insulin glargine 🐶 Veterinary Use | 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 3467.47 9.55 2339 150650 68985 50383150
Hypoglycaemia 3106.78 9.55 1963 151026 51618 50400517
Diabetic ketoacidosis 1827.36 9.55 949 152040 16923 50435212
Hyperglycaemia 1082.33 9.55 890 152099 35515 50416620
Diabetes mellitus inadequate control 1037.02 9.55 588 152401 12557 50439578
Blood glucose decreased 1013.30 9.55 651 152338 17560 50434575
Glycosylated haemoglobin increased 781.91 9.55 454 152535 10152 50441983
Device operational issue 677.92 9.55 157 152832 99 50452036
Blood glucose abnormal 527.59 9.55 299 152690 6373 50445762
Ketoacidosis 498.48 9.55 241 152748 3654 50448481
Blood glucose fluctuation 405.90 9.55 214 152775 3932 50448203
Lactic acidosis 376.50 9.55 484 152505 32871 50419264
Acute kidney injury 361.51 9.55 1505 151484 226553 50225582
Systemic lupus erythematosus 338.51 9.55 22 152967 140600 50311535
Pemphigus 329.06 9.55 7 152982 120159 50331976
Contraindicated product administered 299.92 9.55 46 152943 148912 50303223
Hyperkalaemia 283.47 9.55 516 152473 47573 50404562
Synovitis 282.20 9.55 25 152964 123840 50328295
Glossodynia 278.36 9.55 18 152971 115551 50336584
Diabetic retinopathy 277.54 9.55 135 152854 2075 50450060
Hypoglycaemic coma 276.52 9.55 137 152852 2196 50449939
Treatment failure 273.70 9.55 44 152945 137593 50314542
Hand deformity 269.83 9.55 7 152982 100192 50351943
Alopecia 268.28 9.55 209 152780 244838 50207297
Product storage error 255.53 9.55 245 152744 11979 50440156
Joint swelling 238.49 9.55 234 152755 245052 50207083
Infusion related reaction 236.94 9.55 108 152881 169449 50282686
Renal failure 227.84 9.55 775 152214 105858 50346277
Drug intolerance 221.20 9.55 202 152787 218902 50233233
Arthropathy 216.88 9.55 103 152886 157803 50294332
Anti-cyclic citrullinated peptide antibody positive 193.63 9.55 4 152985 70583 50381552
Abdominal discomfort 188.34 9.55 255 152734 231386 50220749
Drug ineffective 176.32 9.55 1609 151380 817724 49634411
Drug hypersensitivity 172.89 9.55 309 152680 250701 50201434
Pericarditis 166.07 9.55 21 152968 78668 50373467
Pain 164.79 9.55 1051 151938 577852 49874283
Diabetic metabolic decompensation 152.31 9.55 79 152910 1401 50450734
Swelling 148.67 9.55 236 152753 200636 50251499
Rheumatoid arthritis 148.00 9.55 240 152749 202310 50249825
Cerebrovascular accident 147.35 9.55 622 152367 94058 50358077
Discomfort 142.28 9.55 75 152914 108305 50343830
Hypoglycaemic unconsciousness 137.71 9.55 59 152930 663 50451472
Cardiac failure congestive 131.80 9.55 555 152434 83827 50368308
Rheumatoid factor positive 128.77 9.55 5 152984 49854 50402281
Musculoskeletal stiffness 127.71 9.55 120 152869 128361 50323774
Rash 127.45 9.55 788 152201 436683 50015452
Fatigue 124.57 9.55 1456 151533 706145 49745990
Myocardial infarction 124.17 9.55 566 152423 88461 50363674
Sinusitis 120.02 9.55 207 152782 170351 50281784
Nasopharyngitis 117.63 9.55 255 152734 192672 50259463
Euglycaemic diabetic ketoacidosis 116.74 9.55 84 152905 2735 50449400
Exposure during pregnancy 114.61 9.55 691 152298 120324 50331811
Therapeutic product effect incomplete 110.61 9.55 70 152919 91445 50360690
Therapeutic product effect decreased 110.22 9.55 150 152839 135900 50316235
Device malfunction 109.74 9.55 178 152811 14943 50437192
Arthralgia 107.59 9.55 831 152158 437871 50014264
Pancreatitis 107.48 9.55 328 152661 42286 50409849
Incorrect dose administered by device 103.24 9.55 85 152904 3390 50448745
Hypersensitivity 98.24 9.55 328 152661 214833 50237302
Wrong product administered 98.22 9.55 100 152889 5260 50446875
Hepatic enzyme increased 98.22 9.55 165 152824 137215 50314920
Wound 98.03 9.55 105 152884 105689 50346446
Device issue 97.59 9.55 198 152791 19774 50432361
Dehydration 95.34 9.55 787 152202 151662 50300473
Folliculitis 94.72 9.55 6 152983 39219 50412916
Accidental underdose 94.24 9.55 44 152945 614 50451521
Diabetic neuropathy 92.66 9.55 81 152908 3510 50448625
Irritable bowel syndrome 90.55 9.55 22 152967 51419 50400716
Insulin resistance 85.17 9.55 42 152947 666 50451469
Stomatitis 84.86 9.55 109 152880 101235 50350900
Premature delivery 84.53 9.55 207 152782 23456 50428679
Diabetes mellitus 84.05 9.55 332 152657 48701 50403434
Off label use 83.64 9.55 975 152014 473451 49978684
Helicobacter infection 82.29 9.55 24 152965 49678 50402457
Pharyngitis 81.37 9.55 170 152819 17333 50434802
Muscle injury 80.52 9.55 9 152980 37102 50415033
Hypoglycaemic seizure 78.93 9.55 35 152954 430 50451705
Product administration error 78.70 9.55 180 152809 19519 50432616
Metabolic acidosis 78.30 9.55 277 152712 38548 50413587
Pancreatic carcinoma 77.78 9.55 95 152894 6119 50446016
Inappropriate schedule of product administration 76.33 9.55 423 152566 71408 50380727
Toothache 74.96 9.55 161 152828 16733 50435402
Gangrene 72.59 9.55 80 152909 4612 50447523
Coronary artery disease 72.35 9.55 226 152763 29500 50422635
Incorrect dose administered 72.13 9.55 314 152675 48100 50404035
Loss of consciousness 71.92 9.55 551 152438 103802 50348333
Hypoglycaemia unawareness 70.56 9.55 22 152967 88 50452047
Blindness 70.32 9.55 159 152830 17110 50435025
Anti-insulin antibody positive 70.09 9.55 21 152968 71 50452064
Renal impairment 69.03 9.55 428 152561 75233 50376902
Chronic kidney disease 64.73 9.55 265 152724 39506 50412629
Gait inability 64.49 9.55 252 152737 36775 50415360
Wrong technique in device usage process 61.99 9.55 55 152934 2431 50449704
Diabetic complication 61.03 9.55 35 152954 763 50451372
Febrile neutropenia 60.37 9.55 128 152861 97539 50354596
Rhabdomyolysis 59.58 9.55 255 152734 38772 50413363
Peripheral swelling 58.19 9.55 374 152615 205562 50246573
Infection 58.06 9.55 297 152692 172657 50279478
Loss of personal independence in daily activities 57.95 9.55 76 152913 69974 50382161
Product quality issue 57.85 9.55 215 152774 30643 50421492
Hypoglycaemic encephalopathy 57.29 9.55 24 152965 254 50451881
Type 1 diabetes mellitus 56.89 9.55 58 152931 3055 50449080
Peritonitis bacterial 56.31 9.55 70 152919 4591 50447544
Hyperinsulinaemic hypoglycaemia 55.86 9.55 16 152973 44 50452091
White blood cell count decreased 55.25 9.55 175 152814 116547 50335588
C-reactive protein abnormal 54.98 9.55 9 152980 27800 50424335
Ketosis 54.06 9.55 28 152961 495 50451640
Diabetic nephropathy 53.40 9.55 39 152950 1300 50450835
Diabetic coma 51.71 9.55 30 152959 669 50451466
Visual acuity reduced 51.69 9.55 156 152833 19983 50432152
Intentional product use issue 50.79 9.55 97 152892 76821 50375314
Cardiac arrest 50.72 9.55 429 152560 83222 50368913
Vitreous haemorrhage 50.35 9.55 42 152947 1706 50450429
Hip arthroplasty 49.81 9.55 15 152974 30414 50421721
Drug administered in wrong device 49.65 9.55 13 152976 22 50452113
Blood creatinine increased 49.62 9.55 397 152592 75763 50376372
Device expulsion 49.42 9.55 13 152976 28809 50423326
Shock 49.33 9.55 156 152833 20494 50431641
Migraine 48.78 9.55 96 152893 75184 50376951
Ill-defined disorder 47.60 9.55 57 152932 54597 50397538
Drug abuse 47.41 9.55 67 152922 59779 50392356
Hypoglycaemia neonatal 46.90 9.55 31 152958 877 50451258
Pancreatitis acute 46.39 9.55 168 152821 23644 50428491
Emphysematous pyelonephritis 45.72 9.55 18 152971 160 50451975
Arterial occlusive disease 45.41 9.55 64 152925 4744 50447391
Anuria 45.19 9.55 103 152886 11141 50440994
Diabetic foot 45.04 9.55 35 152954 1283 50450852
Renal injury 44.02 9.55 87 152902 8524 50443611
Increased insulin requirement 43.95 9.55 14 152975 61 50452074
Fear 43.44 9.55 119 152870 14430 50437705
Acute myocardial infarction 42.18 9.55 188 152801 29085 50423050
Hyperglycaemic hyperosmolar nonketotic syndrome 41.64 9.55 25 152964 595 50451540
Blood ketone body increased 41.62 9.55 19 152970 251 50451884
Sopor 41.08 9.55 143 152846 19736 50432399
Psoriatic arthropathy 41.01 9.55 49 152940 46983 50405152
Dialysis 40.79 9.55 89 152900 9349 50442786
Multiple organ dysfunction syndrome 40.54 9.55 276 152713 50061 50402074
Glycosylated haemoglobin abnormal 40.00 9.55 14 152975 86 50452049
Foetal exposure during pregnancy 39.64 9.55 176 152813 27183 50424952
Diabetic gastroparesis 39.37 9.55 17 152972 195 50451940
Premature baby 38.85 9.55 133 152856 18204 50433931
Intestinal malrotation 38.64 9.55 20 152969 353 50451782
Pulmonary oedema 38.63 9.55 267 152722 48671 50403464
Impaired healing 36.36 9.55 100 152889 69686 50382449
Injury associated with device 36.36 9.55 46 152943 3071 50449064
Eye haemorrhage 36.16 9.55 73 152916 7262 50444873
Malignant neoplasm progression 35.96 9.55 97 152892 68027 50384108
Treatment noncompliance 35.03 9.55 182 152807 29968 50422167
Pre-eclampsia 34.93 9.55 76 152913 7968 50444167
Diabetic ketoacidotic hyperglycaemic coma 34.89 9.55 11 152978 46 50452089
Angina unstable 34.57 9.55 68 152921 6638 50445497
Cataract 34.39 9.55 253 152736 47047 50405088
Neutropenia 34.39 9.55 284 152705 147681 50304454
Product dispensing error 34.14 9.55 80 152909 8811 50443324
Large for dates baby 34.11 9.55 20 152969 455 50451680
Cardiac failure 33.69 9.55 365 152624 75675 50376460
Insomnia 33.19 9.55 353 152636 174512 50277623
Non-cardiogenic pulmonary oedema 32.86 9.55 21 152968 560 50451575
Blister 31.96 9.55 141 152848 85277 50366858
Conjoined twins 31.88 9.55 16 152973 264 50451871
Congenital bladder anomaly 31.72 9.55 14 152975 170 50451965
Knee arthroplasty 31.63 9.55 37 152952 35809 50416326
Ketonuria 31.62 9.55 19 152970 453 50451682
Respiratory failure 31.33 9.55 417 152572 90764 50361371
Generalised oedema 31.22 9.55 102 152887 13629 50438506
Bursitis 31.03 9.55 14 152975 22121 50430014
Glycosuria 30.92 9.55 26 152963 1068 50451067
Product use in unapproved indication 30.84 9.55 214 152775 115605 50336530
Disease progression 30.81 9.55 167 152822 95699 50356436
Pemphigoid 30.58 9.55 60 152929 5847 50446288
Anti-insulin antibody increased 30.28 9.55 10 152979 50 50452085
Infective pulmonary exacerbation of cystic fibrosis 30.19 9.55 71 152918 7838 50444297
Drug dose omission by device 30.17 9.55 39 152950 2660 50449475
Diabetic hyperglycaemic coma 30.13 9.55 9 152980 30 50452105
Caesarean section 29.34 9.55 109 152880 15530 50436605
C-reactive protein increased 29.15 9.55 103 152886 66371 50385764
Underdose 29.04 9.55 130 152859 20148 50431987
Polyhydramnios 28.72 9.55 33 152956 1992 50450143
Mental status changes 28.68 9.55 198 152791 36074 50416061
Wrong technique in product usage process 28.68 9.55 275 152714 55235 50396900
Product complaint 28.66 9.55 88 152901 11378 50440757
Haemodialysis 28.65 9.55 72 152917 8290 50443845
Crystal nephropathy 28.63 9.55 22 152967 793 50451342
Left ventricular hypertrophy 28.54 9.55 52 152937 4793 50447342
Retinopathy 28.48 9.55 38 152951 2674 50449461
Musculoskeletal pain 28.32 9.55 117 152872 72060 50380075
Urachal abnormality 28.00 9.55 13 152976 179 50451956
Gastrointestinal disorder 27.95 9.55 169 152820 94287 50357848
Vomiting 27.44 9.55 1677 151312 459081 49993054
Renal tubular necrosis 27.27 9.55 80 152909 10088 50442047
Low birth weight baby 27.19 9.55 57 152932 5824 50446311
Persistent cloaca 27.18 9.55 13 152976 192 50451943
Anaemia 27.14 9.55 975 152014 251481 50200654
Shock hypoglycaemic 27.07 9.55 11 152978 107 50452028
Urinary tract infection 27.06 9.55 877 152112 223143 50228992
