 34565 64381456
Fracture 15.39 10.25 56 82655 18699 64397322
Pseudohyponatraemia 15.36 10.25 6 82705 131 64415890
Fibromyalgia 15.23 10.25 14 82697 35717 64380304
Encephalopathy 15.16 10.25 33 82678 58786 64357235
Pancreaticoduodenectomy 15.03 10.25 4 82707 23 64415998
Ketonuria 14.94 10.25 12 82699 1105 64414916
Drug eruption 14.79 10.25 88 82623 36048 64379973
Impaired healing 14.72 10.25 35 82676 60438 64355583
Therapy non-responder 14.60 10.25 40 82671 65859 64350162
Diabetic foetopathy 14.49 10.25 4 82707 27 64415994
Internal haemorrhage 14.43 10.25 31 82680 7636 64408385
Toe amputation 14.38 10.25 20 82691 3480 64412541
Mobility decreased 14.30 10.25 59 82652 85781 64330240
Product packaging quantity issue 14.26 10.25 11 82700 955 64415066
Liver disorder 14.21 10.25 117 82594 53234 64362787
Bursitis infective 14.19 10.25 12 82699 1188 64414833
Disease progression 14.12 10.25 115 82596 141565 64274456
Anaemia vitamin B12 deficiency 14.08 10.25 9 82702 578 64415443
Intensive care unit acquired weakness 14.03 10.25 14 82697 1713 64414308
Decreased vibratory sense 13.99 10.25 9 82702 585 64415436
Nephrotic syndrome 13.96 10.25 35 82676 9532 64406489
Pulmonary tumour thrombotic microangiopathy 13.96 10.25 5 82706 85 64415936
Brain contusion 13.85 10.25 12 82699 1227 64414794
Radioallergosorbent test positive 13.79 10.25 4 82707 33 64415988
Vitamin B12 deficiency 13.78 10.25 25 82686 5447 64410574
Device dislocation 13.70 10.25 5 82706 21173 64394848
Toxic skin eruption 13.70 10.25 55 82656 19229 64396792
Intentional overdose 13.66 10.25 64 82647 89880 64326141
Urticaria chronic 13.60 10.25 8 82703 443 64415578
Lymphopenia 13.59 10.25 8 82703 25649 64390372
Cerebral haemorrhage 13.58 10.25 112 82599 50978 64365043
Drug ineffective for unapproved indication 13.50 10.25 12 82699 31121 64384900
Subdural hygroma 13.48 10.25 8 82703 450 64415571
Impaired insulin secretion 13.48 10.25 4 82707 36 64415985
Electrocardiogram abnormal 13.47 10.25 43 82668 13438 64402583
Diabetic neuropathy 13.37 10.25 25 82686 5576 64410445
Decreased appetite 13.36 10.25 463 82248 280826 64135195
Cholelithiasis 13.33 10.25 102 82609 45404 64370617
Pseudocyst 13.31 10.25 7 82704 311 64415710
Transplant rejection 13.30 10.25 3 82708 17398 64398623
Hyperthermia 13.24 10.25 47 82664 15503 64400518
Hypokinesia 13.15 10.25 49 82662 16547 64399474
Tubulointerstitial nephritis 13.12 10.25 76 82635 30833 64385188
Thrombotic cerebral infarction 13.10 10.25 8 82703 474 64415547
Palindromic rheumatism 13.07 10.25 7 82704 323 64415698
Device related infection 13.05 10.25 12 82699 30614 64385407
Respiratory tract congestion 13.04 10.25 48 82663 16117 64399904
Adverse drug reaction 13.01 10.25 24 82687 45440 64370581
Dystonia 13.00 10.25 4 82707 18861 64397160
Impaired work ability 12.96 10.25 46 82665 15173 64400848
Oedematous pancreatitis 12.87 10.25 10 82701 878 64415143
Acquired mitochondrial DNA mutation 12.83 10.25 3 82708 9 64416012
Hypoglycaemic unconsciousness 12.82 10.25 11 82700 1110 64414911
Pulmonary haematoma 12.68 10.25 5 82706 112 64415909
Procedural headache 12.68 10.25 5 82706 112 64415909
Acute myocardial infarction 12.66 10.25 141 82570 69577 64346444
Prerenal failure 12.62 10.25 18 82693 3204 64412817
Myalgia 12.61 10.25 279 82432 158338 64257683
Joint injury 12.38 10.25 7 82704 22940 64393081
Hepatic steatosis 12.36 10.25 75 82636 30932 64385089
Hyperglycaemic hyperosmolar nonketotic syndrome 12.27 10.25 13 82698 1706 64414315
Emotional distress 12.22 10.25 17 82694 36021 64380000
Bile duct cancer 12.20 10.25 10 82701 948 64415073
Sopor 12.20 10.25 12 82699 29649 64386372
Nephrogenic anaemia 12.19 10.25 18 82693 3307 64412714
Type 2 diabetes mellitus 12.14 10.25 80 82631 33940 64382081
Thrombosis 12.11 10.25 48 82663 70594 64345427
Leukopenia 12.10 10.25 78 82633 101164 64314857
Coma acidotic 11.99 10.25 5 82706 130 64415891
Hepatic enzyme increased 11.82 10.25 108 82603 129835 64286186
Vaginal haemorrhage 11.80 10.25 5 82706 19339 64396682
Pyrexia 11.77 10.25 591 82120 558053 63857968
Vitamin B1 deficiency 11.75 10.25 8 82703 572 64415449
Sinusitis 11.72 10.25 125 82586 145803 64270218
Hypomagnesaemia 11.64 10.25 85 82626 37291 64378730
Urogenital infection fungal 11.63 10.25 3 82708 15 64416006
Campylobacter infection 11.61 10.25 11 82700 1263 64414758
Deep vein thrombosis 11.60 10.25 83 82628 105099 64310922
Sprue-like enteropathy 11.57 10.25 10 82701 1019 64415002
Disease recurrence 11.57 10.25 14 82697 31496 64384525
Oesophageal mucosal tear 11.46 10.25 3 82708 16 64416005
