insulin glargine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4901 160337-95-1

Description:

MoleculeDescription

Synonyms:

  • soliqua
  • insulin glargine
  • insulin glargine (genetical recombination)
  • insulin glargine (rDNA origin)
  • insulin glargine recombinant
  • lantus
  • lantus solostar
  • toujeo
A recombinant LONG ACTING INSULIN and HYPOGLYCEMIC AGENT that is used to manage BLOOD GLUCOSE in patients with DIABETES MELLITUS.
  • Molecular weight: 6062.96
  • Formula: C267H404N72O78S6
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 2437.98
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
40 U P
40 U P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
April 20, 2000 FDA SANOFI AVENTIS US
March 25, 2020 PMDA Sanofi K.K.

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 3339.41 9.33 2302 149257 75059 53122448
Hypoglycaemia 3005.52 9.33 1947 149612 57066 53140441
Diabetic ketoacidosis 1780.57 9.33 947 150612 18968 53178539
Hyperglycaemia 1093.10 9.33 908 150651 39176 53158331
Diabetes mellitus inadequate control 1005.89 9.33 581 150978 13729 53183778
Blood glucose decreased 986.76 9.33 648 150911 19368 53178139
Glycosylated haemoglobin increased 781.51 9.33 459 151100 11196 53186311
Device operational issue 696.12 9.33 158 151401 93 53197414
Blood glucose abnormal 521.81 9.33 300 151259 7019 53190488
Ketoacidosis 477.56 9.33 239 151320 4187 53193320
Blood glucose fluctuation 380.12 9.33 207 151352 4344 53193163
Lactic acidosis 349.00 9.33 478 151081 36775 53160732
Rheumatoid arthritis 346.12 9.33 235 151324 314296 52883211
Acute kidney injury 307.77 9.33 1481 150078 252387 52945120
Systemic lupus erythematosus 273.39 9.33 22 151537 125392 53072115
Diabetic retinopathy 264.36 9.33 132 151427 2300 53195207
Pemphigus 262.62 9.33 7 151552 104024 53093483
Hyperkalaemia 260.83 9.33 515 151044 53741 53143766
Hypoglycaemic coma 253.27 9.33 132 151427 2526 53194981
Contraindicated product administered 241.92 9.33 46 151513 135583 53061924
Product storage error 234.96 9.33 235 151324 12895 53184612
Treatment failure 232.34 9.33 42 151517 128361 53069146
Synovitis 219.12 9.33 25 151534 107868 53089639
Glossodynia 217.44 9.33 18 151541 100273 53097234
Alopecia 216.93 9.33 208 151351 234375 52963132
Hand deformity 209.45 9.33 7 151552 84842 53112665
Renal failure 204.51 9.33 770 150789 117682 53079825
Joint swelling 190.35 9.33 232 151327 234406 52963101
Infusion related reaction 180.17 9.33 110 151449 155847 53041660
Diabetes mellitus 172.57 9.33 435 151124 53464 53144043
Drug hypersensitivity 171.53 9.33 307 151252 264935 52932572
Drug intolerance 164.72 9.33 205 151354 205288 52992219
Arthropathy 160.30 9.33 102 151457 141351 53056156
Diabetic metabolic decompensation 147.01 9.33 78 151481 1550 53195957
Abdominal discomfort 145.46 9.33 253 151306 220809 52976698
Pain 145.19 9.33 1028 150531 587370 52610137
Anti-cyclic citrullinated peptide antibody positive 143.69 9.33 4 151555 57168 53140339
Hypoglycaemic unconsciousness 143.61 9.33 61 151498 717 53196790
Drug ineffective 133.11 9.33 1586 149973 815659 52381848
Euglycaemic diabetic ketoacidosis 125.80 9.33 88 151471 2919 53194588
Exposure during pregnancy 124.87 9.33 691 150868 124169 53073338
Cerebrovascular accident 123.77 9.33 609 150950 104565 53092942
Pericarditis 123.32 9.33 18 151541 64388 53133119
Cardiac failure congestive 116.28 9.33 547 151012 92210 53105297
Fatigue 114.49 9.33 1429 150130 729077 52468430
Swelling 113.98 9.33 232 151327 190873 53006634
Rash 111.10 9.33 777 150782 445414 52752093
Myocardial infarction 110.34 9.33 566 150993 98788 53098719
Pancreatitis 108.68 9.33 333 151226 45809 53151698
Device malfunction 105.82 9.33 174 151385 15734 53181773
Sinusitis 105.38 9.33 199 151360 168365 53029142
Discomfort 105.20 9.33 71 151488 95401 53102106
Musculoskeletal stiffness 104.20 9.33 118 151441 123250 53074257
Nasopharyngitis 103.53 9.33 247 151312 192048 53005459
Incorrect dose administered by device 100.17 9.33 82 151477 3457 53194050
Therapeutic product effect incomplete 98.81 9.33 70 151489 91714 53105793
Rheumatoid factor positive 96.32 9.33 5 151554 41193 53156314
Wrong product administered 91.58 9.33 99 151460 5949 53191558
Diabetic neuropathy 90.96 9.33 82 151477 3945 53193562
Accidental underdose 89.15 9.33 42 151517 640 53196867
Arthralgia 88.99 9.33 810 150749 438973 52758534
Insulin resistance 83.94 9.33 42 151517 735 53196772
Device issue 80.24 9.33 185 151374 21473 53176034
Premature delivery 79.71 9.33 207 151352 25897 53171610
Dehydration 79.49 9.33 779 150780 167631 53029876
Therapeutic product effect decreased 77.06 9.33 150 151409 125505 53072002
Pharyngitis 76.89 9.33 168 151391 18812 53178695
Hypoglycaemic seizure 76.62 9.33 35 151524 495 53197012
Type 1 diabetes mellitus 75.72 9.33 68 151491 3255 53194252
Hypoglycaemia unawareness 74.59 9.33 23 151536 95 53197412
Pancreatic carcinoma 73.97 9.33 95 151464 6859 53190648
Metabolic acidosis 73.96 9.33 276 151283 41966 53155541
Hypersensitivity 72.87 9.33 329 151230 210336 52987171
Product administration error 72.28 9.33 177 151382 21354 53176153
Toothache 71.93 9.33 158 151401 17756 53179751
Hepatic enzyme increased 69.55 9.33 160 151399 126035 53071472
Stomatitis 69.46 9.33 107 151452 98051 53099456
Gangrene 68.94 9.33 77 151482 4800 53192707
Anti-insulin antibody positive 68.25 9.33 21 151538 86 53197421
Folliculitis 67.85 9.33 6 151553 31703 53165804
Incorrect dose administered 67.61 9.33 306 151253 50739 53146768
Inappropriate schedule of product administration 67.34 9.33 403 151156 74475 53123032
Blindness 67.02 9.33 158 151401 18605 53178902
Gait inability 65.97 9.33 249 151310 38062 53159445
Coronary artery disease 65.80 9.33 227 151332 33210 53164297
Irritable bowel syndrome 63.95 9.33 22 151537 43610 53153897
Febrile neutropenia 63.70 9.33 126 151433 104810 53092697
Loss of consciousness 63.31 9.33 547 151012 113665 53083842
Chronic kidney disease 60.46 9.33 264 151295 43106 53154401
Gestational diabetes 60.44 9.33 93 151466 7946 53189561
Wound 59.94 9.33 105 151454 91452 53106055
Off label use 58.76 9.33 966 150593 471246 52726261
White blood cell count decreased 58.49 9.33 171 151388 124304 53073203
Muscle injury 57.72 9.33 8 151551 29758 53167749
Diabetic complication 56.85 9.33 35 151524 931 53196576
Hypoglycaemic encephalopathy 56.73 9.33 24 151535 279 53197228
Renal impairment 56.52 9.33 418 151141 82900 53114607
Hyperinsulinaemic hypoglycaemia 56.32 9.33 16 151543 46 53197461
Wrong technique in device usage process 55.15 9.33 51 151508 2536 53194971
Ketosis 53.80 9.33 28 151531 534 53196973
Diabetic nephropathy 52.15 9.33 39 151520 1438 53196069
Helicobacter infection 51.82 9.33 23 151536 39046 53158461
Vitreous haemorrhage 51.44 9.33 43 151516 1867 53195640
Loss of personal independence in daily activities 51.43 9.33 74 151485 69741 53127766
Rhabdomyolysis 51.37 9.33 254 151305 43669 53153838
Migraine 50.16 9.33 95 151464 80322 53117185
