insulin aspart 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4981 116094-23-6

Description:

MoleculeDescription

Synonyms:

  • insulin aspart protamine recombinant
  • insulin aspart protamine
  • insulin aspart protamine crystalline
  • insulin aspart
  • insulin aspart recombinant
  • novolog
  • insulin aspart [rDNA origin]
  • novorapid
Insulin that has been modified to contain an ASPARTIC ACID instead of a PROLINE at position 38 of the B-chain.
  • Molecular weight: 5825.60
  • Formula: C256H381N65O79S6
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 2345.16
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
40 U P
40 U P
40 U P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 7, 1999 EMA NovoRapid
June 7, 2000 FDA NOVO NORDISK INC
Sept. 20, 2019 PMDA Novo Nordisk Pharma Ltd.

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
Diabetic ketoacidosis 1613.15 10.55 620 53527 19885 63414990
Hypoglycaemia 1356.50 10.55 764 53383 59301 63375574
Blood glucose increased 1314.68 10.55 843 53304 82913 63351962
Blood glucose decreased 468.05 10.55 265 53882 20687 63414188
Hyperglycaemia 409.44 10.55 316 53831 41551 63393324
Diabetes mellitus inadequate control 383.55 10.55 208 53939 14918 63419957
Acute kidney injury 232.44 10.55 617 53530 262798 63172077
Glycosylated haemoglobin increased 219.55 10.55 135 54012 12263 63422612
Ketoacidosis 216.27 10.55 95 54052 4283 63430592
Blood glucose fluctuation 202.71 10.55 92 54055 4484 63430391
Diabetic retinopathy 195.81 10.55 74 54073 2253 63432622
Hypoglycaemic unconsciousness 179.92 10.55 53 54094 724 63434151
Hypoglycaemic coma 178.04 10.55 71 54076 2504 63432371
Product leakage 162.96 10.55 50 54097 791 63434084
Diabetic metabolic decompensation 146.14 10.55 55 54092 1655 63433220
Drug intolerance 144.61 10.55 42 54105 308619 63126256
Drug ineffective 141.05 10.55 442 53705 1044323 62390552
Arthropathy 136.80 10.55 19 54128 234773 63200102
Blood glucose abnormal 132.29 10.55 83 54064 7809 63427066
Synovitis 127.69 10.55 8 54139 186910 63247965
Contraindicated product administered 123.57 10.55 19 54128 217629 63217246
Alopecia 115.14 10.55 73 54074 337463 63097412
Glossodynia 112.82 10.55 11 54136 178865 63256010
Treatment failure 111.58 10.55 18 54129 199025 63235850
Joint swelling 106.19 10.55 75 54072 327591 63107284
Systemic lupus erythematosus 102.35 10.55 26 54121 208892 63225983
Lactic acidosis 96.56 10.55 140 54007 38147 63396728
Diabetic neuropathy 96.27 10.55 53 54094 3911 63430964
Infusion related reaction 95.45 10.55 45 54102 245476 63189399
Product quality issue 88.78 10.55 130 54017 35735 63399140
Pericarditis 88.75 10.55 6 54141 131573 63303302
Hypoglycaemia unawareness 85.28 10.55 20 54127 102 63434773
Hyper IgE syndrome 84.91 10.55 27 54120 483 63434392
Arthralgia 82.24 10.55 233 53914 569477 62865398
Wound 80.56 10.55 20 54127 163243 63271632
Liquid product physical issue 79.66 10.55 32 54115 1150 63433725
Pain 78.76 10.55 345 53802 740283 62694592
Discomfort 76.08 10.55 24 54123 167350 63267525
Abdominal discomfort 74.29 10.55 99 54048 320786 63114089
Therapeutic product effect decreased 74.16 10.55 36 54111 193151 63241724
Hypoglycaemic seizure 73.54 10.55 24 54123 468 63434407
Rheumatoid arthritis 72.29 10.55 66 54081 253753 63181122
Exposure during pregnancy 69.70 10.55 290 53857 155257 63279618
Diabetic ketosis 69.08 10.55 20 54127 256 63434619
Anti-insulin antibody positive 67.37 10.55 16 54131 87 63434788
Oesophageal spasm 65.68 10.55 38 54109 3085 63431790
Restrictive pulmonary disease 60.80 10.55 30 54117 1765 63433110
Ketosis 60.80 10.55 22 54125 591 63434284
Heart sounds 60.41 10.55 25 54122 971 63433904
Helicobacter infection 60.38 10.55 5 54142 92780 63342095
Foetal exposure during pregnancy 59.91 10.55 102 54045 31860 63403015
Oesophageal pain 59.72 10.55 38 54109 3663 63431212
Musculoskeletal stiffness 58.76 10.55 43 54104 184575 63250300
Prolonged expiration 58.10 10.55 25 54122 1071 63433804
Dehydration 57.53 10.55 296 53851 173058 63261817
Hyperkalaemia 55.98 10.55 135 54012 54068 63380807
Myocardial infarction 55.14 10.55 199 53948 99694 63335181
Completed suicide 54.60 10.55 28 54119 145645 63289230
Toxicity to various agents 54.47 10.55 79 54068 247171 63187704
Hypoglycaemia neonatal 54.20 10.55 23 54124 952 63433923
Sleep apnoea syndrome 52.02 10.55 91 54056 29042 63405833
Infective pulmonary exacerbation of cystic fibrosis 50.38 10.55 49 54098 8768 63426107
Chronic kidney disease 46.80 10.55 113 54034 45285 63389590
Wrong product administered 46.57 10.55 40 54107 6101 63428774
Renal failure 46.29 10.55 211 53936 117441 63317434
Polyuria 46.07 10.55 46 54101 8496 63426379
Euglycaemic diabetic ketoacidosis 45.50 10.55 32 54115 3642 63431233
Swelling 45.49 10.55 105 54042 275273 63159602
Lipodystrophy acquired 45.44 10.55 23 54124 1429 63433446
Diabetes mellitus 45.29 10.55 127 54020 55683 63379192
Irritable bowel syndrome 44.94 10.55 8 54139 82404 63352471
Hypersensitivity 44.89 10.55 116 54031 292569 63142306
Hydrops foetalis 42.85 10.55 17 54130 591 63434284
Premature baby 42.65 10.55 69 54078 20666 63414209
Ketonuria 41.68 10.55 17 54130 636 63434239
Drug hypersensitivity 41.16 10.55 132 54015 310555 63124320
Insulin resistance 39.99 10.55 18 54129 860 63434015
Hepatic enzyme increased 38.60 10.55 71 54076 202257 63232618
Therapeutic product effect incomplete 37.40 10.55 31 54116 125025 63309850
Respiration abnormal 37.30 10.55 36 54111 6381 63428494
Caesarean section 36.85 10.55 58 54089 16974 63417901
International normalised ratio abnormal 36.84 10.55 27 54120 3277 63431598
Polycystic ovaries 35.70 10.55 30 54117 4441 63430434
Mobility decreased 35.06 10.55 31 54116 121128 63313747
Product physical issue 34.87 10.55 31 54116 4949 63429926
Sinusitis 34.60 10.55 90 54057 226563 63208312
Product use issue 33.33 10.55 88 54059 220432 63214443
Pre-eclampsia 33.25 10.55 40 54107 9093 63425782
Bladder agenesis 33.14 10.55 10 54137 149 63434726
Dyslipidaemia 33.03 10.55 36 54111 7357 63427518
Off label use 32.82 10.55 393 53754 674069 62760806
Genitalia external ambiguous 32.72 10.55 10 54137 156 63434719
Cloacal exstrophy 32.72 10.55 10 54137 156 63434719