Injection site haemorrhage 27.01 9.55 132 152857 21214 50430921
Angina pectoris 26.99 9.55 153 152836 26035 50426100
Mobility decreased 26.39 9.55 138 152851 79810 50372325
Visual impairment 26.32 9.55 319 152670 67956 50384179
Adenocarcinoma pancreas 26.26 9.55 23 152966 999 50451136
Device interaction 26.26 9.55 13 152976 208 50451927
Polyuria 26.18 9.55 63 152926 7058 50445077
Fibromyalgia 26.10 9.55 61 152928 44917 50407218
Oropharyngeal pain 25.85 9.55 134 152855 77667 50374468
Sleep disorder 25.63 9.55 88 152901 57195 50394940
Retinal haemorrhage 25.52 9.55 48 152941 4533 50447602
Red blood cell sedimentation rate increased 25.27 9.55 31 152958 29385 50422750
Pyrexia 25.22 9.55 918 152071 379285 50072850
Heparin-induced thrombocytopenia 25.21 9.55 44 152945 3921 50448214
Blood urea increased 25.11 9.55 139 152850 23446 50428689
Device use issue 24.97 9.55 30 152959 1899 50450236
Blood potassium increased 24.91 9.55 107 152882 16291 50435844
Urosepsis 24.33 9.55 102 152887 15363 50436772
Night sweats 24.27 9.55 40 152949 33534 50418601
Erythrodermic psoriasis 24.22 9.55 21 152968 900 50451235
Unresponsive to stimuli 24.15 9.55 167 152822 30442 50421693
Gastrooesophageal reflux disease 24.08 9.55 134 152855 76294 50375841
Coronary artery occlusion 24.04 9.55 63 152926 7440 50444695
Back pain 24.01 9.55 495 152494 219535 50232600
Cholestasis 23.97 9.55 145 152844 25256 50426879
Flushing 23.65 9.55 113 152876 66902 50385233
Myocardial ischaemia 23.53 9.55 83 152906 11530 50440605
Rheumatoid nodule 23.30 9.55 5 152984 12730 50439405
Sepsis 23.29 9.55 546 152443 132379 50319756
Oedema peripheral 23.01 9.55 633 152356 157328 50294807
Drug interaction 22.94 9.55 777 152212 198844 50253291
Glucose urine present 22.88 9.55 18 152971 672 50451463
Impaired gastric emptying 22.81 9.55 68 152921 8650 50443485
Headache 22.62 9.55 1277 151712 505258 49946877
Sprue-like enteropathy 22.61 9.55 16 152973 507 50451628
Oliguria 22.37 9.55 65 152924 8151 50443984
Herpes zoster 22.36 9.55 124 152865 70662 50381473
Injection site erythema 22.21 9.55 134 152855 74802 50377333
Bone pain 22.20 9.55 71 152918 47158 50404977
Ischaemic cardiomyopathy 22.17 9.55 31 152958 2281 50449854
Blood insulin increased 22.12 9.55 10 152979 129 50452006
Neonatal seizure 22.09 9.55 14 152975 368 50451767
Blood pressure fluctuation 22.08 9.55 47 152942 35776 50416359
Diabetic ketosis 21.89 9.55 11 152978 182 50451953
Anti-insulin antibody 21.88 9.55 7 152982 31 50452104
Glomerular filtration rate decreased 21.68 9.55 81 152908 11571 50440564
Injection site reaction 21.62 9.55 78 152911 49954 50402181
Upper respiratory tract infection 21.61 9.55 114 152875 65784 50386351
Glycosylated haemoglobin decreased 21.43 9.55 15 152974 467 50451668
Fall 21.21 9.55 1226 151763 333706 50118429
Body temperature increased 21.14 9.55 39 152950 31302 50420833
Bone density decreased 20.99 9.55 4 152985 11071 50441064
Systemic infection 20.99 9.55 30 152959 2253 50449882
Transient tachypnoea of the newborn 20.86 9.55 9 152980 103 50452032
Insulin C-peptide decreased 20.82 9.55 6 152983 17 50452118
Toe amputation 20.79 9.55 27 152962 1850 50450285
Hypervolaemia 20.64 9.55 140 152849 25359 50426776
Multiple sclerosis relapse 20.60 9.55 64 152925 42900 50409235
Pancreatic carcinoma metastatic 20.51 9.55 28 152961 2014 50450121
Neutrophil count decreased 20.39 9.55 71 152918 45955 50406180
Blood ketone body present 20.32 9.55 6 152983 19 50452116
Foot deformity 20.20 9.55 17 152972 19193 50432942
Ear pain 20.16 9.55 34 152955 28249 50423886
Perinephric abscess 20.14 9.55 10 152979 161 50451974
Anhedonia 20.10 9.55 69 152920 9455 50442680
Blindness unilateral 19.99 9.55 47 152942 5188 50446947
Caudal regression syndrome 19.98 9.55 10 152979 164 50451971
Pyelonephritis 19.91 9.55 94 152895 14895 50437240
Distributive shock 19.79 9.55 18 152971 822 50451313
Peritoneal dialysis complication 19.78 9.55 21 152968 1160 50450975
Facial nerve disorder 19.75 9.55 15 152974 531 50451604
Retinopathy proliferative 19.73 9.55 7 152982 45 50452090
Bradycardia neonatal 19.68 9.55 18 152971 828 50451307
Osteoarthritis 19.65 9.55 124 152865 68482 50383653
Tenosynovitis 19.63 9.55 4 152985 10561 50441574
Blood ketone body 19.47 9.55 7 152982 47 50452088
Asthenia 19.28 9.55 1163 151826 317879 50134256
Device dislocation 19.26 9.55 22 152967 21524 50430611
Intentional self-injury 19.18 9.55 25 152964 23087 50429048
Expired product administered 19.13 9.55 47 152942 5335 50446800
Urine ketone body present 19.06 9.55 29 152960 2304 50449831
Apgar score abnormal 18.90 9.55 5 152984 9 50452126
Gastrointestinal tract mucosal pigmentation 18.86 9.55 15 152974 569 50451566
Respiratory tract malformation 18.74 9.55 8 152981 89 50452046
Oral herpes 18.71 9.55 21 152968 20704 50431431
Bone erosion 18.70 9.55 6 152983 11681 50440454
Peripheral vascular disorder 18.65 9.55 47 152942 5420 50446715
Acne 18.64 9.55 19 152970 19576 50432559
Product dose omission issue 18.52 9.55 705 152284 183133 50269002
Hypertriglyceridaemia 18.52 9.55 47 152942 5444 50446691
Injection site pain 18.52 9.55 453 152536 110571 50341564
Urticaria 18.42 9.55 278 152711 129283 50322852
Immunodeficiency 18.38 9.55 11 152978 14817 50437318
Muscle spasticity 18.32 9.55 15 152974 17169 50434966
Hepatic cirrhosis 18.32 9.55 103 152886 17474 50434661
Immobilisation prolonged 18.13 9.55 8 152981 97 50452038
Microphthalmos 18.12 9.55 9 152980 145 50451990
Cardiogenic shock 18.01 9.55 94 152895 15505 50436630
Diabetic microangiopathy 17.94 9.55 5 152984 12 50452123
Diabetic gangrene 17.94 9.55 5 152984 12 50452123
Retinal coloboma 17.85 9.55 6 152983 32 50452103
Polydipsia 17.73 9.55 33 152956 3091 50449044
Basal cell carcinoma 17.66 9.55 27 152962 23329 50428806
Cognitive disorder 17.63 9.55 71 152918 44052 50408083
Infected dermal cyst 17.60 9.55 13 152976 441 50451694
Device leakage 17.47 9.55 48 152941 5830 50446305
Therapy non-responder 17.44 9.55 87 152902 50935 50401200
Pulmonary artery stenosis 17.43 9.55 9 152980 158 50451977
Acidosis 17.31 9.55 69 152920 10158 50441977
Blood cholesterol increased 17.29 9.55 97 152892 55118 50397017
Constipation 17.07 9.55 429 152560 185279 50266856
Infusion site pain 17.01 9.55 8 152981 12338 50439797
Dawn phenomenon 16.99 9.55 4 152985 3 50452132
Diet failure 16.99 9.55 6 152983 38 50452097
Diabetic foot infection 16.99 9.55 9 152980 167 50451968
Pain in extremity 16.92 9.55 664 152325 272201 50179934
Peripheral artery haematoma 16.86 9.55 6 152983 39 50452096
Neutropenic sepsis 16.84 9.55 11 152978 14136 50437999
Arteriosclerosis 16.80 9.55 63 152926 9014 50443121
Cough 16.77 9.55 579 152410 240685 50211450
Product use issue 16.67 9.55 335 152654 149140 50302995
Cardiac disorder 16.64 9.55 201 152788 42778 50409357
Iris coloboma 16.60 9.55 6 152983 41 50452094
Blood triglycerides increased 16.56 9.55 73 152916 11239 50440896
Completed suicide 16.43 9.55 290 152699 131599 50320536
Gastrointestinal haemorrhage 16.35 9.55 312 152677 73009 50379126
Fracture blisters 16.31 9.55 7 152982 79 50452056
Pancreatic neoplasm 16.31 9.55 15 152974 695 50451440
Multiple use of single-use product 16.17 9.55 18 152971 1049 50451086
Maternal exposure during pregnancy 16.09 9.55 364 152625 159414 50292721
Cutaneous amyloidosis 15.99 9.55 4 152985 5 50452130
Dry eye 15.97 9.55 47 152942 32048 50420087
Microalbuminuria 15.96 9.55 11 152978 334 50451801
Drug tolerance decreased 15.96 9.55 4 152985 9156 50442979
Metabolic syndrome 15.90 9.55 20 152969 1327 50450808
Medication error 15.84 9.55 173 152816 35931 50416204
Vitrectomy 15.78 9.55 8 152981 135 50452000
Neoplasm progression 15.77 9.55 41 152948 29116 50423019
Hyperbilirubinaemia neonatal 15.76 9.55 11 152978 341 50451794
Epileptic encephalopathy 15.67 9.55 10 152979 266 50451869
Foot amputation 15.67 9.55 10 152979 266 50451869
Osteoporosis 15.64 9.55 76 152913 44803 50407332
Toxicity to various agents 15.46 9.55 507 152482 211992 50240143
Multi-organ disorder 15.43 9.55 19 152970 1234 50450901
Neck pain 15.40 9.55 105 152884 56962 50395173
Pancreatic failure 15.40 9.55 16 152973 862 50451273
Neonatal tachypnoea 15.37 9.55 6 152983 52 50452083
Diabetic hyperosmolar coma 15.29 9.55 11 152978 358 50451777
End stage renal disease 15.25 9.55 45 152944 5692 50446443
Adverse drug reaction 15.20 9.55 101 152888 55121 50397014
Foetal hypokinesia 15.18 9.55 12 152977 451 50451684
Pulmonary fibrosis 15.11 9.55 32 152957 24405 50427730
Asthma 15.11 9.55 185 152804 89152 50362983
Phaeochromocytoma 15.07 9.55 12 152977 456 50451679
Cold sweat 15.06 9.55 68 152921 10576 50441559
Leukopenia 15.05 9.55 131 152858 67397 50384738
Renal dysplasia 15.02 9.55 8 152981 150 50451985
Neonatal respiratory distress syndrome 15.02 9.55 28 152961 2626 50449509
Acute coronary syndrome 14.88 9.55 62 152927 9312 50442823
Vascular calcification 14.88 9.55 14 152975 668 50451467
Contusion 14.84 9.55 244 152745 111939 50340196
Device delivery system issue 14.78 9.55 12 152977 469 50451666
Oesophageal carcinoma recurrent 14.67 9.55 5 152984 28 50452107
International normalised ratio increased 14.67 9.55 197 152792 42955 50409180
Joint stiffness 14.64 9.55 45 152944 30263 50421872
Encephalopathy 14.55 9.55 161 152828 33550 50418585
Pyelonephritis fungal 14.48 9.55 7 152982 106 50452029
Cataract diabetic 14.41 9.55 3 152986 0 50452135
Somogyi phenomenon 14.41 9.55 3 152986 0 50452135
Product odour abnormal 14.35 9.55 17 152972 1060 50451075
Nasal congestion 14.32 9.55 93 152896 51027 50401108
Hypothermia 14.28 9.55 73 152916 11943 50440192
Dementia 14.27 9.55 90 152899 15907 50436228
Panniculitis 14.27 9.55 4 152985 8499 50443636
Neuropathic arthropathy 14.22 9.55 9 152980 236 50451899
Device mechanical issue 14.20 9.55 6 152983 65 50452070
Hyperlactacidaemia 14.19 9.55 26 152963 2407 50449728
Foetal macrosomia 14.04 9.55 6 152983 67 50452068
Eyelid bleeding 13.98 9.55 5 152984 33 50452102
Intestinal transit time abnormal 13.88 9.55 6 152983 69 50452066
Radiation fibrosis 13.86 9.55 5 152984 34 50452101
Patella fracture 13.80 9.55 22 152967 1820 50450315
Heavy menstrual bleeding 13.74 9.55 16 152973 15521 50436614
Electrolyte imbalance 13.74 9.55 94 152895 17075 50435060
Vitamin B12 deficiency 13.71 9.55 34 152955 3882 50448253
Dermatitis papillaris capillitii 13.71 9.55 4 152985 12 50452123
Candida sepsis 13.68 9.55 18 152971 1249 50450886
Tachypnoea 13.62 9.55 83 152906 14494 50437641
Hyperosmolar state 13.60 9.55 9 152980 255 50451880
Transient ischaemic attack 13.52 9.55 153 152836 32057 50420078
Blood glucose normal 13.47 9.55 4 152985 13 50452122
Tinnitus 13.42 9.55 42 152947 28090 50424045
Retinal detachment 13.41 9.55 40 152949 5089 50447046
Accidental overdose 13.36 9.55 103 152886 19430 50432705
Foetal arrhythmia 13.35 9.55 7 152982 127 50452008
Full blood count abnormal 13.34 9.55 32 152957 23356 50428779
Anti-GAD antibody positive 13.27 9.55 5 152984 39 50452096
Choroidal effusion 13.27 9.55 11 152978 443 50451692
Liquid product physical issue 13.25 9.55 14 152975 769 50451366
Colitis ulcerative 13.21 9.55 19 152970 16835 50435300
Pulmonary embolism 13.19 9.55 222 152767 101482 50350653
Atrioventricular block first degree 13.15 9.55 45 152944 6156 50445979
Psychotic disorder 13.12 9.55 29 152960 21783 50430352
