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: 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 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
S (Water solubility) 50 mg/mL Bocci G, Oprea TI, Benet LZ

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 860.04 10.98 699 63910 83057 63341356
Hypoglycaemia 658.18 10.98 521 64088 59544 63364869
Pancreatitis 601.68 10.98 455 64154 48600 63375813
Diabetes mellitus inadequate control 554.00 10.98 282 64327 14844 63409569
Pancreatic carcinoma 444.88 10.98 196 64413 7432 63416981
Carotid artery thrombosis 350.88 10.98 125 64484 2669 63421744
Neurologic neglect syndrome 335.16 10.98 120 64489 2601 63421812
Lactic acidosis 325.55 10.98 287 64322 38000 63386413
Glycosylated haemoglobin increased 313.93 10.98 181 64428 12217 63412196
Personality disorder 302.75 10.98 138 64471 5673 63418740
Adjustment disorder 288.34 10.98 112 64497 3066 63421347
Hemiplegia 279.28 10.98 152 64457 9171 63415242
Pancreatic carcinoma metastatic 264.29 10.98 95 64514 2083 63422330
Diabetic ketoacidosis 250.77 10.98 190 64419 20315 63404098
Acute kidney injury 224.26 10.98 682 63927 262733 63161680
Affect lability 223.24 10.98 140 64469 11011 63413402
Pemphigoid 198.76 10.98 112 64497 7232 63417181
Sensory loss 191.15 10.98 123 64486 10115 63414298
Motor dysfunction 187.98 10.98 124 64485 10637 63413776
Systemic lupus erythematosus 178.69 10.98 8 64601 208910 63215503
Pancreatitis acute 177.60 10.98 176 64433 26990 63397423
Contraindicated product administered 169.16 10.98 14 64595 217634 63206779
Blood glucose abnormal 167.90 10.98 103 64506 7789 63416624
Pemphigus 167.85 10.98 4 64605 183722 63240691
Coordination abnormal 167.02 10.98 127 64482 13646 63410767
Hyperglycaemia 161.45 10.98 206 64403 41661 63382752
Drug intolerance 158.64 10.98 58 64551 308603 63115810
Off label use 155.70 10.98 281 64328 674181 62750232
Glossodynia 143.25 10.98 10 64599 178866 63245547
Synovitis 142.58 10.98 13 64596 186905 63237508
Muscle spasticity 140.24 10.98 140 64469 21654 63402759
Hemiparesis 139.67 10.98 144 64465 23138 63401275
Treatment failure 138.85 10.98 19 64590 199024 63225389
Maternal exposure during pregnancy 135.96 10.98 29 64580 220033 63204380
Aphasia 134.59 10.98 167 64442 32833 63391580
Drug ineffective 131.10 10.98 584 64025 1044181 62380232
Euglycaemic diabetic ketoacidosis 130.13 10.98 67 64542 3607 63420806
Eating disorder 127.63 10.98 125 64484 18891 63405522
Ketoacidosis 127.30 10.98 70 64539 4308 63420105
Therapeutic product effect decreased 126.65 10.98 22 64587 193165 63231248
No adverse event 125.11 10.98 181 64428 41224 63383189
Lung diffusion test abnormal 122.04 10.98 34 64575 309 63424104
Arthropathy 117.44 10.98 46 64563 234746 63189667
Infusion related reaction 111.90 10.98 55 64554 245466 63178947
Blood glucose decreased 103.58 10.98 117 64492 20835 63403578
Product use issue 102.62 10.98 48 64561 220472 63203941
Bile duct stent insertion 100.69 10.98 21 64588 42 63424371
Dysarthria 100.03 10.98 166 64443 42545 63381868
Product dose omission issue 98.27 10.98 485 64124 233828 63190585
Adenocarcinoma pancreas 97.82 10.98 38 64571 1040 63423373
Joint swelling 97.47 10.98 114 64495 327552 63096861
Product residue present 95.17 10.98 56 64553 3923 63420490
Blood glucose fluctuation 92.96 10.98 58 64551 4518 63419895
Hand deformity 92.55 10.98 24 64585 159433 63264980
Muscular weakness 92.12 10.98 304 64305 122049 63302364
Cerebrovascular accident 88.22 10.98 276 64333 107748 63316665
Hyperkalaemia 85.81 10.98 178 64431 54025 63370388
Lipase increased 85.67 10.98 75 64534 9825 63414588
Dysphagia 85.33 10.98 240 64369 88345 63336068
Pancreaticoduodenectomy 83.19 10.98 16 64593 16 63424397
Arterial occlusive disease 79.06 10.98 58 64551 5900 63418513
Gangrene 77.64 10.98 58 64551 6065 63418348
Exposure during pregnancy 76.87 10.98 31 64578 155516 63268897
Skin haemorrhage 76.56 10.98 71 64538 10023 63414390
Duodenal ulcer perforation 75.64 10.98 3 64606 87206 63337207
Wrong technique in product usage process 74.42 10.98 183 64426 62157 63362256
Sinus congestion 74.34 10.98 92 64517 18031 63406382
Pain 72.33 10.98 450 64159 740178 62684235
Wound 67.89 10.98 41 64568 163222 63261191
Product use in unapproved indication 67.71 10.98 50 64559 179030 63245383
Eosinophilic myocarditis 67.62 10.98 25 64584 595 63423818
Lower respiratory tract infection 65.98 10.98 26 64583 132281 63292132
Pericarditis 65.38 10.98 26 64583 131553 63292860
Alopecia 64.63 10.98 156 64453 337380 63087033
Hypoglycaemic coma 63.59 10.98 37 64572 2538 63421875
Rhinorrhoea 62.48 10.98 177 64432 65400 63359013
Musculoskeletal stiffness 61.84 10.98 58 64551 184560 63239853
Hypersensitivity 60.29 10.98 130 64479 292555 63131858
Swelling 59.51 10.98 119 64490 275259 63149154
Discomfort 59.15 10.98 50 64559 167324 63257089
Metabolic acidosis 56.67 10.98 135 64474 44934 63379479
Helicobacter infection 55.70 10.98 13 64596 92772 63331641
Hepatic enzyme increased 55.29 10.98 75 64534 202253 63222160
Respiratory tract congestion 51.02 10.98 76 64533 17756 63406657
MELAS syndrome 50.27 10.98 14 64595 127 63424286
Metastases to liver 50.22 10.98 88 64521 23551 63400862
Toxicity to various agents 49.93 10.98 111 64498 247139 63177274
Sneezing 48.38 10.98 75 64534 18143 63406270
Sinus disorder 47.81 10.98 88 64521 24465 63399948
Abdominal discomfort 47.76 10.98 167 64442 320718 63103695
Psoriatic arthropathy 47.27 10.98 17 64592 91503 63332910
Temperature perception test abnormal 43.84 10.98 9 64600 16 63424397
Pancreatectomy 42.51 10.98 9 64600 20 63424393
Pneumobilia 42.23 10.98 12 64597 118 63424295
Pancreatitis chronic 41.87 10.98 28 64581 2456 63421957
Bursitis infective 40.50 10.98 22 64587 1321 63423092
Product packaging quantity issue 40.26 10.98 22 64587 1337 63423076
Irritable bowel syndrome 39.77 10.98 17 64592 82395 63342018
Impaired healing 39.56 10.98 28 64581 102514 63321899
Drug hypersensitivity 39.01 10.98 173 64436 310514 63113899
Diabetic neuropathy 38.31 10.98 32 64577 3932 63420481
Diabetic metabolic decompensation 38.12 10.98 23 64586 1687 63422726
Skin exfoliation 37.84 10.98 113 64496 42989 63381424
Renal cyst 37.05 10.98 49 64560 10253 63414160
Nausea 36.14 10.98 1130 63479 853341 62571072
Cerebral infarction 36.10 10.98 77 64532 23816 63400597
Hypoglycaemic encephalopathy 35.58 10.98 13 64596 299 63424114
Intentional product use issue 35.33 10.98 47 64562 127845 63296568
Neutropenia 34.95 10.98 79 64530 174926 63249487
Dehydration 34.76 10.98 298 64311 173056 63251357
Urine ketone body present 34.65 10.98 25 64584 2478 63421935
Haemoglobin increased 34.34 10.98 29 64580 3617 63420796
Pancreatic mass 33.07 10.98 17 64592 912 63423501
Acetonaemia 32.87 10.98 10 64599 127 63424286
Radiotherapy 32.47 10.98 13 64596 386 63424027
Injury 32.44 10.98 17 64592 73230 63351183
Fibromyalgia 32.30 10.98 21 64588 80399 63344014
Blister 31.67 10.98 52 64557 129762 63294651
Arthralgia 31.55 10.98 400 64209 569310 62855103
Condition aggravated 31.50 10.98 260 64349 401957 63022456
Angina pectoris 31.43 10.98 84 64525 29994 63394419
Completed suicide 31.39 10.98 63 64546 145610 63278803
Palpitations 31.12 10.98 209 64400 112561 63311852
Genital infection female 31.09 10.98 9 64600 95 63424318
