insulin glulisine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
5057 207748-29-6

Description:

MoleculeDescription

Synonyms:

  • insulin glulisine
  • insulin glulisine (genetical recombination)
  • HMR 1964
  • apidra
  • glulisine apidra
  • insulin glulisine recombinant
  • insulin glulisine [rDNA origin]
  • insulin glulisine (rDNA origin)
Insulin glulisine [rDNA origin] is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glulisine differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid.
  • Molecular weight: 5822.64
  • Formula: C258H384N64O78S6
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 2293.28
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
40 U P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
April 16, 2004 FDA SANOFI AVENTIS US
Sept. 27, 2004 EMA

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
Hypoglycaemia 539.18 20.17 190 5332 69658 90553267
Diabetic ketoacidosis 327.44 20.17 101 5421 24306 90598619
Blood glucose increased 223.38 20.17 111 5411 95135 90527790
Hyperglycaemia 203.35 20.17 86 5436 50884 90572041
Diabetes mellitus inadequate control 175.37 20.17 59 5463 18625 90604300
Acute kidney injury 96.98 20.17 108 5414 320279 90302646
Wrong product administered 91.27 20.17 29 5493 7636 90615289
Blood glucose abnormal 77.41 20.17 27 5495 9465 90613460
Glycosylated haemoglobin increased 74.66 20.17 30 5492 15532 90607393
Sopor 64.43 20.17 31 5491 24613 90598312
Ketoacidosis 61.81 20.17 20 5502 5575 90617350
Hypoglycaemic coma 51.36 20.17 15 5507 2975 90619950
Blood glucose decreased 50.94 20.17 26 5496 23403 90599522
Hyperkalaemia 49.76 20.17 37 5485 64927 90557998
Blood glucose fluctuation 47.45 20.17 16 5506 5067 90617858
Medical device site abscess 43.49 20.17 8 5514 203 90622722
Medical device site cellulitis 42.94 20.17 8 5514 218 90622707
Dehydration 39.92 20.17 54 5468 194393 90428532
Product prescribing error 37.01 20.17 23 5499 30122 90592803
Anti-insulin antibody positive 34.58 20.17 6 5516 108 90622817
Lactic acidosis 32.63 20.17 26 5496 50437 90572488
Diabetic retinal oedema 32.28 20.17 7 5515 415 90622510
Type III immune complex mediated reaction 32.26 20.17 7 5515 416 90622509
Multiple lentigines syndrome 30.78 20.17 6 5516 209 90622716
Cerebrovascular accident 29.53 20.17 37 5485 123496 90499429
Systemic infection 29.26 20.17 11 5511 4764 90618161
Syncope 28.98 20.17 38 5484 132625 90490300
Cataract subcapsular 28.45 20.17 7 5515 724 90622201
Diabetic retinopathy 27.18 20.17 9 5513 2693 90620232
Product quality issue 26.07 20.17 28 5494 79297 90543628
Daydreaming 25.99 20.17 6 5516 473 90622452
Haemorrhagic erosive gastritis 25.74 20.17 6 5516 493 90622432
Macular oedema 25.40 20.17 10 5512 4899 90618026
Episcleritis 25.07 20.17 7 5515 1183 90621742
Loss of consciousness 24.39 20.17 36 5486 140202 90482723
Thyroid cyst 24.02 20.17 6 5516 660 90622265
Simple partial seizures 23.43 20.17 6 5516 729 90622196
Hypoglycaemic unconsciousness 22.83 20.17 6 5516 808 90622117
Monoclonal gammopathy 22.40 20.17 6 5516 869 90622056
General physical health deterioration 21.95 20.17 59 5463 355056 90267869
Exposure during pregnancy 21.64 20.17 46 5476 238364 90384561
Product storage error 21.26 20.17 14 5508 20227 90602698
Cystoid macular oedema 21.15 20.17 7 5515 2093 90620832

