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

Stem definitionDrug idCAS RN
4198 7647-14-5

Description:

MoleculeDescription

Synonyms:

  • sodium chloride
A ubiquitous sodium salt that is commonly used to season food.
  • Molecular weight: 58.44
  • Formula: ClNa
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
1 g O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Dec. 16, 1965 FDA HOSPIRA

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
Myelosuppression 6334.54 10.00 2606 146132 50985 90428724
White blood cell count decreased 1627.72 10.00 1670 147068 165439 90314270
Neutrophil count decreased 957.89 10.00 853 147885 70679 90409030
Agranulocytosis 887.32 10.00 609 148129 34393 90445316
Infective pulmonary exacerbation of cystic fibrosis 849.04 10.00 389 148349 9890 90469819
Hereditary angioedema 624.96 10.00 306 148432 9059 90470650
Hepatic function abnormal 619.48 10.00 552 148186 45736 90433973
Chest discomfort 527.04 10.00 870 147868 137495 90342214
Bone marrow failure 514.07 10.00 425 148313 31796 90447913
Synovitis 513.73 10.00 5 148733 329747 90149962
Chills 494.79 10.00 824 147914 131157 90348552
Joint swelling 468.53 10.00 124 148614 503176 89976533
Systemic lupus erythematosus 460.89 10.00 35 148703 361861 90117848
Arthropathy 459.22 10.00 38 148700 366204 90113505
Hand deformity 454.79 10.00 6 148732 296356 90183353
Drug intolerance 432.55 10.00 102 148636 447489 90032220
Contraindicated product administered 428.19 10.00 24 148714 320115 90159594
Glossodynia 412.89 10.00 30 148708 321749 90157960
Rheumatoid arthritis 389.36 10.00 64 148674 362550 90117159
Pericarditis 371.54 10.00 17 148721 270134 90209575
Alopecia 370.19 10.00 175 148563 494896 89984813
Treatment failure 356.06 10.00 41 148697 303887 90175822
Therapeutic product effect decreased 341.84 10.00 31 148707 277540 90202169
Helicobacter infection 330.25 10.00 9 148729 226841 90252868
Hyperchloraemia 324.34 10.00 100 148638 788 90478921
Granulocyte count decreased 322.38 10.00 129 148609 2323 90477386
Pyrexia 313.70 10.00 2003 146735 658482 89821227
Wound 308.90 10.00 61 148677 302919 90176790
Psoriatic arthropathy 308.72 10.00 16 148722 228319 90251390
Folliculitis 280.48 10.00 13 148725 204340 90275369
Macular degeneration 275.98 10.00 326 148412 37644 90442065
Muscle injury 269.06 10.00 4 148734 176650 90303059
Temperature intolerance 264.58 10.00 192 148546 11838 90467871
Hyperpyrexia 260.39 10.00 136 148602 4625 90475084
Nausea 259.67 10.00 2870 145868 1107446 89372263
Musculoskeletal stiffness 246.99 10.00 89 148649 296443 90183266
Hepatic enzyme increased 240.91 10.00 147 148591 360589 90119120
Irritable bowel syndrome 240.36 10.00 29 148709 207419 90272290
Mobility decreased 240.28 10.00 58 148680 250676 90229033
Peritonitis bacterial 236.05 10.00 131 148607 5040 90474669
Cystic fibrosis 228.26 10.00 117 148621 3824 90475885
Swelling 223.51 10.00 215 148523 418843 90060866
Vomiting 222.09 10.00 2118 146620 786175 89693534
Platelet count decreased 208.44 10.00 594 148144 136375 90343334
Type 2 diabetes mellitus 200.72 10.00 44 148694 203200 90276509
Tachypnoea 197.94 10.00 208 148530 21101 90458608
Flushing 197.70 10.00 444 148294 88047 90391662
Drug ineffective 196.68 10.00 1400 147338 1382898 89096811
Arthralgia 187.70 10.00 653 148085 777869 89701840
Abdominal discomfort 187.69 10.00 309 148429 477019 90002690
Completed suicide 187.44 10.00 13 148725 145045 90334664
Infusion site pain 182.15 10.00 192 148546 19546 90460163
Drug hypersensitivity 172.31 10.00 311 148427 463298 90016411
