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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

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 5994.68 9.57 3235 187019 92011 90346182
Hypoglycaemia 4187.44 9.57 2299 187955 67549 90370644
Diabetic ketoacidosis 2244.79 9.57 1073 189181 23334 90414859
Diabetes mellitus inadequate control 1551.11 9.57 766 189488 17918 90420275
Blood glucose decreased 1395.93 9.57 769 189485 22660 90415533
Hyperglycaemia 1386.76 9.57 1019 189235 49951 90388242
Glycosylated haemoglobin increased 1036.30 9.57 550 189704 15012 90423181
Blood glucose abnormal 895.88 9.57 425 189829 9067 90429126
Acute kidney injury 673.84 9.57 1826 188428 318561 90119632
Device operational issue 670.85 9.57 191 190063 819 90437374
Lactic acidosis 654.15 9.57 660 189594 49803 90388390
Systemic lupus erythematosus 650.79 9.57 25 190229 361871 90076322
Product storage error 647.83 9.57 447 189807 19794 90418399
Ketoacidosis 629.44 9.57 283 189971 5312 90432881
Pemphigus 626.82 9.57 12 190242 326852 90111341
Blood glucose fluctuation 606.74 9.57 268 189986 4815 90433378
Glossodynia 593.39 9.57 18 190236 321761 90116432
Hand deformity 580.31 9.57 8 190246 296354 90141839
Synovitis 533.66 9.57 42 190212 329710 90108483
Infusion related reaction 522.04 9.57 118 190136 416662 90021531
Anti-cyclic citrullinated peptide antibody positive 468.98 9.57 5 190249 236428 90201765
Contraindicated product administered 446.96 9.57 69 190185 320070 90118123
Treatment failure 432.37 9.57 62 190192 303866 90134327
Arthropathy 425.21 9.57 121 190133 366121 90072072
Hypoglycaemic coma 417.07 9.57 176 190078 2814 90435379
Joint swelling 414.38 9.57 274 189980 503026 89935167
Hyperkalaemia 412.56 9.57 591 189663 64373 90373820
Cerebrovascular accident 409.83 9.57 842 189412 122691 90315502
Alopecia 402.89 9.57 273 189981 494798 89943395
Pericarditis 398.84 9.57 49 190205 270102 90168091
Folliculitis 397.85 9.57 6 190248 204347 90233846
Device issue 385.79 9.57 388 189866 29149 90409044
Helicobacter infection 384.06 9.57 23 190231 226827 90211366
Diabetic retinopathy 356.84 9.57 153 190101 2549 90435644
Renal failure 356.01 9.57 824 189430 130183 90308010
Drug intolerance 354.59 9.57 254 190000 447337 89990856
Irritable bowel syndrome 342.37 9.57 24 190230 207424 90230769
Rheumatoid factor positive 334.29 9.57 5 190249 171645 90266548
Hepatic enzyme increased 325.35 9.57 176 190078 360560 90077633
Muscle injury 325.06 9.57 10 190244 176644 90261549
Discomfort 303.18 9.57 99 190155 274236 90163957
Psoriatic arthropathy 297.21 9.57 59 190195 228276 90209917
Swelling 294.16 9.57 268 189986 418790 90019403
Wound 294.01 9.57 134 190120 302846 90135347
Abdominal discomfort 291.40 9.57 344 189910 476984 89961209
Gangrene 283.19 9.57 227 190027 12649 90425544
Inappropriate schedule of product administration 281.55 9.57 821 189433 149112 90289081
Cardiac failure congestive 279.40 9.57 631 189623 98063 90340130
Device mechanical issue 273.40 9.57 99 190155 1024 90437169
Musculoskeletal stiffness 261.05 9.57 149 190105 296383 90141810
Stomatitis 259.56 9.57 126 190128 274572 90163621
Sleep disorder due to general medical condition, insomnia type 249.50 9.57 4 190250 128690 90309503
Arterial occlusive disease 245.58 9.57 206 190048 12240 90425953
Myocardial infarction 243.51 9.57 625 189629 105347 90332846
Fibromyalgia 241.34 9.57 67 190187 206202 90231991
Drug hypersensitivity 236.80 9.57 380 189874 463229 89974964
Dehydration 221.21 9.57 901 189353 193546 90244647
Therapeutic product effect decreased 220.28 9.57 157 190097 277414 90160779
Hypersensitivity 218.07 9.57 388 189866 454289 89983904
Impaired healing 209.95 9.57 115 190139 234084 90204109
C-reactive protein abnormal 209.46 9.57 15 190239 127414 90310779
Ill-defined disorder 209.06 9.57 64 190190 184827 90253366
Diabetic metabolic decompensation 204.38 9.57 94 190160 1863 90436330
Liver injury 202.16 9.57 54 190200 170513 90267680
Therapeutic product effect incomplete 202.11 9.57 77 190177 193819 90244374
Bursitis 201.43 9.57 21 190233 131633 90306560
Joint range of motion decreased 199.11 9.57 25 190229 135618 90302575
Blister 192.34 9.57 152 190102 254846 90183347
Angina pectoris 191.84 9.57 316 189938 38844 90399349
Type 2 diabetes mellitus 190.76 9.57 94 190160 203150 90235043
Rash 189.43 9.57 944 189310 795156 89643037
Lip dry 188.31 9.57 5 190249 100950 90337243
Carotid artery thrombosis 184.60 9.57 153 190101 8939 90429254
Euglycaemic diabetic ketoacidosis 182.21 9.57 130 190124 6071 90432122
Hemiplegia 180.02 9.57 195 190059 15965 90422228
Neurologic neglect syndrome 179.88 9.57 149 190105 8698 90429495
Hypoglycaemic unconsciousness 176.87 9.57 66 190188 748 90437445
Blood cholesterol increased 172.56 9.57 112 190142 207900 90230293
Cataract 165.37 9.57 425 189829 71667 90366526
Adjustment disorder 164.74 9.57 147 190107 9495 90428698
Mobility decreased 163.43 9.57 171 190083 250563 90187630
Incorrect dose administered 155.61 9.57 440 189814 78490 90359703
Off label use 155.57 9.57 1523 188731 1100729 89337464
Intentional product use issue 155.25 9.57 136 190118 216756 90221437
Sleep disorder 154.46 9.57 114 190140 197916 90240277
Incorrect dose administered by device 154.31 9.57 114 190140 5623 90432570
Multi-organ disorder 152.79 9.57 80 190174 2120 90436073
Product dispensing error 147.15 9.57 154 190100 12119 90426074
Night sweats 144.77 9.57 45 190209 128721 90309472
Diabetes mellitus 143.20 9.57 377 189877 64498 90373695
Eye haemorrhage 142.68 9.57 139 190115 10041 90428152
Coordination abnormal 142.48 9.57 199 190055 21157 90417036
Metabolic acidosis 142.21 9.57 342 189912 55334 90382859
Loss of consciousness 140.20 9.57 625 189629 139613 90298580
Sensory loss 139.79 9.57 181 190073 17894 90420299
Grip strength decreased 138.47 9.57 16 190238 92560 90345633
Personality disorder 138.33 9.57 150 190104 12294 90425899
Skin haemorrhage 137.86 9.57 196 190058 21184 90417009
Wrong product administered 137.23 9.57 120 190134 7545 90430648
Product use in unapproved indication 137.10 9.57 315 189939 335921 90102272
Drug ineffective 134.29 9.57 2074 188180 1382224 89055969
Deep vein thrombosis postoperative 133.99 9.57 3 190251 70806 90367387
Respiratory syncytial virus test positive 133.45 9.57 58 190196 1000 90437193
Diabetic neuropathy 132.35 9.57 95 190159 4479 90433714
Arthralgia 131.64 9.57 1026 189228 777496 89660697
Infection 130.75 9.57 361 189893 361733 90076460
Pulmonary fibrosis 129.33 9.57 33 190221 107470 90330723
Fall 129.07 9.57 1562 188692 480248 89957945
Hemiparesis 128.75 9.57 236 190018 31583 90406610
Renal impairment 128.22 9.57 499 189755 104922 90333271
Wheezing 127.26 9.57 189 190065 237891 90200302
Peripheral venous disease 126.79 9.57 14 190240 83907 90354286
Pain 126.41 9.57 1411 188843 994930 89443263
Device malfunction 126.07 9.57 186 190068 20791 90417402
Motor dysfunction 123.56 9.57 176 190078 19054 90419139
Device defective 123.48 9.57 82 190172 3404 90434789
Prescribed overdose 123.30 9.57 27 190227 97598 90340595
Coronary artery disease 123.16 9.57 239 190015 33384 90404809
Blindness 120.30 9.57 207 190047 26361 90411832
Migraine 119.43 9.57 134 190120 190258 90247935
Rhabdomyolysis 117.37 9.57 302 189952 50954 90387239
Osteoarthritis 117.15 9.57 143 190111 195587 90242606
Wound infection 116.39 9.57 39 190215 106363 90331830
Aphasia 115.86 9.57 269 189985 42543 90395650
Chronic kidney disease 114.18 9.57 295 189959 49896 90388297
Peripheral swelling 113.46 9.57 464 189790 412642 90025551
Insulin resistance 112.78 9.57 53 190201 1105 90437088
Inflammation 112.78 9.57 125 190129 178467 90259726
Pulmonary oedema 112.66 9.57 336 189918 61744 90376449
Eating disorder 112.05 9.57 207 190047 27866 90410327
Nasopharyngitis 111.97 9.57 457 189797 406647 90031546
Injury associated with device 111.81 9.57 85 190169 4379 90433814
Dysarthria 111.59 9.57 308 189946 54174 90384019
Accidental underdose 109.56 9.57 51 190203 1040 90437153
Lower respiratory tract infection 106.92 9.57 229 190025 250430 90187763
Affect lability 106.88 9.57 159 190095 17904 90420289
Autoimmune disorder 103.71 9.57 18 190236 76726 90361467
Dry mouth 103.41 9.57 141 190113 183918 90254275
Pancreatitis 103.06 9.57 352 189902 69474 90368719
Hip arthroplasty 102.71 9.57 18 190236 76190 90362003
Blepharospasm 102.45 9.57 3 190251 55442 90382751
C-reactive protein increased 101.86 9.57 139 190115 181250 90256943
Pharyngitis 100.69 9.57 172 190082 21775 90416418
Product administration error 99.44 9.57 190 190064 26233 90411960
Pancreatic carcinoma 98.45 9.57 104 190150 8273 90429920
Urticaria 98.43 9.57 332 189922 312402 90125791
Cardiac arrest 97.66 9.57 458 189796 104477 90333716
Hypercholesterolaemia 97.17 9.57 45 190209 100847 90337346
Toothache 96.48 9.57 170 190084 22060 90416133
Wrong technique in device usage process 93.87 9.57 86 190168 5749 90432444
Injection site pain 93.51 9.57 655 189599 173044 90265149
Human rhinovirus test positive 93.13 9.57 43 190211 860 90437333
Rheumatoid arthritis 92.37 9.57 419 189835 362195 90075998
Hypoglycaemic seizure 91.80 9.57 37 190217 523 90437670
Sinusitis 90.67 9.57 391 189863 342697 90095496
Respiratory failure 88.55 9.57 486 189768 117932 90320261
Sneezing 86.73 9.57 193 190061 29676 90408517
Hypoglycaemic encephalopathy 86.54 9.57 31 190223 310 90437883
Asthma 86.18 9.57 243 190011 241917 90196276
Red blood cell sedimentation rate increased 85.69 9.57 33 190221 82562 90355631
Bone erosion 84.97 9.57 7 190247 53014 90385179
Musculoskeletal pain 84.80 9.57 143 190111 171108 90267085
Blood creatinine increased 84.66 9.57 429 189825 100957 90337236
Diabetic complication 84.02 9.57 41 190213 932 90437261
Respiratory tract congestion 82.86 9.57 180 190074 27230 90410963
X-ray abnormal 82.00 9.57 3 190251 45421 90392772
Diabetic coma 81.77 9.57 37 190217 705 90437488
Hyperinsulinaemic hypoglycaemia 81.46 9.57 24 190230 119 90438074
Premature delivery 81.23 9.57 221 190033 38541 90399652
Injury 81.09 9.57 184 190070 197165 90241028
Urinary tract infection 80.02 9.57 987 189267 304645 90133548
Hypoglycaemia unawareness 79.97 9.57 23 190231 103 90438090
Injection site haemorrhage 78.90 9.57 180 190074 28138 90410055
Anaemia 78.90 9.57 1107 189147 351695 90086498
Sciatica 78.20 9.57 59 190195 101323 90336870
Dialysis 77.72 9.57 107 190147 11222 90426971
Anti-insulin antibody positive 77.70 9.57 22 190232 92 90438101
Sinus congestion 77.17 9.57 175 190079 27249 90410944
Shock 76.97 9.57 180 190074 28598 90409595
Maternal exposure during pregnancy 75.90 9.57 444 189810 359619 90078574
Visual acuity reduced 75.69 9.57 158 190096 23252 90414941
Product use issue 75.45 9.57 396 189858 329523 90108670
Nail disorder 75.27 9.57 16 190238 59051 90379142
Peritonitis bacterial 75.09 9.57 72 190182 5099 90433094
Loss of personal independence in daily activities 74.70 9.57 106 190148 135999 90302194
Fatigue 74.61 9.57 1850 188404 1152173 89286020
Sepsis 73.97 9.57 637 189617 179177 90259016
Viral test positive 73.84 9.57 33 190221 610 90437583
Acute myocardial infarction 73.19 9.57 199 190055 34691 90403502
Malnutrition 73.01 9.57 136 190118 18422 90419771
Knee arthroplasty 72.82 9.57 42 190212 83140 90355053
Dyspepsia 72.62 9.57 196 190058 197964 90240229
Drug interaction 72.45 9.57 893 189361 275560 90162633
Fear 71.98 9.57 127 190127 16495 90421698
Wrong technique in product usage process 71.50 9.57 319 189935 71252 90366941
Foot deformity 70.43 9.57 19 190235 59632 90378561
Pancreatitis acute 70.21 9.57 186 190068 31929 90406264
Type 1 diabetes mellitus 69.87 9.57 67 190187 4745 90433448
Contusion 69.00 9.57 282 189972 250934 90187259
Therapy non-responder 68.74 9.57 113 190141 136591 90301602
Sopor 67.95 9.57 156 190098 24488 90413705
Diabetic nephropathy 66.82 9.57 43 190211 1691 90436502
Taste disorder 66.54 9.57 23 190231 61523 90376670
Obesity 66.42 9.57 74 190180 105433 90332760
Gastrooesophageal reflux disease 65.99 9.57 158 190096 166179 90272014
Liver function test increased 65.93 9.57 49 190205 84806 90353387
Insomnia 65.68 9.57 420 189834 333054 90105139
Palpitations 65.22 9.57 501 189753 136227 90301966
Hypoglycaemia neonatal 64.52 9.57 36 190218 1086 90437107
Live birth 63.67 9.57 44 190210 79063 90359130
Cystitis 63.39 9.57 293 189961 66425 90371768
Sinus disorder 63.02 9.57 187 190067 34260 90403933
Cardiac failure 62.52 9.57 419 189835 109077 90329116
Mental status changes 62.25 9.57 221 190033 44458 90393735
Diabetic foot 61.75 9.57 40 190214 1591 90436602
Myelosuppression 61.54 9.57 18 190236 53573 90384620
Vitreous haemorrhage 61.40 9.57 48 190206 2578 90435615
Ketosis 60.74 9.57 31 190223 778 90437415
Product dose omission issue 59.93 9.57 902 189352 290785 90147408
Exostosis 58.94 9.57 19 190235 53115 90385078
Unresponsive to stimuli 58.74 9.57 195 190059 37926 90400267
Visual impairment 58.73 9.57 477 189777 131888 90306305
Joint stiffness 58.18 9.57 47 190207 77995 90360198
Adverse event 58.16 9.57 98 190156 117320 90320873
Renal injury 57.52 9.57 88 190166 10155 90428038
Vomiting 57.35 9.57 2107 188147 786186 89652007
Road traffic accident 56.92 9.57 86 190168 107540 90330653
Colitis ulcerative 56.31 9.57 28 190226 60238 90377955
Anuria 56.31 9.57 107 190147 14711 90423482
Blood urea increased 55.54 9.57 165 190089 30248 90407945
Frequent bowel movements 55.43 9.57 25 190229 56910 90381283
Mouth haemorrhage 54.90 9.57 78 190176 8423 90429770
Laryngitis 54.81 9.57 19 190235 50734 90387459
Onychomycosis 54.56 9.57 7 190247 37369 90400824
Angina unstable 54.41 9.57 71 190183 7072 90431121
Conjoined twins 53.92 9.57 25 190229 505 90437688
Lung disorder 53.60 9.57 150 190104 149733 90288460
Multiple organ dysfunction syndrome 53.47 9.57 284 189970 68052 90370141
Lupus-like syndrome 53.24 9.57 18 190236 48828 90389365
Paraesthesia 52.54 9.57 309 189945 250017 90188176
Skin exfoliation 52.29 9.57 281 189973 67632 90370561
Drug tolerance decreased 52.16 9.57 4 190250 32126 90406067
Thyroid disorder 51.73 9.57 115 190139 17670 90420523
Increased insulin requirement 50.97 9.57 15 190239 74 90438119
Multiple use of single-use product 50.78 9.57 37 190217 1786 90436407
Urosepsis 50.57 9.57 127 190127 21105 90417088
Product dispensing issue 50.41 9.57 23 190231 447 90437746
Prescribed underdose 50.15 9.57 50 190204 74969 90363224
Pneumonia haemophilus 49.99 9.57 34 190220 1469 90436724
Tongue biting 49.89 9.57 39 190215 2094 90436099
Febrile neutropenia 49.84 9.57 168 190086 158181 90280012
Back injury 49.41 9.57 18 190236 46604 90391589
Generalised oedema 48.60 9.57 117 190137 18936 90419257
Intestinal malrotation 48.39 9.57 22 190232 424 90437769
Drug administered in wrong device 47.62 9.57 13 190241 46 90438147
Hypotension 47.28 9.57 952 189302 324445 90113748
Device use issue 47.05 9.57 48 190206 3665 90434528
Infective pulmonary exacerbation of cystic fibrosis 46.41 9.57 80 190174 10199 90427994
Non-cardiogenic pulmonary oedema 46.30 9.57 30 190224 1194 90436999
Blood ketone body increased 46.22 9.57 20 190234 341 90437852
Finger deformity 46.05 9.57 7 190247 32890 90405303
Premature baby 45.74 9.57 136 190118 24941 90413252
Adverse drug reaction 45.37 9.57 112 190142 116589 90321604
Diabetic ketoacidotic hyperglycaemic coma 44.88 9.57 13 190241 60 90438133
Glycosylated haemoglobin abnormal 44.75 9.57 18 190236 253 90437940
Haemodialysis 44.75 9.57 72 190182 8675 90429518
Exposure during pregnancy 44.30 9.57 725 189529 237685 90200508
Caesarean section 44.12 9.57 111 190143 18466 90419727
Expired product administered 43.95 9.57 63 190191 6859 90431334
Lower limb fracture 43.93 9.57 69 190185 84944 90353249
Gastrointestinal haemorrhage 43.76 9.57 332 189922 89916 90348277
Immunodeficiency 43.65 9.57 18 190236 43216 90394977
Systemic infection 43.63 9.57 52 190202 4723 90433470
Hyperglycaemic hyperosmolar nonketotic syndrome 43.24 9.57 30 190224 1339 90436854
Blood potassium increased 43.17 9.57 118 190136 20631 90417562
Device expulsion 42.97 9.57 16 190238 40870 90397323
Ear infection 42.76 9.57 50 190204 69725 90368468
Polyuria 42.56 9.57 76 190178 9964 90428229
Foetal exposure during pregnancy 42.51 9.57 191 190063 42784 90395409
Hypertension 42.46 9.57 690 189564 456842 89981351
Heparin-induced thrombocytopenia 42.34 9.57 54 190200 5258 90432935
Osteoporosis 42.12 9.57 87 190167 96444 90341749
Hypoaesthesia 42.00 9.57 439 189815 313771 90124422