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 299.41 19.01 163 7154 59691 42554327
Hyperglycaemia 240.62 19.01 129 7188 45730 42568288
Blood glucose increased 143.38 19.01 111 7206 73588 42540430
Diabetes mellitus inadequate control 133.37 19.01 61 7256 15329 42598689
Blood glucose abnormal 126.32 19.01 47 7270 7006 42607012
Blood glucose fluctuation 125.92 19.01 42 7275 4545 42609473
Wrong product administered 98.86 19.01 38 7279 6188 42607830
Intestinal haemorrhage 76.90 19.01 28 7289 3923 42610095
Glycosylated haemoglobin increased 75.11 19.01 39 7278 12885 42601133
Hypoglycaemic coma 66.94 19.01 23 7294 2721 42611297
Metabolic acidosis 65.49 19.01 61 7256 51797 42562221
Anti-insulin antibody positive 59.13 19.01 12 7305 175 42613843
Haematoma 51.75 19.01 41 7276 27982 42586036
Diabetic ketoacidosis 50.74 19.01 37 7280 22330 42591688
Blood glucose decreased 47.76 19.01 30 7287 14189 42599829
Substance use 43.97 19.01 15 7302 1736 42612282
Urinary incontinence 42.81 19.01 33 7284 21635 42592383
Pancreatic carcinoma 36.89 19.01 22 7295 9484 42604534
Ketoacidosis 36.49 19.01 18 7299 5334 42608684
Morganella infection 35.56 19.01 10 7307 609 42613409
Bronchial haemorrhage 34.29 19.01 10 7307 694 42613324
Cognitive disorder 33.44 19.01 35 7282 34137 42579881
Pulmonary oedema 32.79 19.01 43 7274 53229 42560789
Waist circumference increased 30.98 19.01 10 7307 974 42613044
Anti-insulin antibody increased 30.57 19.01 6 7311 73 42613945
Acute kidney injury 30.41 19.01 134 7183 367203 42246815
Renal failure 29.93 19.01 72 7245 143654 42470364
Diabetic bullosis 29.92 19.01 5 7312 22 42613996
Mucosal haemorrhage 28.67 19.01 11 7306 1779 42612239
Contraindicated product administered 28.59 19.01 28 7289 25244 42588774
Device operational issue 28.20 19.01 7 7310 262 42613756
Hyperhidrosis 27.66 19.01 53 7264 90459 42523559
Balance disorder 27.08 19.01 37 7280 47608 42566410
Hyperinsulinaemic hypoglycaemia 27.02 19.01 6 7311 137 42613881
Toxicity to various agents 26.28 19.01 4 7313 229132 42384886
Electrocardiogram T wave amplitude decreased 25.76 19.01 7 7310 375 42613643
Contusion 24.46 19.01 33 7284 41952 42572066
Hydrocholecystis 23.77 19.01 7 7310 502 42613516
Sopor 23.68 19.01 19 7298 13183 42600835
General physical health deterioration 23.55 19.01 68 7249 151178 42462840
Transferrin saturation decreased 23.37 19.01 7 7310 533 42613485
Gastric haemorrhage 22.95 19.01 17 7300 10498 42603520
Hypoglycaemic encephalopathy 22.18 19.01 6 7311 316 42613702
Atrial enlargement 21.30 19.01 7 7310 722 42613296
Electrocardiogram ST segment abnormal 20.98 19.01 7 7310 757 42613261
Glomerular filtration rate increased 20.54 19.01 7 7310 807 42613211
Anaemia 20.00 19.01 98 7219 280180 42333838
Product storage error 19.91 19.01 16 7301 11124 42602894
Off label use 19.81 19.01 51 7266 638284 41975734
Anaemia of malignant disease 19.11 19.01 6 7311 535 42613483
Electrocardiogram abnormal 19.05 19.01 15 7302 10130 42603888