Stomatitis 171.05 10.00 121 148617 274577 90205132
C-reactive protein abnormal 168.86 10.00 10 148728 127419 90352290
Ovarian hyperstimulation syndrome 167.68 10.00 110 148628 5752 90473957
Peritoneal dialysis complication 165.99 10.00 67 148671 1235 90478474
Swollen joint count increased 163.34 10.00 4 148734 111202 90368507
Osteoarthritis 162.48 10.00 59 148679 195671 90284038
Blood cholesterol increased 162.31 10.00 69 148669 207943 90271766
Bursitis 161.19 10.00 15 148723 131639 90348070
Joint range of motion decreased 154.56 10.00 20 148718 135623 90344086
Impaired healing 154.09 10.00 97 148641 234102 90245607
Blister 150.15 10.00 119 148619 254879 90224830
Facet joint syndrome 146.60 10.00 3 148735 98386 90381323
Sepsis 144.03 10.00 631 148107 179183 90300526
Dyspnoea 141.11 10.00 2126 146612 878829 89600880
Ill-defined disorder 140.03 10.00 64 148674 184827 90294882
Psoriasis 139.89 10.00 35 148703 147719 90331990
Toxic anterior segment syndrome 139.66 10.00 70 148668 2180 90477529
Injury 139.38 10.00 75 148663 197274 90282435
Hyponatraemia 134.32 10.00 503 148235 133035 90346674
Granulocytopenia 133.06 10.00 99 148639 6342 90473367
Infusion site extravasation 129.90 10.00 119 148619 10209 90469500
Leukopenia 129.79 10.00 412 148326 100298 90379411
Lower respiratory tract infection 128.46 10.00 133 148605 250526 90229183
Cytokine release syndrome 127.27 10.00 191 148547 27782 90451927
Poor venous access 126.17 10.00 158 148580 19369 90460340
Gait inability 121.78 10.00 44 148694 146412 90333297
Hypernatraemia 119.71 10.00 109 148629 9278 90470431
Sleep disorder due to general medical condition, insomnia type 118.93 10.00 32 148706 128662 90351047
Incorrect drug administration rate 118.60 10.00 85 148653 5138 90474571
Blood pressure decreased 117.98 10.00 329 148409 74566 90405143
Inflammation 113.33 10.00 77 148661 178515 90301194
Fibromyalgia 113.16 10.00 103 148635 206166 90273543
Pulmonary fibrosis 110.82 10.00 21 148717 107482 90372227
Hypercholesterolaemia 109.96 10.00 17 148721 100875 90378834
Fungal peritonitis 109.93 10.00 41 148697 605 90479104
Paraesthesia oral 109.67 10.00 191 148547 31468 90448241
Knee arthroplasty 108.78 10.00 7 148731 83175 90396534
Pallor 107.95 10.00 198 148540 33967 90445742
Lip dry 107.80 10.00 18 148720 100937 90378772
Sensitisation 106.58 10.00 73 148665 4102 90475607
Insurance issue 103.62 10.00 108 148630 10850 90468859
Abdominal distension 103.54 10.00 457 148281 130144 90349565
Obesity 101.80 10.00 24 148714 105483 90374226
Peripheral venous disease 101.56 10.00 10 148728 83911 90395798
Oxygen saturation decreased 100.79 10.00 396 148342 107087 90372622
Sciatica 99.95 10.00 22 148716 101360 90378349
General physical health deterioration 98.60 10.00 279 148459 354836 90124873
Hypokalaemia 95.88 10.00 448 148290 130668 90349041
Peripheral swelling 95.61 10.00 352 148386 412754 90066955
Dry mouth 95.03 10.00 97 148641 183962 90295747
Peritonitis 94.61 10.00 138 148600 19567 90460142
Infusion site swelling 94.17 10.00 106 148632 11614 90468095
Condition aggravated 93.68 10.00 583 148155 594962 89884747
Urinary tract infection 92.52 10.00 835 147903 304797 90174912
Toxicity to various agents 92.39 10.00 210 148528 287636 90192073
Device interaction 92.25 10.00 28 148710 208 90479501
Insomnia 91.83 10.00 263 148475 333211 90146498
Red blood cell sedimentation rate increased 89.82 10.00 14 148724 82581 90397128
Infusion site haemorrhage 89.68 10.00 73 148665 5338 90474371
Hypotension 89.49 10.00 871 147867 324526 90155183
