sitagliptin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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: OFP
    • 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 µM/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
S (Water solubility) 50 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AKT1,AKT3,GRK2,PDK1,PDK2,PDK4 7
kinase-selectivity-class PDK1 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 5.152 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 1
rat-kpuu-brain Rat brain Kpuu 0.024 % High 1

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 1005.99 11.02 761 78814 94485 90454387
Hypoglycaemia 831.56 11.02 600 78975 69248 90479624
Diabetes mellitus inadequate control 756.66 11.02 356 79219 18328 90530544
Lactic acidosis 565.31 11.02 418 79157 50045 90498827
Carotid artery thrombosis 547.91 11.02 229 79346 8863 90540009
Pancreatitis 541.51 11.02 466 79109 69360 90479512
Neurologic neglect syndrome 533.71 11.02 223 79352 8624 90540248
Personality disorder 515.82 11.02 241 79334 12203 90536669
Adjustment disorder 498.90 11.02 218 79357 9424 90539448
Pancreatic carcinoma 498.12 11.02 209 79366 8168 90540704
Hemiplegia 496.20 11.02 255 79320 15905 90532967
Affect lability 439.13 11.02 244 79331 17819 90531053
Sensory loss 406.45 11.02 232 79343 17843 90531029
Acute kidney injury 399.17 11.02 873 78702 319514 90229358
Euglycaemic diabetic ketoacidosis 389.87 11.02 161 79414 6040 90542832
Motor dysfunction 382.64 11.02 228 79347 19002 90529870
Coordination abnormal 373.15 11.02 233 79342 21123 90527749
Glycosylated haemoglobin increased 372.24 11.02 208 79367 15354 90533518
Diabetic ketoacidosis 359.12 11.02 239 79336 24168 90524704
Hemiparesis 323.92 11.02 249 79326 31570 90517302
Gangrene 313.15 11.02 174 79401 12702 90536170
Arterial occlusive disease 310.40 11.02 171 79404 12275 90536597
Eating disorder 308.58 11.02 230 79345 27843 90521029
Aphasia 306.22 11.02 273 79302 42539 90506333
Muscle spasticity 290.61 11.02 244 79331 35078 90513794
Systemic lupus erythematosus 277.28 11.02 9 79566 361887 90186985
Pancreatic carcinoma metastatic 269.43 11.02 95 79480 2293 90546579
Pemphigus 254.50 11.02 7 79568 326857 90222015
Dysarthria 252.38 11.02 274 79301 54208 90494664
Skin haemorrhage 250.38 11.02 182 79393 21198 90527674
Sinus congestion 243.44 11.02 198 79377 27226 90521646
Glossodynia 239.59 11.02 10 79565 321769 90227103
Hyperglycaemia 226.82 11.02 251 79324 50719 90498153
Dysphagia 222.40 11.02 373 79202 111905 90436967
Pemphigoid 222.29 11.02 123 79452 8903 90539969
Synovitis 219.24 11.02 19 79556 329733 90219139
Cerebrovascular accident 215.49 11.02 388 79187 123145 90425727
Ketoacidosis 209.33 11.02 101 79474 5494 90543378
Sinus disorder 200.70 11.02 196 79379 34251 90514621
Maternal exposure during pregnancy 198.13 11.02 38 79537 360025 90188847
Blood glucose abnormal 197.86 11.02 116 79459 9376 90539496
Respiratory tract congestion 196.40 11.02 175 79400 27235 90521637
Contraindicated product administered 196.01 11.02 25 79550 320114 90228758
Off label use 195.76 11.02 424 79151 1101828 89447044
Pancreatitis acute 195.13 11.02 187 79388 31928 90516944
Infusion related reaction 194.46 11.02 62 79513 416718 90132154
Treatment failure 192.85 11.02 21 79554 303907 90244965
Sneezing 191.17 11.02 179 79396 29690 90519182
Drug intolerance 186.28 11.02 80 79495 447511 90101361
Angina pectoris 184.94 11.02 199 79376 38961 90509911
Duodenal ulcer perforation 179.02 11.02 3 79572 221285 90327587
Arthropathy 178.98 11.02 50 79525 366192 90182680
Hand deformity 177.00 11.02 25 79550 296337 90252535
Joint swelling 166.13 11.02 120 79455 503180 90045692
Hyperkalaemia 162.10 11.02 240 79335 64724 90484148
Rhinorrhoea 161.18 11.02 283 79292 88033 90460839
Therapeutic product effect decreased 155.42 11.02 28 79547 277543 90271329
Helicobacter infection 150.92 11.02 13 79562 226837 90322035
Cataract 150.09 11.02 245 79330 71847 90477025
Skin exfoliation 147.11 11.02 235 79340 67678 90481194
Palpitations 147.04 11.02 352 79223 136376 90412496
Wound 146.81 11.02 42 79533 302938 90245934
Pericarditis 129.86 11.02 38 79537 270113 90278759
Drug ineffective 128.12 11.02 705 78870 1383593 89165279
Psoriatic arthropathy 127.88 11.02 23 79552 228312 90320560
Irritable bowel syndrome 127.41 11.02 16 79559 207432 90341440
Cystitis 127.21 11.02 218 79357 66500 90482372
Lower respiratory tract infection 126.61 11.02 32 79543 250627 90298245
Metabolic acidosis 126.59 11.02 197 79378 55479 90493393
Hepatic enzyme increased 120.27 11.02 85 79490 360651 90188221
Lung diffusion test abnormal 119.42 11.02 32 79543 292 90548580
Muscular weakness 118.53 11.02 425 79150 206241 90342631
Impaired healing 118.08 11.02 30 79545 234169 90314703
Exposure during pregnancy 115.56 11.02 33 79542 238377 90310495
Hypersensitivity 114.00 11.02 139 79436 454538 90094334
Injury 112.43 11.02 19 79556 197330 90351542
Blood glucose decreased 112.26 11.02 120 79455 23309 90525563
Swelling 110.55 11.02 123 79452 418935 90129937
Product use in unapproved indication 109.76 11.02 81 79494 336155 90212717
Fibromyalgia 108.76 11.02 24 79551 206245 90342627
Adenocarcinoma pancreas 103.67 11.02 39 79536 1137 90547735
Blood glucose fluctuation 103.00 11.02 61 79514 5022 90543850
Bile duct stent insertion 102.81 11.02 21 79554 45 90548827
Product residue present 101.63 11.02 57 79518 4234 90544638
Influenza like illness 101.55 11.02 221 79354 80390 90468482
Alopecia 100.89 11.02 175 79400 494896 90053976
Product dose omission issue 99.19 11.02 512 79063 291175 90257697
Discomfort 96.30 11.02 61 79514 274274 90274598
Musculoskeletal stiffness 96.04 11.02 72 79503 296460 90252412
Liver injury 95.89 11.02 17 79558 170550 90378322
Sleep disorder due to general medical condition, insomnia type 95.71 11.02 4 79571 128690 90420182
No adverse event 95.65 11.02 195 79380 67787 90481085
Lipase increased 89.80 11.02 76 79499 11035 90537837
Wrong technique in product usage process 86.51 11.02 193 79382 71378 90477494
Pancreaticoduodenectomy 85.55 11.02 16 79559 16 90548856
Stomatitis 84.78 11.02 70 79505 274628 90274244
Blister 83.75 11.02 61 79514 254937 90293935
Hypoglycaemic coma 82.67 11.02 44 79531 2946 90545926
Drug hypersensitivity 78.88 11.02 182 79393 463427 90085445
Influenza 77.76 11.02 284 79291 138980 90409892
Blood pressure inadequately controlled 75.17 11.02 54 79521 6170 90542702
Blood pressure increased 73.94 11.02 356 79219 196861 90352011
Wound infection 73.84 11.02 5 79570 106397 90442475
Ill-defined disorder 73.74 11.02 35 79540 184856 90364016
Blood cholesterol increased 70.61 11.02 48 79527 207964 90340908
Eosinophilic myocarditis 68.79 11.02 25 79550 660 90548212
Exercise tolerance decreased 68.01 11.02 55 79520 7496 90541376
Intentional product use issue 67.24 11.02 55 79520 216837 90332035
Condition aggravated 67.14 11.02 282 79293 595263 89953609
Lip dry 66.53 11.02 6 79569 100949 90447923
Dehydration 66.51 11.02 342 79233 194105 90354767
Joint range of motion decreased 65.29 11.02 19 79556 135624 90413248
Fall 65.25 11.02 678 78897 481132 90067740
MELAS syndrome 64.14 11.02 18 79557 198 90548674
Abdominal discomfort 62.21 11.02 213 79362 477115 90071757
Nausea 60.71 11.02 1336 78239 1108980 89439892
Chest discomfort 58.67 11.02 259 79316 138106 90410766
Peripheral venous disease 58.06 11.02 4 79571 83917 90464955
Grip strength decreased 57.16 11.02 7 79568 92569 90456303
Therapy non-responder 55.87 11.02 25 79550 136679 90412193
Product use issue 54.88 11.02 131 79444 329788 90219084
Sciatica 53.01 11.02 12 79563 101370 90447502
Infection 52.47 11.02 154 79421 361940 90186932
Renal impairment 52.25 11.02 207 79368 105214 90443658
Inflammation 52.06 11.02 48 79527 178544 90370328
Arthralgia 50.99 11.02 438 79137 778084 89770788
Rhabdomyolysis 50.84 11.02 128 79447 51128 90497744
Metastases to liver 50.83 11.02 91 79484 28716 90520156
Pulmonary fibrosis 50.03 11.02 16 79559 107487 90441385
Pruritus genital 49.30 11.02 37 79538 4521 90544351
Diabetic neuropathy 49.19 11.02 37 79538 4537 90544335
Autoimmune disorder 46.90 11.02 6 79569 76738 90472134
Migraine 46.80 11.02 59 79516 190333 90358539
Multiple drug therapy 46.76 11.02 43 79532 6966 90541906
Pancreatectomy 45.92 11.02 9 79566 14 90548858
Pain 45.33 11.02 610 78965 995731 89553141
Temperature perception test abnormal 45.17 11.02 9 79566 16 90548856
Pneumobilia 45.15 11.02 13 79562 158 90548714
Sleep disorder 44.99 11.02 65 79510 197965 90350907
Cerebral infarction 44.37 11.02 82 79493 26514 90522358
Gait inability 44.32 11.02 38 79537 146418 90402454
Diabetic metabolic decompensation 43.66 11.02 25 79550 1932 90546940
Mobility decreased 42.93 11.02 98 79477 250636 90298236
Product packaging quantity issue 42.68 11.02 23 79552 1579 90547293
Pancreatitis chronic 42.19 11.02 28 79547 2815 90546057
Full blood count abnormal 41.23 11.02 96 79479 36501 90512371
Bursitis infective 41.13 11.02 22 79553 1488 90547384
Lower limb fracture 40.74 11.02 12 79563 85001 90463871
Psoriasis 40.58 11.02 245 79330 147509 90401363
Hypoaesthesia 40.36 11.02 141 79434 314069 90234803
Vomiting 40.25 11.02 940 78635 787353 89761519
Urine ketone body present 39.98 11.02 26 79549 2526 90546346
Renal cyst 39.96 11.02 53 79522 12897 90535975
Cough 39.85 11.02 497 79078 368465 90180407
Diabetes mellitus 39.36 11.02 136 79439 64739 90484133
Renal disorder 39.08 11.02 96 79479 37763 90511109
Bursitis 38.82 11.02 35 79540 131619 90417253
Milk-alkali syndrome 38.81 11.02 20 79555 1253 90547619