Congenital ectopic bladder 32.41 10.55 9 54138 98 63434777
Caudal regression syndrome 32.09 10.55 10 54137 167 63434708
Depressive symptom 31.68 10.55 27 54120 4075 63430800
Gastrointestinal malformation 31.49 10.55 10 54137 178 63434697
Lymphoedema 31.30 10.55 44 54103 11648 63423227
Tethered cord syndrome 31.22 10.55 11 54136 273 63434602
Meconium stain 30.83 10.55 10 54137 191 63434684
Cerebrovascular accident 30.77 10.55 177 53970 107847 63327028
Congenital multiplex arthrogryposis 30.66 10.55 7 54140 31 63434844
Impaired healing 29.95 10.55 26 54121 102516 63332359
Device failure 29.92 10.55 31 54116 5980 63428895
Gastrointestinal disorder congenital 29.77 10.55 9 54138 135 63434740
Lethargy 29.56 10.55 110 54037 55897 63378978
Congenital genital malformation 29.06 10.55 9 54138 147 63434728
Dialysis 29.05 10.55 40 54107 10387 63424488
Blood ketone body 27.96 10.55 7 54140 49 63434826
Hyperhidrosis 27.71 10.55 172 53975 107664 63327211
Hip arthroplasty 27.37 10.55 4 54143 47642 63387233
Pancreatitis 27.28 10.55 98 54049 48957 63385918
Blood cholesterol increased 27.27 10.55 24 54123 94008 63340867
Blister 27.09 10.55 43 54104 129771 63305104
Blood ketone body increased 26.91 10.55 10 54137 290 63434585
Coronavirus test positive 26.88 10.55 13 54134 732 63434143
Neural tube defect 26.78 10.55 9 54138 193 63434682
Diabetic gastroparesis 26.72 10.55 10 54137 296 63434579
Anencephaly 26.69 10.55 10 54137 297 63434578
Appetite disorder 26.54 10.55 32 54115 7289 63427586
Diabetic nephropathy 26.16 10.55 16 54131 1438 63433437
Rash 26.04 10.55 330 53817 560541 62874334
Hospitalisation 25.94 10.55 142 54005 84939 63349936
Nasopharyngitis 25.93 10.55 120 54027 254137 63180738
Ultrasound antenatal screen 25.79 10.55 9 54138 217 63434658
Sepsis neonatal 25.70 10.55 11 54136 465 63434410
Productive cough 25.32 10.55 114 54033 63094 63371781
Abdominal pain 25.06 10.55 370 53777 293086 63141789
Fracture blisters 24.98 10.55 7 54140 79 63434796
Impaired gastric emptying 24.91 10.55 37 54110 10295 63424580
Urosepsis 24.58 10.55 51 54096 18473 63416402
Knee arthroplasty 24.21 10.55 8 54139 54198 63380677
Anal atresia 24.17 10.55 10 54137 388 63434487
Flank pain 23.94 10.55 47 54100 16363 63418512
Vomiting 23.53 10.55 634 53513 558983 62875892
Abscess 23.43 10.55 47 54100 16621 63418254
Type 1 diabetes mellitus 23.43 10.55 22 54125 3768 63431107
Restless legs syndrome 23.40 10.55 50 54097 18481 63416394
Dyspnoea 23.38 10.55 733 53414 660580 62774295
Product use in unapproved indication 23.05 10.55 77 54070 179003 63255872
Accidental underdose 23.05 10.55 12 54135 791 63434084
Diabetic ketoacidotic hyperglycaemic coma 22.84 10.55 6 54141 52 63434823
Neonatal respiratory distress syndrome 22.69 10.55 19 54128 2799 63432076
Bicuspid aortic valve 22.62 10.55 7 54140 114 63434761
Gastrointestinal disorder 22.49 10.55 49 54098 131190 63303685
Fatigue 22.37 10.55 582 53565 887446 62547429
Cystic fibrosis 22.06 10.55 20 54127 3276 63431599
Fear-related avoidance of activities 21.77 10.55 7 54140 130 63434745
Bursitis 21.54 10.55 3 54144 37038 63397837
Diabetic hyperosmolar coma 21.47 10.55 9 54138 361 63434514
Acute myocardial infarction 21.23 10.55 68 54079 32056 63402819
Product dispensing error 20.79 10.55 34 54113 10271 63424604
Urinary tract infection 20.77 10.55 329 53818 264355 63170520
Rales 20.54 10.55 38 54109 12659 63422216
Fluid retention 20.52 10.55 103 54044 59583 63375292
Psoriatic arthropathy 20.36 10.55 29 54118 91491 63343384
Angina pectoris 20.18 10.55 64 54083 30014 63404861
Ill-defined disorder 20.15 10.55 24 54123 81731 63353144
Meningomyelocele 19.96 10.55 10 54137 608 63434267
Premature delivery 19.92 10.55 64 54083 30217 63404658
Polyhydramnios 19.72 10.55 16 54131 2255 63432620
Hypervolaemia 19.56 10.55 61 54086 28352 63406523
Large intestine polyp 19.36 10.55 29 54118 8128 63426747
Umbilical cord abnormality 19.29 10.55 10 54137 653 63434222
Therapy non-responder 19.01 10.55 22 54125 75879 63358996
Rhabdomyolysis 18.92 10.55 81 54066 43870 63391005
Headache 18.39 10.55 406 53741 632835 62802040
Hyperglycaemic unconsciousness 18.20 10.55 3 54144 0 63434875
Shoulder dystocia 18.20 10.55 3 54144 0 63434875
Exomphalos 17.95 10.55 9 54138 548 63434327
Device expulsion 17.76 10.55 4 54143 34918 63399957
Decreased insulin requirement 17.66 10.55 6 54141 133 63434742
Carcinoid crisis 17.23 10.55 7 54140 259 63434616
High risk pregnancy 17.06 10.55 6 54141 148 63434727
Intentional overdose 17.03 10.55 115 54032 74037 63360838
Spina bifida 16.87 10.55 10 54137 849 63434026
Device operational issue 16.74 10.55 7 54140 279 63434596
Lymphangiectasia 16.60 10.55 5 54142 74 63434801
Mesenteric arterial occlusion 16.55 10.55 6 54141 162 63434713
Diabetic foot 16.53 10.55 12 54135 1435 63433440
Butterfly rash 16.48 10.55 13 54134 1760 63433115
Congenital anomaly 16.46 10.55 13 54134 1763 63433112
Increased insulin requirement 16.42 10.55 5 54142 77 63434798
Product container issue 16.35 10.55 13 54134 1780 63433095
Therapeutic response decreased 16.32 10.55 17 54130 61508 63373367
Fall 16.31 10.55 444 53703 391890 63042985
Loss of consciousness 16.21 10.55 163 53984 117958 63316917
Hypoglycaemic encephalopathy 16.16 10.55 7 54140 305 63434570
Diabetic hepatopathy 16.13 10.55 3 54144 3 63434872
Hepatic encephalopathy 16.08 10.55 32 54115 11250 63423625
Infection 16.00 10.55 122 54025 229051 63205824
Generalised oedema 15.90 10.55 39 54108 15779 63419096
White blood cell count decreased 15.79 10.55 63 54084 139041 63295834
Maculopathy 15.68 10.55 14 54133 2248 63432627
Red blood cell sedimentation rate increased 15.67 10.55 9 54138 43973 63390902
Acute painful neuropathy of rapid glycaemic control 15.67 10.55 3 54144 4 63434871
Metabolic acidosis 15.65 10.55 78 54069 44991 63389884
Foetal hypokinesia 15.58 10.55 8 54139 512 63434363
Therapeutic drug monitoring analysis incorrectly performed 15.50 10.55 7 54140 337 63434538
Pneumonia 15.49 10.55 504 53643 456263 62978612
Cardiac septal hypertrophy 15.09 10.55 6 54141 210 63434665
Cholestasis 14.86 10.55 57 54090 29377 63405498
Mental status changes 14.80 10.55 70 54077 39529 63395346