Infusion site erythema 88.94 10.00 111 148627 13559 90466150
Polycystic ovaries 88.94 10.00 74 148664 5580 90474129
Confusional state 88.76 10.00 330 148408 385875 90093834
Hypersensitivity 88.68 10.00 414 148324 454263 90025446
Hospitalisation 87.37 10.00 429 148309 127671 90352038
Osmotic demyelination syndrome 87.37 10.00 40 148698 1014 90478695
Discomfort 87.35 10.00 201 148537 274134 90205575
Procedural pain 86.66 10.00 178 148560 33182 90446527
Sleep disorder 86.59 10.00 119 148619 197911 90281798
Musculoskeletal pain 85.32 10.00 93 148645 171158 90308551
Maternal exposure during pregnancy 85.15 10.00 304 148434 359759 90119950
Anaphylactic shock 84.86 10.00 171 148567 31446 90448263
Arthritis 84.32 10.00 90 148648 167225 90312484
Cough 83.77 10.00 950 147788 368012 90111697
Pain 83.34 10.00 1144 147594 995197 89484512
Cyanosis 83.08 10.00 129 148609 19326 90460383
Hip arthroplasty 82.68 10.00 13 148725 76195 90403514
Illness 82.59 10.00 309 148429 81660 90398049
Ejection fraction 82.48 10.00 55 148683 2956 90476753
Depression 82.08 10.00 238 148500 300363 90179346
Erythema 81.88 10.00 650 148088 228596 90251113
Ejection fraction abnormal 81.81 10.00 51 148687 2440 90477269
Chronic sinusitis 81.67 10.00 143 148595 23659 90456050
Prescribed underdose 80.93 10.00 13 148725 75006 90404703
Adjustment disorder with depressed mood 79.86 10.00 3 148735 56750 90422959
Night sweats 78.42 10.00 58 148680 128708 90351001
Suspected product quality issue 75.64 10.00 28 148710 404 90479305
Memory impairment 75.24 10.00 130 148608 197114 90282595
Liver disorder 74.66 10.00 54 148684 121215 90358494
Cardiac arrest 73.40 10.00 354 148384 104581 90375128
Death 71.66 10.00 1099 147639 455452 90024257
Infusion site coldness 71.42 10.00 23 148715 212 90479497
Product use issue 71.23 10.00 289 148449 329630 90150079
Acidosis hyperchloraemic 70.78 10.00 33 148705 873 90478836
Wound infection 68.66 10.00 45 148693 106357 90373352
Lower limb fracture 68.22 10.00 27 148711 84986 90394723
Therapeutic response decreased 68.00 10.00 31 148707 89698 90390011
Wound infection pseudomonas 67.91 10.00 42 148696 1981 90477728
Autoimmune disorder 67.37 10.00 21 148717 76723 90402986
Lymphatic fistula 66.65 10.00 37 148701 1424 90478285
Nail disorder 66.57 10.00 9 148729 59058 90420651
Haemarthrosis 66.44 10.00 54 148684 3940 90475769
Hypervolaemia 66.13 10.00 158 148580 32599 90447110
Drug interaction 65.60 10.00 233 148505 276220 90203489
Femoral hernia incarcerated 65.55 10.00 37 148701 1471 90478238
Hyponatraemic encephalopathy 65.46 10.00 23 148715 283 90479426
Vascular device infection 65.23 10.00 89 148649 11863 90467846
Therapy non-responder 65.08 10.00 77 148661 136627 90343082
Cardiovascular disorder 64.06 10.00 94 148644 13398 90466311
Blepharospasm 63.57 10.00 8 148730 55437 90424272
Febrile neutropenia 63.25 10.00 461 148277 157888 90321821
COVID-19 62.61 10.00 483 148255 168360 90311349
Product preparation issue 62.22 10.00 42 148696 2304 90477405
Blood sodium decreased 62.13 10.00 139 148599 27474 90452235
Cystic fibrosis respiratory infection suppression 62.13 10.00 23 148715 332 90479377
Extravasation 59.98 10.00 45 148693 2919 90476790
Maternal exposure during delivery 59.80 10.00 50 148688 3796 90475913
Onychomadesis 59.76 10.00 4 148734 45994 90433715
Inappropriate schedule of product administration 59.03 10.00 435 148303 149498 90330211
Pulmonary function test decreased 58.91 10.00 53 148685 4441 90475268
Pantoea agglomerans infection 58.85 10.00 15 148723 52 90479657
Gamma-glutamyltransferase decreased 58.11 10.00 22 148716 339 90479370