Adjustment disorder with depressed mood 38.42 11.02 3 79572 56750 90492122
Red blood cell sedimentation rate increased 37.20 11.02 13 79562 82582 90466290
Renal failure 37.11 11.02 219 79356 130788 90418084
Hypoglycaemic encephalopathy 36.32 11.02 13 79562 328 90548544
Tubulointerstitial nephritis 35.99 11.02 73 79502 25270 90523602
Blood creatine phosphokinase increased 34.83 11.02 86 79489 33937 90514935
Flatulence 34.63 11.02 97 79478 41270 90507602
Hip arthroplasty 34.31 11.02 12 79563 76196 90472676
C-reactive protein increased 34.31 11.02 67 79508 181322 90367550
Prescribed overdose 33.82 11.02 22 79553 97603 90451269
Anxiety 33.75 11.02 418 79157 309354 90239518
Asthenia 33.15 11.02 655 78920 533096 90015776
Acidosis 33.12 11.02 48 79527 12688 90536184
Anuria 33.07 11.02 52 79523 14766 90534106
Product prescribing error 32.78 11.02 78 79497 30067 90518805
Rash 32.75 11.02 497 79078 795603 89753269
Glycosylated haemoglobin abnormal 31.41 11.02 11 79564 260 90548612
Genital infection female 31.36 11.02 9 79566 108 90548764
Pancreatic mass 31.19 11.02 17 79558 1194 90547678
Arthritis 30.96 11.02 252 79323 167063 90381809
Myelosuppression 30.86 11.02 5 79570 53586 90495286
Altered state of consciousness 30.49 11.02 78 79497 31454 90517418
Diarrhoea 29.63 11.02 1054 78521 938136 89610736
Hypercholesterolaemia 29.53 11.02 27 79548 100865 90448007
Night sweats 29.50 11.02 42 79533 128724 90420148
Peripheral swelling 29.45 11.02 227 79348 412879 90135993
Foot deformity 29.36 11.02 8 79567 59643 90489229
Acetonaemia 29.23 11.02 11 79564 321 90548551
Road traffic accident 28.97 11.02 31 79544 107595 90441277
Diabetic complication 28.84 11.02 15 79560 958 90547914
Cardiospasm 28.73 11.02 24 79551 3422 90545450
Craniofacial fracture 28.68 11.02 12 79563 465 90548407
Knee arthroplasty 28.47 11.02 19 79556 83163 90465709
Joint dislocation 28.45 11.02 3 79572 44579 90504293
Palmoplantar keratoderma 28.36 11.02 24 79551 3483 90545389
Exostosis 28.36 11.02 6 79569 53128 90495744
Bone erosion 28.27 11.02 6 79569 53015 90495857
Hypovolaemia 28.26 11.02 44 79531 12387 90536485
Glomerular filtration rate decreased 27.99 11.02 52 79523 16880 90531992
Pancreatic stent placement 27.85 11.02 5 79570 3 90548869
Inability to afford medication 27.69 11.02 24 79551 3598 90545274
Tubulointerstitial nephritis and uveitis syndrome 27.59 11.02 10 79565 262 90548610
Nail disorder 27.11 11.02 9 79566 59058 90489814
Pancreatic duct dilatation 26.67 11.02 11 79564 411 90548461
Paraesthesia 26.63 11.02 121 79454 250205 90298667
Injection site reaction 26.53 11.02 25 79550 92055 90456817
Weight increased 26.45 11.02 237 79338 417690 90131182
Oedema peripheral 26.37 11.02 344 79231 257571 90291301
Therapeutic product effect incomplete 26.25 11.02 85 79490 193811 90355061
Drug ineffective for unapproved indication 25.97 11.02 13 79562 66631 90482241
Prescribed underdose 25.86 11.02 17 79558 75002 90473870
Anaemia 25.72 11.02 444 79131 352358 90196514
Urticaria 25.63 11.02 165 79410 312569 90236303
Hypomagnesaemia 25.54 11.02 79 79496 35509 90513363
Intensive care unit acquired weakness 25.50 11.02 14 79561 997 90547875
Febrile neutropenia 25.42 11.02 64 79511 158285 90390587
Urosepsis 25.36 11.02 57 79518 21175 90527697
Myalgia 25.33 11.02 250 79325 174875 90373997
Endometrial disorder 25.32 11.02 13 79562 808 90548064
Blood creatinine increased 25.26 11.02 164 79411 101222 90447650
Tonsillectomy 25.05 11.02 14 79561 1033 90547839
Angioedema 24.92 11.02 118 79457 64758 90484114
Decreased vibratory sense 24.73 11.02 10 79565 355 90548517
Prevertebral soft tissue swelling of cervical space 24.59 11.02 6 79569 36 90548836
Aortic arteriosclerosis 24.56 11.02 32 79543 7652 90541220
Neutropenia 24.35 11.02 108 79467 224796 90324076
Impaired work ability 24.34 11.02 53 79522 19273 90529599
Peripheral artery haematoma 24.18 11.02 6 79569 39 90548833
Splenic vein occlusion 24.16 11.02 4 79571 0 90548872
Insulin-requiring type 2 diabetes mellitus 24.02 11.02 7 79568 89 90548783
Small fibre neuropathy 23.89 11.02 12 79563 712 90548160
Malaise 23.76 11.02 678 78897 585308 89963564
Radiotherapy 23.73 11.02 13 79562 922 90547950
Wheezing 23.62 11.02 118 79457 237962 90310910
Amylase increased 23.47 11.02 30 79545 7042 90541830
Joint noise 23.43 11.02 26 79549 5264 90543608
Back injury 23.42 11.02 6 79569 46616 90502256
Sleep terror 23.41 11.02 24 79551 4440 90544432
Hyperlactacidaemia 23.09 11.02 23 79552 4113 90544759
Cardiac failure 23.07 11.02 170 79405 109326 90439546
Disorientation 22.96 11.02 88 79487 44026 90504846
Pancreatic neoplasm 22.84 11.02 13 79562 993 90547879
Laryngitis 22.83 11.02 8 79567 50745 90498127
Carotid artery occlusion 22.79 11.02 28 79547 6314 90542558
Obesity 22.63 11.02 36 79539 105471 90443401
Pancreatic neuroendocrine tumour 22.58 11.02 11 79564 611 90548261
Bladder trabeculation 22.46 11.02 6 79569 54 90548818
Depression 22.44 11.02 163 79412 300438 90248434
Lung disorder 22.22 11.02 63 79512 149820 90399052
Embolic cerebellar infarction 22.16 11.02 5 79570 20 90548852
Haemoglobin increased 22.14 11.02 30 79545 7451 90541421
Cholelithiasis 22.02 11.02 98 79477 52408 90496464
Enterococcus test positive 21.95 11.02 14 79561 1315 90547557
Coeliac disease 21.92 11.02 6 79569 44604 90504268
Increased appetite 21.83 11.02 38 79537 11727 90537145
Memory impairment 21.79 11.02 94 79481 197150 90351722
Anaemia vitamin B12 deficiency 21.77 11.02 11 79564 661 90548211
Dry mouth 21.39 11.02 86 79489 183973 90364899
Mucosal inflammation 21.34 11.02 12 79563 57613 90491259
Adverse drug reaction 21.29 11.02 44 79531 116657 90432215
Circumstance or information capable of leading to medication error 21.29 11.02 24 79551 4943 90543929
Blood lactic acid increased 21.27 11.02 32 79543 8746 90540126
Glomerulonephritis minimal lesion 21.17 11.02 9 79566 363 90548509
Hepatic steatosis 21.16 11.02 76 79499 36869 90512003
Liver function test increased 21.15 11.02 26 79549 84829 90464043
Micturition disorder 21.07 11.02 19 79556 3001 90545871
Intestinal transit time abnormal 21.06 11.02 6 79569 70 90548802
Diabetic retinopathy 20.85 11.02 18 79557 2684 90546188
Atrial tachycardia 20.81 11.02 26 79549 5964 90542908
Injection site erythema 20.76 11.02 34 79541 98468 90450404
Shock 20.76 11.02 64 79511 28714 90520158
Transient ischaemic attack 20.75 11.02 84 79491 43092 90505780
Pancreatitis necrotising 20.72 11.02 17 79558 2364 90546508
Diabetic ketosis 20.60 11.02 10 79565 551 90548321
Tri-iodothyronine free decreased 20.48 11.02 9 79566 394 90548478
Hyponatraemia 20.47 11.02 193 79382 133345 90415527
Explorative laparotomy 20.19 11.02 6 79569 82 90548790
Pancreatic pseudocyst 19.77 11.02 11 79564 804 90548068
Dyspepsia 19.77 11.02 98 79477 198062 90350810
Incisional hernia repair 19.77 11.02 4 79571 8 90548864
Pancreatic cyst 19.70 11.02 16 79559 2194 90546678
Immunisation 19.68 11.02 16 79559 2197 90546675
Radioallergosorbent test positive 19.59 11.02 5 79570 37 90548835
Splenectomy 19.58 11.02 10 79565 615 90548257
Muscle atrophy 19.47 11.02 30 79545 8371 90540501
Sedation 19.38 11.02 9 79566 48162 90500710
Peripheral vascular disorder 19.35 11.02 26 79549 6405 90542467
Biliary obstruction 19.33 11.02 19 79556 3343 90545529
Fear-related avoidance of activities 19.29 11.02 7 79568 184 90548688
Myocardial infarction 19.27 11.02 159 79416 105813 90443059
Finger deformity 19.10 11.02 3 79572 32894 90515978
Treatment noncompliance 19.08 11.02 93 79482 51634 90497238
Walking aid user 18.97 11.02 4 79571 35502 90513370
Serotonin syndrome 18.80 11.02 5 79570 37882 90510990
Vision blurred 18.74 11.02 163 79412 110130 90438742
Cholangitis 18.58 11.02 27 79548 7155 90541717
Internal haemorrhage 18.49 11.02 25 79550 6195 90542677
Hysterectomy 18.43 11.02 35 79540 11549 90537323
Hepatic function abnormal 18.37 11.02 85 79490 46203 90502669
Joint stiffness 18.33 11.02 25 79550 78017 90470855
Portal vein cavernous transformation 18.17 11.02 6 79569 118 90548754
Radiotherapy to pancreas 18.12 11.02 3 79572 0 90548872
Toxicity to various agents 17.86 11.02 164 79411 287682 90261190
Drug abuse 17.75 11.02 28 79547 82319 90466553
Epilepsy 17.68 11.02 28 79547 82178 90466694
Tension headache 17.66 11.02 27 79548 7482 90541390
Ketonuria 17.49 11.02 10 79565 771 90548101
Hypokinesia 17.48 11.02 41 79534 15656 90533216
Myelopathy 17.13 11.02 18 79557 3426 90545446
Metastases to lymph nodes 16.99 11.02 34 79541 11655 90537217
Dysuria 16.87 11.02 74 79501 39327 90509545
Neck pain 16.82 11.02 48 79527 113915 90434957
Completed suicide 16.71 11.02 68 79507 144990 90403882
Peripheral sensorimotor neuropathy 16.55 11.02 14 79561 2031 90546841
Pollakiuria 16.49 11.02 65 79510 32940 90515932
Acute coronary syndrome 16.38 11.02 32 79543 10781 90538091
Tongue oedema 16.34 11.02 22 79553 5432 90543440
Constipation 16.34 11.02 341 79234 280054 90268818
Diabetic ulcer 16.31 11.02 6 79569 164 90548708
Urinary tract infection 16.31 11.02 367 79208 305265 90243607
Arteriosclerosis 16.30 11.02 32 79543 10821 90538051
Carcinoid crisis 16.27 11.02 7 79568 291 90548581
Generalised oedema 16.26 11.02 45 79530 19008 90529864
Product monitoring error 16.23 11.02 20 79555 4524 90544348
Fear of falling 16.18 11.02 9 79566 658 90548214
Gastric disorder 16.09 11.02 65 79510 33319 90515553
Leukopenia 15.93 11.02 41 79534 100669 90448203
Device dislocation 15.91 11.02 4 79571 31478 90517394
Mesenteric arterial occlusion 15.91 11.02 6 79569 176 90548696
Renal arteriosclerosis 15.76 11.02 6 79569 181 90548691