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 722.05 17.48 315 11429 115789 110461766
Hyperglycaemia 386.94 17.48 186 11558 84904 110492651
Blood glucose increased 294.05 17.48 180 11564 132316 110445239
Diabetic ketoacidosis 270.08 17.48 117 11627 41941 110535614
Diabetes mellitus inadequate control 269.91 17.48 106 11638 29669 110547886
Blood glucose abnormal 149.52 17.48 55 11689 12861 110564694
Wrong product administered 139.28 17.48 50 11694 10910 110566645
Acute kidney injury 138.45 17.48 244 11500 635186 109942369
Glycosylated haemoglobin increased 136.32 17.48 61 11683 23558 110553997
Blood glucose fluctuation 124.34 17.48 42 11702 7656 110569899
Hypoglycaemic coma 100.57 17.48 33 11711 5500 110572055
Anti-insulin antibody positive 84.03 17.48 16 11728 275 110577280
Metabolic acidosis 78.67 17.48 73 11671 99671 110477884
Ketoacidosis 77.82 17.48 32 11712 10055 110567500
Sopor 71.69 17.48 46 11698 36500 110541055
Blood glucose decreased 70.24 17.48 42 11702 29446 110548109
Intestinal haemorrhage 55.64 17.48 23 11721 7318 110570237
Hyperkalaemia 50.45 17.48 67 11677 135729 110441826
Medical device site cellulitis 50.13 17.48 10 11734 221 110577334
General physical health deterioration 49.75 17.48 127 11617 425168 110152387
Pancreatic carcinoma 45.65 17.48 25 11719 14847 110562708
Lactic acidosis 42.76 17.48 51 11693 92760 110484795
Substance use 41.75 17.48 14 11730 2492 110575063
Haematoma 40.77 17.48 40 11704 58436 110519119
Loss of consciousness 39.45 17.48 73 11671 196233 110381322
Medical device site abscess 39.09 17.48 8 11736 202 110577353
Syncope 39.06 17.48 74 11670 202462 110375093
Anaemia 37.18 17.48 135 11609 546951 110030604
Hyperinsulinaemic hypoglycaemia 36.46 17.48 8 11736 284 110577271
Dehydration 36.38 17.48 87 11657 279424 110298131
Systemic infection 34.33 17.48 18 11726 9801 110567754
Diabetic bullosis 32.71 17.48 5 11739 20 110577535
Morganella infection 32.39 17.48 10 11734 1369 110576186
Bronchial haemorrhage 32.33 17.48 10 11734 1377 110576178
Renal failure 32.18 17.48 73 11671 226501 110351054
Hyperhidrosis 31.95 17.48 65 11679 187233 110390322
Anti-insulin antibody increased 31.09 17.48 6 11738 111 110577444
Waist circumference increased 29.76 17.48 10 11734 1791 110575764
Hypoglycaemic encephalopathy 29.36 17.48 8 11736 705 110576850
Hypoglycaemic unconsciousness 29.30 17.48 9 11735 1211 110576344
Pulmonary oedema 28.99 17.48 44 11700 100615 110476940
Product prescribing error 28.36 17.48 31 11713 51300 110526255
Mucosal haemorrhage 28.21 17.48 11 11733 3009 110574546
Diabetic retinal oedema 28.05 17.48 7 11737 437 110577118
Toxicity to various agents 26.49 17.48 9 11735 480546 110097009
Multiple lentigines syndrome 26.41 17.48 6 11738 250 110577305
Type III immune complex mediated reaction 26.28 17.48 8 11736 1045 110576510
Abdominal discomfort 26.26 17.48 5 11739 393853 110183702
Hydrocholecystis 26.00 17.48 7 11737 590 110576965
Product storage error 25.51 17.48 20 11724 21708 110555847
Electrocardiogram T wave amplitude decreased 23.79 17.48 7 11737 814 110576741
Product administration error 23.26 17.48 24 11720 37193 110540362
Diabetic retinopathy 23.12 17.48 10 11734 3554 110574001
Infusion related reaction 23.07 17.48 6 11738 381156 110196399
Urinary incontinence 22.86 17.48 27 11717 48560 110528995
Thyroid cyst 22.64 17.48 6 11738 476 110577079
Gastric haemorrhage 21.66 17.48 16 11728 15899 110561656
Joint swelling 21.61 17.48 10 11734 442835 110134720
Device operational issue 21.57 17.48 7 11737 1125 110576430
Atrial enlargement 21.46 17.48 7 11737 1144 110576411
Anti-insulin antibody 20.94 17.48 4 11740 70 110577485
Cataract subcapsular 20.83 17.48 7 11737 1254 110576301
Episcleritis 20.80 17.48 7 11737 1259 110576296
Multiple use of single-use product 20.64 17.48 7 11737 1289 110576266
Transferrin saturation decreased 20.40 17.48 7 11737 1336 110576219
Anxiety 19.83 17.48 6 11738 345072 110232483
Haemorrhagic erosive gastritis 19.77 17.48 6 11738 776 110576779
Electrocardiogram abnormal 19.37 17.48 16 11728 18693 110558862
Sinusitis 19.28 17.48 4 11740 296684 110280871
Urine ketone body present 19.25 17.48 9 11735 3837 110573718
Liquid product physical issue 19.20 17.48 7 11737 1593 110575962
Diabetic foot 18.71 17.48 9 11735 4086 110573469
Insulin resistance 18.65 17.48 7 11737 1727 110575828
Hypoglycaemic seizure 18.48 17.48 6 11738 966 110576589
Inflammatory marker increased 18.48 17.48 14 11730 14455 110563100
Medication error 18.47 17.48 37 11707 105329 110472226
Electrocardiogram ST segment abnormal 18.45 17.48 7 11737 1778 110575777
Anaemia of malignant disease 18.34 17.48 6 11738 990 110576565
Troponin T increased 18.28 17.48 9 11735 4297 110573258
Simple partial seizures 18.11 17.48 6 11738 1030 110576525
Asthenia 18.03 17.48 130 11614 688869 109888686
Glomerular filtration rate increased 17.87 17.48 7 11737 1938 110575617
Insomnia 17.81 17.48 8 11736 360582 110216973
Musculoskeletal stiffness 17.72 17.48 4 11740 279818 110297737
Dyspnoea 17.58 17.48 187 11557 1106685 109470870