Device expulsion 49.26 9.33 12 151547 29801 53167706
Infection 48.76 9.33 288 151271 171917 53025590
Diabetic coma 48.30 9.33 30 151529 811 53196696
Drug abuse 47.73 9.33 70 151489 65456 53132051
Foetal exposure during pregnancy 47.38 9.33 210 151349 34505 53163002
Shock 46.32 9.33 158 151401 22981 53174526
Visual acuity reduced 46.31 9.33 155 151404 22330 53175177
C-reactive protein abnormal 45.61 9.33 9 151550 25861 53171646
Hypoglycaemia neonatal 45.35 9.33 31 151528 990 53196517
Drug administered in wrong device 44.96 9.33 12 151547 25 53197482
Peripheral swelling 44.48 9.33 373 151186 205735 52991772
Pancreatitis acute 44.37 9.33 169 151390 25940 53171567
Hyperglycaemic hyperosmolar nonketotic syndrome 44.32 9.33 26 151533 632 53196875
Blood creatinine increased 44.29 9.33 393 151166 82269 53115238
Emphysematous pyelonephritis 43.92 9.33 18 151541 192 53197315
Anuria 43.61 9.33 104 151455 12336 53185171
Glycosylated haemoglobin abnormal 42.35 9.33 15 151544 103 53197404
Cardiac arrest 42.07 9.33 429 151130 93238 53104269
Product quality issue 41.81 9.33 212 151347 36811 53160696
Arterial occlusive disease 41.65 9.33 61 151498 4988 53192519
Blood ketone body increased 40.90 9.33 19 151540 280 53197227
Increased insulin requirement 40.32 9.33 13 151546 64 53197443
Hip arthroplasty 39.22 9.33 15 151544 27847 53169660
Neutropenia 39.06 9.33 278 151281 158907 53038600
Diabetic foot 38.84 9.33 35 151524 1683 53195824
Diabetic gastroparesis 38.63 9.33 17 151542 219 53197288
Psoriatic arthropathy 38.62 9.33 48 151511 48142 53149365
Premature baby 38.58 9.33 134 151425 19667 53177840
Renal injury 38.23 9.33 86 151473 9818 53187689
Intestinal malrotation 38.12 9.33 20 151539 388 53197119
Dialysis 37.93 9.33 88 151471 10254 53187253
Intentional product use issue 37.48 9.33 95 151464 72399 53125108
Fear 37.23 9.33 118 151441 16523 53180984
Sopor 37.10 9.33 138 151421 20946 53176561
Multiple organ dysfunction syndrome 35.87 9.33 276 151283 55401 53142106
Pre-eclampsia 35.55 9.33 77 151482 8570 53188937
Insomnia 35.37 9.33 350 151209 186722 53010785
Non-cardiogenic pulmonary oedema 35.28 9.33 22 151537 599 53196908
Malignant neoplasm progression 35.27 9.33 96 151463 71445 53126062
Acute myocardial infarction 35.24 9.33 187 151372 33048 53164459
Cataract 34.24 9.33 250 151309 49370 53148137
Large for dates baby 33.63 9.33 20 151539 499 53197008
Treatment noncompliance 33.08 9.33 183 151376 32852 53164655
Ill-defined disorder 32.99 9.33 56 151503 49388 53148119
Pulmonary oedema 32.79 9.33 263 151296 53460 53144047
Asthma 32.57 9.33 179 151380 108793 53088714
Angina unstable 32.43 9.33 68 151491 7400 53190107
Diabetic ketoacidotic hyperglycaemic coma 32.31 9.33 11 151548 66 53197441
Conjoined twins 32.08 9.33 16 151543 278 53197229
Pemphigoid 31.95 9.33 62 151497 6382 53191125
Ketonuria 31.56 9.33 19 151540 485 53197022
Congenital bladder anomaly 31.36 9.33 14 151545 187 53197320
Disease progression 31.25 9.33 166 151393 101754 53095753
Injury associated with device 31.22 9.33 42 151517 3173 53194334
Drug dose omission by device 30.83 9.33 37 151522 2492 53195015
Anti-insulin antibody increased 30.41 9.33 10 151549 53 53197454
Product dispensing error 30.03 9.33 80 151479 10160 53187347
Glycosuria 29.68 9.33 26 151533 1204 53196303
Diabetic hyperglycaemic coma 29.62 9.33 9 151550 35 53197472
Generalised oedema 29.26 9.33 102 151457 14997 53182510
Retinopathy 29.26 9.33 38 151521 2774 53194733
Crystal nephropathy 28.77 9.33 22 151537 839 53196668
Pyrexia 28.60 9.33 900 150659 402293 52795214
Underdose 28.47 9.33 129 151430 21393 53176114
Product complaint 28.42 9.33 88 151471 12169 53185338
Musculoskeletal pain 28.07 9.33 114 151445 75086 53122421
Urachal abnormality 27.96 9.33 13 151546 192 53197315
Caesarean section 27.71 9.33 110 151449 17210 53180297
Eye haemorrhage 27.48 9.33 65 151494 7669 53189838
Renal tubular necrosis 27.42 9.33 83 151476 11336 53186171
Oropharyngeal pain 27.41 9.33 128 151431 81140 53116367
Gastrooesophageal reflux disease 27.41 9.33 131 151428 82532 53114975
Shock hypoglycaemic 27.38 9.33 11 151548 111 53197396
Bursitis 27.17 9.33 15 151544 22477 53175030
Cardiogenic shock 27.15 9.33 110 151449 17372 53180135
Headache 27.10 9.33 1248 150311 535573 52661934
Persistent cloaca 26.91 9.33 13 151546 210 53197297
Injection site haemorrhage 26.84 9.33 129 151430 21922 53175585
Left ventricular hypertrophy 26.81 9.33 51 151508 5172 53192335
Low birth weight baby 26.70 9.33 57 151502 6280 53191227
Mental status changes 26.52 9.33 198 151361 39373 53158134
Respiratory failure 26.52 9.33 417 151142 100095 53097412
Haemodialysis 26.10 9.33 72 151487 9332 53188175
Back pain 25.90 9.33 489 151070 233758 52963749
Device interaction 25.60 9.33 13 151546 235 53197272
Cardiac failure 25.31 9.33 363 151196 85481 53112026
C-reactive protein increased 25.28 9.33 103 151456 67783 53129724
Diabetic ketosis 24.78 9.33 12 151547 195 53197312
Adenocarcinoma pancreas 24.73 9.33 23 151536 1152 53196355
Polyhydramnios 24.62 9.33 31 151528 2194 53195313
Polyuria 24.42 9.33 63 151496 7848 53189659
Sprue-like enteropathy 24.37 9.33 16 151543 477 53197030
Knee arthroplasty 24.31 9.33 36 151523 33533 53163974
Product use in unapproved indication 24.29 9.33 203 151356 112086 53085421
Visual impairment 24.22 9.33 315 151244 72597 53124910
Retinal haemorrhage 24.22 9.33 48 151511 5017 53192490
Wrong technique in product usage process 24.16 9.33 269 151290 59763 53137744
Sleep disorder 24.07 9.33 86 151473 58784 53138723
Night sweats 23.85 9.33 39 151520 34908 53162599
Peritonitis bacterial 23.69 9.33 70 151489 9435 53188072
Erythrodermic psoriasis 23.67 9.33 21 151538 989 53196518
Injection site pain 23.63 9.33 453 151106 112938 53084569
Respiratory tract malformation 23.60 9.33 9 151550 78 53197429
Bone pain 23.58 9.33 70 151489 50652 53146855
Angina pectoris 23.55 9.33 151 151408 28574 53168933
Impaired healing 23.54 9.33 98 151461 64107 53133400
Flushing 23.34 9.33 112 151447 70488 53127019
Device use issue 23.07 9.33 28 151531 1908 53195599
Body temperature increased 22.95 9.33 36 151523 32763 53164744
Impaired gastric emptying 22.92 9.33 67 151492 8976 53188531
Blood potassium increased 22.90 9.33 106 151453 17735 53179772
Muscle spasticity 22.88 9.33 11 151548 17827 53179680
Heparin-induced thrombocytopenia 22.83 9.33 44 151515 4505 53193002
Heart injury 22.70 9.33 22 151537 1161 53196346
Myocardial ischaemia 22.54 9.33 84 151475 12760 53184747
Neonatal seizure 22.52 9.33 14 151545 379 53197128
Blood insulin increased 22.37 9.33 10 151549 134 53197373
Anti-insulin antibody 22.31 9.33 7 151552 31 53197476
Urosepsis 22.30 9.33 100 151459 16510 53180997
Glomerular filtration rate decreased 21.99 9.33 83 151476 12684 53184823
Neutrophil count decreased 21.93 9.33 69 151490 49029 53148478
Device dislocation 21.67 9.33 21 151538 23576 53173931
Urinary tract infection 21.66 9.33 860 150699 239043 52958464
Coronary artery occlusion 21.58 9.33 62 151497 8225 53189282