Hyperlipidaemia 15.64 11.02 50 79525 22866 90526006
Chronic kidney disease 15.58 11.02 86 79489 50105 90498767
Jaundice 15.42 11.02 63 79512 32454 90516418
Lip swelling 15.40 11.02 71 79504 38539 90510333
Multiple sclerosis relapse 15.30 11.02 14 79561 52291 90496581
Ear pain 15.11 11.02 17 79558 57685 90491187
Onychomycosis 15.01 11.02 7 79568 37369 90511503
Upper respiratory tract irritation 14.94 11.02 6 79569 209 90548663
Pseudomonal bacteraemia 14.82 11.02 13 79562 1981 90546891
Product colour issue 14.74 11.02 9 79566 783 90548089
Frequent bowel movements 14.66 11.02 17 79558 56918 90491954
Mixed liver injury 14.64 11.02 25 79550 7598 90541274
Hunger 14.60 11.02 23 79552 6540 90542332
Hyperglycaemic hyperosmolar nonketotic syndrome 14.56 11.02 11 79564 1358 90547514
Bile duct stone 14.55 11.02 18 79557 4089 90544783
Foetal exposure during pregnancy 14.46 11.02 10 79565 42965 90505907
Premature delivery 14.46 11.02 8 79567 38754 90510118
Infusion site scar 14.22 11.02 8 79567 598 90548274
Abdominal pain 14.16 11.02 451 79124 395270 90153602
Underdose 14.05 11.02 16 79559 54001 90494871
Coma acidotic 14.01 11.02 5 79570 125 90548747
Acquired mitochondrial DNA mutation 13.97 11.02 3 79572 9 90548863
Pancreatic enzymes increased 13.96 11.02 9 79566 861 90548011
Systemic infection 13.91 11.02 19 79556 4756 90544116
Meibomianitis 13.86 11.02 4 79571 49 90548823
Type 2 diabetes mellitus 13.85 11.02 113 79462 203131 90345741
Acute myocardial infarction 13.79 11.02 64 79511 34826 90514046
Hyperthermia 13.77 11.02 29 79546 10306 90538566
Haematochezia 13.76 11.02 108 79467 70805 90478067
Pain of skin 13.74 11.02 38 79537 16044 90532828
Disease recurrence 13.71 11.02 8 79567 37645 90511227
Glycosylated haemoglobin decreased 13.71 11.02 8 79567 641 90548231
Cognitive disorder 13.63 11.02 106 79469 69301 90479571
Gout 13.59 11.02 39 79536 16820 90532052
Hepatic necrosis 13.55 11.02 22 79553 6416 90542456
Colitis ulcerative 13.46 11.02 20 79555 60246 90488626
Arrhythmia 13.45 11.02 73 79502 42259 90506613
Non-alcoholic steatohepatitis 13.45 11.02 12 79563 1870 90547002
Peptic ulcer 13.32 11.02 20 79555 5455 90543417
Product size issue 13.30 11.02 7 79568 458 90548414
Renal tubular acidosis 13.16 11.02 13 79562 2302 90546570
Contusion 13.16 11.02 149 79426 251067 90297805
Disease progression 13.14 11.02 82 79493 156533 90392339
Splenic calcification 12.93 11.02 3 79572 14 90548858
Dizziness 12.75 11.02 636 78939 588648 89960224
Stent placement 12.66 11.02 17 79558 4186 90544686
Renal cancer metastatic 12.63 11.02 6 79569 315 90548557
Confusional state 12.50 11.02 435 79140 385770 90163102
Intraventricular haemorrhage 12.45 11.02 13 79562 2456 90546416
Faecaloma 12.45 11.02 28 79547 10403 90538469
Cerebral reperfusion injury 12.44 11.02 3 79572 17 90548855
Osteoarthritis 12.36 11.02 111 79464 195619 90353253
Depressed mood 12.36 11.02 81 79494 50141 90498731
Vitamin B12 decreased 12.36 11.02 19 79556 5291 90543581
Oesophageal mucosal tear 12.29 11.02 3 79572 18 90548854
Diabetic nephropathy 12.28 11.02 11 79564 1723 90547149
Prerenal failure 12.25 11.02 12 79563 2103 90546769
Soft tissue necrosis 12.16 11.02 8 79567 792 90548080
Hepatic cancer 12.12 11.02 18 79557 4863 90544009
Urine albumin/creatinine ratio increased 12.11 11.02 7 79568 551 90548321
Loss of personal independence in daily activities 12.08 11.02 70 79505 136035 90412837
Genital infection 12.07 11.02 5 79570 189 90548683
Reperfusion injury 12.05 11.02 4 79571 80 90548792
Splenic granuloma 12.02 11.02 3 79572 20 90548852
Portal fibrosis 12.01 11.02 6 79569 352 90548520
Disability assessment scale score increased 11.99 11.02 16 79559 3915 90544957
Congestive hepatopathy 11.90 11.02 14 79561 3019 90545853
Oral mucosal discolouration 11.88 11.02 6 79569 360 90548512
Skin turgor decreased 11.82 11.02 7 79568 576 90548296
Ventricular tachycardia 11.82 11.02 48 79527 24660 90524212
Gamma-glutamyltransferase increased 11.76 11.02 65 79510 37887 90510985
Vipoma 11.73 11.02 4 79571 87 90548785
Arteriosclerosis coronary artery 11.71 11.02 26 79549 9577 90539295
Adrenal mass 11.66 11.02 9 79566 1146 90547726
Metastasis 11.62 11.02 20 79555 6117 90542755
Infrequent bowel movements 11.51 11.02 10 79565 1504 90547368
Interstitial lung disease 11.49 11.02 110 79465 76295 90472577
Lymphopenia 11.39 11.02 3 79572 22878 90525994
Nephroangiosclerosis 11.35 11.02 5 79570 220 90548652
Musculoskeletal pain 11.31 11.02 96 79479 171155 90377717
Haematemesis 11.29 11.02 59 79516 33667 90515205
Cholecystectomy 11.28 11.02 29 79546 11726 90537146
Anosmia 11.27 11.02 26 79549 9822 90539050
Blood triglycerides increased 11.25 11.02 32 79543 13729 90535143
Hypoprothrombinaemia 11.17 11.02 6 79569 409 90548463
Flushing 11.15 11.02 40 79535 88451 90460421
Facial pain 11.12 11.02 31 79544 13151 90535721
Weight decreased 11.09 11.02 423 79152 379487 90169385
Drug level above therapeutic 11.09 11.02 19 79556 5790 90543082
Immunodeficiency 11.03 11.02 13 79562 43221 90505651

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 647.74 10.83 533 64524 42735 42513543
Hypoglycaemia 622.63 10.83 600 64457 59254 42497024
Diabetes mellitus inadequate control 571.53 10.83 332 64725 15058 42541220
Blood glucose increased 490.41 10.83 583 64474 73116 42483162
Pancreatic carcinoma 437.09 10.83 236 64821 9270 42547008
Lactic acidosis 344.52 10.83 384 64673 44877 42511401
Pancreatic carcinoma metastatic 339.62 10.83 141 64916 3025 42553253
Glycosylated haemoglobin increased 304.31 10.83 209 64848 12715 42543563
Pancreatitis acute 232.02 10.83 271 64786 33293 42522985
Off label use 211.93 10.83 410 64647 637925 41918353
Diabetic ketoacidosis 189.69 10.83 201 64856 22166 42534112
Adenocarcinoma pancreas 175.44 10.83 71 64986 1423 42554855
Pemphigoid 174.99 10.83 143 64914 11324 42544954
Pancreaticoduodenectomy 163.03 10.83 34 65023 34 42556244
Ketoacidosis 161.22 10.83 101 64956 5251 42551027
Product monitoring error 157.74 10.83 93 64964 4330 42551948
Drug abuse 141.36 10.83 4 65053 104767 42451511
Hyperglycaemia 133.42 10.83 246 64811 45613 42510665
Acute kidney injury 123.11 10.83 969 64088 366368 42189910
Metastases to liver 116.42 10.83 134 64923 16192 42540086
Lipase increased 115.47 10.83 109 64948 10457 42545821
Euglycaemic diabetic ketoacidosis 113.47 10.83 83 64974 5577 42550701
Interstitial lung disease 111.63 10.83 317 64740 78145 42478133
Bile duct stent insertion 108.68 10.83 27 65030 90 42556188
Pancreatectomy 104.51 10.83 21 65036 14 42556264
Toxicity to various agents 98.61 10.83 123 64934 229013 42327265
Hyperkalaemia 94.60 10.83 304 64753 80154 42476124
Blood glucose abnormal 93.27 10.83 81 64976 6972 42549306
Drug ineffective 87.10 10.83 585 64472 629612 41926666
General physical health deterioration 82.25 10.83 451 64606 150795 42405483
Product use in unapproved indication 80.39 10.83 98 64959 184358 42371920
Radiotherapy 73.61 10.83 33 65024 858 42555420
Pancreatitis chronic 73.28 10.83 45 65012 2257 42554021
Metabolic acidosis 72.24 10.83 208 64849 51650 42504628
Glycosylated haemoglobin abnormal 63.08 10.83 22 65035 286 42555992
No adverse event 62.77 10.83 165 64892 38856 42517422
Pancreatic stent placement 61.67 10.83 12 65045 5 42556273
Seronegative arthritis 60.78 10.83 32 65025 1192 42555086
Cerebral infarction 58.75 10.83 140 64917 31029 42525249
Bladder cancer 56.70 10.83 97 64960 16950 42539328
Explorative laparotomy 54.87 10.83 12 65045 18 42556260
Blood glucose decreased 54.15 10.83 86 64971 14133 42542145
Product dose omission issue 51.86 10.83 408 64649 153957 42402321
Blood glucose fluctuation 51.42 10.83 48 65009 4539 42551739
Renal cyst 50.17 10.83 69 64988 9970 42546308
Cholelithiasis 49.66 10.83 110 64947 23236 42533042
Disease progression 49.26 10.83 90 64967 143566 42412712
Hypomagnesaemia 48.43 10.83 123 64934 28365 42527913
Biliary sphincterotomy 46.79 10.83 9 65048 3 42556275
Hyperlipidaemia 46.47 10.83 102 64955 21414 42534864
Dyslipidaemia 45.97 10.83 64 64993 9354 42546924
Dizziness 45.32 10.83 580 64477 248674 42307604
Diabetic neuropathy 44.58 10.83 44 65013 4458 42551820
Neutropenia 43.62 10.83 157 64900 199274 42357004
Drug ineffective for unapproved indication 42.97 10.83 9 65048 46154 42510124
Diabetic foetopathy 42.73 10.83 15 65042 199 42556079
Product residue present 42.43 10.83 35 65022 2806 42553472
Diabetic nephropathy 41.73 10.83 32 65025 2309 42553969
Diverticulum intestinal 41.65 10.83 45 65012 5068 42551210
Renal impairment 41.30 10.83 299 64758 109929 42446349
Prostatomegaly 41.20 10.83 49 65008 6128 42550150
Amylase increased 41.01 10.83 51 65006 6678 42549600
Febrile neutropenia 40.08 10.83 147 64910 185556 42370722
Mucosal inflammation 39.55 10.83 13 65044 49361 42506917
Hypoglycaemic coma 39.31 10.83 33 65024 2711 42553567
Cholecystectomy 39.16 10.83 36 65021 3338 42552940
Renal failure 38.84 10.83 362 64695 143364 42412914
Glycosylated haemoglobin decreased 38.35 10.83 17 65040 430 42555848
Insulin-requiring type 2 diabetes mellitus 37.99 10.83 13 65044 159 42556119
Therapeutic drug monitoring analysis not performed 37.05 10.83 18 65039 564 42555714
Drug intolerance 36.85 10.83 41 65016 80383 42475895
Pancreatitis necrotising 36.76 10.83 36 65021 3613 42552665
Oedema peripheral 34.91 10.83 339 64718 135737 42420541
Pemphigus 34.84 10.83 27 65030 1979 42554299
Weight decreased 34.49 10.83 476 64581 207472 42348806
Alcoholic ketoacidosis 34.37 10.83 9 65048 39 42556239
Pancreatic cyst 33.80 10.83 20 65037 937 42555341