Foetal exposure timing unspecified 13.12 9.55 8 152981 196 50451939
Macular oedema 13.08 9.55 32 152957 3622 50448513
Necrotising fasciitis 12.94 9.55 26 152963 2578 50449557
Amputation 12.92 9.55 7 152982 136 50451999
Ulcer 12.87 9.55 26 152963 20174 50431961
Thirst 12.86 9.55 65 152924 10585 50441550
Large intestine polyp 12.84 9.55 50 152939 7282 50444853
Blood triglycerides abnormal 12.84 9.55 9 152980 281 50451854
BRASH syndrome 12.80 9.55 8 152981 205 50451930
Urinary tract infection fungal 12.76 9.55 12 152977 572 50451563
Labelled drug-food interaction issue 12.64 9.55 4 152985 17 50452118
Blood parathyroid hormone decreased 12.60 9.55 3 152986 7111 50445024
Influenza like illness 12.57 9.55 112 152877 57347 50394788
Osteopenia 12.56 9.55 20 152969 16998 50435137
Nephrogenic systemic fibrosis 12.55 9.55 35 152954 4287 50447848
Pulse pressure decreased 12.50 9.55 8 152981 214 50451921
Diabetic eye disease 12.44 9.55 7 152982 147 50451988
Paraesthesia 12.37 9.55 273 152716 119970 50332165
Tricuspid valve disease 12.37 9.55 8 152981 218 50451917
Leg amputation 12.36 9.55 22 152967 1991 50450144
Hypertensive crisis 12.36 9.55 75 152914 13079 50439056
Fructosamine increased 12.34 9.55 3 152986 3 50452132
Diabetic hepatopathy 12.34 9.55 3 152986 3 50452132
Pulmonary renal syndrome 12.34 9.55 10 152979 390 50451745
Fasting 12.28 9.55 4 152985 19 50452116
Myositis 12.27 9.55 52 152937 7868 50444267
Pulseless electrical activity 12.27 9.55 47 152942 6794 50445341
Therapeutic response decreased 12.20 9.55 88 152901 47143 50404992
Hospitalisation 12.18 9.55 280 152709 67657 50384478
Hot flush 12.05 9.55 81 152908 44088 50408047
Retroperitoneal oedema 11.95 9.55 4 152985 21 50452114
Urinary tract obstruction 11.90 9.55 20 152969 1728 50450407
Diabetic retinal oedema 11.89 9.55 9 152980 317 50451818
Myelosuppression 11.87 9.55 14 152975 13503 50438632
Hemiplegia 11.86 9.55 49 152940 7332 50444803
Hyperinsulinaemia 11.85 9.55 6 152983 101 50452034
Cerebral calcification 11.83 9.55 7 152982 162 50451973
Hyperhidrosis 11.80 9.55 354 152635 89072 50363063
Sweat gland tumour 11.79 9.55 6 152983 102 50452033
Weight decreased 11.79 9.55 798 152191 220447 50231688
General physical health deterioration 11.78 9.55 535 152454 141899 50310236
Acute respiratory failure 11.76 9.55 136 152853 28646 50423489
Ventricular fibrillation 11.76 9.55 63 152926 10496 50441639
Body mass index increased 11.74 9.55 15 152974 1011 50451124
Bradycardia 11.69 9.55 266 152723 64160 50387975
Open angle glaucoma 11.66 9.55 8 152981 241 50451894
Latent autoimmune diabetes in adults 11.65 9.55 4 152985 23 50452112
Injection site nodule 11.65 9.55 29 152960 3319 50448816
Joint range of motion decreased 11.65 9.55 24 152965 18488 50433647
Malnutrition 11.64 9.55 74 152915 13115 50439020
Tumour rupture 11.59 9.55 6 152983 106 50452029
Tracheobronchitis 11.54 9.55 15 152974 1029 50451106
Pancreatic pseudocyst 11.52 9.55 11 152978 535 50451600
Oral pain 11.51 9.55 38 152951 24995 50427140
Breath sounds 11.49 9.55 6 152983 108 50452027
International normalised ratio abnormal 11.38 9.55 26 152963 2817 50449318
Lower respiratory tract infection 11.33 9.55 211 152778 94990 50357145
Pancreatic cyst 11.31 9.55 17 152972 1336 50450799
Respiratory tract infection 11.29 9.55 54 152935 31963 50420172
Disorientation 11.25 9.55 160 152829 35324 50416811
Hepatic steatosis 11.24 9.55 118 152871 24266 50427869
Leukocytosis 11.23 9.55 111 152878 22468 50429667
Pulse absent 11.20 9.55 36 152953 4770 50447365
Azotaemia 11.19 9.55 32 152957 3976 50448159
Gestational hypertension 11.16 9.55 22 152967 2151 50449984
Gout 11.16 9.55 66 152923 11404 50440731
Haemodynamic instability 11.16 9.55 51 152938 7973 50444162
Cortisol increased 11.10 9.55 9 152980 351 50451784
Haematoma 11.09 9.55 141 152848 30369 50421766
Hyperleukocytosis 11.04 9.55 10 152979 454 50451681
Ventricular septal defect 11.03 9.55 32 152957 4009 50448126
Blood insulin abnormal 10.99 9.55 4 152985 28 50452107
High density lipoprotein decreased 10.98 9.55 19 152970 1681 50450454
Megacolon 10.93 9.55 19 152970 1687 50450448
Ankylosing spondylitis 10.91 9.55 4 152985 7161 50444974
Necrobiosis lipoidica diabeticorum 10.87 9.55 4 152985 29 50452106
Complications of transplanted liver 10.84 9.55 9 152980 363 50451772
Congenital intestinal malformation 10.82 9.55 3 152986 7 50452128
Hip fracture 10.80 9.55 123 152866 25808 50426327
Brain malformation 10.76 9.55 5 152984 69 50452066
Inflammation 10.74 9.55 115 152874 56797 50395338
Groin abscess 10.73 9.55 13 152976 830 50451305
Pain in jaw 10.72 9.55 70 152919 38358 50413777
Injection site swelling 10.71 9.55 78 152911 41695 50410440
Respiratory distress 10.70 9.55 140 152849 30349 50421786
Dermatitis exfoliative 10.63 9.55 37 152952 5105 50447030
Mood swings 10.63 9.55 20 152969 15934 50436201
Emphysematous cystitis 10.58 9.55 6 152983 128 50452007
Drug dependence 10.52 9.55 28 152961 19731 50432404
Premature rupture of membranes 10.39 9.55 34 152955 4546 50447589
Product contamination physical 10.39 9.55 5 152984 75 50452060
Binge eating 10.33 9.55 9 152980 388 50451747
Ectopic ACTH syndrome 10.33 9.55 6 152983 134 50452001
Glucose-6-phosphate dehydrogenase deficiency 10.32 9.55 7 152982 207 50451928
Factor VIII deficiency 10.28 9.55 3 152986 9 50452126
Fibrodysplasia ossificans progressiva 10.28 9.55 3 152986 9 50452126
Umbilical hernia, obstructive 10.28 9.55 3 152986 9 50452126
Post viral fatigue syndrome 10.28 9.55 8 152981 294 50451841
Gastrointestinal carcinoma 10.24 9.55 17 152972 1454 50450681
Thrombotic microangiopathy 10.24 9.55 7 152982 8784 50443351
Depressed level of consciousness 10.22 9.55 217 152772 51736 50400399
Dyspepsia 10.18 9.55 160 152829 73937 50378198
Food allergy 10.14 9.55 6 152983 8131 50444004
Hypoperfusion 10.12 9.55 16 152973 1314 50450821
Catheter site haematoma 10.10 9.55 6 152983 140 50451995
Dysstasia 10.07 9.55 90 152899 17729 50434406
Cerebral vascular occlusion 10.05 9.55 3 152986 10 50452125
Nonreassuring foetal heart rate pattern 10.02 9.55 4 152985 37 50452098
Hepatic failure 10.01 9.55 145 152844 32138 50419997
Dry mouth 10.01 9.55 115 152874 56063 50396072
Vascular graft 10.00 9.55 12 152977 759 50451376
Oligohydramnios 9.90 9.55 39 152950 5711 50446424
Joint effusion 9.90 9.55 15 152974 13006 50439129
Staphylococcal infection 9.89 9.55 157 152832 35459 50416676
Haemophagocytic lymphohistiocytosis 9.89 9.55 7 152982 8626 50443509
Rabbit syndrome 9.87 9.55 8 152981 312 50451823
Pruritus 9.85 9.55 731 152258 282837 50169298
Rhinorrhoea 9.82 9.55 104 152885 51479 50400656
Dystonia 9.80 9.55 13 152976 11913 50440222
Vascular purpura 9.79 9.55 15 152974 1199 50450936
Tumour compression 9.75 9.55 4 152985 40 50452095
Liver function test increased 9.73 9.55 42 152947 25564 50426571
Bundle branch block left 9.73 9.55 41 152948 6189 50445946
Angiopathy 9.71 9.55 31 152958 4091 50448044
Adverse event 9.70 9.55 85 152904 43678 50408457
Cell death 9.70 9.55 21 152968 2194 50449941
Bacterial pyelonephritis 9.70 9.55 8 152981 320 50451815
Neonatal tachycardia 9.62 9.55 3 152986 12 50452123
Altered state of consciousness 9.62 9.55 105 152884 21805 50430330
Haematotoxicity 9.58 9.55 6 152983 7889 50444246
Influenza 9.58 9.55 202 152787 89336 50362799
Injection site warmth 9.58 9.55 17 152972 13849 50438286
Haemorrhoids thrombosed 9.58 9.55 4 152985 42 50452093
Haemangioma congenital 9.56 9.55 9 152980 430 50451705
Hypovolaemia 9.56 9.55 55 152934 9410 50442725

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 2945.45 10.26 2232 148555 46114 29377626
Blood glucose increased 2214.99 10.26 2060 148727 56924 29366816
Diabetic ketoacidosis 993.92 10.26 750 150037 15323 29408417
Blood glucose decreased 891.08 10.26 627 150160 11442 29412298
Diabetes mellitus inadequate control 816.92 10.26 596 150191 11538 29412202
Hyperglycaemia 709.02 10.26 874 149913 33413 29390327
Glycosylated haemoglobin increased 485.51 10.26 395 150392 9031 29414709
Device operational issue 451.08 10.26 112 150675 33 29423707
Blood glucose abnormal 381.86 10.26 267 150520 4816 29418924
Blood glucose fluctuation 352.56 10.26 223 150564 3374 29420366
Hypoglycaemic coma 287.11 10.26 163 150624 2000 29421740
Ketoacidosis 243.12 10.26 178 150609 3461 29420279
Drug abuse 240.58 10.26 56 150731 79827 29343913
Product storage error 230.55 10.26 220 150567 6250 29417490
Diabetic retinopathy 197.35 10.26 115 150672 1487 29422253
Hypoglycaemic unconsciousness 153.80 10.26 76 150711 687 29423053
Diabetic neuropathy 147.94 10.26 135 150652 3618 29420122
Acute kidney injury 143.10 10.26 2017 148770 263250 29160490
Lactic acidosis 140.47 10.26 405 150382 29842 29393898
Diabetic foot 140.40 10.26 105 150682 2111 29421629
Hyperkalaemia 133.27 10.26 643 150144 60749 29362991
Diabetic metabolic decompensation 131.84 10.26 85 150702 1331 29422409
Febrile neutropenia 128.49 10.26 235 150552 112005 29311735
Off label use 124.54 10.26 961 149826 299839 29123901
Toxicity to various agents 113.31 10.26 478 150309 173183 29250557
Hypoglycaemic seizure 107.43 10.26 45 150742 264 29423476
Wrong product administered 100.84 10.26 120 150667 4411 29419329
Drug ineffective 99.03 10.26 1283 149504 361887 29061853
Device issue 98.70 10.26 157 150630 7623 29416117
Inappropriate schedule of product administration 96.63 10.26 466 150321 44006 29379734
Myocardial infarction 95.65 10.26 920 149867 109376 29314364
Insulin resistance 95.35 10.26 49 150738 485 29423255
Neutropenia 91.22 10.26 354 150433 131357 29292383
Pancreatic carcinoma 90.31 10.26 144 150643 7006 29416734
Product use in unapproved indication 87.34 10.26 196 150591 86679 29337061
Wrong technique in device usage process 79.17 10.26 56 150731 1029 29422711
Renal failure 78.88 10.26 938 149849 117661 29306079
Completed suicide 78.73 10.26 219 150568 90027 29333713
Anti-insulin antibody positive 76.48 10.26 31 150756 165 29423575
Toe amputation 74.35 10.26 72 150715 2083 29421657
Increased insulin requirement 72.78 10.26 24 150763 61 29423679
Euglycaemic diabetic ketoacidosis 72.76 10.26 78 150709 2552 29421188
Device malfunction 72.20 10.26 144 150643 8363 29415377
Cutaneous amyloidosis 70.95 10.26 20 150767 22 29423718
Hypoglycaemia unawareness 70.05 10.26 25 150762 87 29423653
Diabetes mellitus 66.39 10.26 388 150399 39443 29384297
Death 64.53 10.26 1294 149493 340790 29082950
Incorrect dose administered 62.07 10.26 332 150455 32652 29391088
Diabetic nephropathy 61.08 10.26 61 150726 1834 29421906
White blood cell count decreased 59.63 10.26 221 150566 83141 29340599
Nasopharyngitis 58.81 10.26 136 150651 59529 29364211
Drug administered in wrong device 54.41 10.26 16 150771 23 29423717
Cardiac failure congestive 53.67 10.26 612 150175 75969 29347771
Renal injury 53.66 10.26 143 150644 10059 29413681
Pyrexia 53.26 10.26 1091 149696 286531 29137209
Rash 52.82 10.26 667 150120 189152 29234588
Pancreatic carcinoma metastatic 52.39 10.26 67 150720 2654 29421086
Ketonuria 51.99 10.26 34 150753 546 29423194
Loss of consciousness 51.97 10.26 592 150195 73464 29350276
Hypoglycaemia neonatal 51.02 10.26 53 150734 1671 29422069
Drug resistance 49.35 10.26 24 150763 21516 29402224
Injury 49.12 10.26 210 150577 18836 29404904
Renal impairment 47.89 10.26 629 150158 80704 29343036