Blood urea increased 21.57 9.33 138 151421 26093 53171414
Bone density decreased 21.39 9.33 3 151556 11061 53186446
Herpes zoster 21.35 9.33 123 151436 73896 53123611
Fibromyalgia 21.09 9.33 60 151499 44015 53153492
Limb malformation 20.64 9.33 15 151544 529 53196978
Glucose urine present 20.62 9.33 17 151542 724 53196783
Cough 20.54 9.33 564 150995 256329 52941178
Glycosylated haemoglobin decreased 20.47 9.33 15 151544 536 53196971
Caudal regression syndrome 20.46 9.33 10 151549 166 53197341
Transient tachypnoea of the newborn 20.38 9.33 9 151550 117 53197390
Ear pain 20.36 9.33 33 151526 29640 53167867
Oedema peripheral 20.33 9.33 632 150927 170155 53027352
Anaemia 20.32 9.33 971 150588 275747 52921760
Oliguria 20.20 9.33 65 151494 9173 53188334
Toe amputation 20.13 9.33 27 151532 2034 53195473
Multiple sclerosis relapse 20.06 9.33 63 151496 44790 53152717
Multiple use of single-use product 20.05 9.33 16 151543 650 53196857
Unresponsive to stimuli 20.04 9.33 163 151396 33263 53164244
Blood ketone body present 20.02 9.33 6 151553 22 53197485
Insulin C-peptide decreased 20.02 9.33 6 151553 22 53197485
Upper respiratory tract infection 19.83 9.33 115 151444 68982 53128525
Mobility decreased 19.78 9.33 131 151428 76140 53121367
Bradycardia neonatal 19.62 9.33 18 151541 886 53196621
Blood ketone body 19.53 9.33 7 151552 50 53197457
Red blood cell sedimentation rate increased 19.44 9.33 31 151528 28026 53169481
Perinephric abscess 19.44 9.33 10 151549 186 53197321
Intentional self-injury 19.42 9.33 26 151533 25258 53172249
Retinopathy proliferative 19.41 9.33 7 151552 51 53197456
Distributive shock 19.38 9.33 18 151541 900 53196607
Device leakage 19.37 9.33 49 151510 6031 53191476
Ischaemic cardiomyopathy 19.37 9.33 30 151529 2578 53194929
Constipation 19.29 9.33 423 151136 197989 52999518
Pulmonary embolism 19.23 9.33 220 151339 114222 53083285
Rheumatoid nodule 19.17 9.33 5 151554 11859 53185648
Blindness unilateral 19.13 9.33 47 151512 5680 53191827
Colitis ulcerative 19.04 9.33 19 151540 21042 53176465
Vomiting 19.00 9.33 1649 149910 495490 52702017
Cholestasis 18.90 9.33 143 151416 28552 53168955
Gastrointestinal tract mucosal pigmentation 18.47 9.33 15 151544 625 53196882
Urine ketone body present 18.43 9.33 28 151531 2366 53195141
Injection site erythema 18.40 9.33 136 151423 77113 53120394
Hepatic cirrhosis 18.15 9.33 100 151459 17922 53179585
Drug interaction 18.14 9.33 779 150780 218550 52978957
Blister 18.12 9.33 140 151419 78613 53118894
Pancreatic neoplasm 18.10 9.33 16 151543 750 53196757
Infected dermal cyst 18.00 9.33 13 151546 454 53197053
Blood pressure fluctuation 17.93 9.33 47 151512 35423 53162084
Acne 17.82 9.33 21 151538 21565 53175942
Pyelonephritis 17.78 9.33 93 151466 16344 53181163
Microphthalmos 17.76 9.33 9 151550 162 53197345
Heavy menstrual bleeding 17.73 9.33 14 151545 17362 53180145
Apgar score abnormal 17.70 9.33 5 151554 14 53197493
Pancreatic carcinoma metastatic 17.56 9.33 28 151531 2466 53195041
Product dose omission issue 17.54 9.33 688 150871 190932 53006575
Medication error 17.50 9.33 169 151390 36196 53161311
Congenital musculoskeletal anomaly 17.41 9.33 13 151546 478 53197029
Retinal coloboma 17.35 9.33 6 151553 38 53197469
Infusion site pain 17.28 9.33 6 151553 11827 53185680
Dawn phenomenon 17.24 9.33 4 151555 3 53197504
Anhedonia 17.20 9.33 68 151491 10619 53186888
Leukopenia 17.18 9.33 130 151429 73333 53124174
Infective pulmonary exacerbation of cystic fibrosis 17.17 9.33 70 151489 11086 53186421
Neck pain 17.16 9.33 100 151459 59916 53137591
Oral herpes 17.07 9.33 21 151538 21158 53176349
Polydipsia 16.93 9.33 33 151526 3407 53194100
Facial nerve disorder 16.92 9.33 14 151545 599 53196908
Osteoarthritis 16.84 9.33 124 151435 70362 53127145
Diabetic gangrene 16.75 9.33 5 151554 18 53197489
Dry eye 16.69 9.33 45 151514 33599 53163908
Immunodeficiency 16.65 9.33 11 151548 14956 53182551
Pain in extremity 16.57 9.33 652 150907 284398 52913109
Pulmonary artery stenosis 16.52 9.33 9 151550 189 53197318
Foot deformity 16.50 9.33 17 151542 18551 53178956
Tenosynovitis 16.42 9.33 4 151555 9935 53187572
Peripheral vascular disorder 16.20 9.33 46 151513 6062 53191445
Pancreatic failure 16.16 9.33 16 151543 867 53196640
Sepsis 16.16 9.33 537 151022 145892 53051615
Diet failure 16.15 9.33 6 151553 48 53197459
Product odour abnormal 16.15 9.33 19 151540 1253 53196254
Vitrectomy 16.04 9.33 8 151551 139 53197368
Neutropenic sepsis 15.98 9.33 11 151548 14638 53182869
Iris coloboma 15.94 9.33 6 151553 50 53197457
Microalbuminuria 15.93 9.33 11 151548 357 53197150
Gastrointestinal disorder 15.92 9.33 171 151388 89833 53107674
Metabolic syndrome 15.90 9.33 20 151539 1414 53196093
Bone erosion 15.70 9.33 6 151553 11146 53186361
Diabetic microangiopathy 15.61 9.33 5 151554 24 53197483
Acidosis 15.61 9.33 69 151490 11323 53186184
Epileptic encephalopathy 15.45 9.33 10 151549 291 53197216
Anxiety 15.42 9.33 433 151126 196271 53001236
Cognitive disorder 15.41 9.33 70 151489 44708 53152799
Expired product administered 15.34 9.33 44 151515 5832 53191675
Hypertriglyceridaemia 15.31 9.33 46 151513 6258 53191249
Blood triglycerides increased 15.30 9.33 73 151486 12368 53185139
Diabetic foot infection 15.30 9.33 9 151550 220 53197287
Basal cell carcinoma 15.27 9.33 27 151532 23442 53174065
Arteriosclerosis 15.21 9.33 63 151496 10048 53187459
Patella fracture 15.18 9.33 23 151536 1939 53195568
Cutaneous amyloidosis 15.09 9.33 4 151555 8 53197499
Hyperbilirubinaemia neonatal 15.06 9.33 11 151548 391 53197116
Psychotic disorder 15.03 9.33 29 151530 24356 53173151
Systemic infection 14.99 9.33 24 151535 2121 53195386
Oesophageal carcinoma recurrent 14.98 9.33 5 151554 28 53197479
End stage renal disease 14.95 9.33 45 151514 6126 53191381
Fall 14.94 9.33 1197 150362 357243 52840264
Renal dysplasia 14.85 9.33 8 151551 164 53197343
Anti-GAD antibody positive 14.83 9.33 5 151554 29 53197478
Completed suicide 14.80 9.33 290 151269 137911 53059596
Foetal hypokinesia 14.76 9.33 12 151547 501 53197006
Neuropathic arthropathy 14.73 9.33 9 151550 236 53197271
Peripheral artery haematoma 14.72 9.33 6 151553 63 53197444
Liquid product physical issue 14.65 9.33 14 151545 726 53196781
Foot amputation 14.64 9.33 10 151549 319 53197188
Product contamination with body fluid 14.60 9.33 3 151556 0 53197507
Cataract diabetic 14.60 9.33 3 151556 0 53197507
Somogyi phenomenon 14.60 9.33 3 151556 0 53197507
Influenza like illness 14.56 9.33 107 151452 60752 53136755
Foetal macrosomia 14.48 9.33 6 151553 66 53197441
Neonatal respiratory distress syndrome 14.31 9.33 28 151531 2899 53194608
Urticaria 14.29 9.33 286 151273 135599 53061908
Tinnitus 14.27 9.33 42 151517 30477 53167030
Injection site reaction 14.23 9.33 86 151473 51080 53146427
Hypothermia 14.21 9.33 74 151485 12982 53184525
Neoplasm progression 14.11 9.33 41 151518 29878 53167629
Osteoporosis 14.05 9.33 76 151483 46384 53151123
BRASH syndrome 13.92 9.33 8 151551 187 53197320
Hospitalisation 13.88 9.33 281 151278 70731 53126776