Nephropathy 33.78 10.83 47 65010 6864 42549414
Drug dependence 33.34 10.83 3 65054 29091 42527187
Pancreatic enzymes increased 32.58 10.83 19 65038 866 42555412
Splenectomy 32.17 10.83 15 65042 428 42555850
Large for dates baby 31.71 10.83 19 65038 911 42555367
Epiploic appendagitis 31.40 10.83 9 65048 58 42556220
Circumstance or information capable of leading to medication error 31.36 10.83 28 65029 2500 42553778
Diabetes mellitus 31.14 10.83 177 64880 59910 42496368
Angioedema 31.12 10.83 138 64919 42339 42513939
Death 30.87 10.83 520 64537 470665 42085613
Electrolyte imbalance 30.28 10.83 75 64982 17026 42539252
Pancreatic disorder 30.14 10.83 25 65032 2020 42554258
Wrong technique in product usage process 30.10 10.83 137 64920 42498 42513780
Gastrointestinal tube insertion 29.94 10.83 22 65035 1488 42554790
Autoimmune pancreatitis 29.85 10.83 14 65043 405 42555873
Pancreatic pseudocyst 29.84 10.83 18 65039 874 42555404
Pharyngeal necrosis 29.71 10.83 9 65048 72 42556206
Thirst 29.20 10.83 51 65006 9057 42547221
Rhabdomyolysis 28.84 10.83 211 64846 77808 42478470
Pollakiuria 28.22 10.83 87 64970 22418 42533860
Metastases to lymph nodes 28.14 10.83 40 65017 5958 42550320
Gastroenterostomy 28.12 10.83 8 65049 50 42556228
Type 2 diabetes mellitus 27.58 10.83 76 64981 18395 42537883
Treatment failure 27.52 10.83 33 65024 62591 42493687
Dysuria 27.47 10.83 107 64950 30989 42525289
Polyuria 26.97 10.83 52 65005 9959 42546319
Body mass index abnormal 26.49 10.83 10 65047 165 42556113
Vomiting projectile 26.48 10.83 16 65041 779 42555499
Pancreatic mass 26.01 10.83 17 65040 951 42555327
Drug resistance 25.75 10.83 10 65047 34238 42522040
Pyrexia 25.40 10.83 436 64621 393606 42162672
Dehydration 25.33 10.83 329 64728 141438 42414840
Foetal exposure during pregnancy 25.30 10.83 21 65036 47290 42508988
Inability to afford medication 25.25 10.83 23 65034 2107 42554171
Thrombosis 25.22 10.83 41 65016 68470 42487808
Intentional product use issue 24.60 10.83 45 65012 71788 42484490
COVID-19 24.20 10.83 93 64964 115855 42440423
Musculoskeletal pain 24.18 10.83 108 64949 33232 42523046
Labelled drug-drug interaction medication error 24.15 10.83 65 64992 15517 42540761
Sprue-like enteropathy 24.11 10.83 14 65043 633 42555645
Intentional product misuse 23.77 10.83 36 65021 61864 42494414
Therapeutic drug monitoring analysis incorrectly performed 23.59 10.83 11 65046 314 42555964
Prohormone brain natriuretic peptide increased 23.52 10.83 8 65049 96 42556182
Brain contusion 23.33 10.83 16 65041 970 42555308
Gastrooesophageal reflux disease 22.91 10.83 132 64925 44891 42511387
Hypoxia 22.78 10.83 45 65012 69741 42486537
Sedation 22.74 10.83 9 65048 30466 42525812
Hyperlipasaemia 22.47 10.83 13 65044 584 42555694
Radiotherapy to pancreas 21.95 10.83 4 65053 0 42556278
Intestinal adhesion lysis 21.95 10.83 4 65053 0 42556278
Seizure 21.89 10.83 102 64955 120459 42435819
Food aversion 21.36 10.83 12 65045 509 42555769
Neurotoxicity 21.22 10.83 5 65052 23646 42532632
Leg amputation 21.22 10.83 23 65034 2600 42553678
Loss of personal independence in daily activities 21.10 10.83 27 65030 49789 42506489
Pancreatolithiasis 21.05 10.83 7 65050 78 42556200
Psoriatic arthropathy 21.03 10.83 6 65051 24961 42531317
Aortic arteriosclerosis 20.93 10.83 32 65025 5088 42551190
Cardiac failure 20.80 10.83 252 64805 106604 42449674
Metastases to peritoneum 20.74 10.83 22 65035 2427 42553851
Bile duct cancer 20.67 10.83 13 65044 680 42555598
Prostatic calcification 20.45 10.83 8 65049 146 42556132
Pancreatic duct dilatation 20.28 10.83 7 65050 88 42556190
Vena cava filter insertion 20.28 10.83 5 65052 16 42556262
Pyelitis 20.26 10.83 8 65049 150 42556128
Therapeutic product effect decreased 20.17 10.83 18 65039 39132 42517146
Diabetic retinopathy 20.12 10.83 20 65037 2043 42554235
Diverticulum 20.11 10.83 39 65018 7502 42548776
Colon cancer 19.90 10.83 45 65012 9636 42546642
Phlebolith 19.71 10.83 4 65053 3 42556275
Papillary renal cell carcinoma 19.67 10.83 10 65047 346 42555932
Hyperlactacidaemia 19.56 10.83 29 65028 4487 42551791
Tonsillectomy 19.55 10.83 11 65046 468 42555810
Radiation necrosis 19.29 10.83 9 65048 257 42556021
Thrombocytopenia 19.05 10.83 192 64865 190087 42366191
Adverse event 19.00 10.83 79 64978 23561 42532717
Blood thyroid stimulating hormone increased 18.77 10.83 31 65026 5261 42551017
Blood creatinine increased 18.69 10.83 253 64804 109750 42446528
Staphylococcal infection 18.58 10.83 18 65039 37625 42518653
Gastrointestinal mucosal necrosis 18.55 10.83 8 65049 189 42556089
Urinary hesitation 18.49 10.83 23 65034 3012 42553266
Urine ketone body present 18.41 10.83 16 65041 1378 42554900
Biliary dilatation 18.34 10.83 16 65041 1385 42554893
Vitamin B1 deficiency 18.16 10.83 10 65047 408 42555870
Metastases to lung 18.05 10.83 48 65009 11376 42544902
Diabetic metabolic decompensation 18.01 10.83 19 65038 2083 42554195
Pneumocystis jirovecii infection 17.95 10.83 22 65035 2838 42553440
Large intestine polyp 17.87 10.83 42 65015 9223 42547055
Generalised tonic-clonic seizure 17.79 10.83 9 65048 26370 42529908
Product prescribing error 17.76 10.83 83 64974 26029 42530249
Cytomegalovirus infection 17.69 10.83 14 65043 32292 42523986
Onychoclasis 17.62 10.83 21 65036 2631 42553647
Peripancreatic fluid collection 17.61 10.83 5 65052 31 42556247
Electrocardiogram abnormal 17.44 10.83 44 65013 10101 42546177
Pneumobilia 17.26 10.83 7 65050 141 42556137
Ductal adenocarcinoma of pancreas 17.21 10.83 5 65052 34 42556244
Myelosuppression 17.06 10.83 22 65035 40439 42515839
Drug eruption 16.92 10.83 75 64982 23000 42533278
Urticaria chronic 16.82 10.83 7 65050 151 42556127
Product packaging quantity issue 16.81 10.83 15 65042 1338 42554940
Lower respiratory tract infection 16.77 10.83 23 65034 41183 42515095
Potentiating drug interaction 16.70 10.83 33 65024 6435 42549843
Pancreatic neoplasm 16.68 10.83 13 65044 961 42555317
Lumbosacral radiculoplexus neuropathy 16.67 10.83 6 65051 86 42556192
Malignant ascites 16.64 10.83 11 65046 627 42555651
Suicidal ideation 16.64 10.83 30 65027 48131 42508147
Alopecia universalis 16.53 10.83 7 65050 158 42556120
Pancreatic sphincterotomy 16.46 10.83 3 65054 0 42556278
Choledochoenterostomy 16.46 10.83 3 65054 0 42556278
Blood elastase increased 16.46 10.83 3 65054 0 42556278
Splenic vein occlusion 16.46 10.83 3 65054 0 42556278
Biopsy pancreas 16.46 10.83 3 65054 0 42556278
Duodenal sphincterotomy 16.46 10.83 3 65054 0 42556278
Decreased appetite 16.34 10.83 398 64659 192739 42363539
Proteinuria 16.33 10.83 74 64983 22909 42533369
Bile duct stone 16.31 10.83 21 65036 2846 42553432
Blood triglycerides abnormal 16.28 10.83 8 65049 257 42556021
Knee operation 16.27 10.83 20 65037 2588 42553690
Metabolic alkalosis 16.26 10.83 18 65039 2083 42554195
Coma 16.24 10.83 36 65021 53518 42502760
Completed suicide 16.13 10.83 84 64973 96381 42459897
Vitamin B1 decreased 16.10 10.83 9 65048 378 42555900
Therapy non-responder 16.07 10.83 36 65021 53323 42502955
Pancreatic carcinoma recurrent 16.01 10.83 6 65051 97 42556181
Insulin C-peptide increased 15.84 10.83 6 65051 100 42556178
Groin abscess 15.77 10.83 12 65045 856 42555422
Hypercapnic coma 15.72 10.83 7 65050 179 42556099
Suicide attempt 15.67 10.83 29 65028 46071 42510207
Duplicate therapy error 15.44 10.83 8 65049 288 42555990
Nephroangiosclerosis 15.37 10.83 7 65050 189 42556089
Condition aggravated 15.35 10.83 293 64764 260461 42295817
Spinal osteoarthritis 15.28 10.83 38 65019 8648 42547630
Palindromic rheumatism 15.23 10.83 7 65050 193 42556085
Cytopenia 15.12 10.83 4 65053 17493 42538785
Musculoskeletal stiffness 15.04 10.83 42 65015 57723 42498555
Osteonecrosis 14.95 10.83 3 65054 15862 42540416
Romberg test positive 14.93 10.83 5 65052 57 42556221
Pulmonary embolism 14.92 10.83 114 64943 119498 42436780
Oedematous pancreatitis 14.89 10.83 11 65046 750 42555528
Nephrogenic anaemia 14.81 10.83 19 65038 2567 42553711
Therapy partial responder 14.80 10.83 6 65051 20015 42536263
Somnolence 14.69 10.83 141 64916 140964 42415314
Urogenital infection fungal 14.65 10.83 4 65053 21 42556257
Stent placement 14.63 10.83 28 65029 5332 42550946
Anion gap increased 14.61 10.83 17 65040 2077 42554201
Bile duct stenosis 14.56 10.83 14 65043 1374 42554904
Linear IgA disease 14.55 10.83 17 65040 2086 42554192
Thrombotic cerebral infarction 14.50 10.83 9 65048 460 42555818
Thyroid neoplasm 14.50 10.83 9 65048 460 42555818
Hepatic steatosis 14.45 10.83 68 64989 21380 42534898
Nephrolithiasis 14.41 10.83 101 64956 36729 42519549
Unresponsive to stimuli 14.39 10.83 16 65041 31387 42524891
Biliary neoplasm 14.38 10.83 3 65054 3 42556275
Biliary obstruction 14.37 10.83 21 65036 3208 42553070
Pseudohyponatraemia 14.27 10.83 6 65051 133 42556145
Haemophagocytic lymphohistiocytosis 14.24 10.83 5 65052 18217 42538061
Bladder irrigation 14.20 10.83 5 65052 67 42556211
Intentional self-injury 14.07 10.83 3 65054 15199 42541079
Stress 14.00 10.83 29 65028 44183 42512095
Weight increased 13.94 10.83 237 64820 107746 42448532
Abdominal pain 13.92 10.83 385 64672 190086 42366192
Ketonuria 13.91 10.83 10 65047 654 42555624
Amaurosis 13.82 10.83 11 65046 838 42555440
Agitation 13.79 10.83 51 65006 64263 42492015
Pancreatic fistula 13.62 10.83 5 65052 76 42556202
Urinary tract infection 13.58 10.83 220 64837 99064 42457214
Respiratory arrest 13.56 10.83 14 65043 28410 42527868
Substance use 13.55 10.83 15 65042 1736 42554542
Renal mass 13.55 10.83 16 65041 1986 42554292