Meibomianitis 11.39 10.25 4 82707 64 64415957
Multiple sclerosis 11.39 10.25 5 82706 18936 64397085
Loss of personal independence in daily activities 11.33 10.25 51 82660 72403 64343618
Intentional product misuse 11.24 10.25 51 82660 72244 64343777
Coronavirus infection 11.16 10.25 23 82688 5507 64410514
Haemorrhage subcutaneous 11.08 10.25 20 82691 4341 64411680
Oral mucosal discolouration 11.06 10.25 6 82705 284 64415737
Putamen haemorrhage 11.03 10.25 7 82704 444 64415577
Proteinuria 11.02 10.25 67 82644 27656 64388365
Neuropathy peripheral 10.99 10.25 97 82614 117428 64298593
Infusion site rash 10.95 10.25 10 82701 1096 64414925
Unevaluable event 10.92 10.25 31 82680 50458 64365563
Chronic kidney disease 10.91 10.25 118 82593 57801 64358220
Blood calcium decreased 10.90 10.25 10 82701 25544 64390477
Peripheral swelling 10.77 10.25 196 82515 208957 64207064
Eczema asteatotic 10.74 10.25 7 82704 465 64415556
Respiratory failure 10.67 10.25 144 82567 161039 64254982
Genital swelling 10.61 10.25 6 82705 308 64415713
Immune-mediated myositis 10.55 10.25 15 82696 2663 64413358
Erythema multiforme 10.54 10.25 44 82667 15657 64400364
Renal cancer metastatic 10.51 10.25 8 82703 681 64415340
Oscillopsia 10.50 10.25 5 82706 179 64415842
Suicide attempt 10.50 10.25 51 82660 70956 64345065
Idiopathic pulmonary fibrosis 10.39 10.25 18 82693 3782 64412239
Ill-defined disorder 10.32 10.25 26 82685 44026 64371995

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10BD07 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD12 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD24 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BH01 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Dipeptidyl peptidase 4 (DPP-4) inhibitors
ATC A10BH51 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Dipeptidyl peptidase 4 (DPP-4) inhibitors
MeSH PA D054873 Dipeptidyl-Peptidase IV Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006728 Hormones
MeSH PA D007004 Hypoglycemic Agents
MeSH PA D054795 Incretins
MeSH PA D011480 Protease Inhibitors
FDA MoA N0000175912 Dipeptidyl Peptidase 4 Inhibitors
FDA EPC N0000175913 Dipeptidyl Peptidase 4 Inhibitor
CHEBI has role CHEBI:35526 antidiabetic
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:48353 serine proteinase inhibitors
CHEBI has role CHEBI:68612 dipeptidyl peptidase-4 inhibitors
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Alcoholism contraindication 7200002
Asthenia contraindication 13791008
Myocardial infarction contraindication 22298006 DOID:5844
Acute vomiting contraindication 23971007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Dehydration contraindication 34095006
Infectious disease contraindication 40733004
Ketoacidosis contraindication 56051008
Metabolic acidosis contraindication 59455009
Hypopituitarism contraindication 74728003 DOID:9406
Cardiogenic shock contraindication 89138009
Kidney disease contraindication 90708001 DOID:557
Lactic acidosis contraindication 91273001 DOID:3650
Cobalamin deficiency contraindication 190634004
Decompensated cardiac failure contraindication 195111005
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Hypoglycemic disorder contraindication 237630007
Sepsis syndrome contraindication 238150007
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Fever contraindication 386661006
Surgical procedure contraindication 387713003
Severe diarrhea contraindication 409587002
Traumatic injury contraindication 417746004
Fever greater than 100.4 Fahrenheit contraindication 426000000
Radiography with IV Iodinated Contrast Agent contraindication
Severe Hypoxemia contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.1 Basic
pKa2 2.67 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 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
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 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
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 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 AND/OR A SULFONYLUREA
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 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
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 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
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 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 AND/OR A SULFONYLUREA
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 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
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 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