Disorganised speech 57.92 10.00 37 148701 1848 90477861
C-reactive protein increased 57.62 10.00 133 148605 181256 90298453
Coeliac disease 57.60 10.00 4 148734 44606 90435103
Pancreatic steatosis 57.44 10.00 35 148703 1607 90478102
Arterial haemorrhage 57.15 10.00 41 148697 2482 90477227
Hypoxia 57.09 10.00 253 148485 72146 90407563
Vaginal flatulence 55.65 10.00 85 148653 12553 90467156
Osteoporosis 55.58 10.00 46 148692 96485 90383224
Exostosis 55.57 10.00 10 148728 53124 90426585
Unresponsive to stimuli 54.73 10.00 162 148576 37959 90441750
Productive cough 54.63 10.00 261 148477 76802 90402907
Live birth 54.46 10.00 31 148707 79076 90400633
Weight increased 54.40 10.00 432 148306 417495 90062214
Amnesia 53.95 10.00 59 148679 108446 90371263
Infusion site induration 53.94 10.00 33 148705 1526 90478183
Anaphylactoid reaction 53.32 10.00 50 148688 4418 90475291
Prescribed overdose 53.21 10.00 49 148689 97576 90382133
Device infusion issue 52.95 10.00 40 148698 2622 90477087
Cold sweat 52.79 10.00 88 148650 13993 90465716
Dehydration 52.18 10.00 518 148220 193929 90285780
Device related infection 50.57 10.00 123 148615 25663 90454046
Back injury 50.47 10.00 8 148730 46614 90433095
Seroma 50.12 10.00 41 148697 3019 90476690
Gadolinium deposition disease 49.95 10.00 15 148723 107 90479602
Abdominal pain upper 49.48 10.00 331 148407 332343 90147366
Nephrectomy 49.06 10.00 34 148704 1947 90477762
Abdominal pain 49.04 10.00 917 147821 394804 90084905
Joint stiffness 49.02 10.00 34 148704 78008 90401701
Proctitis 48.91 10.00 89 148649 15170 90464539
Aspartate aminotransferase increased 47.80 10.00 311 148427 102626 90377083
Foot deformity 47.77 10.00 19 148719 59632 90420077
Gait disturbance 46.79 10.00 244 148494 260252 90219457
Anaphylactic reaction 46.65 10.00 274 148464 87250 90392459
Feeling cold 46.58 10.00 124 148614 27341 90452368
Breast cancer stage II 46.12 10.00 3 148735 35331 90444378
Female genital tract fistula 46.01 10.00 95 148643 17773 90461936
Intentional overdose 45.58 10.00 52 148686 93782 90385927
Burkholderia cepacia complex infection 45.02 10.00 16 148722 204 90479505
Headache 44.86 10.00 1785 146953 860961 89618748
Endophthalmitis 43.98 10.00 46 148692 4639 90475070
Lymphocyte count decreased 43.86 10.00 142 148596 34908 90444801
Encapsulating peritoneal sclerosis 43.57 10.00 18 148720 353 90479356
Lupus-like syndrome 43.53 10.00 13 148725 48833 90430876
Air embolism 43.47 10.00 18 148720 355 90479354
Infusion site bruising 42.98 10.00 44 148694 4328 90475381
Back pain 42.45 10.00 744 147994 316431 90163278
Suicide attempt 42.10 10.00 37 148701 75362 90404347
Suspected transmission of an infectious agent via product 42.04 10.00 18 148720 387 90479322
Respiratory tract infection 41.80 10.00 200 148538 58878 90420831
Ultrafiltration failure 41.66 10.00 16 148722 257 90479452
Haematuria 41.45 10.00 139 148599 34798 90444911
Onychomycosis 41.40 10.00 6 148732 37370 90442339
Blood fibrinogen decreased 41.08 10.00 25 148713 1145 90478564
Product preparation error 41.00 10.00 66 148672 10195 90469514
Vein disorder 40.99 10.00 48 148690 5488 90474221
Adverse drug reaction 40.86 10.00 81 148657 116620 90363089
Eructation 40.78 10.00 68 148670 10814 90468895
Loss of personal independence in daily activities 40.69 10.00 103 148635 136002 90343707
Adverse event 40.68 10.00 82 148656 117336 90362373
Hepatic cirrhosis 40.47 10.00 27 148711 63226 90416483
Oral candidiasis 40.25 10.00 139 148599 35316 90444393
Contusion 39.87 10.00 245 148493 250971 90228738