Retinopathy 13.44 10.83 17 65040 2264 42554014
Pancytopenia 13.41 10.83 115 64942 117628 42438650
Genital swelling 13.39 10.83 7 65050 257 42556021
Blood ketone body increased 13.37 10.83 9 65048 529 42555749
Genital lesion 13.21 10.83 7 65050 264 42556014
Asthma-chronic obstructive pulmonary disease overlap syndrome 13.19 10.83 14 65043 1545 42554733
Dementia 13.19 10.83 55 65002 16425 42539853
Gallbladder disorder 12.90 10.83 32 65025 7270 42549008
Gastrostomy 12.79 10.83 11 65046 934 42555344
Haematochezia 12.78 10.83 141 64916 58295 42497983
Bladder transitional cell carcinoma 12.78 10.83 18 65039 2658 42553620
Pseudocyst 12.75 10.83 6 65051 175 42556103
Impaired quality of life 12.72 10.83 3 65054 14174 42542104
Synovitis 12.64 10.83 4 65053 15563 42540715
Intraductal papillary-mucinous carcinoma of pancreas 12.57 10.83 3 65054 8 42556270
Anxiety 12.54 10.83 118 64939 118442 42437836
Infusion related reaction 12.53 10.83 49 65008 60757 42495521
Hepatotoxicity 12.46 10.83 12 65045 25155 42531123
Pain 12.38 10.83 282 64775 244566 42311712
Haemorrhage 12.35 10.83 49 65008 60514 42495764
Procedural headache 12.33 10.83 4 65053 41 42556237
Renal stone removal 12.33 10.83 4 65053 41 42556237
Adrenal mass 12.33 10.83 10 65047 783 42555495
Bile duct adenocarcinoma 12.31 10.83 3 65054 9 42556269
Subdural hygroma 12.30 10.83 8 65049 444 42555834
Nightmare 12.30 10.83 12 65045 25000 42531278
Eczema asteatotic 12.28 10.83 8 65049 445 42555833
Chronic kidney disease 12.24 10.83 118 64939 47123 42509155
Unevaluable event 12.17 10.83 21 65036 34267 42522011
Cyst removal 12.16 10.83 4 65053 43 42556235
Device related infection 12.13 10.83 8 65049 20271 42536007
Hypoglycaemic encephalopathy 12.09 10.83 7 65050 315 42555963
Nasal neoplasm 12.05 10.83 5 65052 107 42556171
Cervicobrachial syndrome 11.95 10.83 7 65050 322 42555956
Transplant rejection 11.94 10.83 3 65054 13585 42542693
Gastric cancer 11.93 10.83 30 65027 6873 42549405
Umbilical hernia repair 11.91 10.83 4 65053 46 42556232
Anaemia 11.85 10.83 532 64525 279746 42276532
Post streptococcal glomerulonephritis 11.76 10.83 5 65052 114 42556164
Fracture 11.76 10.83 33 65024 8070 42548208
Polydipsia 11.71 10.83 23 65034 4465 42551813
Abdominal hernia repair 11.68 10.83 4 65053 49 42556229
Melaena 11.68 10.83 100 64957 38646 42517632
Nodular rash 11.68 10.83 5 65052 116 42556162
Duodenitis 11.61 10.83 26 65031 5530 42550748
Arthropathy 11.57 10.83 17 65040 29580 42526698
Hepatic function abnormal 11.54 10.83 125 64932 51442 42504836
Toe amputation 11.54 10.83 18 65039 2911 42553367
Malignant neoplasm of ampulla of Vater 11.46 10.83 3 65054 13 42556265
Superinfection 11.44 10.83 18 65039 2933 42553345
Metastases to spleen 11.43 10.83 8 65049 501 42555777
Pyelonephritis 11.26 10.83 32 65025 7882 42548396
Hepatic cyst 11.23 10.83 18 65039 2980 42553298
Nephrotic syndrome 11.21 10.83 34 65023 8684 42547594
Lipoma 11.14 10.83 15 65042 2123 42554155
Prerenal failure 11.08 10.83 16 65041 2417 42553861
Flatulence 11.05 10.83 71 64986 25081 42531197
Balanoposthitis 11.04 10.83 13 65044 1608 42554670
Accidental exposure to product 10.96 10.83 9 65048 20384 42535894
Posterior reversible encephalopathy syndrome 10.95 10.83 3 65054 12818 42543460
Dystonia 10.91 10.83 3 65054 12787 42543491
Drug hypersensitivity 10.91 10.83 98 64959 99291 42456987

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
Hypoglycaemia 1218.70 10.65 1000 116580 115104 110356615
Blood glucose increased 1047.31 10.65 971 116609 131525 110340194
Diabetes mellitus inadequate control 1035.90 10.65 544 117036 29231 110442488
Lactic acidosis 887.96 10.65 758 116822 92053 110379666
Pancreatitis 597.00 10.65 610 116970 92923 110378796
Diabetic ketoacidosis 528.30 10.65 403 117177 41655 110430064
Acute kidney injury 519.33 10.65 1668 115912 633762 109837957
Carotid artery thrombosis 505.36 10.65 233 117347 9405 110462314
Glycosylated haemoglobin increased 497.08 10.65 311 117269 23308 110448411
Neurologic neglect syndrome 494.47 10.65 227 117353 9071 110462648
Personality disorder 476.35 10.65 245 117335 12592 110459127
Adjustment disorder 450.26 10.65 223 117357 10572 110461147
Euglycaemic diabetic ketoacidosis 426.00 10.65 220 117360 11403 110460316
Pancreatic carcinoma 420.65 10.65 237 117343 14635 110457084
Hemiplegia 415.17 10.65 274 117306 22508 110449211
Pemphigoid 408.44 10.65 257 117323 19450 110452269
Affect lability 388.65 10.65 244 117336 18393 110453326
Ketoacidosis 358.41 10.65 187 117393 9900 110461819
Pancreatitis acute 348.49 10.65 373 117207 59901 110411818
Sensory loss 340.76 10.65 237 117343 21220 110450499
Hyperglycaemia 337.50 10.65 434 117146 84656 110387063
Coordination abnormal 321.76 10.65 244 117336 24984 110446735
Motor dysfunction 315.58 10.65 238 117342 24168 110447551
Gangrene 291.61 10.65 194 117386 16147 110455572
Off label use 286.76 10.65 744 116836 1499441 108972278
Hyperkalaemia 281.08 10.65 512 117068 135284 110336435
Eating disorder 270.58 10.65 240 117340 30618 110441101
Arterial occlusive disease 266.58 10.65 179 117401 15129 110456590
Muscle spasticity 254.38 10.65 248 117332 35667 110436052
Hemiparesis 247.27 10.65 268 117312 43635 110428084
Systemic lupus erythematosus 245.76 10.65 5 117575 254333 110217386
Synovitis 232.24 10.65 15 117565 274077 110197642
Aphasia 218.50 10.65 291 117289 58706 110413013
Metabolic acidosis 215.20 10.65 383 117197 99361 110372358
Skin haemorrhage 207.59 10.65 188 117392 24639 110447080
Drug intolerance 206.26 10.65 87 117493 406425 110065294
Sinus congestion 205.80 10.65 205 117375 30254 110441465
Blood glucose abnormal 198.86 10.65 140 117440 12776 110458943
Lipase increased 198.02 10.65 162 117418 18510 110453209
Glossodynia 194.64 10.65 10 117570 221994 110249725
Sneezing 186.71 10.65 199 117381 31785 110439934
Sinus disorder 179.44 10.65 197 117383 32531 110439188
Maternal exposure during pregnancy 177.44 10.65 29 117551 254854 110216865
Product monitoring error 176.44 10.65 113 117467 8814 110462905
Dysphagia 171.82 10.65 452 117128 153148 110318571
Drug ineffective 170.02 10.65 938 116642 1519602 108952117
Dysarthria 169.99 10.65 314 117266 83807 110387912
Arthropathy 167.27 10.65 49 117531 287473 110184246
Duodenal ulcer perforation 165.92 10.65 5 117575 177695 110294024
Treatment failure 165.45 10.65 45 117535 277189 110194530
Therapeutic product effect decreased 163.08 10.65 31 117549 244285 110227434
Respiratory tract congestion 157.61 10.65 179 117401 30678 110441041
Infusion related reaction 157.48 10.65 106 117474 381056 110090663
Hand deformity 156.32 10.65 23 117557 218483 110253236
Angina pectoris 155.15 10.65 255 117325 62040 110409679
Product use in unapproved indication 154.16 10.65 149 117431 447228 110024491
Folliculitis 148.72 10.65 7 117573 167646 110304073
Helicobacter infection 148.16 10.65 12 117568 181865 110289854
Interstitial lung disease 144.74 10.65 399 117181 138935 110332784
Cerebrovascular accident 140.23 10.65 468 117112 180816 110290903
Psoriatic arthropathy 137.80 10.65 22 117558 196739 110274980
Pemphigus 137.44 10.65 30 117550 214540 110257179
Joint swelling 136.41 10.65 162 117418 442683 110029036
Irritable bowel syndrome 133.30 10.65 11 117569 164204 110307515
Fibromyalgia 122.21 10.65 18 117562 170891 110300828
Hypoglycaemic coma 121.81 10.65 75 117505 5458 110466261
Lower respiratory tract infection 121.68 10.65 53 117527 243053 110228666
Hypersensitivity 121.01 10.65 151 117429 403847 110067872
Drug abuse 119.47 10.65 22 117558 177389 110294330
Blood glucose decreased 117.79 10.65 151 117429 29337 110442382
C-reactive protein abnormal 116.38 10.65 5 117575 129690 110342029
Wound 114.37 10.65 53 117527 234384 110237335
Cerebral infarction 114.28 10.65 201 117379 51637 110420082
Product residue present 111.96 10.65 63 117517 3878 110467841
Cataract 110.15 10.65 254 117326 79231 110392488
Cystitis 109.69 10.65 227 117353 65809 110405910
Rhinorrhoea 109.59 10.65 297 117283 102369 110369350
Pericarditis 109.29 10.65 48 117532 219066 110252653
Lung diffusion test abnormal 107.09 10.65 32 117548 363 110471356
Drug hypersensitivity 106.88 10.65 200 117380 453890 110017829
Injury 105.30 10.65 29 117551 177236 110294483
Renal impairment 102.05 10.65 434 117146 188011 110283708
Impaired healing 101.46 10.65 41 117539 196676 110275043
Swelling 99.17 10.65 137 117443 350904 110120815
Exposure during pregnancy 98.31 10.65 28 117552 167396 110304323
Stomatitis 97.76 10.65 86 117494 270156 110201563
Palpitations 96.75 10.65 380 117200 158832 110312887
Skin exfoliation 96.00 10.65 256 117324 87395 110384324
Alopecia 95.57 10.65 150 117430 364603 110107116
Musculoskeletal stiffness 95.38 10.65 94 117486 279728 110191991
Muscular weakness 92.57 10.65 514 117066 247954 110223765
Sleep disorder due to general medical condition, insomnia type 91.81 10.65 5 117575 105638 110366081
Blood cholesterol increased 91.33 10.65 41 117539 184744 110286975
Contraindicated product administered 91.02 10.65 78 117502 248189 110223530
Hepatic enzyme increased 88.87 10.65 127 117453 320765 110150954
Dehydration 83.57 10.65 546 117034 278965 110192754
Renal failure 82.59 10.65 466 117114 226108 110245611
Joint range of motion decreased 82.25 10.65 15 117565 121817 110349902
Toxicity to various agents 81.81 10.65 251 117329 480304 109991415
Influenza like illness 80.94 10.65 242 117338 88170 110383549
Lip dry 80.40 10.65 7 117573 100076 110371643
Blood glucose fluctuation 79.97 10.65 66 117514 7632 110464087