Anuria 31.02 10.98 50 64559 12501 63411912
Therapy non-responder 30.24 10.98 20 64589 75881 63348532
Tubulointerstitial nephritis 29.90 10.98 64 64545 19839 63404574
Cataract 29.72 10.98 126 64483 56927 63367486
Injection site erythema 29.18 10.98 25 64584 83149 63341264
Product prescribing error 29.09 10.98 75 64534 26214 63398199
Stomatitis 29.04 10.98 61 64548 138664 63285749
Pruritus genital 28.97 10.98 23 64586 2631 63421782
Oedema peripheral 28.68 10.98 307 64302 189204 63235209
Renal disorder 28.52 10.98 86 64523 32888 63391525
Small fibre neuropathy 27.32 10.98 12 64597 451 63423962
Tubulointerstitial nephritis and uveitis syndrome 27.17 10.98 10 64599 235 63424178
Liver injury 26.87 10.98 14 64595 60506 63363907
Asthenia 26.75 10.98 543 64066 383061 63041352
Pancreatic duct dilatation 26.74 10.98 10 64599 246 63424167
Diabetes mellitus 26.59 10.98 120 64489 55690 63368723
Diarrhoea 26.56 10.98 932 63677 714434 62709979
Drug abuse 26.43 10.98 21 64588 72497 63351916
Hepatic steatosis 25.79 10.98 76 64533 28693 63395720
Pancreatic stent placement 25.52 10.98 5 64604 6 63424407
Tonsillectomy 25.46 10.98 14 64595 861 63423552
Cystitis 25.28 10.98 117 64492 54874 63369539
Anaemia vitamin B12 deficiency 25.18 10.98 11 64598 408 63424005
Febrile neutropenia 24.86 10.98 52 64557 118397 63306016
Hip arthroplasty 24.34 10.98 9 64600 47637 63376776
Joint noise 24.26 10.98 26 64583 4366 63420047
Decreased vibratory sense 24.01 10.98 10 64599 329 63424084
Gastric disorder 23.88 10.98 88 64521 37281 63387132
Prevertebral soft tissue swelling of cervical space 23.71 10.98 6 64603 36 63424377
Splenic vein occlusion 23.57 10.98 4 64605 0 63424413
Angioedema 23.50 10.98 104 64505 47861 63376552
Glomerular filtration rate decreased 23.48 10.98 46 64563 13395 63411018
Circumstance or information capable of leading to medication error 23.32 10.98 24 64585 3846 63420567
Peripheral artery haematoma 23.30 10.98 6 64603 39 63424374
Blood pressure inadequately controlled 23.25 10.98 27 64582 4951 63419462
Full blood count abnormal 23.12 10.98 78 64531 31639 63392774
Altered state of consciousness 22.95 10.98 67 64542 25163 63399250
Seronegative arthritis 22.86 10.98 24 64585 3935 63420478
Insulin-requiring type 2 diabetes mellitus 22.65 10.98 7 64602 94 63424319
Mixed liver injury 22.65 10.98 26 64583 4709 63419704
Foetal exposure during pregnancy 22.38 10.98 3 64606 31959 63392454
Infection 22.35 10.98 139 64470 229034 63195379
Mobility decreased 22.35 10.98 57 64552 121102 63303311
Cardiospasm 21.84 10.98 17 64592 1890 63422523
Adverse event 21.60 10.98 130 64479 67429 63356984
Bladder trabeculation 21.59 10.98 6 64603 54 63424359
Pancreatic pseudocyst 21.45 10.98 11 64598 587 63423826
Embolic cerebellar infarction 21.43 10.98 5 64604 20 63424393
Abdominal pain 21.30 10.98 418 64191 293038 63131375
Dizziness 21.19 10.98 580 64029 429345 62995068
Exercise tolerance decreased 21.10 10.98 27 64582 5470 63418943
Tri-iodothyronine free decreased 21.09 10.98 9 64600 315 63424098
Palmoplantar keratoderma 21.07 10.98 17 64592 1990 63422423
Amylase increased 21.02 10.98 29 64580 6316 63418097
Metastases to lymph nodes 20.85 10.98 33 64576 8125 63416288
Intensive care unit acquired weakness 20.81 10.98 12 64597 809 63423604
Inability to afford medication 20.75 10.98 18 64591 2329 63422084
Ill-defined disorder 20.64 10.98 32 64577 81723 63342690
Rhabdomyolysis 20.56 10.98 94 64515 43857 63380556
Fear-related avoidance of activities 20.55 10.98 7 64602 130 63424283
Impaired work ability 20.52 10.98 51 64558 17424 63406989
Renal impairment 20.46 10.98 157 64452 88198 63336215
Intestinal transit time abnormal 20.19 10.98 6 64603 70 63424343
Aortic arteriosclerosis 20.01 10.98 28 64581 6181 63418232
Flatulence 19.94 10.98 79 64530 34623 63389790
Diabetic complication 19.63 10.98 12 64597 901 63423512
Abdominal pain upper 19.61 10.98 307 64302 206137 63218276
Endometrial disorder 19.26 10.98 11 64598 728 63423685
Internal haemorrhage 19.25 10.98 25 64584 5140 63419273
Vomiting 19.23 10.98 723 63886 558894 62865519
Mucosal inflammation 19.19 10.98 12 64597 46916 63377497
Blood creatinine increased 19.19 10.98 154 64455 87690 63336723
Explorative laparotomy 19.19 10.98 6 64603 84 63424329
Multiple drug therapy 19.11 10.98 21 64588 3625 63420788
Splenectomy 19.09 10.98 10 64599 558 63423855
Acidosis 19.08 10.98 38 64571 11195 63413218
Multiple sclerosis relapse 19.01 10.98 13 64596 48465 63375948
Rheumatoid arthritis 18.97 10.98 166 64443 253653 63170760
General physical health deterioration 18.94 10.98 299 64310 201103 63223310
Incisional hernia repair 18.56 10.98 4 64605 10 63424403
Adverse drug reaction 18.46 10.98 33 64576 79681 63344732
Renal failure 18.45 10.98 192 64417 117460 63306953
Hysterectomy 18.43 10.98 34 64575 9465 63414948
Blood cholesterol increased 18.32 10.98 43 64566 93989 63330424
Radioallergosorbent test positive 18.30 10.98 5 64604 42 63424371
Pancreatic cyst 17.99 10.98 14 64595 1556 63422857
Leukopenia 17.89 10.98 32 64577 77258 63347155
Cholelithiasis 17.70 10.98 90 64519 43835 63380578
Radiotherapy to pancreas 17.67 10.98 3 64606 0 63424413
Peripheral vascular disorder 17.66 10.98 26 64583 6009 63418404
Micturition disorder 17.62 10.98 17 64592 2521 63421892
Biliary obstruction 17.39 10.98 18 64591 2903 63421510
Muscle atrophy 17.36 10.98 28 64581 7005 63417408
Portal vein cavernous transformation 17.30 10.98 6 64603 118 63424295
Migraine 17.28 10.98 51 64558 103295 63321118
Sedation 17.19 10.98 9 64600 38800 63385613
Haematochezia 17.09 10.98 103 64506 53441 63370972
Sinusitis 17.04 10.98 148 64461 226505 63197908
Sleep disorder due to a general medical condition 16.96 10.98 38 64571 12150 63412263
Diabetic retinopathy 16.94 10.98 16 64593 2311 63422102
Pancreatitis necrotising 16.92 10.98 14 64595 1698 63422715
Enterococcus test positive 16.89 10.98 12 64597 1161 63423252
Increased appetite 16.87 10.98 33 64576 9597 63414816
Sleep terror 16.84 10.98 17 64592 2663 63421750
Tongue oedema 16.78 10.98 22 64587 4564 63419849
Flushing 16.57 10.98 32 64577 75055 63349358
Cholangitis 16.34 10.98 24 64585 5537 63418876
Myalgia 16.31 10.98 224 64385 146305 63278108
Carcinoid crisis 16.04 10.98 7 64602 259 63424154
Knee arthroplasty 15.92 10.98 19 64590 54187 63370226
Influenza 15.91 10.98 175 64434 108547 63315866
Urosepsis 15.72 10.98 48 64561 18476 63405937
Glycosylated haemoglobin abnormal 15.70 10.98 6 64603 157 63424256
Dysuria 15.66 10.98 72 64537 33666 63390747
Injection site reaction 15.66 10.98 22 64587 58502 63365911
Weight decreased 15.53 10.98 380 64229 276418 63147995
Mesenteric arterial occlusion 15.52 10.98 6 64603 162 63424251
Serotonin syndrome 15.37 10.98 5 64604 28677 63395736
Peripheral swelling 15.32 10.98 185 64424 265757 63158656
Product colour issue 15.07 10.98 9 64600 648 63423765
Urine albumin/creatinine ratio increased 15.04 10.98 7 64602 302 63424111
Premature delivery 15.00 10.98 6 64603 30275 63394138
Myelosuppression 14.87 10.98 3 64606 23700 63400713
Gout 14.82 10.98 38 64571 13233 63411180
Device dislocation 14.65 10.98 4 64605 25701 63398712
Rash 14.63 10.98 447 64162 560424 62863989
Red blood cell sedimentation rate increased 14.49 10.98 14 64595 43968 63380445
Vision blurred 14.40 10.98 150 64459 91774 63332639