Asthenia 41.77 9.57 1439 188815 532312 89905881
International normalised ratio increased 41.46 9.57 203 190051 47113 90391080
Hypervolaemia 41.40 9.57 157 190097 32600 90405593
White blood cell count decreased 41.36 9.57 195 190059 166914 90271279
Transient ischaemic attack 41.29 9.57 190 190064 42986 90395207
Pre-eclampsia 41.02 9.57 79 190175 10969 90427224
Coma 40.89 9.57 277 189977 72355 90365838
Diabetic gastroparesis 40.56 9.57 18 190236 327 90437866
Pemphigoid 40.43 9.57 70 190184 8956 90429237
Bradycardia 40.39 9.57 308 189946 83539 90354654
Epilepsy 40.35 9.57 69 190185 82137 90356056
Product complaint 40.06 9.57 88 190166 13412 90424781
Cholestasis 39.47 9.57 166 190088 36133 90402060
Large for dates baby 39.29 9.57 20 190234 499 90437694
Left ventricular hypertrophy 39.13 9.57 56 190198 6088 90432105
Injection site reaction 38.50 9.57 85 190169 91995 90346198
Cardiac disorder 38.28 9.57 227 190027 56645 90381548
Retinopathy 38.24 9.57 42 190212 3492 90434701
Muscle spasticity 38.00 9.57 161 190093 35161 90403032
Glycosylated haemoglobin decreased 37.80 9.57 21 190233 628 90437565
Disease progression 37.45 9.57 185 190069 156430 90281763
Impaired gastric emptying 37.45 9.57 83 190171 12726 90425467
Glomerular filtration rate decreased 36.94 9.57 98 190156 16834 90421359
Joint dislocation 36.94 9.57 24 190230 44558 90393635
Congenital bladder anomaly 36.84 9.57 15 190239 218 90437975
Emphysematous pyelonephritis 36.77 9.57 17 190237 341 90437852
Dysphagia 36.77 9.57 379 189875 111899 90326294
Product label confusion 36.66 9.57 3 190251 22847 90415346
Coronary artery occlusion 36.58 9.57 65 190189 8489 90429704
Syncope 36.22 9.57 432 189822 132231 90305962
Adverse reaction 35.96 9.57 9 190245 29703 90408490
Blindness transient 35.92 9.57 46 190208 4497 90433696
Crystal nephropathy 35.83 9.57 25 190229 1126 90437067
Anti-insulin antibody increased 35.48 9.57 10 190244 41 90438152
Myocardial ischaemia 35.42 9.57 85 190169 13729 90424464
Ischaemic cardiomyopathy 35.35 9.57 35 190219 2578 90435615
Treatment noncompliance 35.16 9.57 207 190047 51520 90386673
Neck pain 35.12 9.57 122 190132 113841 90324352
Glycosuria 35.11 9.57 27 190227 1415 90436778
Nausea 35.08 9.57 2744 187510 1107572 89330621
Shock hypoglycaemic 34.81 9.57 12 190242 106 90438087
Polyhydramnios 34.69 9.57 34 190220 2474 90435719
Gastrointestinal disorder 34.55 9.57 358 189896 256329 90181864
Sleep disorder due to a general medical condition 34.54 9.57 26 190228 44712 90393481
Blood pressure increased 34.52 9.57 594 189660 196623 90241570
Ketonuria 34.19 9.57 21 190233 760 90437433
Renal tubular necrosis 33.56 9.57 86 190168 14469 90423724
Adenocarcinoma pancreas 33.05 9.57 24 190230 1152 90437041
Urachal abnormality 32.99 9.57 14 190240 227 90437966
Diabetic hyperglycaemic coma 32.94 9.57 9 190245 32 90438161
Delirium 32.64 9.57 111 190143 104248 90333945
Ear pain 32.59 9.57 44 190210 57658 90380535
Malignant neoplasm progression 32.53 9.57 115 190139 106755 90331438
Hypertriglyceridaemia 32.52 9.57 59 190195 7830 90430363
Blood triglycerides increased 32.45 9.57 82 190172 13679 90424514
Keratitis 32.36 9.57 41 190213 3965 90434228
Fibromuscular dysplasia 32.35 9.57 15 190239 303 90437890
Toe amputation 32.32 9.57 30 190224 2039 90436154
Persistent cloaca 32.28 9.57 14 190240 240 90437953
Pericardial effusion 32.25 9.57 158 190096 36675 90401518
Retinal haemorrhage 31.64 9.57 49 190205 5715 90432478
Dementia 31.51 9.57 116 190138 23745 90414448
Hypovolaemia 31.34 9.57 76 190178 12355 90425838
Hepatic steatosis 31.29 9.57 157 190097 36788 90401405
Chronic sinusitis 31.25 9.57 6 190248 23796 90414397
Pyelonephritis 31.04 9.57 107 190147 21209 90416984
Encephalopathy 31.01 9.57 185 190069 46259 90391934
Injection site bruising 30.96 9.57 202 190052 52105 90386088
Leukocytosis 30.85 9.57 138 190116 30852 90407341
Food allergy 30.29 9.57 8 190246 25470 90412723
Cutaneous amyloidosis 29.99 9.57 7 190247 10 90438183
Drug ineffective for unapproved indication 29.98 9.57 59 190195 66585 90371608
Device interaction 29.97 9.57 13 190241 223 90437970
Cardio-respiratory arrest 29.89 9.57 231 190023 62909 90375284
Atrial fibrillation 29.30 9.57 418 189836 133193 90305000
Urine ketone body present 28.78 9.57 31 190223 2521 90435672
Pancreatic carcinoma metastatic 28.69 9.57 30 190224 2358 90435835
Glucose urine present 28.60 9.57 20 190234 904 90437289
Tongue injury 28.58 9.57 17 190237 580 90437613
Hyperhidrosis 28.54 9.57 423 189831 135882 90302311
Electrolyte imbalance 28.53 9.57 112 190142 23633 90414560
Drug-induced liver injury 28.29 9.57 96 190158 90222 90347971
Ulcer haemorrhage 28.17 9.57 10 190244 26311 90411882
Blood creatinine abnormal 28.12 9.57 39 190215 4118 90434075
Angiopathy 27.89 9.57 45 190209 5435 90432758
Anhedonia 27.88 9.57 69 190185 11362 90426831
Bradycardia neonatal 27.79 9.57 21 190233 1072 90437121
Peripheral vascular disorder 27.67 9.57 49 190205 6382 90431811
Liver disorder 27.43 9.57 146 190108 121123 90317070
Diabetic hepatopathy 27.38 9.57 6 190248 5 90438188
Blood insulin increased 27.32 9.57 11 190243 155 90438038
Coeliac disease 27.30 9.57 32 190222 44578 90393615
Low birth weight baby 27.29 9.57 61 190193 9406 90428787
Oedema peripheral 27.03 9.57 721 189533 257194 90180999
Haematoma 27.02 9.57 157 190097 38891 90399302
Arteriosclerosis 26.99 9.57 66 190188 10787 90427406
Pruritus 26.97 9.57 899 189355 540626 89897567
Cellulitis 26.97 9.57 302 189952 91035 90347158
Walking aid user 26.94 9.57 21 190233 35485 90402708
Diabetic ketosis 26.92 9.57 16 190238 545 90437648
Tremor 26.67 9.57 461 189793 152712 90285481
Rheumatoid nodule 26.66 9.57 5 190249 20161 90418032
Peritoneal dialysis complication 26.62 9.57 22 190232 1280 90436913
Disorientation 26.50 9.57 171 190083 43943 90394250
Musculoskeletal toxicity 26.28 9.57 16 190238 570 90437623
Neutropenia 26.20 9.57 324 189930 224580 90213613
Chest discomfort 26.14 9.57 422 189832 137943 90300250
Acute coronary syndrome 26.09 9.57 65 190189 10748 90427445
Blindness unilateral 25.93 9.57 53 190201 7683 90430510
Endocarditis enterococcal 25.68 9.57 12 190242 247 90437946
Chest wall mass 25.54 9.57 16 190238 600 90437593
Depressed level of consciousness 25.42 9.57 249 190005 72535 90365658
Erythrodermic psoriasis 25.39 9.57 20 190234 1086 90437107
Hypothermia 25.19 9.57 81 190173 15494 90422699
Sedation complication 25.15 9.57 3 190251 16941 90421252
Emotional distress 25.10 9.57 147 190107 36515 90401678
Acidosis 25.08 9.57 71 190183 12665 90425528
Scan abnormal 25.05 9.57 16 190238 621 90437572
Blood creatine phosphokinase increased 24.99 9.57 139 190115 33884 90404309
Anti-insulin antibody 24.97 9.57 7 190247 28 90438165
Oliguria 24.73 9.57 63 190191 10561 90427632
Blood albumin abnormal 24.72 9.57 20 190234 1129 90437064
Atrioventricular block first degree 24.71 9.57 55 190199 8456 90429737
Oedema 24.69 9.57 285 189969 200010 90238183
Altered state of consciousness 24.63 9.57 131 190123 31401 90406792
Renal disorder 24.13 9.57 149 190105 37710 90400483
Diabetic gangrene 24.12 9.57 6 190248 13 90438180
Bone density decreased 23.58 9.57 4 190250 17341 90420852
Facial nerve disorder 23.31 9.57 15 190239 590 90437603
Maternal exposure timing unspecified 23.29 9.57 9 190245 22474 90415719
Muscle spasms 23.28 9.57 380 189874 251503 90186690
Polydipsia 23.27 9.57 36 190218 4195 90433998
Muscle necrosis 23.21 9.57 17 190237 827 90437366
Influenza like illness 23.10 9.57 265 189989 80346 90357847
Product odour abnormal 23.05 9.57 22 190232 1549 90436644
Myalgia 23.01 9.57 505 189749 174620 90263573
International normalised ratio abnormal 22.97 9.57 34 190220 3811 90434382
Mitral valve replacement 22.94 9.57 14 190240 501 90437692
Tachypnoea 22.82 9.57 97 190157 21212 90416981
Nephrogenic systemic fibrosis 22.65 9.57 35 190219 4073 90434120
Device dispensing error 22.57 9.57 10 190244 181 90438012
Ischaemic stroke 22.28 9.57 99 190155 22067 90416126
Loose tooth 22.22 9.57 33 190221 3710 90434483
Caudal regression syndrome 22.17 9.57 10 190244 189 90438004
Exposure to allergen 22.09 9.57 14 190240 536 90437657
Acute respiratory failure 22.00 9.57 160 190094 42758 90395435
Immobilisation prolonged 21.78 9.57 9 190245 136 90438057
Transient tachypnoea of the newborn 21.78 9.57 9 190245 136 90438057
Pustular psoriasis 21.73 9.57 6 190248 18550 90419643
Insulin C-peptide decreased 21.60 9.57 7 190247 50 90438143
Hypertensive crisis 21.46 9.57 84 190170 17700 90420493
Liquid product physical issue 21.41 9.57 21 190233 1529 90436664
Sprue-like enteropathy 21.38 9.57 17 190237 936 90437257
Anti-GAD antibody positive 21.25 9.57 7 190247 53 90438140
Gastrointestinal tract mucosal pigmentation 21.14 9.57 15 190239 694 90437499
Hyperlactacidaemia 21.10 9.57 34 190220 4102 90434091
Infected dermal cyst 21.08 9.57 13 190241 474 90437719
Drug abuse 21.01 9.57 95 190159 82252 90355941
Device leakage 20.96 9.57 57 190197 9934 90428259
Hepatic failure 20.88 9.57 149 190105 39579 90398614
Neonatal respiratory distress syndrome 20.84 9.57 29 190225 3072 90435121
General symptom 20.81 9.57 3 190251 14665 90423528
Device delivery system issue 20.76 9.57 22 190232 1756 90436437
Diabetic microangiopathy 20.71 9.57 5 190249 9 90438184
Neonatal seizure 20.62 9.57 14 190240 603 90437590
Leg amputation 20.62 9.57 25 190229 2312 90435881
Retinopathy proliferative 20.39 9.57 7 190247 61 90438132
Hip fracture 20.35 9.57 129 190125 32948 90405245
Somnolence 20.35 9.57 579 189675 208505 90229688
Pancreatic failure 20.21 9.57 20 190234 1472 90436721
Hypophagia 20.19 9.57 137 190117 35800 90402393
Drug dose omission by device 20.12 9.57 57 190197 10174 90428019
Microphthalmos 20.11 9.57 9 190245 167 90438026
Retinal coloboma 20.00 9.57 6 190248 32 90438161
Pruritus genital 19.96 9.57 35 190219 4523 90433670
Diabetic foot infection 19.96 9.57 10 190244 241 90437952
Cold sweat 19.91 9.57 70 190184 14011 90424182
Radiculopathy 19.85 9.57 7 190247 18498 90419695
Respiratory distress 19.85 9.57 145 190109 38801 90399392
Therapeutic drug monitoring analysis incorrectly performed 19.77 9.57 11 190243 330 90437863
Apgar score abnormal 19.75 9.57 5 190249 12 90438181
Peripheral arterial occlusive disease 19.61 9.57 35 190219 4586 90433607
Carotid artery occlusion 19.57 9.57 42 190212 6300 90431893
Vascular stent stenosis 19.47 9.57 14 190240 662 90437531
Hyponatraemia 19.46 9.57 391 189863 133147 90305046
Head injury 19.41 9.57 122 190132 31066 90407127
Necrobiosis lipoidica diabeticorum 19.41 9.57 6 190248 36 90438157
Hypoacusis 19.28 9.57 112 190142 27738 90410455
Fracture blisters 19.28 9.57 7 190247 73 90438120
Gastroenteritis 19.24 9.57 116 190138 29113 90409080
Neutrophil count decreased 19.18 9.57 81 190173 71451 90366742
Accidental overdose 19.12 9.57 113 190141 28160 90410033
Blood ketone body 19.11 9.57 7 190247 75 90438118
Mast cell activation syndrome 19.11 9.57 20 190234 1574 90436619
Staphylococcal infection 19.06 9.57 170 190084 48269 90389924
Blood ketone body present 19.03 9.57 7 190247 76 90438117
Peripheral artery haematoma 19.00 9.57 6 190248 39 90438154
Accidental exposure to product 18.95 9.57 153 190101 42213 90395980
Myopathy 18.94 9.57 67 190187 13451 90424742
Patella fracture 18.94 9.57 25 190229 2518 90435675
Drug tolerance 18.84 9.57 7 190247 17909 90420284
Oropharyngeal pain 18.80 9.57 153 190101 115034 90323159
Iris coloboma 18.75 9.57 6 190248 41 90438152
Dermatitis exfoliative 18.64 9.57 38 190216 5498 90432695
Nervousness 18.64 9.57 129 190125 33927 90404266
Premature rupture of membranes 18.54 9.57 38 190216 5520 90432673
Bronchiectasis 18.53 9.57 12 190242 22318 90415875
Pancreatic neoplasm 18.51 9.57 16 190238 990 90437203
Tenosynovitis 18.45 9.57 4 190250 14563 90423630
Dawn phenomenon 18.44 9.57 4 190250 3 90438190
Cerebral infarction 18.44 9.57 107 190147 26489 90411704
Megacolon 18.43 9.57 23 190231 2191 90436002
Phaeochromocytoma 18.28 9.57 13 190241 604 90437589
Vaginal discharge 18.25 9.57 9 190245 19455 90418738
Panniculitis 18.25 9.57 4 190250 14454 90423739
Diabetic hyperosmolar coma 18.24 9.57 11 190243 385 90437808
Hyperbilirubinaemia neonatal 18.24 9.57 11 190243 385 90437808
Product prescribing error 18.19 9.57 117 190137 30028 90408165
Pyrexia 18.16 9.57 1169 189085 659316 89778877
Macular oedema 18.10 9.57 35 190219 4874 90433319
End stage renal disease 18.09 9.57 49 190205 8522 90429671
Metabolic syndrome 18.03 9.57 21 190233 1861 90436332
Polyarthritis 17.95 9.57 8 190246 18342 90419851
Blood alkaline phosphatase abnormal 17.91 9.57 18 190236 1350 90436843
Weight increased 17.80 9.57 707 189547 417220 90020973
Influenza 17.78 9.57 400 189854 138864 90299329
Device dislocation 17.78 9.57 24 190230 31458 90406735
Spondylitis 17.74 9.57 4 190250 14174 90424019
Retinal detachment 17.51 9.57 42 190212 6780 90431413
Vascular calcification 17.49 9.57 14 190240 778 90437415
Chronic fatigue syndrome 17.49 9.57 19 190235 1560 90436633
Osteomyelitis 17.38 9.57 109 190145 27737 90410456
Thirst 17.31 9.57 74 190180 16221 90421972
Body temperature increased 17.30 9.57 43 190211 44667 90393526
Foot amputation 17.28 9.57 10 190244 324 90437869
Large intestine polyp 17.21 9.57 51 190203 9335 90428858
Hypernatraemia 17.21 9.57 51 190203 9336 90428857
Microalbuminuria 16.96 9.57 12 190242 553 90437640
Blood pressure fluctuation 16.90 9.57 55 190199 52358 90385835
Therapeutic response decreased 16.63 9.57 115 190139 89614 90348579
Myoclonus 16.62 9.57 82 190172 19086 90419107
Bundle branch block left 16.56 9.57 45 190209 7840 90430353
Blood alkaline phosphatase increased 16.55 9.57 164 190090 47915 90390278
Temperature regulation disorder 16.55 9.57 5 190249 14574 90423619
Glomerular filtration rate increased 16.51 9.57 21 190233 2039 90436154
Hyperosmolar state 16.48 9.57 9 190245 260 90437933
Oesophageal carcinoma recurrent 16.47 9.57 5 190249 28 90438165
Upper respiratory tract infection 16.43 9.57 181 190073 128137 90310056
Nasal congestion 16.42 9.57 105 190149 83309 90354884
Arrhythmia 16.37 9.57 148 190106 42184 90396009
Rash vesicular 16.19 9.57 9 190245 18188 90420005
Intercepted product storage error 16.08 9.57 11 190243 480 90437713
Pulse pressure decreased 16.08 9.57 8 190246 190 90438003
Colitis 15.93 9.57 84 190170 69858 90368335
Intestinal transit time abnormal 15.92 9.57 6 190248 70 90438123
Dry eye 15.90 9.57 65 190189 57866 90380327
Epileptic encephalopathy 15.87 9.57 10 190244 379 90437814
Foetal hypokinesia 15.84 9.57 12 190242 615 90437578
Weight decreased 15.78 9.57 961 189293 378949 90059244
Noninfective gingivitis 15.78 9.57 21 190233 2132 90436061
Peripheral ischaemia 15.76 9.57 36 190218 5631 90432562
Blood bilirubin abnormal 15.71 9.57 20 190234 1944 90436249
Medical device site abscess 15.59 9.57 8 190246 203 90437990
Condition aggravated 15.53 9.57 1059 189195 594486 89843707
Cataract diabetic 15.51 9.57 3 190251 0 90438193
Somogyi phenomenon 15.51 9.57 3 190251 0 90438193
Product contamination with body fluid 15.51 9.57 3 190251 0 90438193
Pulmonary artery stenosis 15.48 9.57 9 190245 294 90437899
Rhinorrhoea 15.44 9.57 266 189988 88050 90350143
Injection site nodule 15.42 9.57 31 190223 4442 90433751
Feeling abnormal 15.41 9.57 460 189794 166775 90271418
Blood insulin abnormal 15.40 9.57 5 190249 36 90438157
Complications of transplanted liver 15.37 9.57 10 190244 401 90437792
Aortic valve replacement 15.29 9.57 14 190240 935 90437258
Pulse absent 15.25 9.57 37 190217 6018 90432175
Dermo-hypodermitis 15.19 9.57 13 190241 794 90437399
Thrombotic microangiopathy 15.19 9.57 7 190247 15736 90422457
Radiation fibrosis 15.16 9.57 5 190249 38 90438155
Ballismus 15.16 9.57 7 190247 140 90438053
Dermatitis papillaris capillitii 15.15 9.57 4 190250 12 90438181
Hyperlipidaemia 15.12 9.57 91 190163 22825 90415368
Full blood count abnormal 15.12 9.57 34 190220 36563 90401630
Medical device site cellulitis 15.08 9.57 8 190246 218 90437975
Haemoglobin decreased 15.07 9.57 446 189808 161510 90276683
Diet failure 15.05 9.57 5 190249 39 90438154
Oligohydramnios 15.03 9.57 41 190213 7160 90431033
Pulseless electrical activity 14.94 9.57 47 190207 8885 90429308
Depression 14.94 9.57 499 189755 300102 90138091
Insulin C-peptide increased 14.94 9.57 6 190248 84 90438109
Blood glucose normal 14.91 9.57 4 190250 13 90438180
Azotaemia 14.90 9.57 34 190220 5314 90432879
Septic shock 14.90 9.57 254 190000 83906 90354287
Normochromic normocytic anaemia 14.85 9.57 33 190221 5069 90433124
Agitation neonatal 14.84 9.57 11 190243 545 90437648
Body mass index increased 14.84 9.57 17 190237 1480 90436713
Oral herpes 14.80 9.57 30 190224 33494 90404699
Amnesia 14.72 9.57 151 190103 108354 90329839
Pancreatic disorder 14.58 9.57 24 190230 2947 90435246
Vitrectomy 14.56 9.57 8 190246 234 90437959
Vascular graft 14.56 9.57 13 190241 840 90437353
Cardiospasm 14.50 9.57 26 190228 3420 90434773
Atrial tachycardia 14.44 9.57 36 190218 5954 90432239
Haemoglobin abnormal 14.39 9.57 40 190214 7060 90431133
Coronary artery bypass 14.36 9.57 21 190233 2328 90435865
Pulmonary renal syndrome 14.35 9.57 11 190243 574 90437619
Eyelid bleeding 14.33 9.57 5 190249 46 90438147
Ventricular fibrillation 14.32 9.57 63 190191 13981 90424212
Type 3 diabetes mellitus 14.27 9.57 4 190250 16 90438177
Cerebrovascular disorder 14.22 9.57 23 190231 2783 90435410
Blood parathyroid hormone decreased 14.21 9.57 4 190250 12212 90425981
Cardiogenic shock 14.18 9.57 94 190160 24374 90413819
Cardiovascular disorder 14.13 9.57 61 190193 13431 90424762
Device failure 14.13 9.57 39 190215 6858 90431335
Rash pustular 14.06 9.57 43 190211 8006 90430187
Amniorrhexis 14.05 9.57 5 190249 49 90438144
Gestational hypertension 14.05 9.57 24 190230 3038 90435155
Respiratory tract infection 13.99 9.57 70 190184 59008 90379185
Urinary tract candidiasis 13.92 9.57 12 190242 740 90437453
Amputation 13.91 9.57 8 190246 256 90437937
Pancreatic cyst 13.86 9.57 20 190234 2190 90436003
Pregnancy 13.86 9.57 75 190179 61972 90376221
Unevaluable event 13.83 9.57 176 190078 54672 90383521
Needle issue 13.83 9.57 62 190192 13872 90424321
Gout 13.83 9.57 71 190183 16788 90421405
Diabetic eye disease 13.81 9.57 7 190247 173 90438020
Proteinuria 13.81 9.57 90 190164 23201 90414992
Dysstasia 13.77 9.57 95 190159 24957 90413236
Fasting 13.72 9.57 4 190250 19 90438174
Biliary obstruction 13.68 9.57 25 190229 3337 90434856
Paralysis 13.67 9.57 54 190200 11424 90426769
Kidney transplant rejection 13.67 9.57 31 190223 4826 90433367
Breath sounds 13.62 9.57 6 190248 107 90438086
Malignant sweat gland neoplasm 13.62 9.57 6 190248 107 90438086
Urinary tract obstruction 13.60 9.57 20 190234 2229 90435964
Macular degeneration 13.56 9.57 38 190216 37932 90400261
Arthritis 13.52 9.57 453 189801 166862 90271331
Maternal drugs affecting foetus 13.52 9.57 32 190222 5123 90433070
Fructosamine increased 13.43 9.57 3 190251 3 90438190
Endocarditis 13.38 9.57 39 190215 7074 90431119
Neuropathic arthropathy 13.31 9.57 9 190245 385 90437808
Tricuspid valve disease 13.24 9.57 8 190246 281 90437912
Vision blurred 13.22 9.57 314 189940 109979 90328214
Cystic fibrosis 13.21 9.57 27 190227 3914 90434279
Brain injury 13.21 9.57 41 190213 7697 90430496
Renal transplant 13.20 9.57 17 190237 1671 90436522
Eye allergy 13.15 9.57 15 190239 1300 90436893
Lipodystrophy acquired 13.04 9.57 16 190238 1498 90436695
Wrong drug 13.01 9.57 8 190246 290 90437903
Feeling hot 13.01 9.57 103 190151 77905 90360288
Basal cell carcinoma 13.01 9.57 32 190222 33357 90404836
Pain in extremity 12.95 9.57 794 189460 449735 89988458
Retroperitoneal oedema 12.94 9.57 4 190250 24 90438169
Palmoplantar keratoderma 12.93 9.57 25 190229 3482 90434711
Pneumonia aspiration 12.83 9.57 137 190117 40803 90397390
Clostridium difficile colitis 12.80 9.57 98 190156 26608 90411585
Neoplasm progression 12.79 9.57 49 190205 44437 90393756
Foetal disorder 12.77 9.57 8 190246 300 90437893
Diabetic retinal oedema 12.75 9.57 9 190245 413 90437780
Peripheral embolism 12.74 9.57 15 190239 1345 90436848
Sudden death 12.74 9.57 51 190203 10858 90427335
Open angle glaucoma 12.72 9.57 8 190246 302 90437891
Impaired quality of life 12.72 9.57 18 190236 23126 90415067
Neuropathy peripheral 12.69 9.57 377 189877 136593 90301600
Renal aplasia 12.68 9.57 9 190245 417 90437776
Exercise lack of 12.64 9.57 9 190245 419 90437774
Blood triglycerides abnormal 12.64 9.57 9 190245 419 90437774
Malaise 12.64 9.57 1410 188844 584576 89853617
Pyelonephritis fungal 12.61 9.57 7 190247 209 90437984
Foetal arrhythmia 12.58 9.57 7 190247 210 90437983
Hospitalisation 12.53 9.57 355 189899 127745 90310448
Ventricular septal defect 12.52 9.57 32 190222 5375 90432818
Brain malformation 12.51 9.57 5 190249 69 90438124
Disease recurrence 12.50 9.57 39 190215 37614 90400579
Obstructed labour 12.46 9.57 7 190247 214 90437979
High density lipoprotein decreased 12.45 9.57 21 190233 2630 90435563
Tumour compression 12.45 9.57 5 190249 70 90438123
Cytokine release syndrome 12.38 9.57 25 190229 27948 90410245
Investigation 12.36 9.57 16 190238 1581 90436612
Thyroid cancer 12.34 9.57 35 190219 6249 90431944
Necrotising fasciitis 12.32 9.57 26 190228 3854 90434339
Intentional self-injury 12.32 9.57 27 190227 29307 90408886
Groin abscess 12.30 9.57 14 190240 1211 90436982
Angioedema 12.29 9.57 198 190056 64678 90373515
Bradyarrhythmia 12.24 9.57 20 190234 2441 90435752
Umbilical hernia, obstructive 12.22 9.57 3 190251 6 90438187
Neutropenic sepsis 12.21 9.57 12 190242 18118 90420075
Lymphangiectasia 12.20 9.57 5 190249 74 90438119
Latent autoimmune diabetes in adults 12.18 9.57 4 190250 30 90438163
Acne 12.17 9.57 26 190228 28481 90409712
Cerebral ischaemia 12.16 9.57 38 190216 7158 90431035
Autonomic neuropathy 12.16 9.57 15 190239 1412 90436781
Hyperinsulinaemia 12.08 9.57 6 190248 142 90438051
Diabetic vascular disorder 12.06 9.57 4 190250 31 90438162
Pollakiuria 12.06 9.57 114 190140 32891 90405302
Blindness cortical 12.05 9.57 10 190244 585 90437608
Rabbit syndrome 12.05 9.57 8 190246 332 90437861
Labyrinthitis 12.01 9.57 21 190233 2708 90435485
Hepatic encephalopathy 12.00 9.57 59 190195 13713 90424480
Nervous system disorder 11.94 9.57 82 190172 21511 90416682
Urinary tract infection fungal 11.93 9.57 11 190243 741 90437452
Dermatitis bullous 11.86 9.57 48 190206 10268 90427925
Rash erythematous 11.79 9.57 84 190170 65020 90373173
Leukopenia 11.75 9.57 145 190109 100565 90337628
Neonatal tachypnoea 11.74 9.57 6 190248 151 90438042
Urine output decreased 11.71 9.57 55 190199 12548 90425645
Injection site mass 11.69 9.57 83 190171 22007 90416186
Congenital uterine anomaly 11.63 9.57 6 190248 154 90438039
Memory impairment 11.63 9.57 320 189934 196924 90241269
Tubulointerstitial nephritis 11.59 9.57 92 190162 25251 90412942
Cell death 11.53 9.57 22 190232 3033 90435160
Tumour rupture 11.53 9.57 7 190247 248 90437945
Hyperphagia 11.52 9.57 21 190233 2797 90435396
Haemodynamic instability 11.48 9.57 52 190202 11687 90426506
Ventricular tachycardia 11.47 9.57 90 190164 24618 90413575
Procedural pain 11.47 9.57 34 190220 33326 90404867
Product quality issue 11.47 9.57 232 190022 79093 90359100
Cerebral calcification 11.46 9.57 6 190248 159 90438034
Waist circumference increased 11.46 9.57 12 190242 945 90437248
Silent myocardial infarction 11.45 9.57 8 190246 361 90437832
Labelled drug-food interaction issue 11.44 9.57 4 190250 37 90438156
Stress 11.42 9.57 237 190017 81158 90357035
Eye irritation 11.41 9.57 35 190219 33943 90404250
Therapeutic drug monitoring analysis not performed 11.37 9.57 14 190240 1315 90436878
Fibrodysplasia ossificans progressiva 11.37 9.57 3 190251 9 90438184
Lethargy 11.34 9.57 191 190063 62948 90375245
Renal cell carcinoma 11.31 9.57 25 190229 3826 90434367
Vascular purpura 11.30 9.57 16 190238 1722 90436471
Cholangitis 11.30 9.57 37 190217 7145 90431048
Cortisol increased 11.29 9.57 9 190245 497 90437696
Diabetic ulcer 11.29 9.57 6 190248 164 90438029
Vitamin B12 deficiency 11.27 9.57 38 190216 7448 90430745
Flushing 11.25 9.57 125 190129 88366 90349827
Heavy menstrual bleeding 11.25 9.57 16 190238 20514 90417679
Sweat gland tumour 11.22 9.57 6 190248 166 90438027
Blood bicarbonate decreased 11.21 9.57 22 190232 3097 90435096
Pancreatic pseudocyst 11.18 9.57 11 190243 804 90437389
Renal dysplasia 11.17 9.57 8 190246 376 90437817
Calciphylaxis 11.16 9.57 23 190231 3353 90434840
Joint effusion 11.16 9.57 15 190239 19695 90418498
Factor VIII deficiency 11.13 9.57 3 190251 10 90438183
Blood calcium abnormal 11.12 9.57 17 190237 1960 90436233
Drug level above therapeutic 11.07 9.57 32 190222 5777 90432416
Injection site injury 11.03 9.57 12 190242 987 90437206
Ankylosing spondylitis 10.98 9.57 7 190247 13126 90425067
Post procedural complication 10.94 9.57 73 190181 18969 90419224
Tracheobronchitis 10.92 9.57 15 190239 1570 90436623
Mesenteric arterial occlusion 10.91 9.57 6 190248 176 90438017
Oral candidiasis 10.89 9.57 38 190216 35417 90402776
Respiratory tract malformation 10.88 9.57 6 190248 177 90438016
Atrial septal defect 10.85 9.57 40 190214 8194 90429999
Hepatomegaly 10.84 9.57 56 190198 13270 90424923
Eye operation 10.84 9.57 20 190234 2689 90435504
Premature labour 10.74 9.57 56 190198 13320 90424873
Multiple sclerosis relapse 10.73 9.57 65 190189 52240 90385953
Melaena 10.70 9.57 116 190138 34681 90403512
Retinal exudates 10.70 9.57 10 190244 686 90437507
Eczema 10.69 9.57 66 190188 52804 90385389
Diverticulitis intestinal perforated 10.63 9.57 8 190246 406 90437787
Haemangioma congenital 10.55 9.57 9 190245 547 90437646
Hunger 10.49 9.57 34 190220 6529 90431664
Restlessness 10.49 9.57 118 190136 35602 90402591
Type III immune complex mediated reaction 10.47 9.57 8 190246 415 90437778
Posterior capsule opacification 10.46 9.57 6 190248 191 90438002
Back disorder 10.43 9.57 24 190230 25607 90412586
Blood pH decreased 10.38 9.57 19 190235 2539 90435654
Helicobacter test positive 10.37 9.57 9 190245 560 90437633
Arteriovenous fistula site infection 10.37 9.57 4 190250 50 90438143
Neisseria infection 10.31 9.57 5 190249 112 90438081
Crush syndrome 10.30 9.57 7 190247 302 90437891
Bone pain 10.26 9.57 82 190172 61901 90376292
Ulcer 10.26 9.57 35 190219 32847 90405346
Ureteric obstruction 10.25 9.57 17 190237 2101 90436092
Hypomania 10.19 9.57 3 190251 8894 90429299
Lipohypertrophy 10.19 9.57 10 190244 729 90437464
Brain stem haematoma 10.16 9.57 3 190251 15 90438178
Escherichia sepsis 10.10 9.57 31 190223 5785 90432408
Suicide attempt 10.08 9.57 218 190036 75181 90363012
Device breakage 10.06 9.57 57 190197 13987 90424206
Renal cancer metastatic 10.06 9.57 7 190247 314 90437879
Foetal exposure timing unspecified 10.05 9.57 8 190246 441 90437752
Neonatal tachycardia 10.00 9.57 3 190251 16 90438177
Electrocardiogram Q waves 10.00 9.57 3 190251 16 90438177
Atrioventricular block complete 10.00 9.57 44 190210 9767 90428426
Lipoatrophy 9.98 9.57 7 190247 318 90437875
Acanthosis nigricans 9.96 9.57 4 190250 56 90438137
Arterial insufficiency 9.95 9.57 6 190248 210 90437983
Emphysematous cystitis 9.94 9.57 7 190247 320 90437873
Ischaemia 9.93 9.57 29 190225 5266 90432927
Phantom limb syndrome 9.92 9.57 6 190248 211 90437982
Catheter site haematoma 9.92 9.57 6 190248 211 90437982
Psychotic disorder 9.91 9.57 33 190221 31197 90406996
Sleep terror 9.90 9.57 26 190228 4438 90433755
Renal abscess 9.90 9.57 12 190242 1109 90437084
No adverse event 9.89 9.57 93 190161 67889 90370304
Decubitus ulcer 9.86 9.57 50 190204 11763 90426430
Pancreatic abscess 9.85 9.57 3 190251 17 90438176
Cerebral reperfusion injury 9.85 9.57 3 190251 17 90438176
Jaundice 9.81 9.57 108 190146 32409 90405784
Drug resistance 9.78 9.57 32 190222 30417 90407776
Breast cancer stage I 9.73 9.57 4 190250 9620 90428573
Haemorrhagic ascites 9.71 9.57 5 190249 128 90438065
VIIIth nerve lesion 9.71 9.57 3 190251 18 90438175
Immunisation 9.70 9.57 17 190237 2196 90435997
Subdural haematoma 9.68 9.57 64 190190 16581 90421612
Therapeutic response shortened 9.66 9.57 21 190233 22858 90415335
Bloody peritoneal effluent 9.59 9.57 4 190250 62 90438131
Overlap syndrome 9.58 9.57 3 190251 8545 90429648

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 3674.36 10.44 2566 175463 57288 42386018
Blood glucose increased 3352.12 10.44 2638 175391 71061 42372245
Blood glucose decreased 1174.72 10.44 735 177294 13484 42429822
Diabetes mellitus inadequate control 1172.97 10.44 756 177273 14634 42428672
Diabetic ketoacidosis 1128.53 10.44 853 177176 21514 42421792
Hyperglycaemia 872.63 10.44 1016 177013 44843 42398463
Glycosylated haemoglobin increased 636.51 10.44 486 177543 12438 42430868
Blood glucose abnormal 533.61 10.44 345 177684 6708 42436598
Blood glucose fluctuation 511.88 10.44 288 177741 4299 42439007
Device operational issue 503.09 10.44 133 177896 136 42443170
Product storage error 492.40 10.44 393 177636 10747 42432559
Hypoglycaemic coma 426.88 10.44 215 177814 2529 42440777
Off label use 319.11 10.44 1480 176549 636855 41806451
Ketoacidosis 271.72 10.44 205 177824 5147 42438159
Drug abuse 249.07 10.44 65 177964 104706 42338600
Device issue 236.39 10.44 287 177742 13222 42430084
Diabetic retinopathy 220.66 10.44 126 177903 1937 42441369
Febrile neutropenia 208.02 10.44 283 177746 185420 42257886
Drug ineffective 205.96 10.44 1668 176361 628529 41814777
Acute kidney injury 196.32 10.44 2369 175660 364968 42078338
Hyperkalaemia 194.28 10.44 757 177272 79701 42363605
Product use in unapproved indication 193.87 10.44 294 177735 184162 42259144
Lactic acidosis 189.45 10.44 514 177515 44747 42398559
Diabetic neuropathy 188.69 10.44 154 177875 4348 42438958
Hypoglycaemic unconsciousness 172.59 10.44 78 177951 706 42442600
Diabetic foot 172.38 10.44 125 177904 2948 42440358
Diabetic metabolic decompensation 152.07 10.44 100 177929 2002 42441304
Inappropriate schedule of product administration 151.62 10.44 796 177233 95106 42348200
Myocardial infarction 147.15 10.44 954 177075 123055 42320251
Renal failure 125.79 10.44 1028 177001 142698 42300608
Hypoglycaemic seizure 124.90 10.44 51 177978 350 42442956
Neutropenia 116.50 10.44 434 177595 198997 42244309
Disease progression 113.14 10.44 272 177757 143384 42299922
Toxicity to various agents 112.60 10.44 533 177496 228603 42214703
Insulin resistance 110.00 10.44 58 177971 755 42442551
Euglycaemic diabetic ketoacidosis 106.83 10.44 125 177904 5535 42437771
Pancreatic carcinoma 105.53 10.44 162 177867 9344 42433962
Wrong product administered 98.86 10.44 126 177903 6100 42437206
Device mechanical issue 98.72 10.44 60 177969 1041 42442265
Myelosuppression 96.29 10.44 25 178004 40436 42402870
Cardiac failure congestive 92.13 10.44 643 177386 84959 42358347
Hypoglycaemia unawareness 89.39 10.44 31 177998 125 42443181
Treatment failure 89.29 10.44 78 177951 62546 42380760
Toe amputation 88.16 10.44 83 177946 2846 42440460
Anti-insulin antibody positive 87.59 10.44 32 177997 155 42443151
Cutaneous amyloidosis 81.56 10.44 22 178007 26 42443280
COVID-19 81.01 10.44 233 177796 115715 42327591
Multiple use of single-use product 80.03 10.44 38 177991 389 42442917
Loss of consciousness 78.80 10.44 657 177372 91697 42351609
Neuritis 77.65 10.44 112 177917 6108 42437198
Accidental underdose 77.22 10.44 43 177986 628 42442678
Pulmonary vasculitis 77.02 10.44 112 177917 6154 42437152
Increased insulin requirement 76.69 10.44 27 178002 115 42443191
Metabolic acidosis 76.16 10.44 422 177607 51436 42391870
Diabetic nephropathy 69.81 10.44 66 177963 2275 42441031
Drug intolerance 68.37 10.44 146 177883 80278 42363028
Incorrect dose administered 67.37 10.44 415 177614 52559 42390747
Diabetic complication 66.83 10.44 41 177988 724 42442582
Cerebrovascular accident 65.51 10.44 657 177372 96503 42346803
Pancreatic carcinoma metastatic 64.95 10.44 73 177956 3093 42440213
White blood cell count decreased 63.88 10.44 241 177788 110155 42333151
Rash 62.50 10.44 799 177230 276155 42167151
Incorrect dose administered by device 60.78 10.44 66 177963 2690 42440616
Wrong technique in device usage process 60.76 10.44 66 177963 2691 42440615
Drug ineffective for unapproved indication 60.52 10.44 62 177967 46101 42397205
Nasopharyngitis 59.97 10.44 167 177862 83829 42359477
Renal injury 59.09 10.44 147 177882 12133 42431173
Chronic kidney disease 58.76 10.44 368 177661 46873 42396433
Product quality issue 58.43 10.44 186 177843 17696 42425610
Renal impairment 58.11 10.44 710 177319 109518 42333788
Pyrexia 57.25 10.44 1233 176796 392809 42050497
Injury 57.11 10.44 214 177815 22102 42421204
Visual impairment 56.87 10.44 341 177688 42772 42400534
Device malfunction 56.64 10.44 145 177884 12182 42431124
Ketonuria 56.51 10.44 35 177994 629 42442677
Vitreous haemorrhage 55.77 10.44 63 177966 2684 42440622
Fear 55.68 10.44 134 177895 10831 42432475
Device defective 55 10.44 50 177979 1638 42441668
Injury associated with device 54.82 10.44 46 177983 1351 42441955
Drug resistance 54.71 10.44 38 177991 34210 42409096
Therapy partial responder 54.58 10.44 9 178020 20012 42423294
Diabetic coma 54.52 10.44 40 177989 961 42442345
Product complaint 54.28 10.44 93 177936 5884 42437422
Drug dependence 52.45 10.44 28 178001 29066 42414240
Gangrene 52.24 10.44 84 177945 5042 42438264
Type 1 diabetes mellitus 51.98 10.44 87 177942 5400 42437906
Oedema peripheral 51.70 10.44 827 177202 135249 42308057
Acute myocardial infarction 50.77 10.44 416 177613 57749 42385557
Impaired gastric emptying 50.72 10.44 76 177953 4290 42439016
Coronary artery disease 50.60 10.44 391 177638 53329 42389977
Hypoglycaemia neonatal 50.07 10.44 53 177976 2097 42441209
Mucosal inflammation 49.58 10.44 81 177948 49293 42394013
Neurological symptom 49.56 10.44 121 177908 9870 42433436
Emotional distress 49.52 10.44 164 177865 15929 42427377
Eye haemorrhage 49.02 10.44 79 177950 4751 42438555
Ketosis 48.92 10.44 36 177993 869 42442437
Product dispensing issue 48.73 10.44 23 178006 232 42443074
Diabetes mellitus 48.35 10.44 422 177607 59665 42383641
Total lung capacity abnormal 48.31 10.44 75 177954 4368 42438938
Arthralgia 47.03 10.44 590 177439 204648 42238658
Blindness 46.50 10.44 173 177856 17805 42425501
Anhedonia 46.14 10.44 100 177929 7540 42435766
Therapy non-responder 46.07 10.44 96 177933 53263 42390043
Joint swelling 45.81 10.44 139 177890 67883 42375423
Death 45.60 10.44 1562 176467 469623 41973683
Drug hypersensitivity 45.38 10.44 237 177792 99152 42344154
Infusion related reaction 44.82 10.44 119 177910 60687 42382619
Synovitis 44.74 10.44 6 178023 15561 42427745
Leg amputation 44.70 10.44 55 177974 2568 42440738
Drug administered in wrong device 44.26 10.44 17 178012 97 42443209
Eosinophilic granulomatosis with polyangiitis 43.26 10.44 105 177924 8533 42434773
Lower respiratory tract infection 42.89 10.44 66 177963 41140 42402166
Rheumatoid arthritis 42.26 10.44 70 177959 42370 42400936
Haemophagocytic lymphohistiocytosis 41.96 10.44 12 178017 18210 42425096
Musculoskeletal stiffness 41.86 10.44 114 177915 57651 42385655
Glycosylated haemoglobin abnormal 41.75 10.44 22 178007 286 42443020
Intentional product use issue 41.42 10.44 157 177872 71676 42371630
Hypoglycaemic encephalopathy 40.83 10.44 22 178007 300 42443006
Shock hypoglycaemic 40.67 10.44 15 178014 75 42443231
Injection site pain 40.47 10.44 394 177635 57404 42385902
Malignant neoplasm progression 40.25 10.44 276 177753 108124 42335182
Retinopathy 39.15 10.44 48 177981 2233 42441073
Peritonitis bacterial 38.93 10.44 88 177941 6827 42436479
Sinusitis 38.42 10.44 88 177941 47204 42396102
Tinnitus 37.78 10.44 39 177990 28899 42414407
Completed suicide 36.11 10.44 245 177784 96220 42347086
Forced expiratory volume decreased 35.31 10.44 90 177939 7540 42435766
Cytokine release syndrome 35.25 10.44 84 177945 44443 42398863
Normochromic normocytic anaemia 35.23 10.44 100 177929 8931 42434375
Product administration error 35.19 10.44 161 177868 18182 42425124
Anti-insulin antibody increased 35.09 10.44 13 178016 66 42443240
Pneumonia 35.08 10.44 1425 176604 420724 42022582
Rhabdomyolysis 35.00 10.44 488 177541 77531 42365775
Antineutrophil cytoplasmic antibody positive 34.60 10.44 64 177965 4301 42439005
Hepatic encephalopathy 34.33 10.44 148 177881 16294 42427012
Dialysis 34.11 10.44 119 177910 11867 42431439
Pancreatitis 33.83 10.44 302 177727 42966 42400340
Neutrophil count decreased 33.77 10.44 143 177886 63272 42380034
Respiratory symptom 33.12 10.44 112 177917 10994 42432312
Mycotic allergy 33.01 10.44 67 177962 4824 42438482
Spirometry abnormal 32.98 10.44 69 177960 5077 42438229
Mite allergy 32.73 10.44 68 177961 4978 42438328
Microalbuminuria 32.70 10.44 28 178001 846 42442460
Mental status changes 32.43 10.44 293 177736 41822 42401484
Nightmare 32.32 10.44 34 177995 24978 42418328
Cardiac failure 31.85 10.44 625 177404 106231 42337075
Treatment noncompliance 31.56 10.44 267 177762 37405 42405901
Aggression 31.36 10.44 88 177941 44075 42399231
Arthropathy 31.19 10.44 47 177982 29550 42413756
Erythema 31.18 10.44 297 177732 108496 42334810
Cough 31.05 10.44 540 177489 177563 42265743
Headache 31.00 10.44 762 177267 238607 42204699
Blood creatinine increased 30.66 10.44 637 177392 109366 42333940
Dehydration 30.28 10.44 791 177238 140976 42302330
Product dispensing error 30.20 10.44 85 177944 7554 42435752
Dust allergy 30.18 10.44 68 177961 5264 42438042
Pulmonary alveolar haemorrhage 29.89 10.44 132 177897 14684 42428622
Skin ulcer 29.71 10.44 196 177833 25405 42417901
Stomatitis 29.66 10.44 109 177920 50220 42393086
Migraine 29.13 10.44 38 177991 25376 42417930
Appendicitis 28.98 10.44 26 178003 20587 42422719
Arteriosclerosis 28.85 10.44 150 177879 17839 42425467
Blindness transient 28.83 10.44 46 177983 2743 42440563
Hypothermia 28.75 10.44 116 177913 12399 42430907
Pancreatitis acute 28.71 10.44 239 177790 33325 42409981
Osteomyelitis 28.57 10.44 151 177878 18072 42425234
Diabetic foot infection 28.11 10.44 24 178005 722 42442584
Impaired quality of life 28.07 10.44 12 178017 14165 42429141
Akathisia 27.82 10.44 5 178024 10446 42432860
Blood insulin increased 27.78 10.44 18 178011 351 42442955
Diabetic ketosis 27.73 10.44 16 178013 251 42443055
Conjunctivitis allergic 27.64 10.44 70 177959 5841 42437465
Pneumocystis jirovecii pneumonia 27.50 10.44 39 177990 25142 42418164
Pathogen resistance 27.38 10.44 7 178022 11443 42431863
Asthenia 27.32 10.44 1434 176595 279359 42163947
Injection site haemorrhage 27.13 10.44 109 177920 11627 42431679
Glycosylated haemoglobin decreased 26.95 10.44 19 178010 428 42442878
Decreased insulin requirement 26.89 10.44 6 178023 0 42443306
Tumour lysis syndrome 26.78 10.44 32 177997 22199 42421107
Immune reconstitution inflammatory syndrome 26.69 10.44 5 178024 10138 42433168
Pancreatitis chronic 26.64 10.44 40 177989 2262 42441044
Cytomegalovirus infection reactivation 26.41 10.44 7 178022 11171 42432135
Alveolar lung disease 26.38 10.44 19 178010 443 42442863
Colitis ulcerative 26.22 10.44 43 177986 26132 42417174
Anaphylactic shock 26.11 10.44 36 177993 23481 42419825
Peripheral vascular disorder 25.95 10.44 64 177965 5253 42438053
Foetal disorder 25.84 10.44 27 178002 1052 42442254
Hyperhidrosis 25.83 10.44 526 177503 89986 42353320
Therapeutic product effect decreased 25.64 10.44 81 177948 39069 42404237
Macular oedema 25.42 10.44 50 177979 3519 42439787
Acetonaemia 25.42 10.44 15 178014 246 42443060
Diabetic foetopathy 25.41 10.44 14 178015 200 42443106
Pancytopenia 25.27 10.44 343 177686 117400 42325906
Cold sweat 25.22 10.44 104 177925 11226 42432080
Insomnia 25.19 10.44 345 177684 117908 42325398
Neuropathy peripheral 25.13 10.44 288 177741 101565 42341741
Anti-GAD antibody positive 25.12 10.44 8 178021 23 42443283
Myelodysplastic syndrome 25.07 10.44 35 177994 22710 42420596
Hot flush 25.03 10.44 34 177995 22317 42420989
Psoriatic arthropathy 25.02 10.44 41 177988 24926 42418380
Urine ketone body present 25.01 10.44 30 177999 1364 42441942
Adenocarcinoma pancreas 24.93 10.44 31 177998 1463 42441843
Platelet count decreased 24.84 10.44 418 177611 138163 42305143
Plasmapheresis 24.73 10.44 18 178011 427 42442879
Cardiovascular disorder 24.67 10.44 116 177913 13249 42430057
Angina unstable 24.63 10.44 104 177925 11344 42431962
Therapeutic drug monitoring analysis not performed 24.58 10.44 20 178009 562 42442744
Sedation 24.51 10.44 57 177972 30418 42412888
Hypervolaemia 24.43 10.44 173 177856 22952 42420354
Diabetic retinal oedema 24.36 10.44 14 178015 218 42443088
Amputation 24.04 10.44 23 178006 805 42442501
No adverse event 24.00 10.44 83 177946 38938 42404368
Blood ketone body increased 23.81 10.44 19 178010 519 42442787
Neutropenic sepsis 23.78 10.44 19 178010 15927 42427379
Systemic infection 23.68 10.44 61 177968 5144 42438162
Localised infection 23.66 10.44 156 177873 20217 42423089
Hypersensitivity 23.63 10.44 191 177838 72179 42371127
Extremity necrosis 23.63 10.44 38 177991 2281 42441025
Rhythm idioventricular 23.62 10.44 16 178013 337 42442969
Fatigue 23.59 10.44 1536 176493 434105 42009201
Suture rupture 23.58 10.44 18 178011 460 42442846
Drug reaction with eosinophilia and systemic symptoms 23.58 10.44 93 177936 41982 42401324
Myasthenia gravis 23.11 10.44 20 178009 16117 42427189
Pulmonary interstitial emphysema syndrome 23.05 10.44 19 178010 544 42442762
Rhinorrhoea 22.84 10.44 63 177966 31731 42411575
Intentional self-injury 22.81 10.44 18 178011 15184 42428122
Diaphragmatic disorder 22.78 10.44 27 178002 1212 42442094
Gingival pain 22.75 10.44 4 178025 8490 42434816
Leukopenia 22.73 10.44 201 177828 74545 42368761
Bone marrow failure 22.72 10.44 67 177962 33026 42410280
Diabetic eye disease 22.57 10.44 10 178019 86 42443220
Alopecia 22.56 10.44 56 177973 29220 42414086
Frequent bowel movements 22.55 10.44 34 177995 21373 42421933
Progressive multifocal leukoencephalopathy 22.47 10.44 10 178019 11526 42431780
Blood triglycerides increased 22.42 10.44 128 177901 15768 42427538
Product monitoring error 22.40 10.44 54 177975 4369 42438937
Herpes zoster 22.38 10.44 85 177944 38792 42404514
Polyuria 22.37 10.44 92 177937 9919 42433387
Neuralgia 22.25 10.44 46 177983 25601 42417705
Haematotoxicity 22.23 10.44 9 178020 10976 42432330
Visual acuity reduced 21.99 10.44 137 177892 17413 42425893
Glomerular filtration rate decreased 21.98 10.44 130 177899 16221 42427085
Condition aggravated 21.85 10.44 879 177150 259875 42183431
Insulin autoimmune syndrome 21.85 10.44 18 178011 515 42442791
Pulmonary fibrosis 21.77 10.44 188 177841 26493 42416813
Infective pulmonary exacerbation of cystic fibrosis 21.71 10.44 77 177952 7741 42435565
Myopathy 21.55 10.44 114 177915 13647 42429659
Foot amputation 21.53 10.44 22 178007 835 42442471
Inflammation 21.49 10.44 71 177958 33776 42409530
Injection site nodule 21.46 10.44 35 177994 2126 42441180
Pneumonitis 21.04 10.44 96 177933 41622 42401684
Acute graft versus host disease in skin 21.01 10.44 3 178026 7421 42435885
Angina pectoris 20.98 10.44 220 177809 32676 42410630
Bacterial infection 20.96 10.44 54 177975 27825 42415481
Neuropathic arthropathy 20.81 10.44 12 178017 188 42443118
Capillaritis 20.67 10.44 35 177994 2193 42441113
Multiple-drug resistance 20.62 10.44 3 178026 7319 42435987
Prostate cancer 20.62 10.44 106 177923 44537 42398769
Diabetic gastroparesis 20.28 10.44 10 178019 112 42443194
Vasculitis 20.25 10.44 139 177890 18255 42425051
Neutropenia neonatal 20.23 10.44 22 178007 898 42442408
Lymphopenia 20.16 10.44 37 177992 21526 42421780
Oedematous pancreatitis 19.97 10.44 20 178009 741 42442565
Peripheral ischaemia 19.87 10.44 66 177963 6419 42436887
Diabetic ulcer 19.86 10.44 9 178020 82 42443224
Extrasystoles 19.84 10.44 50 177979 4159 42439147
Respiratory depression 19.84 10.44 30 177999 18838 42424468
Hypoacusis 19.81 10.44 140 177889 18562 42424744
Acute graft versus host disease 19.69 10.44 5 178024 8210 42435096
Product name confusion 19.67 10.44 9 178020 84 42443222
Posterior reversible encephalopathy syndrome 19.47 10.44 15 178014 12806 42430500
Medication error 19.42 10.44 218 177811 32936 42410370
Extrapyramidal disorder 19.37 10.44 24 178005 16388 42426918
Alcohol poisoning 19.37 10.44 4 178025 7570 42435736
Pulmonary embolism 19.15 10.44 368 177661 119244 42324062
Colitis 19.10 10.44 115 177914 46457 42396849
Device use issue 19.04 10.44 22 178007 961 42442345
Ventricular hyperkinesia 18.88 10.44 12 178017 226 42443080
Upper motor neurone lesion 18.88 10.44 11 178018 176 42443130
Hyperinsulinaemic hypoglycaemia 18.78 10.44 10 178019 133 42443173
Neonatal respiratory arrest 18.66 10.44 7 178022 37 42443269
Vitreous floaters 18.65 10.44 49 177980 4181 42439125
Blood potassium increased 18.62 10.44 137 177892 18399 42424907
Acute coronary syndrome 18.60 10.44 116 177913 14749 42428557
Hyperglycaemic hyperosmolar nonketotic syndrome 18.56 10.44 28 178001 1590 42441716
Insulin C-peptide increased 18.55 10.44 9 178020 97 42443209
Back pain 18.41 10.44 451 177578 141325 42301981
Adverse drug reaction 18.37 10.44 87 177942 37347 42405959
Disease recurrence 18.33 10.44 63 177966 29615 42413691
Large for dates baby 18.32 10.44 21 178008 909 42442397
Ureteric compression 18.24 10.44 13 178016 298 42443008
Weight increased 18.22 10.44 585 177444 107398 42335908
Interstitial lung disease 18.14 10.44 225 177804 78237 42365069
Unevaluable event 18.10 10.44 221 177808 34067 42409239
Drug effective for unapproved indication 18.04 10.44 3 178026 6630 42436676
Nephrogenic systemic fibrosis 18.00 10.44 43 177986 3458 42439848
Micturition urgency 17.97 10.44 14 178015 11884 42431422
Diabetic bullosis 17.96 10.44 6 178023 21 42443285
Obstructive airways disorder 17.92 10.44 170 177859 24589 42418717
Diabetic gangrene 17.87 10.44 12 178017 249 42443057
Confusional state 17.72 10.44 863 177166 166734 42276572
Generalised oedema 17.55 10.44 117 177912 15219 42428087
Left atrial dilatation 17.53 10.44 34 177995 2368 42440938
Oral herpes 17.31 10.44 5 178024 7539 42435767
Influenza 17.27 10.44 171 177858 62004 42381302
Flour sensitivity 17.15 10.44 6 178023 25 42443281
Thrombocytopenia 17.11 10.44 636 177393 189643 42253663
Periodontitis 17.00 10.44 32 177997 2179 42441127
Hypertensive crisis 16.99 10.44 86 177943 10120 42433186
Rhinitis 16.96 10.44 15 178014 11962 42431344
Right atrial enlargement 16.81 10.44 12 178017 276 42443030
Oedema 16.80 10.44 308 177721 51693 42391613
Constipation 16.78 10.44 533 177496 161758 42281548
Escherichia urinary tract infection 16.71 10.44 48 177981 4315 42438991
Hepatic cirrhosis 16.69 10.44 140 177889 19562 42423744
Gallbladder neoplasm 16.60 10.44 6 178023 28 42443278
Myocardial ischaemia 16.56 10.44 129 177900 17633 42425673
Cystitis haemorrhagic 16.56 10.44 5 178024 7324 42435982
Mucosal dryness 16.42 10.44 27 178002 1651 42441655
Basal cell carcinoma 16.36 10.44 45 177984 22688 42420618
Upper respiratory tract infection 16.33 10.44 106 177923 42067 42401239
Oxygen saturation decreased 16.30 10.44 182 177847 64505 42378801
Blood urea increased 16.30 10.44 209 177820 32584 42410722
Device dispensing error 16.27 10.44 8 178021 89 42443217
Lipohypertrophy 16.26 10.44 12 178017 291 42443015
Peripheral arterial occlusive disease 16.20 10.44 64 177965 6774 42436532
Incorrect route of product administration 16.12 10.44 50 177979 24255 42419051
Impaired work ability 16.12 10.44 16 178013 12075 42431231
Post transplant lymphoproliferative disorder 16.11 10.44 9 178020 9111 42434195
Intentional product misuse 16.06 10.44 173 177856 61727 42381579
Nasal congestion 16.03 10.44 66 177963 29435 42413871
Hypovolaemia 15.88 10.44 92 177937 11393 42431913
Hypochromic anaemia 15.81 10.44 21 178008 1059 42442247
Chronic graft versus host disease 15.79 10.44 3 178026 6022 42437284
Pancreatic failure 15.70 10.44 21 178008 1066 42442240
Somogyi phenomenon 15.70 10.44 4 178025 3 42443303
Arthritis 15.65 10.44 107 177922 41958 42401348
Arrhythmia 15.65 10.44 246 177783 40071 42403235
Behaviour disorder 15.60 10.44 5 178024 7049 42436257
Skin pressure mark 15.52 10.44 7 178022 63 42443243
Oropharyngeal pain 15.39 10.44 109 177920 42401 42400905
Systemic lupus erythematosus 15.35 10.44 10 178019 9314 42433992
Acute myeloid leukaemia 15.32 10.44 45 177984 22211 42421095
Hypochromasia 15.31 10.44 12 178017 319 42442987
Injection site hypertrophy 15.30 10.44 5 178024 16 42443290
Lung disorder 15.19 10.44 283 177746 47640 42395666
Nodule 15.18 10.44 97 177932 12437 42430869
Eczema 15.14 10.44 82 177947 34004 42409302
Insulin C-peptide decreased 15.10 10.44 6 178023 38 42443268
Hepatic function abnormal 15.10 10.44 140 177889 51427 42391879
Suicidal ideation 14.86 10.44 129 177900 48032 42395274
Poisoning 14.86 10.44 24 178005 14675 42428631
Liver transplant failure 14.85 10.44 8 178021 109 42443197
Hypotension 14.82 10.44 1259 176770 256372 42186934
Blood ketone body present 14.80 10.44 7 178022 71 42443235
Sleep disorder 14.77 10.44 129 177900 47966 42395340
Clostridium difficile infection 14.75 10.44 47 177982 22612 42420694
Hyperosmolar state 14.73 10.44 14 178015 486 42442820
Haemodialysis 14.72 10.44 83 177946 10177 42433129
Cytomegalovirus viraemia 14.69 10.44 13 178016 10364 42432942
Ischaemic cardiomyopathy 14.62 10.44 60 177969 6462 42436844
Cardiac disorder 14.49 10.44 286 177743 48646 42394660
Ocular hyperaemia 14.39 10.44 28 178001 15935 42427371
Iron deficiency 14.33 10.44 15 178014 11046 42432260
Hepatocellular carcinoma 14.32 10.44 70 177959 8124 42435182
Bronchiectasis 14.25 10.44 34 177995 17985 42425321
Extra dose administered 14.20 10.44 54 177975 5615 42437691
Blood pressure fluctuation 14.12 10.44 61 177968 26847 42416459
Creatinine renal clearance decreased 14.08 10.44 40 177989 3573 42439733
Neurotoxicity 14.08 10.44 51 177978 23600 42419706
Rash macular 14.06 10.44 31 177998 16860 42426446
Blindness unilateral 14.06 10.44 52 177977 5336 42437970
Delusion 14.03 10.44 25 178004 14709 42428597
Chest pain 14.02 10.44 715 177314 138815 42304491
Haematoma muscle 13.98 10.44 29 178000 2121 42441185
Epstein-Barr virus infection 13.97 10.44 12 178017 9706 42433600
Arteriosclerosis coronary artery 13.90 10.44 129 177900 18548 42424758
Acute pulmonary oedema 13.78 10.44 72 177957 8579 42434727
Multiple sclerosis relapse 13.76 10.44 24 178005 14240 42429066
Glomerular filtration rate increased 13.76 10.44 17 178012 797 42442509
Haematochezia 13.72 10.44 167 177862 58269 42385037
Eye infection staphylococcal 13.70 10.44 7 178022 85 42443221
Psychotic disorder 13.68 10.44 69 177960 29139 42414167
Fungal endocarditis 13.68 10.44 13 178016 451 42442855
Retinal haemorrhage 13.67 10.44 54 177975 5716 42437590
Dry mouth 13.60 10.44 104 177925 39775 42403531
Foetal hypokinesia 13.59 10.44 12 178017 378 42442928
Foetal arrhythmia 13.57 10.44 8 178021 131 42443175
Retinal aneurysm 13.57 10.44 8 178021 131 42443175
Agitation 13.56 10.44 188 177841 64126 42379180
Hallucination, auditory 13.46 10.44 26 178003 14838 42428468
Strangulated umbilical hernia 13.45 10.44 3 178026 0 42443306
Base excess abnormal 13.45 10.44 3 178026 0 42443306
Supranuclear palsy 13.45 10.44 3 178026 0 42443306
Venous stent insertion 13.45 10.44 3 178026 0 42443306
Cerebellar artery occlusion 13.45 10.44 3 178026 0 42443306
Device delivery system issue 13.42 10.44 19 178010 1018 42442288
Device failure 13.37 10.44 33 177996 2710 42440596
Amylase decreased 13.35 10.44 7 178022 90 42443216
Potentiating drug interaction 13.33 10.44 58 177971 6410 42436896
Squamous cell carcinoma 13.31 10.44 21 178008 12961 42430345
Mitral valve thickening 13.31 10.44 13 178016 467 42442839
Renal disorder 13.28 10.44 182 177847 28798 42414508
Somnolence 13.27 10.44 469 177560 140636 42302670
Myocarditis 13.25 10.44 38 177991 18900 42424406
Visceral venous thrombosis 13.24 10.44 5 178024 27 42443279
Product temperature excursion issue 13.17 10.44 13 178016 473 42442833
Muscle spasticity 13.15 10.44 6 178023 6816 42436490
Hunger 13.14 10.44 27 178002 1961 42441345
Device ineffective 13.09 10.44 5 178024 28 42443278
Syringe issue 13.00 10.44 10 178019 8546 42434760
Depressed mood 12.90 10.44 52 177977 23332 42419974
Obsessive-compulsive disorder 12.89 10.44 6 178023 6737 42436569
Preternatural anus 12.83 10.44 7 178022 98 42443208
Graft versus host disease in skin 12.83 10.44 3 178026 5209 42438097
Intestinal haemorrhage 12.82 10.44 41 177988 3910 42439396
Intestinal obstruction 12.81 10.44 64 177965 27094 42416212
Benign prostatic hyperplasia 12.79 10.44 45 177984 21007 42422299
Neoplasm progression 12.75 10.44 70 177959 28930 42414376
Pain 12.74 10.44 866 177163 243982 42199324
Anti-insulin antibody 12.54 10.44 5 178024 32 42443274
Hepatic neoplasm 12.46 10.44 28 178001 2163 42441143
Mucormycosis 12.46 10.44 61 177968 7082 42436224
Hypogammaglobulinaemia 12.41 10.44 19 178010 11872 42431434
Ankylosing spondylitis 12.41 10.44 7 178022 7049 42436257
Mydriasis 12.40 10.44 11 178018 8759 42434547
Immunosuppressant drug level decreased 12.33 10.44 25 178004 1799 42441507
Bladder irrigation 12.26 10.44 6 178023 66 42443240
High density lipoprotein decreased 12.24 10.44 40 177989 3857 42439449
Oesophageal tuberculosis 12.20 10.44 4 178025 13 42443293
Optic discs blurred 12.10 10.44 6 178023 68 42443238
Glycosuria 12.03 10.44 21 178008 1349 42441957
Guillain-Barre syndrome 11.95 10.44 61 177968 7202 42436104
Congenital cystic kidney disease 11.95 10.44 12 178017 446 42442860
Respiratory tract infection 11.87 10.44 63 177966 26259 42417047
Dermatitis atopic 11.85 10.44 21 178008 12383 42430923
Retinal exudates 11.83 10.44 16 178013 821 42442485
Epistaxis 11.82 10.44 202 177827 66624 42376682
Pneumonia aspiration 11.80 10.44 143 177886 49935 42393371
Hypothyroidism 11.79 10.44 194 177835 31890 42411416
Dry skin 11.79 10.44 137 177892 48201 42395105
Neonatal respiratory depression 11.77 10.44 12 178017 454 42442852
Therapeutic product effect incomplete 11.73 10.44 217 177812 70722 42372584
Trichoglossia 11.71 10.44 11 178018 376 42442930
Depression 11.68 10.44 365 177664 110998 42332308
Parosmia 11.68 10.44 9 178020 7682 42435624
Sinus arrest 11.65 10.44 27 178002 2129 42441177
Substance abuse 11.62 10.44 12 178017 8893 42434413
Diabetic hyperglycaemic coma 11.59 10.44 5 178024 40 42443266
Expired product administered 11.56 10.44 41 177988 4122 42439184
Poor quality product administered 11.50 10.44 28 178001 2280 42441026
Blood ketone body 11.49 10.44 7 178022 122 42443184
Pneumothorax 11.38 10.44 55 177974 23488 42419818
Peritoneal dialysis complication 11.38 10.44 25 178004 1902 42441404
Ostectomy 11.38 10.44 3 178026 3 42443303
Polycythaemia neonatorum 11.38 10.44 3 178026 3 42443303
Infection 11.35 10.44 369 177660 111699 42331607
Acidosis 11.35 10.44 89 177940 12190 42431116
Nephropathy 11.34 10.44 58 177971 6853 42436453
Second primary malignancy 11.30 10.44 14 178015 9561 42433745
Hypophosphataemia 11.29 10.44 47 177982 20898 42422408
Varices oesophageal 11.28 10.44 42 177987 4323 42438983
Apallic syndrome 11.27 10.44 10 178019 317 42442989
Catatonia 11.25 10.44 6 178023 6233 42437073
Irritability 11.25 10.44 70 177959 28058 42415248
Electrolyte imbalance 11.20 10.44 115 177914 16986 42426320
Newborn persistent pulmonary hypertension 11.20 10.44 7 178022 128 42443178
Tachycardia 11.17 10.44 329 177700 100758 42342548
Device interaction 11.16 10.44 13 178016 573 42442733
Arteriospasm coronary 11.13 10.44 3 178026 4735 42438571
Paradoxical drug reaction 11.13 10.44 3 178026 4735 42438571
Pleuritic pain 11.11 10.44 8 178021 7069 42436237
Anal fissure 11.09 10.44 4 178025 5235 42438071
Campylobacter test positive 11.06 10.44 6 178023 83 42443223
Diffuse large B-cell lymphoma 10.97 10.44 14 178015 9440 42433866
C-reactive protein increased 10.96 10.44 193 177836 63367 42379939
Immune-mediated enterocolitis 10.93 10.44 5 178024 5672 42437634
Laboratory test abnormal 10.93 10.44 54 177975 22924 42420382
Lymphadenopathy 10.91 10.44 88 177941 33277 42410029
Generalised tonic-clonic seizure 10.89 10.44 65 177964 26314 42416992
Schizophrenia 10.88 10.44 17 178012 10533 42432773
Actinic keratosis 10.87 10.44 4 178025 5172 42438134
Anaphylactic reaction 10.87 10.44 120 177909 42623 42400683
Total cholesterol/HDL ratio increased 10.84 10.44 8 178021 194 42443112
Hypertriglyceridaemia 10.84 10.44 76 177953 10050 42433256
Thrombotic microangiopathy 10.83 10.44 29 178000 14753 42428553
Rhinovirus infection 10.81 10.44 7 178022 6541 42436765
Bronchial haemorrhage 10.79 10.44 14 178015 690 42442616
Graft versus host disease in gastrointestinal tract 10.76 10.44 4 178025 5139 42438167
Therapy interrupted 10.75 10.44 52 177977 22198 42421108
Hyperphosphataemia 10.72 10.44 24 178005 12980 42430326
Retinopathy proliferative 10.69 10.44 6 178023 89 42443217
Metabolic encephalopathy 10.69 10.44 47 177982 5218 42438088
Atrial septal defect 10.67 10.44 63 177966 7856 42435450
Left atrial enlargement 10.60 10.44 17 178012 1018 42442288
Morganella infection 10.58 10.44 13 178016 606 42442700
Diabetic hyperosmolar coma 10.57 10.44 12 178017 514 42442792
Intraventricular haemorrhage 10.57 10.44 38 177991 3846 42439460
Diverticulitis 10.55 10.44 54 177975 22719 42420587
Acral peeling skin syndrome 10.55 10.44 5 178024 51 42443255
Fear of death 10.53 10.44 13 178016 609 42442697
Jaundice 10.52 10.44 203 177826 34386 42408920
Blood test abnormal 10.49 10.44 24 178005 12882 42430424
Congenital bladder anomaly 10.48 10.44 9 178020 273 42443033
Premature baby 10.44 10.44 145 177884 23008 42420298

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 7191.84 9.51 4292 300891 111812 110172304
Blood glucose increased 6808.68 9.51 4348 300835 128148 110155968
Diabetic ketoacidosis 2678.12 9.51 1585 303598 40473 110243643
Diabetes mellitus inadequate control 2239.81 9.51 1251 303932 28524 110255592
Hyperglycaemia 1963.43 9.51 1730 303453 83360 110200756
Blood glucose decreased 1860.52 9.51 1105 304078 28383 110255733
Glycosylated haemoglobin increased 1259.51 9.51 795 304388 22824 110261292
Blood glucose abnormal 1029.59 9.51 564 304619 12352 110271764
Device operational issue 1009.09 9.51 286 304897 846 110283270
Acute kidney injury 968.92 9.51 3888 301295 631542 109652574
Blood glucose fluctuation 842.95 9.51 416 304767 7282 110276834
Lactic acidosis 816.58 9.51 1138 304045 91673 110192443
Hypoglycaemic coma 790.01 9.51 359 304824 5174 110278942
Ketoacidosis 750.65 9.51 421 304762 9666 110274450
Product storage error 665.74 9.51 521 304662 21207 110262909
Hyperkalaemia 615.00 9.51 1236 303947 134560 110149556
Systemic lupus erythematosus 594.25 9.51 25 305158 254313 110029803
Synovitis 585.23 9.51 45 305138 274047 110010069
Hand deformity 556.73 9.51 9 305174 218497 110065619
Pemphigus 522.54 9.51 15 305168 214555 110069561
Device issue 520.27 9.51 556 304627 33979 110250137
Infusion related reaction 517.74 9.51 202 304981 380960 109903156
Glossodynia 511.46 9.51 24 305159 221980 110062136
Anti-cyclic citrullinated peptide antibody positive 474.56 9.51 5 305178 181979 110102137
Duodenal ulcer perforation 467.54 9.51 4 305179 177696 110106420
Joint swelling 466.62 9.51 326 304857 442519 109841597
Renal failure 463.05 9.51 1527 303656 225047 110059069
Arthropathy 443.76 9.51 122 305061 287400 109996716
Treatment failure 416.09 9.51 124 305059 277110 110007006
Alopecia 403.75 9.51 254 304929 364499 109919617
Drug intolerance 401.47 9.51 320 304863 406192 109877924
Folliculitis 396.55 9.51 15 305168 167638 110116478
Diabetic retinopathy 391.40 9.51 193 304990 3371 110280745
Inappropriate schedule of product administration 390.03 9.51 1343 303840 202294 110081822
Pericarditis 386.37 9.51 69 305114 219045 110065071
Helicobacter infection 384.96 9.51 31 305152 181846 110102270
Cerebrovascular accident 380.39 9.51 1233 303950 180051 110104065
Irritable bowel syndrome 367.97 9.51 21 305162 164194 110119922
Myocardial infarction 365.40 9.51 1264 303919 190819 110093297
Psoriatic arthropathy 346.83 9.51 62 305121 196699 110087417
Rheumatoid factor positive 337.06 9.51 5 305178 131635 110152481
Muscle injury 324.98 9.51 15 305168 140792 110143324
Off label use 324.63 9.51 2621 302562 1497564 108786552
Rheumatic fever 321.28 9.51 3 305180 122576 110161540
Diabetic metabolic decompensation 318.72 9.51 173 305010 3716 110280400
Fibromyalgia 314.26 9.51 48 305135 170861 110113255
Drug hypersensitivity 310.61 9.51 483 304700 453607 109830509
Device mechanical issue 310.19 9.51 138 305045 1886 110282230
Cardiac failure congestive 305.92 9.51 1015 304168 149985 110134131
Contraindicated product administered 295.79 9.51 158 305025 248109 110036007
Euglycaemic diabetic ketoacidosis 293.45 9.51 249 304934 11374 110272742
Gangrene 289.35 9.51 287 304896 16054 110268062
C-reactive protein abnormal 289.30 9.51 17 305166 129678 110154438
Stomatitis 288.35 9.51 196 304987 270046 110014070
Musculoskeletal stiffness 277.72 9.51 219 304964 279603 110004513
Hepatic enzyme increased 274.63 9.51 288 304895 320604 109963512
Hypoglycaemic unconsciousness 273.42 9.51 109 305074 1111 110283005
Drug ineffective 271.98 9.51 2787 302396 1517753 108766363
Sleep disorder due to general medical condition, insomnia type 270.51 9.51 4 305179 105639 110178477
Product use in unapproved indication 267.54 9.51 518 304665 446859 109837257
Hypersensitivity 265.62 9.51 441 304742 403557 109880559
Therapeutic product effect decreased 256.91 9.51 180 305003 244136 110039980
Abdominal discomfort 256.09 9.51 433 304750 393425 109890691
Ill-defined disorder 244.83 9.51 65 305118 156788 110127328
Lip dry 243.58 9.51 7 305176 100076 110184040
Bursitis 239.95 9.51 36 305147 129882 110154234
Metabolic acidosis 238.34 9.51 710 304473 99034 110185082
Swelling 235.57 9.51 378 304805 350663 109933453
Diabetic foot 233.80 9.51 144 305039 3951 110280165
Dehydration 227.90 9.51 1435 303748 278076 110006040
Loss of consciousness 227.80 9.51 1109 304074 195197 110088919
Arthralgia 225.15 9.51 1248 303935 778384 109505732
Wound 224.50 9.51 190 304993 234247 110049869
Renal impairment 216.80 9.51 1062 304121 187383 110096733
Diabetic neuropathy 214.75 9.51 168 305015 6831 110277285
Lower respiratory tract infection 213.85 9.51 213 304970 242893 110041223
Rash 202.23 9.51 1381 303802 819583 109464533
Incorrect dose administered by device 201.41 9.51 160 305023 6654 110277462
Rhabdomyolysis 198.91 9.51 757 304426 119644 110164472
Impaired healing 198.90 9.51 151 305032 196566 110087550
Arterial occlusive disease 193.64 9.51 225 304958 15083 110269033
Joint range of motion decreased 192.97 9.51 49 305134 121783 110162333
Intentional product use issue 188.88 9.51 244 304939 247662 110036454
Nasopharyngitis 187.76 9.51 516 304667 393845 109890271
Device defective 182.36 9.51 120 305063 3702 110280414
Inflammation 179.67 9.51 161 305022 193077 110091039
Osteoarthritis 176.06 9.51 147 305036 182476 110101640
Migraine 175.79 9.51 130 305053 171522 110112594
Febrile neutropenia 173.02 9.51 386 304797 316381 109967735
Discomfort 171.24 9.51 204 304979 214503 110069613
Hypoglycaemic seizure 170.87 9.51 73 305110 899 110283217
Drug abuse 168.34 9.51 145 305038 177266 110106850
Pancreatic carcinoma 165.82 9.51 205 304978 14667 110269449
Angina pectoris 163.82 9.51 459 304724 61836 110222280
Peripheral venous disease 163.17 9.51 20 305163 84097 110200019
Dry mouth 160.50 9.51 189 304994 199759 110084357
Blister 159.00 9.51 238 304945 227138 110056978
Blood cholesterol increased 156.71 9.51 167 305016 184618 110099498
Insulin resistance 155.77 9.51 82 305101 1652 110282464
Liver injury 153.91 9.51 114 305069 150299 110133817
Sleep disorder 152.87 9.51 194 304989 198450 110085666
Chronic kidney disease 151.91 9.51 510 304673 75781 110208335
Coronary artery disease 151.48 9.51 489 304694 71201 110212915
Acute myocardial infarction 151.14 9.51 542 304641 83235 110200881
Night sweats 149.89 9.51 92 305091 133891 110150225
Type 2 diabetes mellitus 149.37 9.51 161 305022 177071 110107045
Deep vein thrombosis postoperative 148.67 9.51 3 305180 59288 110224828
Grip strength decreased 148.53 9.51 22 305161 80152 110203964
Carotid artery thrombosis 148.37 9.51 157 305026 9481 110274635
Myelosuppression 147.38 9.51 39 305144 94301 110189815
Neurologic neglect syndrome 145.88 9.51 153 305030 9145 110274971
Eye haemorrhage 145.50 9.51 171 305012 11603 110272513
Mobility decreased 145.19 9.51 271 304912 237151 110046965
Maternal exposure during pregnancy 142.95 9.51 306 304877 254577 110029539
Wrong technique in device usage process 142.62 9.51 132 305051 6769 110277347
Diabetes mellitus 141.81 9.51 597 304586 98784 110185332
Wrong product administered 140.15 9.51 162 305021 10798 110273318
Anti-insulin antibody positive 136.98 9.51 45 305138 246 110283870
Blepharospasm 136.64 9.51 3 305180 54848 110229268
Rheumatoid arthritis 128.82 9.51 411 304772 299202 109984914
Sinusitis 126.85 9.51 408 304775 296280 109987836
Renal injury 126.57 9.51 203 304980 18510 110265606
Adjustment disorder 125.53 9.51 152 305031 10643 110273473
Therapeutic product effect incomplete 125.23 9.51 269 304914 223536 110060580
Fear 124.43 9.51 227 304956 22966 110261150
Multiple use of single-use product 121.31 9.51 63 305120 1233 110282883
Hypoglycaemia unawareness 120.66 9.51 40 305143 226 110283890
Product administration error 119.03 9.51 295 304888 36922 110247194
Product dispensing error 117.03 9.51 182 305001 16163 110267953
Pain 116.28 9.51 1895 303288 953060 109331056
Drug interaction 115.99 9.51 1982 303201 498201 109785915
Hemiplegia 115.98 9.51 218 304965 22564 110261552
Wound infection 115.40 9.51 61 305122 96404 110187712
Toe amputation 113.76 9.51 95 305088 4243 110279873
Hypoglycaemic encephalopathy 113.73 9.51 50 305133 663 110283453
Urticaria 113.58 9.51 473 304710 318384 109965732
Diabetic coma 112.51 9.51 61 305122 1307 110282809
Autoimmune disorder 112.42 9.51 22 305161 65461 110218655
Cardiac failure 112.28 9.51 894 304289 186732 110097384
Multi-organ disorder 112.14 9.51 85 305098 3296 110280820
Pulmonary vasculitis 112.06 9.51 113 305070 6447 110277669
Injury associated with device 110.74 9.51 94 305089 4295 110279821
Musculoskeletal pain 110.04 9.51 211 304972 182812 110101304
Increased insulin requirement 109.86 9.51 36 305147 195 110283921
Infection 109.69 9.51 570 304613 361630 109922486
Onychomadesis 108.24 9.51 4 305179 45659 110238457
Personality disorder 107.76 9.51 154 305029 12683 110271433
Dislocation of vertebra 106.59 9.51 3 305180 43718 110240398
Vitreous haemorrhage 106.56 9.51 94 305089 4526 110279590
Incorrect dose administered 106.47 9.51 566 304617 103075 110181041
Coordination abnormal 106.26 9.51 223 304960 25005 110259111
Blood creatinine increased 105.94 9.51 865 304318 182024 110102092
Peripheral swelling 105.09 9.51 668 304515 403366 109880750
Respiratory syncytial virus test positive 104.80 9.51 60 305123 1434 110282682
Peritonitis bacterial 104.49 9.51 137 305046 10396 110273720
Cutaneous amyloidosis 103.57 9.51 26 305157 39 110284077
Therapy non-responder 102.98 9.51 172 305011 157135 110126981
Diabetic nephropathy 102.89 9.51 82 305101 3426 110280690
Dialysis 102.70 9.51 190 304993 19429 110264687
Neuritis 102.49 9.51 114 305069 7285 110276831
Nail disorder 100.44 9.51 19 305164 57916 110226200
Sensory loss 100.26 9.51 198 304985 21259 110262857
Mental status changes 99.95 9.51 446 304737 75676 110208440
Product dispensing issue 98.33 9.51 44 305139 610 110283506
C-reactive protein increased 97.85 9.51 293 304890 217626 110066490
Live birth 97.26 9.51 35 305148 69449 110214667
Gastrooesophageal reflux disease 96.83 9.51 221 304962 179755 110104361
Prescribed overdose 96.76 9.51 61 305122 87520 110196596
Skin haemorrhage 96.02 9.51 212 304971 24615 110259501
Eating disorder 95.95 9.51 242 304941 30616 110253500
Hypoaesthesia 94.29 9.51 496 304687 313727 109970389
Pulmonary oedema 94.21 9.51 536 304647 100123 110183993
Diabetic complication 94.14 9.51 55 305128 1367 110282749
Hyperinsulinaemic hypoglycaemia 94.05 9.51 34 305149 258 110283858
Ketosis 93.38 9.51 59 305124 1695 110282421
Bone erosion 92.50 9.51 10 305173 46361 110237755
Fall 91.11 9.51 2244 302939 601238 109682878
Pancreatitis 90.81 9.51 503 304680 93030 110191086
Hypotension 90.19 9.51 1984 303199 521865 109762251
Insomnia 89.79 9.51 604 304579 359986 109924130
Sciatica 89.49 9.51 74 305109 92325 110191791
X-ray abnormal 88.13 9.51 4 305179 38113 110246003
Red blood cell sedimentation rate increased 87.25 9.51 54 305129 78248 110205868
Type 1 diabetes mellitus 87.16 9.51 116 305067 8931 110275185
Ketonuria 85.86 9.51 52 305131 1383 110282733
Cataract 85.72 9.51 440 304743 79045 110205071
Hip arthroplasty 85.43 9.51 24 305159 55789 110228327
Pancreatitis acute 83.58 9.51 359 304824 59915 110224201
Hypercholesterolaemia 82.84 9.51 77 305106 90760 110193356
Colitis ulcerative 82.59 9.51 56 305127 77307 110206809
Blindness 82.29 9.51 254 304929 36105 110248011
Taste disorder 81.73 9.51 39 305144 65348 110218768
Frequent bowel movements 81.27 9.51 48 305135 71342 110212774
Angina unstable 80.88 9.51 155 305028 16277 110267839
Injection site pain 79.75 9.51 796 304387 177126 110106990
Motor dysfunction 79.68 9.51 195 304988 24211 110259905
Disease progression 79.62 9.51 374 304809 243660 110040456
Hemiparesis 79.14 9.51 284 304899 43619 110240497
Neutropenia 77.40 9.51 661 304522 373959 109910157
Anhedonia 76.51 9.51 146 305037 15282 110268834
Human rhinovirus test positive 76.37 9.51 46 305137 1211 110282905
Wheezing 75.92 9.51 404 304779 254826 110029290
Systemic infection 75.47 9.51 113 305070 9706 110274410
Obesity 75.06 9.51 123 305060 113228 110170888
Polyuria 74.94 9.51 157 305026 17581 110266535
Total lung capacity abnormal 74.74 9.51 77 305106 4506 110279610
Asthma 74.55 9.51 396 304787 249895 110034221
Foot deformity 73.92 9.51 21 305162 48459 110235657
Respiratory failure 73.07 9.51 912 304271 214420 110069696
Affect lability 73.04 9.51 160 305023 18477 110265639
Paraesthesia 72.98 9.51 455 304728 276066 110008050
Treatment noncompliance 72.51 9.51 395 304788 72595 110211521
Drug ineffective for unapproved indication 72.47 9.51 107 305076 102731 110181385
Sepsis 72.14 9.51 1287 303896 326059 109958057
Fatigue 72.04 9.51 2688 302495 1213270 109070846
Infective pulmonary exacerbation of cystic fibrosis 69.85 9.51 137 305046 14634 110269482
Pancreatic carcinoma metastatic 69.80 9.51 71 305112 4093 110280023
Contusion 69.62 9.51 369 304814 232992 110051124
Injection site haemorrhage 69.50 9.51 225 304958 32803 110251313
Knee arthroplasty 69.35 9.51 47 305136 64901 110219215
Aphasia 68.14 9.51 333 304850 58664 110225452
Asthenia 67.70 9.51 2429 302754 686570 109597546
Coeliac disease 67.17 9.51 18 305165 43169 110240947
White blood cell count decreased 66.62 9.51 366 304817 229024 110055092
Cardiac arrest 66.62 9.51 833 304350 195920 110088196
Normochromic normocytic anaemia 66.53 9.51 125 305058 12932 110271184
Hypothermia 66.41 9.51 191 304992 26111 110258005
Retinopathy 66.15 9.51 71 305112 4358 110279758
Glomerular filtration rate decreased 64.34 9.51 201 304982 28755 110255361
Unresponsive to stimuli 63.89 9.51 346 304837 63444 110220672
Anaemia 63.23 9.51 1966 303217 545120 109738996
Blindness transient 63.05 9.51 80 305103 5876 110278240
Emotional distress 62.86 9.51 268 304915 44579 110239537
Bradycardia 62.70 9.51 681 304502 154836 110129280
Dyspepsia 62.68 9.51 292 304891 190673 110093443
Cardiac disorder 62.29 9.51 392 304791 75888 110208228
Onychomycosis 61.97 9.51 15 305168 38516 110245600
Gastrointestinal haemorrhage 61.83 9.51 714 304469 164804 110119312
Hyperhidrosis 61.72 9.51 789 304394 186509 110097607
Arteriosclerosis 61.71 9.51 179 305004 24588 110259528
Glycosylated haemoglobin abnormal 61.60 9.51 29 305154 455 110283661
Haemodialysis 61.53 9.51 145 305038 17574 110266542
Blood urea increased 60.49 9.51 306 304877 54651 110229465
Eosinophilic granulomatosis with polyangiitis 60.40 9.51 107 305076 10579 110273537
Oedema peripheral 60.10 9.51 1256 303927 327404 109956712
Neck pain 60.10 9.51 159 305024 122971 110161145
Myocardial ischaemia 60.01 9.51 186 304997 26498 110257618
Hepatic encephalopathy 59.91 9.51 193 304990 28063 110256053
Adverse event 59.83 9.51 132 305051 108677 110175439
Adverse drug reaction 59.75 9.51 126 305057 105433 110178683
Blood triglycerides increased 59.69 9.51 173 305010 23753 110260363
Visual acuity reduced 59.60 9.51 210 304973 31963 110252153
Finger deformity 59.21 9.51 10 305173 33082 110251034
Visual impairment 59.06 9.51 599 304584 133829 110150287
Impaired gastric emptying 59.03 9.51 120 305063 13155 110270961
Viral test positive 58.23 9.51 34 305149 844 110283272
Back injury 58.13 9.51 29 305154 47370 110236746
Exostosis 58.07 9.51 27 305156 45929 110238187
Sopor 58.04 9.51 227 304956 36319 110247797
Accidental underdose 57.51 9.51 39 305144 1266 110282850
Dysarthria 57.13 9.51 413 304770 83708 110200408
Blood insulin increased 56.88 9.51 26 305157 380 110283736
Lower limb fracture 56.48 9.51 75 305108 75273 110208843
Syncope 56.06 9.51 827 304356 201709 110082407
Anuria 55.97 9.51 171 305012 24170 110259946
Acute coronary syndrome 55.63 9.51 165 305018 22947 110261169
Spirometry abnormal 55.31 9.51 72 305111 5425 110278691
Shock hypoglycaemic 55.29 9.51 22 305161 223 110283893
Ear infection 55.07 9.51 55 305128 62677 110221439
Hypervolaemia 54.87 9.51 276 304907 49184 110234932
Anti-insulin antibody increased 54.70 9.51 18 305165 99 110284017
Lupus-like syndrome 54.67 9.51 22 305161 40770 110243346
Osteoporosis 54.56 9.51 98 305085 87054 110197062
Generalised oedema 53.97 9.51 197 304986 30507 110253609
Epilepsy 53.93 9.51 123 305060 100086 110184030
Hyperglycaemic hyperosmolar nonketotic syndrome 53.55 9.51 53 305130 2956 110281160
Neurological symptom 53.41 9.51 127 305056 15481 110268635
Sinus congestion 53.17 9.51 195 304988 30264 110253852
Product complaint 52.56 9.51 118 305065 13854 110270262
Injection site reaction 52.38 9.51 104 305079 88966 110195150
Wrong technique in product usage process 52.11 9.51 416 304767 86932 110197184
Laryngitis 51.94 9.51 26 305157 42385 110241731
Antineutrophil cytoplasmic antibody positive 51.87 9.51 67 305116 5009 110279107
Device expulsion 51.73 9.51 11 305172 30880 110253236
Pemphigoid 51.59 9.51 145 305038 19562 110264554
Diabetic ketosis 51.12 9.51 32 305151 904 110283212
Non-cardiogenic pulmonary oedema 51.10 9.51 43 305140 1941 110282175
Tongue biting 50.89 9.51 51 305132 2888 110281228
Blood potassium increased 50.77 9.51 204 304979 33045 110251071
Blood ketone body increased 50.12 9.51 31 305152 857 110283259
Drug tolerance decreased 50.00 9.51 8 305175 27532 110256584
Microalbuminuria 49.58 9.51 35 305148 1214 110282902
Urosepsis 49.09 9.51 191 304992 30484 110253632
Liver function test increased 49.03 9.51 107 305076 88441 110195675
Unevaluable event 48.13 9.51 304 304879 58923 110225193
Muscle spasms 47.97 9.51 513 304670 277644 110006472
Sneezing 47.85 9.51 195 304988 31789 110252327
Mite allergy 47.80 9.51 69 305114 5734 110278382
Dust allergy 47.47 9.51 70 305113 5931 110278185
Renal tubular necrosis 47.35 9.51 188 304995 30287 110253829
Cold sweat 47.18 9.51 151 305032 21880 110262236
Myopathy 47.17 9.51 164 305019 24796 110259320
Product use issue 47.10 9.51 592 304591 311103 109973013
Hypovolaemia 46.82 9.51 149 305034 21525 110262591
Leg amputation 46.79 9.51 58 305125 4160 110279956
Pulmonary alveolar haemorrhage 46.75 9.51 142 305041 20008 110264108
Adverse reaction 46.66 9.51 12 305171 29582 110254534
Shock 46.66 9.51 280 304903 53308 110230808
Mycotic allergy 46.45 9.51 69 305114 5885 110278231
Ear pain 46.34 9.51 47 305136 53179 110230937
Glycosuria 46.20 9.51 46 305137 2584 110281532
Encephalopathy 46.17 9.51 382 304801 80673 110203443
Maternal exposure timing unspecified 46.11 9.51 3 305180 21010 110263106
Urine ketone body present 46.10 9.51 55 305128 3791 110280325
International normalised ratio increased 45.25 9.51 401 304782 86371 110197745
COVID-19 45.12 9.51 445 304738 244615 110039501
Ischaemic cardiomyopathy 45.00 9.51 80 305103 7931 110276185
Product label confusion 44.95 9.51 5 305178 22672 110261444
Diabetic gastroparesis 44.88 9.51 22 305161 379 110283737
Headache 44.54 9.51 1986 303197 880391 109403725
Cholestasis 44.52 9.51 318 304865 64200 110219916
Respiratory symptom 44.18 9.51 115 305068 14830 110269286
Respiratory tract congestion 43.71 9.51 185 304998 30672 110253444
Gastrointestinal disorder 43.44 9.51 442 304741 241510 110042606
Pregnancy 43.44 9.51 46 305137 51021 110233095
Hypertensive crisis 43.36 9.51 157 305026 24215 110259901
Sedation complication 43.08 9.51 3 305180 19852 110264264
Adenocarcinoma pancreas 42.40 9.51 41 305142 2222 110281894
Road traffic accident 42.25 9.51 153 305030 107245 110176871
Electrolyte imbalance 42.04 9.51 208 304975 36820 110247296
Device use issue 41.93 9.51 52 305131 3732 110280384
Sinus disorder 41.64 9.51 190 304993 32538 110251578
Left ventricular hypertrophy 41.32 9.51 104 305079 13140 110270976
Conjunctivitis allergic 41.25 9.51 71 305112 6860 110277256
Mouth haemorrhage 41.12 9.51 105 305078 13383 110270733
Peripheral vascular disorder 41.11 9.51 80 305103 8496 110275620
Device delivery system issue 40.64 9.51 39 305144 2094 110282022
Malnutrition 40.56 9.51 166 305017 27113 110257003
Oropharyngeal pain 40.27 9.51 214 304969 135062 110149054
Product dose omission issue 40.25 9.51 1168 304015 320614 109963502
Oral herpes 40.03 9.51 25 305158 36055 110248061
Joint stiffness 39.98 9.51 78 305105 67165 110216951
Drug administered in wrong device 39.96 9.51 15 305168 128 110283988
Pyrexia 39.94 9.51 2049 303134 896216 109387900
Liver disorder 39.63 9.51 230 304953 142013 110142103
Hypertriglyceridaemia 39.52 9.51 116 305067 16038 110268078
Drug dependence 39.35 9.51 48 305135 49972 110234144
Cardiovascular disorder 39.13 9.51 145 305038 22615 110261501
Haematoma 39.07 9.51 286 304897 58190 110225926
Peripheral arterial occlusive disease 39.04 9.51 82 305101 9198 110274918
Neutrophil count decreased 39.04 9.51 186 304997 120755 110163361
Device interaction 38.84 9.51 25 305158 742 110283374
Chronic sinusitis 37.99 9.51 11 305172 25073 110259043
Diabetic foot infection 37.96 9.51 26 305157 858 110283258
Expired product administered 37.94 9.51 76 305107 8244 110275872
Pneumonia haemophilus 37.89 9.51 42 305141 2673 110281443
Malignant neoplasm progression 37.84 9.51 304 304879 174263 110109853
Toxicity to various agents 37.79 9.51 1023 304160 479532 109804584
Diabetic hyperglycaemic coma 37.75 9.51 13 305170 84 110284032
Forced expiratory volume decreased 37.54 9.51 100 305083 13076 110271040
Skin exfoliation 37.27 9.51 388 304795 87263 110196853
Renal disorder 37.17 9.51 249 304934 49230 110234886
Anti-insulin antibody 37.09 9.51 12 305171 62 110284054
Foot amputation 36.62 9.51 28 305155 1100 110283016
Drug resistance 36.55 9.51 62 305121 56312 110227804
Vomiting 36.43 9.51 2951 302232 907724 109376392
Diabetic ketoacidotic hyperglycaemic coma 36.38 9.51 17 305166 262 110283854
Haemophagocytic lymphohistiocytosis 36.23 9.51 21 305162 31538 110252578
Nasal congestion 36.08 9.51 144 305039 98138 110185978
Glycosylated haemoglobin decreased 35.93 9.51 25 305158 847 110283269
Mucosal inflammation 35.84 9.51 140 305043 96001 110188115
Anti-GAD antibody positive 35.73 9.51 12 305171 71 110284045
Hypophagia 35.51 9.51 258 304925 52368 110231748
Thyroid disorder 35.16 9.51 115 305068 16854 110267262
Heparin-induced thrombocytopenia 34.90 9.51 89 305094 11335 110272781
Peritoneal dialysis complication 34.87 9.51 39 305144 2507 110281609
Insulin autoimmune syndrome 34.68 9.51 23 305160 719 110283397
Pruritus 34.63 9.51 1284 303899 580276 109703840
Arrhythmia 34.48 9.51 318 304865 69257 110214859
Hepatocellular carcinoma 34.47 9.51 81 305102 9799 110274317
Rheumatoid nodule 34.46 9.51 7 305176 20289 110263827
Arteriosclerosis coronary artery 34.35 9.51 149 305034 24969 110259147
Therapeutic drug monitoring analysis not performed 34.34 9.51 34 305149 1897 110282219
Osteomyelitis 34.30 9.51 195 304988 36405 110247711
Immunodeficiency 34.15 9.51 34 305149 38804 110245312
Hot flush 33.97 9.51 83 305100 65953 110218163
Jaundice 33.64 9.51 279 304904 58957 110225159
Polydipsia 33.60 9.51 69 305114 7619 110276497
Depression 33.57 9.51 645 304538 316690 109967426
Prescribed underdose 33.47 9.51 82 305101 65092 110219024
Acidosis 33.42 9.51 137 305046 22394 110261722
Device dispensing error 33.14 9.51 15 305168 214 110283902
Proctitis 32.88 9.51 4 305179 16923 110267193
Cellulitis 32.70 9.51 509 304674 125507 110158609
Blood pressure fluctuation 32.57 9.51 102 305081 74722 110209394
Infusion site reaction 32.41 9.51 5 305178 17677 110266439
Macular oedema 32.20 9.51 64 305119 6902 110277214
Dry eye 32.07 9.51 66 305117 55727 110228389
Product monitoring error 32.03 9.51 74 305109 8853 110275263
Therapy partial responder 31.95 9.51 33 305150 37028 110247088
Potentiating drug interaction 31.80 9.51 87 305096 11556 110272560
Food allergy 31.62 9.51 8 305175 19940 110264176
Peripheral ischaemia 31.58 9.51 84 305099 10974 110273142
Capillaritis 31.10 9.51 36 305147 2403 110281713
Hypoacusis 30.71 9.51 184 304999 35007 110249109
High density lipoprotein decreased 30.61 9.51 56 305127 5677 110278439
Oliguria 30.53 9.51 117 305066 18540 110265576
Leukocytosis 30.29 9.51 253 304930 53575 110230541
Retinal haemorrhage 30.05 9.51 75 305108 9426 110274690
Hypertension 29.95 9.51 1128 304055 508956 109775160
Altered state of consciousness 29.88 9.51 266 304917 57360 110226756
Pulmonary interstitial emphysema syndrome 29.76 9.51 19 305164 556 110283560
Emphysematous pyelonephritis 29.67 9.51 19 305164 559 110283557
Extremity necrosis 29.57 9.51 44 305139 3758 110280358
Injection site nodule 29.52 9.51 49 305134 4597 110279519
Impaired quality of life 29.11 9.51 24 305159 29993 110254123
Cytokine release syndrome 29.10 9.51 98 305085 70208 110213908