Retinal detachment 13.84 9.33 41 151518 5534 53191973
Neonatal tachypnoea 13.80 9.33 6 151553 75 53197432
Hyperosmolar state 13.72 9.33 9 151550 268 53197239
Blood glucose normal 13.72 9.33 4 151555 13 53197494
Dementia 13.70 9.33 88 151471 16662 53180845
Lung cyst 13.62 9.33 7 151552 130 53197377
Diabetic hyperosmolar coma 13.62 9.33 11 151548 455 53197052
Cardiac disorder 13.60 9.33 198 151361 46768 53150739
Nasal congestion 13.58 9.33 92 151467 53195 53144312
Radiation fibrosis 13.46 9.33 5 151554 40 53197467
Asthenia 13.45 9.33 1142 150417 342448 52855059
Acute coronary syndrome 13.43 9.33 62 151497 10362 53187145
Atrioventricular block first degree 13.41 9.33 45 151514 6490 53191017
Pyelonephritis fungal 13.38 9.33 7 151552 135 53197372
Cold sweat 13.32 9.33 67 151492 11595 53185912
Hot flush 13.26 9.33 79 151480 47081 53150426
Hyperlactacidaemia 13.24 9.33 26 151533 2699 53194808
Paraesthesia 13.22 9.33 269 151290 127246 53070261
Joint stiffness 13.22 9.33 43 151516 30240 53167267
Gastrointestinal haemorrhage 13.19 9.33 310 151249 80020 53117487
Vitamin B12 deficiency 13.18 9.33 34 151525 4235 53193272
Foetal exposure timing unspecified 13.16 9.33 8 151551 208 53197299
Vasoplegia syndrome 13.15 9.33 17 151542 1235 53196272
Dermatitis papillaris capillitii 13.07 9.33 4 151555 16 53197491
Blood triglycerides abnormal 13.07 9.33 9 151550 291 53197216
Encephalopathy 13.06 9.33 161 151398 36647 53160860
Eyelid bleeding 13.05 9.33 5 151554 44 53197463
Osteopenia 12.98 9.33 20 151539 18335 53179172
Multiple sclerosis 12.96 9.33 37 151522 27116 53170391
Pulmonary renal syndrome 12.84 9.33 10 151549 392 53197115
General physical health deterioration 12.84 9.33 525 151034 146417 53051090
Vascular calcification 12.82 9.33 13 151546 725 53196782
Macular oedema 12.68 9.33 33 151526 4132 53193375
Intestinal transit time abnormal 12.64 9.33 6 151553 93 53197414
Large intestine polyp 12.61 9.33 51 151508 8046 53189461
Diabetic hepatopathy 12.53 9.33 3 151556 3 53197504
Fructosamine increased 12.53 9.33 3 151556 3 53197504
Pulmonary malformation 12.51 9.33 7 151552 155 53197352
Influenza 12.50 9.33 193 151366 95186 53102321
Candida sepsis 12.42 9.33 18 151541 1458 53196049
Choroidal effusion 12.38 9.33 11 151548 519 53196988
Electrolyte imbalance 12.37 9.33 94 151465 18790 53178717
Amputation 12.36 9.33 7 151552 159 53197348
Fluid overload 12.26 9.33 127 151432 27704 53169803
Gestational hypertension 12.25 9.33 23 151536 2310 53195197
Injection site nodule 12.22 9.33 29 151530 3428 53194079
Thirst 12.20 9.33 65 151494 11501 53186006
Groin abscess 12.19 9.33 14 151545 900 53196607
Tachypnoea 12.18 9.33 82 151477 15772 53181735
International normalised ratio increased 12.15 9.33 197 151362 47564 53149943
Hyperinsulinaemia 12.15 9.33 6 151553 102 53197405
Myositis 12.09 9.33 52 151507 8431 53189076
Ankylosing spondylitis 12.07 9.33 4 151555 8121 53189386
Fracture blisters 12.06 9.33 5 151554 55 53197452
Pulse pressure decreased 12.05 9.33 8 151551 243 53197264
Retroperitoneal oedema 12.04 9.33 4 151555 22 53197485
Leg amputation 12.02 9.33 22 151537 2167 53195340
Respiratory tract infection 12.00 9.33 51 151508 33173 53164334
Rhinorrhoea 11.97 9.33 96 151463 53482 53144025
Electrocardiogram U wave present 11.94 9.33 6 151553 106 53197401
Diabetic eye disease 11.83 9.33 7 151552 173 53197334
Tricuspid valve disease 11.83 9.33 8 151551 251 53197256
Urinary tract infection fungal 11.81 9.33 12 151547 671 53196836
Oral pain 11.79 9.33 38 151521 26799 53170708
Nephrogenic systemic fibrosis 11.78 9.33 35 151524 4732 53192775
Pulseless electrical activity 11.65 9.33 47 151512 7407 53190100
Phaeochromocytoma 11.63 9.33 11 151548 563 53196944
Gastrointestinal carcinoma 11.59 9.33 17 151542 1392 53196115
Urinary tract obstruction 11.59 9.33 20 151539 1881 53195626
Device delivery system issue 11.56 9.33 11 151548 567 53196940
Mood swings 11.48 9.33 20 151539 17466 53180041
Fasting 11.48 9.33 4 151555 26 53197481
Ulcer 11.46 9.33 26 151533 20593 53176914
Therapy non-responder 11.45 9.33 87 151472 49033 53148474
Pulmonary fibrosis 11.44 9.33 33 151526 24102 53173405
Accidental overdose 11.43 9.33 102 151457 21377 53176130
Dry mouth 11.41 9.33 111 151448 59439 53138068
Pancreatic pseudocyst 11.39 9.33 11 151548 578 53196929
Maternal exposure during breast feeding 11.37 9.33 28 151531 3389 53194118
Panniculitis 11.35 9.33 4 151555 7810 53189697
Transient ischaemic attack 11.30 9.33 153 151406 35572 53161935
Sweat gland tumour 11.23 9.33 6 151553 121 53197386
Poor quality sleep 11.21 9.33 20 151539 17303 53180204
Drug dependence 11.20 9.33 28 151531 21444 53176063
Foetal arrhythmia 11.18 9.33 7 151552 192 53197315
Tumour rupture 11.05 9.33 6 151553 125 53197382
Breath sounds 11.05 9.33 6 151553 125 53197382
Tracheobronchitis 11.04 9.33 15 151544 1144 53196363
Pain in jaw 10.98 9.33 69 151490 40600 53156907
International normalised ratio abnormal 10.97 9.33 26 151533 3071 53194436
Blood cholesterol increased 10.92 9.33 97 151462 52892 53144615
Ventricular septal defect 10.81 9.33 32 151527 4318 53193189
Hyperhidrosis 10.68 9.33 355 151204 96438 53101069
Gout 10.67 9.33 66 151493 12333 53185174
Hyperleukocytosis 10.67 9.33 10 151549 506 53197001
Necrobiosis lipoidica diabeticorum 10.66 9.33 4 151555 33 53197474
Hip fracture 10.64 9.33 125 151434 28132 53169375
Pancreatic cyst 10.60 9.33 16 151543 1344 53196163
Product contamination physical 10.57 9.33 5 151554 77 53197430
Cortisol increased 10.55 9.33 9 151550 402 53197105
Cerebral calcification 10.54 9.33 7 151552 213 53197294
Open angle glaucoma 10.53 9.33 8 151551 302 53197205
Pneumocystis jirovecii pneumonia 10.51 9.33 19 151540 16359 53181148
Umbilical hernia, obstructive 10.47 9.33 3 151556 9 53197498
High density lipoprotein decreased 10.42 9.33 19 151540 1866 53195641
Dystonia 10.40 9.33 13 151546 13008 53184499
Cytotoxic oedema 10.37 9.33 6 151553 142 53197365
Glucose-6-phosphate dehydrogenase deficiency 10.37 9.33 7 151552 219 53197288
Complications of transplanted liver 10.36 9.33 9 151550 412 53197095
Acute respiratory failure 10.36 9.33 135 151424 31123 53166384
Brain malformation 10.34 9.33 5 151554 81 53197426
CSF pressure increased 10.33 9.33 6 151553 143 53197364
Kidney malformation 10.28 9.33 5 151554 82 53197425
Adverse drug reaction 10.26 9.33 100 151459 53525 53143982
Blood count abnormal 10.21 9.33 27 151532 20288 53177219
Thrombotic microangiopathy 10.20 9.33 7 151552 9330 53188177
Depressed level of consciousness 10.18 9.33 214 151345 54214 53143293
Premature rupture of membranes 10.12 9.33 34 151525 4906 53192601
Azotaemia 10.09 9.33 32 151527 4481 53193026
Hypoperfusion 10.08 9.33 16 151543 1404 53196103
Binge eating 10.07 9.33 9 151550 428 53197079
Immobilisation prolonged 10.07 9.33 5 151554 86 53197421
Rash erythematous 10.07 9.33 64 151495 37559 53159948
Vascular graft 10.06 9.33 12 151547 803 53196704
Oligohydramnios 10.05 9.33 39 151520 6037 53191470
Rabbit syndrome 10.01 9.33 8 151551 326 53197181