Pulmonary oedema 39.55 10.00 204 148534 61876 90417833
Disturbance in social behaviour 39.10 10.00 41 148697 4147 90475562
Tetany 38.95 10.00 33 148705 2551 90477158
Dysphoria 38.49 10.00 49 148689 6105 90473604
Rash 38.41 10.00 1004 147734 795096 89684613
Peripheral coldness 38.31 10.00 76 148662 13816 90465893
Radiculopathy 38.15 10.00 90 148648 18415 90461294
Respiratory failure 38.07 10.00 328 148410 118090 90361619
Burning sensation 38.02 10.00 205 148533 63247 90416462
Blood test abnormal 37.99 10.00 97 148641 20855 90458854
Staphylococcal infection 37.98 10.00 169 148569 48270 90431439
Wound dehiscence 37.44 10.00 47 148691 5775 90473934
Aortic valve stenosis 36.92 10.00 40 148698 4200 90475509
Drug abuse 36.46 10.00 49 148689 82298 90397411
Walking aid user 36.45 10.00 7 148731 35499 90444210
Lung disorder 36.42 10.00 125 148613 149758 90329951
Rhinitis allergic 36.10 10.00 83 148655 16702 90463007
Cardiogenic shock 36.09 10.00 105 148633 24363 90455346
Gastrointestinal disorder 35.88 10.00 260 148478 256427 90223282
Product administration error 35.77 10.00 110 148628 26313 90453396
Hepatitis 35.68 10.00 38 148700 70701 90409008
Cardiac disorder 35.62 10.00 186 148552 56686 90423023
Acute respiratory failure 35.37 10.00 152 148586 42766 90436943
Myocardial reperfusion injury 35.37 10.00 12 148726 132 90479577
Vaginal discharge 35.18 10.00 90 148648 19374 90460335
Anterior chamber inflammation 35.01 10.00 16 148722 404 90479305
Anaemia 34.94 10.00 791 147947 352011 90127698
Heart rate increased 34.88 10.00 310 148428 112592 90367117
Meningitis aseptic 34.81 10.00 49 148689 6724 90472985
Acute pulmonary oedema 34.75 10.00 59 148679 9521 90470188
Immune effector cell-associated neurotoxicity syndrome 34.62 10.00 45 148693 5723 90473986
Hypoaesthesia oral 34.51 10.00 78 148660 15522 90464187
Tension 34.29 10.00 36 148702 3646 90476063
Catheter site pain 34.23 10.00 44 148694 5535 90474174
Hepatic cytolysis 34.16 10.00 5 148733 30911 90448798
Fatigue 34.13 10.00 1548 147190 1152475 89327234
Tachyarrhythmia 33.74 10.00 43 148695 5363 90474346
Sinus tachycardia 33.43 10.00 113 148625 28400 90451309
Post procedural complication 33.34 10.00 87 148651 18955 90460754
Product contamination 33.33 10.00 22 148716 1162 90478547
Discoloured vomit 33.20 10.00 22 148716 1170 90478539
Bacteraemia 33.19 10.00 96 148642 22204 90457505
Suspected product contamination 32.86 10.00 10 148728 75 90479634
Pneumonia 32.82 10.00 1319 147419 636740 89842969
Excessive eye blinking 32.70 10.00 23 148715 1349 90478360
Pain in extremity 32.41 10.00 532 148206 449997 90029712
Dermatitis contact 32.36 10.00 70 148668 13525 90466184
Haemoptysis 32.22 10.00 124 148614 33196 90446513
Infusion site rash 31.99 10.00 29 148709 2454 90477255
Infusion site pruritus 31.93 10.00 47 148691 6718 90472991
Throat irritation 31.71 10.00 161 148577 48534 90431175
Feeling hot 31.64 10.00 228 148510 77780 90401929
Drug tolerance decreased 31.60 10.00 7 148731 32123 90447586
Seizure 31.46 10.00 386 148352 152243 90327466
Seasonal allergy 31.41 10.00 96 148642 22887 90456822
Throat tightness 31.24 10.00 113 148625 29371 90450338
Decreased appetite 30.91 10.00 823 147915 375717 90103992
Cytopenia 30.83 10.00 80 148658 17369 90462340
Diverticulum intestinal 30.17 10.00 54 148684 9088 90470621
Haemodialysis complication 30.04 10.00 12 148726 215 90479494
Laryngospasm 30.00 10.00 32 148706 3301 90476408
Laryngeal oedema 29.90 10.00 46 148692 6835 90472874
Sopor 29.65 10.00 3 148735 24641 90455068
Laryngitis 29.44 10.00 24 148714 50729 90428980