Vasculitis 29.06 9.51 184 304999 35689 110248427
Loss of personal independence in daily activities 29.05 9.51 269 304914 149751 110134365
Hyperlactacidaemia 28.98 9.51 68 305115 8218 110275898
Cardio-respiratory arrest 28.97 9.51 465 304718 115371 110168745
Diabetic hepatopathy 28.96 9.51 7 305176 8 110284108
Tremor 28.64 9.51 746 304437 201486 110082630
Diabetic hyperosmolar coma 28.43 9.51 22 305161 880 110283236
Cystitis 28.40 9.51 293 304890 65743 110218373
Fibromuscular dysplasia 28.15 9.51 15 305168 310 110283806
Liquid product physical issue 28.14 9.51 28 305155 1572 110282544
Pre-eclampsia 28.12 9.51 69 305114 8581 110275535
Transient ischaemic attack 28.04 9.51 285 304898 63697 110220419
Acetonaemia 27.59 9.51 18 305165 547 110283569
Amputation 27.44 9.51 22 305161 927 110283189
Peripheral artery haematoma 27.35 9.51 11 305172 115 110284001
Blood creatine phosphokinase increased 27.17 9.51 315 304868 72762 110211354
Hyperosmolar state 26.97 9.51 20 305163 750 110283366
Neutropenic sepsis 26.94 9.51 27 305156 30719 110253397
Vaginal discharge 26.86 9.51 8 305175 17900 110266216
Erythema 26.52 9.51 607 304576 290840 109993276
Crystal nephropathy 26.40 9.51 29 305154 1827 110282289
Pharyngitis 26.40 9.51 138 305045 24960 110259156
Diabetic gangrene 26.31 9.51 13 305170 228 110283888
Intentional self-injury 26.31 9.51 39 305144 37390 110246726
Erythrodermic psoriasis 26.19 9.51 30 305153 1980 110282136
Bone pain 26.14 9.51 92 305091 65041 110219075
Nephrogenic systemic fibrosis 26.10 9.51 51 305132 5432 110278684
Confusional state 26.07 9.51 1561 303622 467119 109816997
Alveolar lung disease 25.91 9.51 19 305164 700 110283416
Blood ketone body 25.85 9.51 12 305171 182 110283934
Urinary tract infection 25.79 9.51 1124 304059 325158 109958958
Insulin C-peptide increased 25.74 9.51 12 305171 184 110283932
Condition aggravated 25.64 9.51 1715 303468 733121 109550995
Hepatic steatosis 25.63 9.51 226 304957 48605 110235511
Oedematous pancreatitis 25.56 9.51 27 305156 1627 110282489
Decreased insulin requirement 25.42 9.51 11 305172 140 110283976
Tenosynovitis 24.92 9.51 7 305176 16276 110267840
Glucose urine present 24.63 9.51 31 305152 2258 110281858
Caesarean section 24.57 9.51 89 305094 13728 110270388
Coronary artery occlusion 24.26 9.51 97 305086 15675 110268441
Colitis 24.15 9.51 174 305009 102149 110181967
Injury 24.10 9.51 344 304839 176921 110107195
Therapeutic drug monitoring analysis incorrectly performed 23.84 9.51 18 305165 694 110283422
Disorientation 23.81 9.51 299 304884 70372 110213744
Cystic fibrosis 23.74 9.51 45 305138 4686 110279430
Kidney transplant rejection 23.73 9.51 80 305103 11907 110272209
Multiple-drug resistance 23.68 9.51 4 305179 13231 110270885
Wrong drug 23.58 9.51 15 305168 436 110283680
Upper respiratory tract infection 23.52 9.51 240 304943 131088 110153028
Keratitis 23.47 9.51 47 305136 5097 110279019
Back pain 23.44 9.51 813 304370 370183 109913933
Eye irritation 23.38 9.51 35 305148 33417 110250699
Sinus arrest 23.37 9.51 42 305141 4200 110279916
Tinnitus 23.31 9.51 87 305096 60453 110223663
Atrial fibrillation 23.31 9.51 813 304370 228829 110055287
Latent autoimmune diabetes in adults 23.28 9.51 11 305172 174 110283942
Left atrial dilatation 23.23 9.51 38 305145 3522 110280594
Walking aid user 23.16 9.51 21 305162 25054 110259062
Product prescribing error 23.15 9.51 230 304953 51101 110233015
Coronary artery stenosis 23.11 9.51 87 305096 13671 110270445
Ureteric compression 23.07 9.51 13 305170 301 110283815
Metabolic syndrome 23.03 9.51 36 305147 3211 110280905
Toothache 23.02 9.51 127 305056 23448 110260668
Hypoxia 23.00 9.51 493 304690 129022 110155094
Mucormycosis 22.90 9.51 73 305110 10555 110273561
Haematotoxicity 22.85 9.51 15 305168 21067 110263049
Polyarthritis 22.66 9.51 12 305171 18951 110265165
Diaphragmatic disorder 22.66 9.51 27 305156 1859 110282257
Insulin C-peptide decreased 22.64 9.51 9 305174 91 110284025
Flushing 22.41 9.51 183 305000 104553 110179563
Device dislocation 22.32 9.51 33 305150 31671 110252445
Weight decreased 22.23 9.51 1538 303645 466519 109817597
Ischaemic stroke 22.19 9.51 192 304991 41071 110243045
Dawn phenomenon 22.14 9.51 5 305178 3 110284113
Pyelonephritis 22.02 9.51 132 305051 25118 110258998
Blood ketone body present 22.01 9.51 10 305173 144 110283972
Haemoptysis 21.99 9.51 297 304886 71057 110213059
Bronchiectasis 21.98 9.51 42 305141 36451 110247665
Retinal aneurysm 21.85 9.51 12 305171 264 110283852
Joint dislocation 21.80 9.51 38 305145 34152 110249964
Bundle branch block right 21.72 9.51 79 305104 12212 110271904
Basal cell carcinoma 21.67 9.51 59 305124 45211 110238905
Suture rupture 21.63 9.51 17 305166 696 110283420
Extrasystoles 21.58 9.51 61 305122 8257 110275859
Plasmapheresis 21.51 9.51 18 305165 806 110283310
Multiple sclerosis relapse 21.50 9.51 69 305114 50171 110233945
Cerebral infarction 21.34 9.51 228 304955 51610 110232506
Cytomegalovirus infection reactivation 21.33 9.51 12 305171 18321 110265795
Diabetic retinal oedema 21.33 9.51 14 305169 430 110283686
Blood parathyroid hormone decreased 21.24 9.51 5 305178 13084 110271032
Tongue injury 21.21 9.51 16 305167 616 110283500
Joint effusion 21.17 9.51 16 305167 20889 110263227
Mydriasis 21.14 9.51 18 305165 22139 110261977
Head injury 21 9.51 196 304987 42821 110241295
Feeling hot 20.98 9.51 156 305027 90950 110193166
Biliary obstruction 20.97 9.51 47 305136 5511 110278605
Bone density decreased 20.93 9.51 9 305174 16033 110268083
Hepatic neoplasm 20.93 9.51 38 305145 3829 110280287
Blindness unilateral 20.89 9.51 67 305116 9719 110274397
Endocarditis enterococcal 20.87 9.51 13 305170 364 110283752
Coma 20.72 9.51 448 304735 117421 110166695
Somogyi phenomenon 20.55 9.51 5 305178 6 110284110
Neuropathic arthropathy 20.47 9.51 15 305168 552 110283564
Haematuria 20.30 9.51 332 304851 82673 110201443
Ventricular hyperkinesia 20.16 9.51 12 305171 309 110283807
Needle issue 20.10 9.51 100 305083 17740 110266376
Paraesthesia oral 20.07 9.51 39 305144 33632 110250484
Cardiogenic shock 19.92 9.51 244 304939 57094 110227022
Acute respiratory failure 19.91 9.51 305 304878 74955 110209161
Hypoglycaemia neonatal 19.85 9.51 7 305176 49 110284067
Sedation 19.77 9.51 112 305071 69571 110214545
Blood alkaline phosphatase increased 19.75 9.51 290 304893 70645 110213471
Seronegative arthritis 19.55 9.51 6 305177 13171 110270945
Herpes zoster 19.43 9.51 198 304985 108181 110175935
Pancreatitis chronic 19.42 9.51 40 305143 4425 110279691
Pancreatic failure 19.41 9.51 28 305155 2326 110281790
Palpitations 19.36 9.51 576 304607 158636 110125480
Respiratory tract infection 19.31 9.51 117 305066 71500 110212616
Anaphylactic shock 19.25 9.51 75 305108 51471 110232645
Pancreatic disorder 19.23 9.51 37 305146 3897 110280219
Nervousness 19.05 9.51 170 305013 36681 110247435
Myoclonus 19.05 9.51 156 305027 32842 110251274
Multiple organ dysfunction syndrome 19.04 9.51 551 304632 151159 110132957
Pulse pressure decreased 19.04 9.51 13 305170 427 110283689
Pulseless electrical activity 18.93 9.51 94 305089 16663 110267453
Premature delivery 18.87 9.51 147 305036 30485 110253631
Acute graft versus host disease 18.87 9.51 6 305177 12875 110271241
Depressed level of consciousness 18.86 9.51 424 304759 111854 110172262
Exposure to toxic agent 18.82 9.51 6 305177 12852 110271264
Eosinophilic pneumonia 18.75 9.51 53 305130 7174 110276942
Presyncope 18.74 9.51 212 304971 48675 110235441
Injection site erythema 18.61 9.51 168 305015 94008 110190108
Liver transplant failure 18.57 9.51 9 305174 151 110283965
Mast cell activation syndrome 18.56 9.51 22 305161 1506 110282610
Tachypnoea 18.49 9.51 178 305005 39217 110244899
Rhinitis 18.41 9.51 21 305162 22524 110261592
Nightmare 18.34 9.51 51 305132 38812 110245304
Exposure to allergen 18.29 9.51 14 305169 551 110283565
Diabetic ulcer 18.25 9.51 10 305173 219 110283897
Adenovirus infection 18.24 9.51 4 305179 10990 110273126
Neoplasm progression 18.23 9.51 104 305079 64491 110219625
Disease recurrence 18.17 9.51 96 305087 60688 110223428
Rhythm idioventricular 18.16 9.51 16 305167 769 110283347
Retinal exudates 18.16 9.51 20 305163 1264 110282852
Incorrect route of product administration 18.15 9.51 103 305080 63958 110220158
Product name confusion 18.13 9.51 10 305173 222 110283894
Oral candidiasis 18.11 9.51 63 305120 44697 110239419
Immobilisation prolonged 18.11 9.51 9 305174 160 110283956
Throat irritation 18.09 9.51 81 305102 53471 110230645
Pneumocystis jirovecii pneumonia 18.08 9.51 59 305124 42676 110241440
Lymphangiectasia 18.07 9.51 8 305175 108 110284008
Hypernatraemia 18.04 9.51 97 305086 17736 110266380
Sudden death 17.86 9.51 122 305061 24273 110259843
Pulse absent 17.82 9.51 70 305113 11222 110272894
Eosinophilia 17.79 9.51 241 304942 57695 110226421
Gait inability 17.72 9.51 267 304916 136109 110148007
Muscle spasticity 17.71 9.51 164 305019 35751 110248365
Drug tolerance 17.71 9.51 12 305171 16573 110267543
Dermatitis exfoliative 17.63 9.51 70 305113 11277 110272839
Hypothyroidism 17.61 9.51 291 304892 72608 110211508
Blood insulin abnormal 17.52 9.51 6 305177 38 110284078
Paradoxical drug reaction 17.49 9.51 3 305180 9814 110274302
Aortic valve replacement 17.46 9.51 22 305161 1604 110282512
Renal cell carcinoma 17.41 9.51 53 305130 7477 110276639
Patella fracture 17.35 9.51 27 305156 2399 110281717
Fracture blisters 17.33 9.51 7 305176 74 110284042
Gingival pain 17.32 9.51 11 305172 15725 110268391
Guillain-Barre syndrome 17.27 9.51 67 305116 10677 110273439
Arterial bypass operation 17.26 9.51 6 305177 40 110284076
Phimosis 17.24 9.51 16 305167 823 110283293
Memory impairment 17.12 9.51 413 304770 196531 110087585
Spondylitis 17.12 9.51 5 305178 11333 110272783
Device malfunction 17.07 9.51 125 305058 25433 110258683
Ankylosing spondylitis 17.07 9.51 11 305172 15601 110268515
Groin abscess 17.06 9.51 24 305159 1948 110282168
Mitral valve replacement 17.02 9.51 14 305169 612 110283504
Panniculitis 17.01 9.51 11 305172 15571 110268545
ECG signs of myocardial ischaemia 17.00 9.51 12 305171 416 110283700
Delirium 16.98 9.51 266 304917 134759 110149357
Aphthous ulcer 16.92 9.51 20 305163 21116 110263000
Upper motor neurone lesion 16.90 9.51 11 305172 333 110283783
Acute pulmonary oedema 16.89 9.51 92 305091 16904 110267212
Drug effective for unapproved indication 16.88 9.51 9 305174 14158 110269958
Dementia 16.83 9.51 147 305036 31526 110252590
Melaena 16.81 9.51 275 304908 68482 110215634
Obstructive airways disorder 16.74 9.51 198 304985 45951 110238165
Amnesia 16.74 9.51 198 304985 105210 110178906
Sprue-like enteropathy 16.73 9.51 22 305161 1674 110282442
Haemoglobin decreased 16.69 9.51 843 304340 247884 110036232
Acne 16.57 9.51 43 305140 33477 110250639
Vitrectomy 16.51 9.51 10 305173 266 110283850
Flour sensitivity 16.49 9.51 5 305178 20 110284096
Blood glucose normal 16.49 9.51 5 305178 20 110284096
Diabetic bullosis 16.49 9.51 5 305178 20 110284096
Hypomania 16.37 9.51 4 305179 10206 110273910
Coronary artery bypass 16.35 9.51 45 305138 5997 110278119
Product odour abnormal 16.34 9.51 21 305162 1562 110282554
Urinary tract infection fungal 16.32 9.51 19 305164 1276 110282840
Thrombotic microangiopathy 16.32 9.51 35 305148 29114 110255002
Facial nerve disorder 16.24 9.51 15 305168 767 110283349
Metabolic encephalopathy 16.20 9.51 67 305116 10993 110273123
Localised infection 16.20 9.51 186 304997 42862 110241254
Skin pressure mark 16.19 9.51 7 305176 89 110284027
Hyperinsulinaemia 16.15 9.51 10 305173 277 110283839
Ureteric obstruction 16.10 9.51 30 305153 3084 110281032
Lung disorder 16.09 9.51 376 304807 179671 110104445
Body temperature increased 16.03 9.51 87 305096 54626 110229490
Immunosuppressant drug level decreased 15.99 9.51 28 305155 2743 110281373
Heavy menstrual bleeding 15.97 9.51 13 305170 16352 110267764
Polyhydramnios 15.95 9.51 23 305160 1910 110282206
Ulcer 15.93 9.51 63 305120 43053 110241063
Abdominal pain upper 15.90 9.51 794 304389 348317 109935799
Intraventricular haemorrhage 15.89 9.51 42 305141 5465 110278651
Blood chloride increased 15.82 9.51 46 305137 6326 110277790
No adverse event 15.80 9.51 129 305054 73710 110210406
Completed suicide 15.80 9.51 529 304654 241852 110042264
Laser therapy 15.75 9.51 5 305178 24 110284092
Eye infection staphylococcal 15.72 9.51 9 305174 215 110283901
Immune reconstitution inflammatory syndrome 15.70 9.51 13 305170 16213 110267903
Constipation 15.67 9.51 817 304366 356969 109927147
Retinopathy proliferative 15.67 9.51 8 305175 151 110283965
Metabolic disorder 15.66 9.51 64 305119 10446 110273670
Atrioventricular block complete 15.65 9.51 102 305081 19980 110264136
Preternatural anus 15.58 9.51 7 305176 98 110284018
Proteinuria 15.55 9.51 174 305009 39844 110244272
Atrioventricular block first degree 15.51 9.51 79 305104 14146 110269970
Psychotic disorder 15.48 9.51 80 305103 50857 110233259
Hypochromasia 15.46 9.51 14 305169 698 110283418
Injection site hypertrophy 15.46 9.51 7 305176 100 110284016
Calciphylaxis 15.35 9.51 35 305148 4152 110279964
Silent myocardial infarction 15.31 9.51 14 305169 707 110283409
Laboratory test abnormal 15.29 9.51 66 305117 44013 110240103
Paralysis 15.20 9.51 84 305099 15516 110268600
Postprandial hypoglycaemia 15.16 9.51 8 305175 162 110283954
Low density lipoprotein increased 15.15 9.51 64 305119 10602 110273514
Injection site mass 15.10 9.51 118 305065 24495 110259621
Pyelocaliectasis 15.09 9.51 17 305166 1102 110283014
Premature rupture of membranes 15.08 9.51 37 305146 4600 110279516
Blood creatinine abnormal 15.08 9.51 43 305140 5849 110278267
Extra dose administered 15.03 9.51 70 305113 12089 110272027
Right atrial enlargement 15.00 9.51 12 305171 504 110283612
Leukopenia 14.94 9.51 305 304878 148486 110135630
MELAS syndrome 14.90 9.51 10 305173 319 110283797
Nasal polyps 14.85 9.51 9 305174 13191 110270925
Cardioactive drug level increased 14.84 9.51 33 305150 3849 110280267
Amylase decreased 14.84 9.51 9 305174 240 110283876
Visceral venous thrombosis 14.69 9.51 5 305178 31 110284085
Base excess abnormal 14.69 9.51 3 305180 0 110284116
Lipase increased 14.65 9.51 95 305088 18577 110265539
Cholangitis 14.63 9.51 86 305097 16249 110267867
Blood bicarbonate decreased 14.54 9.51 42 305141 5755 110278361
Acute myeloid leukaemia 14.52 9.51 55 305128 38055 110246061
Hypokalaemia 14.51 9.51 629 304554 181819 110102297
Foetal hypokinesia 14.48 9.51 11 305172 428 110283688
Infusion site pain 14.47 9.51 16 305167 17403 110266713
Amyloidosis 14.43 9.51 29 305154 3152 110280964
Injection site bruising 14.43 9.51 210 304973 51053 110233063
Necrobiosis lipoidica diabeticorum 14.43 9.51 5 305178 33 110284083
Optic discs blurred 14.33 9.51 6 305177 70 110284046
Cardiac ventricular disorder 14.31 9.51 10 305173 341 110283775
Periodontitis 14.31 9.51 39 305144 5169 110278947
Extrapyramidal disorder 14.29 9.51 37 305146 28830 110255286
Disseminated cryptococcosis 14.24 9.51 26 305157 2631 110281485
Skin induration 14.22 9.51 35 305148 4360 110279756
Medullary thyroid cancer 14.19 9.51 10 305173 346 110283770
Device failure 14.18 9.51 48 305135 7159 110276957
Rebound effect 14.16 9.51 12 305171 14794 110269322
Posterior reversible encephalopathy syndrome 14.15 9.51 47 305136 33814 110250302
Urinary tract candidiasis 14.13 9.51 17 305166 1182 110282934
Bronchopulmonary aspergillosis allergic 14.11 9.51 3 305180 8423 110275693
Dermatitis papillaris capillitii 14.07 9.51 4 305179 12 110284104
Pulmonary toxicity 13.99 9.51 17 305166 17729 110266387
Bladder cancer 13.99 9.51 100 305083 20192 110263924
Epileptic encephalopathy 13.96 9.51 13 305170 672 110283444
Therapeutic response decreased 13.92 9.51 185 304998 96314 110187802
Eyelid bleeding 13.89 9.51 6 305177 76 110284040
Osteopenia 13.87 9.51 25 305158 22184 110261932
Oesophageal tuberculosis 13.83 9.51 4 305179 13 110284103
Glycogen storage disease type VIII 13.83 9.51 4 305179 13 110284103
Post procedural complication 13.79 9.51 123 305060 26535 110257581
Diet failure 13.71 9.51 5 305178 39 110284077
Dissociation 13.70 9.51 5 305178 9837 110274279
Epstein-Barr virus infection 13.69 9.51 19 305164 18719 110265397
Hypertransaminasaemia 13.68 9.51 29 305154 24226 110259890
Pseudohyponatraemia 13.65 9.51 8 305175 200 110283916
Haemodynamic instability 13.64 9.51 109 305074 22779 110261337