Diabetic complication 47.87 10.26 34 150753 629 29423111
Fear 47.76 10.26 131 150656 9373 29414367
Product complaint 47.69 10.26 93 150694 5312 29418428
Cerebrovascular accident 47.05 10.26 599 150188 76312 29347428
Vitreous haemorrhage 45.93 10.26 54 150733 1959 29421781
Rheumatoid arthritis 45.70 10.26 58 150729 32094 29391646
Treatment failure 45.25 10.26 74 150713 36865 29386875
Incorrect dose administered by device 44.99 10.26 47 150740 1492 29422248
Blindness 44.66 10.26 149 150638 11874 29411866
Eye haemorrhage 44.13 10.26 73 150714 3663 29420077
Type 1 diabetes mellitus 44.12 10.26 72 150715 3572 29420168
Aggression 43.72 10.26 71 150716 35470 29388270
Accidental underdose 42.65 10.26 26 150761 367 29423373
Pneumonia 41.78 10.26 1279 149508 318893 29104847
Drug dependence 41.46 10.26 28 150759 20953 29402787
Joint swelling 41.37 10.26 123 150664 49507 29374233
Emotional distress 41.22 10.26 160 150627 13735 29410005
Ketosis 40.89 10.26 26 150761 397 29423343
Diabetic coma 40.81 10.26 33 150754 747 29422993
Metabolic acidosis 40.78 10.26 330 150457 37332 29386408
Therapeutic product effect incomplete 40.02 10.26 88 150699 39217 29384523
Oedema peripheral 40.00 10.26 746 150041 102811 29320929
Chronic kidney disease 39.38 10.26 319 150468 36097 29387643
Multiple use of single-use product 39.18 10.26 20 150767 195 29423545
Impaired gastric emptying 39.00 10.26 62 150725 3008 29420732
Disease progression 38.94 10.26 251 150536 81665 29342075
Coronary artery disease 37.43 10.26 367 150420 43823 29379917
Insomnia 37.26 10.26 282 150505 88479 29335261
Product quality issue 37.01 10.26 170 150617 15725 29408015
Anhedonia 36.94 10.26 100 150687 7100 29416640
Leg amputation 36.90 10.26 49 150738 2015 29421725
Treatment noncompliance 36.54 10.26 230 150557 23997 29399743
Synovitis 36.18 10.26 6 150781 10884 29412856
Shock hypoglycaemic 35.95 10.26 15 150772 87 29423653
Infusion related reaction 35.69 10.26 110 150677 43776 29379964
Stomatitis 35.44 10.26 86 150701 37027 29386713
Drug intolerance 35.40 10.26 127 150660 48252 29375488
Gangrene 35.31 10.26 71 150716 4147 29419593
Visual impairment 34.74 10.26 265 150522 29443 29394297
Mucosal inflammation 34.47 10.26 68 150719 31527 29392213
Injury associated with device 34.30 10.26 31 150756 820 29422920
Sinusitis 34.08 10.26 78 150709 34272 29389468
Product administration error 34.03 10.26 154 150633 14156 29409584
Arthralgia 33.97 10.26 504 150283 139113 29284627
Acute myocardial infarction 33.86 10.26 387 150400 48051 29375689
Medication error 33.64 10.26 204 150583 21007 29402733
Rhabdomyolysis 33.61 10.26 465 150322 60343 29363397
Cardiovascular disorder 33.43 10.26 111 150676 8824 29414916
Drug hypersensitivity 33.33 10.26 208 150579 68198 29355542
Retinopathy 32.69 10.26 43 150744 1752 29421988
Hypoglycaemic encephalopathy 31.12 10.26 19 150768 269 29423471
Diabetic ketosis 29.74 10.26 13 150774 86 29423654
Injection site pain 29.73 10.26 274 150513 32172 29391568
Peritonitis bacterial 29.58 10.26 80 150707 5676 29418064
Hypothermia 29.57 10.26 109 150678 9130 29414610
Neutrophil count decreased 28.27 10.26 120 150667 43447 29380293
Headache 27.83 10.26 675 150112 173332 29250408
Macular oedema 27.66 10.26 47 150740 2411 29421329
Pulmonary embolism 27.65 10.26 253 150534 76281 29347459
Plasmapheresis 27.26 10.26 18 150769 294 29423446
Lower respiratory tract infection 27.25 10.26 59 150728 26443 29397297
Cardiogenic shock 26.99 10.26 179 150608 19011 29404729
Bone marrow failure 26.69 10.26 63 150724 27386 29396354
Mental status changes 26.67 10.26 284 150503 34643 29389097
Immune reconstitution inflammatory syndrome 26.60 10.26 4 150783 7798 29415942
Malignant neoplasm progression 26.32 10.26 245 150542 73614 29350126
Microalbuminuria 26.27 10.26 24 150763 644 29423096
Cardiac failure 26.19 10.26 558 150229 78729 29345011
Blindness transient 26.10 10.26 40 150747 1880 29421860
Myelosuppression 25.98 10.26 15 150772 12212 29411528
Diabetic foot infection 25.90 10.26 23 150764 594 29423146
Decreased insulin requirement 25.70 10.26 6 150781 0 29423740
Arthropathy 25.63 10.26 44 150743 21510 29402230
Pancreatitis acute 25.49 10.26 212 150575 24173 29399567
Intentional self-injury 25.48 10.26 16 150771 12445 29411295
Skin ulcer 25.45 10.26 174 150613 18666 29405074
Urine ketone body present 25.40 10.26 29 150758 1019 29422721
Myelodysplastic syndrome 25.39 10.26 32 150755 17762 29405978
Suture rupture 25.34 10.26 18 150769 333 29423407
Haemophagocytic lymphohistiocytosis 25.15 10.26 11 150776 10493 29413247
Foot amputation 24.97 10.26 21 150766 503 29423237
Acetonaemia 24.84 10.26 13 150774 134 29423606
Cough 24.77 10.26 476 150311 126251 29297489
Pancreatitis chronic 24.46 10.26 40 150747 1988 29421752
Intentional product use issue 24.06 10.26 123 150664 42375 29381365
Rhythm idioventricular 23.99 10.26 16 150771 266 29423474
Localised infection 23.93 10.26 136 150651 13680 29410060
Hyperhidrosis 23.89 10.26 462 150325 64078 29359662
Pathogen resistance 23.80 10.26 6 150781 8110 29415630
Pancreatitis 23.78 10.26 275 150512 34239 29389501
Platelet count decreased 23.69 10.26 383 150404 104289 29319451
Herpes zoster 23.26 10.26 77 150710 29975 29393765
Pneumocystis jirovecii pneumonia 23.09 10.26 31 150756 16748 29406992
Anti-insulin antibody increased 22.77 10.26 10 150777 67 29423673
Diabetic foetopathy 22.58 10.26 14 150773 204 29423536
Interstitial lung disease 22.53 10.26 187 150600 57531 29366209
Hypervolaemia 22.50 10.26 160 150627 17385 29406355
Diabetic eye disease 22.34 10.26 9 150778 47 29423693
Ureteric compression 22.31 10.26 13 150774 168 29423572
Alveolar lung disease 22.30 10.26 17 150770 352 29423388
Polyuria 22.02 10.26 85 150702 7277 29416463
Injection site nodule 21.95 10.26 32 150755 1438 29422302
Therapeutic product effect decreased 21.75 10.26 77 150710 29374 29394366
Diabetic retinal oedema 21.73 10.26 13 150774 177 29423563
Pancytopenia 21.69 10.26 296 150491 82872 29340868
Glycosylated haemoglobin abnormal 21.57 10.26 11 150776 107 29423633
Musculoskeletal stiffness 21.44 10.26 108 150679 37350 29386390
Blood creatinine increased 21.43 10.26 577 150210 84525 29339215
Amputation 21.43 10.26 20 150767 552 29423188
Neutropenic sepsis 21.42 10.26 17 150770 11710 29412030
Oedematous pancreatitis 21.41 10.26 18 150769 431 29423309
Fatigue 21.21 10.26 1362 149425 315459 29108281
Osteomyelitis 21.20 10.26 131 150656 13578 29410162
Glycosylated haemoglobin decreased 21.17 10.26 16 150771 327 29423413
Myopathy 21.17 10.26 108 150679 10425 29413315
Progressive multifocal leukoencephalopathy 21.08 10.26 9 150778 8710 29415030
Agitation 21.04 10.26 164 150623 51140 29372600
Device use issue 20.93 10.26 14 150773 234 29423506
Neuropathic arthropathy 20.87 10.26 12 150775 151 29423589
Therapy non-responder 20.76 10.26 84 150703 30827 29392913
Haematoma muscle 20.73 10.26 25 150762 932 29422808
Weight increased 20.52 10.26 524 150263 76143 29347597
Injection site haemorrhage 20.50 10.26 91 150696 8295 29415445
Hepatic encephalopathy 20.44 10.26 125 150662 12910 29410830
Adenocarcinoma pancreas 20.15 10.26 28 150759 1203 29422537
Mucormycosis 20.12 10.26 65 150722 5093 29418647
Hyperglycaemic hyperosmolar nonketotic syndrome 20.06 10.26 26 150761 1044 29422696
Neonatal respiratory arrest 19.92 10.26 7 150780 23 29423717
Extremity necrosis 19.85 10.26 32 150755 1571 29422169
Psychotic disorder 19.56 10.26 47 150740 20307 29403433
Erythema 19.39 10.26 270 150517 75336 29348404
Dialysis 19.36 10.26 103 150684 10105 29413635
Leukopenia 19.28 10.26 184 150603 55019 29368721
Neuropathy peripheral 19.17 10.26 251 150536 70776 29352964
Peripheral vascular disorder 19.14 10.26 59 150728 4508 29419232
Anti-GAD antibody positive 18.85 10.26 6 150781 13 29423727
Drug reaction with eosinophilia and systemic symptoms 18.84 10.26 76 150711 27916 29395824
Pulmonary interstitial emphysema syndrome 18.83 10.26 17 150770 449 29423291
Diabetic ulcer 18.73 10.26 9 150778 76 29423664
Visual acuity reduced 18.70 10.26 135 150652 14741 29408999
Hypersensitivity 18.62 10.26 176 150611 52727 29371013
Upper motor neurone lesion 18.55 10.26 10 150777 110 29423630
Escherichia urinary tract infection 18.48 10.26 45 150742 2994 29420746
Generalised oedema 18.10 10.26 108 150679 11057 29412683
Hot flush 18.01 10.26 30 150757 14840 29408900
Foetal disorder 17.86 10.26 21 150766 762 29422978
Ventricular hyperkinesia 17.81 10.26 12 150775 203 29423537
Tumour lysis syndrome 17.77 10.26 27 150760 13857 29409883
Glomerular filtration rate decreased 17.64 10.26 108 150679 11158 29412582
Blood ketone body increased 17.57 10.26 15 150772 367 29423373
Tinnitus 17.56 10.26 33 150754 15581 29408159
Hepatic cirrhosis 17.53 10.26 130 150657 14314 29409426
Constipation 17.37 10.26 446 150341 113714 29310026
Large for dates baby 17.33 10.26 22 150765 865 29422875
Influenza 17.12 10.26 134 150653 41747 29381993
Infective pulmonary exacerbation of cystic fibrosis 17.04 10.26 70 150717 6166 29417574
Product name confusion 17.02 10.26 8 150779 64 29423676
Foetal arrhythmia 17.02 10.26 9 150778 95 29423645
Diabetic bullosis 17.01 10.26 6 150781 20 29423720
Eye infection staphylococcal 17.01 10.26 7 150780 39 29423701
Periodontitis 16.93 10.26 32 150755 1785 29421955
Lymphadenopathy 16.87 10.26 68 150719 24981 29398759
Colitis 16.82 10.26 92 150695 31156 29392584
Rhinorrhoea 16.75 10.26 55 150732 21464 29402276
Vitreous floaters 16.67 10.26 44 150743 3077 29420663
Right atrial enlargement 16.67 10.26 12 150775 227 29423513
Sleep disorder 16.55 10.26 66 150721 24320 29399420
Pneumonitis 16.54 10.26 80 150707 27964 29395776
Blood triglycerides increased 16.44 10.26 117 150670 12717 29411023
Posterior reversible encephalopathy syndrome 16.41 10.26 13 150774 8963 29414777
Diabetic gangrene 16.38 10.26 11 150776 185 29423555
Blood insulin increased 16.31 10.26 14 150773 345 29423395
Akathisia 16.24 10.26 7 150780 6735 29417005
Therapeutic drug monitoring analysis not performed 16.21 10.26 16 150771 474 29423266
Flour sensitivity 16.17 10.26 6 150781 24 29423716
Gallbladder neoplasm 15.98 10.26 6 150781 25 29423715
Acute graft versus host disease 15.79 10.26 5 150782 5819 29417921
Angina unstable 15.67 10.26 102 150685 10763 29412977
Respiratory arrest 15.64 10.26 73 150714 25760 29397980
Asthenia 15.62 10.26 1287 149500 213963 29209777
Asthma 15.42 10.26 105 150682 33744 29389996
Diverticulitis 15.39 10.26 43 150744 17661 29406079
Hyperosmolar state 15.34 10.26 14 150773 375 29423365
Oropharyngeal pain 15.33 10.26 87 150700 29198 29394542
Peripheral ischaemia 15.23 10.26 59 150728 5060 29418680
Gastritis fungal 15.16 10.26 8 150779 84 29423656
Anaphylactic shock 15.16 10.26 28 150759 13308 29410432
Delusion 15.15 10.26 21 150766 11195 29412545
Hypovolaemia 15.14 10.26 81 150706 7964 29415776
Inflammation 15.11 10.26 62 150725 22666 29401074
Depression 15.08 10.26 325 150462 84822 29338918
Back pain 14.92 10.26 402 150385 101882 29321858
Somogyi phenomenon 14.91 10.26 4 150783 3 29423737
Systemic infection 14.84 10.26 33 150754 2068 29421672
Multiple sclerosis relapse 14.81 10.26 22 150765 11397 29412343
Guillain-Barre syndrome 14.80 10.26 58 150729 5000 29418740
Mucosal dryness 14.78 10.26 22 150765 1007 29422733
Left atrial dilatation 14.78 10.26 29 150758 1664 29422076
Oedema 14.70 10.26 289 150498 40194 29383546
Acute pulmonary oedema 14.68 10.26 71 150716 6708 29417032
Liver transplant failure 14.61 10.26 8 150779 91 29423649
Skin pressure mark 14.58 10.26 7 150780 59 29423681
Enzyme inhibition 14.57 10.26 5 150782 15 29423725
Visceral venous thrombosis 14.57 10.26 5 150782 15 29423725
Pancreatic failure 14.47 10.26 18 150769 693 29423047
Post transplant lymphoproliferative disorder 14.39 10.26 5 150782 5488 29418252
Hallucination 14.38 10.26 152 150635 44560 29379180
Neuroleptic malignant syndrome 14.20 10.26 39 150748 16109 29407631
Alopecia 14.02 10.26 50 150737 19034 29404706
Cold sweat 13.99 10.26 85 150702 8757 29414983
Respiratory depression 13.99 10.26 30 150757 13493 29410247
Neutropenia neonatal 13.96 10.26 17 150770 640 29423100
Hallucination, auditory 13.95 10.26 17 150770 9576 29414164
Hypochromasia 13.94 10.26 12 150775 297 29423443
Underdose 13.94 10.26 106 150681 11763 29411977
Product temperature excursion issue 13.92 10.26 4 150783 5 29423735
Mitral valve thickening 13.89 10.26 13 150774 360 29423380
Peripheral arterial occlusive disease 13.89 10.26 57 150730 5019 29418721
Sedation 13.88 10.26 44 150743 17361 29406379
Acute coronary syndrome 13.88 10.26 109 150678 12216 29411524
Epistaxis 13.84 10.26 183 150604 51521 29372219
Stress 13.82 10.26 169 150618 21321 29402419
Acute myeloid leukaemia 13.70 10.26 41 150746 16472 29407268
Depressed mood 13.53 10.26 41 150746 16407 29407333
Cardiac disorder 13.53 10.26 266 150521 36997 29386743
Generalised tonic-clonic seizure 13.50 10.26 51 150736 19088 29404652
Retinal haemorrhage 13.47 10.26 52 150735 4452 29419288
Cystitis haemorrhagic 13.41 10.26 4 150783 4838 29418902
Blood pressure fluctuation 13.40 10.26 54 150733 19840 29403900
Blindness unilateral 13.34 10.26 46 150741 3728 29420012
Diabetic gastroparesis 13.30 10.26 8 150779 110 29423630
Congenital cystic kidney disease 13.20 10.26 13 150774 384 29423356
Therapy partial responder 13.17 10.26 5 150782 5194 29418546
Haematotoxicity 13.15 10.26 9 150778 6690 29417050
Insulin C-peptide decreased 13.09 10.26 6 150781 45 29423695
Morganella infection 13.08 10.26 14 150773 457 29423283
Lipohypertrophy 13.08 10.26 10 150777 208 29423532
Squamous cell carcinoma 13.06 10.26 20 150767 10231 29413509
Blood potassium increased 13.05 10.26 123 150664 14528 29409212
Mania 12.97 10.26 15 150772 8648 29415092
Muscle abscess 12.87 10.26 14 150773 466 29423274
Suicidal ideation 12.86 10.26 114 150673 34602 29389138
Supranuclear palsy 12.85 10.26 3 150784 0 29423740
Cerebellar artery occlusion 12.85 10.26 3 150784 0 29423740
Strangulated umbilical hernia 12.85 10.26 3 150784 0 29423740
Retinal aneurysm 12.82 10.26 8 150779 118 29423622
Diarrhoea 12.71 10.26 1494 149293 331204 29092536
Diaphragmatic disorder 12.71 10.26 20 150767 962 29422778
Chromoblastomycosis 12.66 10.26 6 150781 49 29423691
Acute graft versus host disease in skin 12.65 10.26 4 150783 4660 29419080
Basal cell carcinoma 12.63 10.26 44 150743 16866 29406874
Intraventricular haemorrhage 12.61 10.26 38 150749 2868 29420872
Fungal endocarditis 12.59 10.26 11 150776 278 29423462
Postprandial hypoglycaemia 12.47 10.26 4 150783 9 29423731
Device failure 12.41 10.26 30 150757 1986 29421754
Diabetic hyperosmolar coma 12.40 10.26 12 150775 347 29423393
Alanine aminotransferase increased 12.21 10.26 272 150515 70672 29353068
Eosinophilic pneumonia 12.15 10.26 37 150750 2809 29420931
Retinal exudates 12.12 10.26 16 150771 654 29423086
Mean platelet volume increased 12.06 10.26 13 150774 428 29423312
Thrombocytopenia 12.06 10.26 563 150224 134260 29289480
Oesophageal tuberculosis 11.91 10.26 4 150783 11 29423729
Parvimonas micra infection 11.91 10.26 4 150783 11 29423729
Foetal hypokinesia 11.87 10.26 12 150775 366 29423374
Granulocytopenia 11.84 10.26 8 150779 5986 29417754
Febrile bone marrow aplasia 11.82 10.26 12 150775 7339 29416401
Chronic graft versus host disease 11.77 10.26 3 150784 4026 29419714
Pneumonia aspiration 11.77 10.26 125 150662 36612 29387128
Meningitis fungal 11.72 10.26 7 150780 95 29423645
Hyperinsulinaemic hypoglycaemia 11.71 10.26 6 150781 59 29423681
Bladder cancer 11.65 10.26 90 150697 10037 29413703
Epstein-Barr virus infection 11.62 10.26 10 150777 6619 29417121
Hepatic function abnormal 11.62 10.26 136 150651 39123 29384617
Angina pectoris 11.56 10.26 203 150584 27647 29396093
Parkinsonism 11.56 10.26 12 150775 7266 29416474
Drug eruption 11.55 10.26 45 150742 16696 29407044
Preternatural anus 11.53 10.26 7 150780 98 29423642
Hypogammaglobulinaemia 11.51 10.26 8 150779 5899 29417841
Diabetic hyperglycaemic coma 11.45 10.26 5 150782 33 29423707
Dysphagia 11.43 10.26 204 150583 54722 29369018
Productive cough 11.42 10.26 103 150684 31156 29392584
Allergic transfusion reaction 11.41 10.26 4 150783 13 29423727
Clostridium difficile infection 11.39 10.26 43 150744 16098 29407642
Non-cardiogenic pulmonary oedema 11.39 10.26 15 150772 612 29423128
Nephropathy 11.31 10.26 55 150732 5208 29418532
Extrapyramidal disorder 11.23 10.26 24 150763 10807 29412933
Multiple-drug resistance 11.21 10.26 3 150784 3897 29419843
Sexual dysfunction 11.17 10.26 8 150779 5806 29417934
Unevaluable event 11.14 10.26 214 150573 29637 29394103
Myasthenic syndrome 11.13 10.26 12 150775 395 29423345
Immune-mediated myositis 11.13 10.26 25 150762 1578 29422162
Psoriatic arthropathy 11.12 10.26 38 150749 14653 29409087
Newborn persistent pulmonary hypertension 11.12 10.26 7 150780 105 29423635
Loss of personal independence in daily activities 11.06 10.26 80 150707 25360 29398380
Neonatal respiratory depression 11.01 10.26 12 150775 400 29423340
Genital burning sensation 10.98 10.26 4 150783 15 29423725
Pseudohyponatraemia 10.98 10.26 6 150781 68 29423672
Oxygen saturation decreased 10.98 10.26 162 150625 44775 29378965
Optic discs blurred 10.98 10.26 6 150781 68 29423672
Bladder irrigation 10.98 10.26 6 150781 68 29423672
Pulmonary haemorrhage 10.95 10.26 19 150768 9251 29414489
Hyponatraemia 10.88 10.26 262 150525 67371 29356369
Polycythaemia neonatorum 10.79 10.26 3 150784 3 29423737
Diabetic autonomic neuropathy 10.79 10.26 3 150784 3 29423737
Ostectomy 10.79 10.26 3 150784 3 29423737
Ischaemic cardiomyopathy 10.77 10.26 57 150730 5581 29418159
Electrolyte imbalance 10.72 10.26 96 150691 11178 29412562
Left atrial enlargement 10.68 10.26 16 150771 737 29423003
Pneumothorax 10.67 10.26 43 150744 15799 29407941
Laboratory test abnormal 10.65 10.26 52 150735 18133 29405607
Foetal exposure during delivery 10.61 10.26 6 150781 73 29423667
Drug ineffective for unapproved indication 10.60 10.26 37 150750 14177 29409563
Atrial septal defect 10.58 10.26 65 150722 6724 29417016
Cytomegalovirus viraemia 10.52 10.26 10 150777 6310 29417430
Cogwheel rigidity 10.50 10.26 21 150766 1222 29422518
Poisoning 10.48 10.26 22 150765 9971 29413769
Hunger 10.46 10.26 22 150765 1327 29422413
Urinary tract infection fungal 10.46 10.26 11 150776 352 29423388
Tachycardia 10.45 10.26 285 150502 72125 29351615
Flushing 10.39 10.26 96 150691 28896 29394844
Muscle spasticity 10.36 10.26 6 150781 4877 29418863
Heart rate increased 10.35 10.26 138 150649 38800 29384940
Premature baby 10.30 10.26 134 150653 17146 29406594
Blood ketone body 10.27 10.26 6 150781 78 29423662

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 5338.10 9.52 3648 242743 86244 64166097
Blood glucose increased 3823.65 9.52 3092 243299 94981 64157360
Diabetic ketoacidosis 2178.37 9.52 1380 245011 28465 64223876
Hyperglycaemia 1481.73 9.52 1474 244917 59494 64192847
Diabetes mellitus inadequate control 1461.73 9.52 948 245443 20373 64231968
Blood glucose decreased 1285.81 9.52 903 245488 22220 64230121
Device operational issue 985.03 9.52 236 246155 116 64252225
Glycosylated haemoglobin increased 896.14 9.52 628 245763 15391 64236950
Blood glucose abnormal 597.71 9.52 391 246000 8522 64243819
Ketoacidosis 596.46 9.52 355 246036 6508 64245833
Blood glucose fluctuation 538.39 9.52 316 246075 5639 64246702
Acute kidney injury 534.78 9.52 3232 243159 446008 63806333
Hypoglycaemic coma 498.36 9.52 268 246123 4006 64248335
Lactic acidosis 492.60 9.52 860 245531 60550 64191791
Hyperkalaemia 389.09 9.52 1052 245339 100077 64152264
Diabetic retinopathy 311.51 9.52 171 246220 2668 64249673
Renal failure 283.07 9.52 1408 244983 180280 64072061
Synovitis 277.87 9.52 28 246363 99062 64153279
Joint swelling 253.67 9.52 269 246122 215113 64037228
Diabetic metabolic decompensation 252.51 9.52 147 246244 2581 64249760
Drug ineffective 232.68 9.52 2074 244317 838173 63414168
Infusion related reaction 221.19 9.52 182 246209 164285 64088056
Hypoglycaemic unconsciousness 219.37 9.52 100 246291 1021 64251320
Drug abuse 219.20 9.52 116 246275 132258 64120083
Systemic lupus erythematosus 217.42 9.52 22 246369 77590 64174751
Off label use 211.05 9.52 1484 244907 631322 63621019
Alopecia 207.57 9.52 196 246195 165494 64086847
Hand deformity 204.70 9.52 8 246383 62763 64189578
Arthropathy 201.77 9.52 105 246286 120862 64131479
Drug intolerance 197.49 9.52 257 246134 187735 64064606
Product storage error 195.80 9.52 248 246143 13070 64239271
Myocardial infarction 193.14 9.52 1188 245203 164633 64087708
Treatment failure 191.01 9.52 104 246287 116712 64135629
Pemphigus 190.55 9.52 10 246381 60691 64191650
Drug hypersensitivity 185.86 9.52 394 245997 237421 64014920
Nasopharyngitis 184.27 9.52 290 246101 195783 64056558
Euglycaemic diabetic ketoacidosis 184.09 9.52 158 246233 5252 64247089
Diabetic foot 175.49 9.52 121 246270 2884 64249457
Rheumatoid arthritis 173.17 9.52 224 246167 164070 64088271
Anti-cyclic citrullinated peptide antibody positive 169.97 9.52 4 246387 49558 64202783
Glossodynia 167.28 9.52 24 246367 64672 64187669
Contraindicated product administered 163.59 9.52 105 246286 107724 64144617
Cerebrovascular accident 154.10 9.52 976 245415 136607 64115734
Febrile neutropenia 153.29 9.52 303 246088 187354 64064987
Diabetic neuropathy 148.18 9.52 142 246249 5459 64246882
Device issue 147.37 9.52 290 246101 22358 64229983
Arthralgia 143.79 9.52 1044 245347 441216 63811125
Hypoglycaemic seizure 139.32 9.52 65 246326 703 64251638
Cardiac failure congestive 138.06 9.52 913 245478 129667 64122674
Sinusitis 137.86 9.52 215 246176 145713 64106628
Inappropriate schedule of product administration 134.99 9.52 703 245688 91583 64160758
Incorrect dose administered by device 134.03 9.52 117 246274 3980 64248361
Pancreatic carcinoma 129.08 9.52 178 246213 10195 64242146
Rhabdomyolysis 128.87 9.52 691 245700 91035 64161306
Rash 127.57 9.52 1129 245262 457420 63794921
Renal impairment 126.78 9.52 917 245474 134100 64118241
Loss of consciousness 122.12 9.52 977 245414 147388 64104953
Pericarditis 120.47 9.52 44 246347 62472 64189869
Wrong technique in device usage process 118.61 9.52 94 246297 2788 64249553
Abdominal discomfort 116.56 9.52 335 246056 181987 64070354
Therapeutic product effect incomplete 116.48 9.52 134 246257 103348 64148993
Anti-insulin antibody positive 115.88 9.52 43 246348 244 64252097
Hypersensitivity 115.59 9.52 375 246016 196077 64056264
Insulin resistance 114.50 9.52 64 246327 1036 64251305
Duodenal ulcer perforation 114.31 9.52 4 246387 34621 64217720
Diabetes mellitus 114.06 9.52 530 245861 65944 64186397