Peripheral sensorimotor neuropathy 14.25 10.98 12 64597 1491 63422922
Vitamin B12 decreased 14.24 10.98 18 64591 3602 63420811
Infusion site scar 14.20 10.98 8 64601 516 63423897
Bile duct stone 14.10 10.98 18 64591 3638 63420775
Product size issue 14.02 10.98 7 64602 353 63424060
Pancreatic neoplasm 14.02 10.98 9 64600 737 63423676
Upper respiratory tract irritation 13.98 10.98 6 64603 213 63424200
Fatigue 13.88 10.98 751 63858 887277 62537136
Therapeutic product effect incomplete 13.71 10.98 73 64536 124983 63299430
Coma acidotic 13.68 10.98 5 64604 115 63424298
Anaemia 13.63 10.98 393 64216 293037 63131376
Glycosylated haemoglobin decreased 13.63 10.98 8 64601 558 63423855
Transient ischaemic attack 13.60 10.98 75 64534 37678 63386735
Acquired mitochondrial DNA mutation 13.52 10.98 3 64606 9 63424404
Atrial tachycardia 13.48 10.98 19 64590 4221 63420192
Influenza like illness 13.44 10.98 115 64494 66709 63357704
Blood creatine phosphokinase increased 13.44 10.98 64 64545 30366 63394047
Blood lactic acid increased 13.30 10.98 25 64584 7061 63417352
Cardiac failure 13.28 10.98 144 64465 88998 63335415
Hyperlipidaemia 13.28 10.98 47 64562 19524 63404889
Meibomianitis 13.21 10.98 4 64605 50 63424363
Foot deformity 13.03 10.98 6 64603 27847 63396566
Injection site pain 13.02 10.98 78 64531 129722 63294691
Pancreatic neuroendocrine tumour 12.83 10.98 7 64602 424 63423989
Seizure 12.64 10.98 81 64528 132553 63291860
Product monitoring error 12.56 10.98 19 64590 4497 63419916
Acute coronary syndrome 12.37 10.98 30 64579 10096 63414317
Portal fibrosis 12.31 10.98 6 64603 287 63424126
Immunisation 12.30 10.98 10 64599 1183 63423230
Renal cancer metastatic 12.25 10.98 6 64603 290 63424123
Drug ineffective for unapproved indication 12.24 10.98 10 64599 34053 63390360
Stent placement 12.20 10.98 17 64592 3738 63420675
Disease progression 12.20 10.98 74 64535 122684 63301729
Fulminant type 1 diabetes mellitus 12.19 10.98 7 64602 468 63423945
Splenic granuloma 12.15 10.98 3 64606 16 63424397
Hyperthermia 12.13 10.98 28 64581 9128 63415285
Reperfusion injury 12.13 10.98 4 64605 67 63424346
Systemic infection 12.12 10.98 19 64590 4641 63419772
Nephroangiosclerosis 12.11 10.98 5 64604 161 63424252
Cerebral reperfusion injury 12 10.98 3 64606 17 63424396
Tension headache 11.93 10.98 20 64589 5166 63419247
Oesophageal mucosal tear 11.86 10.98 3 64606 18 63424395
Gastrooesophageal reflux disease 11.80 10.98 149 64460 95490 63328923
Pancreatic atrophy 11.80 10.98 5 64604 172 63424241
Intraductal papillary mucinous neoplasm 11.79 10.98 6 64603 315 63424098
Genital infection 11.77 10.98 5 64604 173 63424240
Adrenal mass 11.77 10.98 9 64600 975 63423438
Disease recurrence 11.69 10.98 7 64602 28023 63396390
Basal cell carcinoma 11.66 10.98 7 64602 27984 63396429
Sopor 11.64 10.98 4 64605 22160 63402253
Hepatic function abnormal 11.57 10.98 71 64538 37071 63387342
Infrequent bowel movements 11.54 10.98 10 64599 1292 63423121
Pseudomonal bacteraemia 11.48 10.98 11 64598 1617 63422796
Gallbladder enlargement 11.47 10.98 8 64601 751 63423662
Pancreatic enzymes increased 11.45 10.98 8 64601 754 63423659
Hunger 11.39 10.98 20 64589 5359 63419054
Fall 11.39 10.98 498 64111 391836 63032577
Infusion site rash 11.36 10.98 12 64597 1982 63422431
Sciatica 11.22 10.98 11 64598 34313 63390100
Non-alcoholic steatohepatitis 11.18 10.98 11 64598 1670 63422743
Oral mucosal discolouration 11.13 10.98 6 64603 355 63424058
Pollakiuria 11.09 10.98 57 64552 27880 63396533
Skin turgor decreased 11.07 10.98 7 64602 558 63423855
Disability assessment scale score increased 11.05 10.98 15 64594 3218 63421195

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 634.20 10.95 516 56080 38375 34861960
Hypoglycaemia 552.74 10.95 554 56042 54086 34846249
Blood glucose increased 437.07 10.95 539 56057 66179 34834156
Pancreatic carcinoma 419.17 10.95 229 56367 8672 34891663
Diabetes mellitus inadequate control 401.84 10.95 258 56338 13206 34887129
Pancreatic carcinoma metastatic 338.32 10.95 140 56456 2800 34897535
Glycosylated haemoglobin increased 237.86 10.95 175 56421 11185 34889150
Pancreatitis acute 221.53 10.95 250 56346 27891 34872444
Lactic acidosis 188.37 10.95 256 56340 34516 34865819
Diabetic ketoacidosis 182.30 10.95 183 56413 17849 34882486
Adenocarcinoma pancreas 173.69 10.95 70 56526 1304 34899031
Pancreaticoduodenectomy 160.05 10.95 34 56562 36 34900299
Product monitoring error 145.82 10.95 90 56506 4291 34896044
Drug abuse 141.89 10.95 4 56592 99092 34801243
Off label use 135.35 10.95 300 56296 419224 34481111
Hyperglycaemia 124.84 10.95 227 56369 39253 34861082
Metastases to liver 122.46 10.95 130 56466 13533 34886802
Pemphigoid 114.44 10.95 102 56494 8564 34891771
Toxicity to various agents 114.43 10.95 94 56502 200268 34700067
Bile duct stent insertion 112.13 10.95 27 56569 70 34900265
Lipase increased 109.09 10.95 103 56493 9313 34891022
No adverse event 108.11 10.95 158 56438 22769 34877566
Pancreatectomy 103.28 10.95 21 56575 14 34900321
Ketoacidosis 99.40 10.95 70 56526 4173 34896162
General physical health deterioration 99.27 10.95 441 56155 127828 34772507
Interstitial lung disease 98.75 10.95 280 56316 65002 34835333
Radiotherapy 94.45 10.95 33 56563 405 34899930
Blood glucose abnormal 92.70 10.95 77 56519 5875 34894460
Euglycaemic diabetic ketoacidosis 82.16 10.95 56 56540 3166 34897169
Hyperkalaemia 69.87 10.95 259 56337 69130 34831205
Pancreatitis chronic 69.46 10.95 44 56552 2196 34898139
Acute kidney injury 67.93 10.95 773 55823 304215 34596120
Product use in unapproved indication 67.15 10.95 55 56541 117444 34782891
Pancreatic stent placement 60.96 10.95 12 56584 5 34900330
Hyperlipidaemia 58.41 10.95 93 56503 14436 34885899
Seronegative arthritis 58.12 10.95 30 56566 1009 34899326
Glycosylated haemoglobin abnormal 56.32 10.95 18 56578 164 34900171
Product dose omission issue 55.12 10.95 357 56239 119354 34780981
Bladder cancer 53.21 10.95 95 56501 16183 34884152
Explorative laparotomy 53.03 10.95 12 56584 21 34900314
Cerebral infarction 52.96 10.95 129 56467 27326 34873009
Blood glucose decreased 52.21 10.95 84 56512 13153 34887182
Metabolic acidosis 51.68 10.95 172 56424 43508 34856827
Renal cyst 49.28 10.95 67 56529 9026 34891309
Drug ineffective 49.22 10.95 488 56108 456263 34444072
Blood glucose fluctuation 46.39 10.95 44 56552 4000 34896335
Neutropenia 44.09 10.95 120 56476 156658 34743677
Biliary sphincterotomy 43.68 10.95 9 56587 7 34900328
Cholelithiasis 43.62 10.95 102 56494 21046 34879289
Febrile neutropenia 42.94 10.95 99 56497 136750 34763585
Dyslipidaemia 41.83 10.95 56 56540 7432 34892903
Diabetic foetopathy 41.53 10.95 15 56581 204 34900131
Prostatomegaly 41.23 10.95 47 56549 5294 34895041
Diverticulum intestinal 40.97 10.95 41 56555 3980 34896355
Amylase increased 40.23 10.95 49 56547 5919 34894416
Pancreatitis necrotising 39.49 10.95 34 56562 2724 34897611
Insulin-requiring type 2 diabetes mellitus 38.90 10.95 13 56583 138 34900197
Circumstance or information capable of leading to medication error 38.57 10.95 28 56568 1751 34898584
Product residue present 37.60 10.95 33 56563 2713 34897622
Pancreatic enzymes increased 36.98 10.95 19 56577 633 34899702
Therapeutic drug monitoring analysis not performed 36.55 10.95 18 56578 547 34899788