Rhabdomyolysis 77.75 10.65 293 117287 120108 110351611
Fall 77.62 10.65 981 116599 602501 109869218
Intentional product use issue 75.93 10.65 91 117489 247815 110223904
Discomfort 75.64 10.65 70 117510 214637 110257082
Diabetes mellitus 75.42 10.65 255 117325 99126 110372593
Wound infection 74.19 10.65 8 117572 96457 110375262
Hypomagnesaemia 74.03 10.65 184 117396 60186 110411533
General physical health deterioration 73.12 10.65 732 116848 424563 110047156
Blood pressure inadequately controlled 70.17 10.65 61 117519 7572 110464147
Peripheral venous disease 70.04 10.65 5 117575 84112 110387607
Bladder cancer 68.91 10.65 96 117484 20196 110451523
Bursitis 68.76 10.65 26 117554 129892 110341827
Glycosylated haemoglobin abnormal 68.74 10.65 24 117556 460 110471259
Ill-defined disorder 68.31 10.65 41 117539 156812 110314907
Inflammation 66.89 10.65 64 117516 193174 110278545
Cardiac failure 61.94 10.65 376 117204 187250 110284469
Liver injury 60.50 10.65 43 117537 150370 110321349
Migraine 60.41 10.65 56 117524 171596 110300123
Blister 60 10.65 93 117487 227283 110244436
Amylase increased 59.52 10.65 70 117510 12449 110459270
Grip strength decreased 58.34 10.65 8 117572 80166 110391553
Exercise tolerance decreased 58.25 10.65 68 117512 11999 110459720
Therapy non-responder 58.15 10.65 49 117531 157258 110314461
Psoriasis 56.43 10.65 296 117284 139697 110332022
Product prescribing error 56.27 10.65 150 117430 51181 110420538
Urine ketone body present 55.32 10.65 40 117540 3806 110467913
Mucosal inflammation 54.75 10.65 17 117563 96124 110375595
Pancreatitis necrotising 54.73 10.65 46 117534 5455 110466264
Drug ineffective for unapproved indication 53.72 10.65 21 117559 102817 110368902
Sleep disorder 53.61 10.65 80 117500 198564 110273155
Hypoaesthesia 53.52 10.65 164 117416 314059 110157660
Wrong technique in product usage process 53.46 10.65 209 117371 87139 110384580
MELAS syndrome 53.29 10.65 18 117562 311 110471408
Product use issue 51.45 10.65 165 117415 311530 110160189
Red blood cell sedimentation rate increased 50.01 10.65 11 117569 78291 110393428
Sciatica 49.72 10.65 18 117562 92381 110379338
Hyperlactacidaemia 49.14 10.65 52 117528 8234 110463485
Arthralgia 48.82 10.65 562 117018 779070 109692649
Mobility decreased 48.69 10.65 113 117467 237309 110234410
Diabetic metabolic decompensation 48.22 10.65 37 117543 3852 110467867
Oedema peripheral 48.18 10.65 548 117032 328112 110143607
Infection 47.89 10.65 210 117370 361990 110109729
Dysuria 47.87 10.65 157 117423 60074 110411645
Adenocarcinoma pancreas 45.60 10.65 29 117551 2234 110469485
Diabetic neuropathy 45.24 10.65 46 117534 6953 110464766
Pollakiuria 44.32 10.65 125 117455 44070 110427649
Condition aggravated 43.58 10.65 536 117044 734300 109737419
Temperature perception test abnormal 43.45 10.65 9 117571 16 110471703
Hypoglycaemic encephalopathy 42.97 10.65 19 117561 694 110471025
Autoimmune disorder 42.23 10.65 9 117571 65474 110406245
Hypercholesterolaemia 42.06 10.65 22 117558 90815 110380904
Pancreatic carcinoma metastatic 41.80 10.65 35 117545 4129 110467590
Hepatic function abnormal 41.79 10.65 197 117383 89098 110382621
Lower limb fracture 41.71 10.65 14 117566 75334 110396385
Angioedema 41.58 10.65 211 117369 98289 110373430
Influenza 41.51 10.65 315 117265 168786 110302933
Blood pressure increased 41.16 10.65 438 117142 257935 110213784
Anaemia 41.11 10.65 813 116767 546273 109925446
Serotonin syndrome 40.54 10.65 7 117573 59146 110412573
Paraesthesia 40.50 10.65 154 117426 276367 110195352
Pain 40.31 10.65 744 116836 954211 109517508
Febrile neutropenia 39.86 10.65 187 117393 316580 110155139
Dizziness 39.68 10.65 997 116583 697196 109774523
Myelosuppression 39.22 10.65 26 117554 94314 110377405
Neutropenia 38.90 10.65 236 117344 374384 110097335
Labelled drug-drug interaction medication error 38.79 10.65 92 117488 29210 110442509
Altered state of consciousness 38.66 10.65 142 117438 57484 110414235
Sedation 38.48 10.65 13 117567 69670 110402049
Eosinophilic myocarditis 37.79 10.65 25 117555 2060 110469659
Pancreatitis chronic 37.69 10.65 34 117546 4431 110467288
Thirst 37.67 10.65 76 117504 21631 110450088
Dry mouth 37.22 10.65 100 117480 199848 110271871
Polyuria 36.80 10.65 67 117513 17671 110454048
Multiple drug therapy 36.76 10.65 44 117536 7970 110463749
Product dose omission issue 36.66 10.65 512 117068 321270 110150449
Dyslipidaemia 36.60 10.65 63 117517 15902 110455817
Haematochezia 36.53 10.65 229 117351 115295 110356424
Flatulence 36.25 10.65 130 117450 52019 110419700
Depression 36.12 10.65 194 117386 317141 110154578
Vomiting 35.57 10.65 1241 116339 909434 109562285
Adjustment disorder with depressed mood 35.43 10.65 3 117577 43880 110427839
Alcoholic ketoacidosis 35.32 10.65 9 117571 53 110471666
Nail disorder 35.30 10.65 9 117571 57926 110413793
Chest discomfort 35.20 10.65 310 117270 173538 110298181
Night sweats 35.14 10.65 55 117525 133928 110337791
Diarrhoea 35.12 10.65 1513 116067 1137992 109333727
Blood creatinine increased 34.93 10.65 322 117258 182567 110289152
Exostosis 34.86 10.65 4 117576 45952 110425767
Therapeutic drug monitoring analysis not performed 34.63 10.65 23 117557 1908 110469811
Diabetic nephropathy 34.21 10.65 29 117551 3479 110468240
Electrolyte imbalance 33.54 10.65 101 117479 36927 110434792
Adverse drug reaction 33.10 10.65 38 117542 105521 110366198
Electrocardiogram abnormal 33.06 10.65 66 117514 18643 110453076
Seronegative arthritis 32.87 10.65 54 117526 13123 110458596
Bone erosion 32.87 10.65 5 117575 46366 110425353
Pulmonary fibrosis 32.80 10.65 36 117544 102006 110369713
Osteoarthritis 32.75 10.65 93 117487 182530 110289189
Blood creatine phosphokinase increased 32.58 10.65 159 117421 72918 110398801
Onychomadesis 32.19 10.65 5 117575 45658 110426061
Genital infection female 31.99 10.65 9 117571 81 110471638
Pancreatic enzymes increased 31.99 10.65 21 117559 1708 110470011
Urosepsis 31.98 10.65 88 117492 30587 110441132
Therapeutic product effect incomplete 31.90 10.65 126 117454 223679 110248040
Abdominal discomfort 31.69 10.65 267 117313 393591 110078128
Weight decreased 31.68 10.65 685 116895 467372 110004347
Asthenia 31.54 10.65 957 116623 688042 109783677
Pharyngeal necrosis 31.51 10.65 9 117571 86 110471633
Leg amputation 31.50 10.65 30 117550 4188 110467531
Gait inability 31.21 10.65 61 117519 136315 110335404
Autoimmune pancreatitis 30.96 10.65 16 117564 830 110470889
Acute myocardial infarction 30.95 10.65 173 117407 83604 110388115
Nausea 30.49 10.65 1605 115975 1234085 109237634
Pancreatic pseudocyst 30.34 10.65 20 117560 1638 110470081
Myocardial infarction 30.28 10.65 325 117255 191758 110279961
Injection site reaction 30.23 10.65 30 117550 89040 110382679
Acidosis 30.11 10.65 71 117509 22460 110449259
Hyperlipasaemia 29.80 10.65 19 117561 1470 110470249
Knee arthroplasty 29.67 10.65 16 117564 64932 110406787
Pancreatic disorder 29.42 10.65 28 117552 3906 110467813
Milk-alkali syndrome 29.17 10.65 21 117559 1984 110469735
Glomerular filtration rate decreased 29.13 10.65 82 117498 28874 110442845
Peripheral swelling 28.98 10.65 282 117298 403752 110067967
Micturition disorder 28.78 10.65 30 117550 4668 110467051
Foot deformity 28.65 10.65 8 117572 48472 110423247
Nephrotic syndrome 28.39 10.65 52 117528 13779 110457940
Injection site erythema 28.36 10.65 35 117545 94141 110377578
Disease progression 27.87 10.65 149 117431 243885 110227834
Diabetic retinopathy 27.87 10.65 26 117554 3538 110468181
Coeliac disease 27.71 10.65 6 117574 43181 110428538
Glycosylated haemoglobin decreased 27.68 10.65 15 117565 857 110470862
Lupus-like syndrome 27.58 10.65 5 117575 40787 110430932
Nephroangiosclerosis 27.48 10.65 12 117568 425 110471294
Drug resistance 27.08 10.65 13 117567 56361 110415358
Renal disorder 26.79 10.65 114 117466 49365 110422354
Potentiating drug interaction 26.77 10.65 46 117534 11597 110460122
Melaena 26.75 10.65 144 117436 68613 110403106
Diabetic ketosis 26.69 10.65 15 117565 921 110470798
Intentional self-injury 26.61 10.65 4 117576 37425 110434294
Prerenal failure 26.47 10.65 28 117552 4431 110467288
Rash 26.36 10.65 668 116912 820296 109651423
Blood thyroid stimulating hormone increased 26.21 10.65 47 117533 12254 110459465
Hypokinesia 26.20 10.65 66 117514 21760 110449959
Completed suicide 26.04 10.65 151 117429 242230 110229489
Pancreatic mass 26.01 10.65 19 117561 1836 110469883
Back injury 25.90 10.65 9 117571 47390 110424329
Joint dislocation 25.87 10.65 3 117577 34187 110437532
Epiploic appendagitis 25.85 10.65 9 117571 171 110471548
Gamma-glutamyltransferase increased 25.64 10.65 131 117449 61178 110410541
Tubulointerstitial nephritis 25.57 10.65 120 117460 54164 110417555
Ketonuria 25.51 10.65 17 117563 1418 110470301
Hip arthroplasty 25.13 10.65 14 117566 55799 110415920
Endometrial disorder 25.07 10.65 13 117567 679 110471040
Laryngitis 25.06 10.65 7 117573 42404 110429315
C-reactive protein increased 24.91 10.65 133 117447 217786 110253933
Colon cancer 24.39 10.65 54 117526 16389 110455330
Full blood count abnormal 24.31 10.65 121 117459 55931 110415788
Drug eruption 24.10 10.65 117 117463 53542 110418177
Proteinuria 23.87 10.65 95 117485 39923 110431796
Respiratory depression 23.74 10.65 3 117577 31998 110439721
Brain contusion 23.57 10.65 17 117563 1611 110470108
Prevertebral soft tissue swelling of cervical space 23.45 10.65 6 117574 36 110471683
Nephropathy 23.19 10.65 47 117533 13420 110458299
Neurotoxicity 23.09 10.65 8 117572 42199 110429520