Neisseria infection 14.71 10.55 5 54142 111 63434764
Extradural haematoma 14.68 10.55 12 54135 1710 63433165
Resting tremor 14.66 10.55 9 54138 814 63434061
Liver injury 14.66 10.55 18 54129 60502 63374373
Blindness transient 14.62 10.55 17 54130 3727 63431148
Dyspepsia 14.52 10.55 42 54105 102154 63332721
Product administration error 14.43 10.55 47 54100 22350 63412525
Suicide attempt 14.31 10.55 95 54052 60823 63374052
Cellulitis 14.24 10.55 119 54028 81839 63353036
Left ventricular hypertrophy 14.22 10.55 20 54127 5295 63429580
Product storage error 14.11 10.55 36 54111 14920 63419955
Tinnitus 14.07 10.55 64 54083 35564 63399311
Hip fracture 14.00 10.55 56 54091 29418 63405457
Retinopathy 13.61 10.55 15 54132 3104 63431771
Conjoined twins 13.58 10.55 6 54141 274 63434601
Anti-insulin antibody increased 13.49 10.55 4 54143 56 63434819
Contusion 13.46 10.55 74 54073 149970 63284905
Coronary artery disease 13.42 10.55 59 54088 32318 63402557
Immunosuppressant drug level increased 13.35 10.55 16 54131 3622 63431253
Trisomy 18 13.30 10.55 5 54142 150 63434725
Multiple lentigines syndrome 13.20 10.55 5 54142 153 63434722
Pemphigoid 13.18 10.55 23 54124 7321 63427554
Diabetic coma 13.18 10.55 8 54139 709 63434166
Renal hypertension 13.17 10.55 5 54142 154 63434721
Hyperglycaemic hyperosmolar nonketotic syndrome 13.15 10.55 9 54138 980 63433895
Lower respiratory tract infection 13.14 10.55 63 54084 132244 63302631
Blood test abnormal 13.10 10.55 36 54111 15593 63419282
Pulmonary fibrosis 13.01 10.55 9 54138 39800 63395075
Macrosomia 12.99 10.55 4 54143 64 63434811
Malaise 12.84 10.55 454 53693 415500 63019375
Sputum increased 12.82 10.55 13 54134 2446 63432429
Therapeutic drug monitoring analysis not performed 12.76 10.55 10 54137 1342 63433533
Ataxia 12.74 10.55 35 54112 15160 63419715
Sleep disorder 12.73 10.55 32 54115 81534 63353341
Congenital aortic valve stenosis 12.71 10.55 4 54143 69 63434806
Blindness cortical 12.67 10.55 7 54140 520 63434355
Intentional product use issue 12.65 10.55 61 54086 127831 63307044
Hepatotoxicity 12.61 10.55 8 54139 37033 63397842
Diabetic retinal oedema 12.61 10.55 6 54141 326 63434549
Incorrect dose administered by device 12.60 10.55 17 54130 4331 63430544
Abortion spontaneous 12.57 10.55 76 54071 47119 63387756
Intraventricular haemorrhage neonatal 12.54 10.55 5 54142 176 63434699
Blood insulin decreased 12.53 10.55 3 54144 17 63434858
Night sweats 12.38 10.55 14 54133 48800 63386075
Splenic thrombosis 12.38 10.55 3 54144 18 63434857
Dyspnoea exertional 12.37 10.55 91 54056 60211 63374664
Foetal macrosomia 12.35 10.55 4 54143 76 63434799
Hepatocellular injury 12.20 10.55 51 54096 27330 63407545
Pancreas transplant 12.11 10.55 3 54144 20 63434855
Pyoderma 12.10 10.55 6 54141 357 63434518
Sopor 12.08 10.55 44 54103 22120 63412755
End stage renal disease 12.07 10.55 21 54126 6672 63428203
Oedema peripheral 11.77 10.55 227 53920 189284 63245591
Vision blurred 11.73 10.55 125 54022 91799 63343076
Haemodialysis complication 11.65 10.55 5 54142 213 63434662
Polymorphic light eruption 11.52 10.55 3 54144 25 63434850
Suspected product quality issue 11.49 10.55 5 54142 220 63434655
Neutrophil count decreased 11.46 10.55 19 54128 56387 63378488
Febrile neutropenia 11.42 10.55 57 54090 118392 63316483
Unresponsive to stimuli 11.37 10.55 58 54089 33758 63401117
Neutropenia 11.36 10.55 95 54052 174910 63259965
Hypernatraemia 11.35 10.55 22 54125 7587 63427288
Jaundice neonatal 11.32 10.55 8 54139 917 63433958
C-reactive protein increased 11.32 10.55 42 54105 94665 63340210
Leukocytosis 11.31 10.55 48 54099 25887 63408988
Pancreatic carcinoma 11.31 10.55 22 54125 7606 63427269
Glucose-6-phosphate dehydrogenase deficiency 11.24 10.55 5 54142 232 63434643
Psychotic disorder 11.13 10.55 4 54143 25708 63409167
Hypothermia 11.11 10.55 31 54116 13550 63421325
Loss of personal independence in daily activities 11.08 10.55 44 54103 97246 63337629
Basal cell carcinoma 11.06 10.55 5 54142 27986 63406889
Ventricular septal defect 11.02 10.55 16 54131 4362 63430513
Foot deformity 10.97 10.55 5 54142 27848 63407027
Selective eating disorder 10.88 10.55 11 54136 2061 63432814
Pancreatitis acute 10.88 10.55 49 54098 27117 63407758
Accidental overdose 10.84 10.55 44 54103 23265 63411610
Respiratory tract haemorrhage 10.81 10.55 6 54141 450 63434425
Expired product administered 10.63 10.55 19 54128 6162 63428713
Eczema 10.59 10.55 55 54092 32236 63402639
Cardiac failure congestive 10.57 10.55 123 54024 92310 63342565

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 1153.21 10.92 804 49217 53836 34853074
Blood glucose increased 664.70 10.92 634 49387 66084 34840826
Diabetic ketoacidosis 644.98 10.92 371 49650 17661 34889249
Blood glucose decreased 356.15 10.92 227 49794 13010 34893900
Diabetes mellitus inadequate control 294.64 10.92 203 49818 13261 34893649
Hyperglycaemia 268.09 10.92 306 49715 39174 34867736
Appendicolith 220.21 10.92 143 49878 8458 34898452
Hypoglycaemic unconsciousness 211.09 10.92 68 49953 730 34906180
Hypoglycaemic coma 206.34 10.92 90 49931 2341 34904569
Blood glucose fluctuation 199.44 10.92 103 49918 3941 34902969
Appendicitis 159.09 10.92 147 49874 14660 34892250
Drug abuse 110.98 10.92 8 50013 99088 34807822
Cardiogenic shock 110.77 10.92 162 49859 26456 34880454
Toxicity to various agents 105.02 10.92 80 49941 200282 34706628
Stress 102.87 10.92 168 49853 30179 34876731
Ascites 100.20 10.92 212 49809 46359 34860551
Ketoacidosis 99.98 10.92 67 49954 4176 34902734
Blood phosphorus increased 89.48 10.92 80 49941 7641 34899269
Glycosylated haemoglobin increased 89.04 10.92 95 49926 11265 34895645
Abdominal distension 88.45 10.92 232 49789 58260 34848650
Diabetic retinopathy 85.92 10.92 45 49976 1772 34905138
Drug ineffective 79.16 10.92 361 49660 456390 34450520
Ventricular fibrillation 79.04 10.92 128 49893 22826 34884084
Blood glucose abnormal 75.65 10.92 65 49956 5887 34901023
Acute kidney injury 71.24 10.92 707 49314 304281 34602629
Hypoglycaemic seizure 70.41 10.92 24 49997 311 34906599
Product quality issue 68.44 10.92 102 49919 16933 34889977
Diabetic metabolic decompensation 67.54 10.92 38 49983 1728 34905182