Musculoskeletal stiffness 112.14 9.52 186 246205 123020 64129321
Rheumatoid factor positive 112.08 9.52 5 246386 34933 64217408
Metabolic acidosis 111.80 9.52 552 245839 70406 64181935
Wrong product administered 109.14 9.52 141 246250 7579 64244762
Therapeutic product effect decreased 107.93 9.52 171 246220 115180 64137161
Pain 106.92 9.52 1481 244910 552030 63700311
Stomatitis 105.89 9.52 159 246232 109446 64142895
Renal injury 100.91 9.52 198 246193 15231 64237110
Hypoglycaemia unawareness 99.69 9.52 34 246357 144 64252197
Product administration error 97.73 9.52 279 246112 27364 64224977
Increased insulin requirement 94.88 9.52 32 246359 130 64252211
Toxicity to various agents 92.82 9.52 914 245477 362599 63889742
Completed suicide 90.69 9.52 495 245896 223919 64028422
Gangrene 89.92 9.52 125 246266 7213 64245128
Neutropenia 89.09 9.52 543 245848 239081 64013260
Pancreatitis 87.78 9.52 455 245936 59152 64193189
Fatigue 87.77 9.52 2185 244206 746545 63505796
Vitreous haemorrhage 86.93 9.52 81 246310 3004 64249337
Sleep disorder due to general medical condition, insomnia type 86.84 9.52 3 246388 26267 64226074
Coronary artery disease 86.04 9.52 457 245934 59976 64192365
Dehydration 85.08 9.52 1230 245161 215533 64036808
Fear 84.77 9.52 217 246174 19954 64232387
Acute myocardial infarction 84.56 9.52 505 245886 69213 64183128
Toe amputation 83.75 9.52 84 246307 3416 64248925
Diabetic nephropathy 83.24 9.52 74 246317 2580 64249761
Cutaneous amyloidosis 83.06 9.52 22 246369 27 64252314
Irritable bowel syndrome 81.54 9.52 21 246370 37348 64214993
Product use in unapproved indication 81.41 9.52 372 246019 176246 64076095
Chronic kidney disease 79.07 9.52 433 245958 57486 64194855
Hypoglycaemic encephalopathy 75.93 9.52 40 246351 572 64251769
Swelling 75.91 9.52 334 246057 159884 64092457
White blood cell count decreased 75.41 9.52 328 246063 157509 64094832
Ketonuria 74.88 9.52 49 246342 1068 64251273
C-reactive protein abnormal 74.56 9.52 11 246380 29036 64223305
Diabetic coma 74.32 9.52 49 246342 1082 64251259
Peritonitis bacterial 72.91 9.52 127 246264 8916 64243425
Ketosis 71.80 9.52 45 246346 908 64251433
Folliculitis 71.45 9.52 14 246377 30063 64222278
Treatment noncompliance 69.72 9.52 340 246051 43142 64209199
Diabetic complication 68.61 9.52 47 246344 1108 64251233
Helicobacter infection 67.42 9.52 31 246360 38331 64214010
Cardiac failure 66.07 9.52 785 245606 131588 64120753
Hepatic enzyme increased 65.81 9.52 264 246127 129679 64122662
Type 1 diabetes mellitus 65.20 9.52 94 246297 5611 64246730
Headache 63.55 9.52 1539 244852 527928 63724413
Hyperinsulinaemic hypoglycaemia 60.93 9.52 22 246369 114 64252227
Muscle injury 59.34 9.52 14 246377 26423 64225918
Blood creatinine increased 57.05 9.52 780 245611 135002 64117339
Migraine 56.66 9.52 95 246296 62582 64189759
Mental status changes 56.55 9.52 414 245977 60748 64191593
Polyuria 56.25 9.52 139 246252 12504 64239837
Anhedonia 56.10 9.52 146 246245 13560 64238781
Intentional product use issue 56.06 9.52 182 246209 95182 64157159
Oedema peripheral 54.70 9.52 1117 245274 209200 64043141
Pyrexia 54.28 9.52 1673 244718 556971 63695370
Pancreatitis acute 54.26 9.52 314 246077 42541 64209800
Device expulsion 54.26 9.52 8 246383 21128 64231213
Blindness 53.94 9.52 196 246195 21823 64230518
Psoriatic arthropathy 53.21 9.52 52 246339 43229 64209112
Ill-defined disorder 52.93 9.52 54 246337 43998 64208343
Hyperglycaemic hyperosmolar nonketotic syndrome 52.07 9.52 47 246344 1672 64250669
Incorrect dose administered 51.50 9.52 403 245988 60362 64191979
Pancreatic carcinoma metastatic 51.49 9.52 65 246326 3413 64248928
Angina unstable 50.73 9.52 152 246239 15315 64237026
Discomfort 50.63 9.52 150 246241 80728 64171613
Dialysis 48.78 9.52 159 246232 16761 64235580
Insomnia 48.51 9.52 502 245889 197334 64055007
Retinopathy 48.41 9.52 62 246329 3303 64249038
Oropharyngeal pain 47.91 9.52 176 246215 88691 64163650
Infective pulmonary exacerbation of cystic fibrosis 47.61 9.52 125 246266 11671 64240670
Back pain 47.54 9.52 671 245720 249500 64002841
Drug administered in wrong device 47.47 9.52 14 246377 32 64252309
Asthenia 47.21 9.52 2042 244349 426002 63826339
Hypothermia 47.17 9.52 175 246216 19681 64232660
Infection 47.03 9.52 465 245926 184415 64067926
Multiple use of single-use product 46.80 9.52 29 246362 573 64251768
Lower respiratory tract infection 46.78 9.52 194 246197 94420 64157921
Loss of personal independence in daily activities 46.35 9.52 133 246258 72321 64180020
Eye haemorrhage 46.09 9.52 100 246291 8260 64244081
Diabetic ketosis 45.82 9.52 24 246367 339 64252002
Wound 45.62 9.52 145 246246 76332 64176009
Shock hypoglycaemic 44.86 9.52 21 246370 229 64252112
Cardiogenic shock 44.64 9.52 243 246148 32184 64220157
Product quality issue 44.23 9.52 228 246163 29571 64222770
Generalised oedema 43.99 9.52 177 246214 20676 64231665
Fibromyalgia 43.84 9.52 43 246348 35688 64216653
Disease progression 43.25 9.52 340 246051 141340 64111001
Peripheral swelling 42.98 9.52 552 245839 208601 64043740
Anti-insulin antibody increased 41.17 9.52 16 246375 105 64252236
Neutrophil count decreased 40.89 9.52 154 246237 77042 64175299
Blood ketone body increased 40.61 9.52 27 246364 605 64251736
Glomerular filtration rate decreased 39.60 9.52 164 246227 19408 64232933
Emphysematous pyelonephritis 39.59 9.52 19 246372 220 64252121
Blood pressure fluctuation 39.57 9.52 87 246304 51784 64200557
Bone pain 39.50 9.52 76 246315 47496 64204845
Microalbuminuria 39.48 9.52 30 246361 835 64251506
Herpes zoster 39.37 9.52 162 246229 79025 64173316
Glycosuria 39.36 9.52 44 246347 2030 64250311
Anuria 39.24 9.52 160 246231 18804 64233537
Malignant neoplasm progression 39.21 9.52 261 246130 112610 64139731
Visual acuity reduced 39.13 9.52 206 246185 26935 64225406
Asthma 38.99 9.52 209 246182 95016 64157325
Product complaint 38.75 9.52 117 246274 11837 64240504
Cough 38.74 9.52 869 245522 301279 63951062
Drug dependence 38.71 9.52 42 246349 33270 64219071
Renal tubular necrosis 38.43 9.52 177 246214 21933 64230408
Flushing 38.42 9.52 162 246229 78486 64173855
Glycosylated haemoglobin abnormal 38.37 9.52 16 246375 129 64252212
Diabetic gastroparesis 38.35 9.52 19 246372 237 64252104
Drug interaction 38.26 9.52 1720 244671 360363 63891978
Cardiac disorder 38.22 9.52 353 246038 55463 64196878
Non-cardiogenic pulmonary oedema 38.13 9.52 35 246356 1273 64251068
Blood insulin increased 38.12 9.52 21 246370 330 64252011
Foot amputation 38.07 9.52 27 246364 674 64251667
Systemic infection 37.89 9.52 63 246328 4258 64248083
Cardiovascular disorder 37.75 9.52 140 246251 15741 64236600
Hot flush 37.40 9.52 75 246316 46160 64206181
Impaired gastric emptying 37.29 9.52 95 246296 8709 64243632
Oral herpes 37.25 9.52 19 246372 22133 64230208
Mucosal inflammation 37.08 9.52 119 246272 62465 64189876
Injection site erythema 36.36 9.52 143 246248 70657 64181684
Haemodialysis 36.06 9.52 145 246246 16932 64235409
Myocardial ischaemia 35.98 9.52 180 246211 23071 64229270
Blood triglycerides increased 35.78 9.52 155 246236 18711 64233630
Intentional self-injury 35.58 9.52 35 246356 29009 64223332
Diabetic hyperglycaemic coma 35.44 9.52 13 246378 71 64252270
Sopor 34.77 9.52 213 246178 29448 64222893
Hyperhidrosis 34.63 9.52 670 245721 124250 64128091
Sleep disorder 34.37 9.52 115 246276 59594 64192747
Urine ketone body present 34.21 9.52 52 246339 3255 64249086
Injury associated with device 34.06 9.52 48 246343 2805 64249536
Acute coronary syndrome 33.87 9.52 155 246236 19155 64233186
Pemphigoid 33.87 9.52 118 246273 12868 64239473
Osteoarthritis 33.77 9.52 126 246265 63210 64189131
Device interaction 33.62 9.52 25 246366 673 64251668
Rhinorrhoea 33.50 9.52 117 246274 59852 64192489
Neutropenic sepsis 33.48 9.52 24 246367 23248 64229093
Sepsis 33.46 9.52 1133 245258 229208 64023133
Emotional distress 33.34 9.52 244 246147 35794 64216547
Myopathy 33.34 9.52 145 246246 17535 64234806
Hepatic encephalopathy 33.25 9.52 164 246227 20902 64231439
Multiple sclerosis relapse 33.04 9.52 67 246324 41068 64211273
Diabetic foot infection 32.87 9.52 25 246366 697 64251644
Accidental underdose 32.54 9.52 24 246367 638 64251703
Myelosuppression 32.46 9.52 26 246365 23804 64228537
Angina pectoris 32.34 9.52 288 246103 44793 64207548
Hip arthroplasty 32.08 9.52 21 246370 21330 64231011
Arterial occlusive disease 32.01 9.52 78 246313 6955 64245386
Gastrooesophageal reflux disease 31.59 9.52 187 246204 82956 64169385
Cardiac arrest 31.49 9.52 791 245600 153273 64099068
Medication error 31.24 9.52 310 246081 49656 64202685
Adenocarcinoma pancreas 30.95 9.52 37 246354 1836 64250505
Injury 30.58 9.52 338 246053 55654 64196687
Device delivery system issue 30.16 9.52 19 246372 387 64251954
Drug resistance 30.09 9.52 55 246336 35047 64217294
Mucormycosis 29.84 9.52 78 246313 7263 64245078
Anti-insulin antibody 29.41 9.52 11 246380 64 64252277
Impaired healing 29.27 9.52 125 246266 60348 64191993
Hypervolaemia 29.24 9.52 248 246143 38037 64214304
Musculoskeletal pain 29.24 9.52 186 246205 81108 64171233
Hepatic cirrhosis 29.05 9.52 186 246205 26112 64226229
Psychotic disorder 28.91 9.52 55 246336 34523 64217818
Macular oedema 28.89 9.52 60 246331 4807 64247534
Leg amputation 28.77 9.52 49 246342 3378 64248963
Diabetic ketoacidotic hyperglycaemic coma 28.75 9.52 15 246376 210 64252131
Pulmonary embolism 28.69 9.52 390 246001 145966 64106375
Therapy non-responder 28.46 9.52 142 246249 65757 64186584
Influenza 28.32 9.52 265 246126 106266 64146075
Haemophagocytic lymphohistiocytosis 28.30 9.52 16 246375 17593 64234748
Ischaemic cardiomyopathy 28.15 9.52 73 246318 6765 64245576
Nasal congestion 27.85 9.52 125 246266 59533 64192808
Rheumatoid nodule 27.81 9.52 7 246384 12644 64239697
Hypertriglyceridaemia 27.66 9.52 100 246291 11105 64241236
Blood potassium increased 27.63 9.52 182 246209 25798 64226543
C-reactive protein increased 27.47 9.52 231 246160 94678 64157663
Cold sweat 27.33 9.52 130 246261 16325 64236016
Constipation 27.30 9.52 667 245724 228670 64023671
Knee arthroplasty 27.21 9.52 38 246353 26961 64225380
Bladder cancer 27.15 9.52 98 246293 10876 64241465
Left ventricular hypertrophy 27.10 9.52 89 246302 9417 64242924
Tenosynovitis 27.09 9.52 6 246385 11827 64240514
Muscle spasticity 27.00 9.52 15 246376 16654 64235687
Upper respiratory tract infection 26.97 9.52 165 246226 72620 64179721
Diabetic hyperosmolar coma 26.60 9.52 22 246369 694 64251647
General physical health deterioration 26.59 9.52 993 245398 203432 64048909
Respiratory failure 26.57 9.52 805 245586 160378 64091963
Bone marrow failure 26.48 9.52 94 246297 47858 64204483
Injection site haemorrhage 26.38 9.52 171 246220 24107 64228234
Inflammation 26.35 9.52 144 246247 65156 64187185
High density lipoprotein decreased 26.24 9.52 51 246340 3895 64248446
Tinnitus 26.24 9.52 57 246334 34076 64218265
Acetonaemia 26.03 9.52 15 246376 258 64252083
Polydipsia 25.90 9.52 64 246327 5757 64246584
Shock 25.75 9.52 241 246150 37999 64214342
Ureteric compression 25.70 9.52 13 246378 170 64252171
Anti-GAD antibody positive 25.69 9.52 9 246382 42 64252299
Injection site nodule 25.57 9.52 45 246346 3185 64249156
Peripheral vascular disorder 25.38 9.52 73 246318 7188 64245153