Upper respiratory tract infection 29.32 10.00 331 148407 127987 90351722
Asthenia 28.98 10.00 1110 147628 532641 89947068
Liver function test increased 28.76 10.00 60 148678 84795 90394914
Hepatic cyst 28.67 10.00 44 148694 6524 90473185
Muscular weakness 28.56 10.00 210 148528 206456 90273253
Nasopharyngitis 28.53 10.00 483 148255 406621 90073088
Pulse abnormal 28.49 10.00 30 148708 3049 90476660
Facial discomfort 28.49 10.00 13 148725 327 90479382
Infusion site infection 28.40 10.00 28 148710 2632 90477077
Brain death 28.34 10.00 34 148704 3987 90475722
Intentional product use issue 28.27 10.00 224 148514 216668 90263041
Initial insomnia 28.21 10.00 53 148685 9257 90470452
Neutropenic sepsis 27.90 10.00 79 148659 18051 90461658
Post-traumatic neck syndrome 27.85 10.00 27 148711 2487 90477222
Respiratory distress 27.66 10.00 132 148606 38814 90440895
Product deposit 27.54 10.00 13 148725 354 90479355
Ischaemic contracture of the left ventricle 27.42 10.00 10 148728 138 90479571
Pharyngitis streptococcal 27.40 10.00 63 148675 12679 90467030
Hepatorenal failure 27.36 10.00 16 148722 681 90479028
Injection site reaction 27.27 10.00 70 148668 92010 90387699
Rapid correction of hyponatraemia 27.03 10.00 10 148728 144 90479565
Viral infection 27.01 10.00 137 148601 41277 90438432
Infusion site discomfort 26.98 10.00 23 148715 1793 90477916
Electrolyte imbalance 26.87 10.00 93 148645 23652 90456057
Oliguria 26.78 10.00 56 148682 10568 90469141
Road traffic accident 26.66 10.00 89 148649 107537 90372172
Blood pressure increased 26.49 10.00 463 148275 196754 90282955
Tachycardia 26.39 10.00 384 148354 157289 90322420
Infusion site irritation 26.18 10.00 20 148718 1333 90478376
Blood creatinine decreased 26.16 10.00 42 148696 6473 90473236
Peritoneal cloudy effluent 26.15 10.00 12 148726 306 90479403
Rhinovirus infection 26.11 10.00 40 148698 5923 90473786
Alanine aminotransferase increased 26.02 10.00 303 148435 118035 90361674
Gastrointestinal haemorrhage 25.95 10.00 244 148494 90004 90389705
Respiratory rate increased 25.89 10.00 71 148667 15930 90463779
Burkholderia test positive 25.85 10.00 11 148727 233 90479476
Intentional self-injury 25.79 10.00 8 148730 29326 90450383
Administration site extravasation 25.62 10.00 19 148719 1211 90478498
Carpal tunnel syndrome 25.60 10.00 92 148646 23836 90455873
Product compounding quality issue 25.58 10.00 7 148731 34 90479675
Product distribution issue 25.58 10.00 31 148707 3674 90476035
Overdose 25.43 10.00 153 148585 157556 90322153
Blood creatine increased 25.40 10.00 43 148695 6924 90472785
Wheezing 25.29 10.00 259 148479 237821 90241888
Postoperative wound infection 25.22 10.00 63 148675 13363 90466346
Pulmonary hypertension 25.21 10.00 137 148601 42386 90437323
Pneumothorax 25.21 10.00 79 148659 19088 90460621
Pseudomonas infection 25.09 10.00 67 148671 14798 90464911
Drug reaction with eosinophilia and systemic symptoms 25.08 10.00 20 148718 42738 90436971
Transaminases increased 24.94 10.00 124 148614 37068 90442641
Aortic arteriosclerosis 24.86 10.00 45 148693 7639 90472070
Mental disorder 24.77 10.00 112 148626 32206 90447503
Product label confusion 24.55 10.00 4 148734 22846 90456863
Cystic fibrosis lung 24.37 10.00 9 148729 129 90479580
Hypothyroidism 24.34 10.00 160 148578 52967 90426742
Muscle spasticity 24.08 10.00 14 148724 35308 90444401
Drug-induced liver injury 23.91 10.00 240 148498 90078 90389631
Renal disorder 23.83 10.00 124 148614 37735 90441974
Lip erosion 23.30 10.00 18 148720 1220 90478489