Cholecystectomy 36.35 10.95 33 56563 2837 34897498
Diabetic nephropathy 36.23 10.95 29 56567 2099 34898236
Mucosal inflammation 34.22 10.95 10 56586 38612 34861723
Pancreatic cyst 33.60 10.95 19 56577 769 34899566
Glycosylated haemoglobin decreased 33.26 10.95 15 56581 372 34899963
Dizziness 32.39 10.95 515 56081 218006 34682329
Splenectomy 31.59 10.95 15 56581 420 34899915
Weight decreased 31.41 10.95 429 56167 175872 34724463
Death 31.03 10.95 456 56140 397593 34502742
Thirst 30.99 10.95 50 56546 7845 34892490
Disease progression 30.90 10.95 82 56514 107995 34792340
Large for dates baby 30.90 10.95 19 56577 899 34899436
Metastases to lymph nodes 30.55 10.95 38 56558 4690 34895645
Gastrointestinal tube insertion 30.33 10.95 21 56575 1218 34899117
Wrong technique in product usage process 30.27 10.95 127 56469 35859 34864476
Diabetes mellitus 29.52 10.95 152 56444 46721 34853614
Hypoglycaemic coma 28.94 10.95 27 56569 2404 34897931
Autoimmune pancreatitis 28.84 10.95 13 56583 322 34900013
Gastroenterostomy 28.37 10.95 8 56588 45 34900290
Pancreatic disorder 27.95 10.95 23 56573 1731 34898604
Diabetic neuropathy 27.55 10.95 34 56562 4163 34896172
Pancreatic mass 26.16 10.95 17 56579 887 34899448
Renal failure 25.87 10.95 324 56272 130233 34770102
Renal impairment 25.83 10.95 250 56346 94263 34806072
Oedema peripheral 25.77 10.95 302 56294 119510 34780825
Vomiting projectile 25.57 10.95 15 56581 651 34899684
Pollakiuria 25.55 10.95 80 56516 19594 34880741
Pemphigus 25.19 10.95 21 56575 1610 34898725
Alcoholic ketoacidosis 25.07 10.95 6 56590 15 34900320
Inability to afford medication 24.96 10.95 20 56576 1450 34898885
Electrolyte imbalance 24.94 10.95 65 56531 14347 34885988
Hypomagnesaemia 24.91 10.95 85 56511 21766 34878569
Rhabdomyolysis 24.74 10.95 192 56404 67971 34832364
Pancreatic pseudocyst 24.68 10.95 16 56580 831 34899504
Gastrooesophageal reflux disease 24.59 10.95 124 56472 37800 34862535
Dysuria 24.55 10.95 98 56498 27054 34873281
Drug resistance 24.32 10.95 6 56590 25921 34874414
Polyuria 24.21 10.95 47 56549 8527 34891808
Treatment failure 24.09 10.95 24 56572 46673 34853662
Drug intolerance 24.03 10.95 37 56559 59533 34840802
Hyperlipasaemia 23.73 10.95 13 56583 494 34899841
Pyrexia 23.71 10.95 388 56208 332625 34567710
Pneumocystis jirovecii infection 23.70 10.95 21 56575 1749 34898586
Body mass index abnormal 23.03 10.95 9 56587 154 34900181
Metastases to peritoneum 22.95 10.95 21 56575 1823 34898512
Food aversion 22.89 10.95 12 56584 417 34899918
Therapeutic drug monitoring analysis incorrectly performed 22.87 10.95 11 56585 317 34900018
Seizure 22.71 10.95 90 56506 104767 34795568
Type 2 diabetes mellitus 22.51 10.95 67 56529 15965 34884370
Biliary dilatation 22.30 10.95 16 56580 982 34899353
Pyelitis 22.07 10.95 8 56588 110 34900225
Prostatic calcification 21.75 10.95 8 56588 115 34900220
Radiotherapy to pancreas 21.71 10.95 4 56592 0 34900335
Intestinal adhesion lysis 21.71 10.95 4 56592 0 34900335
Completed suicide 21.42 10.95 84 56512 98084 34802251
Angioedema 21.35 10.95 118 56478 37256 34863079
Diabetic retinopathy 21.28 10.95 20 56576 1797 34898538
Drug ineffective for unapproved indication 21.27 10.95 6 56590 23709 34876626
Adverse event 21.14 10.95 73 56523 18804 34881531
Product packaging quantity issue 21.00 10.95 15 56581 914 34899421
Cytomegalovirus infection 21.00 10.95 8 56588 26127 34874208
Pancreatolithiasis 20.97 10.95 7 56589 74 34900261
Prohormone brain natriuretic peptide increased 20.81 10.95 7 56589 76 34900259
Tonsillectomy 20.52 10.95 11 56585 400 34899935
Aortic arteriosclerosis 20.48 10.95 31 56565 4605 34895730
Lower respiratory tract infection 20.41 10.95 13 56583 31624 34868711
Musculoskeletal pain 20.36 10.95 104 56492 31859 34868476
Urine ketone body present 20.30 10.95 16 56580 1132 34899203
Haematochezia 20.30 10.95 137 56459 46397 34853938
Therapeutic product effect decreased 20.15 10.95 16 56580 34727 34865608
Vena cava filter insertion 19.99 10.95 5 56591 16 34900319
Urticaria chronic 19.81 10.95 7 56589 89 34900246
Malignant ascites 19.59 10.95 11 56585 439 34899896
Phlebolith 19.48 10.95 4 56592 3 34900332
Suicide attempt 19.17 10.95 21 56575 39095 34861240
Staphylococcal infection 19.11 10.95 15 56581 32745 34867590
Hyperlactacidaemia 19.10 10.95 24 56572 2992 34897343
Urinary hesitation 18.88 10.95 23 56573 2779 34897556
Psychotic disorder 18.80 10.95 8 56588 24444 34875891
Diverticulum 18.72 10.95 38 56558 7121 34893214
Labelled drug-drug interaction medication error 18.71 10.95 60 56536 14879 34885456
Nephropathy 18.65 10.95 34 56562 5883 34894452
Electrocardiogram abnormal 18.41 10.95 44 56552 9203 34891132
Insulin C-peptide increased 18.28 10.95 6 56590 60 34900275
Foetal exposure during pregnancy 18.07 10.95 21 56575 38080 34862255
Diabetic metabolic decompensation 17.98 10.95 18 56578 1748 34898587
Brain contusion 17.95 10.95 13 56583 810 34899525
Peripancreatic fluid collection 17.90 10.95 5 56591 27 34900308
Alopecia universalis 17.85 10.95 7 56589 121 34900214
Pancreatic carcinoma recurrent 17.85 10.95 6 56590 65 34900270
Psoriatic arthropathy 17.77 10.95 5 56591 19793 34880542
Bile duct cancer 17.69 10.95 12 56584 673 34899662
Pseudohyponatraemia 17.60 10.95 6 56590 68 34900267
Intentional product use issue 17.38 10.95 45 56551 59771 34840564
Pancreatic duct dilatation 17.37 10.95 6 56590 71 34900264
Suicidal ideation 17.35 10.95 24 56572 40364 34859971
Neurotoxicity 17.22 10.95 4 56592 18006 34882329
Metastases to lung 17.13 10.95 43 56553 9277 34891058
Knee operation 17.12 10.95 19 56577 2078 34898257
Pancreatic neoplasm 16.81 10.95 13 56583 895 34899440
Vitamin B1 decreased 16.75 10.95 9 56587 329 34900006
Vitamin B1 deficiency 16.72 10.95 9 56587 330 34900005
Pneumobilia 16.45 10.95 6 56590 84 34900251
Hypoxia 16.35 10.95 41 56555 55054 34845281
Ductal adenocarcinoma of pancreas 16.33 10.95 5 56591 39 34900296
Bile duct adenocarcinoma 16.28 10.95 3 56593 0 34900335
Biliary neoplasm 16.28 10.95 3 56593 0 34900335
Duodenal sphincterotomy 16.28 10.95 3 56593 0 34900335
Biopsy pancreas 16.28 10.95 3 56593 0 34900335
Choledochoenterostomy 16.28 10.95 3 56593 0 34900335
Pancreatic sphincterotomy 16.28 10.95 3 56593 0 34900335
Splenic vein occlusion 16.28 10.95 3 56593 0 34900335
Infusion related reaction 16.12 10.95 39 56557 53018 34847317
Colon cancer 16.08 10.95 40 56556 8581 34891754
Coma 16.02 10.95 31 56565 45647 34854688
Genital swelling 16.01 10.95 7 56589 161 34900174
Blood triglycerides abnormal 15.89 10.95 8 56588 255 34900080
COVID-19 15.88 10.95 68 56528 77482 34822853
Thrombocytopenia 15.86 10.95 169 56427 156078 34744257
Cardiac failure 15.79 10.95 221 56375 91027 34809308
Sprue-like enteropathy 15.71 10.95 10 56586 503 34899832
Hypercapnic coma 15.66 10.95 7 56589 170 34900165
Product prescribing error 15.59 10.95 76 56520 22851 34877484
Eczema asteatotic 15.53 10.95 8 56588 268 34900067
Urogenital infection fungal 15.50 10.95 4 56592 15 34900320
Dependence on respirator 15.50 10.95 6 56590 100 34900235
Bile duct stenosis 15.48 10.95 14 56582 1197 34899138
Groin abscess 15.45 10.95 11 56585 667 34899668
Oscillopsia 15.32 10.95 5 56591 49 34900286
Amaurosis 15.25 10.95 11 56585 681 34899654