Hepatic failure 13.63 9.51 266 304917 68473 110215643
Blood pressure diastolic abnormal 13.63 9.51 32 305151 25783 110258333
Bradyarrhythmia 13.61 9.51 37 305146 4897 110279219
Medical device site abscess 13.58 9.51 8 305175 202 110283914
Alcohol poisoning 13.58 9.51 4 305179 9016 110275100
Device ineffective 13.54 9.51 8 305175 203 110283913
Haematocrit increased 13.49 9.51 37 305146 4922 110279194
Dysphagia 13.46 9.51 535 304648 153065 110131051
Klebsiella infection 13.44 9.51 98 305085 19911 110264205
Gallbladder neoplasm 13.42 9.51 6 305177 83 110284033
Left atrial enlargement 13.42 9.51 20 305163 1711 110282405
Radiation fibrosis 13.39 9.51 5 305178 42 110284074
Unintentional medical device removal 13.36 9.51 4 305179 8919 110275197
Amniorrhexis 13.29 9.51 5 305178 43 110284073
Prostatitis 13.24 9.51 36 305147 4765 110279351
Hypochromic anaemia 13.14 9.51 28 305155 3173 110280943
International normalised ratio abnormal 13.10 9.51 43 305140 6314 110277802
Skin hypertrophy 13.08 9.51 37 305146 5010 110279106
Cryptococcosis 13.04 9.51 35 305148 4596 110279520
Multiple injuries 13.01 9.51 30 305153 3584 110280532
Hunger 13.01 9.51 44 305139 6560 110277556
Eczema 12.99 9.51 132 305051 72161 110211955
Chromaturia 12.97 9.51 131 305052 29229 110254887
Septic shock 12.96 9.51 545 304638 156983 110127133
Electrocardiogram ST segment abnormal 12.95 9.51 20 305163 1765 110282351
Diabetic vascular disorder 12.91 9.51 7 305176 150 110283966
Ballismus 12.91 9.51 9 305174 306 110283810
Immune-mediated myositis 12.88 9.51 42 305141 6144 110277972
Medical device site cellulitis 12.88 9.51 8 305175 223 110283893
Cortisol increased 12.86 9.51 12 305171 622 110283494
Muscle necrosis 12.85 9.51 20 305163 1777 110282339
Intestinal haemorrhage 12.81 9.51 47 305136 7294 110276822
Nephropathy 12.78 9.51 72 305111 13395 110270721
Eschar 12.77 9.51 18 305165 1463 110282653
Thirst 12.73 9.51 103 305080 21604 110262512
Bilirubin conjugated increased 12.73 9.51 42 305141 6182 110277934
Intercepted product storage error 12.73 9.51 13 305170 753 110283363
Ulcer haemorrhage 12.72 9.51 27 305156 22544 110261572
Total cholesterol/HDL ratio increased 12.71 9.51 10 305173 410 110283706
Dermo-hypodermitis 12.71 9.51 18 305165 1470 110282646
Upper-airway cough syndrome 12.70 9.51 15 305168 15842 110268274
Mitral valve thickening 12.69 9.51 13 305170 756 110283360
Pulmonary valve stenosis 12.66 9.51 7 305176 156 110283960
Haematoma muscle 12.64 9.51 32 305151 4058 110280058
Hyperglycaemic seizure 12.62 9.51 3 305180 3 110284113
Fructosamine increased 12.62 9.51 3 305180 3 110284113
Penile prosthesis insertion 12.62 9.51 3 305180 3 110284113
Pericardial effusion 12.59 9.51 225 304958 56992 110227124
Urine output decreased 12.59 9.51 96 305087 19780 110264336
Pancreatic neoplasm 12.59 9.51 20 305163 1809 110282307
Orthopnoea 12.57 9.51 62 305121 10959 110273157
Oesophageal varices haemorrhage 12.57 9.51 36 305147 4909 110279207
Acral peeling skin syndrome 12.54 9.51 5 305178 51 110284065
Diabetic microangiopathy 12.54 9.51 5 305178 51 110284065
Myelodysplastic syndrome 12.48 9.51 57 305126 37427 110246689
Ostectomy 12.47 9.51 4 305179 20 110284096
Eye allergy 12.46 9.51 15 305168 1044 110283072
Prothrombin time prolonged 12.45 9.51 86 305097 17175 110266941
Dermatitis atopic 12.44 9.51 33 305150 25508 110258608
Sodium retention 12.41 9.51 8 305175 238 110283878
Bone marrow failure 12.41 9.51 101 305082 57747 110226369
Pharyngitis streptococcal 12.41 9.51 11 305172 13266 110270850
Hip fracture 12.39 9.51 150 305033 35001 110249115
Incision site pain 12.38 9.51 27 305156 3108 110281008
Retroperitoneal oedema 12.31 9.51 4 305179 21 110284095
Haemoglobin increased 12.31 9.51 54 305129 9093 110275023
Injection site swelling 12.30 9.51 110 305073 61680 110222436
Rhinitis allergic 12.28 9.51 19 305164 17903 110266213
Intestinal transit time abnormal 12.26 9.51 6 305177 103 110284013
Appendicitis 12.25 9.51 39 305144 28425 110255691
Skin ulcer 12.19 9.51 245 304938 63400 110220716
Cognitive disorder 12.18 9.51 169 305014 87342 110196774
Bronchial haemorrhage 12.18 9.51 17 305166 1370 110282746
Pulmonary fibrosis 12.17 9.51 203 304980 101839 110182277
Pleuritic pain 12.16 9.51 16 305167 16124 110267992
Suspected product tampering 12.16 9.51 3 305180 4 110284112
Aplastic anaemia 12.15 9.51 31 305152 24277 110259839
Urinary incontinence 12.13 9.51 195 304988 48392 110235724
Laryngeal leukoplakia 12.13 9.51 5 305178 56 110284060
Conjunctivitis 12.09 9.51 50 305133 33742 110250374
Staphylococcal infection 12.02 9.51 265 304918 69679 110214437
Obstructed labour 11.98 9.51 7 305176 174 110283942
Chest pain 11.97 9.51 1200 303983 375175 109908941
Granulomatous lymphadenitis 11.97 9.51 10 305173 447 110283669
Open angle glaucoma 11.90 9.51 11 305172 563 110283553
Ascites 11.89 9.51 338 304845 92470 110191646
Subcapsular renal haematoma 11.89 9.51 14 305169 952 110283164
Urine albumin/creatinine ratio increased 11.86 9.51 15 305168 1098 110283018
Graft versus host disease in skin 11.82 9.51 4 305179 8250 110275866
Genital infection fungal 11.79 9.51 8 305175 260 110283856
Fungal endocarditis 11.78 9.51 13 305170 823 110283293
Vitamin B12 deficiency 11.78 9.51 57 305126 9998 110274118
Mouth ulceration 11.78 9.51 81 305102 48057 110236059
Intercapillary glomerulosclerosis 11.76 9.51 6 305177 113 110284003
Overdose 11.75 9.51 772 304411 233022 110051094
Bladder irrigation 11.74 9.51 5 305178 61 110284055
Hypoxic-ischaemic encephalopathy 11.73 9.51 52 305131 8795 110275321
Therapeutic response shortened 11.73 9.51 42 305141 29541 110254575
Blood test abnormal 11.68 9.51 40 305143 28514 110255602
Electrocardiogram abnormal 11.65 9.51 90 305093 18619 110265497
Mania 11.62 9.51 25 305158 20771 110263345
Device leakage 11.60 9.51 80 305103 15968 110268148
Product temperature excursion issue 11.59 9.51 13 305170 838 110283278
Progressive multifocal leukoencephalopathy 11.59 9.51 33 305150 24923 110259193
Hydrocholecystis 11.53 9.51 11 305172 586 110283530
Fasting 11.53 9.51 5 305178 64 110284052
Blood lactic acid increased 11.51 9.51 79 305104 15742 110268374
Drug-induced liver injury 11.50 9.51 248 304935 119819 110164297
Subgaleal haematoma 11.48 9.51 6 305177 119 110283997
Lipohypertrophy 11.43 9.51 14 305169 992 110283124
Muscle abscess 11.42 9.51 17 305166 1452 110282664
Urethral abscess 11.41 9.51 3 305180 6 110284110
Product contamination with body fluid 11.41 9.51 3 305180 6 110284110
Albuminuria 11.37 9.51 14 305169 997 110283119
Left ventricular enlargement 11.35 9.51 13 305170 858 110283258
Adrenomegaly 11.34 9.51 10 305173 481 110283635
Arterial insufficiency 11.33 9.51 9 305174 374 110283742
Chronic graft versus host disease 11.28 9.51 6 305177 9451 110274665
Cytomegalovirus infection 11.25 9.51 96 305087 54348 110229768
Starvation 11.24 9.51 14 305169 1009 110283107
Scoliosis 11.24 9.51 5 305178 8728 110275388
Pancreatic pseudocyst 11.23 9.51 18 305165 1640 110282476
Diverticulitis 11.23 9.51 94 305089 53428 110230688
Infected skin ulcer 11.19 9.51 30 305153 3937 110280179
Middle insomnia 11.16 9.51 25 305158 20477 110263639
Myasthenia gravis 11.09 9.51 27 305156 21484 110262632
Cytomegalovirus viraemia 11.09 9.51 20 305163 17744 110266372
Endocarditis 11.09 9.51 69 305114 13302 110270814
Poor quality product administered 11.04 9.51 33 305150 4608 110279508
Ischaemia 11.01 9.51 52 305131 9031 110275085
Acanthosis nigricans 10.99 9.51 7 305176 204 110283912
Pancreatic cyst 10.99 9.51 24 305159 2766 110281350
Micturition urgency 10.98 9.51 23 305160 19297 110264819
Lipoatrophy 10.97 9.51 11 305172 623 110283493
Gestational hypertension 10.90 9.51 21 305162 2213 110281903
Ear discomfort 10.90 9.51 9 305174 11240 110272876
Cardiopulmonary failure 10.90 9.51 47 305136 7856 110276260
Substance abuse 10.85 9.51 11 305172 12452 110271664
Oesophageal carcinoma recurrent 10.82 9.51 5 305178 75 110284041
Vessel puncture site inflammation 10.81 9.51 3 305180 8 110284108
Non-proliferative retinopathy 10.81 9.51 3 305180 8 110284108
Mucosal dryness 10.80 9.51 31 305152 4232 110279884
Schizophrenia 10.79 9.51 28 305155 21798 110262318
Morganella infection 10.78 9.51 16 305167 1363 110282753
Anal fissure 10.75 9.51 7 305176 9874 110274242
Dermatitis bullous 10.73 9.51 84 305099 17445 110266671
Campylobacter test positive 10.72 9.51 6 305177 137 110283979
Haemorrhagic transformation stroke 10.70 9.51 25 305158 3012 110281104
Second primary malignancy 10.70 9.51 21 305162 18047 110266069
Parainfluenzae virus infection 10.67 9.51 3 305180 6971 110277145
Foaming at mouth 10.67 9.51 21 305162 2249 110281867
Tumour rupture 10.60 9.51 11 305172 649 110283467
Abscess limb 10.56 9.51 49 305134 8448 110275668
Fibrodysplasia ossificans progressiva 10.55 9.51 3 305180 9 110284107
Leukoencephalomyelitis 10.55 9.51 3 305180 9 110284107
Pituitary-dependent Cushing's syndrome 10.55 9.51 3 305180 9 110284107
Cerebellar artery occlusion 10.55 9.51 3 305180 9 110284107
Diabetic eye disease 10.52 9.51 7 305176 220 110283896
Osteomyelitis fungal 10.51 9.51 9 305174 416 110283700
Polycythaemia 10.51 9.51 26 305157 3249 110280867
Weight increased 10.49 9.51 1006 304177 418638 109865478
Respiratory depression 10.45 9.51 49 305134 31952 110252164
Breath sounds 10.42 9.51 6 305177 145 110283971
Decubitus ulcer 10.41 9.51 86 305097 18150 110265966
Injection site injury 10.40 9.51 14 305169 1090 110283026
Clang associations 10.38 9.51 4 305179 37 110284079
Rash erythematous 10.36 9.51 161 305022 81671 110202445
Nasal oedema 10.36 9.51 3 305180 6836 110277280
Septic embolus 10.31 9.51 21 305162 2305 110281811
Blood loss anaemia 10.29 9.51 85 305098 17940 110266176
Blood pH abnormal 10.28 9.51 4 305179 38 110284078
Post transplant lymphoproliferative disorder 10.28 9.51 17 305166 15596 110268520
Gastrointestinal tract mucosal pigmentation 10.25 9.51 15 305168 1262 110282854
Graft versus host disease in gastrointestinal tract 10.25 9.51 6 305177 8962 110275154
Radiculopathy 10.19 9.51 24 305159 19312 110264804
Procedural pain 10.17 9.51 57 305126 35508 110248608
Malignant sweat gland neoplasm 10.17 9.51 6 305177 152 110283964
Hypercapnia 10.16 9.51 59 305124 11100 110273016
Blood bicarbonate abnormal 10.13 9.51 6 305177 153 110283963
Large intestine polyp 10.13 9.51 74 305109 15043 110269073
Vascular purpura 10.12 9.51 28 305155 3743 110280373
Blood pressure increased 10.07 9.51 836 304347 257537 110026579
Immune-mediated enterocolitis 10.06 9.51 8 305175 10177 110273939
General symptom 9.99 9.51 6 305177 8840 110275276
Phaeochromocytoma 9.99 9.51 12 305171 833 110283283
Complication of device insertion 9.98 9.51 6 305177 8832 110275284
Oxygen saturation decreased 9.90 9.51 344 304839 156638 110127478
Cortisol free urine decreased 9.89 9.51 3 305180 12 110284104
Hepatobiliary cancer 9.89 9.51 3 305180 12 110284104
Umbilical hernia, obstructive 9.89 9.51 3 305180 12 110284104
Atrioventricular block 9.86 9.51 80 305103 16797 110267319
Haemorrhagic tumour necrosis 9.85 9.51 4 305179 43 110284073
Ammonia increased 9.84 9.51 47 305136 8203 110275913
Fungal peritonitis 9.83 9.51 15 305168 1310 110282806
Lack of injection site rotation 9.80 9.51 14 305169 1152 110282964
Pain in jaw 9.80 9.51 92 305091 51085 110233031
Chromoblastomycosis 9.76 9.51 6 305177 164 110283952
Accidental overdose 9.75 9.51 199 304984 51635 110232481
Pustular psoriasis 9.74 9.51 14 305169 13591 110270525
Product administered to patient of inappropriate age 9.73 9.51 5 305178 8031 110276085
Respiratory distress 9.72 9.51 254 304929 68620 110215496
Wound haemorrhage 9.72 9.51 32 305151 4706 110279410
Medication error 9.70 9.51 369 304814 104997 110179119
Strangulated umbilical hernia 9.70 9.51 3 305180 13 110284103
Retroperitoneal haematoma 9.67 9.51 38 305145 6093 110278023
Lethargy 9.66 9.51 332 304851 93244 110190872
Renal transplant 9.66 9.51 25 305158 3213 110280903
Acquired haemophilia 9.65 9.51 22 305161 2609 110281507
Costal cartilage fracture 9.64 9.51 7 305176 254 110283862
Infected dermal cyst 9.64 9.51 15 305168 1333 110282783
Eye disorder 9.61 9.51 122 305061 28784 110255332
Necrotising fasciitis 9.60 9.51 44 305139 7547 110276569
Skin toxicity 9.60 9.51 11 305172 11772 110272344
Hepatic calcification 9.59 9.51 8 305175 357 110283759
Pelvic organ injury 9.52 9.51 3 305180 14 110284102

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
FDA EPC N0000175944 Insulin
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:145947 antiatherosclerotic agent
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35821 anticholesteremic drug
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:50864 insulin-sensitizing drug
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:76916 hyperglycemic agent
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

A10AE Insulins and analogues for injection, long-acting 9 drugs

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:749436 CHEBI
CHEMBL1201497 ChEMBL_ID
118984454 PUBCHEM_CID
DB00047 DRUGBANK_ID
D000069036 MESH_DESCRIPTOR_UI
7548 INN_ID
7572 IUPHAR_LIGAND_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
DB00030 DRUGBANK_ID
118984375 PUBCHEM_CID
5186 INN_ID
CHEBI:5931 CHEBI
2ZM8CX04RZ INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BASAGLAR KwikPen HUMAN PRESCRIPTION DRUG LABEL 1 0002-7715 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
BASAGLAR Tempo Pen HUMAN PRESCRIPTION DRUG LABEL 1 0002-8214 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Rezvoglar KwikPen HUMAN PRESCRIPTION DRUG LABEL 1 0002-8980 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 33 sections
Soliqua 100/33 HUMAN PRESCRIPTION DRUG LABEL 2 0024-5761 INJECTION, SOLUTION 100 U SUBCUTANEOUS BLA 34 sections
TOUJEO HUMAN PRESCRIPTION DRUG LABEL 1 0024-5869 INJECTION, SOLUTION 300 U SUBCUTANEOUS BLA 33 sections
TOUJEO Max HUMAN PRESCRIPTION DRUG LABEL 1 0024-5871 INJECTION, SOLUTION 300 U SUBCUTANEOUS BLA 33 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 0088-2219 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 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 33 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 0088-5021 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
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 50090-0876 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 32 sections
Lantus Solostar HUMAN PRESCRIPTION DRUG LABEL 1 50090-1398 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 32 sections
TOUJEO HUMAN PRESCRIPTION DRUG LABEL 1 50090-2193 INJECTION, SOLUTION 300 U SUBCUTANEOUS BLA 32 sections
LANTUS SOLOSTAR HUMAN PRESCRIPTION DRUG LABEL 1 50090-4068 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 32 sections
TOUJEO Max HUMAN PRESCRIPTION DRUG LABEL 1 50090-4177 INJECTION, SOLUTION 300 U SUBCUTANEOUS BLA 32 sections
Insulin Glargine Solostar HUMAN PRESCRIPTION DRUG LABEL 1 50090-6178 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 32 sections
REZVOGLAR KWIKPEN HUMAN PRESCRIPTION DRUG LABEL 1 50090-6439 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 32 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 54868-4626 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 26 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 54868-5765 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 26 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 54868-6231 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 26 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 55045-3685 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 28 sections
Lantus HUMAN PRESCRIPTION DRUG LABEL 1 64725-2220 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS NDA 29 sections
INSULIN GLARGINE HUMAN PRESCRIPTION DRUG LABEL 1 72572-422 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
INSULIN GLARGINE HUMAN PRESCRIPTION DRUG LABEL 1 72572-424 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
SEMGLEE HUMAN PRESCRIPTION DRUG LABEL 1 83257-011 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
SEMGLEE HUMAN PRESCRIPTION DRUG LABEL 1 83257-012 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Insulin Glargine HUMAN PRESCRIPTION DRUG LABEL 1 83257-014 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections
Insulin Glargine HUMAN PRESCRIPTION DRUG LABEL 1 83257-015 INJECTION, SOLUTION 100 [iU] SUBCUTANEOUS BLA 27 sections