Bladder transitional cell carcinoma 22.90 10.65 21 117559 2795 110468924
Systemic infection 22.84 10.65 39 117541 9780 110461939
Papillary renal cell carcinoma 22.78 10.65 10 117570 359 110471360
Chronic kidney disease 22.74 10.65 149 117431 76142 110395577
Urticaria 22.66 10.65 223 117357 318634 110153085
Finger deformity 22.49 10.65 4 117576 33088 110438631
Upper gastrointestinal haemorrhage 22.33 10.65 109 117471 49987 110421732
Gastric disorder 22.20 10.65 82 117498 33275 110438444
Gastric cancer 22.11 10.65 41 117539 10967 110460752
Blood ketone body increased 22.04 10.65 13 117567 875 110470844
Glomerulonephritis minimal lesion 22.03 10.65 14 117566 1077 110470642
Epilepsy 21.92 10.65 46 117534 100163 110371556
Craniofacial fracture 21.86 10.65 13 117567 888 110470831
Tubulointerstitial nephritis and uveitis syndrome 21.86 10.65 10 117570 396 110471323
Bile duct stone 21.72 10.65 30 117550 6259 110465460
Anuria 21.68 10.65 66 117514 24275 110447444
Onychomycosis 21.60 10.65 7 117573 38524 110433195
Drug interaction 21.60 10.65 690 116890 499493 109972226
Acetonaemia 21.58 10.65 11 117569 554 110471165
Blood lactic acid increased 21.30 10.65 50 117530 15771 110455948
Device dislocation 21.19 10.65 4 117576 31700 110440019
Osteonecrosis 21.03 10.65 5 117575 33736 110437983
Urinary tract infection 20.94 10.65 474 117106 325808 110145911
Pruritus genital 20.88 10.65 30 117550 6492 110465227
Cough 20.76 10.65 640 116940 461001 110010718
Embolic cerebellar infarction 20.65 10.65 5 117575 23 110471696
Bursitis infective 20.43 10.65 15 117565 1461 110470258
Loss of personal independence in daily activities 20.40 10.65 86 117494 149934 110321785
Fear-related avoidance of activities 20.30 10.65 7 117573 129 110471590
Anion gap increased 20.17 10.65 24 117556 4320 110467399
Fracture 20.04 10.65 65 117515 24723 110446996
Linear IgA disease 19.97 10.65 24 117556 4365 110467354
Gastrointestinal mucosal necrosis 19.88 10.65 8 117572 230 110471489
Wheezing 19.64 10.65 175 117405 255055 110216664
Hypovolaemic shock 19.53 10.65 46 117534 14537 110457182
Posterior reversible encephalopathy syndrome 19.25 10.65 6 117574 33855 110437864
Therapeutic drug monitoring analysis incorrectly performed 19.20 10.65 11 117569 701 110471018
Pancreatic neuroendocrine tumour 19.03 10.65 12 117568 911 110470808
Flushing 19.02 10.65 53 117527 104683 110367036
Cerebral haemorrhage 18.83 10.65 126 117454 64842 110406877
Radioallergosorbent test positive 18.76 10.65 5 117575 36 110471683
Disorientation 18.67 10.65 134 117446 70537 110401182
Sprue-like enteropathy 18.58 10.65 15 117565 1681 110470038
Bladder trabeculation 18.55 10.65 6 117574 90 110471629
Pain of skin 18.49 10.65 55 117525 19974 110451745
Jaundice 18.46 10.65 117 117463 59119 110412600
Cholelithiasis 18.38 10.65 123 117457 63299 110408420
Internal haemorrhage 18.36 10.65 36 117544 10035 110461684
Acquired haemophilia 18.31 10.65 18 117562 2613 110469106
Drug level above therapeutic 18.26 10.65 39 117541 11549 110460170
Liver function test increased 18.26 10.65 42 117538 88506 110383213
Multiple sclerosis relapse 18.13 10.65 16 117564 50224 110421495
Small fibre neuropathy 18.11 10.65 12 117568 991 110470728
Insomnia 18.08 10.65 272 117308 360318 110111401
Intensive care unit acquired weakness 18.04 10.65 17 117563 2342 110469377
Obesity 18.00 10.65 61 117519 113290 110358429
Abdominal pain 17.99 10.65 691 116889 512298 109959421
Generalised tonic-clonic seizure 17.89 10.65 19 117561 54661 110417058
Insulin C-peptide increased 17.81 10.65 7 117573 189 110471530
Intestinal transit time abnormal 17.80 10.65 6 117574 103 110471616
Tri-iodothyronine free decreased 17.72 10.65 9 117571 450 110471269
Prescribed overdose 17.69 10.65 42 117538 87539 110384180
Increased appetite 17.68 10.65 45 117535 14932 110456787
Hepatotoxicity 17.62 10.65 25 117555 63375 110408344
Lung disorder 17.35 10.65 116 117464 179931 110291788
Polydipsia 17.18 10.65 30 117550 7658 110464061
Multiple congenital abnormalities 17.14 10.65 6 117574 116 110471603
Lumbosacral radiculoplexus neuropathy 17.09 10.65 6 117574 117 110471602
Confusional state 17.07 10.65 634 116946 468046 110003673
Malaise 16.97 10.65 875 116705 670944 109800775
Peripheral artery haematoma 16.95 10.65 6 117574 120 110471599
Oedematous pancreatitis 16.80 10.65 14 117566 1640 110470079
Food aversion 16.80 10.65 14 117566 1641 110470078
Diabetic ulcer 16.75 10.65 7 117573 222 110471497
Pneumocystis jirovecii infection 16.74 10.65 22 117558 4378 110467341
Colitis ulcerative 16.52 10.65 36 117544 77327 110394392
Body mass index abnormal 16.51 10.65 11 117569 917 110470802
Memory impairment 16.51 10.65 132 117448 196812 110274907
Portal vein cavernous transformation 16.41 10.65 6 117574 132 110471587
Bladder irrigation 16.40 10.65 5 117575 61 110471658
Hyperglycaemic hyperosmolar nonketotic syndrome 16.30 10.65 18 117562 2991 110468728
Incorrect route of product administration 16.14 10.65 27 117553 64034 110407685
Nephrogenic anaemia 16.06 10.65 22 117558 4555 110467164
Muscle spasms 16.02 10.65 204 117376 277953 110193766
Hypoglycaemic unconsciousness 16.00 10.65 12 117568 1208 110470511
Anaemia vitamin B12 deficiency 15.93 10.65 12 117568 1215 110470504
Neck pain 15.88 10.65 72 117508 123058 110348661
Prohormone brain natriuretic peptide increased 15.70 10.65 8 117572 403 110471316
Tongue oedema 15.65 10.65 30 117550 8226 110463493
Pancreatectomy 15.63 10.65 4 117576 24 110471695
Road traffic accident 15.59 10.65 60 117520 107338 110364381
Pancreatic neoplasm 15.58 10.65 14 117566 1815 110469904
Thrombotic cerebral infarction 15.56 10.65 10 117570 784 110470935
Diabetic foetopathy 15.49 10.65 4 117576 25 110471694
Hyponatraemia 15.49 10.65 321 117259 217332 110254387
Frequent bowel movements 15.42 10.65 33 117547 71357 110400362
Pyelitis 15.39 10.65 8 117572 420 110471299
Vitamin D deficiency 15.32 10.65 49 117531 18503 110453216
Oral candidiasis 15.28 10.65 15 117565 44745 110426974
Infusion site scar 15.25 10.65 8 117572 428 110471291
Duplicate therapy error 15.20 10.65 8 117572 431 110471288
Bradycardia 15.17 10.65 241 117339 155276 110316443
Chronic sinusitis 15.08 10.65 4 117576 25080 110446639
Bile duct cancer 15.01 10.65 11 117569 1069 110470650
Hepatic steatosis 14.94 10.65 96 117484 48735 110422984
Inability to afford medication 14.92 10.65 20 117560 4056 110467663
Myalgia 14.87 10.65 325 117255 222056 110249663
Ulcer haemorrhage 14.76 10.65 3 117577 22568 110449151
Glucose urine present 14.71 10.65 15 117565 2274 110469445
Groin abscess 14.68 10.65 14 117566 1958 110469761
Lacunar infarction 14.67 10.65 25 117555 6261 110465458
Haemoglobin increased 14.66 10.65 31 117549 9116 110462603
Testicular swelling 14.62 10.65 13 117567 1663 110470056
Transplant rejection 14.62 10.65 4 117576 24563 110447156
Joint stiffness 14.60 10.65 31 117549 67212 110404507
Vomiting projectile 14.56 10.65 15 117565 2303 110469416
Poisoning deliberate 14.39 10.65 5 117575 26326 110445393
Cytopenia 14.38 10.65 7 117573 30109 110441610
Dermatitis exfoliative 14.35 10.65 35 117545 11312 110460407
Intraventricular haemorrhage 14.32 10.65 23 117557 5484 110466235
Urinary hesitation 14.29 10.65 21 117559 4637 110467082
Miosis 14.22 10.65 3 117577 21980 110449739
Injection site pain 14.12 10.65 121 117459 177801 110293918
Joint noise 14.10 10.65 22 117558 5121 110466598
Haemophagocytic lymphohistiocytosis 14.09 10.65 8 117572 31551 110440168
Vitamin B1 decreased 14.04 10.65 10 117570 929 110470790
Pseudohyponatraemia 14.03 10.65 6 117574 202 110471517
Testicular pain 13.97 10.65 15 117565 2414 110469305
Toe amputation 13.95 10.65 20 117560 4318 110467401
Decreased appetite 13.95 10.65 629 116951 475217 109996502
Decreased vibratory sense 13.95 10.65 9 117571 711 110471008
Body temperature increased 13.84 10.65 23 117557 54690 110417029
Toxic skin eruption 13.83 10.65 62 117518 27453 110444266
Product packaging quantity issue 13.83 10.65 13 117567 1786 110469933
Ear pain 13.81 10.65 22 117558 53204 110418515
Shock 13.81 10.65 101 117479 53487 110418232
Embolic cerebral infarction 13.77 10.65 12 117568 1494 110470225
Vitamin B1 deficiency 13.75 10.65 10 117570 960 110470759
Peptic ulcer 13.61 10.65 27 117553 7592 110464127
Delirium tremens 13.60 10.65 9 117571 742 110470977
Pseudocyst 13.58 10.65 7 117573 361 110471358
Contusion 13.49 10.65 171 117409 233190 110238529
Basal cell carcinoma 13.44 10.65 17 117563 45253 110426466
Carbohydrate antigen 19-9 increased 13.43 10.65 8 117572 548 110471171
Acquired mitochondrial DNA mutation 13.39 10.65 3 117577 9 110471710
Post procedural erythema 13.39 10.65 3 117577 9 110471710
Dyspepsia 13.37 10.65 134 117446 190831 110280888
Post streptococcal glomerulonephritis 13.35 10.65 5 117575 118 110471601
Premature delivery 13.34 10.65 8 117572 30624 110441095
Erythema multiforme 13.33 10.65 51 117529 21046 110450673
Atrial fibrillation 13.31 10.65 329 117251 229313 110242406
Peripheral arterial occlusive disease 13.23 10.65 30 117550 9250 110462469
Amaurosis 13.22 10.65 12 117568 1577 110470142
Alopecia universalis 13.17 10.65 7 117573 385 110471334
Thrombosis 13.16 10.65 65 117515 108597 110363122
Idiopathic pulmonary fibrosis 13.15 10.65 21 117559 4983 110466736
Hyperthermia 13.09 10.65 51 117529 21221 110450498
Disability 13.01 10.65 8 117572 30215 110441504
Hypocalcaemia 12.93 10.65 116 117464 65250 110406469
Haemorrhage subcutaneous 12.89 10.65 22 117558 5517 110466202
Palindromic rheumatism 12.85 10.65 7 117573 404 110471315