Gastrointestinal mucosal necrosis 15.11 10.95 7 56589 185 34900150
Large intestine polyp 15.06 10.95 37 56559 7877 34892458
Nephroangiosclerosis 14.97 10.95 7 56589 189 34900146
Respiratory arrest 14.94 10.95 14 56582 28029 34872306
Romberg test positive 14.89 10.95 5 56591 54 34900281
Nephrolithiasis 14.88 10.95 92 56504 30241 34870094
Osteonecrosis 14.86 10.95 3 56593 14887 34885448
Blood creatinine increased 14.85 10.95 226 56370 94750 34805585
Palindromic rheumatism 14.77 10.95 7 56589 195 34900140
Asthma-chronic obstructive pulmonary disease overlap syndrome 14.75 10.95 14 56582 1273 34899062
Spinal osteoarthritis 14.70 10.95 36 56560 7647 34892688
Nephrogenic anaemia 14.65 10.95 18 56578 2193 34898142
Anaemia 14.56 10.95 487 56109 232848 34667487
Stent placement 14.54 10.95 28 56568 5050 34895285
Biliary obstruction 14.53 10.95 20 56576 2725 34897610
Unresponsive to stimuli 14.41 10.95 14 56582 27555 34872780
Unevaluable event 14.37 10.95 19 56577 32571 34867764
Thyroid neoplasm 14.30 10.95 9 56587 444 34899891
Renal mass 14.13 10.95 16 56580 1788 34898547
Bile duct stone 13.98 10.95 19 56577 2558 34897777
Umbilical hernia repair 13.97 10.95 4 56592 24 34900311
Thrombosis 13.87 10.95 39 56557 50419 34849916
Subdural hygroma 13.75 10.95 8 56588 342 34899993
Bladder irrigation 13.65 10.95 5 56591 71 34900264
Weight increased 13.64 10.95 219 56377 92814 34807521
Hypercholesterolaemia 13.63 10.95 38 56558 8724 34891611
Drug eruption 13.56 10.95 66 56530 19832 34880503
Oedematous pancreatitis 13.54 10.95 9 56587 488 34899847
Dehydration 13.50 10.95 290 56306 129679 34770656
Intentional product misuse 13.49 10.95 34 56562 45577 34854758
Pancreatic fistula 13.40 10.95 5 56591 75 34900260
Hallucination 13.29 10.95 41 56555 51457 34848878
Generalised tonic-clonic seizure 13.25 10.95 9 56587 21165 34879170
Encephalopathy 13.25 10.95 23 56573 35296 34865039
Agitation 13.24 10.95 48 56548 57351 34842984
Aggression 13.18 10.95 27 56569 38937 34861398
Genital lesion 13.15 10.95 7 56589 251 34900084
Thrombotic cerebral infarction 13.14 10.95 8 56588 372 34899963
Sedation 13.05 10.95 9 56587 20997 34879338
Pulmonary mass 13.02 10.95 48 56548 12764 34887571
Fracture 13.01 10.95 32 56564 6817 34893518
Gallbladder disorder 12.89 10.95 31 56565 6511 34893824
Adrenal mass 12.86 10.95 10 56586 694 34899641
Superinfection 12.80 10.95 18 56578 2501 34897834
Toe amputation 12.78 10.95 18 56578 2506 34897829
Dementia 12.73 10.95 50 56546 13698 34886637
Acute respiratory distress syndrome 12.66 10.95 14 56582 25955 34874380
Procedural headache 12.56 10.95 4 56592 36 34900299
Heart rate decreased 12.53 10.95 20 56576 31725 34868610
Abdominal pain 12.47 10.95 350 56246 163268 34737067
Pseudocyst 12.44 10.95 6 56590 174 34900161
Retinopathy 12.40 10.95 16 56580 2048 34898287
Intraductal papillary-mucinous carcinoma of pancreas 12.40 10.95 3 56593 8 34900327
Campylobacter infection 12.39 10.95 11 56585 918 34899417
Cyst removal 12.37 10.95 4 56592 38 34900297
Arthroscopy 12.27 10.95 5 56591 96 34900239
Renal stone removal 12.10 10.95 4 56592 41 34900294
Bladder transitional cell carcinoma 12.08 10.95 18 56578 2637 34897698
Blood ketone body increased 12.01 10.95 8 56588 435 34899900
Gastrostomy 11.98 10.95 10 56586 768 34899567
Accidental exposure to product 11.93 10.95 3 56593 12799 34887536
Malignant neoplasm of ampulla of Vater 11.90 10.95 3 56593 10 34900325
Duodenitis 11.89 10.95 25 56571 4803 34895532
Hepatic steatosis 11.87 10.95 60 56536 18302 34882033
Pneumonitis 11.87 10.95 23 56573 33855 34866480
Anion gap increased 11.87 10.95 15 56581 1881 34898454
Ketonuria 11.86 10.95 9 56587 602 34899733
Toxic skin eruption 11.86 10.95 43 56553 11342 34888993
Synovitis 11.82 10.95 4 56592 14062 34886273
Nodular rash 11.81 10.95 5 56591 106 34900229
Cervicobrachial syndrome 11.64 10.95 7 56589 318 34900017
Injection site nodule 11.64 10.95 14 56582 1669 34898666
Metastases to spleen 11.60 10.95 8 56588 461 34899874
Arthropathy 11.54 10.95 16 56580 26891 34873444
Alanine aminotransferase increased 11.51 10.95 80 56516 80735 34819600
Hypoglycaemic seizure 11.45 10.95 7 56589 328 34900007
Proteinuria 11.42 10.95 60 56536 18582 34881753
Flushing 11.37 10.95 22 56574 32398 34867937
Pain 11.27 10.95 249 56347 204426 34695909
Abdominal hernia repair 11.24 10.95 4 56592 52 34900283
Nasal neoplasm 11.24 10.95 5 56591 120 34900215
Loss of personal independence in daily activities 11.22 10.95 23 56573 33156 34867179
Post streptococcal glomerulonephritis 11.16 10.95 5 56591 122 34900213
High density lipoprotein abnormal 11.10 10.95 4 56592 54 34900281

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 998.04 10.32 885 94342 100709 79548452
Blood glucose increased 893.18 10.32 879 94348 114096 79535065
Diabetes mellitus inadequate control 682.34 10.32 401 94826 23863 79625298
Pancreatitis 650.45 10.32 586 94641 67989 79581172
Lactic acidosis 522.03 10.32 525 94702 69834 79579327
Diabetic ketoacidosis 418.31 10.32 338 94889 33784 79615377
Glycosylated haemoglobin increased 381.76 10.32 255 94972 19005 79630156
Pancreatic carcinoma 364.94 10.32 218 95009 13359 79635802
Pancreatitis acute 322.57 10.32 345 94882 49259 79599902
Carotid artery thrombosis 317.04 10.32 124 95103 2929 79646232
Pemphigoid 311.33 10.32 206 95021 15109 79634052
Neurologic neglect syndrome 305.16 10.32 119 95108 2788 79646373
Acute kidney injury 285.44 10.32 1301 93926 518103 79131058
Personality disorder 268.47 10.32 136 95091 6010 79643151
Hyperglycaemia 263.06 10.32 370 94857 69965 79579196
Adjustment disorder 246.17 10.32 112 95115 3888 79645273
Hemiplegia 222.23 10.32 166 95061 14773 79634388
Euglycaemic diabetic ketoacidosis 210.64 10.32 120 95107 6724 79642437
Ketoacidosis 208.18 10.32 125 95102 7729 79641432
Off label use 197.00 10.32 502 94725 906713 78742448
Affect lability 192.24 10.32 136 95091 11123 79638038
Lipase increased 186.86 10.32 156 95071 16310 79632851
Hyperkalaemia 182.03 10.32 414 94813 113984 79535177
Blood glucose abnormal 176.64 10.32 126 95101 10440 79638721
General physical health deterioration 165.51 10.32 709 94518 274529 79374632
Product monitoring error 155.35 10.32 109 95118 8797 79640364
Sensory loss 147.24 10.32 123 95104 12868 79636293
Motor dysfunction 145.66 10.32 129 95098 14604 79634557
Drug intolerance 143.39 10.32 68 95159 264051 79385110
Synovitis 141.25 10.32 10 95217 150724 79498437
Drug ineffective 137.90 10.32 745 94482 1080168 78568993
Drug abuse 136.03 10.32 17 95210 162674 79486487
Coordination abnormal 135.32 10.32 133 95094 17179 79631982
Systemic lupus erythematosus 126.42 10.32 4 95223 121145 79528016
Toxicity to various agents 125.87 10.32 193 95034 421347 79227814
Interstitial lung disease 122.43 10.32 353 94874 112247 79536914
Muscle spasticity 121.64 10.32 139 95088 21336 79627825
Metabolic acidosis 120.66 10.32 289 94938 82240 79566921
Therapeutic product effect decreased 117.35 10.32 26 95201 163837 79485324
Blood glucose decreased 111.65 10.32 147 95080 26087 79623074
Treatment failure 108.89 10.32 34 95193 170452 79478709
Product residue present 108.82 10.32 62 95165 3474 79645687
Lung diffusion test abnormal 108.07 10.32 33 95194 357 79648804
Eating disorder 107.28 10.32 128 95099 20569 79628592
Arthropathy 101.75 10.32 42 95185 177069 79472092