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10AB06 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, fast-acting
FDA CS M0011417 Insulin
FDA Chemical/Ingredient N0000004931 Insulin
FDA EPC N0000175453 Insulin Analog
MeSH PA D007004 Hypoglycemic Agents
FDA EPC N0000175944 Insulin
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35821 anticholesteremic drug
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:50864 insulin-sensitizing drug
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:76916 hyperglycemic agent
CHEBI has role CHEBI:145947 antiatherosclerotic agent
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

A10AB Insulins and analogues for injection, fast-acting 5 drugs
insulin aspartinsulin beefinsulin humaninsulin lisproinsulin pork

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus indication 73211009 DOID:9351




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
7XIY785AZD UNII
D04540 KEGG_DRUG
4021469 VUID
N0000179777 NUI
4017559 VANDF
4017569 VANDF
4019786 VANDF
4021469 VANDF
C1313386 UMLSCUI
CHEBI:749555 CHEBI
CHEMBL1201613 ChEMBL_ID
168324397 PUBCHEM_CID
DB01309 DRUGBANK_ID
8044 INN_ID
C479079 MESH_SUPPLEMENTAL_RECORD_UI
253182 RXNORM
18596 MMSL
4885 MMSL
4886 MMSL
53478 MMSL
d00262 MMSL
d04369 MMSL
d05278 MMSL
000869 NDDF
000870 NDDF
006518 NDDF
010953 NDDF
126210001 SNOMEDCT_US
411530000 SNOMEDCT_US
411532008 SNOMEDCT_US
417423002 SNOMEDCT_US
420609005 SNOMEDCT_US
96367001 SNOMEDCT_US
C0795635 UMLSCUI
DB00030 DRUGBANK_ID
118984375 PUBCHEM_CID
5186 INN_ID
CHEBI:5931 CHEBI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Apidra HUMAN PRESCRIPTION DRUG LABEL 1 0088-2500 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Apidra SoloStar HUMAN PRESCRIPTION DRUG LABEL 1 0088-2502 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections