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
March 25, 2020 PMDA Sanofi K.K.
April 20, 2000 FDA SANOFI AVENTIS US
June 9, 2000 EMA sanofi-aventis Deutschland GmbH

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 4459.92 9.49 2756 163385 81000 63241881
Hypoglycaemia 3502.00 9.49 2096 164045 57969 63264912
Diabetic ketoacidosis 1978.55 9.49 999 165142 19506 63303375
Diabetes mellitus inadequate control 1314.51 9.49 687 165454 14439 63308442
Hyperglycaemia 1196.40 9.49 942 165199 40925 63281956
Blood glucose decreased 1161.91 9.49 709 165432 20243 63302638
Glycosylated haemoglobin increased 870.66 9.49 489 165652 11909 63310972
Blood glucose abnormal 727.40 9.49 373 165768 7519 63315362
Device operational issue 715.35 9.49 163 165978 123 63322758
Ketoacidosis 535.44 9.49 251 165890 4127 63318754
Acute kidney injury 478.77 9.49 1646 164495 261769 63061112
Blood glucose fluctuation 470.72 9.49 233 165908 4343 63318538
Lactic acidosis 456.96 9.49 532 165609 37755 63285126
Systemic lupus erythematosus 451.66 9.49 23 166118 208895 63113986
Pemphigus 444.85 9.49 7 166134 183719 63139162
Product storage error 395.98 9.49 322 165819 14634 63308247
Glossodynia 392.05 9.49 18 166123 178858 63144023
Hand deformity 378.15 9.49 8 166133 159449 63163432
Contraindicated product administered 377.57 9.49 59 166082 217589 63105292
Treatment failure 345.13 9.49 54 166087 198989 63123892
Synovitis 344.63 9.49 42 166099 186876 63136005
Hyperkalaemia 328.25 9.49 543 165598 53660 63269221
Alopecia 327.91 9.49 243 165898 337293 62985588
Infusion related reaction 321.97 9.49 120 166021 245401 63077480
Hypoglycaemic coma 306.79 9.49 145 165996 2430 63320451
Arthropathy 305.78 9.49 116 166025 234676 63088205
Diabetic retinopathy 301.92 9.49 139 166002 2188 63320693
Drug intolerance 291.08 9.49 229 165912 308432 63014449
Joint swelling 290.68 9.49 258 165883 327408 62995473
Anti-cyclic citrullinated peptide antibody positive 278.84 9.49 5 166136 116207 63206674
Renal failure 268.72 9.49 796 165345 116856 63206025
Abdominal discomfort 235.96 9.49 296 165845 320589 63002292
Device issue 234.28 9.49 300 165841 23481 63299400
Discomfort 225.79 9.49 78 166063 167296 63155585
Pericarditis 216.35 9.49 41 166100 131538 63191343
Swelling 205.57 9.49 251 165890 275127 63047754
Rheumatoid factor positive 197.08 9.49 5 166136 84401 63238480
Cerebrovascular accident 192.18 9.49 671 165470 107353 63215528
Diabetic metabolic decompensation 184.62 9.49 90 166051 1620 63321261
Musculoskeletal stiffness 182.84 9.49 130 166011 184488 63138393
Pain 180.93 9.49 1167 164974 739461 62583420
Drug ineffective 175.52 9.49 1821 164320 1042944 62279937
Drug hypersensitivity 171.23 9.49 347 165794 310340 63012541
Hepatic enzyme increased 167.86 9.49 169 165972 202159 63120722
Therapeutic product effect decreased 167.67 9.49 155 165986 193032 63129849
Cardiac failure congestive 165.99 9.49 576 165565 91857 63231024
Inappropriate schedule of product administration 164.77 9.49 622 165519 103343 63219538
Helicobacter infection 163.41 9.49 24 166117 92761 63230120
Wound 157.70 9.49 118 166023 163145 63159736
Folliculitis 157.57 9.49 6 166135 70311 63252570
Myocardial infarction 156.12 9.49 595 165546 99298 63223583
Hypoglycaemic unconsciousness 155.35 9.49 63 166078 714 63322167
Device mechanical issue 152.39 9.49 47 166094 215 63322666
Rash 151.84 9.49 855 165286 560016 62762865
Rheumatoid arthritis 149.83 9.49 272 165869 253547 63069334
Euglycaemic diabetic ketoacidosis 148.54 9.49 102 166039 3572 63319309
Therapeutic product effect incomplete 143.43 9.49 74 166067 124982 63197899
Irritable bowel syndrome 141.29 9.49 23 166118 82389 63240492
Off label use 135.93 9.49 1122 165019 673340 62649541
Muscle injury 135.58 9.49 9 166132 65336 63257545
Hypersensitivity 135.38 9.49 359 165782 292326 63030555
Fatigue 133.64 9.49 1586 164555 886442 62436439
Nasopharyngitis 130.83 9.49 295 165846 253962 63068919
Arthralgia 130.17 9.49 915 165226 568795 62754086
Sinusitis 130.11 9.49 247 165894 226406 63096475
Dehydration 129.15 9.49 836 165305 172518 63150363
Incorrect dose administered by device 128.75 9.49 100 166041 4248 63318633
Sleep disorder due to general medical condition, insomnia type 122.24 9.49 3 166138 52214 63270667
Wrong product administered 117.68 9.49 110 166031 6031 63316850
Stomatitis 113.73 9.49 117 166024 138608 63184273
Device malfunction 113.60 9.49 183 165958 17674 63305207
Pancreatitis 112.92 9.49 333 165808 48722 63274159
Diabetic neuropathy 112.69 9.49 89 166052 3875 63319006
Psoriatic arthropathy 106.66 9.49 53 166088 91467 63231414
Diabetes mellitus 102.95 9.49 351 165790 55459 63267422
Gangrene 101.00 9.49 101 166040 6022 63316859
Incorrect dose administered 100.16 9.49 365 165776 59603 63263278
Blindness 92.71 9.49 187 165954 21512 63301369
Metabolic acidosis 92.58 9.49 294 165847 44775 63278106
Accidental underdose 91.94 9.49 44 166097 759 63322122
Exposure during pregnancy 90.66 9.49 707 165434 154840 63168041
Loss of consciousness 89.97 9.49 573 165568 117548 63205333
Intentional product use issue 89.70 9.49 122 166019 127770 63195111
Insulin resistance 88.21 9.49 44 166097 834 63322047
Pharyngitis 86.55 9.49 174 165967 19969 63302912
Coronary artery disease 86.49 9.49 232 165909 32145 63290736
Product administration error 86.31 9.49 185 165956 22212 63300669
Wrong technique in device usage process 85.94 9.49 73 166068 3525 63319356
Renal impairment 83.70 9.49 454 165687 87901 63234980
Toothache 82.68 9.49 166 165975 19033 63303848
Hypoglycaemic seizure 81.88 9.49 35 166106 457 63322424
Loss of personal independence in daily activities 80.92 9.49 81 166060 97209 63225672
Hypoglycaemia unawareness 80.00 9.49 24 166117 98 63322783
Premature delivery 79.90 9.49 216 165925 30065 63292816
Chronic kidney disease 78.08 9.49 279 165862 45119 63277762
Pancreatic carcinoma 77.91 9.49 98 166043 7530 63315351
Hip arthroplasty 75.87 9.49 16 166125 47630 63275251
Anti-insulin antibody positive 75.12 9.49 22 166119 81 63322800
Infection 73.40 9.49 329 165812 228844 63094037
C-reactive protein abnormal 72.34 9.49 16 166125 46080 63276801
Hypoglycaemic encephalopathy 71.80 9.49 28 166113 284 63322597
Ill-defined disorder 71.57 9.49 65 166076 81690 63241191
Rhabdomyolysis 71.27 9.49 265 165876 43686 63279195
Fibromyalgia 70.33 9.49 64 166077 80356 63242525
Blister 69.68 9.49 147 165994 129667 63193214
Injury associated with device 68.97 9.49 65 166076 3601 63319280
Product quality issue 67.40 9.49 227 165914 35638 63287243
Diabetic complication 66.77 9.49 37 166104 876 63322005
Peripheral swelling 66.63 9.49 415 165726 265527 63057354
Cardiac arrest 65.02 9.49 440 165701 92105 63230776
Arterial occlusive disease 64.80 9.49 79 166062 5879 63317002
Product use in unapproved indication 62.32 9.49 249 165892 178831 63144050
Peritonitis bacterial 61.89 9.49 70 166071 4809 63318072
Type 1 diabetes mellitus 61.56 9.49 62 166079 3728 63319153
Impaired healing 61.22 9.49 109 166032 102433 63220448
Visual acuity reduced 60.94 9.49 159 165982 21667 63301214
Diabetic coma 60.65 9.49 32 166109 685 63322196
Hyperinsulinaemic hypoglycaemia 58.38 9.49 17 166124 61 63322820
Febrile neutropenia 57.98 9.49 141 166000 118308 63204573
Mobility decreased 57.92 9.49 146 165995 121013 63201868
Diabetic nephropathy 57.91 9.49 40 166101 1414 63321467
Visual impairment 57.25 9.49 398 165743 84048 63238833
Ketosis 56.55 9.49 29 166112 584 63322297
Shock 55.64 9.49 161 165980 23302 63299579
Migraine 55.48 9.49 117 166024 103229 63219652
White blood cell count decreased 54.58 9.49 184 165957 138920 63183961
Blood creatinine increased 54.34 9.49 405 165736 87439 63235442
Pulmonary oedema 54.02 9.49 285 165856 54588 63268293
Eye haemorrhage 53.94 9.49 87 166054 8409 63314472
Dialysis 53.33 9.49 97 166044 10330 63312551
Product dispensing error 52.88 9.49 96 166045 10209 63312672
Vitreous haemorrhage 51.87 9.49 43 166098 2007 63320874
Hypoglycaemia neonatal 51.49 9.49 32 166109 943 63321938
Knee arthroplasty 51.25 9.49 40 166101 54166 63268715
Pancreatitis acute 51.09 9.49 172 165969 26994 63295887
Anuria 51.06 9.49 106 166035 12445 63310436
Blood cholesterol increased 50.86 9.49 106 166035 93926 63228955
Drug administered in wrong device 50.80 9.49 13 166128 24 63322857
Liver injury 50.76 9.49 50 166091 60470 63262411
Fear 50.47 9.49 121 166020 15645 63307236
Bursitis 50.36 9.49 17 166124 37024 63285857
Product use issue 50.23 9.49 354 165787 220166 63102715
Device expulsion 49.30 9.49 15 166126 34907 63287974
Acute myocardial infarction 49.03 9.49 190 165951 31934 63290947
Increased insulin requirement 48.92 9.49 15 166126 67 63322814
Sopor 47.73 9.49 147 165994 22017 63300864
Injection site pain 47.38 9.49 534 165607 129266 63193615
Device defective 47.26 9.49 40 166101 1922 63320959
Renal injury 47.25 9.49 87 166054 9352 63313529
Cataract 46.69 9.49 282 165859 56771 63266110
Diabetic foot 46.63 9.49 35 166106 1412 63321469
Anaemia 46.06 9.49 1048 165093 292382 63030499
Blood ketone body increased 45.54 9.49 20 166121 280 63322601
Wrong technique in product usage process 44.74 9.49 298 165843 62042 63260839
Multiple organ dysfunction syndrome 44.23 9.49 277 165864 56475 63266406
Emphysematous pyelonephritis 43.78 9.49 19 166122 258 63322623
Non-cardiogenic pulmonary oedema 43.76 9.49 26 166115 705 63322176
Angina pectoris 43.57 9.49 175 165966 29903 63292978
Gait inability 43.49 9.49 262 165879 52697 63270184
Pre-eclampsia 43.00 9.49 82 166059 9051 63313830
Sleep disorder 42.40 9.49 94 166047 81472 63241409
Premature baby 42.33 9.49 135 166006 20600 63302281
Gastrointestinal disorder 42.23 9.49 188 165953 131051 63191830
Red blood cell sedimentation rate increased 42.15 9.49 32 166109 43950 63278931
Intestinal malrotation 41.02 9.49 20 166121 360 63322521
Generalised oedema 40.89 9.49 112 166029 15706 63307175
Foetal exposure during pregnancy 40.86 9.49 179 165962 31783 63291098
Respiratory failure 40.84 9.49 427 165714 101431 63221450
Night sweats 40.17 9.49 41 166100 48773 63274108
Sepsis 39.87 9.49 592 165549 152531 63170350
Injection site haemorrhage 39.75 9.49 147 165994 24167 63298714
Urosepsis 39.10 9.49 122 166019 18402 63304479
Multi-organ disorder 38.85 9.49 32 166109 1480 63321401
Angina unstable 38.85 9.49 68 166073 7027 63315854
Glycosylated haemoglobin abnormal 38.83 9.49 15 166126 148 63322733
Disease progression 38.80 9.49 177 165964 122581 63200300
C-reactive protein increased 38.71 9.49 123 166018 94584 63228297
Mental status changes 38.51 9.49 205 165936 39394 63283487
Fall 38.41 9.49 1319 164822 391015 62931866
Cardiac failure 38.28 9.49 379 165762 88763 63234118
Drug abuse 38.17 9.49 83 166058 72435 63250446
Pemphigoid 37.15 9.49 68 166073 7276 63315605
Drug interaction 37.07 9.49 822 165319 228309 63094572
Cholestasis 36.99 9.49 164 165977 29270 63293611
Hyperglycaemic hyperosmolar nonketotic syndrome 36.58 9.49 26 166115 963 63321918
Vomiting 36.57 9.49 1802 164339 557815 62765066
Large for dates baby 36.50 9.49 20 166121 463 63322418
Diabetic ketoacidotic hyperglycaemic coma 36.27 9.49 11 166130 47 63322834
Urinary tract infection 36.27 9.49 928 165213 263756 63059125
Diabetic gastroparesis 35.74 9.49 17 166124 289 63322592
Device use issue 35.54 9.49 39 166102 2591 63320290
Infective pulmonary exacerbation of cystic fibrosis 35.32 9.49 74 166067 8743 63314138
Heparin-induced thrombocytopenia 34.83 9.49 51 166090 4531 63318350
Osteoarthritis 34.79 9.49 130 166011 95213 63227668
Malignant neoplasm progression 34.73 9.49 105 166036 82016 63240865
Polyuria 34.58 9.49 72 166069 8470 63314411
Therapy non-responder 34.33 9.49 94 166047 75807 63247074
Conjoined twins 34.07 9.49 16 166125 264 63322617
Caesarean section 33.96 9.49 110 166031 16922 63305959
Congenital bladder anomaly 33.66 9.49 14 166127 170 63322711
Unresponsive to stimuli 32.84 9.49 175 165966 33641 63289240
Maternal exposure during pregnancy 32.82 9.49 393 165748 219669 63103212
Glycosuria 32.76 9.49 26 166115 1140 63321741
Blood potassium increased 32.74 9.49 114 166027 18195 63304686
Asthma 32.45 9.49 198 165943 127363 63195518
Neutropenia 32.42 9.49 297 165844 174708 63148173
Haemodialysis 32.30 9.49 72 166069 8875 63314006
Drug tolerance decreased 31.98 9.49 4 166137 17469 63305412
Retinopathy 31.74 9.49 40 166101 3079 63319802
Anti-insulin antibody increased 31.70 9.49 10 166131 50 63322831
Systemic infection 31.35 9.49 49 166092 4611 63318270
Prescribed overdose 31.28 9.49 26 166115 34127 63288754
Pulmonary fibrosis 31.01 9.49 35 166106 39774 63283107
Blood urea increased 30.93 9.49 144 165997 26235 63296646
Ketonuria 30.91 9.49 20 166121 633 63322248
Treatment noncompliance 30.86 9.49 185 165956 37140 63285741
Left ventricular hypertrophy 30.49 9.49 52 166089 5263 63317618
Product complaint 30.47 9.49 88 166053 12721 63310160