Completed suicide 65.84 10.92 29 49992 98139 34808771
Product leakage 61.82 10.92 25 49996 535 34906375
Trisomy 18 57.27 10.92 26 49995 745 34906165
Diabetic foot 56.21 10.92 40 49981 2748 34904162
Hydrops foetalis 54.35 10.92 26 49995 841 34906069
Cleft lip and palate 53.10 10.92 26 49995 886 34906024
Anti-insulin antibody positive 52.89 10.92 17 50004 181 34906729
Hyponatraemia 52.54 10.92 246 49775 82445 34824465
Hyperkalaemia 49.76 10.92 214 49807 69175 34837735
Vomiting 48.79 10.92 555 49466 247066 34659844
Ultrasound antenatal screen 45.29 10.92 20 50001 536 34906374
Hypoglycaemia neonatal 44.74 10.92 30 49991 1871 34905039
Myasthenia gravis 39.16 10.92 49 49972 6891 34900019
Sepsis 39.15 10.92 387 49634 166174 34740736
General physical health deterioration 38.86 10.92 315 49706 127954 34778956
Chronic kidney disease 37.52 10.92 137 49884 41073 34865837
Diabetic neuropathy 34.48 10.92 36 49985 4161 34902749
Disease progression 34.27 10.92 64 49957 108013 34798897
Wrong product administered 33.90 10.92 40 49981 5294 34901616
Dry mouth 33.34 10.92 107 49914 30058 34876852
Insulin resistance 33.13 10.92 17 50004 641 34906269
Device malfunction 33.03 10.92 56 49965 10365 34896545
Abortion spontaneous 31.33 10.92 14 50007 386 34906524
Liquid product physical issue 31.30 10.92 15 50006 487 34906423
Multiple organ dysfunction syndrome 29.41 10.92 199 49822 76367 34830543
Febrile neutropenia 29.39 10.92 99 49922 136750 34770160
Pulmonary valve stenosis congenital 29.17 10.92 10 50011 132 34906778
Hypoglycaemia unawareness 28.83 10.92 10 50011 137 34906773
Diabetic nephropathy 28.60 10.92 24 49997 2104 34904806
Periodontitis 28.29 10.92 23 49998 1929 34904981
Constipation 27.79 10.92 309 49712 136673 34770237
Foetal exposure during pregnancy 27.67 10.92 118 49903 37983 34868927
Blood ketone body increased 26.91 10.92 13 50008 430 34906480
Cutaneous amyloidosis 26.36 10.92 7 50014 35 34906875
Infective pulmonary exacerbation of cystic fibrosis 26.28 10.92 40 49981 6761 34900149
Insulin autoimmune syndrome 25.25 10.92 11 50010 285 34906625
Abdominal pain 24.99 10.92 350 49671 163268 34743642
Diabetic ketoacidotic hyperglycaemic coma 24.50 10.92 9 50012 147 34906763
Drug therapy 24.47 10.92 17 50004 1124 34905786
Diabetic complication 24.10 10.92 14 50007 677 34906233
Treatment failure 23.95 10.92 19 50002 46678 34860232
Lymphangitis 23.92 10.92 13 50008 552 34906358
Product use in unapproved indication 23.23 10.92 88 49933 117411 34789499
Hyperphosphataemia 22.94 10.92 30 49991 4407 34902503
Diabetic macroangiopathy 22.62 10.92 5 50016 9 34906901
Vitreous haemorrhage 22.51 10.92 22 49999 2351 34904559
Gallbladder neoplasm 22.44 10.92 6 50015 31 34906879
Loss of consciousness 22.35 10.92 198 49823 82469 34824441
Bronchopneumopathy 22.29 10.92 12 50009 500 34906410
Blood uric acid increased 22.06 10.92 45 49976 9579 34897331
Nausea 22.01 10.92 639 49382 339269 34567641
Hypoglycaemic encephalopathy 21.94 10.92 10 50011 289 34906621
Analgesic therapy 21.71 10.92 15 50006 983 34905927
Toe amputation 21.37 10.92 22 49999 2502 34904408
Infusion related reaction 21.03 10.92 27 49994 53030 34853880
Cystic fibrosis 20.85 10.92 18 50003 1640 34905270
Pulmonary vasculitis 20.53 10.92 12 50009 587 34906323
Pemphigoid 20.44 10.92 41 49980 8625 34898285
Aggression 19.80 10.92 16 50005 38948 34867962
Hallucination 19.60 10.92 27 49994 51471 34855439
Congenital bladder anomaly 19.32 10.92 9 50012 274 34906636
Sleep disorder therapy 19.08 10.92 14 50007 1009 34905901
Congenital cystic kidney disease 18.86 10.92 10 50011 404 34906506
Hepatotoxicity 18.59 10.92 4 50017 21481 34885429
Anti-insulin antibody 18.51 10.92 5 50016 27 34906883
Diabetic coma 18.13 10.92 13 50008 904 34906006
Overdose 18.12 10.92 68 49953 90991 34815919
Diabetic ketosis 18.03 10.92 7 50014 134 34906776
Neuritis 17.91 10.92 13 50008 921 34905989
Skin ulcer 17.86 10.92 71 49950 22145 34884765
Genitalia external ambiguous 17.82 10.92 8 50013 223 34906687
Product physical issue 17.74 10.92 20 50001 2521 34904389
Dysmetria 17.71 10.92 11 50010 601 34906309
Varicose vein 17.55 10.92 15 50006 1348 34905562
Osteitis 17.37 10.92 16 50005 1588 34905322
Impaired gastric emptying 17.32 10.92 23 49998 3430 34903480
Diabetes mellitus 16.33 10.92 119 49902 46754 34860156
Haemolytic anaemia 16.26 10.92 42 49979 10437 34896473
Gingival hypertrophy 15.65 10.92 16 50005 1805 34905105
Cold sweat 15.47 10.92 40 49981 9947 34896963
Renal aplasia 15.47 10.92 11 50010 755 34906155
Adenocarcinoma pancreas 15.45 10.92 14 50007 1360 34905550
Therapeutic drug monitoring analysis incorrectly performed 15.16 10.92 8 50013 320 34906590
Vitamin B12 increased 14.73 10.92 8 50013 339 34906571
Polycythaemia neonatorum 14.58 10.92 3 50018 3 34906907
Peripheral artery haematoma 14.31 10.92 5 50016 70 34906840
Wrong technique in device usage process 14.31 10.92 14 50007 1498 34905412
Diabetic foot infection 14.29 10.92 10 50011 669 34906241
Therapeutic product effect incomplete 14.25 10.92 32 49989 50509 34856401
Insulin-requiring type 2 diabetes mellitus 14.16 10.92 6 50015 145 34906765
Hyperinsulinaemic hypoglycaemia 14.12 10.92 5 50016 73 34906837
Diabetic gangrene 14.07 10.92 7 50014 247 34906663
Drug resistance 14.00 10.92 10 50011 25917 34880993
Fine motor skill dysfunction 13.99 10.92 15 50006 1787 34905123
Foetal hypokinesia 13.98 10.92 8 50013 376 34906534
Euglycaemic diabetic ketoacidosis 13.96 10.92 20 50001 3202 34903708
Truncus arteriosus persistent 13.93 10.92 4 50017 28 34906882
Cardiac output decreased 13.88 10.92 11 50010 889 34906021
Pancreatitis 13.70 10.92 99 49922 38792 34868118
Eye haemorrhage 13.46 10.92 23 49998 4282 34902628
Blood pressure fluctuation 13.29 10.92 10 50011 25239 34881671
Neonatal respiratory depression 13.22 10.92 8 50013 417 34906493
Incorrect route of product administration 13.21 10.92 49 49972 14796 34892114
Pain 13.09 10.92 210 49811 204465 34702445
Mucosal inflammation 13.01 10.92 22 49999 38600 34868310
Dry gangrene 12.98 10.92 8 50013 431 34906479
Herpes zoster reactivation 12.91 10.92 7 50014 296 34906614
Sedation 12.86 10.92 7 50014 20999 34885911
Haematochezia 12.68 10.92 30 49991 46504 34860406