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 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 AND/OR A SULFONYLUREA
1GM;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 100MG BASE 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;EQ 100MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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
10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
15MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL 6699871 July 26, 2022 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
5MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL 6699871 July 26, 2022 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
10MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL 7326708 Nov. 24, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL 7326708 Nov. 24, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL 7326708 Nov. 24, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM;EQ 50MG BASE 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;EQ 50MG BASE 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;EQ 100MG BASE 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;EQ 50MG BASE 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;EQ 50MG BASE 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
15MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL 7326708 Nov. 24, 2026 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
5MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL 7326708 Nov. 24, 2026 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
1GM;EQ 50MG BASE 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;EQ 50MG BASE 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
15MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 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
5MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 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
15MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL 9439901 Oct. 21, 2030 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
5MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL 9439901 Oct. 21, 2030 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL Aug. 12, 2022 INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL Aug. 12, 2022 INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL Aug. 12, 2022 INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
1GM;EQ 50MG BASE JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL Aug. 12, 2022 INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
500MG;EQ 50MG BASE JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL Aug. 12, 2022 INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
1GM;EQ 100MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL Aug. 12, 2022 INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
1GM;EQ 50MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL Aug. 12, 2022 INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
500MG;EQ 50MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL Aug. 12, 2022 INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
15MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL Dec. 19, 2022 NEW CHEMICAL ENTITY
5MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL Dec. 19, 2022 NEW CHEMICAL ENTITY
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
1GM;EQ 50MG BASE JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
1GM;EQ 100MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
1GM;EQ 50MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL Dec. 4, 2023 ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL Dec. 4, 2023 ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL Dec. 4, 2023 ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
1GM;EQ 50MG BASE JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL Dec. 4, 2023 ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
500MG;EQ 50MG BASE JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL Dec. 4, 2023 ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
1GM;EQ 50MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL Dec. 4, 2023 ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
500MG;EQ 50MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL Dec. 4, 2023 ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
EQ 100MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL June 4, 2024 PEDIATRIC EXCLUSIVITY
EQ 25MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL June 4, 2024 PEDIATRIC EXCLUSIVITY