Product use in unapproved indication 101.15 10.32 90 95137 250269 79398892
Hemiparesis 98.29 10.32 158 95069 33575 79615586
Cerebral infarction 98.04 10.32 187 95040 45489 79603672
Maternal exposure during pregnancy 93.17 10.32 24 95203 136514 79512647
Hypoglycaemic coma 91.85 10.32 62 95165 4698 79644463
Glossodynia 90.91 10.32 9 95218 103328 79545833
Infusion related reaction 89.18 10.32 86 95141 230151 79419010
Aphasia 85.51 10.32 179 95048 46553 79602608
Product use issue 84.06 10.32 76 95151 209746 79439415
Gangrene 77.87 10.32 73 95154 8891 79640270
Joint swelling 75.21 10.32 144 95083 288502 79360659
Contraindicated product administered 74.66 10.32 48 95179 157490 79491671
Seronegative arthritis 69.47 10.32 52 95175 4640 79644521
Blood glucose fluctuation 69.04 10.32 60 95167 6622 79642539
Muscular weakness 68.28 10.32 375 94852 160354 79488807
Lower respiratory tract infection 65.99 10.32 36 95191 129184 79519977
Hypersensitivity 64.73 10.32 135 95092 262104 79387057
Hand deformity 64.09 10.32 22 95205 103897 79545264
Pemphigus 61.56 10.32 21 95206 99561 79549600
Dysarthria 61.31 10.32 199 95028 67423 79581738
Bladder cancer 60.39 10.32 94 95133 19432 79629729
Duodenal ulcer perforation 60.29 10.32 5 95222 66206 79582955
Dysphagia 60.18 10.32 297 94930 121839 79527322
Diabetes mellitus 59.14 10.32 217 95010 78173 79570988
Sinus congestion 59.07 10.32 94 95133 19802 79629359
Arterial occlusive disease 58.82 10.32 61 95166 8395 79640766
Skin haemorrhage 58.67 10.32 72 95155 11909 79637252
Pain 55.57 10.32 555 94672 703247 78945914
Rhabdomyolysis 55.31 10.32 257 94970 102874 79546287
Exposure during pregnancy 54.88 10.32 26 95201 101106 79548055
Amylase increased 54.31 10.32 67 95160 11142 79638019
Musculoskeletal stiffness 53.22 10.32 79 95148 174929 79474232
Sneezing 53.03 10.32 89 95138 19594 79629567
Glycosylated haemoglobin abnormal 52.84 10.32 17 95210 221 79648940
Pancreatitis necrotising 52.77 10.32 41 95186 3867 79645294
Neutropenia 52.03 10.32 173 95054 287537 79361624
Urine ketone body present 51.65 10.32 39 95188 3526 79645635
Drug hypersensitivity 51.18 10.32 184 95043 298732 79350429
Haematochezia 50.42 10.32 223 95004 87422 79561739
Product prescribing error 50.13 10.32 142 95085 44671 79604490
Cerebrovascular accident 49.27 10.32 336 94891 154956 79494205
Psoriatic arthropathy 48.99 10.32 16 95211 77983 79571178
Dizziness 48.77 10.32 891 94336 525550 79123611
Renal impairment 48.65 10.32 339 94888 157444 79491717
Mucosal inflammation 48.37 10.32 15 95212 75565 79573596
Wrong technique in product usage process 47.95 10.32 195 95032 73680 79575481
Eosinophilic myocarditis 47.49 10.32 25 95202 1197 79647964
Febrile neutropenia 47.41 10.32 131 95096 230868 79418293
Alopecia 46.89 10.32 132 95095 231223 79417938
Renal failure 46.54 10.32 404 94823 200564 79448597
Helicobacter infection 46.13 10.32 13 95214 69691 79579470
Folliculitis 45.75 10.32 6 95221 55374 79593787
Completed suicide 45.66 10.32 146 95081 245621 79403540
Swelling 44.39 10.32 123 95104 216588 79432573
Dehydration 43.72 10.32 471 94756 247716 79401445
Diabetic metabolic decompensation 42.93 10.32 34 95193 3298 79645863
Oedema peripheral 42.70 10.32 475 94752 251813 79397348
MELAS syndrome 42.70 10.32 14 95213 194 79648967
Temperature perception test abnormal 42.41 10.32 9 95218 16 79649145
Irritable bowel syndrome 42.33 10.32 11 95216 62230 79586931
Hypoglycaemic encephalopathy 42.23 10.32 19 95208 642 79648519
Dysuria 41.80 10.32 145 95082 50806 79598355
Cardiac failure 41.07 10.32 321 94906 154521 79494640
Sinus disorder 41.03 10.32 86 95141 22378 79626783
Wound 40.91 10.32 47 95180 116132 79533029
C-reactive protein abnormal 40.54 10.32 5 95222 48362 79600799
Adenocarcinoma pancreas 40.47 10.32 27 95200 2006 79647155
Pericarditis 40.25 10.32 39 95188 104197 79544964
No adverse event 39.81 10.32 116 95111 37076 79612085
Pancreatic carcinoma metastatic 39.38 10.32 34 95193 3719 79645442
Discomfort 38.87 10.32 56 95171 125561 79523600
Stomatitis 38.38 10.32 73 95154 146684 79502477
Rhinorrhoea 38.18 10.32 186 95041 75888 79573273
Product dose omission issue 37.84 10.32 457 94770 247080 79402081
Fibromyalgia 37.35 10.32 15 95212 64325 79584836
Injury 36.18 10.32 24 95203 77472 79571689
Pollakiuria 35.81 10.32 112 95115 37205 79611956
Pancreatitis chronic 35.43 10.32 33 95194 3986 79645175
Respiratory tract congestion 34.84 10.32 75 95152 19879 79629282
Injection site erythema 34.16 10.32 26 95201 78171 79570990
Angioedema 34.02 10.32 180 95047 75855 79573306
Intentional product use issue 33.69 10.32 83 95144 152029 79497132
Thirst 33.68 10.32 71 95156 18548 79630613
Genital infection female 32.58 10.32 9 95218 66 79649095
Diarrhoea 32.55 10.32 1322 93905 879167 78769994
Serotonin syndrome 32.51 10.32 7 95220 45020 79604141
Therapeutic drug monitoring analysis not performed 32.16 10.32 23 95204 1913 79647248
Weight decreased 32.07 10.32 599 94628 354599 79294562
Hepatic function abnormal 31.98 10.32 172 95055 72935 79576226
Dyslipidaemia 31.87 10.32 53 95174 11580 79637581
Anaemia 31.82 10.32 725 94502 444290 79204871
Pancreatic enzymes increased 31.78 10.32 20 95207 1345 79647816
Polyuria 31.63 10.32 61 95166 14953 79634208
Hepatic enzyme increased 30.84 10.32 113 95114 182497 79466664
Arthralgia 30.42 10.32 490 94737 571313 79077848
Autoimmune pancreatitis 29.77 10.32 15 95212 655 79648506
Pancreatic mass 29.68 10.32 20 95207 1511 79647650
Impaired healing 29.22 10.32 37 95190 87618 79561543
Nephroangiosclerosis 28.74 10.32 12 95215 337 79648824
Therapy non-responder 28.70 10.32 41 95186 92264 79556897
Altered state of consciousness 28.69 10.32 116 95111 43706 79605455
Sedation 28.68 10.32 13 95214 51882 79597279
Angina pectoris 28.52 10.32 130 95097 51602 79597559
Labelled drug-drug interaction medication error 28.41 10.32 85 95142 27565 79621596
Diabetic retinopathy 28.34 10.32 26 95201 3080 79646081
Blood cholesterol increased 28.26 10.32 35 95192 83685 79565476
Hyperlipasaemia 28.26 10.32 18 95209 1236 79647925
Gastric disorder 27.70 10.32 103 95124 37330 79611831
Mobility decreased 27.58 10.32 66 95161 122109 79527052
Alcoholic ketoacidosis 26.89 10.32 6 95221 15 79649146
Asthenia 26.79 10.32 800 94427 510889 79138272
Abdominal pain 26.70 10.32 631 94596 388938 79260223
Flushing 26.67 10.32 40 95187 88228 79560933
Pancreatic pseudocyst 26.49 10.32 18 95209 1379 79647782
Red blood cell sedimentation rate increased 26.20 10.32 11 95216 45931 79603230
Drug ineffective for unapproved indication 25.11 10.32 15 95212 51223 79597938
Electrocardiogram abnormal 24.86 10.32 59 95168 16678 79632483
Hyperlactacidaemia 24.81 10.32 32 95195 5563 79643598
Electrolyte imbalance 24.57 10.32 87 95140 30794 79618367
Pancreatic disorder 24.49 10.32 25 95202 3377 79645784
Micturition disorder 24.39 10.32 27 95200 4001 79645160
Drug resistance 24.24 10.32 10 95217 42203 79606958
Fall 24.08 10.32 757 94470 486872 79162289
Diabetic nephropathy 23.70 10.32 23 95204 2924 79646237
Small fibre neuropathy 23.60 10.32 12 95215 534 79648627
Neurotoxicity 23.59 10.32 5 95222 32513 79616648
Glycosylated haemoglobin decreased 23.48 10.32 13 95214 689 79648472
Blood creatinine increased 23.12 10.32 285 94942 154772 79494389
Respiratory depression 22.81 10.32 3 95224 27627 79621534