Infusion site mass 23.30 10.00 23 148715 2166 90477543
Colitis 23.14 10.00 195 148543 69747 90409962
Vasodilatation 23.03 10.00 26 148712 2858 90476851
Infusion site discharge 23.02 10.00 24 148714 2411 90477298
Incorrect route of product administration 22.91 10.00 152 148586 50474 90429235
Sleep apnoea syndrome 22.84 10.00 108 148630 31639 90448070
Disability 22.74 10.00 20 148718 40725 90438984
Groin pain 22.62 10.00 57 148681 12156 90467553
Pleural effusion 22.55 10.00 282 148456 111709 90368000
Sputum increased 22.50 10.00 26 148712 2931 90476778
Confusion postoperative 22.31 10.00 10 148728 241 90479468
Escherichia infection 22.29 10.00 67 148671 15828 90463881
Bloody peritoneal effluent 22.29 10.00 7 148731 59 90479650
Laryngeal discomfort 22.22 10.00 12 148726 437 90479272
Toxic epidermal necrolysis 22.20 10.00 109 148629 32419 90447290
Taste disorder 22.16 10.00 42 148696 61504 90418205
Poor quality product administered 22.10 10.00 30 148708 3978 90475731
Influenza 22.07 10.00 336 148402 138928 90340781
Carbon dioxide decreased 21.88 10.00 25 148713 2783 90476926
Faecaloma 21.80 10.00 51 148687 10380 90469329
Metabolic alkalosis 21.79 10.00 28 148710 3521 90476188
Infective exacerbation of bronchiectasis 21.61 10.00 12 148726 462 90479247
Oropharyngeal pain 21.48 10.00 286 148452 114901 90364808
Suicidal ideation 21.22 10.00 57 148681 73798 90405911
Nephrocalcinosis 21.22 10.00 17 148721 1215 90478494
Mental status changes postoperative 21.22 10.00 9 148729 189 90479520
Tricuspid valve incompetence 21.13 10.00 68 148670 16663 90463046
Pregnancy 20.92 10.00 44 148694 62003 90417706
Hypocalcaemia 20.89 10.00 130 148608 42238 90437471
Internal haemorrhage 20.86 10.00 37 148701 6183 90473526
Pustular psoriasis 20.50 10.00 3 148735 18553 90461156
Cognitive disorder 20.37 10.00 53 148685 69354 90410355
Intentional product misuse 20.25 10.00 77 148661 89527 90390182
Injection site granuloma 20.16 10.00 7 148731 83 90479626
Gastrointestinal infection 20.05 10.00 51 148687 10939 90468770
Obstetric procedure complication 19.92 10.00 5 148733 16 90479693
Hypochloraemia 19.86 10.00 23 148715 2599 90477110
Asphyxia 19.76 10.00 39 148699 7064 90472645
Procedural complication 19.75 10.00 35 148703 5843 90473866
Osteonecrosis of jaw 19.72 10.00 21 148717 39082 90440627
Hypoalbuminaemia 19.52 10.00 64 148674 15833 90463876
Ventricular fibrillation 19.51 10.00 59 148679 13985 90465724
Interleukin level increased 19.32 10.00 13 148725 709 90479000
Septic shock 19.18 10.00 217 148521 83943 90395766
Acidosis 19.12 10.00 55 148683 12681 90467028
Cataract operation complication 19.08 10.00 8 148730 163 90479546
Agitation 19.08 10.00 181 148557 66917 90412792
Dysphagia 19.00 10.00 274 148464 112004 90367705
Eye infection 18.98 10.00 59 148679 14195 90465514
Extradural haematoma 18.87 10.00 20 148718 2048 90477661
Femur fracture 18.84 10.00 29 148709 46053 90433656
Palpitations 18.72 10.00 322 148416 136406 90343303
Vein rupture 18.70 10.00 18 148720 1643 90478066
B-lymphocyte abnormalities 18.54 10.00 9 148729 261 90479448
Bacterial infection 18.53 10.00 82 148656 23362 90456347
Haemodilution 18.48 10.00 7 148731 108 90479601
Oedema 18.46 10.00 225 148513 200070 90279639
Laboratory test abnormal 18.43 10.00 25 148713 41829 90437880
Hyperkalaemia 18.35 10.00 175 148563 64789 90414920
Stevens-Johnson syndrome 18.34 10.00 96 148642 29280 90450429
Metabolic acidosis 18.30 10.00 155 148583 55521 90424188
Body temperature abnormal 18.25 10.00 22 148716 2593 90477116
Catheter site infection 18.15 10.00 33 148705 5621 90474088