EQ 50MG BASE JANUVIA MERCK SHARP DOHME N021995 Oct. 16, 2006 RX TABLET ORAL June 4, 2024 PEDIATRIC EXCLUSIVITY
1GM;EQ 50MG BASE JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL June 4, 2024 PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE JANUMET MERCK SHARP DOHME N022044 March 30, 2007 RX TABLET ORAL June 4, 2024 PEDIATRIC EXCLUSIVITY
1GM;EQ 50MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL June 4, 2024 PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE JANUMET XR MERCK SHARP DOHME N202270 Feb. 2, 2012 RX TABLET, EXTENDED RELEASE ORAL June 4, 2024 PEDIATRIC EXCLUSIVITY
15MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL Sept. 17, 2024 REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV
5MG;EQ 100MG BASE STEGLUJAN MERCK SHARP DOHME N209805 Dec. 19, 2017 RX TABLET ORAL Sept. 17, 2024 REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Dipeptidyl peptidase 4 Enzyme INHIBITOR Ki 7.77 WOMBAT-PK CHEMBL
Angiotensin-converting enzyme Enzyme IC50 4.96 CHEMBL
Prolyl endopeptidase FAP Enzyme IC50 5.23 CHEMBL
Dipeptidyl peptidase 8 Enzyme IC50 4.96 CHEMBL
Dipeptidyl peptidase 9 Enzyme IC50 4.70 CHEMBL
Dipeptidyl peptidase 2 Enzyme IC50 4.22 CHEMBL
Dipeptidyl peptidase 4 Enzyme IC50 7.16 CHEMBL
Dipeptidyl peptidase 4 Enzyme IC50 7.48 CHEMBL
Dipeptidyl peptidase IV Unclassified IC50 4.75 CHEMBL

External reference:

IDSource
4025780 VUID
N0000179787 NUI
D06645 KEGG_DRUG
654671-77-9 SECONDARY_CAS_RN
4025780 VANDF
4025781 VANDF
C1667080 UMLSCUI
CHEBI:40237 CHEBI
715 PDB_CHEM_ID
CHEMBL1422 ChEMBL_ID
CHEMBL1201174 ChEMBL_ID
D000068900 MESH_DESCRIPTOR_UI
DB01261 DRUGBANK_ID
4369359 PUBCHEM_CID
6286 IUPHAR_LIGAND_ID
8692 INN_ID
654671-78-0 SECONDARY_CAS_RN
862156-92-1 SECONDARY_CAS_RN
QFP0P1DV7Z UNII
593411 RXNORM
23649 MMSL
89034 MMSL
d05896 MMSL
011790 NDDF
011791 NDDF
423307000 SNOMEDCT_US
424106006 SNOMEDCT_US
425508009 SNOMEDCT_US
CHEMBL393336 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
JANUMET XR HUMAN PRESCRIPTION DRUG LABEL 2 0006-0078 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 30 sections
JANUMET XR HUMAN PRESCRIPTION DRUG LABEL 2 0006-0080 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 30 sections
JANUMET XR HUMAN PRESCRIPTION DRUG LABEL 2 0006-0081 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL NDA 30 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 0006-0112 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 0006-0221 TABLET, FILM COATED 25 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 0006-0277 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-0575 TABLET, FILM COATED 50 mg ORAL NDA 29 sections
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-0577 TABLET, FILM COATED 50 mg ORAL NDA 29 sections
STEGLUJAN HUMAN PRESCRIPTION DRUG LABEL 2 0006-5367 TABLET, FILM COATED 100 mg ORAL NDA 28 sections
STEGLUJAN HUMAN PRESCRIPTION DRUG LABEL 2 0006-5368 TABLET, FILM COATED 100 mg ORAL NDA 28 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-1036 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-3472 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-3527 TABLET, FILM COATED 25 mg ORAL NDA 26 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-4084 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-4086 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-4087 TABLET, FILM COATED 25 mg ORAL NDA 27 sections
JANUMET XR HUMAN PRESCRIPTION DRUG LABEL 2 50090-4411 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 30 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-5517 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-5517 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-5547 TABLET, FILM COATED 25 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-5585 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 50090-5618 TABLET, FILM COATED 50 mg ORAL NDA 29 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 54868-5840 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 54868-6031 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 55154-5040 TABLET, FILM COATED 50 mg ORAL NDA 28 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 55154-5040 TABLET, FILM COATED 50 mg ORAL NDA 28 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 55154-5042 TABLET, FILM COATED 100 mg ORAL NDA 28 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 58118-0277 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 70518-2548 TABLET, FILM COATED 50 mg ORAL NDA 29 sections
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 70518-2548 TABLET, FILM COATED 50 mg ORAL NDA 29 sections