Adenocarcinoma pancreas 30.21 9.49 24 166117 1054 63321827
Diabetic hyperglycaemic coma 30.15 9.49 9 166132 36 63322845
Urachal abnormality 29.80 9.49 13 166128 179 63322702
Impaired gastric emptying 29.59 9.49 76 166065 10256 63312625
Polyhydramnios 29.52 9.49 33 166108 2238 63320643
Joint range of motion decreased 29.32 9.49 25 166116 32403 63290478
Insomnia 29.26 9.49 392 165749 214860 63108021
Persistent cloaca 28.98 9.49 13 166128 192 63322689
Rheumatoid nodule 28.92 9.49 5 166136 17150 63305731
Adverse drug reaction 28.88 9.49 109 166032 79605 63243276
Crystal nephropathy 28.75 9.49 22 166119 914 63321967
Gastrooesophageal reflux disease 28.40 9.49 141 166000 95498 63227383
Foot deformity 28.35 9.49 19 166122 27834 63295047
Oedema peripheral 28.20 9.49 672 165469 188839 63134042
Hemiplegia 28.19 9.49 70 166071 9253 63313628
Shock hypoglycaemic 28.00 9.49 11 166130 114 63322767
Device interaction 27.88 9.49 13 166128 211 63322670
Retinal haemorrhage 27.70 9.49 48 166093 4921 63317960
Coronary artery occlusion 27.45 9.49 64 166077 8127 63314754
Keratitis 27.34 9.49 39 166102 3383 63319498
Expired product administered 27.28 9.49 54 166087 6127 63316754
Multiple use of single-use product 27.20 9.49 26 166115 1466 63321415
Ischaemic cardiomyopathy 27.19 9.49 33 166108 2444 63320437
Product dose omission issue 27.13 9.49 804 165337 233509 63089372
Renal tubular necrosis 26.72 9.49 80 166061 11798 63311083
Myocardial ischaemia 26.50 9.49 84 166057 12775 63310106
Hypervolaemia 26.22 9.49 145 165996 28268 63294613
Pyelonephritis fungal 26.20 9.49 11 166130 137 63322744
Bone erosion 26.13 9.49 7 166134 17710 63305171
Adverse event 26.05 9.49 90 166051 67469 63255412
Oropharyngeal pain 25.99 9.49 143 165998 94344 63228537
Glycosylated haemoglobin decreased 25.97 9.49 17 166124 549 63322332
Musculoskeletal pain 25.74 9.49 139 166002 92138 63230743
Sedation complication 25.71 9.49 3 166138 13819 63309062
Pancreatic carcinoma metastatic 25.53 9.49 30 166111 2148 63320733
Type 2 diabetes mellitus 25.36 9.49 84 166057 63784 63259097
Low birth weight baby 25.32 9.49 57 166084 7072 63315809
Diabetic ketosis 25.30 9.49 13 166128 263 63322618
Bone density decreased 25.21 9.49 4 166137 14608 63308273
Oliguria 25.10 9.49 66 166075 9035 63313846
Lip dry 25.03 9.49 5 166136 15465 63307416
Transient ischaemic attack 25.02 9.49 177 165964 37576 63285305
Erythrodermic psoriasis 25.02 9.49 21 166120 997 63321884
Insulin C-peptide decreased 24.99 9.49 7 166134 21 63322860
Contusion 24.70 9.49 262 165879 149782 63173099
Toe amputation 24.57 9.49 28 166113 1939 63320942
Hypertriglyceridaemia 24.46 9.49 52 166089 6207 63316674
Pyrexia 24.43 9.49 995 165146 469483 62853398
Lower respiratory tract infection 24.30 9.49 225 165916 132082 63190799
Glucose urine present 24.24 9.49 18 166123 714 63322167
Joint stiffness 23.66 9.49 46 166095 41823 63281058
Asthenia 23.50 9.49 1228 164913 382376 62940505
Inflammation 23.46 9.49 123 166018 82150 63240731
Device delivery system issue 23.45 9.49 18 166123 751 63322130
Glomerular filtration rate decreased 23.44 9.49 83 166058 13358 63309523
Blindness unilateral 23.41 9.49 51 166090 6190 63316691
Blood insulin increased 23.10 9.49 10 166131 135 63322746
Myelosuppression 23.03 9.49 17 166124 23686 63299195
Malnutrition 22.95 9.49 90 166051 15208 63307673
Anti-insulin antibody 22.88 9.49 7 166134 31 63322850
Urticaria 22.87 9.49 301 165840 165501 63157380
Blood pressure fluctuation 22.76 9.49 55 166086 46262 63276619
Gastrointestinal haemorrhage 22.76 9.49 318 165823 80858 63242023
Drug dose omission by device 22.47 9.49 43 166098 4758 63318123
Pyelonephritis 22.29 9.49 99 166042 17679 63305202
Urine ketone body present 22.20 9.49 30 166111 2473 63320408
Headache 21.78 9.49 1397 164744 631844 62691037
Peritoneal dialysis complication 21.75 9.49 21 166120 1199 63321682
Immunodeficiency 21.74 9.49 13 166128 20241 63302640
Grip strength decreased 21.63 9.49 16 166125 22271 63300610
Tachypnoea 21.43 9.49 96 166045 17206 63305675
Tenosynovitis 21.22 9.49 5 166136 13790 63309091
Caudal regression syndrome 21.19 9.49 10 166131 167 63322714
Muscle necrosis 21.17 9.49 16 166125 652 63322229
Facial nerve disorder 21.14 9.49 15 166126 554 63322327
Anhedonia 21.09 9.49 70 166071 10904 63311977
Upper respiratory tract infection 21.04 9.49 127 166014 81920 63240961
Ear pain 21.00 9.49 39 166102 36079 63286802
Dry mouth 20.78 9.49 119 166022 77744 63245137
Underdose 20.76 9.49 133 166008 27323 63295558
Transient tachypnoea of the newborn 20.75 9.49 9 166132 122 63322759
Device dislocation 20.69 9.49 22 166119 25683 63297198
Injection site reaction 20.57 9.49 81 166060 58443 63264438
Neutrophil count decreased 20.51 9.49 77 166064 56329 63266552
Leukocytosis 20.46 9.49 127 166014 25808 63297073
Dyspepsia 20.44 9.49 170 165971 102026 63220855
Gastrointestinal tract mucosal pigmentation 20.38 9.49 15 166126 587 63322294
Electrolyte imbalance 20.25 9.49 105 166036 19971 63302910
International normalised ratio increased 20.22 9.49 198 165943 46227 63276654
Blood ketone body 20.21 9.49 7 166134 49 63322832
Bradycardia neonatal 20.09 9.49 18 166123 934 63321947
Peripheral vascular disorder 20.05 9.49 47 166094 5988 63316893
Body temperature increased 20.04 9.49 42 166099 37150 63285731
Cutaneous amyloidosis 19.99 9.49 5 166136 8 63322873
Neonatal seizure 19.95 9.49 14 166127 508 63322373
Deep vein thrombosis postoperative 19.87 9.49 3 166138 11366 63311515
Retinopathy proliferative 19.85 9.49 7 166134 52 63322829
International normalised ratio abnormal 19.85 9.49 33 166108 3271 63319610
Sprue-like enteropathy 19.67 9.49 16 166125 727 63322154
Apgar score abnormal 19.62 9.49 5 166136 9 63322872
Perinephric abscess 19.61 9.49 10 166131 199 63322682
Full blood count abnormal 19.57 9.49 33 166108 31684 63291197
Encephalopathy 19.49 9.49 170 165971 38450 63284431
Cardiac disorder 19.41 9.49 211 165930 50605 63272276
Polydipsia 19.31 9.49 34 166107 3530 63319351
Acidosis 19.28 9.49 69 166072 11164 63311717
COVID-19 19.22 9.49 196 165945 112907 63209974
Colitis ulcerative 19.19 9.49 24 166117 26067 63296814
Blood triglycerides increased 19.17 9.49 74 166067 12414 63310467
Device leakage 19.10 9.49 51 166090 7045 63315836
Bone pain 18.97 9.49 76 166065 54565 63268316
Infected dermal cyst 18.96 9.49 13 166128 454 63322427
Acute coronary syndrome 18.94 9.49 64 166077 10062 63312819
Cardiogenic shock 18.94 9.49 95 166046 17837 63305044
Microphthalmos 18.92 9.49 9 166132 153 63322728
Immobilisation prolonged 18.82 9.49 8 166133 103 63322778
Dementia 18.76 9.49 98 166043 18696 63304185
Retinal coloboma 18.70 9.49 6 166135 32 63322849
Hypovolaemia 18.69 9.49 66 166075 10607 63312274
Diabetic microangiopathy 18.66 9.49 5 166136 12 63322869
Paraesthesia 18.48 9.49 294 165847 156672 63166209
Basal cell carcinoma 18.33 9.49 28 166113 27963 63294918
Urinary tract candidiasis 18.31 9.49 14 166127 581 63322300
Arteriosclerosis 18.28 9.49 63 166078 10003 63312878
Nasal congestion 18.26 9.49 99 166042 65561 63257320
Necrobiosis lipoidica diabeticorum 18.25 9.49 6 166135 35 63322846
Herpes zoster 17.96 9.49 134 166007 82328 63240553
Infusion site pain 17.86 9.49 11 166130 16858 63306023
Diabetic gangrene 17.85 9.49 5 166136 15 63322866
Hyperlactacidaemia 17.85 9.49 29 166112 2820 63320061
Flushing 17.83 9.49 119 166022 74968 63247913
Distributive shock 17.81 9.49 20 166121 1363 63321518
Panniculitis 17.76 9.49 4 166137 11381 63311500
Diet failure 17.70 9.49 6 166135 39 63322842
Peripheral artery haematoma 17.70 9.49 6 166135 39 63322842
Acne 17.58 9.49 21 166120 23272 63299609
Dawn phenomenon 17.56 9.49 4 166137 3 63322878
Pancreatic neoplasm 17.54 9.49 15 166126 731 63322150
Acute respiratory failure 17.50 9.49 152 165989 34333 63288548
Bradycardia 17.46 9.49 279 165862 72948 63249933
Iris coloboma 17.45 9.49 6 166135 41 63322840
Therapeutic drug monitoring analysis incorrectly performed 17.43 9.49 11 166130 333 63322548
Osteoporosis 17.33 9.49 84 166057 57254 63265627
Anti-GAD antibody positive 17.32 9.49 6 166135 42 63322839
Dry eye 17.32 9.49 52 166089 40709 63282172
Hypothermia 17.31 9.49 76 166065 13505 63309376
Fracture blisters 17.29 9.49 7 166134 79 63322802
Pulmonary artery stenosis 17.17 9.49 9 166132 190 63322691
Hyperhidrosis 17.14 9.49 386 165755 107450 63215431
Multiple sclerosis relapse 17.10 9.49 67 166074 48411 63274470
Neutropenic sepsis 17.02 9.49 11 166130 16427 63306454
Diabetic foot infection 17 9.49 9 166132 194 63322687
Wheezing 16.94 9.49 164 165977 95431 63227450
Haematoma 16.91 9.49 152 165989 34668 63288213
Liquid product physical issue 16.80 9.49 18 166123 1164 63321717
Neonatal respiratory distress syndrome 16.73 9.49 28 166113 2790 63320091
Diabetic hyperosmolar coma 16.70 9.49 11 166130 359 63322522
Disorientation 16.57 9.49 167 165974 39285 63283596
Neoplasm progression 16.56 9.49 45 166096 36383 63286498
Intentional self-injury 16.53 9.49 26 166115 25661 63297220
Peripheral arterial occlusive disease 16.53 9.49 35 166106 4166 63318715
Epileptic encephalopathy 16.32 9.49 10 166131 287 63322594
Oral herpes 16.21 9.49 27 166114 26047 63296834
Blood parathyroid hormone decreased 16.19 9.49 3 166138 9788 63313093
Back pain 16.05 9.49 548 165593 263597 63059284
Constipation 16.01 9.49 457 165684 224486 63098395
Injection site bruising 16.00 9.49 174 165967 41736 63281145
Hypernatraemia 15.95 9.49 50 166091 7559 63315322
Hyperbilirubinaemia neonatal 15.95 9.49 11 166130 388 63322493
End stage renal disease 15.94 9.49 46 166095 6647 63316234
Blood ketone body present 15.92 9.49 6 166135 55 63322826
Foot amputation 15.81 9.49 10 166131 304 63322577
Cold sweat 15.80 9.49 68 166073 11979 63310902
Microalbuminuria 15.77 9.49 11 166130 395 63322486
Chronic sinusitis 15.63 9.49 7 166134 12836 63310045
Metabolic syndrome 15.58 9.49 20 166121 1568 63321313
Megacolon 15.56 9.49 22 166119 1893 63320988
Pancreatic failure 15.55 9.49 16 166125 987 63321894
Phaeochromocytoma 15.50 9.49 12 166129 507 63322374
Foetal hypokinesia 15.48 9.49 12 166129 508 63322373
Product odour abnormal 15.44 9.49 18 166123 1278 63321603
Oesophageal carcinoma recurrent 15.38 9.49 5 166136 28 63322853
Respiratory distress 15.38 9.49 146 165995 33805 63289076
Bronchiectasis 15.14 9.49 12 166129 16130 63306751
Vascular calcification 15.11 9.49 14 166127 759 63322122
Frequent bowel movements 15.10 9.49 23 166118 22999 63299882
Vitrectomy 15.09 9.49 8 166133 173 63322708
Neck pain 14.93 9.49 113 166028 69205 63253676
Macular oedema 14.91 9.49 32 166109 3845 63319036
Leg amputation 14.90 9.49 23 166118 2141 63320740
Patella fracture 14.88 9.49 23 166118 2143 63320738
Neuropathic arthropathy 14.86 9.49 9 166132 253 63322628
Cataract diabetic 14.85 9.49 3 166138 0 63322881
Somogyi phenomenon 14.85 9.49 3 166138 0 63322881
Ischaemic stroke 14.84 9.49 89 166052 17868 63305013
Large intestine polyp 14.77 9.49 51 166090 8106 63314775
Accidental overdose 14.71 9.49 108 166033 23201 63299680
Ear infection 14.67 9.49 51 166090 38162 63284719
Intestinal transit time abnormal 14.64 9.49 6 166135 70 63322811
Nephrogenic systemic fibrosis 14.62 9.49 35 166106 4521 63318360
Respiratory tract malformation 14.61 9.49 8 166133 185 63322696
Impaired quality of life 14.58 9.49 9 166132 13774 63309107
Radiation fibrosis 14.56 9.49 5 166136 34 63322847
Candida sepsis 14.53 9.49 18 166123 1362 63321519
Atrioventricular block first degree 14.52 9.49 47 166094 7226 63315655
Blood insulin abnormal 14.44 9.49 5 166136 35 63322846
Hypotension 14.39 9.49 861 165280 271743 63051138
Hyperosmolar state 14.37 9.49 9 166132 269 63322612
Foetal macrosomia 14.34 9.49 6 166135 74 63322807
Carotid artery thrombosis 14.30 9.49 26 166115 2768 63320113
Dermatitis papillaris capillitii 14.28 9.49 4 166137 12 63322869
Choroidal effusion 14.21 9.49 11 166130 465 63322416
Eyelid bleeding 14.20 9.49 5 166136 37 63322844
Hemiparesis 14.19 9.49 107 166034 23175 63299706
Retinal detachment 14.19 9.49 41 166100 5928 63316953
Blood glucose normal 14.04 9.49 4 166137 13 63322868
Pruritus genital 13.97 9.49 25 166116 2629 63320252
Dysarthria 13.92 9.49 172 165969 42539 63280342
Ankylosing spondylitis 13.90 9.49 5 166136 10469 63312412
Pruritus 13.87 9.49 789 165352 360664 62962217
Depressed level of consciousness 13.87 9.49 234 165907 61844 63261037
Coma 13.79 9.49 241 165900 64123 63258758
Ballismus 13.78 9.49 7 166134 138 63322743
Injection site erythema 13.78 9.49 145 165996 83029 63239852
Altered state of consciousness 13.75 9.49 113 166028 25117 63297764
Hepatic steatosis 13.67 9.49 125 166016 28644 63294237
Ulcer 13.63 9.49 30 166111 26077 63296804
Pulseless electrical activity 13.60 9.49 47 166094 7474 63315407
Hepatic failure 13.59 9.49 148 165993 35508 63287373
Pain in extremity 13.56 9.49 719 165422 330767 62992114
Medication error 13.53 9.49 202 165939 52082 63270799