Nonreassuring foetal heart rate pattern 9.99 9.33 4 151555 40 53197467
Blood insulin abnormal 9.99 9.33 4 151555 40 53197467
Nephropathy 9.99 9.33 36 151523 5381 53192126
Contusion 9.93 9.33 239 151320 110493 53087014
Body mass index increased 9.93 9.33 14 151545 1106 53196401
Inflammation 9.92 9.33 109 151450 57027 53140480
Psoriasis 9.85 9.33 181 151378 86908 53110599
Megacolon 9.85 9.33 19 151540 1947 53195560
Tumour compression 9.82 9.33 4 151555 42 53197465
Dysstasia 9.81 9.33 90 151469 19009 53178498
Fibrodysplasia ossificans progressiva 9.81 9.33 3 151556 12 53197495
Haemophagocytic lymphohistiocytosis 9.79 9.33 7 151552 9130 53188377
Dry skin 9.77 9.33 83 151476 45677 53151830
Injection site swelling 9.70 9.33 76 151483 42552 53154955
Emphysematous cystitis 9.70 9.33 6 151553 161 53197346
Joint range of motion decreased 9.69 9.33 23 151536 17933 53179574
Weight decreased 9.67 9.33 784 150775 234164 52963343
Labelled drug-food interaction issue 9.61 9.33 3 151556 13 53197494
Cerebral vascular occlusion 9.61 9.33 3 151556 13 53197494
Blood parathyroid hormone decreased 9.58 9.33 3 151556 6315 53191192
Bacterial pyelonephritis 9.58 9.33 8 151551 347 53197160
Leukocytosis 9.57 9.33 110 151449 24624 53172883
Liver function test increased 9.54 9.33 41 151518 26587 53170920
Catheter site haematoma 9.54 9.33 6 151553 166 53197341
Diverticulitis 9.53 9.33 61 151498 35740 53161767
Metastases to bone 9.48 9.33 26 151533 19302 53178205
Adverse reaction 9.47 9.33 7 151552 8980 53188527
Factor VIII deficiency 9.44 9.33 3 151556 14 53197493
Injection site warmth 9.42 9.33 16 151543 14112 53183395
Osteonecrosis of jaw 9.41 9.33 62 151497 36084 53161423
Status epilepticus 9.41 9.33 18 151541 15166 53182341
Therapeutic response decreased 9.40 9.33 88 151471 47481 53150026
Hepatic steatosis 9.38 9.33 115 151444 26144 53171363
Blood creatinine abnormal 9.35 9.33 23 151536 2781 53194726
Ventricular fibrillation 9.35 9.33 62 151497 11863 53185644
Necrotising fasciitis 9.34 9.33 23 151536 2784 53194723

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
Hypoglycaemia 2910.43 10.24 2232 147766 52150 32311378
Blood glucose increased 2182.68 10.24 2044 147954 63197 32300331
Diabetic ketoacidosis 983.19 10.24 748 149250 17184 32346344
Blood glucose decreased 887.48 10.24 629 149369 12905 32350623
Diabetes mellitus inadequate control 764.99 10.24 579 149419 13189 32350339
Hyperglycaemia 724.04 10.24 889 149109 37502 32326026
Glycosylated haemoglobin increased 490.68 10.24 397 149601 9992 32353536
Device operational issue 474.51 10.24 115 149883 34 32363494
Blood glucose abnormal 369.16 10.24 261 149737 5327 32358201
Blood glucose fluctuation 348.34 10.24 222 149776 3787 32359741
Hypoglycaemic coma 281.14 10.24 162 149836 2281 32361247
Ketoacidosis 237.58 10.24 178 149820 3986 32359542
Drug abuse 206.88 10.24 57 149941 80186 32283342
Product storage error 203.76 10.24 206 149792 6972 32356556
Diabetic retinopathy 198.29 10.24 117 149881 1726 32361802
Hypoglycaemic unconsciousness 153.57 10.24 76 149922 770 32362758
Diabetic neuropathy 151.51 10.24 137 149861 4023 32359505
Diabetes mellitus 145.38 10.24 499 149499 44674 32318854
Diabetic metabolic decompensation 136.94 10.24 87 149911 1475 32362053
Lactic acidosis 132.02 10.24 397 149601 33139 32330389
Acute kidney injury 130.93 10.24 1988 148010 291480 32072048
Hyperkalaemia 128.45 10.24 649 149349 69101 32294427
Diabetic foot 128.04 10.24 107 149891 2819 32360709
Febrile neutropenia 118.15 10.24 233 149765 119333 32244195
Hypoglycaemic seizure 107.62 10.24 45 149953 295 32363233
Wrong product administered 100.60 10.24 120 149878 4900 32358628
Inappropriate schedule of product administration 97.80 10.24 445 149553 45380 32318148
Insulin resistance 95.13 10.24 49 149949 544 32362984
Off label use 85.82 10.24 952 149046 305368 32058160
Neutropenia 85.76 10.24 351 149647 141824 32221704
Myocardial infarction 85.41 10.24 921 149077 124755 32238773
Pancreatic carcinoma 84.99 10.24 144 149854 8162 32355366
Toxicity to various agents 83.91 10.24 480 149518 177561 32185967
Drug ineffective 83.77 10.24 1256 148742 382221 31981307
Device issue 80.17 10.24 146 149852 8766 32354762
Euglycaemic diabetic ketoacidosis 78.86 10.24 80 149918 2718 32360810
Anti-insulin antibody positive 76.84 10.24 31 149967 183 32363345
Device malfunction 76.20 10.24 144 149854 8895 32354633
Death 75.76 10.24 1276 148722 381241 31982287
Toe amputation 74.45 10.24 72 149926 2306 32361222
Rheumatoid arthritis 74.20 10.24 58 149940 44486 32319042
Wrong technique in device usage process 72.22 10.24 54 149944 1205 32362323
Cutaneous amyloidosis 72.01 10.24 20 149978 24 32363504
Renal failure 70.91 10.24 939 149059 133539 32229989
Increased insulin requirement 70.38 10.24 24 149974 80 32363448
Product use in unapproved indication 68.43 10.24 192 149806 87012 32276516
Hypoglycaemia unawareness 66.53 10.24 25 149973 118 32363410
Incorrect dose administered 65.88 10.24 328 149670 34700 32328828
Completed suicide 62.50 10.24 218 149780 92299 32271229
Diabetic nephropathy 59.52 10.24 61 149937 2098 32361430
Pyrexia 59.20 10.24 1080 148918 318888 32044640
White blood cell count decreased 58.23 10.24 220 149778 90978 32272550
Hypoglycaemia neonatal 57.82 10.24 54 149944 1654 32361874
Cardiac failure congestive 54.45 10.24 615 149383 84237 32279291
Nasopharyngitis 54.16 10.24 135 149863 63652 32299876
Type 1 diabetes mellitus 54 10.24 79 149919 3944 32359584
Rash 52.55 10.24 666 149332 208667 32154861
Drug administered in wrong device 51.53 10.24 15 149983 24 32363504
Ketonuria 51.47 10.24 34 149964 618 32362910
Product complaint 49.60 10.24 93 149905 5710 32357818
Loss of consciousness 49.30 10.24 591 149407 82116 32281412
Renal injury 47.69 10.24 143 149855 11912 32351616
Pancreatic carcinoma metastatic 47.06 10.24 67 149931 3262 32360266
Blindness 46.64 10.24 150 149848 12976 32350552
Drug resistance 46.33 10.24 24 149974 22941 32340587
Treatment failure 46.27 10.24 68 149930 39095 32324433
Vitreous haemorrhage 46.08 10.24 54 149944 2163 32361365
Incorrect dose administered by device 46.06 10.24 46 149952 1533 32361995
Eye haemorrhage 45.89 10.24 73 149925 3924 32359604
Pneumonia 44.99 10.24 1272 148726 353980 32009548
Cerebrovascular accident 44.72 10.24 601 149397 85719 32277809
Accidental underdose 44.39 10.24 26 149972 378 32363150
Aggression 44.03 10.24 71 149927 39318 32324210
Metabolic acidosis 43.36 10.24 329 149669 40370 32323158
Injury 43.03 10.24 210 149788 22035 32341493
Drug dependence 42.48 10.24 28 149970 23456 32340072
Fear 41.73 10.24 131 149867 11188 32352340
Chronic kidney disease 41.39 10.24 321 149677 39654 32323874
Ketosis 40.91 10.24 26 149972 441 32363087
Insomnia 40.77 10.24 283 149715 100065 32263463
Renal impairment 40.34 10.24 622 149376 91350 32272178
Cardiogenic shock 39.92 10.24 195 149803 20467 32343061
Oedema peripheral 39.64 10.24 743 149255 113348 32250180
Injection site pain 39.10 10.24 274 149724 32784 32330744