Premature delivery 25.38 9.52 139 246252 18450 64233891
Urticaria 25.25 9.52 403 245988 146914 64105427
Neck pain 25.22 9.52 135 246256 61398 64190943
Pre-eclampsia 25.12 9.52 66 246325 6165 64246176
Rheumatic fever 25.09 9.52 3 246388 9291 64243050
Blood urea increased 24.79 9.52 268 246123 43885 64208456
Drug dose omission by device 24.62 9.52 46 246345 3411 64248930
Electrolyte imbalance 24.56 9.52 173 246218 25070 64227271
Hyperlactacidaemia 24.52 9.52 56 246335 4788 64247553
Oedematous pancreatitis 24.42 9.52 23 246368 865 64251476
Hyperosmolar state 24.40 9.52 20 246371 623 64251718
Infusion site pain 24.36 9.52 5 246386 10392 64241949
Peripheral arterial occlusive disease 24.19 9.52 70 246321 6917 64245424
Erythrodermic psoriasis 24.16 9.52 30 246361 1549 64250792
Red blood cell sedimentation rate increased 24.14 9.52 52 246339 31183 64221158
Unevaluable event 24.11 9.52 297 246094 50192 64202149
Erythema 23.95 9.52 538 245853 186532 64065809
Pain in jaw 23.79 9.52 78 246313 40677 64211664
Device use issue 23.63 9.52 32 246359 1801 64250540
Wrong technique in product usage process 23.61 9.52 364 246027 64610 64187731
Retinal haemorrhage 23.60 9.52 72 246319 7326 64245015
Neuropathic arthropathy 23.49 9.52 15 246376 313 64252028
Injection site reaction 23.49 9.52 95 246296 46569 64205772
Pulmonary interstitial emphysema syndrome 23.24 9.52 17 246374 446 64251895
Device dislocation 23.20 9.52 28 246363 21150 64231191
Pneumocystis jirovecii pneumonia 23.07 9.52 44 246347 27590 64224751
Cognitive disorder 23.05 9.52 120 246271 54967 64197374
Glycosylated haemoglobin decreased 23.04 9.52 19 246372 597 64251744
Peritoneal dialysis complication 23.00 9.52 35 246356 2193 64250148
Acidosis 22.92 9.52 131 246260 17664 64234677
Bursitis 22.91 9.52 29 246362 21456 64230885
Osteoporosis 22.90 9.52 83 246308 41997 64210344
Blood ketone body 22.87 9.52 11 246380 128 64252213
Oliguria 22.66 9.52 113 246278 14463 64237878
Crystal nephropathy 22.59 9.52 26 246365 1239 64251102
Pharyngitis 22.49 9.52 137 246254 18902 64233439
Foot deformity 22.49 9.52 18 246373 16486 64235855
Diverticulitis 22.48 9.52 74 246317 38544 64213797
Insulin C-peptide decreased 22.20 9.52 9 246382 67 64252274
Amputation 22.14 9.52 18 246373 554 64251787
Decreased insulin requirement 22.01 9.52 11 246380 140 64252201
Hypovolaemia 21.95 9.52 117 246274 15369 64236972
Influenza like illness 21.77 9.52 142 246249 61560 64190781
Basal cell carcinoma 21.69 9.52 54 246337 30784 64221557
Vomiting 21.66 9.52 2413 243978 548704 63703637
Latent autoimmune diabetes in adults 21.64 9.52 9 246382 72 64252269
Confusional state 21.64 9.52 1212 245179 259932 63992409
Liquid product physical issue 21.62 9.52 21 246370 821 64251520
Distributive shock 21.58 9.52 31 246360 1844 64250497
Sprue-like enteropathy 21.56 9.52 23 246368 1006 64251335
Plasmapheresis 21.39 9.52 18 246373 582 64251759
Heparin-induced thrombocytopenia 21.21 9.52 76 246315 8403 64243938
Pulmonary oedema 21.13 9.52 420 245971 78254 64174087
Dry eye 21.05 9.52 50 246341 28969 64223372
Hypoglycaemia neonatal 21.05 9.52 8 246383 49 64252292
Gastrointestinal disorder 21.01 9.52 230 246161 89479 64162862
Alveolar lung disease 21.00 9.52 17 246374 520 64251821
Ear pain 21 9.52 40 246351 25096 64227245
Bone erosion 20.95 9.52 9 246382 11586 64240755
Diabetic gangrene 20.90 9.52 11 246380 157 64252184
Maternal exposure during pregnancy 20.83 9.52 250 246141 95634 64156707
Visual impairment 20.76 9.52 398 245993 73679 64178662
Hepatocellular carcinoma 20.75 9.52 75 246316 8328 64244013
Exposure during pregnancy 20.64 9.52 414 245977 77261 64175080
Joint effusion 20.58 9.52 13 246378 13460 64238881
Dawn phenomenon 20.52 9.52 5 246386 3 64252338
Immune reconstitution inflammatory syndrome 20.52 9.52 11 246380 12459 64239882
Diabetic retinal oedema 20.33 9.52 14 246377 333 64252008
Suture rupture 20.17 9.52 17 246374 551 64251790
Anaemia 20.01 9.52 1693 244698 376987 63875354
Gastrointestinal haemorrhage 19.49 9.52 652 245739 131660 64120681
Retinal aneurysm 19.42 9.52 12 246379 236 64252105
Acute myeloid leukaemia 19.39 9.52 48 246343 27415 64224926
Rhythm idioventricular 19.29 9.52 16 246375 507 64251834
Mydriasis 19.28 9.52 18 246373 15294 64237047
Peripheral ischaemia 19.20 9.52 73 246318 8305 64244036
Pain in extremity 19.18 9.52 954 245437 302131 63950210
Oxygen saturation decreased 19.10 9.52 291 246100 106885 64145456
Multiple organ dysfunction syndrome 19.06 9.52 515 245876 100898 64151443
Acne 19.05 9.52 37 246354 23044 64229297
Extremity necrosis 19.00 9.52 36 246355 2698 64249643
Somogyi phenomenon 18.94 9.52 5 246386 6 64252335
Hypertensive crisis 18.90 9.52 127 246264 18121 64234220
Urinary tract infection fungal 18.75 9.52 20 246371 875 64251466
Therapeutic drug monitoring analysis not performed 18.50 9.52 23 246368 1189 64251152
Mania 18.41 9.52 21 246370 16265 64236076
Toothache 18.38 9.52 122 246269 17337 64235004
Ventricular hyperkinesia 18.36 9.52 12 246379 261 64252080
Epileptic encephalopathy 18.23 9.52 14 246377 396 64251945
Acute graft versus host disease 18.17 9.52 6 246385 9078 64243263
Cholestasis 18.11 9.52 256 246135 44616 64207725
Postprandial hypoglycaemia 17.96 9.52 8 246383 77 64252264
Unresponsive to stimuli 17.80 9.52 281 246110 50112 64202229
Liver transplant failure 17.77 9.52 9 246382 118 64252223
Blood insulin abnormal 17.74 9.52 5 246386 9 64252332
Metabolic syndrome 17.67 9.52 32 246359 2316 64250025
Leukopenia 17.66 9.52 276 246115 100966 64151375
Haematotoxicity 17.65 9.52 14 246377 12882 64239459
Osteomyelitis 17.65 9.52 172 246219 27415 64224926
Phimosis 17.61 9.52 14 246377 417 64251924
Bone density decreased 17.55 9.52 8 246383 9944 64242397
Glucose urine present 17.36 9.52 26 246365 1606 64250735
Full blood count abnormal 17.34 9.52 57 246334 29700 64222641
Renal disorder 17.30 9.52 209 246182 35156 64217185
Sleep disorder due to a general medical condition 17.26 9.52 5 246386 8229 64244112
Caesarean section 17.24 9.52 87 246304 11187 64241154
Gait inability 17.21 9.52 242 246149 42126 64210215
Immune-mediated myositis 17.07 9.52 34 246357 2644 64249697
Oedema 17.03 9.52 466 245925 91469 64160872
Eosinophilic pneumonia 16.96 9.52 47 246344 4530 64247811
Haematoma muscle 16.89 9.52 27 246364 1766 64250575
Injection site swelling 16.79 9.52 91 246300 41262 64211079
Weight decreased 16.78 9.52 1288 245103 284451 63967890
Hypotension 16.76 9.52 1681 244710 379293 63873048
Acute graft versus host disease in skin 16.69 9.52 3 246388 6852 64245489
Heavy menstrual bleeding 16.67 9.52 13 246378 12064 64240277
Dry mouth 16.61 9.52 149 246242 60269 64192072
Patella fracture 16.59 9.52 25 246366 1553 64250788
Heart rate increased 16.54 9.52 271 246120 98404 64153937
Aggression 16.51 9.52 106 246285 46126 64206215
Blood ketone body present 16.42 9.52 7 246384 60 64252281
Body temperature increased 16.41 9.52 78 246313 36588 64215753
Anaphylactic shock 16.38 9.52 60 246331 30268 64222073
Mitral valve thickening 16.33 9.52 13 246378 388 64251953
Leukocytosis 16.32 9.52 218 246173 37522 64214819
Unintentional medical device removal 16.28 9.52 3 246388 6731 64245610
Right atrial enlargement 16.14 9.52 12 246379 323 64252018
Injection site pruritus 16.05 9.52 82 246309 37744 64214597
Food allergy 16.04 9.52 5 246386 7846 64244495
Immobilisation prolonged 15.99 9.52 8 246383 102 64252239
Adenovirus infection 15.97 9.52 4 246387 7251 64245090
Myelodysplastic syndrome 15.95 9.52 53 246338 27526 64224815
Vitrectomy 15.90 9.52 10 246381 203 64252138
Pulse pressure decreased 15.89 9.52 13 246378 404 64251937
Transient ischaemic attack 15.85 9.52 247 246144 43935 64208406
Encephalopathy 15.79 9.52 314 246077 58505 64193836
Blister 15.77 9.52 216 246175 80751 64171590
Parkinsonism 15.75 9.52 19 246372 14354 64237987
Fall 15.66 9.52 1820 244571 415006 63837335
Diet failure 15.62 9.52 6 246385 38 64252303
Product name confusion 15.61 9.52 9 246382 155 64252186
Perinephric abscess 15.61 9.52 10 246381 210 64252131
Blindness unilateral 15.57 9.52 59 246332 6702 64245639
Cystic fibrosis 15.54 9.52 38 246353 3396 64248945
Osteopenia 15.53 9.52 22 246369 15518 64236823
Foetal macrosomia 15.53 9.52 4 246387 4 64252337
Visceral venous thrombosis 15.51 9.52 5 246386 17 64252324
Cellulitis 15.49 9.52 468 245923 93189 64159152
ECG signs of myocardial ischaemia 15.40 9.52 12 246379 347 64251994
Mood swings 15.30 9.52 27 246364 17441 64234900
Progressive multifocal leukoencephalopathy 15.24 9.52 29 246362 18203 64234138
Lymphadenopathy 15.20 9.52 110 246281 46576 64205765
Pancreatic failure 15.16 9.52 23 246368 1437 64250904
Left atrial dilatation 15.15 9.52 33 246358 2733 64249608
Mouth ulceration 15.13 9.52 68 246323 32376 64219965
Enzyme inhibition 15.09 9.52 5 246386 19 64252322
Contusion 15.08 9.52 326 246065 113639 64138702
Drug eruption 14.96 9.52 79 246312 36057 64216284
Blindness transient 14.95 9.52 42 246349 4080 64248261
Pyelonephritis 14.89 9.52 115 246276 17151 64235190
Flour sensitivity 14.89 9.52 5 246386 20 64252321
Diabetic bullosis 14.89 9.52 5 246386 20 64252321
Blood glucose normal 14.89 9.52 5 246386 20 64252321
Arterial bypass operation 14.87 9.52 6 246385 44 64252297
Conjunctivitis 14.82 9.52 35 246356 20319 64232022
Upper motor neurone lesion 14.77 9.52 10 246381 231 64252110
Posterior reversible encephalopathy syndrome 14.76 9.52 42 246349 22904 64229437
Peripheral artery haematoma 14.76 9.52 6 246385 45 64252296
Fracture blisters 14.74 9.52 7 246384 79 64252262
Skin pressure mark 14.74 9.52 7 246384 79 64252262
Retinal exudates 14.71 9.52 20 246371 1130 64251211
Guillain-Barre syndrome 14.69 9.52 63 246328 7572 64244769
Arrhythmia 14.67 9.52 284 246107 52660 64199681
Pyelocaliectasis 14.59 9.52 17 246374 821 64251520
Bradycardia 14.58 9.52 571 245820 117648 64134693
Device mechanical issue 14.56 9.52 8 246383 125 64252216
Product dispensing error 14.56 9.52 84 246307 11366 64240975
Musculoskeletal disorder 14.52 9.52 29 246362 17877 64234464
Nephropathy 14.47 9.52 67 246324 8319 64244022
Device defective 14.46 9.52 21 246370 1262 64251079
Device malfunction 14.42 9.52 116 246275 17517 64234824
Tooth disorder 14.41 9.52 41 246350 22361 64229980
Pulse absent 14.37 9.52 70 246321 8876 64243465
Colitis 14.31 9.52 149 246242 58525 64193816
Mobility decreased 14.31 9.52 236 246155 85604 64166737
Diabetic ulcer 14.30 9.52 10 246381 244 64252097
Paradoxical drug reaction 14.22 9.52 3 246388 6117 64246224
Hyperinsulinaemia 14.21 9.52 9 246382 185 64252156
Colitis ulcerative 14.19 9.52 43 246348 22985 64229356
Bundle branch block right 14.16 9.52 77 246314 10192 64242149
Platelet count decreased 14.14 9.52 511 245880 167200 64085141
Foetal hypokinesia 14.12 9.52 11 246380 318 64252023
Hallucination, auditory 14.11 9.52 27 246364 16912 64235429
Facial nerve disorder 14.07 9.52 15 246376 656 64251685
Nephrogenic systemic fibrosis 14.05 9.52 52 246339 5840 64246501
Pulseless electrical activity 14.01 9.52 90 246301 12649 64239692
Blood creatinine abnormal 13.95 9.52 41 246350 4086 64248255
Delusion 13.91 9.52 30 246361 17984 64234357
Hepatic neoplasm 13.87 9.52 34 246357 3043 64249298
Sedation 13.83 9.52 97 246294 41365 64210976
Sinus arrest 13.77 9.52 34 246357 3056 64249285
Penile prosthesis insertion 13.71 9.52 3 246388 0 64252341