Complications of transplanted liver 13.51 9.49 10 166131 395 63322486
Heavy menstrual bleeding 13.44 9.49 16 166125 17757 63305124
Hypertensive crisis 13.43 9.49 77 166064 15209 63307672
Diabetic eye disease 13.39 9.49 7 166134 147 63322734
Joint effusion 13.29 9.49 15 166126 17045 63305836
Pulse pressure decreased 13.24 9.49 8 166133 224 63322657
Gout 13.10 9.49 69 166072 13202 63309679
Peripheral ischaemia 13.07 9.49 35 166106 4843 63318038
Psychotic disorder 13.06 9.49 30 166111 25682 63297199
Aphasia 13.06 9.49 138 166003 32862 63290019
Type 3 diabetes mellitus 13.02 9.49 4 166137 18 63322863
Gestational hypertension 13.02 9.49 23 166118 2394 63320487
Cognitive disorder 12.98 9.49 89 166052 55726 63267155
Body mass index increased 12.98 9.49 16 166125 1204 63321677
Hip fracture 12.98 9.49 126 166015 29348 63293533
Fibromuscular dysplasia 12.92 9.49 8 166133 234 63322647
Therapeutic response decreased 12.92 9.49 101 166040 61424 63261457
Diabetic retinal oedema 12.91 9.49 9 166132 323 63322558
Fasting 12.85 9.49 4 166137 19 63322862
Labelled drug-food interaction issue 12.85 9.49 4 166137 19 63322862
Thyroid cancer 12.82 9.49 38 166103 5573 63317308
Fructosamine increased 12.77 9.49 3 166138 3 63322878
Diabetic hepatopathy 12.77 9.49 3 166138 3 63322878
Renal dysplasia 12.74 9.49 8 166133 240 63322641
Necrotising fasciitis 12.74 9.49 26 166115 3015 63319866
Food allergy 12.69 9.49 7 166134 11394 63311487
Bundle branch block left 12.66 9.49 44 166097 7015 63315866
Ventricular fibrillation 12.62 9.49 63 166078 11804 63311077
Blood triglycerides abnormal 12.62 9.49 9 166132 335 63322546
Toxicity to various agents 12.56 9.49 524 165617 246726 63076155
Premature rupture of membranes 12.55 9.49 35 166106 4958 63317923
Cerebral calcification 12.55 9.49 7 166134 168 63322713
Retroperitoneal oedema 12.52 9.49 4 166137 21 63322860
Dermatitis exfoliative 12.50 9.49 37 166104 5422 63317459
Skin haemorrhage 12.50 9.49 56 166085 10038 63312843
Pulmonary renal syndrome 12.49 9.49 10 166131 444 63322437
Tricuspid valve disease 12.48 9.49 8 166133 249 63322632
Tumour rupture 12.47 9.49 7 166134 170 63322711
Urinary tract infection fungal 12.46 9.49 12 166129 683 63322198
Autoimmune disorder 12.43 9.49 16 166125 17161 63305720
Hospitalisation 12.43 9.49 301 165840 84780 63238101
Hyperinsulinaemia 12.41 9.49 6 166135 106 63322775
Foetal arrhythmia 12.40 9.49 7 166134 172 63322709
Sweat gland tumour 12.36 9.49 6 166135 107 63322774
X-ray abnormal 12.35 9.49 3 166138 8107 63314774
Ventricular septal defect 12.33 9.49 32 166109 4346 63318535
Vascular graft 12.32 9.49 13 166128 826 63322055
Breath sounds 12.31 9.49 6 166135 108 63322773
Neurologic neglect syndrome 12.28 9.49 24 166117 2697 63320184
Biliary obstruction 12.27 9.49 25 166116 2896 63319985
Latent autoimmune diabetes in adults 12.22 9.49 4 166137 23 63322858
Hot flush 12.18 9.49 81 166060 51078 63271803
Haemodynamic instability 12.15 9.49 52 166089 9138 63313743
Foetal exposure timing unspecified 12.12 9.49 8 166133 262 63322619
Pancreatic pseudocyst 12.02 9.49 11 166130 587 63322294
Open angle glaucoma 12.01 9.49 8 166133 266 63322615
Cellulitis 11.98 9.49 290 165851 81668 63241213
Cardio-respiratory arrest 11.96 9.49 222 165919 59737 63263144
Myositis 11.92 9.49 52 166089 9214 63313667
Pulse absent 11.90 9.49 36 166105 5338 63317543
Azotaemia 11.90 9.49 32 166109 4439 63318442
Urinary tract obstruction 11.88 9.49 21 166120 2187 63320694
Injection site nodule 11.81 9.49 29 166112 3806 63319075
Liver function test increased 11.79 9.49 45 166096 32766 63290115
Pulmonary toxicity 11.75 9.49 5 166136 9450 63313431
Oligohydramnios 11.70 9.49 40 166101 6326 63316555
Exercise lack of 11.65 9.49 9 166132 379 63322502
Peripheral venous disease 11.63 9.49 14 166127 15463 63307418
Obstructed labour 11.58 9.49 7 166134 196 63322685
Exostosis 11.57 9.49 18 166123 17844 63305037
Hepatic cirrhosis 11.52 9.49 107 166034 24627 63298254
Leukopenia 11.51 9.49 138 166003 77152 63245729
Brain malformation 11.45 9.49 5 166136 69 63322812
Cardiovascular disorder 11.38 9.49 61 166080 11751 63311130
Staphylococcal infection 11.31 9.49 161 165980 41095 63281786
Respiratory tract infection 11.28 9.49 63 166078 41420 63281461
Tracheobronchitis 11.26 9.49 15 166126 1220 63321661
Pancreatic cyst 11.25 9.49 17 166124 1553 63321328
Bradyarrhythmia 11.23 9.49 20 166121 2095 63320786
Blindness cortical 11.19 9.49 10 166131 517 63322364
Lymphangiectasia 11.14 9.49 5 166136 74 63322807
Laryngitis 11.08 9.49 17 166124 16950 63305931
Cerebrovascular disorder 11.03 9.49 23 166118 2709 63320172
Thrombotic microangiopathy 11.03 9.49 7 166134 10554 63312327
Post viral fatigue syndrome 10.96 9.49 8 166133 309 63322572
Osteopenia 10.95 9.49 22 166119 19763 63303118
Carotid artery occlusion 10.92 9.49 32 166109 4662 63318219
Amputation 10.92 9.49 7 166134 218 63322663
Myoclonus 10.87 9.49 75 166066 15793 63307088
High density lipoprotein decreased 10.86 9.49 20 166121 2150 63320731
Cortisol increased 10.86 9.49 9 166132 420 63322461
Renal disorder 10.84 9.49 133 166008 32841 63290040
Overdose 10.74 9.49 385 165756 114693 63208188
Factor VIII deficiency 10.71 9.49 3 166138 9 63322872
Fibrodysplasia ossificans progressiva 10.71 9.49 3 166138 9 63322872
Umbilical hernia, obstructive 10.71 9.49 3 166138 9 63322872
Pancreatic disorder 10.69 9.49 22 166119 2566 63320315
Cough 10.68 9.49 642 165499 292101 63030780
Neonatal tachypnoea 10.68 9.49 6 166135 146 63322735
Hypoperfusion 10.68 9.49 16 166125 1451 63321430
Groin abscess 10.65 9.49 13 166128 969 63321912
Rabbit syndrome 10.63 9.49 8 166133 324 63322557
High risk pregnancy 10.61 9.49 6 166135 148 63322733
Completed suicide 10.60 9.49 295 165846 145378 63177503
Glucose-6-phosphate dehydrogenase deficiency 10.59 9.49 7 166134 230 63322651
Emotional distress 10.58 9.49 131 166010 32418 63290463
Accidental exposure to product 10.56 9.49 114 166027 27291 63295590
Escherichia bacteraemia 10.54 9.49 28 166113 3855 63319026
Weight decreased 10.53 9.49 851 165290 275947 63046934
Prescribed underdose 10.49 9.49 41 166100 29648 63293233
Haemangioma congenital 10.45 9.49 9 166132 443 63322438
Gastroenteritis 10.43 9.49 111 166030 26479 63296402
Retinal injury 10.40 9.49 7 166134 237 63322644
Vitamin B12 deficiency 10.35 9.49 34 166107 5269 63317612
Poor quality sleep 10.33 9.49 23 166118 19912 63302969
Hyperlipidaemia 10.32 9.49 87 166054 19484 63303397
Angiopathy 10.31 9.49 31 166110 4582 63318299
Drug ineffective for unapproved indication 10.23 9.49 50 166091 34013 63288868
Cystic fibrosis 10.23 9.49 25 166116 3271 63319610
Bacterial pyelonephritis 10.21 9.49 8 166133 344 63322537
Blindness transient 10.17 9.49 27 166114 3717 63319164
Ectopic ACTH syndrome 10.15 9.49 6 166135 161 63322720
Paralysis 10.14 9.49 52 166089 9848 63313033
Acanthosis nigricans 10.13 9.49 4 166137 42 63322839
Mesenteric arterial occlusion 10.12 9.49 6 166135 162 63322719
Atrial fibrillation 10.11 9.49 387 165754 116249 63206632
Dysstasia 10.08 9.49 92 166049 21074 63301807
Emphysematous cystitis 10.02 9.49 6 166135 165 63322716
Binge eating 9.95 9.49 9 166132 473 63322408
Dystonia 9.86 9.49 13 166128 13806 63309075
Pancreatic abscess 9.86 9.49 3 166138 13 63322868
Drug dependence 9.86 9.49 32 166109 24451 63298430
Haemophagocytic lymphohistiocytosis 9.84 9.49 8 166133 10619 63312262
Syncope 9.83 9.49 388 165753 116997 63205884
Tumour compression 9.81 9.49 4 166137 46 63322835
Rash erythematous 9.78 9.49 68 166073 42442 63280439
Atrial septal defect 9.75 9.49 40 166101 6898 63315983
Disease recurrence 9.72 9.49 39 166102 27991 63294890
Silent myocardial infarction 9.71 9.49 8 166133 370 63322511
Cytokine release syndrome 9.68 9.49 14 166127 14300 63308581
Enterococcal sepsis 9.66 9.49 15 166126 1403 63321478
Coronary artery bypass 9.63 9.49 20 166121 2349 63320532
Catheter site haematoma 9.62 9.49 6 166135 178 63322703
Dysphonia 9.61 9.49 79 166062 47535 63275346
Waist circumference increased 9.60 9.49 12 166129 916 63321965
Investigation 9.60 9.49 16 166125 1589 63321292
Foetal disorder 9.60 9.49 7 166134 270 63322611
Product contamination physical 9.52 9.49 5 166136 106 63322775
Arteriovenous fistula site infection 9.51 9.49 4 166137 50 63322831
Diabetic vascular disorder 9.51 9.49 3 166138 15 63322866

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 3231.49 10.18 2381 158917 52259 34743374
Blood glucose increased 2690.27 10.18 2322 158976 64396 34731237
Diabetic ketoacidosis 1052.60 10.18 781 160517 17251 34778382
Blood glucose decreased 1008.98 10.18 675 160623 12562 34783071
Diabetes mellitus inadequate control 986.61 10.18 670 160628 12794 34782839
Hyperglycaemia 812.91 10.18 956 160342 38524 34757109
Glycosylated haemoglobin increased 555.40 10.18 443 160855 10917 34784716
Blood glucose abnormal 473.92 10.18 312 160986 5640 34789993
Device operational issue 472.37 10.18 118 161180 55 34795578
Blood glucose fluctuation 430.63 10.18 255 161043 3789 34791844
Product storage error 345.17 10.18 292 161006 7830 34787803
Hypoglycaemic coma 328.13 10.18 179 161119 2252 34793381
Drug abuse 273.86 10.18 61 161237 99035 34696598
Ketoacidosis 261.47 10.18 190 161108 4053 34791580
Off label use 219.68 10.18 1094 160204 418430 34377203
Diabetic retinopathy 210.43 10.18 121 161177 1696 34793937
Diabetic neuropathy 170.37 10.18 147 161151 4050 34791583
Acute kidney injury 166.36 10.18 2141 159157 302847 34492786
Lactic acidosis 164.57 10.18 440 160858 34332 34761301
Diabetic foot 163.10 10.18 121 161177 2667 34792966
Device issue 162.80 10.18 213 161085 9564 34786069
Hyperkalaemia 158.86 10.18 688 160610 68701 34726932
Hypoglycaemic unconsciousness 157.77 10.18 76 161222 722 34794911
Inappropriate schedule of product administration 149.81 10.18 627 160671 61669 34733964
Febrile neutropenia 147.49 10.18 253 161045 136596 34659037
Diabetic metabolic decompensation 136.75 10.18 91 161207 1675 34793958
Product use in unapproved indication 124.06 10.18 220 161078 117279 34678354
Drug ineffective 123.19 10.18 1433 159865 455318 34340315
Toxicity to various agents 116.51 10.18 502 160796 199860 34595773
Hypoglycaemic seizure 111.64 10.18 46 161252 289 34795344
Myocardial infarction 108.20 10.18 940 160358 120145 34675488
Renal failure 105.67 10.18 992 160306 129565 34666068
Neutropenia 102.39 10.18 375 160923 156403 34639230
Insulin resistance 101.61 10.18 53 161245 605 34795028
Wrong product administered 99.54 10.18 123 161175 5211 34790422
Pancreatic carcinoma 85.41 10.18 150 161148 8751 34786882
Hypoglycaemia unawareness 84.36 10.18 30 161268 117 34795516
Anti-insulin antibody positive 82.71 10.18 32 161266 166 34795467
Euglycaemic diabetic ketoacidosis 81.59 10.18 87 161211 3135 34792498
Wrong technique in device usage process 78.25 10.18 61 161237 1451 34794182
Toe amputation 76.35 10.18 75 161223 2449 34793184
Cutaneous amyloidosis 72.93 10.18 20 161278 22 34795611
Increased insulin requirement 72.71 10.18 25 161273 86 34795547
Incorrect dose administered 68.96 10.18 369 160929 40146 34755487
Disease progression 68.23 10.18 262 161036 107815 34687818
Loss of consciousness 67.74 10.18 630 160668 82037 34713596
Completed suicide 66.56 10.18 231 161067 97937 34697696
Metabolic acidosis 66.48 10.18 386 160912 43294 34752339
Cardiac failure congestive 66.44 10.18 631 160667 82639 34712994
Device malfunction 64.27 10.18 146 161152 10275 34785358
Diabetic nephropathy 63.93 10.18 63 161235 2065 34793568
Diabetes mellitus 63.58 10.18 402 160896 46471 34749162
Death 63.40 10.18 1378 159920 396671 34398962
Pancreatic carcinoma metastatic 60.09 10.18 71 161227 2869 34792764
White blood cell count decreased 59.84 10.18 232 161066 95213 34700420
Renal impairment 59.70 10.18 683 160615 93830 34701803
Nasopharyngitis 59.51 10.18 148 161150 69820 34725813
Cerebrovascular accident 57.72 10.18 622 160676 84189 34711444
Treatment failure 56.26 10.18 80 161218 46617 34749016
Rash 55.86 10.18 709 160589 222043 34573590
Drug resistance 55.52 10.18 25 161273 25902 34769731
Renal injury 54.29 10.18 143 161155 11052 34784581
Incorrect dose administered by device 53.96 10.18 54 161244 1804 34793829
Accidental underdose 53.64 10.18 32 161266 482 34795151
Ketonuria 53.48 10.18 34 161264 577 34795056
Hypoglycaemia neonatal 52.92 10.18 54 161244 1847 34793786
Drug administered in wrong device 52.70 10.18 16 161282 32 34795601
Diabetic complication 52.05 10.18 35 161263 656 34794977
Injury 51.07 10.18 210 161088 20477 34775156
Type 1 diabetes mellitus 50.59 10.18 79 161219 4179 34791454
Pyrexia 50.06 10.18 1163 160135 331850 34463783
Vitreous haemorrhage 49.65 10.18 58 161240 2315 34793318
Diabetic coma 49.65 10.18 38 161260 879 34794754
Rheumatoid arthritis 49.64 10.18 62 161236 38176 34757457
Fear 48.96 10.18 132 161166 10344 34785289
Product complaint 48.60 10.18 93 161205 5797 34789836
Oedema peripheral 47.93 10.18 798 160500 119014 34676619
Gangrene 47.56 10.18 80 161218 4506 34791127
Coronary artery disease 47.31 10.18 383 160915 47922 34747711
Multiple use of single-use product 47.28 10.18 25 161273 294 34795339
Myelosuppression 47.22 10.18 15 161283 19250 34776383
Product quality issue 46.13 10.18 178 161120 16857 34778776
Blindness 45.95 10.18 163 161135 14823 34780810
Joint swelling 45.42 10.18 134 161164 59756 34735877
Drug dependence 45.01 10.18 28 161270 24189 34771444
Device mechanical issue 44.76 10.18 21 161277 187 34795446
Eye haemorrhage 44.52 10.18 75 161223 4230 34791403
COVID-19 43.93 10.18 196 161102 77354 34718279
Infusion related reaction 43.74 10.18 114 161184 52943 34742690
Drug intolerance 43.23 10.18 136 161162 59434 34736199
Emotional distress 43.16 10.18 160 161138 14866 34780767
Leg amputation 43.03 10.18 52 161246 2152 34793481
Injury associated with device 42.90 10.18 38 161260 1085 34794548
Arthralgia 42.67 10.18 541 160757 169500 34626133
Cardiovascular disorder 42.36 10.18 122 161176 9934 34785699
Impaired gastric emptying 42.33 10.18 65 161233 3388 34792245
Synovitis 42.33 10.18 7 161291 14059 34781574
Ketosis 41.82 10.18 27 161271 471 34795162
Treatment noncompliance 41.25 10.18 246 161052 27854 34767779
Chronic kidney disease 40.49 10.18 327 160971 40883 34754750
Visual impairment 40.15 10.18 293 161005 35509 34760124
Aggression 40.13 10.18 74 161224 38890 34756743
Anhedonia 40.00 10.18 100 161198 7485 34788148
Therapeutic product effect incomplete 39.85 10.18 111 161187 50430 34745203
Sinusitis 39.72 10.18 82 161216 41320 34754313
Injection site pain 39.69 10.18 312 160986 38693 34756940
Mucosal inflammation 38.33 10.18 75 161223 38547 34757086
Acute myocardial infarction 37.94 10.18 397 160901 53322 34742311
Pneumonia 37.57 10.18 1333 159965 361294 34434339
Shock hypoglycaemic 37.40 10.18 15 161283 87 34795546
Intentional product use issue 36.45 10.18 147 161151 59669 34735964
Drug hypersensitivity 35.30 10.18 222 161076 80307 34715326
Retinopathy 34.41 10.18 45 161253 2019 34793614
Rhabdomyolysis 34.20 10.18 472 160826 67691 34727942
Stomatitis 33.79 10.18 93 161205 42421 34753212
Hepatic encephalopathy 33.09 10.18 145 161153 14540 34781093
Insomnia 33.06 10.18 313 160985 103594 34692039
Peritonitis bacterial 32.69 10.18 81 161217 6029 34789604
Hypoglycaemic encephalopathy 32.21 10.18 19 161279 280 34795353
Product administration error 32.10 10.18 155 161143 16189 34779444
Glycosylated haemoglobin abnormal 32.00 10.18 16 161282 166 34795467
Arthropathy 31.52 10.18 47 161251 26860 34768773
Mental status changes 31.05 10.18 290 161008 37793 34757840
Lower respiratory tract infection 30.91 10.18 62 161236 31575 34764058
Medication error 30.86 10.18 213 161085 25352 34770281
Malignant neoplasm progression 30.74 10.18 259 161039 87787 34707846
Musculoskeletal stiffness 30.18 10.18 112 161186 46568 34749065
Diabetic ketosis 29.62 10.18 14 161284 127 34795506
C-reactive protein abnormal 29.41 10.18 3 161295 8707 34786926
Therapy non-responder 29.37 10.18 88 161210 39058 34756575
Blindness transient 28.84 10.18 43 161255 2183 34793450
Haemophagocytic lymphohistiocytosis 28.58 10.18 12 161286 12961 34782672
Skin ulcer 28.55 10.18 188 161110 22028 34773605
Therapy partial responder 28.46 10.18 5 161293 9611 34786022
Cough 28.23 10.18 505 160793 149635 34645998
Product temperature excursion issue 28.13 10.18 11 161287 59 34795574
Plasmapheresis 27.98 10.18 18 161280 312 34795321
Neutrophil count decreased 27.84 10.18 131 161167 50973 34744660
Pancreatitis 27.73 10.18 288 161010 38603 34757030
Pancreatitis acute 27.48 10.18 223 161075 27918 34767715
Device defective 27.44 10.18 25 161273 741 34794892
Microalbuminuria 27.31 10.18 24 161274 678 34794955
Immune reconstitution inflammatory syndrome 27.17 10.18 4 161294 8755 34786878
Cardiac failure 26.89 10.18 580 160718 90668 34704965
Anti-insulin antibody increased 26.71 10.18 11 161287 69 34795564
Macular oedema 26.53 10.18 48 161250 2866 34792767
Hypothermia 26.44 10.18 109 161189 10639 34784994
Decreased insulin requirement 26.30 10.18 6 161292 0 34795633
Therapeutic product effect decreased 26.14 10.18 78 161220 34665 34760968
Diabetic foot infection 25.99 10.18 23 161275 656 34794977
Suture rupture 25.85 10.18 18 161280 358 34795275
Diabetic eye disease 25.67 10.18 10 161288 53 34795580
Urine ketone body present 25.60 10.18 29 161269 1119 34794514
Blood creatinine increased 25.57 10.18 596 160702 94380 34701253
Pneumocystis jirovecii pneumonia 25.53 10.18 32 161266 19678 34775955
Dialysis 25.51 10.18 111 161187 11097 34784536
Intentional self-injury 25.48 10.18 16 161282 13755 34781878
Platelet count decreased 25.34 10.18 394 160904 119323 34676310
Prostate cancer 25.07 10.18 96 161202 39553 34756080
Acetonaemia 24.73 10.18 13 161285 151 34795482
Pulmonary embolism 24.59 10.18 280 161018 89466 34706167
Pancreatitis chronic 24.47 10.18 40 161258 2200 34793433
Myopathy 24.46 10.18 112 161186 11442 34784191
Headache 24.41 10.18 722 160576 199913 34595720
Myelodysplastic syndrome 24.04 10.18 32 161266 19176 34776457
Herpes zoster 23.93 10.18 80 161218 34319 34761314
Pathogen resistance 23.93 10.18 7 161291 9475 34786158
Diabetic foetopathy 23.81 10.18 14 161284 205 34795428
Tinnitus 23.70 10.18 35 161263 20083 34775550
Hypervolaemia 23.66 10.18 164 161134 19545 34776088
Oedematous pancreatitis 23.47 10.18 19 161279 478 34795155
Rhythm idioventricular 23.42 10.18 16 161282 308 34795325
Therapeutic drug monitoring analysis not performed 23.36 10.18 20 161278 545 34795088
Fatigue 23.33 10.18 1437 159861 369216 34426417
Bone marrow failure 23.24 10.18 64 161234 29189 34766444
Injection site haemorrhage 23.20 10.18 98 161200 9670 34785963
Alveolar lung disease 23.13 10.18 17 161281 369 34795264
Osteomyelitis 22.87 10.18 140 161158 15996 34779637
Diabetic retinal oedema 22.62 10.18 13 161285 182 34795451
Hyperhidrosis 22.58 10.18 482 160816 75210 34720423
Injection site nodule 22.51 10.18 33 161265 1650 34793983
Polyuria 21.92 10.18 88 161210 8486 34787147
Constipation 21.73 10.18 474 160824 136508 34659125
Hot flush 21.70 10.18 31 161267 18035 34777598
Erythema 21.66 10.18 284 161014 88496 34707137
Neutropenic sepsis 21.60 10.18 19 161279 13748 34781885
Diaphragmatic disorder 21.57 10.18 28 161270 1247 34794386
Progressive multifocal leukoencephalopathy 21.56 10.18 9 161289 9755 34785878
Hyperglycaemic hyperosmolar nonketotic syndrome 21.48 10.18 28 161270 1252 34794381
Interstitial lung disease 21.46 10.18 195 161103 65087 34730546
Pneumonitis 21.43 10.18 82 161216 33796 34761837
Cold sweat 21.29 10.18 97 161201 9890 34785743
Neuropathic arthropathy 21.19 10.18 12 161286 163 34795470
Peripheral vascular disorder 21.11 10.18 61 161237 4975 34790658
Glycosylated haemoglobin decreased 20.87 10.18 16 161282 371 34795262
Amputation 20.75 10.18 21 161277 711 34794922
Neonatal respiratory arrest 20.60 10.18 7 161291 23 34795610
Psychotic disorder 20.56 10.18 52 161246 24400 34771233
Hypersensitivity 20.20 10.18 182 161116 60853 34734780
Asthenia 20.16 10.18 1351 159947 243900 34551733
Foot amputation 20.07 10.18 21 161277 740 34794893
Back pain 20.02 10.18 419 160879 121370 34674263
Infective pulmonary exacerbation of cystic fibrosis 20.02 10.18 73 161225 6728 34788905
Adenocarcinoma pancreas 19.93 10.18 28 161270 1346 34794287
Extremity necrosis 19.92 10.18 34 161264 1938 34793695
Systemic infection 19.83 10.18 61 161237 5151 34790482
Weight increased 19.83 10.18 566 160732 92467 34703166
Visual acuity reduced 19.75 10.18 135 161163 16014 34779619
Neuropathy peripheral 19.71 10.18 268 161030 82995 34712638
Blood insulin increased 19.67 10.18 15 161283 345 34795288
Alopecia 19.56 10.18 53 161245 24302 34771331
Anti-GAD antibody positive 19.44 10.18 6 161292 13 34795620
Mucormycosis 19.40 10.18 66 161232 5876 34789757
Appendicitis 19.22 10.18 24 161274 14783 34780850
Sleep disorder 19.22 10.18 78 161220 31610 34764023
Diabetic gastroparesis 19.18 10.18 10 161288 114 34795519
Generalised oedema 19.09 10.18 110 161188 12298 34783335
Glomerular filtration rate increased 19.03 10.18 16 161282 425 34795208
Blood ketone body increased 18.97 10.18 16 161282 427 34795206
Inflammation 18.87 10.18 67 161231 28228 34767405
Ventricular hyperkinesia 18.86 10.18 12 161286 204 34795429
Tumour lysis syndrome 18.83 10.18 31 161267 17028 34778605
Drug ineffective for unapproved indication 18.75 10.18 52 161246 23663 34771970
Upper motor neurone lesion 18.74 10.18 10 161288 120 34795513
Akathisia 18.69 10.18 7 161291 8102 34787531
Foetal disorder 18.65 10.18 21 161277 805 34794828
Pulmonary interstitial emphysema syndrome 18.57 10.18 17 161281 507 34795126
Large for dates baby 18.48 10.18 22 161276 896 34794737
Latent autoimmune diabetes in adults 18.45 10.18 8 161290 58 34795575
Peripheral ischaemia 18.42 10.18 63 161235 5624 34790009
Confusional state 18.34 10.18 827 160471 143333 34652300
Rhinorrhoea 18.33 10.18 59 161239 25609 34770024
Psoriatic arthropathy 18.33 10.18 40 161258 19758 34775875
Ureteric compression 18.31 10.18 13 161285 267 34795366
Diabetic ulcer 18.20 10.18 9 161289 91 34795542
Blood pressure fluctuation 18.06 10.18 58 161240 25191 34770442
Localised infection 18.06 10.18 141 161157 17446 34778187
Leukopenia 18.05 10.18 194 161104 62662 34732971
Escherichia urinary tract infection 17.91 10.18 46 161252 3500 34792133
Pancytopenia 17.89 10.18 320 160978 94837 34700796
Influenza 17.82 10.18 145 161153 49521 34746112
Product name confusion 17.78 10.18 8 161290 64 34795569
Angina unstable 17.73 10.18 103 161195 11550 34784083
Colitis 17.62 10.18 102 161196 37648 34757985
Periodontitis 17.58 10.18 32 161266 1920 34793713
Anaphylactic shock 17.57 10.18 29 161269 15912 34779721
Pancreatic failure 17.53 10.18 20 161278 778 34794855
Respiratory depression 17.49 10.18 30 161268 16215 34779418
Glomerular filtration rate decreased 17.46 10.18 111 161187 12850 34782783
Device delivery system issue 17.27 10.18 16 161282 485 34795148
Eye infection staphylococcal 17.26 10.18 7 161291 42 34795591
Foetal arrhythmia 17.08 10.18 9 161289 105 34795528
Acute pulmonary oedema 16.92 10.18 73 161225 7270 34788363
Diabetic bullosis 16.75 10.18 6 161292 24 34795609
Flour sensitivity 16.75 10.18 6 161292 24 34795609
Right atrial enlargement 16.71 10.18 12 161286 251 34795382
Blood triglycerides increased 16.52 10.18 117 161181 14042 34781591
Hypochromic anaemia 16.48 10.18 21 161277 918 34794715
Multiple sclerosis relapse 16.31 10.18 22 161276 13111 34782522
Hepatic cirrhosis 16.25 10.18 136 161162 17178 34778455
Post transplant lymphoproliferative disorder 16.14 10.18 5 161293 6523 34789110
Lipohypertrophy 16.11 10.18 12 161286 266 34795367
Lymphadenopathy 16.07 10.18 72 161226 28391 34767242
Drug reaction with eosinophilia and systemic symptoms 16.05 10.18 88 161210 32924 34762709
Acute graft versus host disease 16.05 10.18 5 161293 6498 34789135
Gastritis fungal 15.92 10.18 8 161290 84 34795549
Haematotoxicity 15.89 10.18 9 161289 8185 34787448
Oedema 15.88 10.18 298 161000 45443 34750190
Hyperosmolar state 15.83 10.18 14 161284 399 34795234
Hypogammaglobulinaemia 15.75 10.18 8 161290 7732 34787901
Haematoma muscle 15.72 10.18 25 161273 1343 34794290
Diverticulitis 15.71 10.18 44 161254 19960 34775673
Migraine 15.62 10.18 36 161262 17442 34778191
Vitreous floaters 15.59 10.18 44 161254 3541 34792092
Gallbladder neoplasm 15.53 10.18 6 161292 31 34795602
Device use issue 15.41 10.18 17 161281 637 34794996
Liver transplant failure 15.36 10.18 8 161290 91 34795542
Somogyi phenomenon 15.31 10.18 4 161294 3 34795630
Posterior reversible encephalopathy syndrome 15.30 10.18 14 161284 9940 34785693
Acute coronary syndrome 15.26 10.18 111 161187 13434 34782199
Insulin C-peptide increased 15.25 10.18 7 161291 59 34795574
Angina pectoris 15.24 10.18 216 161082 31147 34764486
Depression 15.10 10.18 337 160961 96761 34698872
Enzyme inhibition 15.05 10.18 5 161293 15 34795618
Visceral venous thrombosis 15.05 10.18 5 161293 15 34795618
Multiple-drug resistance 14.92 10.18 3 161295 5236 34790397
Skin pressure mark 14.86 10.18 7 161291 63 34795570
Diabetic gangrene 14.80 10.18 11 161287 243 34795390
Depressed mood 14.80 10.18 43 161255 19274 34776359
Left atrial dilatation 14.64 10.18 30 161268 1966 34793667
Respiratory arrest 14.62 10.18 73 161225 27970 34767663
Product monitoring error 14.60 10.18 49 161249 4332 34791301
Hypochromasia 14.59 10.18 12 161286 309 34795324
Cytomegalovirus infection reactivation 14.43 10.18 3 161295 5115 34790518
Neuroleptic malignant syndrome 14.42 10.18 39 161259 17895 34777738
Mitral valve thickening 14.39 10.18 13 161285 381 34795252
Hypovolaemia 14.30 10.18 82 161216 9152 34786481
Neutropenia neonatal 14.23 10.18 17 161281 695 34794938
Basal cell carcinoma 14.17 10.18 45 161253 19613 34776020
Hyperinsulinaemic hypoglycaemia 14.14 10.18 7 161291 71 34795562
Peripheral arterial occlusive disease 14.00 10.18 59 161239 5815 34789818
Congenital cystic kidney disease 13.84 10.18 13 161285 401 34795232
Clostridium difficile infection 13.80 10.18 43 161255 18855 34776778
Loss of personal independence in daily activities 13.75 10.18 93 161205 33086 34762547
Condition aggravated 13.69 10.18 736 160562 191460 34604173
Extrapyramidal disorder 13.67 10.18 24 161274 12856 34782777
Insulin C-peptide decreased 13.67 10.18 6 161292 45 34795588
Retinal haemorrhage 13.63 10.18 53 161245 5036 34790597
Blindness unilateral 13.58 10.18 49 161249 4493 34791140
Oxygen saturation decreased 13.55 10.18 171 161127 53647 34741986
Mucosal dryness 13.51 10.18 23 161275 1308 34794325
Squamous cell carcinoma 13.48 10.18 20 161278 11455 34784178
Retinal aneurysm 13.44 10.18 8 161290 120 34795513
Device failure 13.24 10.18 32 161266 2344 34793289
Chromoblastomycosis 13.23 10.18 6 161292 49 34795584
Urethral abscess 13.15 10.18 3 161295 0 34795633
Cerebellar artery occlusion 13.15 10.18 3 161295 0 34795633
Supranuclear palsy 13.15 10.18 3 161295 0 34795633
Strangulated umbilical hernia 13.15 10.18 3 161295 0 34795633
Thrombocytopenia 13.15 10.18 588 160710 155659 34639974
Suicidal ideation 13.11 10.18 121 161177 40267 34755366
Morganella infection 13.05 10.18 14 161284 508 34795125
Acute myeloid leukaemia 13.04 10.18 42 161256 18228 34777405
Nephropathy 13.01 10.18 58 161240 5859 34789774
Delusion 13.00 10.18 24 161274 12611 34783022
Alanine aminotransferase increased 12.99 10.18 279 161019 80536 34715097
Cystitis haemorrhagic 12.92 10.18 5 161293 5674 34789959
Guillain-Barre syndrome 12.88 10.18 59 161239 6028 34789605
Fungal endocarditis 12.83 10.18 12 161286 368 34795265
Acute graft versus host disease in skin 12.83 10.18 4 161294 5197 34790436
Agitation 12.78 10.18 187 161111 57212 34738421
Foetal hypokinesia 12.73 10.18 12 161286 372 34795261
Arrhythmia 12.68 10.18 234 161064 35574 34760059
Nephrogenic systemic fibrosis 12.65 10.18 44 161254 3961 34791672
Blood potassium increased 12.64 10.18 124 161174 16371 34779262
Epstein-Barr virus infection 12.62 10.18 10 161288 7618 34788015
Unevaluable event 12.61 10.18 216 161082 32374 34763259
Oropharyngeal pain 12.55 10.18 104 161194 35381 34760252
Hallucination 12.46 10.18 165 161133 51333 34744300
Product dispensing issue 12.36 10.18 6 161292 58 34795575
Disease recurrence 12.35 10.18 54 161244 21436 34774197
Cardiac disorder 12.33 10.18 273 161025 42853 34752780
Hepatic function abnormal 12.30 10.18 138 161160 44225 34751408
Oesophageal tuberculosis 12.30 10.18 4 161294 11 34795622
Parvimonas micra infection 12.30 10.18 4 161294 11 34795622
Underdose 12.28 10.18 107 161191 13673 34781960
Epistaxis 12.21 10.18 192 161106 58059 34737574
Preternatural anus 12.18 10.18 7 161291 98 34795535
C-reactive protein increased 12.13 10.18 176 161122 53922 34741711
Dehydration 12.12 10.18 724 160574 129245 34666388
Muscle spasticity 12.11 10.18 6 161292 5882 34789751
Glycosuria 12.07 10.18 21 161277 1216 34794417
Lymphopenia 12.05 10.18 37 161261 16298 34779335
Neuritis 12.04 10.18 18 161280 916 34794717
Premature baby 11.98 10.18 141 161157 19492 34776141
Myocardial ischaemia 11.97 10.18 128 161170 17280 34778353
Non-cardiogenic pulmonary oedema 11.94 10.18 15 161283 646 34794987
Poisoning 11.91 10.18 24 161274 12202 34783431
Retinal exudates 11.86 10.18 16 161282 740 34794893
Hepatocellular carcinoma 11.84 10.18 67 161231 7442 34788191
Hypertensive crisis 11.82 10.18 75 161223 8676 34786957
Allergic transfusion reaction 11.81 10.18 4 161294 13 34795620
Postprandial hypoglycaemia 11.81 10.18 4 161294 13 34795620
Hypertriglyceridaemia 11.78 10.18 73 161225 8375 34787258
Colitis ulcerative 11.78 10.18 38 161260 16482 34779151
Mania 11.74 10.18 16 161282 9495 34786138
Neonatal respiratory depression 11.70 10.18 12 161286 413 34795220
Generalised tonic-clonic seizure 11.69 10.18 54 161244 21120 34774513
Diabetic hyperglycaemic coma 11.68 10.18 5 161293 35 34795598
Granulocytopenia 11.65 10.18 8 161290 6559 34789074
Cardiogenic shock 11.63 10.18 180 161118 26438 34769195
Meningitis fungal 11.59 10.18 7 161291 108 34795525
Injection site hypertrophy 11.58 10.18 4 161294 14 34795619
Intestinal haemorrhage 11.56 10.18 39 161259 3457 34792176
Intestinal obstruction 11.56 10.18 60 161238 22762 34772871
Pseudohyponatraemia 11.54 10.18 6 161292 68 34795565
Optic discs blurred 11.54 10.18 6 161292 68 34795565
Chronic graft versus host disease 11.46 10.18 3 161295 4370 34791263
Sinus arrest 11.43 10.18 25 161273 1715 34793918
Ischaemic cardiomyopathy 11.42 10.18 59 161239 6330 34789303
Bladder irrigation 11.39 10.18 6 161292 70 34795563
Heart rate increased 11.39 10.18 148 161150 46195 34749438
Intraventricular haemorrhage 11.34 10.18 39 161259 3492 34792141
Asthma 11.32 10.18 134 161164 42522 34753111
Insulin autoimmune syndrome 11.27 10.18 10 161288 286 34795347
Laboratory test abnormal 11.26 10.18 52 161246 20339 34775294
Extrasystoles 11.22 10.18 41 161257 3782 34791851
Mean platelet volume increased 11.17 10.18 13 161285 517 34795116
Diabetic hyperosmolar coma 11.15 10.18 12 161286 437 34795196
Cytokine release syndrome 11.11 10.18 61 161237 22816 34772817
Muscle abscess 11.09 10.18 14 161284 606 34795027
Non-proliferative retinopathy 11.08 10.18 3 161295 3 34795630
Polycythaemia neonatorum 11.08 10.18 3 161295 3 34795630
Ostectomy 11.08 10.18 3 161295 3 34795630
Nightmare 11.05 10.18 32 161266 14359 34781274
Atrial septal defect 11.03 10.18 65 161233 7327 34788306
Renal disorder 11.02 10.18 172 161126 25308 34770325
Obsessive-compulsive disorder 10.95 10.18 6 161292 5558 34790075
Newborn persistent pulmonary hypertension 10.95 10.18 7 161291 120 34795513
Extra dose administered 10.94 10.18 42 161256 3967 34791666
Genital burning sensation 10.80 10.18 4 161294 18 34795615
Cytomegalovirus viraemia 10.78 10.18 11 161287 7419 34788214
Sedation 10.77 10.18 55 161243 20951 34774682
Parkinsonism 10.76 10.18 13 161285 8125 34787508
Sexual dysfunction 10.76 10.18 8 161290 6295 34789338
Wrong drug 10.76 10.18 6 161292 79 34795554
Upper respiratory tract infection 10.75 10.18 99 161199 32960 34762673
Seasonal allergy 10.73 10.18 9 161289 6666 34788967
Cogwheel rigidity 10.73 10.18 21 161277 1331 34794302
Intentional product misuse 10.72 10.18 147 161151 45464 34750169
Eosinophilic pneumonia 10.66 10.18 38 161260 3463 34792170
Blood ketone body 10.63 10.18 6 161292 81 34795552
Retinopathy proliferative 10.63 10.18 6 161292 81 34795552
Diabetic autonomic neuropathy 10.63 10.18 3 161295 4 34795629
Diabetic vascular disorder 10.61 10.18 5 161293 45 34795588
Blood urea increased 10.60 10.18 198 161100 30166 34765467
Catatonia 10.52 10.18 5 161293 5020 34790613
Tenosynovitis 10.44 10.18 4 161294 4566 34791067
Impaired quality of life 10.44 10.18 7 161291 5811 34789822
Actinic keratosis 10.43 10.18 4 161294 4563 34791070
Pancreas transplant rejection 10.42 10.18 8 161290 186 34795447
Cardiac ventricular disorder 10.31 10.18 9 161289 252 34795381
Rash macular 10.27 10.18 28 161270 12814 34782819
Pneumonia aspiration 10.23 10.18 134 161164 41769 34753864
Influenza like illness 10.22 10.18 80 161218 27554 34768079
Device interaction 10.19 10.18 13 161285 569 34795064

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 6008.04 9.27 3914 263362 97680 79379432
Blood glucose increased 4950.45 9.27 3645 263631 111330 79365782
Diabetic ketoacidosis 2358.23 9.27 1453 265823 32669 79444443
Diabetes mellitus inadequate control 1853.57 9.27 1102 266174 23162 79453950
Hyperglycaemia 1701.36 9.27 1599 265677 68736 79408376
Blood glucose decreased 1498.86 9.27 991 266285 25243 79451869
Device operational issue 1042.59 9.27 246 267030 146 79476966
Glycosylated haemoglobin increased 1029.06 9.27 698 266578 18562 79458550
Blood glucose abnormal 835.81 9.27 491 266785 10075 79467037
Acute kidney injury 679.79 9.27 3484 263792 515920 78961192
Ketoacidosis 642.41 9.27 373 266903 7481 79469631
Blood glucose fluctuation 640.27 9.27 352 266924 6330 79470782
Lactic acidosis 589.68 9.27 935 266341 69424 79407688
Hypoglycaemic coma 572.96 9.27 292 266984 4468 79472644
Hyperkalaemia 468.25 9.27 1123 266153 113275 79363837
Synovitis 349.37 9.27 46 267230 150688 79326424
Product storage error 348.77 9.27 346 266930 15880 79461232
Renal failure 348.07 9.27 1465 265811 199503 79277609
Off label use 335.44 9.27 1735 265541 905480 78571632
Diabetic retinopathy 334.97 9.27 177 267099 2929 79474183
Systemic lupus erythematosus 320.19 9.27 22 267254 121127 79355985
Joint swelling 318.19 9.27 299 266977 288347 79188765
Device issue 317.14 9.27 422 266854 26686 79450426
Infusion related reaction 307.69 9.27 196 267080 230041 79247071
Hand deformity 306.61 9.27 9 267267 103910 79373202
Pemphigus 288.88 9.27 10 267266 99572 79377540
Arthropathy 283.79 9.27 119 267157 176992 79300120
Drug intolerance 274.51 9.27 288 266988 263831 79213281
Diabetic metabolic decompensation 274.49 9.27 159 267117 3173 79473939
Alopecia 267.68 9.27 229 267047 231126 79245986
Treatment failure 262.96 9.27 121 267155 170365 79306747
Inappropriate schedule of product administration 261.42 9.27 1012 266264 132616 79344496
Glossodynia 258.48 9.27 24 267252 103313 79373799
Anti-cyclic citrullinated peptide antibody positive 253.70 9.27 5 267271 83138 79393974
Drug ineffective 248.78 9.27 2373 264903 1078540 78398572
Hypoglycaemic unconsciousness 239.74 9.27 104 267172 1079 79476033
Myocardial infarction 234.07 9.27 1227 266049 182902 79294210
Drug abuse 224.95 9.27 133 267143 162558 79314554
Euglycaemic diabetic ketoacidosis 222.10 9.27 184 267092 6660 79470452
Contraindicated product administered 216.10 9.27 130 267146 157408 79319704
Nasopharyngitis 206.95 9.27 332 266944 253549 79223563
Drug hypersensitivity 204.56 9.27 435 266841 298481 79178631
Diabetic foot 204.43 9.27 136 267140 3496 79473616
Duodenal ulcer perforation 201.94 9.27 4 267272 66207 79410905
Cerebrovascular accident 200.20 9.27 1039 266237 154253 79322859
Arthralgia 185.96 9.27 1139 266137 570664 78906448
Rheumatoid arthritis 184.04 9.27 258 267018 208212 79268900
Cardiac failure congestive 182.33 9.27 951 266325 141451 79335661
Pericarditis 182.06 9.27 61 267215 104175 79372937
Diabetic neuropathy 180.96 9.27 157 267119 6059 79471053
Rheumatoid factor positive 177.17 9.27 5 267271 59834 79417278
Therapeutic product effect decreased 174.33 9.27 175 267101 163688 79313424
Device mechanical issue 172.63 9.27 61 267215 343 79476769
Musculoskeletal stiffness 171.65 9.27 200 267076 174808 79302304
Incorrect dose administered by device 170.01 9.27 138 267138 4851 79472261
Sinusitis 164.67 9.27 250 267026 195251 79281861
Febrile neutropenia 161.48 9.27 332 266944 230667 79246445
Metabolic acidosis 161.30 9.27 625 266651 81904 79395208
Renal impairment 161.25 9.27 992 266284 156791 79320321
Abdominal discomfort 159.16 9.27 380 266896 250347 79226765
Hypersensitivity 158.23 9.27 408 266868 261831 79215281
Loss of consciousness 156.87 9.27 1032 266244 166911 79310201
Rash 151.74 9.27 1226 266050 577132 78899980
Hypoglycaemic seizure 146.24 9.27 66 267210 758 79476354
Rhabdomyolysis 144.82 9.27 707 266569 102424 79374688
Wrong technique in device usage process 142.74 9.27 114 267162 3914 79473198
Therapeutic product effect incomplete 140.91 9.27 160 267116 141485 79335627
Helicobacter infection 138.09 9.27 32 267244 69672 79407440
Stomatitis 137.25 9.27 174 267102 146583 79330529
Irritable bowel syndrome 137.19 9.27 22 267254 62219 79414893
Folliculitis 132.94 9.27 15 267261 55365 79421747
Sleep disorder due to general medical condition, insomnia type 131.37 9.27 3 267273 43553 79433559
Product use in unapproved indication 130.86 9.27 417 266859 249942 79227170
Pain 128.55 9.27 1627 265649 702175 78774937
Gangrene 127.75 9.27 154 267122 8810 79468302
Anti-insulin antibody positive 127.65 9.27 45 267231 251 79476861
Insulin resistance 124.87 9.27 70 267206 1309 79475803
Diabetes mellitus 124.44 9.27 557 266719 77833 79399279
Psoriatic arthropathy 122.34 9.27 54 267222 77945 79399167
Wrong product administered 120.63 9.27 150 267126 8862 79468250
Hepatic enzyme increased 120.48 9.27 271 267005 182339 79294773
Pancreatic carcinoma 120.01 9.27 185 267091 13392 79463720
Swelling 116.03 9.27 357 266919 216354 79260758
Dehydration 114.48 9.27 1304 265972 246883 79230229
Muscle injury 114.46 9.27 14 267262 48547 79428565
Hypoglycaemia unawareness 113.49 9.27 39 267237 199 79476913
Coronary artery disease 112.92 9.27 477 266799 64997 79412115
Renal injury 106.25 9.27 198 267078 16729 79460383
C-reactive protein abnormal 102.42 9.27 19 267257 48348 79428764
Increased insulin requirement 102.41 9.27 34 267242 153 79476959
Intentional product use issue 101.76 9.27 224 267052 151888 79325224