Diabetic complication 38.56 10.24 33 149965 899 32362629
Therapeutic product effect incomplete 37.07 10.24 85 149913 41256 32322272
Medication error 36.84 10.24 203 149795 22332 32341196
Diabetic coma 36.74 10.24 32 149966 893 32362635
Leg amputation 36.62 10.24 49 149949 2249 32361279
Emotional distress 36.00 10.24 160 149838 16146 32347382
Gangrene 35.38 10.24 73 149925 4809 32358719
Shock hypoglycaemic 35.29 10.24 15 149983 103 32363425
Multiple use of single-use product 35.25 10.24 16 149982 131 32363397
Stomatitis 35.04 10.24 84 149914 40145 32323383
Coronary artery disease 34.97 10.24 367 149631 49339 32314189
Impaired gastric emptying 34.53 10.24 59 149939 3367 32360161
Product administration error 34.25 10.24 153 149845 15472 32348056
Headache 33.78 10.24 670 149328 195527 32168001
Treatment noncompliance 33.67 10.24 228 149770 26974 32336554
Synovitis 33.66 10.24 5 149993 10873 32352655
Rhabdomyolysis 33.46 10.24 465 149533 66800 32296728
Anhedonia 33.10 10.24 100 149898 8364 32355164
Joint swelling 32.87 10.24 125 149873 51610 32311918
Visual impairment 32.34 10.24 261 149737 32627 32330901
Injury associated with device 32.25 10.24 29 149969 845 32362683
Hypoglycaemic encephalopathy 31.92 10.24 19 149979 285 32363243
Disease progression 31.45 10.24 253 149745 86609 32276919
Drug hypersensitivity 31.30 10.24 204 149794 73196 32290332
Heart injury 31.06 10.24 34 149964 1263 32362265
Retinopathy 30.66 10.24 43 149955 2064 32361464
Mucosal inflammation 30.58 10.24 68 149930 33366 32330162
Immune reconstitution inflammatory syndrome 30.50 10.24 4 149994 9555 32353973
Diabetic ketosis 30.49 10.24 13 149985 90 32363438
Hypothermia 30.22 10.24 109 149889 9994 32353534
Asthma 29.62 10.24 104 149894 43961 32319567
Infusion related reaction 29.08 10.24 110 149888 45489 32318039
Acute myocardial infarction 28.96 10.24 385 149613 54764 32308764
Plasma cell myeloma 28.34 10.24 153 149845 57461 32306067
Sinusitis 28.28 10.24 81 149917 36479 32327049
Product quality issue 28.00 10.24 168 149830 19065 32344463
Drug intolerance 27.80 10.24 128 149870 50107 32313421
Pulmonary embolism 27.45 10.24 250 149748 83409 32280119
Cardiovascular disorder 27.17 10.24 110 149888 10652 32352876
Lower respiratory tract infection 27.13 10.24 59 149939 29184 32334344
Arthralgia 27.04 10.24 502 149496 147946 32215582
Bone marrow failure 26.86 10.24 63 149935 30341 32333187
Myelodysplastic syndrome 26.51 10.24 32 149966 20006 32343522
Hyperglycaemic hyperosmolar nonketotic syndrome 26.41 10.24 29 149969 1081 32362447
Foot amputation 26.06 10.24 21 149977 525 32363003
Plasmapheresis 26.02 10.24 18 149980 354 32363174
Mental status changes 26.00 10.24 281 149717 38056 32325472
Pathogen resistance 25.94 10.24 6 149992 9504 32354024
Intentional self-injury 25.92 10.24 16 149982 13884 32349644
Urine ketone body present 25.90 10.24 29 149969 1105 32362423
Pancreatitis chronic 25.84 10.24 41 149957 2199 32361329
Macular oedema 25.58 10.24 47 149951 2841 32360687
Pancreatitis 25.58 10.24 279 149719 37872 32325656
Neutrophil count decreased 25.56 10.24 121 149877 47018 32316510
Acetonaemia 25.47 10.24 12 149986 108 32363420
Diabetic foot infection 25.30 10.24 23 149975 680 32362848
Skin ulcer 25.09 10.24 173 149825 20586 32342942
Agitation 24.95 10.24 158 149840 57078 32306450
Pancreatitis acute 24.78 10.24 213 149785 27122 32336406
Interstitial lung disease 24.61 10.24 187 149811 64814 32298714
Suture rupture 24.53 10.24 18 149980 390 32363138
Microalbuminuria 24.37 10.24 23 149975 714 32362814
Psychotic disorder 24.34 10.24 43 149955 22977 32340551
Haemophagocytic lymphohistiocytosis 24.15 10.24 11 149987 11324 32352204
Pneumocystis jirovecii pneumonia 24.06 10.24 31 149967 18839 32344689
Decreased insulin requirement 23.88 10.24 6 149992 3 32363525
Cough 23.88 10.24 474 149524 138343 32225185
Blindness transient 23.64 10.24 39 149959 2162 32361366
Localised infection 23.62 10.24 135 149863 15052 32348476
Rhythm idioventricular 23.56 10.24 16 149982 305 32363223
Hyperhidrosis 23.51 10.24 460 149538 70708 32292820
Myopathy 23.33 10.24 109 149889 11232 32352296
Injection site nodule 23.06 10.24 32 149966 1521 32362007
Injection site haemorrhage 23.00 10.24 89 149909 8439 32355089
Diabetic foetopathy 22.96 10.24 14 149984 220 32363308
Polyuria 22.92 10.24 85 149913 7900 32355628
Fatigue 22.86 10.24 1355 148643 349346 32014182
Anti-insulin antibody increased 22.45 10.24 10 149988 78 32363450
Drug reaction with eosinophilia and systemic symptoms 22.28 10.24 76 149922 32409 32331119
Malignant neoplasm progression 22.24 10.24 243 149755 78253 32285275
Amputation 22.04 10.24 20 149978 590 32362938
Arthropathy 22.02 10.24 44 149954 22445 32341083
Platelet count decreased 21.96 10.24 384 149614 114207 32249321
Oedematous pancreatitis 21.87 10.24 18 149980 464 32363064
Neutropenic sepsis 21.83 10.24 16 149982 12683 32350845
Pancytopenia 21.83 10.24 293 149705 90942 32272586
Weight increased 21.33 10.24 521 149477 83142 32280386
Glycosylated haemoglobin decreased 21.32 10.24 16 149982 359 32363169
Herpes zoster 21.28 10.24 77 149921 32264 32331264
Diabetic eye disease 21.27 10.24 9 149989 61 32363467
Progressive multifocal leukoencephalopathy 20.70 10.24 9 149989 9522 32354006
Hallucination 20.57 10.24 150 149848 52469 32311059
Mucormycosis 20.44 10.24 65 149933 5589 32357939
Leukopenia 20.01 10.24 179 149819 59943 32303585
Erythema 19.84 10.24 267 149731 82838 32280690
Myelosuppression 19.69 10.24 15 149983 11661 32351867
Cardiac failure 19.64 10.24 558 149440 91115 32272413
Glycosylated haemoglobin abnormal 19.58 10.24 11 149987 147 32363381
Constipation 19.53 10.24 439 149559 125934 32237594
Mania 19.53 10.24 10 149988 9622 32353906
Upper motor neurone lesion 19.49 10.24 10 149988 110 32363418
Therapeutic product effect decreased 19.02 10.24 76 149922 30941 32332587
Depression 19.00 10.24 324 149674 96736 32266792
Extremity necrosis 18.83 10.24 32 149966 1818 32361710
Adenocarcinoma pancreas 18.81 10.24 28 149970 1420 32362108
Dialysis 18.66 10.24 102 149896 11186 32352342
Large for dates baby 18.43 10.24 22 149976 899 32362629
Osteomyelitis 18.14 10.24 129 149869 15504 32348024
Blood creatinine increased 18.13 10.24 576 149422 95556 32267972
Neuropathy peripheral 18.13 10.24 248 149750 76734 32286794
Foetal disorder 18.12 10.24 20 149978 750 32362778
Visual acuity reduced 18.11 10.24 134 149864 16311 32347217
Periodontitis 18.07 10.24 32 149966 1879 32361649
Device use issue 17.86 10.24 13 149985 278 32363250
Diabetic retinal oedema 17.78 10.24 13 149985 280 32363248
Psoriasis 17.78 10.24 132 149866 45991 32317537
Peripheral vascular disorder 17.61 10.24 59 149939 5213 32358315
Neuropathic arthropathy 17.60 10.24 11 149987 181 32363347
Diabetic bullosis 17.60 10.24 6 149992 20 32363508
Anti-GAD antibody positive 17.60 10.24 6 149992 20 32363508
Alveolar lung disease 17.58 10.24 15 149983 407 32363121
Product name confusion 17.58 10.24 8 149990 66 32363462