Treatment noncompliance 12.61 10.92 76 49945 28024 34878886
Hepatocellular carcinoma 12.60 10.92 31 49990 7478 34899432
Therapy non-responder 12.55 10.92 23 49998 39123 34867787
Anxiety 12.51 10.92 87 49934 99341 34807569
Spermatic cord disorder 12.51 10.92 3 50018 9 34906901
Myelosuppression 12.42 10.92 6 50015 19259 34887651
Gangrene 12.41 10.92 23 49998 4563 34902347
Increased insulin requirement 12.41 10.92 5 50016 106 34906804
Device failure 12.18 10.92 16 50005 2360 34904550
Product administration error 12.16 10.92 51 49970 16293 34890617
Hepatic cirrhosis 12.09 10.92 53 49968 17261 34889649
Ketosis 12.06 10.92 8 50013 490 34906420
Product storage error 12.04 10.92 32 49989 8090 34898820
Basophil count abnormal 11.84 10.92 3 50018 12 34906898
Headache 11.80 10.92 209 49812 200426 34706484
Microalbuminuria 11.74 10.92 9 50012 693 34906217
Product complaint 11.72 10.92 26 49995 5864 34901046
Serotonin syndrome 11.69 10.92 7 50014 19926 34886984
Death 11.63 10.92 459 49562 397590 34509320
Neutrophil count decreased 11.63 10.92 36 49985 51068 34855842
Off label use 11.57 10.92 487 49534 419037 34487873
Heart disease congenital 11.56 10.92 12 50009 1378 34905532
Hunger 11.51 10.92 13 50008 1641 34905269
Postprandial hypoglycaemia 11.47 10.92 3 50018 14 34906896
Funguria 11.45 10.92 4 50017 56 34906854
Incorrect dose administered 11.44 10.92 98 49923 40417 34866493
Hypospadias 11.22 10.92 18 50003 3183 34903727
Nasopharyngitis 11.03 10.92 57 49964 69911 34836999
Heart rate increased 11.01 10.92 32 49989 46311 34860599
Stenosis 10.98 10.92 12 50009 1461 34905449
Haemorrhagic stroke 10.97 10.92 27 49994 6512 34900398

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 2272.85 9.92 1408 86842 100186 79555952
Diabetic ketoacidosis 1888.49 9.92 866 87384 33256 79622882
Blood glucose increased 1508.24 9.92 1147 87103 113828 79542310
Blood glucose decreased 689.57 9.92 404 87846 25830 79630308
Hyperglycaemia 614.35 9.92 555 87695 69780 79586358
Diabetes mellitus inadequate control 581.25 9.92 352 87898 23912 79632226
Hypoglycaemic coma 371.20 9.92 154 88096 4606 79651532
Hypoglycaemic unconsciousness 348.00 9.92 103 88147 1080 79655058
Blood glucose fluctuation 324.13 9.92 155 88095 6527 79649611
Acute kidney injury 277.61 9.92 1223 87027 518181 79137957
Ketoacidosis 274.70 9.92 146 88104 7708 79648430
Appendicolith 252.16 9.92 142 88108 8409 79647729
Diabetic retinopathy 237.17 9.92 99 88151 3007 79653131
Glycosylated haemoglobin increased 231.93 9.92 183 88067 19077 79637061
Product leakage 198.73 9.92 64 88186 906 79655232
Diabetic metabolic decompensation 194.90 9.92 88 88162 3244 79652894
Appendicitis 169.52 9.92 158 88092 20636 79635502
Drug ineffective 164.74 9.92 629 87621 1080284 78575854
Product quality issue 162.23 9.92 194 88056 33746 79622392
Blood glucose abnormal 150.56 9.92 111 88139 10455 79645683
Toxicity to various agents 149.17 9.92 148 88102 421392 79234746
Completed suicide 132.58 9.92 53 88197 245714 79410424
Synovitis 128.81 9.92 10 88240 150724 79505414
Arthropathy 121.77 9.92 24 88226 177087 79479051
Hypoglycaemic seizure 119.78 9.92 42 88208 782 79655356
Infusion related reaction 111.17 9.92 58 88192 230179 79425959
Joint swelling 105.92 9.92 98 88152 288548 79367590
Anti-insulin antibody positive 105.85 9.92 30 88220 266 79655872
Hand deformity 101.14 9.92 3 88247 103916 79552222
Drug intolerance 100.10 9.92 87 88163 264032 79392106
Hyperkalaemia 99.85 9.92 316 87934 114082 79542056
Cardiogenic shock 97.27 9.92 170 88080 41744 79614394
Liquid product physical issue 94.98 9.92 39 88211 1135 79655003
Treatment failure 94.84 9.92 35 88215 170451 79485687
Arthralgia 92.45 9.92 324 87926 571479 79084659
Diabetic neuropathy 92.41 9.92 67 88183 6149 79649989
Alopecia 91.62 9.92 73 88177 231282 79424856
Blood phosphorus increased 90.91 9.92 82 88168 10265 79645873
Abdominal distension 89.73 9.92 314 87936 119336 79536802
Hypoglycaemia unawareness 89.09 9.92 25 88225 213 79655925
Contraindicated product administered 88.21 9.92 32 88218 157506 79498632
Pain 87.11 9.92 442 87808 703360 78952778
Ascites 80.45 9.92 224 88026 75338 79580800
Glossodynia 80.05 9.92 10 88240 103327 79552811
Stress 77.01 9.92 228 88022 79384 79576754
Rheumatoid arthritis 76.18 9.92 71 88179 208399 79447739
Infective pulmonary exacerbation of cystic fibrosis 75.91 9.92 82 88168 12769 79643369
Drug abuse 75.57 9.92 43 88207 162648 79493490
Therapeutic product effect decreased 75.14 9.92 44 88206 163819 79492319
Hyper IgE syndrome 75.02 9.92 27 88223 544 79655594
Ventricular fibrillation 74.74 9.92 130 88120 31796 79624342
Diabetic ketosis 74.65 9.92 26 88224 474 79655664
Hydrops foetalis 73.86 9.92 29 88221 749 79655389
Chronic kidney disease 73.29 9.92 199 88051 65955 79590183
Systemic lupus erythematosus 72.38 9.92 22 88228 121127 79535011
Lactic acidosis 70.44 9.92 204 88046 70155 79585983
Ultrasound antenatal screen 69.92 9.92 27 88223 666 79655472
Diabetic foot 67.73 9.92 45 88205 3587 79652551
Wrong product administered 66.83 9.92 65 88185 8947 79647191
Oesophageal spasm 64.88 9.92 43 88207 3413 79652725
Pericarditis 63.97 9.92 18 88232 104218 79551920
Insulin resistance 63.88 9.92 31 88219 1348 79654790
Ketosis 63.52 9.92 29 88221 1097 79655041
Vomiting 62.54 9.92 1059 87191 664769 78991369
Trisomy 18 62.42 9.92 24 88226 585 79655553
Cleft lip and palate 59.25 9.92 24 88226 674 79655464
Helicobacter infection 58.49 9.92 5 88245 69699 79586439
Abdominal pain 57.73 9.92 672 87578 388897 79267241
Exposure during pregnancy 56.64 9.92 242 88008 100890 79555248
Oesophageal pain 54.41 9.92 42 88208 4237 79651901
Sinusitis 53.93 9.92 83 88167 195418 79460720
Euglycaemic diabetic ketoacidosis 53.85 9.92 51 88199 6793 79649345
Abdominal discomfort 52.13 9.92 126 88124 250601 79405537
Heart sounds 51.74 9.92 24 88226 942 79655196
Blood ketone body increased 51.74 9.92 22 88228 700 79655438
Diabetic nephropathy 51.33 9.92 35 88215 2912 79653226
Irritable bowel syndrome 50.79 9.92 5 88245 62236 79593902
Sepsis 49.32 9.92 485 87765 268943 79387195
Product physical issue 48.74 9.92 39 88211 4146 79651992
Musculoskeletal stiffness 48.56 9.92 74 88176 174934 79481204