Prevertebral soft tissue swelling of cervical space 22.76 10.32 6 95221 36 79649125
Tubulointerstitial nephritis and uveitis syndrome 22.59 10.32 10 95217 325 79648836
Acetonaemia 22.39 10.32 10 95217 332 79648829
Blood pressure inadequately controlled 22.34 10.32 32 95195 6145 79643016
Infection 22.31 10.32 183 95044 241529 79407632
Osteonecrosis 22.11 10.32 5 95222 31090 79618071
Body mass index abnormal 21.95 10.32 9 95218 241 79648920
Depression 21.94 10.32 160 95067 216630 79432531
Glomerular filtration rate decreased 21.65 10.32 68 95159 22634 79626527
Hip arthroplasty 21.31 10.32 8 95219 35748 79613413
Adverse drug reaction 21.13 10.32 29 95198 66363 79582798
Flatulence 21.10 10.32 104 95123 42620 79606541
Full blood count abnormal 21.05 10.32 100 95127 40374 79608787
Vomiting 21.04 10.32 984 94243 664844 78984317
Fear-related avoidance of activities 21.03 10.32 7 95220 102 79649059
Multiple sclerosis relapse 20.93 10.32 15 95212 46518 79602643
Food aversion 20.88 10.32 14 95213 1049 79648112
Diabetic neuropathy 20.74 10.32 31 95196 6185 79642976
Embolic cerebellar infarction 20.63 10.32 5 95222 20 79649141
Bursitis infective 20.54 10.32 15 95212 1289 79647872
Urosepsis 20.52 10.32 74 95153 26421 79622740
Renal disorder 20.45 10.32 102 95125 42003 79607158
Pneumocystis jirovecii infection 20.35 10.32 21 95206 2873 79646288
Bladder trabeculation 20.26 10.32 6 95221 58 79649103
Disease progression 20.17 10.32 133 95094 184229 79464932
Bladder transitional cell carcinoma 20.04 10.32 20 95207 2630 79646531
Insulin C-peptide increased 20.03 10.32 7 95220 119 79649042
Migraine 19.95 10.32 47 95180 87446 79561715
Systemic infection 19.79 10.32 39 95188 9713 79639448
Cystitis 19.73 10.32 119 95108 52613 79596548
Basal cell carcinoma 19.68 10.32 10 95217 37365 79611796
Haemoglobin increased 19.63 10.32 30 95197 6102 79643059
Endometrial disorder 19.47 10.32 11 95216 606 79648555
Exercise tolerance decreased 19.29 10.32 37 95190 9034 79640127
Intestinal transit time abnormal 19.24 10.32 6 95221 70 79649091
Posterior reversible encephalopathy syndrome 19.15 10.32 4 95223 26277 79622884
Abdominal pain upper 18.99 10.32 374 94853 223445 79425716
Gamma-glutamyltransferase increased 18.95 10.32 121 95106 54559 79594602
Cytomegalovirus infection 18.85 10.32 14 95213 42630 79606531
Bile duct stone 18.83 10.32 28 95199 5561 79643600
Skin exfoliation 18.53 10.32 121 95106 54979 79594182
Anuria 18.37 10.32 61 95166 20902 79628259
Tri-iodothyronine free decreased 18.34 10.32 9 95218 371 79648790
Colon cancer 18.21 10.32 48 95179 14475 79634686
Groin abscess 18.20 10.32 15 95212 1540 79647621
Therapeutic drug monitoring analysis incorrectly performed 17.96 10.32 11 95216 705 79648456
Seizure 17.86 10.32 142 95085 188692 79460469
Upper gastrointestinal haemorrhage 17.85 10.32 97 95130 41283 79607878
Psychotic disorder 17.78 10.32 14 95213 41388 79607773
Vitamin B1 decreased 17.67 10.32 10 95217 553 79648608
Brain contusion 17.67 10.32 14 95213 1359 79647802
Radioallergosorbent test positive 17.61 10.32 5 95222 41 79649120
Injection site reaction 17.36 10.32 24 95203 54761 79594400
Carcinoid tumour of the pancreas 17.20 10.32 3 95224 0 79649161
Hypokinesia 17.18 10.32 56 95171 19004 79630157
Sinusitis 17.14 10.32 150 95077 195351 79453810
Hypomagnesaemia 17 10.32 105 95122 46806 79602355
Knee arthroplasty 16.90 10.32 16 95211 43232 79605929
Acidosis 16.87 10.32 57 95170 19705 79629456
Wrong patient received product 16.81 10.32 24 95203 4594 79644567
Sleep disorder due to a general medical condition 16.71 10.32 46 95181 14231 79634930
Injection site pain 16.67 10.32 89 95138 129749 79519412
Nausea 16.60 10.32 1342 93885 955854 78693307
Multiple congenital abnormalities 16.60 10.32 6 95221 113 79649048
Inflammation 16.49 10.32 57 95170 93696 79555465
Joint noise 16.49 10.32 22 95205 3952 79645209
Encephalopathy 16.35 10.32 35 95192 67362 79581799
Generalised tonic-clonic seizure 16.29 10.32 17 95210 43893 79605268
Pyelitis 16.19 10.32 8 95219 335 79648826
Fracture 16.14 10.32 60 95167 21741 79627420
Urogenital infection fungal 16.13 10.32 4 95223 18 79649143
Testicular swelling 16.09 10.32 13 95214 1297 79647864
Portal vein cavernous transformation 16.08 10.32 6 95221 124 79649037
Tubulointerstitial nephritis 16.07 10.32 89 95138 38146 79611015
Anion gap increased 16.06 10.32 21 95206 3699 79645462
Peripheral artery haematoma 16.04 10.32 6 95221 125 79649036
Gastrointestinal mucosal necrosis 15.94 10.32 7 95220 223 79648938
Blister 15.84 10.32 81 95146 119395 79529766
Pseudohyponatraemia 15.78 10.32 6 95221 131 79649030
Hepatotoxicity 15.78 10.32 23 95204 51329 79597832
Infusion site scar 15.76 10.32 8 95219 355 79648806
Bladder irrigation 15.61 10.32 5 95222 64 79649097
Cerebral haemorrhage 15.52 10.32 120 95107 57553 79591608
Melaena 15.45 10.32 125 95102 60765 79588396
Increased appetite 15.44 10.32 40 95187 11938 79637223
Myocardial infarction 15.39 10.32 307 94920 183822 79465339
Intensive care unit acquired weakness 15.38 10.32 15 95212 1918 79647243
Blood ketone body increased 15.37 10.32 10 95217 712 79648449
Acute myocardial infarction 15.35 10.32 150 95077 76886 79572275
Hepatic steatosis 15.30 10.32 87 95140 37651 79611510
Palpitations 15.27 10.32 224 95003 126386 79522775
Impaired work ability 15.27 10.32 55 95172 19626 79629535
Gastric cancer 15.25 10.32 36 95191 10143 79639018
Device dislocation 15.16 10.32 6 95221 25964 79623197
Paraesthesia 15.14 10.32 136 95091 176187 79472974
Hypoglycaemic unconsciousness 15.09 10.32 12 95215 1171 79647990
Therapeutic product effect incomplete 15.08 10.32 103 95124 141542 79507619
Amaurosis 15.02 10.32 12 95215 1179 79647982
Wound infection 14.92 10.32 5 95222 23986 79625175
Thrombotic cerebral infarction 14.89 10.32 9 95218 563 79648598
Urine albumin/creatinine ratio increased 14.88 10.32 9 95218 564 79648597
Ketonuria 14.87 10.32 12 95215 1196 79647965
Diabetic foetopathy 14.77 10.32 4 95223 27 79649134
Pancreatectomy 14.77 10.32 4 95223 27 79649134
Anaemia vitamin B12 deficiency 14.58 10.32 10 95217 778 79648383
Proteinuria 14.57 10.32 77 95150 32425 79616736
Multiple drug therapy 14.56 10.32 21 95206 4057 79645104
Ill-defined disorder 14.53 10.32 36 95191 65839 79583322
Prohormone brain natriuretic peptide increased 14.53 10.32 7 95220 277 79648884
Pancreaticoduodenectomy 14.52 10.32 4 95223 29 79649132
Cataract 14.42 10.32 125 95102 61995 79587166
Procedural headache 14.32 10.32 6 95221 170 79648991
Alopecia universalis 14.21 10.32 7 95220 291 79648870
Suicide attempt 14.20 10.32 51 95176 82881 79566280
Pain of skin 14.15 10.32 44 95183 14569 79634592
Dystonia 14.14 10.32 4 95223 21395 79627766
Nephropathy 14.11 10.32 34 95193 9704 79639457
Internal haemorrhage 14.06 10.32 32 95195 8801 79640360
Condition aggravated 14.02 10.32 474 94753 500650 79148511
Campylobacter infection 13.98 10.32 14 95213 1849 79647312
Tongue oedema 13.89 10.32 28 95199 7089 79642072
Urinary hesitation 13.84 10.32 21 95206 4245 79644916
Mixed liver injury 13.83 10.32 29 95198 7549 79641612
Nephrogenic anaemia 13.80 10.32 20 95207 3882 79645279
Toxic skin eruption 13.79 10.32 58 95169 22235 79626926
Toe amputation 13.76 10.32 20 95207 3891 79645270
Product packaging quantity issue 13.71 10.32 12 95215 1337 79647824