Product administration error 99.74 9.27 283 266993 31563 79445549
Acute myocardial infarction 98.90 9.27 515 266761 76521 79400591
Discomfort 98.80 9.27 168 267108 125449 79351663
Fibromyalgia 98.63 9.27 46 267230 64294 79412818
Fatigue 97.68 9.27 2373 264903 927354 78549758
Pancreatitis 97.60 9.27 472 266804 68103 79409009
Fear 94.36 9.27 220 267056 21766 79455346
Chronic kidney disease 93.19 9.27 454 266822 65700 79411412
Vitreous haemorrhage 92.70 9.27 86 267190 3627 79473485
Toe amputation 92.68 9.27 88 267188 3823 79473289
Neutropenia 92.29 9.27 575 266701 287135 79189977
Diabetic coma 90.76 9.27 55 267221 1196 79475916
Cutaneous amyloidosis 89.92 9.27 23 267253 28 79477084
Hypoglycaemic encephalopathy 89.72 9.27 44 267232 617 79476495
Diabetic nephropathy 88.96 9.27 76 267200 2871 79474241
Toxicity to various agents 86.20 9.27 950 266326 420590 79056522
Rheumatic fever 82.24 9.27 3 267273 28522 79448590
Peritonitis bacterial 81.27 9.27 128 267148 9439 79467673
Ketonuria 79.73 9.27 50 267226 1158 79475954
Ill-defined disorder 78.83 9.27 63 267213 65812 79411300
Ketosis 77.85 9.27 48 267228 1078 79476034
Wound 76.94 9.27 172 267104 116007 79361105
White blood cell count decreased 76.69 9.27 347 266929 187941 79289171
Lower respiratory tract infection 74.87 9.27 205 267071 129015 79348097
Diabetic complication 74.67 9.27 49 267227 1230 79475882
Cardiac failure 73.79 9.27 819 266457 154023 79323089
Type 1 diabetes mellitus 73.78 9.27 103 267173 6816 79470296
Device defective 73.77 9.27 57 267219 1863 79475249
Treatment noncompliance 73.11 9.27 358 266918 51910 79425202
Migraine 71.60 9.27 114 267162 87379 79389733
Mental status changes 70.88 9.27 425 266851 66534 79410578
Injury associated with device 70.28 9.27 72 267204 3434 79473678
Loss of personal independence in daily activities 69.46 9.27 150 267126 102430 79374682
Dialysis 68.84 9.27 175 267101 18287 79458825
Completed suicide 68.45 9.27 512 266764 245255 79231857
Blindness 67.34 9.27 229 267047 28154 79448958
Hyperinsulinaemic hypoglycaemia 66.90 9.27 24 267252 142 79476970
Incorrect dose administered 66.76 9.27 463 266813 76167 79400945
Oedema peripheral 65.88 9.27 1200 266076 251088 79226024
Blood creatinine increased 65.80 9.27 802 266474 154255 79322857
Disease progression 65.74 9.27 356 266920 184006 79293106
Drug interaction 65.65 9.27 1839 265437 413344 79063768
Polyuria 65.27 9.27 151 267125 14863 79462249
Headache 65.13 9.27 1681 265595 652091 78825021
Multiple use of single-use product 62.89 9.27 39 267237 885 79476227
Eye haemorrhage 62.33 9.27 115 267161 9642 79467470
Infection 61.99 9.27 515 266761 241197 79235915
Pancreatitis acute 61.86 9.27 329 266947 49275 79427837
Anhedonia 61.67 9.27 147 267129 14751 79462361
Myelosuppression 61.47 9.27 29 267247 40267 79436845
Pancreatic carcinoma metastatic 61.03 9.27 69 267207 3684 79473428
Hip arthroplasty 60.57 9.27 22 267254 35734 79441378
Asthma 58.64 9.27 243 267033 134852 79342260
Peripheral swelling 56.90 9.27 603 266673 269014 79208098
Angina unstable 56.84 9.27 152 267124 16375 79460737
Product quality issue 56.75 9.27 245 267031 33695 79443417
Osteoarthritis 56.39 9.27 131 267145 87178 79389934
Systemic infection 56.19 9.27 110 267166 9642 79467470
Infective pulmonary exacerbation of cystic fibrosis 55.59 9.27 129 267147 12722 79464390
Device expulsion 55.09 9.27 10 267266 25851 79451261
Asthenia 54.37 9.27 2163 265113 509526 78967586
Sleep disorder 53.39 9.27 131 267145 85546 79391566
Device delivery system issue 52.68 9.27 32 267244 699 79476413
Generalised oedema 52.52 9.27 187 267089 23522 79453590
Retinopathy 52.45 9.27 65 267211 3826 79473286
Pyrexia 51.74 9.27 1809 265467 676900 78800212
Hyperglycaemic hyperosmolar nonketotic syndrome 51.14 9.27 50 267226 2253 79474859
Knee arthroplasty 50.95 9.27 42 267234 43206 79433906
Impaired healing 50.81 9.27 139 267137 87516 79389596
Angina pectoris 50.75 9.27 322 266954 51410 79425702
COVID-19 50.57 9.27 315 266961 157359 79319753
Diabetic ketosis 49.72 9.27 27 267249 473 79476639
Hepatic encephalopathy 49.65 9.27 186 267090 23980 79453132
Therapy non-responder 49.40 9.27 152 267124 92153 79384959
Hypothermia 49.19 9.27 178 267098 22568 79454544
Inflammation 48.34 9.27 157 267119 93596 79383516
Non-cardiogenic pulmonary oedema 48.01 9.27 40 267236 1459 79475653
Cardiovascular disorder 47.76 9.27 151 267125 17874 79459238
Back pain 47.17 9.27 726 266550 303454 79173658
Bursitis 47.16 9.27 31 267245 35813 79441299
Shock hypoglycaemic 46.93 9.27 21 267255 236 79476876
Visual acuity reduced 46.45 9.27 209 267067 29260 79447852
Blister 46.37 9.27 224 267052 119252 79357860
Insomnia 46.35 9.27 562 266714 244608 79232504
Arterial occlusive disease 45.86 9.27 93 267183 8363 79468749
Oropharyngeal pain 45.42 9.27 200 267076 109153 79367959
Pulmonary oedema 45.36 9.27 474 266802 87780 79389332
Glycosylated haemoglobin abnormal 45.23 9.27 20 267256 218 79476894
Drug administered in wrong device 44.93 9.27 14 267262 49 79477063
Impaired gastric emptying 44.87 9.27 104 267172 10249 79466863
Blood pressure fluctuation 44.78 9.27 99 267177 67046 79410066
Red blood cell sedimentation rate increased 44.47 9.27 53 267223 45889 79431223
Anuria 44.45 9.27 163 267113 20800 79456312
Maternal exposure during pregnancy 44.18 9.27 272 267004 136266 79340846
Glycosuria 43.98 9.27 45 267231 2143 79474969
Myocardial ischaemia 43.27 9.27 185 267091 25334 79451778
Visual impairment 43.27 9.27 486 266790 91645 79385467
Blood insulin increased 43.08 9.27 22 267254 338 79476774
Blood ketone body increased 42.98 9.27 28 267248 694 79476418
Anti-insulin antibody increased 42.95 9.27 16 267260 107 79477005
Pemphigoid 42.14 9.27 130 267146 15185 79461927
Glomerular filtration rate decreased 41.97 9.27 169 267107 22533 79454579
Haemodialysis 41.71 9.27 145 267131 18023 79459089
Cardiac arrest 41.59 9.27 809 266467 171287 79305825
Microalbuminuria 41.40 9.27 30 267246 888 79476224
Sepsis 41.29 9.27 1189 266087 268239 79208873
Product complaint 41.19 9.27 118 267158 13231 79463881
Sedation complication 40.93 9.27 3 267273 15666 79461446
Hot flush 40.78 9.27 76 267200 54801 79422311
Cardiac disorder 40.58 9.27 367 266909 65390 79411722
Drug dependence 40.58 9.27 46 267230 40723 79436389
Sopor 40.51 9.27 218 267058 32792 79444320
Acute coronary syndrome 40.42 9.27 159 267117 20974 79456138
Malignant neoplasm progression 40.40 9.27 278 266998 135712 79341400
Respiratory failure 40.25 9.27 840 266436 180071 79297041
C-reactive protein increased 40.22 9.27 260 267016 128767 79348345
Neutrophil count decreased 40.15 9.27 170 267106 93789 79383323
Diabetic gastroparesis 40.09 9.27 21 267255 341 79476771
Mobility decreased 39.73 9.27 243 267033 121932 79355180
Gastrooesophageal reflux disease 39.56 9.27 197 267079 104049 79373063
Myopathy 39.56 9.27 155 267121 20408 79456704
Renal tubular necrosis 39.03 9.27 177 267099 24862 79452250
Injection site pain 38.70 9.27 631 266645 129207 79347905
Blood triglycerides increased 38.39 9.27 156 267120 20884 79456228
Dry mouth 38.39 9.27 158 267118 87861 79389251
Emotional distress 38.11 9.27 247 267029 39722 79437390
Urine ketone body present 37.90 9.27 53 267223 3512 79473600
Emphysematous pyelonephritis 37.84 9.27 20 267256 331 79476781
Injection site haemorrhage 37.62 9.27 189 267087 27681 79449431
Herpes zoster 37.60 9.27 172 267104 92911 79384201
Hyperhidrosis 37.57 9.27 715 266561 150777 79326335
Anaemia 37.46 9.27 1837 265439 443178 79033934
Bone pain 37.32 9.27 82 267194 55660 79421452
Leg amputation 36.76 9.27 53 267223 3613 79473499
Gastrointestinal disorder 36.21 9.27 250 267026 121955 79355157
Cold sweat 36.01 9.27 141 267135 18558 79458554
Diabetic hyperglycaemic coma 35.81 9.27 13 267263 80 79477032
Nasal congestion 35.56 9.27 134 267142 76418 79400694
Hypervolaemia 35.46 9.27 255 267021 42435 79434677
Mucosal inflammation 35.30 9.27 132 267144 75448 79401664
Cough 35.13 9.27 948 266328 365841 79111271
Device interaction 34.94 9.27 25 267251 725 79476387
Hypotension 34.87 9.27 1807 265469 438510 79038602
Rheumatoid nodule 34.54 9.27 8 267268 17430 79459682
Oral herpes 34.45 9.27 25 267251 27429 79449683
Urticaria 34.43 9.27 426 266850 184775 79292337
Adenocarcinoma pancreas 34.12 9.27 38 267238 1995 79475117
Hypertriglyceridaemia 34.00 9.27 107 267169 12633 79464479
Blindness transient 33.98 9.27 59 267217 4717 79472395
Left ventricular hypertrophy 33.64 9.27 98 267178 11093 79466019
Drug resistance 33.60 9.27 56 267220 42157 79434955
Foot amputation 33.46 9.27 27 267249 941 79476171
Diabetic foot infection 33.30 9.27 25 267251 782 79476330
Blood cholesterol increased 33.05 9.27 156 267120 83564 79393548
Ischaemic cardiomyopathy 33.02 9.27 77 267199 7618 79469494
Intentional self-injury 32.90 9.27 36 267240 32383 79444729
Foot deformity 32.80 9.27 20 267256 24054 79453058
Wrong technique in product usage process 32.58 9.27 385 266891 73490 79403622
Blood potassium increased 32.38 9.27 188 267088 29087 79448025
Encephalopathy 32.32 9.27 357 266919 67040 79410072
Neutropenic sepsis 32.23 9.27 26 267250 27038 79450074
Device use issue 32.03 9.27 43 267233 2741 79474371
Bone erosion 31.94 9.27 10 267266 17837 79459275
Cardiogenic shock 31.77 9.27 245 267031 41669 79435443
Latent autoimmune diabetes in adults 31.75 9.27 12 267264 84 79477028
Peripheral arterial occlusive disease 31.54 9.27 79 267197 8179 79468933
Confusional state 31.36 9.27 1334 265942 316663 79160449
Urosepsis 31.19 9.27 173 267103 26322 79450790
Flushing 31.14 9.27 171 267105 88097 79389015
Tenosynovitis 31.08 9.27 7 267269 15547 79461565
Constipation 31.03 9.27 717 266559 282333 79194779
Blood urea increased 30.98 9.27 274 267002 48516 79428596
Upper respiratory tract infection 30.87 9.27 179 267097 90989 79386123
Pre-eclampsia 30.81 9.27 71 267205 6970 79470142
Multiple sclerosis relapse 30.71 9.27 69 267207 46464 79430648
Lip dry 30.69 9.27 7 267269 15411 79461701
Macular oedema 30.64 9.27 61 267215 5413 79471699
Hypovolaemia 30.58 9.27 129 267147 17562 79459550
Anti-insulin antibody 30.54 9.27 11 267265 66 79477046
Musculoskeletal pain 30.52 9.27 209 267067 102145 79374967
Diabetic ketoacidotic hyperglycaemic coma 30.36 9.27 15 267261 214 79476898
Mucormycosis 30.25 9.27 79 267197 8390 79468722
Gastrointestinal haemorrhage 30.00 9.27 677 266599 147042 79330070
Shock 29.98 9.27 249 267027 43299 79433813
Haemophagocytic lymphohistiocytosis 29.95 9.27 18 267258 21819 79455293
Accidental underdose 29.70 9.27 24 267252 838 79476274
Therapeutic drug monitoring analysis not performed 28.80 9.27 34 267242 1902 79475210
Peripheral vascular disorder 28.78 9.27 75 267201 7955 79469157
Unevaluable event 28.78 9.27 299 266977 55286 79421826
Cholestasis 28.75 9.27 284 266992 51825 79425287
Ear pain 28.65 9.27 41 267235 32828 79444284
Unresponsive to stimuli 28.37 9.27 299 266977 55489 79421623
Heparin-induced thrombocytopenia 28.35 9.27 84 267192 9598 79467514
Polydipsia 28.24 9.27 66 267210 6539 79470573
Fall 27.99 9.27 1945 265331 485684 78991428
Peripheral ischaemia 27.64 9.27 82 267194 9375 79467737
Psychotic disorder 27.64 9.27 61 267215 41341 79435771
Rhinorrhoea 27.59 9.27 146 267130 75928 79401184
Oliguria 27.47 9.27 118 267158 16191 79460921
Hyperlactacidaemia 27.38 9.27 59 267217 5536 79471576
Acetonaemia 27.32 9.27 16 267260 326 79476786
Product dispensing error 27.17 9.27 102 267174 13161 79463951
Infusion site pain 27.11 9.27 7 267269 14169 79462943
Diabetic hyperosmolar coma 27.06 9.27 22 267254 775 79476337
Night sweats 27.01 9.27 87 267189 52008 79425104
Anti-GAD antibody positive 26.84 9.27 9 267267 42 79477070
Neck pain 26.66 9.27 146 267130 75271 79401841
Electrolyte imbalance 26.54 9.27 186 267090 30695 79446417
Peritoneal dialysis complication 26.54 9.27 36 267240 2318 79474794
Bradycardia 26.51 9.27 618 266658 134939 79342173
Osteoporosis 26.26 9.27 93 267183 54019 79423093
Paraesthesia 26.24 9.27 424 266852 175899 79301213
Contusion 26.24 9.27 346 266930 148430 79328682
Device dislocation 26.18 9.27 29 267247 25941 79451171
Hepatocellular carcinoma 26.16 9.27 78 267198 8943 79468169
Medication error 26.11 9.27 348 266928 68294 79408818
Hypertensive crisis 26.06 9.27 138 267138 20632 79456480
Grip strength decreased 26.05 9.27 21 267255 21848 79455264
Adverse drug reaction 26.03 9.27 124 267152 66268 79410844
Vomiting 25.96 9.27 2579 264697 663249 78813863
Retinal haemorrhage 25.71 9.27 73 267203 8144 79468968
Hyperosmolar state 25.64 9.27 20 267256 663 79476449
Deep vein thrombosis postoperative 25.58 9.27 3 267273 10749 79466363
Leukocytosis 25.53 9.27 240 267036 43215 79433897
Multi-organ disorder 25.35 9.27 37 267239 2551 79474561
Acidosis 25.27 9.27 132 267144 19630 79457482
Injection site erythema 25.17 9.27 156 267120 78041 79399071
Liquid product physical issue 25.16 9.27 25 267251 1149 79475963