Discomfort 48.01 9.92 41 88209 125576 79530562
Diabetic ketoacidotic hyperglycaemic coma 46.47 9.92 15 88235 214 79655924
Prolonged expiration 45.50 9.92 24 88226 1247 79654891
Folliculitis 43.77 9.92 5 88245 55375 79600763
Restrictive pulmonary disease 43.26 9.92 30 88220 2565 79653573
Therapeutic product effect incomplete 43.17 9.92 56 88194 141589 79514549
Dehydration 42.16 9.92 440 87810 247747 79408391
Ketonuria 40.96 9.92 22 88228 1186 79654952
Nasopharyngitis 40.82 9.92 144 88106 253737 79402401
Muscle injury 39.36 9.92 4 88246 48557 79607581
Product use in unapproved indication 38.93 9.92 144 88106 250215 79405923
Hyponatraemia 37.99 9.92 331 87919 177517 79478621
Myasthenia gravis 37.94 9.92 52 88198 10347 79645791
Multiple organ dysfunction syndrome 37.68 9.92 245 88005 120001 79536137
Mobility decreased 37.54 9.92 48 88202 122127 79534011
C-reactive protein abnormal 36.69 9.92 5 88245 48362 79607776
Cystic fibrosis 36.57 9.92 32 88218 3848 79652290
Headache 36.13 9.92 508 87742 653264 79002874
Drug hypersensitivity 36.12 9.92 189 88061 298727 79357411
Diabetes mellitus 36.02 9.92 177 88073 78213 79577925
Pemphigoid 35.37 9.92 62 88188 15253 79640885
Hyperhidrosis 35.02 9.92 287 87963 151205 79504933
Dyslipidaemia 34.88 9.92 53 88197 11580 79644558
Hypoglycaemic encephalopathy 34.10 9.92 16 88234 645 79655493
Loss of consciousness 34.03 9.92 309 87941 167634 79488504
Hepatic enzyme increased 33.95 9.92 97 88153 182513 79473625
Device malfunction 33.89 9.92 74 88176 21374 79634764
Pancreatitis 33.79 9.92 158 88092 68417 79587721
Insulin autoimmune syndrome 33.76 9.92 14 88236 418 79655720
Polycystic ovaries 33.30 9.92 30 88220 3749 79652389
Off label use 32.45 9.92 761 87489 906454 78749684
Cutaneous amyloidosis 31.69 9.92 8 88242 43 79656095
Hypersensitivity 31.57 9.92 166 88084 262073 79394065
Febrile neutropenia 30.82 9.92 141 88109 230858 79425280
Pre-eclampsia 30.01 9.92 38 88212 7003 79649135
Therapeutic drug monitoring analysis incorrectly performed 29.91 9.92 15 88235 701 79655437
Vitreous haemorrhage 29.85 9.92 28 88222 3685 79652453
Wound 29.53 9.92 52 88198 116127 79540011
Hospitalisation 29.52 9.92 192 88058 94044 79562094
Hip arthroplasty 28.84 9.92 3 88247 35753 79620385
Product administration error 28.71 9.92 89 88161 31757 79624381
Respiration abnormal 28.50 9.92 39 88211 7749 79648389
Sleep apnoea syndrome 28.42 9.92 97 88153 36381 79619757
Caesarean section 27.99 9.92 50 88200 12485 79643653
Drug therapy 27.66 9.92 17 88233 1184 79654954
Hepatic encephalopathy 27.06 9.92 73 88177 24093 79632045
Myocardial infarction 26.93 9.92 317 87933 183812 79472326
Impaired gastric emptying 26.67 9.92 44 88206 10309 79645829
Polyuria 26.27 9.92 54 88196 14960 79641178
Hepatotoxicity 26.18 9.92 12 88238 51340 79604798
Lymphoedema 25.80 9.92 48 88202 12365 79643773
Cold sweat 25.65 9.92 61 88189 18638 79637500
Diabetic hepatopathy 25.58 9.92 5 88245 5 79656133
Increased insulin requirement 25.16 9.92 9 88241 178 79655960
Analgesic therapy 25.08 9.92 15 88235 994 79655144
Device operational issue 25.00 9.92 11 88239 381 79655757
Hyperphosphataemia 24.97 9.92 33 88217 6343 79649795
Renal failure 24.70 9.92 335 87915 200633 79455505
Dyspnoea 24.35 9.92 1170 87080 855855 78800283
Gastrointestinal disorder 24.14 9.92 63 88187 122142 79533996
Hepatocellular carcinoma 24.13 9.92 39 88211 8982 79647156
Dialysis 24.01 9.92 59 88191 18403 79637735
Device failure 23.89 9.92 32 88218 6229 79649909
Disease progression 23.72 9.92 114 88136 184248 79471890
Fluid retention 23.58 9.92 145 88105 69664 79586474
Coronavirus test positive 23.53 9.92 15 88235 1114 79655024
Blood ketone body 23.49 9.92 8 88242 136 79656002
Lethargy 23.28 9.92 162 88088 81130 79575008
Fracture blisters 23.18 9.92 7 88243 79 79656059
Red blood cell sedimentation rate increased 23.01 9.92 11 88239 45931 79610207
Bronchopneumopathy 22.92 9.92 13 88237 780 79655358
Therapy non-responder 22.84 9.92 42 88208 92263 79563875
Psoriatic arthropathy 22.58 9.92 32 88218 77967 79578171
Diabetic gastroparesis 22.58 9.92 10 88240 352 79655786
Sleep disorder therapy 22.33 9.92 14 88236 1010 79655128
Ill-defined disorder 22.25 9.92 24 88226 65851 79590287
Blood uric acid increased 22.15 9.92 47 88203 13313 79642825
Product use issue 21.93 9.92 139 88111 209683 79446455
Impaired healing 21.59 9.92 40 88210 87615 79568523
Fear-related avoidance of activities 21.55 9.92 7 88243 102 79656036
Rash 21.50 9.92 482 87768 577876 79078262
Neutrophil count decreased 21.31 9.92 45 88205 93914 79562224
Drug resistance 21.31 9.92 10 88240 42203 79613935
International normalised ratio abnormal 21.28 9.92 29 88221 5739 79650399
Myelosuppression 21.20 9.92 9 88241 40287 79615851
Blood pressure fluctuation 21.02 9.92 26 88224 67119 79589019
Rales 20.99 9.92 59 88191 19942 79636196
Incorrect dose administered 20.95 9.92 151 88099 76479 79579659
Intentional product use issue 20.79 9.92 92 88158 152020 79504118
Pulmonary vasculitis 20.72 9.92 12 88238 749 79655389
Treatment noncompliance 20.53 9.92 113 88137 52155 79603983
Lymphangitis 20.53 9.92 15 88235 1393 79654745
Constipation 20.51 9.92 433 87817 282617 79373521
Lower respiratory tract infection 20.28 9.92 74 88176 129146 79526992
Type 1 diabetes mellitus 20.01 9.92 31 88219 6888 79649250
Pancreatitis acute 20.00 9.92 108 88142 49496 79606642
Hyperglycaemic hyperosmolar nonketotic syndrome 19.74 9.92 18 88232 2285 79653853
Swelling 19.48 9.92 150 88100 216561 79439577
Decreased insulin requirement 19.31 9.92 7 88243 144 79655994
Diabetic macroangiopathy 19.27 9.92 7 88243 145 79655993
Foetal macrosomia 19.19 9.92 4 88246 7 79656131
C-reactive protein increased 18.89 9.92 76 88174 128951 79527187
Bursitis 18.86 9.92 8 88242 35836 79620302
Insulin-requiring type 2 diabetes mellitus 18.75 9.92 7 88243 157 79655981
Appetite disorder 18.75 9.92 32 88218 7707 79648431
Gallbladder neoplasm 18.63 9.92 6 88244 85 79656053
Urosepsis 18.53 9.92 68 88182 26427 79629711
Cellulitis 18.33 9.92 193 88057 108867 79547271
Heart rate decreased 18.30 9.92 31 88219 70285 79585853
Polyhydramnios 17.87 9.92 15 88235 1705 79654433