Impaired quality of life 12.85 10.65 8 117572 30009 110441710
Upper respiratory tract irritation 12.83 10.65 6 117574 250 110471469
Subdural hygroma 12.80 10.65 8 117572 598 110471121
Pyelonephritis 12.77 10.65 57 117523 25193 110446526
Procedural headache 12.74 10.65 6 117574 254 110471465
Gastrointestinal haemorrhage 12.74 10.65 247 117333 165271 110306448
Diabetic coma 12.71 10.65 11 117569 1357 110470362
Balanoposthitis 12.66 10.65 11 117569 1365 110470354
No adverse event 12.60 10.65 127 117453 73712 110398007
Radiation necrosis 12.55 10.65 9 117571 845 110470874
Urogenital infection fungal 12.55 10.65 4 117576 57 110471662
Campylobacter infection 12.49 10.65 14 117566 2365 110469354
Complication associated with device 12.46 10.65 3 117577 20070 110451649
Pulmonary haematoma 12.45 10.65 5 117575 143 110471576
Mesenteric arterial occlusion 12.44 10.65 6 117574 268 110471451
Seizure 12.44 10.65 163 117417 221022 110250697
Cholecystitis acute 12.41 10.65 41 117539 15741 110455978
Calculus urinary 12.36 10.65 16 117564 3136 110468583
Brain oedema 12.36 10.65 9 117571 31089 110440630
Wrong patient received product 12.34 10.65 24 117556 6650 110465069
Dystonia 12.32 10.65 6 117574 25799 110445920
Duodenitis 12.31 10.65 29 117551 9167 110462552
Coma acidotic 12.29 10.65 5 117575 148 110471571
Blood ketone body present 12.26 10.65 5 117575 149 110471570
Ketosis 12.21 10.65 12 117568 1742 110469977
Thyroiditis subacute 12.10 10.65 7 117573 454 110471265
Anti-insulin antibody positive 12.10 10.65 6 117574 285 110471434
Impaired insulin secretion 12.07 10.65 4 117576 65 110471654
Dialysis 12.04 10.65 47 117533 19572 110452147
Procedural pain 12.04 10.65 12 117568 35553 110436166
Oesophageal mucosal tear 12.02 10.65 3 117577 16 110471703
Pulmonary tumour thrombotic microangiopathy 12.01 10.65 5 117575 157 110471562
Fear of falling 12.01 10.65 9 117571 904 110470815
Therapy partial responder 11.99 10.65 13 117567 37048 110434671
Hypocapnia 11.94 10.65 9 117571 913 110470806
Cervicobrachial syndrome 11.92 10.65 10 117570 1182 110470537
Cytomegalovirus infection 11.90 10.65 25 117555 54419 110417300
Substance use 11.89 10.65 14 117566 2492 110469227
Suicide attempt 11.87 10.65 63 117517 103331 110368388
Rotator cuff syndrome 11.78 10.65 42 117538 16752 110454967
Haematemesis 11.75 10.65 105 117475 59003 110412716
Walking aid user 11.71 10.65 6 117574 25069 110446650
Vitamin B12 deficiency 11.65 10.65 30 117550 10025 110461694
Disease recurrence 11.61 10.65 30 117550 60754 110410965
Device related infection 11.57 10.65 15 117565 39504 110432215
Acute coronary syndrome 11.56 10.65 52 117528 23060 110448659
Arthritis 11.54 10.65 246 117334 167340 110304379
Pancreaticoduodenectomy 11.54 10.65 4 117576 75 110471644
Impaired work ability 11.43 10.65 57 117523 26362 110445357
Hypercapnic coma 11.39 10.65 7 117573 508 110471211
Feeling hot 11.32 10.65 54 117526 91052 110380667
Medication error 11.32 10.65 166 117414 105200 110366519
Albumin urine present 11.22 10.65 8 117572 745 110470974
Placental insufficiency 11.21 10.65 10 117570 1284 110470435
Portal venous gas 11.18 10.65 7 117573 525 110471194
Cardiac failure acute 11.17 10.65 53 117527 24025 110447694
Nightmare 11.12 10.65 15 117565 38848 110432871
Nasal neoplasm 11.12 10.65 5 117575 190 110471529
Faecaloma 11.08 10.65 38 117542 14870 110456849
Urticaria chronic 11.07 10.65 8 117572 760 110470959
Meibomianitis 11.07 10.65 4 117576 85 110471634
Pseudomonal bacteraemia 11.02 10.65 18 117562 4353 110467366
Putamen haemorrhage 11.02 10.65 7 117573 538 110471181
Therapeutic response decreased 10.96 10.65 59 117521 96440 110375279
Lipoma 10.95 10.65 17 117563 3938 110467781
Physical deconditioning 10.93 10.65 16 117564 3521 110468198
Carcinoid crisis 10.90 10.65 7 117573 548 110471171
Pancreatic duct dilatation 10.90 10.65 6 117574 354 110471365
Photophobia 10.85 10.65 7 117573 25764 110445955
Renal cancer metastatic 10.84 10.65 8 117572 786 110470933
Labelled drug-disease interaction medication error 10.80 10.65 6 117574 360 110471359
Hypoxia 10.76 10.65 87 117493 129428 110342291
Skin erosion 10.76 10.65 21 117559 5833 110465886
Palmoplantar keratoderma 10.74 10.65 20 117560 5367 110466352
Constipation 10.71 10.65 474 117106 357312 110114407
Pancreatic cyst 10.69 10.65 14 117566 2776 110468943
Community acquired infection 10.66 10.65 3 117577 27 110471692

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 A10BD29 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD31 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 D004791 Enzyme Inhibitors
MeSH PA D006728 Hormones
MeSH PA D007004 Hypoglycemic Agents
MeSH PA D011480 Protease Inhibitors
MeSH PA D054795 Incretins
MeSH PA D054873 Dipeptidyl-Peptidase IV Inhibitors
FDA MoA N0000175912 Dipeptidyl Peptidase 4 Inhibitors
FDA EPC N0000175913 Dipeptidyl Peptidase 4 Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:35821 anticholesteremic drug
CHEBI has role CHEBI:48353 serine proteinase inhibitor
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:68612 EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:78298 environmental contaminant

Related Drugs by ATC class:

A10BD Combinations of oral blood glucose lowering drugs 19 drugs
acarbosealogliptincanagliflozindapagliflozinempagliflozinertugliflozinevogliptingemigliptinglimepiridelinagliptinlobeglitazonemetformin show all 19 →
A10BH Dipeptidyl peptidase 4 (DPP-4) inhibitors 9 drugs
alogliptinevogliptingemigliptinlinagliptinrosuvastatinsaxagliptinsimvastatinteneligliptinvildagliptin

Drug Use | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

None

🐶 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 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 MSD 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 MSD 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 MSD 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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
15MG;EQ 100MG BASE STEGLUJAN MSD SUB MERCK N209805 Dec. 19, 2017 RX TABLET ORAL 8080580 Dec. 19, 2031 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
5MG;EQ 100MG BASE STEGLUJAN MSD SUB MERCK N209805 Dec. 19, 2017 RX TABLET ORAL 8080580 Dec. 19, 2031 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 SITAGLIPTIN PHOSPHATE SANDOZ A202387 Jan. 14, 2026 RX TABLET ORAL Nov. 24, 2026 PATENT CHALLENGE
EQ 25MG BASE SITAGLIPTIN PHOSPHATE SANDOZ A202387 Jan. 14, 2026 RX TABLET ORAL Nov. 24, 2026 PATENT CHALLENGE
EQ 50MG BASE SITAGLIPTIN PHOSPHATE SANDOZ A202387 Jan. 14, 2026 RX TABLET ORAL Nov. 24, 2026 PATENT CHALLENGE
1GM;EQ 50MG BASE SITAGLIPTIN AND METFORMIN HYDROCHLORIDE SANDOZ A202388 Dec. 2, 2025 RX TABLET ORAL Nov. 24, 2026 PATENT CHALLENGE
500MG;EQ 50MG BASE SITAGLIPTIN AND METFORMIN HYDROCHLORIDE SANDOZ A202388 Dec. 2, 2025 RX TABLET ORAL Nov. 24, 2026 PATENT CHALLENGE
EQ 100MG BASE SITAGLIPTIN PHOSPHATE APOTEX A202425 Jan. 20, 2026 RX TABLET ORAL Nov. 24, 2026 PATENT CHALLENGE
EQ 25MG BASE SITAGLIPTIN PHOSPHATE APOTEX A202425 Jan. 20, 2026 RX TABLET ORAL Nov. 24, 2026 PATENT CHALLENGE
EQ 50MG BASE SITAGLIPTIN PHOSPHATE APOTEX A202425 Jan. 20, 2026 RX TABLET ORAL Nov. 24, 2026 PATENT CHALLENGE

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 Enzyme 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
QFP0P1DV7Z UNII
593411 RXNORM
110023 MMSL
22317 MMSL
23649 MMSL
89034 MMSL
d05896 MMSL
011790 NDDF
011791 NDDF
423307000 SNOMEDCT_US
424106006 SNOMEDCT_US
425508009 SNOMEDCT_US
CHEMBL6068334 ChEMBL_ID
654671-78-0 SECONDARY_CAS_RN
862156-92-1 SECONDARY_CAS_RN
QFP0P1DV7Z INXIGHT DRUGS

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 0006-0112 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 0006-0221 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
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
Sitagliptin HUMAN PRESCRIPTION DRUG LABEL 1 0480-2607 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Sitagliptin HUMAN PRESCRIPTION DRUG LABEL 1 0480-2608 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Sitagliptin HUMAN PRESCRIPTION DRUG LABEL 1 0480-2609 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Sitagliptin Phosphate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5766 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Sitagliptin Phosphate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5768 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Sitagliptin Phosphate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5770 TABLET, FILM COATED 100 mg ORAL ANDA 26 sections
Sitagliptin and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0781-5801 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Sitagliptin and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0781-5802 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Sitagliptin and Metformin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 10370-317 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL ANDA 28 sections
Sitagliptin and Metformin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 10370-318 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL ANDA 28 sections
Sitagliptin and Metformin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 10370-351 TABLET, FILM COATED, EXTENDED RELEASE 100 mg ORAL ANDA 28 sections
BRYNOVIN Human Prescription Drug Label 1 24338-017 SOLUTION 25 mg ORAL NDA 26 sections
JANUVIA HUMAN PRESCRIPTION DRUG LABEL 1 50090-1036 TABLET, FILM COATED 100 mg ORAL NDA 26 sections
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