Strangulated umbilical hernia 13.71 9.52 3 246388 0 64252341
Muscle abscess 13.63 9.52 17 246374 882 64251459
Neoplasm progression 13.59 9.52 96 246295 40868 64211473
Multiple-drug resistance 13.54 9.52 4 246387 6498 64245843
Ear infection 13.52 9.52 45 246346 23359 64228982
Injection site warmth 13.51 9.52 19 246372 13443 64238898
Polyhydramnios 13.47 9.52 22 246369 1465 64250876
Pancreatitis chronic 13.46 9.52 37 246354 3549 64248792
Eye irritation 13.45 9.52 25 246366 15831 64236510
Preternatural anus 13.42 9.52 7 246384 98 64252243
Acquired haemophilia 13.38 9.52 23 246368 1597 64250744
Left atrial enlargement 13.28 9.52 18 246373 1014 64251327
Throat irritation 13.27 9.52 72 246319 32639 64219702
Calciphylaxis 13.27 9.52 35 246356 3277 64249064
Cortisol increased 13.25 9.52 12 246379 429 64251912
Acute pulmonary oedema 13.18 9.52 89 246302 12720 64239621
Immunodeficiency 13.17 9.52 26 246365 16098 64236243
Haematoma 13.13 9.52 249 246142 46001 64206340
Oesophageal tuberculosis 13.04 9.52 4 246387 11 64252330
Jaundice 13.03 9.52 259 246132 48253 64204088
Injection site pain 13.02 9.52 535 245856 110873 64141468
Hepatic steatosis 12.96 9.52 178 246213 30829 64221512
Respiratory depression 12.91 9.52 46 246345 23397 64228944
Intraventricular haemorrhage 12.86 9.52 40 246351 4113 64248228
Eyelid bleeding 12.85 9.52 6 246385 65 64252276
Agitation 12.81 9.52 249 246142 88118 64164223
Second primary malignancy 12.80 9.52 17 246374 12320 64240021
Device leakage 12.79 9.52 64 246327 8202 64244139
Dermatitis papillaris capillitii 12.79 9.52 4 246387 12 64252329
Insulin C-peptide increased 12.76 9.52 7 246384 109 64252232
Eye infection staphylococcal 12.76 9.52 7 246384 109 64252232
Open angle glaucoma 12.75 9.52 11 246380 368 64251973
Fasting 12.72 9.52 5 246386 34 64252307
Paraesthesia 12.71 9.52 404 245987 134118 64118223
Biliary obstruction 12.70 9.52 38 246353 3826 64248515
Night sweats 12.69 9.52 83 246308 35963 64216378
Pyelonephritis fungal 12.65 9.52 7 246384 111 64252230
Retinopathy proliferative 12.65 9.52 7 246384 111 64252230
Optic discs blurred 12.61 9.52 6 246385 68 64252273
Ear discomfort 12.61 9.52 6 246385 7274 64245067
Adverse drug reaction 12.55 9.52 112 246279 45352 64206989
Glycogen storage disease type VIII 12.55 9.52 4 246387 13 64252328
Intestinal transit time abnormal 12.54 9.52 6 246385 69 64252272
Hypochromasia 12.52 9.52 14 246377 646 64251695
Ankylosing spondylitis 12.50 9.52 8 246383 8226 64244115
Dysphonia 12.48 9.52 115 246276 46267 64206074
Neurotoxicity 12.44 9.52 58 246333 27346 64224995
Extrapyramidal disorder 12.42 9.52 36 246355 19516 64232825
Atrioventricular block complete 12.42 9.52 96 246295 14322 64238019
Gallbladder neoplasm 12.39 9.52 6 246385 71 64252270
Oesophageal carcinoma recurrent 12.36 9.52 5 246386 37 64252304
Radiation fibrosis 12.36 9.52 5 246386 37 64252304
Groin abscess 12.35 9.52 20 246371 1322 64251019
Ureteric obstruction 12.26 9.52 28 246363 2394 64249947
Bronchiectasis 12.26 9.52 22 246369 14118 64238223
Interstitial lung disease 12.23 9.52 282 246109 97450 64154891
Epstein-Barr virus infection 12.16 9.52 18 246373 12470 64239871
Haemodynamic instability 12.14 9.52 98 246293 14814 64237527
Morganella infection 12.12 9.52 17 246374 989 64251352
Chromoblastomycosis 12.10 9.52 6 246385 75 64252266
Coronary artery stenosis 12.08 9.52 79 246312 11169 64241172
Depression 11.96 9.52 575 245816 182716 64069625
Product dose omission issue 11.95 9.52 881 245510 193866 64058475
Glucose-6-phosphate dehydrogenase deficiency 11.94 9.52 10 246381 321 64252020
Pneumonia 11.90 9.52 1917 244474 557659 63694682
Arthritis 11.90 9.52 237 246154 83577 64168764
Gastritis fungal 11.81 9.52 8 246383 185 64252156
Altered state of consciousness 11.79 9.52 207 246184 37695 64214646
Respiratory tract infection 11.76 9.52 89 246302 37318 64215023
Ostectomy 11.72 9.52 4 246387 17 64252324
Tendonitis 11.71 9.52 39 246352 20243 64232098
Panniculitis 11.71 9.52 10 246381 8869 64243472
Pseudohyponatraemia 11.68 9.52 7 246384 130 64252211
Graft versus host disease in skin 11.67 9.52 3 246388 5344 64246997
Cerebellar artery occlusion 11.65 9.52 3 246388 3 64252338
Fructosamine increased 11.65 9.52 3 246388 3 64252338
Meniscus injury 11.65 9.52 4 246387 5903 64246438
Penile abscess 11.65 9.52 3 246388 3 64252338
Hyperglycaemic seizure 11.65 9.52 3 246388 3 64252338
Urine albumin/creatinine ratio 11.65 9.52 3 246388 3 64252338
Cardiac ventricular disorder 11.63 9.52 10 246381 333 64252008
Substance abuse 11.61 9.52 11 246380 9281 64243060
Sinus disorder 11.59 9.52 30 246361 16878 64235463
Polyarthritis 11.57 9.52 12 246379 9703 64242638
Tooth infection 11.54 9.52 24 246367 14577 64237764
End stage renal disease 11.51 9.52 74 246317 10401 64241940
Metabolic disorder 11.50 9.52 59 246332 7638 64244703
Urosepsis 11.44 9.52 132 246259 21962 64230379
Diaphragmatic disorder 11.44 9.52 20 246371 1408 64250933
Labelled drug-food interaction issue 11.36 9.52 4 246387 19 64252322
Drug ineffective for unapproved indication 11.31 9.52 71 246320 31062 64221279
Anxiety 11.28 9.52 646 245745 202003 64050338
Aphthous ulcer 11.26 9.52 20 246371 12886 64239455
Insulin autoimmune syndrome 11.24 9.52 10 246381 349 64251992
Mood altered 11.22 9.52 28 246363 15951 64236390
Expired product administered 11.21 9.52 49 246342 5938 64246403
Middle insomnia 11.19 9.52 20 246371 12857 64239484
Tumour rupture 11.19 9.52 10 246381 351 64251990
Diabetic hepatopathy 11.19 9.52 3 246388 4 64252337
Vessel puncture site inflammation 11.19 9.52 3 246388 4 64252337
Sodium retention 11.14 9.52 6 246385 90 64252251
Ataxia 11.09 9.52 45 246346 22039 64230302
Drug specific antibody present 11.05 9.52 3 246388 5151 64247190
Retroperitoneal oedema 11.04 9.52 4 246387 21 64252320
Acral peeling skin syndrome 10.97 9.52 5 246386 51 64252290
Panic attack 10.96 9.52 42 246349 20911 64231430
Depressed mood 10.90 9.52 102 246289 40910 64211431
Dermatitis contact 10.85 9.52 11 246380 8989 64243352
Ascites 10.84 9.52 312 246079 61689 64190652
Exposure to toxic agent 10.79 9.52 5 246386 6154 64246187
Diabetic vascular disorder 10.72 9.52 5 246386 54 64252287
Dose calculation error 10.72 9.52 7 246384 152 64252189
Ectopic ACTH syndrome 10.72 9.52 7 246384 152 64252189
Total cholesterol/HDL ratio increased 10.71 9.52 8 246383 217 64252124
Underdose 10.68 9.52 148 246243 25681 64226660
Acute respiratory failure 10.67 9.52 258 246133 49676 64202665
International normalised ratio increased 10.63 9.52 386 246005 78781 64173560
Oral candidiasis 10.61 9.52 49 246342 23163 64229178
Laser therapy 10.59 9.52 4 246387 24 64252317
Laryngeal leukoplakia 10.56 9.52 5 246386 56 64252285
Scoliosis 10.55 9.52 5 246386 6077 64246264
Malignant melanoma 10.51 9.52 21 246370 12943 64239398
Needle issue 10.50 9.52 66 246325 9206 64243135
Cholangitis 10.49 9.52 74 246317 10728 64241613
Pancreatic neoplasm 10.48 9.52 19 246372 1376 64250965
Diabetic eye disease 10.48 9.52 7 246384 158 64252183
Rash erythematous 10.48 9.52 127 246264 48506 64203835
Left ventricular enlargement 10.47 9.52 13 246378 671 64251670
Clostridium difficile infection 10.47 9.52 88 246303 36075 64216266
Candida sepsis 10.45 9.52 25 246366 2203 64250138
Blood phosphorus increased 10.45 9.52 42 246349 4904 64247437
Pathogen resistance 10.44 9.52 20 246371 12523 64239818
Vesicoureteric reflux 10.42 9.52 6 246385 103 64252238
Pancreatic pseudocyst 10.34 9.52 18 246373 1263 64251078
Kidney transplant rejection 10.34 9.52 67 246324 9444 64242897
Proteinuria 10.33 9.52 156 246235 27567 64224774
Parvimonas micra infection 10.33 9.52 4 246387 26 64252315
Blood chloride increased 10.32 9.52 41 246350 4762 64247579
Wrong drug 10.31 9.52 8 246383 230 64252111
Subcapsular renal haematoma 10.31 9.52 13 246378 682 64251659
Tongue disorder 10.29 9.52 19 246372 12061 64240280
Hallucination 10.28 9.52 206 246185 72582 64179759
Diabetic microangiopathy 10.26 9.52 5 246386 60 64252281
Febrile bone marrow aplasia 10.22 9.52 17 246374 11238 64241103
Joint stiffness 10.21 9.52 71 246320 30333 64222008
Gastrointestinal tract mucosal pigmentation 10.20 9.52 15 246376 912 64251429
Osteonecrosis of jaw 10.18 9.52 100 246291 39725 64212616
Periodontitis 10.17 9.52 37 246354 4122 64248219
Stress 10.14 9.52 303 246088 60231 64192110
Pneumothorax 10.12 9.52 53 246338 24245 64228096
Klebsiella infection 10.12 9.52 86 246305 13195 64239146
Lymphopenia 10.12 9.52 57 246334 25600 64226741
Bladder irrigation 10.12 9.52 5 246386 62 64252279
Suicidal ideation 10.11 9.52 186 246205 66356 64185985
Fungal endocarditis 10.10 9.52 11 246380 493 64251848
Pruritus 10.08 9.52 1042 245349 311358 63940983
Tendon pain 10.06 9.52 3 246388 4845 64247496
Post transplant lymphoproliferative disorder 10.05 9.52 13 246378 9531 64242810
Pericarditis fungal 10.04 9.52 7 246384 170 64252171
Pharyngitis streptococcal 9.99 9.52 11 246380 8657 64243684
Obstructive airways disorder 9.98 9.52 50 246341 23135 64229206
Low density lipoprotein increased 9.98 9.52 57 246334 7683 64244658
Ventricular fibrillation 9.98 9.52 137 246254 23723 64228618
Choroidal effusion 9.97 9.52 12 246379 600 64251741
Osteonecrosis 9.94 9.52 65 246326 28164 64224177
Irritability 9.94 9.52 91 246300 36655 64215686
Epistaxis 9.94 9.52 292 246099 97839 64154502
Cryptococcosis 9.92 9.52 28 246363 2727 64249614
Death 9.89 9.52 1657 244734 481048 63771293
Paralysis 9.87 9.52 77 246314 11518 64240823
Vasoplegia syndrome 9.85 9.52 28 246363 2739 64249602
Oral pain 9.83 9.52 63 246328 27430 64224911
Red blood cell count decreased 9.81 9.52 128 246263 48258 64204083
Large intestine polyp 9.81 9.52 73 246318 10764 64241577
Meningitis fungal 9.79 9.52 7 246384 177 64252164
Pulmonary tuberculosis 9.75 9.52 8 246383 7236 64245105
Cerebral cyst 9.72 9.52 9 246382 331 64252010
Chronic graft versus host disease 9.66 9.52 6 246385 6270 64246071
Septic embolus 9.63 9.52 21 246370 1741 64250600
Hepatobiliary cancer 9.59 9.52 3 246388 9 64252332
Fibrodysplasia ossificans progressiva 9.59 9.52 3 246388 9 64252332
Mean platelet volume increased 9.59 9.52 15 246376 963 64251378
Incision site pain 9.59 9.52 27 246364 2627 64249714
Osmotic demyelination syndrome 9.55 9.52 17 246374 1214 64251127

FDA Adverse Event Reporting System (Pediatric)

None

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 antidiabetic
FDA EPC N0000175944 Insulin

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

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




🐶 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
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
7548 INN_ID
7572 IUPHAR_LIGAND_ID
118984375 PUBCHEM_CID
DB00030 DRUGBANK_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
5186 INN_ID

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 33 sections
Soliqua 100/33 HUMAN PRESCRIPTION DRUG LABEL 2 0024-5761 INJECTION, SOLUTION 100 U SUBCUTANEOUS BLA 33 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
Insulin Glargine Solostar HUMAN PRESCRIPTION DRUG LABEL 1 0955-1728 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Insulin Glargine HUMAN PRESCRIPTION DRUG LABEL 1 0955-1729 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 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
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