Infection 17.87 9.92 176 88074 241536 79414602
Adenocarcinoma pancreas 17.64 9.92 16 88234 2017 79654121
Neuritis 17.58 9.92 15 88235 1743 79654395
Adverse drug reaction 17.53 9.92 29 88221 66363 79589775
Hyperglycaemic unconsciousness 17.42 9.92 3 88247 0 79656138
Haemorrhagic stroke 17.33 9.92 38 88212 11008 79645130
Hypervolaemia 17.24 9.92 93 88157 42597 79613541
Dyspepsia 17.21 9.92 62 88188 108625 79547513
Periodontitis 17.19 9.92 23 88227 4473 79651665
Product container issue 17.14 9.92 13 88237 1278 79654860
White blood cell count decreased 17.07 9.92 130 88120 188158 79467980
Anti-insulin antibody increased 16.85 9.92 6 88244 117 79656021
Product dispensing error 16.84 9.92 42 88208 13221 79642917
Device expulsion 16.75 9.92 4 88246 25857 79630281
Knee arthroplasty 16.66 9.92 14 88236 43234 79612904
Arthritis 16.60 9.92 68 88182 114812 79541326
Gangrene 16.59 9.92 33 88217 8931 79647207
Angina pectoris 16.56 9.92 106 88144 51626 79604512
Toe amputation 16.50 9.92 21 88229 3890 79652248
Blood insulin increased 16.40 9.92 8 88242 352 79655786
Foetal hypokinesia 16.31 9.92 8 88242 356 79655782
General physical health deterioration 16.20 9.92 409 87841 274829 79381309
Poisoning 16.19 9.92 4 88246 25268 79630870
Adverse event 16.18 9.92 26 88224 60188 79595950
Depressive symptom 16.15 9.92 27 88223 6396 79649742
Subgaleal haematoma 16.14 9.92 6 88244 133 79656005
Wrong technique in device usage process 16.01 9.92 21 88229 4007 79652131
Cerebrovascular accident 15.97 9.92 251 87999 155041 79501097
End stage renal disease 15.83 9.92 39 88211 12181 79643957
Metabolic acidosis 15.77 9.92 150 88100 82379 79573759
Hypothermia 15.59 9.92 58 88192 22688 79633450
Hypernatraemia 15.53 9.92 43 88207 14408 79641730
Anti-insulin antibody 15.45 9.92 5 88245 72 79656066
Suspected product tampering 15.35 9.92 3 88247 3 79656135
Hyperglycaemic seizure 15.35 9.92 3 88247 3 79656135
Injection site reaction 15.34 9.92 23 88227 54762 79601376
Respiratory arrest 15.32 9.92 25 88225 57525 79598613
Contusion 15.31 9.92 99 88151 148677 79507461
Diabetic coma 15.30 9.92 12 88238 1239 79654899
Product storage error 15.23 9.92 46 88204 16180 79639958
Diabetic hyperosmolar coma 15.16 9.92 10 88240 787 79655351
Hyperinsulinaemic hypoglycaemia 15.10 9.92 6 88244 160 79655978
Fatigue 15.04 9.92 859 87391 928868 78727270
Neutropenia 14.98 9.92 226 88024 287484 79368654
Acute painful neuropathy of rapid glycaemic control 14.89 9.92 3 88247 4 79656134
Immunodeficiency 14.84 9.92 3 88247 21765 79634373
Rhabdomyolysis 14.82 9.92 177 88073 102954 79553184
Erythema 14.71 9.92 167 88083 223123 79433015
Inflammation 14.50 9.92 54 88196 93699 79562439
Suspected product quality issue 14.31 9.92 7 88243 310 79655828
Cholestatic liver injury 14.10 9.92 22 88228 4919 79651219
Blood ketone body present 14.07 9.92 5 88245 97 79656041
Oedema peripheral 14.00 9.92 372 87878 251916 79404222
Abortion spontaneous 13.82 9.92 67 88183 29440 79626698
Sputum increased 13.81 9.92 21 88229 4592 79651546
Premature delivery 13.78 9.92 57 88193 23410 79632728
Fall 13.64 9.92 665 87585 486964 79169174
Blister 13.61 9.92 77 88173 119399 79536739
Eye haemorrhage 13.57 9.92 32 88218 9725 79646413
Diabetic gangrene 13.55 9.92 6 88244 211 79655927
Lymphangiectasia 13.53 9.92 5 88245 109 79656029
Coronary artery disease 13.52 9.92 121 88129 65353 79590785
Glucose-6-phosphate dehydrogenase deficiency 13.50 9.92 7 88243 351 79655787
Diabetic retinal oedema 13.48 9.92 7 88243 352 79655786
Generalised oedema 13.47 9.92 57 88193 23652 79632486
Gingival hypertrophy 13.46 9.92 17 88233 3125 79653013
Somnolence 13.44 9.92 353 87897 238628 79417510
Dry gangrene 13.22 9.92 10 88240 979 79655159
Hepatocellular injury 13.13 9.92 94 88156 47499 79608639
Oral herpes 13.11 9.92 7 88243 27447 79628691
Flank pain 13.10 9.92 50 88200 19794 79636344
Peritonitis bacterial 12.89 9.92 31 88219 9536 79646602
Leg amputation 12.88 9.92 18 88232 3648 79652490
Loss of personal independence in daily activities 12.86 9.92 64 88186 102516 79553622
Peripheral artery haematoma 12.85 9.92 5 88245 126 79656012
Fine motor skill dysfunction 12.78 9.92 22 88228 5335 79650803
Drug clearance decreased 12.69 9.92 17 88233 3310 79652828
Product complaint 12.68 9.92 38 88212 13311 79642827
Mesenteric arterial occlusion 12.67 9.92 6 88244 247 79655891
Hypoaesthesia 12.67 9.92 132 88118 179220 79476918
Night sweats 12.63 9.92 24 88226 52071 79604067
Incorrect dose administered by device 12.58 9.92 21 88229 4968 79651170
Product odour abnormal 12.50 9.92 11 88239 1333 79654805
Osteoarthritis 12.42 9.92 52 88198 87257 79568881
Intentional overdose 12.35 9.92 175 88075 105785 79550353
Swollen tongue 12.28 9.92 85 88165 42485 79613653
Suicide attempt 12.21 9.92 143 88107 82789 79573349
Sleep disorder due to a general medical condition 12.04 9.92 39 88211 14238 79641900
Dialysis device insertion 12.03 9.92 4 88246 63 79656075
Blood potassium increased 11.97 9.92 64 88186 29211 79626927
Mental status changes 11.96 9.92 120 88130 66839 79589299
Nonreassuring foetal heart rate pattern 11.90 9.92 3 88247 16 79656122
Cardiac failure 11.90 9.92 239 88011 154603 79501535
Acute myocardial infarction 11.86 9.92 134 88116 76902 79579236
Progressive multifocal leukoencephalopathy 11.84 9.92 4 88246 20596 79635542
Suicidal ideation 11.79 9.92 44 88206 76296 79579842
Pyoderma 11.77 9.92 7 88243 459 79655679
Nightmare 11.77 9.92 7 88243 25854 79630284
Foot deformity 11.70 9.92 6 88244 24068 79632070
Glomerular filtration rate decreased 11.69 9.92 53 88197 22649 79633489
Microalbuminuria 11.65 9.92 9 88241 909 79655229
Anaemia 11.64 9.92 603 87647 444412 79211726
Hypokalaemia 11.63 9.92 224 88026 143816 79512322
Multiple use of single-use product 11.60 9.92 9 88241 915 79655223
Neisseria infection 11.48 9.92 5 88245 169 79655969
Retrograde ejaculation 11.42 9.92 6 88244 309 79655829
Abscess 11.39 9.92 53 88197 22898 79633240
Haematochezia 11.38 9.92 54 88196 87591 79568547
Therapeutic response decreased 11.35 9.92 37 88213 66816 79589322
Grip strength decreased 11.32 9.92 5 88245 21864 79634274
Foot amputation 11.23 9.92 9 88241 959 79655179
Vision blurred 11.20 9.92 172 88078 105726 79550412