Glycosylated haemoglobin decreased 25.16 9.27 20 267256 682 79476430
High density lipoprotein decreased 25.01 9.27 51 267225 4604 79472508
Blood parathyroid hormone decreased 24.92 9.27 3 267273 10533 79466579
Peripheral artery haematoma 24.87 9.27 11 267265 120 79476992
Haematoma 24.80 9.27 276 267000 51919 79425193
Erythrodermic psoriasis 24.72 9.27 30 267246 1728 79475384
Injection site nodule 24.71 9.27 45 267231 3735 79473377
Erythema 24.63 9.27 565 266711 222725 79254387
Joint effusion 24.49 9.27 15 267261 17999 79459113
Basal cell carcinoma 24.19 9.27 56 267220 37319 79439793
Injection site reaction 24.10 9.27 98 267178 54687 79422425
Blood ketone body 23.87 9.27 11 267265 133 79476979
Neuropathic arthropathy 23.82 9.27 15 267261 350 79476762
Drug ineffective for unapproved indication 23.59 9.27 90 267186 51148 79425964
Premature delivery 23.59 9.27 147 267129 23320 79453792
Oedematous pancreatitis 23.44 9.27 24 267252 1144 79475968
Pulmonary interstitial emphysema syndrome 23.38 9.27 17 267259 506 79476606
Decreased insulin requirement 23.37 9.27 11 267265 140 79476972
Colitis ulcerative 23.35 9.27 51 267225 34691 79442421
Insulin C-peptide decreased 23.22 9.27 9 267267 68 79477044
Bone density decreased 22.97 9.27 8 267268 13339 79463773
Ear infection 22.77 9.27 51 267225 34381 79442731
Adverse event 22.72 9.27 114 267162 60100 79417012
Dry eye 22.59 9.27 57 267219 36874 79440238
Impaired quality of life 22.49 9.27 10 267266 14376 79462736
Extremity necrosis 22.42 9.27 39 267237 3122 79473990
Crystal nephropathy 22.39 9.27 26 267250 1429 79475683
Chronic sinusitis 22.09 9.27 8 267268 13018 79464094
Hypoglycaemia neonatal 22.07 9.27 8 267268 49 79477063
Prescribed overdose 22.00 9.27 60 267216 37823 79439289
Ureteric compression 21.98 9.27 13 267263 270 79476842
Drug tolerance decreased 21.95 9.27 8 267268 12970 79464142
Pain in jaw 21.95 9.27 80 267196 46071 79431041
Alveolar lung disease 21.89 9.27 17 267259 560 79476552
Plasmapheresis 21.74 9.27 18 267258 651 79476461
Diaphragmatic disorder 21.63 9.27 28 267248 1722 79475390
Diabetic retinal oedema 21.56 9.27 14 267262 345 79476767
Liver injury 21.47 9.27 107 267169 56507 79420605
Joint range of motion decreased 21.44 9.27 50 267226 33232 79443880
Food allergy 21.37 9.27 5 267271 10819 79466293
Suture rupture 21.23 9.27 17 267259 586 79476526
Dawn phenomenon 21.17 9.27 5 267271 3 79477109
Pharyngitis 21.16 9.27 138 267138 22237 79454875
Hepatic cirrhosis 21.12 9.27 194 267082 34712 79442400
Osteomyelitis 21.08 9.27 185 267091 32680 79444432
Amputation 21.07 9.27 19 267257 772 79476340
Frequent bowel movements 21.00 9.27 42 267234 29497 79447615
Tinnitus 20.98 9.27 77 267199 44256 79432856
Transient ischaemic attack 20.81 9.27 269 267007 52426 79424686
Pneumocystis jirovecii pneumonia 20.81 9.27 49 267227 32459 79444653
Therapeutic drug monitoring analysis incorrectly performed 20.67 9.27 18 267258 698 79476414
Renal disorder 20.63 9.27 224 267052 41881 79435231
Influenza 20.52 9.27 308 266968 129298 79347814
Therapy partial responder 20.36 9.27 17 267259 17380 79459732
Diverticulitis 20.31 9.27 82 267194 45854 79431258
Bone marrow failure 20.30 9.27 95 267181 51012 79426100
Syncope 20.27 9.27 764 266512 178685 79298427
Cognitive disorder 20.24 9.27 144 267132 69782 79407330
Diabetic hepatopathy 20.06 9.27 5 267271 5 79477107
Acne 19.90 9.27 38 267238 27152 79449960
Product dispensing issue 19.90 9.27 11 267265 200 79476912
Pulmonary embolism 19.88 9.27 431 266845 171223 79305889
Product use issue 19.88 9.27 543 266733 209279 79267833
Sinus arrest 19.84 9.27 40 267236 3582 79473530
Mydriasis 19.73 9.27 18 267258 17625 79459487
Metabolic syndrome 19.69 9.27 34 267242 2706 79474406
General physical health deterioration 19.65 9.27 1119 266157 274119 79202993
Diabetic gangrene 19.61 9.27 11 267265 206 79476906
Retinal aneurysm 19.60 9.27 12 267264 266 79476846
Altered state of consciousness 19.60 9.27 229 267047 43593 79433519
Somogyi phenomenon 19.59 9.27 5 267271 6 79477106
Keratitis 19.37 9.27 44 267232 4278 79472834
Sprue-like enteropathy 19.37 9.27 23 267253 1295 79475817
Blood insulin abnormal 19.26 9.27 6 267270 21 79477091
Arrhythmia 19.08 9.27 300 266976 60972 79416140
Caesarean section 19.08 9.27 88 267188 12447 79464665
Liver transplant failure 18.89 9.27 9 267267 118 79476994
Arthritis 18.88 9.27 271 267005 114609 79362503
Distributive shock 18.86 9.27 33 267243 2654 79474458
Neoplasm progression 18.85 9.27 99 267177 51583 79425529
Throat irritation 18.80 9.27 72 267204 40874 79436238
Ventricular hyperkinesia 18.80 9.27 12 267264 287 79476825
Postprandial hypoglycaemia 18.79 9.27 8 267268 79 79477033
Toothache 18.78 9.27 123 267153 19847 79457265
Acute respiratory failure 18.72 9.27 292 266984 59249 79417863
Product monitoring error 18.67 9.27 69 267207 8837 79468275
Rhythm idioventricular 18.65 9.27 16 267260 608 79476504
Pyelonephritis fungal 18.62 9.27 11 267265 228 79476884
Glucose urine present 18.51 9.27 26 267250 1730 79475382
Autoimmune disorder 18.51 9.27 17 267259 16595 79460517
Pancreatic failure 18.51 9.27 25 267251 1603 79475509
Jaundice 18.47 9.27 266 267010 53083 79424029
Haematotoxicity 18.37 9.27 15 267261 15504 79461608
Oxygen saturation decreased 18.32 9.27 313 266963 128734 79348378
Ankylosing spondylitis 18.28 9.27 9 267267 12196 79464916
Urinary tract infection fungal 18.22 9.27 20 267256 1033 79476079
Immune reconstitution inflammatory syndrome 18.17 9.27 12 267264 13829 79463283
Biliary obstruction 18.15 9.27 45 267231 4629 79472483
Immunodeficiency 18.15 9.27 28 267248 21740 79455372
International normalised ratio increased 18.05 9.27 391 266885 84330 79392782
Anaphylactic shock 18.05 9.27 61 267215 35935 79441177
Blindness unilateral 17.83 9.27 64 267212 8082 79469030
Eye irritation 17.82 9.27 26 267250 20655 79456457
Acute graft versus host disease 17.66 9.27 6 267270 10161 79466951
Nephrogenic systemic fibrosis 17.61 9.27 53 267223 6107 79471005
Product dose omission issue 17.60 9.27 1006 266270 246531 79230581
Wheezing 17.53 9.27 280 266996 116384 79360728
Multiple-drug resistance 17.53 9.27 4 267272 8804 79468308
Urinary tract candidiasis 17.50 9.27 17 267259 760 79476352
Epileptic encephalopathy 17.49 9.27 14 267262 482 79476630
Cellulitis 17.43 9.27 484 266792 108576 79368536
Eosinophilic pneumonia 17.42 9.27 48 267228 5262 79471850
Body temperature increased 17.39 9.27 83 267193 44337 79432775
Mouth ulceration 17.32 9.27 68 267208 38326 79438786
Heavy menstrual bleeding 17.27 9.27 13 267263 13998 79463114
Panniculitis 17.24 9.27 10 267266 12361 79464751
Bundle branch block right 17.14 9.27 79 267197 11172 79465940
Acute myeloid leukaemia 17.14 9.27 50 267226 30835 79446277
Mitral valve thickening 17.12 9.27 13 267263 414 79476698
Colitis 17.08 9.27 160 267116 73147 79403965
Pulseless electrical activity 17.03 9.27 93 267183 14067 79463045
Insulin autoimmune syndrome 16.98 9.27 13 267263 419 79476693
Pulse pressure decreased 16.95 9.27 13 267263 420 79476692
Cystic fibrosis 16.84 9.27 39 267237 3841 79473271
Nephropathy 16.82 9.27 71 267205 9667 79467445
Full blood count abnormal 16.81 9.27 74 267202 40400 79436712
Joint stiffness 16.75 9.27 75 267201 40755 79436357
Lymphangiectasia 16.72 9.27 8 267268 106 79477006
Mania 16.70 9.27 22 267254 18238 79458874
Multiple organ dysfunction syndrome 16.60 9.27 524 266752 119722 79357390
ECG signs of myocardial ischaemia 16.59 9.27 12 267264 354 79476758
Adenovirus infection 16.49 9.27 4 267272 8443 79468669
Pyelonephritis 16.48 9.27 121 267155 20267 79456845
Immobilisation prolonged 16.39 9.27 8 267268 111 79477001
Left atrial dilatation 16.30 9.27 34 267242 3119 79473993
Vitrectomy 16.28 9.27 10 267266 223 79476889
Diet failure 16.25 9.27 6 267270 39 79477073
Drug dose omission by device 16.23 9.27 52 267224 6198 79470914
Acute graft versus host disease in skin 16.23 9.27 3 267273 7655 79469457
Visceral venous thrombosis 16.16 9.27 5 267271 17 79477095
Insulin C-peptide increased 15.95 9.27 8 267268 118 79476994
Expired product administered 15.95 9.27 56 267220 6995 79470117
Pancreatitis chronic 15.93 9.27 39 267237 3980 79473132
Tachypnoea 15.90 9.27 171 267105 31892 79445220
Product name confusion 15.88 9.27 9 267267 172 79476940
Eye infection staphylococcal 15.83 9.27 9 267267 173 79476939
Right atrial enlargement 15.78 9.27 12 267264 383 79476729
Peripheral venous disease 15.78 9.27 18 267258 15891 79461221
Enzyme inhibition 15.73 9.27 5 267271 19 79477093
Musculoskeletal disorder 15.67 9.27 30 267246 21418 79455694
Kidney transplant rejection 15.65 9.27 72 267204 10174 79466938
Retinal exudates 15.64 9.27 20 267256 1215 79475897
Arterial bypass operation 15.64 9.27 6 267270 44 79477068
Fracture blisters 15.62 9.27 7 267269 79 79477033
Retinopathy proliferative 15.55 9.27 8 267268 125 79476987
Blood glucose normal 15.53 9.27 5 267271 20 79477092
Flour sensitivity 15.53 9.27 5 267271 20 79477092
Diabetic bullosis 15.53 9.27 5 267271 20 79477092
Acute pulmonary oedema 15.49 9.27 91 267185 14139 79462973
Pruritus 15.49 9.27 1126 266150 393522 79083590
Conjunctivitis 15.49 9.27 40 267236 25675 79451437
Pain in extremity 15.47 9.27 1033 266243 363505 79113607
Cytokine release syndrome 15.45 9.27 65 267211 35933 79441179
Diabetic ulcer 15.38 9.27 10 267266 247 79476865
Patella fracture 15.35 9.27 25 267251 1896 79475216
Disease recurrence 15.25 9.27 86 267190 44023 79433089
Phimosis 15.24 9.27 14 267262 583 79476529
Guillain-Barre syndrome 15.20 9.27 65 267211 8900 79468212
Perinephric abscess 15.17 9.27 10 267266 253 79476859
Upper motor neurone lesion 15.07 9.27 10 267266 256 79476856
Coronary artery stenosis 15.02 9.27 82 267194 12402 79464710
Pyelocaliectasis 14.91 9.27 17 267259 916 79476196
Exposure to toxic agent 14.90 9.27 6 267270 9152 79467960
Skin pressure mark 14.88 9.27 7 267269 89 79477023
Paradoxical drug reaction 14.83 9.27 3 267273 7182 79469930
Laser therapy 14.80 9.27 5 267271 24 79477088
Aphthous ulcer 14.79 9.27 21 267255 16868 79460244
Facial nerve disorder 14.79 9.27 15 267261 707 79476405
Foetal macrosomia 14.78 9.27 4 267272 7 79477105
Hyperinsulinaemia 14.76 9.27 9 267267 198 79476914
Pulse absent 14.70 9.27 70 267206 10033 79467079
Hypoaesthesia 14.54 9.27 474 266802 178878 79298234
Blood ketone body present 14.48 9.27 7 267269 95 79477017
Sedation 14.48 9.27 108 267168 51787 79425325
Foetal hypokinesia 14.41 9.27 11 267265 353 79476759
Hepatic neoplasm 14.39 9.27 34 267242 3392 79473720
Unintentional medical device removal 14.39 9.27 4 267272 7708 79469404
Dyspepsia 14.35 9.27 267 267009 108420 79368692
Preternatural anus 14.28 9.27 7 267269 98 79477014
Polyarthritis 14.19 9.27 12 267264 12190 79464922
Haematuria 14.13 9.27 316 266960 68520 79408592
Immune-mediated myositis 14.12 9.27 34 267242 3433 79473679
Strangulated umbilical hernia 14.11 9.27 3 267273 0 79477112
Urethral abscess 14.11 9.27 3 267273 0 79477112
Penile prosthesis insertion 14.11 9.27 3 267273 0 79477112
Wrong drug 14.10 9.27 10 267266 286 79476826
Myelodysplastic syndrome 14.10 9.27 53 267223 30248 79446864
Osteopenia 14.03 9.27 25 267251 18339 79458773
Leukopenia 13.94 9.27 291 266985 116222 79360890
Device malfunction 13.90 9.27 121 267155 21327 79455785
Respiratory tract infection 13.74 9.27 101 267175 48588 79428524
Respiratory depression 13.73 9.27 47 267229 27583 79449529
Heart rate increased 13.72 9.27 304 266972 120420 79356692
Ureteric obstruction 13.71 9.27 29 267247 2687 79474425
Influenza like illness 13.67 9.27 164 267112 71543 79405569
Coronary artery occlusion 13.61 9.27 93 267183 15222 79461890
Oesophageal tuberculosis 13.56 9.27 4 267272 11 79477101
Mood swings 13.51 9.27 29 267247 19851 79457261
Pulmonary toxicity 13.48 9.27 14 267262 12900 79464212
Necrobiosis lipoidica diabeticorum 13.48 9.27 5 267271 33 79477079
Tooth disorder 13.47 9.27 44 267232 26189 79450923
Hypochromasia 13.42 9.27 14 267262 682 79476430
Breast cancer stage I 13.42 9.27 3 267273 6697 79470415
Hepatic steatosis 13.40 9.27 189 267087 37549 79439563
Optic discs blurred 13.36 9.27 6 267270 68 79477044
Ear discomfort 13.36 9.27 6 267270 8577 79468535
Blood creatinine abnormal 13.36 9.27 41 267235 4776 79472336
Heart rate decreased 13.34 9.27 161 267115 70155 79406957
Dermatitis papillaris capillitii 13.30 9.27 4 267272 12 79477100
Calciphylaxis 13.30 9.27 35 267241 3735 79473377
Haematoma muscle 13.29 9.27 28 267248 2587 79474525
Drug specific antibody present 13.28 9.27 3 267273 6649 79470463
Sleep disorder due to a general medical condition 13.26 9.27 17 267259 14260 79462852
Muscle spasticity 13.25 9.27 33 267243 21442 79455670
Polyhydramnios 13.23 9.27 22 267254 1698 79475414
Intestinal transit time abnormal 13.21 9.27 6 267270 70 79477042
End stage renal disease 13.21 9.27 78 267198 12142 79464970
Depression 13.15 9.27 593 266683 216197 79260915