Tinnitus 17.54 10.24 33 149965 17216 32346312
Sleep disorder 17.40 10.24 64 149934 26688 32336840
Ventricular hyperkinesia 17.35 10.24 12 149986 236 32363292
Escherichia urinary tract infection 17.31 10.24 44 149954 3328 32360200
Delusion 17.27 10.24 21 149977 13087 32350441
Vitreous floaters 17.16 10.24 44 149954 3346 32360182
Therapeutic drug monitoring analysis not performed 17.11 10.24 16 149982 491 32363037
Foetal arrhythmia 17.09 10.24 9 149989 105 32363423
Therapy non-responder 17.02 10.24 85 149913 32569 32330959
Colitis ulcerative 17.00 10.24 33 149965 17018 32346510
Musculoskeletal stiffness 16.79 10.24 109 149889 39155 32324373
Colitis 16.78 10.24 90 149908 33861 32329667
Hepatic encephalopathy 16.76 10.24 122 149876 14773 32348755
Hot flush 16.74 10.24 29 149969 15617 32347911
Acute myeloid leukaemia 16.72 10.24 40 149958 19134 32344394
Hypersensitivity 16.67 10.24 178 149820 57580 32305948
Influenza 16.65 10.24 134 149864 45880 32317648
Blood insulin increased 16.65 10.24 14 149984 372 32363156
Gallbladder neoplasm 16.56 10.24 6 149992 25 32363503
Haematoma muscle 16.44 10.24 22 149976 1010 32362518
Respiratory arrest 16.39 10.24 73 149925 28835 32334693
Right atrial enlargement 16.35 10.24 12 149986 260 32363268
Bladder cancer 15.84 10.24 91 149907 10165 32353363
Ureteric compression 15.66 10.24 12 149986 278 32363250
Lymphadenopathy 15.59 10.24 68 149930 27014 32336514
Pulmonary interstitial emphysema syndrome 15.54 10.24 15 149983 479 32363049
Acute graft versus host disease 15.53 10.24 5 149993 6365 32357163
Blood triglycerides increased 15.46 10.24 118 149880 14501 32349027
Blood ketone body increased 15.31 10.24 14 149984 417 32363111
Posterior reversible encephalopathy syndrome 15.28 10.24 13 149985 9563 32353965
Hyperosmolar state 15.26 10.24 14 149984 419 32363109
Anaphylactic shock 15.08 10.24 29 149969 15005 32348523
Generalised oedema 15.07 10.24 104 149894 12379 32351149
Psoriatic arthropathy 14.99 10.24 38 149960 17822 32345706
Angina unstable 14.95 10.24 103 149895 12252 32351276
Rhinorrhoea 14.94 10.24 55 149943 22931 32340597
Retinal haemorrhage 14.87 10.24 54 149944 4967 32358561
Eye infection staphylococcal 14.86 10.24 7 149991 63 32363465
Diabetic ulcer 14.84 10.24 9 149989 140 32363388
Intentional product use issue 14.78 10.24 124 149874 42087 32321441
Somogyi phenomenon 14.78 10.24 4 149994 4 32363524
Diabetic gangrene 14.73 10.24 11 149987 245 32363283
Hypervolaemia 14.71 10.24 35 149963 2539 32360989
Hepatic function abnormal 14.70 10.24 134 149864 44706 32318822
Akathisia 14.68 10.24 7 149991 7018 32356510
Liver transplant failure 14.64 10.24 8 149990 101 32363427
Asthenia 14.62 10.24 1271 148727 234673 32128855
Pancreatic failure 14.43 10.24 18 149980 770 32362758
Enzyme inhibition 14.37 10.24 5 149993 18 32363510
Peripheral ischaemia 14.35 10.24 59 149939 5752 32357776
Hepatic cirrhosis 14.21 10.24 129 149869 16680 32346848
Acute pulmonary oedema 14.20 10.24 72 149926 7669 32355859
Gastritis fungal 14.17 10.24 8 149990 108 32363420
Diverticulitis 14.10 10.24 43 149955 18985 32344543
Visceral venous thrombosis 13.96 10.24 5 149993 20 32363508
Thrombocytopenia 13.95 10.24 551 149447 147748 32215780
Systemic infection 13.93 10.24 31 149967 2152 32361376
Morganella infection 13.91 10.24 14 149984 471 32363057
Glomerular filtration rate decreased 13.88 10.24 104 149894 12707 32350821
Hypovolaemia 13.86 10.24 79 149919 8798 32354730
Depressed mood 13.82 10.24 41 149957 18259 32345269
Pneumonitis 13.74 10.24 82 149916 30052 32333476
Stress 13.74 10.24 169 149829 23613 32339915
Suicidal ideation 13.74 10.24 111 149887 37972 32325556
Left atrial enlargement 13.67 10.24 16 149982 640 32362888
Oedema 13.64 10.24 288 149710 44859 32318669
Left atrial dilatation 13.57 10.24 28 149970 1844 32361684
Underdose 13.55 10.24 105 149893 12964 32350564
Hypochromasia 13.54 10.24 12 149986 343 32363185
Congenital cystic kidney disease 13.53 10.24 13 149985 413 32363115
Mucosal dryness 13.52 10.24 21 149977 1106 32362422
Neutropenia neonatal 13.51 10.24 16 149982 648 32362880
Post transplant lymphoproliferative disorder 13.50 10.24 5 149993 5829 32357699
Diarrhoea 13.43 10.24 1476 148522 363326 32000202
Oropharyngeal pain 13.43 10.24 87 149911 31265 32332263
Mitral valve thickening 13.42 10.24 13 149985 417 32363111
Muscle spasticity 13.39 10.24 5 149993 5800 32357728
Neuroleptic malignant syndrome 13.35 10.24 39 149959 17456 32346072
Peripheral arterial occlusive disease 13.35 10.24 57 149941 5652 32357876
Alopecia 13.22 10.24 50 149948 20680 32342848
Inflammation 13.20 10.24 63 149935 24430 32339098
Hallucination, auditory 13.20 10.24 17 149981 10333 32353195
Supranuclear palsy 13.15 10.24 3 149995 0 32363528
Schizophrenia 13.15 10.24 16 149982 9968 32353560
Diabetic gastroparesis 13.10 10.24 8 149990 126 32363402
Drug eruption 13.03 10.24 45 149953 19121 32344407
Generalised tonic-clonic seizure 13.02 10.24 50 149948 20589 32342939
Intraventricular haemorrhage 12.91 10.24 38 149960 3132 32360396
Diffuse large B-cell lymphoma 12.89 10.24 12 149986 8450 32355078
Insulin C-peptide decreased 12.83 10.24 6 149992 53 32363475
Dysphagia 12.75 10.24 203 149795 61273 32302255
Febrile bone marrow aplasia 12.74 10.24 12 149986 8403 32355125
Osteonecrosis 12.73 10.24 37 149961 16585 32346943
Pneumonia aspiration 12.63 10.24 125 149873 41031 32322497
Cystitis haemorrhagic 12.50 10.24 4 149994 5110 32358418
Multiple sclerosis relapse 12.46 10.24 22 149976 11759 32351769
Back pain 12.40 10.24 404 149594 110649 32252879
Hyponatraemia 12.33 10.24 256 149742 74257 32289271
Acute coronary syndrome 12.30 10.24 108 149890 13833 32349695
Mean platelet volume increased 12.29 10.24 13 149985 464 32363064
Skin pressure mark 12.28 10.24 6 149992 59 32363469
Retinal aneurysm 12.27 10.24 8 149990 142 32363386
Sedation 12.26 10.24 44 149954 18482 32345046
Flour sensitivity 12.19 10.24 6 149992 60 32363468
Hyperinsulinaemic hypoglycaemia 12.19 10.24 6 149992 60 32363468
Muscle abscess 12.16 10.24 14 149984 550 32362978
Diabetic hyperosmolar coma 12.09 10.24 12 149986 397 32363131
Cold sweat 12.08 10.24 83 149915 9863 32353665
Immune-mediated myositis 12.08 10.24 25 149973 1650 32361878
Epistaxis 12.07 10.24 183 149815 55672 32307856
Postprandial hypoglycaemia 12.04 10.24 4 149994 12 32363516
Alanine aminotransferase increased 12.01 10.24 273 149725 78206 32285322
Blindness unilateral 11.99 10.24 45 149953 4206 32359322
Diaphragmatic disorder 11.94 10.24 20 149978 1123 32362405
Myasthenic syndrome 11.84 10.24 12 149986 407 32363121
Foetal hypokinesia 11.84 10.24 12 149986 407 32363121
Diabetic hyperglycaemic coma 11.80 10.24 5 149993 34 32363494
Chromoblastomycosis 11.78 10.24 6 149992 65 32363463
Muscle rigidity 11.73 10.24 21 149977 11165 32352363
Chronic graft versus host disease 11.72 10.24 3 149995 4437 32359091
Retinal exudates 11.70 10.24 16 149982 750 32362778
Urinary tract infection fungal 11.63 10.24 12 149986 416 32363112