Subdural haemorrhage 11.13 9.92 22 88228 5926 79650212
Carcinoid crisis 11.03 9.92 7 88243 516 79655622
Postprandial hypoglycaemia 11.00 9.92 4 88246 83 79656055
Large intestine polyp 10.98 9.92 35 88215 12673 79643465
Acetonaemia 10.96 9.92 6 88244 336 79655802
Dystonia 10.91 9.92 5 88245 21394 79634744
Mydriasis 10.91 9.92 3 88247 17640 79638498
Multiple lentigines syndrome 10.81 9.92 5 88245 195 79655943
Lack of application site rotation 10.79 9.92 4 88246 88 79656050
Productive cough 10.74 9.92 147 88103 88184 79567954
Acute myeloid leukaemia 10.71 9.92 11 88239 30874 79625264
Troponin increased 10.71 9.92 46 88204 19209 79636929
Neoplasm progression 10.70 9.92 26 88224 51656 79604482
Therapy partial responder 10.68 9.92 3 88247 17394 79638744
Septic necrosis 10.66 9.92 4 88246 91 79656047
Polymorphic light eruption 10.65 9.92 3 88247 26 79656112
Blindness transient 10.60 9.92 19 88231 4757 79651381
Drug dependence 10.58 9.92 18 88232 40751 79615387
Blood pressure diastolic abnormal 10.57 9.92 4 88246 19198 79636940
Vascular purpura 10.57 9.92 15 88235 3083 79653055
High risk pregnancy 10.54 9.92 4 88246 94 79656044
Osteitis 10.48 9.92 17 88233 3926 79652212
Diabetic foot infection 10.43 9.92 8 88242 799 79655339
Basophil count abnormal 10.35 9.92 3 88247 29 79656109
Renal impairment 10.34 9.92 238 88012 157545 79498593
Butterfly rash 10.33 9.92 11 88239 1685 79654453
Conjunctivitis 10.31 9.92 8 88242 25707 79630431
Hot flush 10.30 9.92 29 88221 54848 79601290
Cystic fibrosis related diabetes 10.23 9.92 5 88245 221 79655917
Hepatic cytolysis 10.20 9.92 58 88192 27093 79629045
Basal cell carcinoma 10.17 9.92 16 88234 37359 79618779
Psychomotor hyperactivity 10.17 9.92 3 88247 16846 79639292
Maculopathy 10.12 9.92 14 88236 2811 79653327
Psychotic disorder 10.10 9.92 19 88231 41383 79614755
Sedation 10.06 9.92 27 88223 51868 79604270
Pregnancy 9.97 9.92 9 88241 26842 79629296
Accidental underdose 9.97 9.92 8 88242 854 79655284
Medication error 9.95 9.92 118 88132 68524 79587614
Drug reaction with eosinophilia and systemic symptoms 9.94 9.92 37 88213 64207 79591931

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10AB05 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, fast-acting
ATC A10AD05 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
ATC A10AD06 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
INSULINS AND ANALOGUES
Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
FDA CS M0011417 Insulin
FDA EPC N0000175453 Insulin Analog
CHEBI has role CHEBI:35526 antidiabetic
FDA EPC N0000175944 Insulin
MeSH PA D007004 Hypoglycemic Agents

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
D04475 KEGG_DRUG
4021226 VUID
N0000148670 NUI
4017559 VANDF
4017569 VANDF
4019786 VANDF
4021226 VANDF
4021394 VANDF
CHEBI:5931 CHEBI
CHEMBL1201496 ChEMBL_ID
CHEMBL1201664 ChEMBL_ID
DB01306 DRUGBANK_ID
DB00030 DRUGBANK_ID
253182 RXNORM
15636 MMSL
17095 MMSL
327602 MMSL
37703 MMSL
4885 MMSL
4886 MMSL
d00262 MMSL
d04369 MMSL
d04697 MMSL
d04838 MMSL
000869 NDDF
000870 NDDF
006518 NDDF
007992 NDDF
009607 NDDF
126210001 SNOMEDCT_US
325072002 SNOMEDCT_US
388452006 SNOMEDCT_US
417423002 SNOMEDCT_US
420609005 SNOMEDCT_US
427292001 SNOMEDCT_US
96367001 SNOMEDCT_US
D061267 MESH_DESCRIPTOR_UI
C1708521 UMLSCUI
C0795635 UMLSCUI
7541 INN_ID
16132418 PUBCHEM_CID
5186 INN_ID
118984375 PUBCHEM_CID
D933668QVX UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
NOVOLOG HUMAN PRESCRIPTION DRUG LABEL 1 0169-2100 INJECTION, SOLUTION 100 [iU] INTRAVENOUS BLA 29 sections
NOVOLOG HUMAN PRESCRIPTION DRUG LABEL 1 0169-2100 INJECTION, SOLUTION 100 [iU] INTRAVENOUS BLA 29 sections
NOVOLOG HUMAN PRESCRIPTION DRUG LABEL 1 0169-2101 INJECTION, SOLUTION 100 [iU] INTRAVENOUS BLA 29 sections
NOVOLOG HUMAN PRESCRIPTION DRUG LABEL 1 0169-2101 INJECTION, SOLUTION 100 [iU] INTRAVENOUS BLA 29 sections
NovoLog Mix 70/30 HUMAN PRESCRIPTION DRUG LABEL 1 0169-2200 INJECTION, SUSPENSION 100 [iU] SUBCUTANEOUS BLA 27 sections
NovoLog Mix 70/30 HUMAN PRESCRIPTION DRUG LABEL 1 0169-2200 INJECTION, SUSPENSION 100 [iU] SUBCUTANEOUS BLA 27 sections
NovoLog Mix 70/30 HUMAN PRESCRIPTION DRUG LABEL 1 0169-2201 INJECTION, SUSPENSION 100 [iU] SUBCUTANEOUS BLA 27 sections
NovoLog Mix 70/30 HUMAN PRESCRIPTION DRUG LABEL 1 0169-2201 INJECTION, SUSPENSION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3201 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3201 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3201 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3201 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3204 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3204 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3204 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3204 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3205 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3205 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3205 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3205 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Fiasp HUMAN PRESCRIPTION DRUG LABEL 1 0169-3206 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
NOVOLOG HUMAN PRESCRIPTION DRUG LABEL 1 0169-3303 INJECTION, SOLUTION 100 [iU] INTRAVENOUS BLA 29 sections
NOVOLOG HUMAN PRESCRIPTION DRUG LABEL 1 0169-3303 INJECTION, SOLUTION 100 [iU] INTRAVENOUS BLA 29 sections
NovoLog Mix 70/30 HUMAN PRESCRIPTION DRUG LABEL 1 0169-3685 INJECTION, SUSPENSION 100 [iU] SUBCUTANEOUS BLA 27 sections
NovoLog Mix 70/30 HUMAN PRESCRIPTION DRUG LABEL 1 0169-3685 INJECTION, SUSPENSION 100 [iU] SUBCUTANEOUS BLA 27 sections
NovoLog Mix 70/30 HUMAN PRESCRIPTION DRUG LABEL 1 0169-3696 INJECTION, SUSPENSION 100 [iU] SUBCUTANEOUS BLA 27 sections
NovoLog Mix 70/30 HUMAN PRESCRIPTION DRUG LABEL 1 0169-3696 INJECTION, SUSPENSION 100 [iU] SUBCUTANEOUS BLA 27 sections
NOVOLOG HUMAN PRESCRIPTION DRUG LABEL 1 0169-6338 INJECTION, SOLUTION 100 [iU] INTRAVENOUS BLA 29 sections
NOVOLOG HUMAN PRESCRIPTION DRUG LABEL 1 0169-6338 INJECTION, SOLUTION 100 [iU] INTRAVENOUS BLA 29 sections
NOVOLOG HUMAN PRESCRIPTION DRUG LABEL 1 0169-6339 INJECTION, SOLUTION 100 [iU] INTRAVENOUS BLA 29 sections