Bradyarrhythmia 13.13 9.27 37 267239 4109 79473003
Pregnancy 13.13 9.27 46 267230 26805 79450307
Extrapyramidal disorder 13.11 9.27 36 267240 22643 79454469
Product temperature excursion issue 13.11 9.27 9 267267 244 79476868
Weight decreased 13.10 9.27 1371 265905 353827 79123285
Muscle necrosis 13.07 9.27 20 267256 1438 79475674
Glycogen storage disease type VIII 13.06 9.27 4 267272 13 79477099
Intraventricular haemorrhage 13 9.27 41 267235 4846 79472266
Radiation fibrosis 12.99 9.27 5 267271 37 79477075
Upper-airway cough syndrome 12.99 9.27 12 267264 11681 79465431
Eyelid bleeding 12.99 9.27 6 267270 73 79477039
Hypernatraemia 12.98 9.27 88 267188 14363 79462749
Left atrial enlargement 12.96 9.27 18 267258 1185 79475927
Hypophagia 12.96 9.27 219 267057 45148 79431964
Lymphadenopathy 12.94 9.27 115 267161 53132 79423980
Posterior reversible encephalopathy syndrome 12.87 9.27 45 267231 26236 79450876
Aggression 12.85 9.27 109 267167 50849 79426263
Haemodynamic instability 12.84 9.27 101 267175 17281 79459831
Muscle abscess 12.82 9.27 17 267259 1071 79476041
Acquired haemophilia 12.81 9.27 23 267253 1888 79475224
Blood chloride increased 12.58 9.27 42 267234 5114 79471998
Gastritis fungal 12.58 9.27 8 267268 190 79476922
Medullary thyroid cancer 12.55 9.27 9 267267 262 79476850
Epstein-Barr virus infection 12.55 9.27 18 267258 14398 79462714
Atrioventricular block complete 12.53 9.27 97 267179 16513 79460599
Pseudohyponatraemia 12.53 9.27 7 267269 130 79476982
Platelet count decreased 12.52 9.27 529 266747 194135 79282977
Disorientation 12.52 9.27 287 266989 62489 79414623
Total cholesterol/HDL ratio increased 12.49 9.27 9 267267 264 79476848
Progressive multifocal leukoencephalopathy 12.44 9.27 32 267244 20568 79456544
Open angle glaucoma 12.43 9.27 11 267265 436 79476676
Cortisol increased 12.42 9.27 12 267264 533 79476579
Glucose-6-phosphate dehydrogenase deficiency 12.40 9.27 10 267266 348 79476764
Poisoning deliberate 12.36 9.27 28 267248 18800 79458312
Morganella infection 12.35 9.27 17 267259 1110 79476002
Hypochromic anaemia 12.32 9.27 28 267248 2723 79474389
Dermatitis exfoliative 12.27 9.27 70 267206 10759 79466353
Tremor 12.23 9.27 692 266584 169391 79307721
Cytomegalovirus infection reactivation 12.21 9.27 7 267269 8709 79468403
Tendonitis 12.21 9.27 40 267236 23790 79453322
Cardiac ventricular disorder 12.21 9.27 10 267266 356 79476756
Device leakage 12.19 9.27 70 267206 10786 79466326
Gallbladder neoplasm 12.18 9.27 6 267270 85 79477027
Middle insomnia 12.16 9.27 22 267254 16047 79461065
Subcapsular renal haematoma 12.15 9.27 14 267262 763 79476349
Groin abscess 12.11 9.27 20 267256 1535 79475577
Non-proliferative retinopathy 12.04 9.27 3 267273 3 79477109
Suspected product tampering 12.04 9.27 3 267273 3 79477109
Hyperglycaemic seizure 12.04 9.27 3 267273 3 79477109
Cerebellar artery occlusion 12.04 9.27 3 267273 3 79477109
Fructosamine increased 12.04 9.27 3 267273 3 79477109
Needle issue 11.99 9.27 80 267196 12988 79464124
Scoliosis 11.97 9.27 5 267271 7459 79469653
Device dispensing error 11.94 9.27 7 267269 143 79476969
Chromoblastomycosis 11.88 9.27 6 267270 90 79477022
Osteomyelitis fungal 11.79 9.27 9 267267 289 79476823
Tumour rupture 11.78 9.27 11 267265 468 79476644
Meniscus injury 11.74 9.27 4 267272 6764 79470348
Ostectomy 11.71 9.27 4 267272 20 79477092
Eschar 11.70 9.27 18 267258 1300 79475812
Type 3 diabetes mellitus 11.69 9.27 5 267271 50 79477062
Proteinuria 11.63 9.27 163 267113 32339 79444773
Sudden death 11.61 9.27 121 267155 22390 79454722
Acral peeling skin syndrome 11.60 9.27 5 267271 51 79477061
Vessel puncture site inflammation 11.58 9.27 3 267273 4 79477108
Retroperitoneal oedema 11.55 9.27 4 267272 21 79477091
Amyloidosis 11.53 9.27 27 267249 2679 79474433
Pancreatic neoplasm 11.52 9.27 19 267257 1457 79475655
Obstructed labour 11.48 9.27 7 267269 154 79476958
Injection site warmth 11.45 9.27 20 267256 14787 79462325
Fasting 11.35 9.27 5 267271 54 79477058
Post transplant lymphoproliferative disorder 11.34 9.27 13 267263 11451 79465661
Diabetic eye disease 11.32 9.27 7 267269 158 79476954
Periodontitis 11.31 9.27 37 267239 4459 79472653
Low density lipoprotein increased 11.31 9.27 58 267218 8564 79468548
Extrasystoles 11.23 9.27 52 267224 7367 79469745
Fungal endocarditis 11.22 9.27 12 267264 602 79476510
Laryngeal leukoplakia 11.19 9.27 5 267271 56 79477056
Bronchiectasis 11.18 9.27 38 267238 22348 79454764
Cataract 11.17 9.27 280 266996 61840 79415272
Skin induration 11.17 9.27 37 267239 4488 79472624
Ulcer 11.16 9.27 57 267219 29915 79447197
Hemiplegia 11.14 9.27 87 267189 14852 79462260
Paralysis 11.11 9.27 79 267197 13098 79464014
Silent myocardial infarction 11.10 9.27 13 267263 721 79476391
Hyperlipidaemia 11.07 9.27 135 267141 25958 79451154
Anal fissure 11.06 9.27 6 267270 7697 79469415
Diabetic vascular disorder 11.06 9.27 6 267270 105 79477007
Exposure during pregnancy 11.04 9.27 429 266847 100703 79376409
Injury 11.03 9.27 339 266937 77157 79399955
Skin hypertrophy 11.03 9.27 39 267237 4889 79472223
Cholangitis 11.01 9.27 77 267199 12699 79464413
Blepharospasm 10.98 9.27 3 267273 5848 79471264
Metabolic encephalopathy 10.95 9.27 60 267216 9087 79468025
Fibromuscular dysplasia 10.95 9.27 8 267268 240 79476872
Thrombotic microangiopathy 10.94 9.27 33 267243 20136 79456976
Left ventricular enlargement 10.93 9.27 13 267263 733 79476379
Product prescribing error 10.93 9.27 211 267065 44602 79432510
Pancreatic pseudocyst 10.92 9.27 18 267258 1379 79475733
Albuminuria 10.89 9.27 13 267263 736 79476376
Diabetic microangiopathy 10.89 9.27 5 267271 60 79477052
Klebsiella infection 10.88 9.27 90 267186 15630 79461482
Metabolic disorder 10.87 9.27 60 267216 9110 79468002
Urine albumin/creatinine ratio 10.83 9.27 3 267273 6 79477106
Proctitis 10.82 9.27 4 267272 6428 79470684
Oesophageal carcinoma recurrent 10.81 9.27 5 267271 61 79477051
Depressed mood 10.79 9.27 107 267169 48373 79428739
Oesophageal varices haemorrhage 10.78 9.27 35 267241 4201 79472911
Pharyngitis streptococcal 10.76 9.27 12 267264 10702 79466410
Incision site pain 10.73 9.27 27 267249 2803 79474309
Pulmonary vasculitis 10.72 9.27 13 267263 748 79476364
Premature rupture of membranes 10.70 9.27 34 267242 4035 79473077
Tongue disorder 10.70 9.27 19 267257 13956 79463156
Oral candidiasis 10.66 9.27 57 267219 29571 79447541
Delusion 10.66 9.27 34 267242 20389 79456723
Candida sepsis 10.62 9.27 25 267251 2488 79474624
Ascites 10.62 9.27 330 266946 75232 79401880
Bladder irrigation 10.60 9.27 5 267271 64 79477048
Pancreatitis necrotising 10.59 9.27 33 267243 3875 79473237
Muscle spasms 10.58 9.27 478 266798 174252 79302860
Neuralgia 10.54 9.27 67 267209 33317 79443795
Intercepted product storage error 10.53 9.27 8 267268 255 79476857
Injection site swelling 10.50 9.27 104 267172 47028 79430084
Dysphonia 10.49 9.27 131 267145 56741 79420371
Pericarditis fungal 10.49 9.27 7 267269 181 79476931
Paraplegia 10.47 9.27 39 267237 5014 79472098
Parvimonas micra infection 10.46 9.27 4 267272 29 79477083
Tendon pain 10.43 9.27 3 267273 5655 79471457
Dermatitis contact 10.39 9.27 13 267263 11020 79466092
Arteriosclerosis 10.38 9.27 100 267176 18127 79458985
Hypertensive urgency 10.36 9.27 11 267265 547 79476565
Anaemia vitamin B12 deficiency 10.36 9.27 13 267263 775 79476337
Substance abuse 10.34 9.27 12 267264 10514 79466598
Exostosis 10.32 9.27 26 267250 16832 79460280
Gastrointestinal tract mucosal pigmentation 10.27 9.27 15 267261 1035 79476077
Ataxia 10.27 9.27 46 267230 24993 79452119
Choroidal effusion 10.26 9.27 12 267264 665 79476447
Infusion site erythema 10.17 9.27 10 267266 9450 79467662
Meningitis fungal 10.16 9.27 7 267269 191 79476921
Ectopic ACTH syndrome 10.09 9.27 7 267269 193 79476919
Product odour abnormal 10.08 9.27 17 267259 1327 79475785
Tooth infection 10.08 9.27 31 267245 18801 79458311
Chest pain 10.03 9.27 1087 266189 281217 79195895
Clostridium difficile infection 10.02 9.27 93 267183 42592 79434520
Glomerular filtration rate increased 10.01 9.27 16 267260 1195 79475917
Interstitial lung disease 9.99 9.27 294 266982 112306 79364806
Potentiating drug interaction 9.99 9.27 57 267219 8762 79468350
Fibrodysplasia ossificans progressiva 9.98 9.27 3 267273 9 79477103
Penile abscess 9.98 9.27 3 267273 9 79477103
Acanthosis nigricans 9.97 9.27 7 267269 197 79476915
Cryptococcosis 9.94 9.27 30 267246 3463 79473649
Hyperaesthesia 9.92 9.27 16 267260 12206 79464906
International normalised ratio abnormal 9.92 9.27 42 267234 5726 79471386
Appendicitis 9.92 9.27 36 267240 20758 79456354
Skin toxicity 9.88 9.27 8 267268 8306 79468806
Blood bicarbonate decreased 9.88 9.27 39 267237 5152 79471960
Osmotic demyelination syndrome 9.87 9.27 18 267258 1495 79475617
Accidental overdose 9.87 9.27 187 267089 39394 79437718
Ischaemic stroke 9.86 9.27 161 267115 32970 79444142
Graft versus host disease in skin 9.85 9.27 4 267272 6069 79471043
Injection site hypertrophy 9.84 9.27 5 267271 76 79477036
Renal abscess 9.81 9.27 15 267261 1078 79476034
Subgaleal haematoma 9.80 9.27 6 267270 133 79476979
Cerebral infarction 9.79 9.27 211 267065 45465 79431647
Poor quality sleep 9.77 9.27 41 267235 22681 79454431
Drug eruption 9.77 9.27 97 267179 43838 79433274
Cardioactive drug level increased 9.76 9.27 31 267245 3678 79473434
Spinal disorder 9.76 9.27 12 267264 10248 79466864
Nightmare 9.73 9.27 49 267227 25812 79451300
Rhinitis 9.73 9.27 22 267254 14785 79462327
Injection site mass 9.71 9.27 107 267169 20077 79457035
Intestinal haemorrhage 9.70 9.27 45 267231 6381 79470731
Second primary malignancy 9.70 9.27 21 267255 14329 79462783
Balanoposthitis 9.69 9.27 14 267262 956 79476156
Vesicoureteric reflux 9.68 9.27 6 267270 136 79476976
Clang associations 9.62 9.27 4 267272 37 79477075
Laryngitis 9.62 9.27 25 267251 16014 79461098
Leishmaniasis 9.59 9.27 9 267267 385 79476727
Hypogammaglobulinaemia 9.56 9.27 18 267258 12933 79464179
Device failure 9.56 9.27 44 267232 6217 79470895
Mean platelet volume increased 9.53 9.27 15 267261 1105 79476007
Seasonal allergy 9.52 9.27 26 267250 16380 79460732
Haemorrhagic transformation stroke 9.50 9.27 25 267251 2667 79474445
Large intestine polyp 9.47 9.27 74 267202 12634 79464478
Head injury 9.47 9.27 177 267099 37192 79439920
Normochromic normocytic anaemia 9.46 9.27 51 267225 7676 79469436
Ballismus 9.46 9.27 8 267268 298 79476814
Breath sounds 9.45 9.27 6 267270 142 79476970
Gestational hypertension 9.41 9.27 20 267256 1859 79475253
Illness 9.40 9.27 105 267171 46406 79430706
Haemofiltration 9.39 9.27 5 267271 84 79477028
Sciatica 9.33 9.27 69 267207 33153 79443959
Septic embolus 9.33 9.27 21 267255 2030 79475082
Blood pressure diastolic abnormal 9.32 9.27 33 267243 19169 79457943
Leukoencephalomyelitis 9.32 9.27 3 267273 12 79477100
Cortisol free urine decreased 9.32 9.27 3 267273 12 79477100
Pituitary-dependent Cushing's syndrome 9.32 9.27 3 267273 12 79477100
Hepatobiliary cancer 9.32 9.27 3 267273 12 79477100
Umbilical hernia, obstructive 9.32 9.27 3 267273 12 79477100
Enterococcal sepsis 9.30 9.27 25 267251 2701 79474411
Adrenomegaly 9.27 9.27 9 267267 402 79476710

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
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
118984375 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BASAGLAR KwikPen HUMAN PRESCRIPTION DRUG LABEL 1 0002-7715 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
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
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
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 HUMAN PRESCRIPTION DRUG LABEL 1 0024-5869 INJECTION, SOLUTION 300 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
TOUJEO Max HUMAN PRESCRIPTION DRUG LABEL 1 0024-5871 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 33 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 0088-2219 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 0088-2220 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 0088-2220 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 0088-5020 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 29 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 0088-5020 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 29 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
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 0088-5021 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 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
Insulin Glargine HUMAN PRESCRIPTION DRUG LABEL 1 0955-1729 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Insulin glargine U-300 Max HUMAN PRESCRIPTION DRUG LABEL 1 0955-2900 INJECTION, SOLUTION 300 [iU] SUBCUTANEOUS BLA 33 sections
Insulin glargine U-300 HUMAN PRESCRIPTION DRUG LABEL 1 0955-3900 INJECTION, SOLUTION 300 [iU] SUBCUTANEOUS BLA 33 sections