Non-cardiogenic pulmonary oedema 11.56 10.24 15 149983 668 32362860
Guillain-Barre syndrome 11.55 10.24 53 149945 5421 32358107
Bladder irrigation 11.54 10.24 6 149992 68 32363460
Granulocytopenia 11.47 10.24 8 149990 6507 32357021
Tumour lysis syndrome 11.42 10.24 32 149966 14515 32349013
Oesophageal tuberculosis 11.37 10.24 4 149994 15 32363513
Parvimonas micra infection 11.37 10.24 4 149994 15 32363513
Preternatural anus 11.31 10.24 7 149991 113 32363415
Premature baby 11.31 10.24 133 149865 18385 32345143
Blood potassium increased 11.31 10.24 123 149875 16681 32346847
Clostridium difficile infection 11.30 10.24 43 149955 17753 32345775
Nephropathy 11.20 10.24 55 149943 5785 32357743
Device failure 11.17 10.24 29 149969 2222 32361306
Productive cough 11.16 10.24 102 149896 34014 32329514
Squamous cell carcinoma 11.14 10.24 21 149977 10947 32352581
Paraplegia 11.12 10.24 33 149965 2733 32360795
Strangulated umbilical hernia 11.09 10.24 3 149995 3 32363525
Polycythaemia neonatorum 11.09 10.24 3 149995 3 32363525
Haematotoxicity 11.06 10.24 9 149989 6767 32356761
Extrapyramidal disorder 11.03 10.24 24 149974 11871 32351657
Parkinsonism 11.02 10.24 12 149986 7857 32355671
Retinal ischaemia 10.93 10.24 11 149987 370 32363158
Epstein-Barr virus infection 10.86 10.24 10 149988 7080 32356448
Pneumothorax 10.80 10.24 43 149955 17527 32346001
Withdrawal syndrome 10.80 10.24 25 149973 12097 32351431
Influenza like illness 10.78 10.24 77 149921 27063 32336465
Irritability 10.77 10.24 68 149930 24586 32338942
Tachycardia 10.76 10.24 280 149718 78808 32284720
Cogwheel rigidity 10.75 10.24 21 149977 1329 32362199
Neonatal respiratory depression 10.72 10.24 12 149986 457 32363071
Sexual dysfunction 10.71 10.24 8 149990 6281 32357247
Optic discs blurred 10.69 10.24 6 149992 80 32363448
Wrong drug 10.63 10.24 6 149992 81 32363447
Salivary hypersecretion 10.61 10.24 13 149985 8075 32355453
Pseudolymphoma 10.59 10.24 13 149985 547 32362981
Eosinophilic pneumonia 10.59 10.24 35 149963 3071 32360457
No adverse event 10.56 10.24 52 149946 20001 32343527
Abnormal behaviour 10.56 10.24 75 149923 26391 32337137
Clear cell renal cell carcinoma 10.52 10.24 18 149980 1028 32362500
Cardiac disorder 10.44 10.24 260 149738 41606 32321922
Resting tremor 10.40 10.24 14 149984 646 32362882
Lipohypertrophy 10.40 10.24 10 149988 318 32363210
Hypogammaglobulinaemia 10.33 10.24 8 149990 6168 32357360
Needle issue 10.29 10.24 44 149954 4365 32359163
Device interaction 10.28 10.24 13 149985 564 32362964
Acute graft versus host disease in skin 10.27 10.24 5 149993 4952 32358576

Pharmacologic Action:

SourceCodeDescription
ATC A10AE04 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, long-acting
ATC A10AE54 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, long-acting
FDA CS M0011417 Insulin
FDA Chemical/Ingredient N0000004931 Insulin
FDA EPC N0000175453 Insulin Analog
MeSH PA D007004 Hypoglycemic Agents
CHEBI has role CHEBI:35526 hypoglycemic drug
FDA EPC N0000175944 Insulin

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Diabetes mellitus type 1 indication 46635009 DOID:9744

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Insulin receptor Kinase AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
2ZM8CX04RZ UNII
D03250 KEGG_DRUG
4021223 VUID
N0000179736 NUI
4017559 VANDF
4017569 VANDF
4019786 VANDF
4021223 VANDF
C0907402 UMLSCUI
CHEBI:5931 CHEBI
CHEMBL1201497 ChEMBL_ID
118984454 PUBCHEM_CID
DB00047 DRUGBANK_ID
D000069036 MESH_DESCRIPTOR_UI
7572 IUPHAR_LIGAND_ID
5186 INN_ID
118984375 PUBCHEM_CID
DB00030 DRUGBANK_ID
7548 INN_ID
1604540 RXNORM
31949 MMSL
350503 MMSL
4885 MMSL
4886 MMSL
8888 MMSL
d00262 MMSL
d04369 MMSL
d04538 MMSL
000869 NDDF
000870 NDDF
006518 NDDF
009131 NDDF
009132 NDDF
126210001 SNOMEDCT_US
126212009 SNOMEDCT_US
411529005 SNOMEDCT_US
417423002 SNOMEDCT_US
420609005 SNOMEDCT_US
96367001 SNOMEDCT_US
C0795635 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BASAGLAR KwikPen HUMAN PRESCRIPTION DRUG LABEL 1 0002-7715 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
BASAGLAR Tempo Pen HUMAN PRESCRIPTION DRUG LABEL 1 0002-8214 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Rezvoglar KwikPen HUMAN PRESCRIPTION DRUG LABEL 1 0002-8980 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Soliqua 100/33 HUMAN PRESCRIPTION DRUG LABEL 2 0024-5761 INJECTION, SOLUTION 100 U SUBCUTANEOUS BLA 32 sections
TOUJEO HUMAN PRESCRIPTION DRUG LABEL 1 0024-5869 INJECTION, SOLUTION 300 U SUBCUTANEOUS BLA 33 sections
TOUJEO Max HUMAN PRESCRIPTION DRUG LABEL 1 0024-5871 INJECTION, SOLUTION 300 U SUBCUTANEOUS BLA 33 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 0088-2219 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 0088-2220 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 0088-5020 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 29 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 0088-5021 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 29 sections
SEMGLEE HUMAN PRESCRIPTION DRUG LABEL 1 49502-195 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
SEMGLEE HUMAN PRESCRIPTION DRUG LABEL 1 49502-196 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
SEMGLEE HUMAN PRESCRIPTION DRUG LABEL 1 49502-250 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
SEMGLEE HUMAN PRESCRIPTION DRUG LABEL 1 49502-251 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Insulin Glargine HUMAN PRESCRIPTION DRUG LABEL 1 49502-393 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 28 sections
Insulin Glargine HUMAN PRESCRIPTION DRUG LABEL 1 49502-394 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 28 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 50090-0876 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 26 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 50090-1398 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 26 sections
TOUJEO HUMAN PRESCRIPTION DRUG LABEL 1 50090-2193 INJECTION, SOLUTION 300 U SUBCUTANEOUS BLA 32 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 50090-4068 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 26 sections
TOUJEO Max HUMAN PRESCRIPTION DRUG LABEL 1 50090-4177 INJECTION, SOLUTION 300 U SUBCUTANEOUS BLA 32 sections
SEMGLEE HUMAN PRESCRIPTION DRUG LABEL 1 50090-5835 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 54868-4626 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 26 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 54868-5765 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 26 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 54868-6231 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 26 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 55045-3685 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 28 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 64725-2220 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 29 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 70518-1390 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 26 sections