Blood ketone body present 13.70 10.32 5 95222 97 79649064
Pulmonary tumour thrombotic microangiopathy 13.70 10.32 5 95222 97 79649064
Peripheral swelling 13.65 10.32 233 94994 269384 79379777
Thrombosis 13.57 10.32 53 95174 84047 79565114
Lymphopenia 13.55 10.32 10 95217 30547 79618614
Decreased vibratory sense 13.55 10.32 9 95218 664 79648497
Body temperature increased 13.54 10.32 20 95207 44400 79604761
Psoriasis 13.49 10.32 165 95062 89422 79559739
Blood calcium decreased 13.37 10.32 11 95216 31808 79617353
Foot deformity 13.35 10.32 6 95221 24068 79625093
Vitamin B1 deficiency 13.25 10.32 9 95218 689 79648472
Subdural hygroma 13.23 10.32 8 95219 501 79648660
Pseudocyst 13.18 10.32 7 95220 341 79648820
Sopor 13.15 10.32 12 95215 32998 79616163
Prerenal failure 13.14 10.32 19 95208 3679 79645482
Impaired insulin secretion 13.12 10.32 4 95223 43 79649118
Oedematous pancreatitis 13.11 10.32 11 95216 1157 79648004
Acquired mitochondrial DNA mutation 13.05 10.32 3 95224 9 79649152
Hyperthermia 12.82 10.32 49 95178 17988 79631173
Vaginal haemorrhage 12.80 10.32 5 95222 21812 79627349
Loss of personal independence in daily activities 12.79 10.32 71 95156 102509 79546652
Premature delivery 12.78 10.32 6 95221 23461 79625700
Testicular pain 12.78 10.32 14 95213 2051 79647110
Cholelithiasis 12.77 10.32 107 95120 52557 79596604
Pneumocystis jirovecii pneumonia 12.74 10.32 12 95215 32496 79616665
Fulminant type 1 diabetes mellitus 12.73 10.32 12 95215 1471 79647690
Drug eruption 12.71 10.32 93 95134 43842 79605319
Death 12.52 10.32 551 94676 565963 79083198
Vomiting projectile 12.48 10.32 13 95214 1798 79647363
Post streptococcal glomerulonephritis 12.48 10.32 5 95222 126 79649035
Incorrect route of product administration 12.43 10.32 14 95213 34915 79614246
Pulmonary haematoma 12.41 10.32 5 95222 128 79649033
Vitamin B12 deficiency 12.39 10.32 27 95200 7214 79641947
Coma acidotic 12.33 10.32 5 95222 130 79649031
Decreased appetite 12.31 10.32 513 94714 341905 79307256
Embolic cerebral infarction 12.31 10.32 11 95216 1260 79647901
Abdominal discomfort 12.27 10.32 218 95009 250509 79398652
Type 2 diabetes mellitus 12.26 10.32 113 95114 57009 79592152
Bile duct cancer 12.24 10.32 10 95217 1014 79648147
Mesenteric arterial occlusion 12.23 10.32 6 95221 247 79648914
Emotional distress 12.18 10.32 18 95209 39951 79609210
Transplant rejection 12.18 10.32 4 95223 19433 79629728
Neuropathy peripheral 12.12 10.32 109 95118 141196 79507965
Nephrotic syndrome 12.10 10.32 35 95192 11139 79638022
Upper respiratory tract irritation 12.01 10.32 6 95221 257 79648904
Blood lactic acid increased 11.99 10.32 38 95189 12706 79636455
Haemorrhage subcutaneous 11.97 10.32 21 95206 4788 79644373
Therapy partial responder 11.97 10.32 3 95224 17394 79631767
Urticaria chronic 11.95 10.32 8 95219 598 79648563
Device related infection 11.93 10.32 14 95213 34280 79614881
Agitation 11.90 10.32 70 95157 99645 79549516
Hypercapnic coma 11.89 10.32 7 95220 417 79648744
Unevaluable event 11.78 10.32 31 95196 55554 79593607
Leukopenia 11.78 10.32 86 95141 116427 79532734
Erythema multiforme 11.77 10.32 47 95180 17604 79631557
Palindromic rheumatism 11.71 10.32 7 95220 429 79648732
Oesophageal mucosal tear 11.68 10.32 3 95224 16 79649145
Multiple sclerosis 11.67 10.32 6 95221 22276 79626885
Photophobia 11.57 10.32 5 95222 20523 79628638
Brain oedema 11.55 10.32 8 95219 25255 79623906
Hypoxia 11.53 10.32 74 95153 103169 79545992
Disease recurrence 11.47 10.32 22 95205 44087 79605074
Exostosis 11.42 10.32 3 95224 16855 79632306
Sleep disorder 11.40 10.32 58 95169 85619 79563542
Chronic kidney disease 11.37 10.32 125 95102 66029 79583132
Haemophagocytic lymphohistiocytosis 11.26 10.32 6 95221 21831 79627330
Cervicobrachial syndrome 11.26 10.32 10 95217 1136 79648025
Blood testosterone decreased 11.18 10.32 14 95213 2363 79646798
Magnetic resonance imaging head abnormal 11.17 10.32 15 95212 2711 79646450
Pancreatic neuroendocrine tumour 11.17 10.32 8 95219 667 79648494
Joint range of motion decreased 11.14 10.32 14 95213 33268 79615893
Inability to afford medication 10.97 10.32 15 95212 2758 79646403
Blood triglycerides abnormal 10.92 10.32 7 95220 486 79648675
Meibomianitis 10.84 10.32 4 95223 80 79649081
Genital swelling 10.73 10.32 6 95221 324 79648837
Myalgia 10.72 10.32 294 94933 185347 79463814
Jaundice 10.69 10.32 104 95123 53245 79595916
Bone erosion 10.62 10.32 4 95223 17843 79631318
Putamen haemorrhage 10.62 10.32 7 95220 510 79648651
Polydipsia 10.60 10.32 24 95203 6581 79642580
Renal cancer metastatic 10.60 10.32 8 95219 723 79648438
Myelosuppression 10.57 10.32 20 95207 40276 79608885
Suicidal ideation 10.55 10.32 51 95176 76289 79572872
Carcinoid crisis 10.54 10.32 7 95220 516 79648645
Blood creatine phosphokinase increased 10.51 10.32 123 95104 65967 79583194
Genital infection 10.49 10.32 5 95222 193 79648968
Pruritus genital 10.41 10.32 19 95208 4467 79644694
Oral candidiasis 10.41 10.32 12 95215 29616 79619545
Miosis 10.34 10.32 3 95224 15786 79633375
Community acquired infection 10.32 10.32 3 95224 27 79649134

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 | 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




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 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 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 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 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 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 MSD SUB MERCK 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 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

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 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 MSD SUB MERCK N022044 March 30, 2007 RX TABLET ORAL Feb. 12, 2023 PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE JANUMET MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK N022044 March 30, 2007 RX TABLET ORAL June 4, 2024 PEDIATRIC EXCLUSIVITY
500MG;EQ 50MG BASE JANUMET MSD SUB MERCK 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 MSD SUB MERCK 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 MSD SUB MERCK 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
22317 MMSL
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 0006-0078 TABLET, FILM COATED, EXTENDED RELEASE 50 mg ORAL NDA 30 sections
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 0006-0080 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
JANUMET XR HUMAN PRESCRIPTION DRUG LABEL 2 0006-0081 TABLET, FILM COATED, EXTENDED RELEASE 100 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 0006-0112 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 0006-0221 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
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 0006-0575 TABLET, FILM COATED 50 mg ORAL NDA 29 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
JANUMET HUMAN PRESCRIPTION DRUG LABEL 2 0006-0577 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 0006-5367 TABLET, FILM COATED 100 mg ORAL NDA 28 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
STEGLUJAN HUMAN PRESCRIPTION DRUG LABEL 2 0006-5368 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