Inflammatory marker increased 18.12 10.00 44 148694 9170 90470539
Hyperaemia 18.07 10.00 22 148716 2620 90477089
Blood chloride decreased 17.95 10.00 35 148703 6284 90473425
Distal intestinal obstruction syndrome 17.92 10.00 11 148727 512 90479197
Meningitis chemical 17.85 10.00 9 148729 284 90479425
Mental status changes 17.78 10.00 130 148608 44549 90435160
Diabetes insipidus 17.65 10.00 24 148714 3188 90476521
Anaesthetic complication 17.63 10.00 21 148717 2444 90477265
Necrotic lymphadenopathy 17.55 10.00 7 148731 125 90479584
Eyelid oedema 17.50 10.00 50 148688 11484 90468225
Infusion related reaction 17.49 10.00 844 147894 415936 90063773
Oropharyngeal discomfort 17.47 10.00 39 148699 7696 90472013
Failure to thrive 17.44 10.00 41 148697 8370 90471339
Body temperature increased 17.17 10.00 129 148609 44581 90435128
Haematochezia 17.14 10.00 185 148553 70728 90408981
Central venous catheterisation 17.14 10.00 22 148716 2764 90476945
Moaning 17.13 10.00 14 148724 1029 90478680
Haemolysis 17.12 10.00 41 148697 8469 90471240
Syncope 16.94 10.00 309 148429 132354 90347355
Drug resistance 16.93 10.00 15 148723 30434 90449275
Multiple allergies 16.86 10.00 59 148679 15087 90464622
Feeding disorder 16.79 10.00 65 148673 17447 90462262
Inappropriate antidiuretic hormone secretion 16.79 10.00 70 148668 19435 90460274
Coordination abnormal 16.78 10.00 7 148731 21349 90458360
Rash erythematous 16.75 10.00 172 148566 64932 90414777
Maternal exposure timing unspecified 16.67 10.00 8 148730 22475 90457234
Bone density decreased 16.62 10.00 4 148734 17341 90462368
Genital erosion 16.53 10.00 10 148728 453 90479256
Blood pressure diastolic abnormal 16.47 10.00 6 148732 19875 90459834
Respiratory syncytial virus infection 16.46 10.00 46 148692 10434 90469275
Lethargy 16.34 10.00 167 148571 62972 90416737
Product barcode issue 16.24 10.00 3 148735 0 90479709
Blood urea decreased 16.24 10.00 21 148717 2657 90477052
Gastroenteritis viral 16.15 10.00 95 148643 30260 90449449
Adverse reaction 16.08 10.00 15 148723 29697 90450012
Eosinophilia 15.93 10.00 14 148724 28519 90451190
Retching 15.90 10.00 68 148670 19091 90460618
Infusion site phlebitis 15.88 10.00 6 148732 92 90479617
Anuria 15.88 10.00 57 148681 14761 90464948
Hyperhidrosis 15.86 10.00 313 148425 135992 90343717
Ulcer haemorrhage 15.83 10.00 12 148726 26309 90453400
Device wireless communication issue 15.70 10.00 6 148732 95 90479614
Arrhythmia 15.62 10.00 121 148617 42211 90437498
Ileus 15.53 10.00 61 148677 16485 90463224
Acute kidney injury 15.43 10.00 658 148080 319729 90159980
Obstruction 15.36 10.00 25 148713 3896 90475813
Pulse absent 15.36 10.00 32 148706 6023 90473686
Abortion spontaneous 15.32 10.00 42 148696 54014 90425695
Infusion site thrombosis 15.23 10.00 7 148731 179 90479530
Product contamination microbial 15.16 10.00 8 148730 278 90479431
Vascular compression 15.13 10.00 8 148730 279 90479430
Lung transplant 15.10 10.00 24 148714 3668 90476041
Blood pressure abnormal 14.99 10.00 68 148670 19577 90460132
Incorrect product formulation administered 14.95 10.00 7 148731 187 90479522
Pharyngeal paraesthesia 14.90 10.00 22 148716 3152 90476557
Pelvic fluid collection 14.90 10.00 13 148725 1046 90478663
Visual impairment 14.88 10.00 142 148596 132223 90347486
Device related bacteraemia 14.83 10.00 9 148729 410 90479299
Device occlusion 14.83 10.00 41 148697 9241 90470468
Deafness permanent 14.77 10.00 10 148728 551 90479158
Malnutrition 14.74 10.00 65 148673 18493 90461216
Product container issue 14.65 10.00 18 148720 2163 90477546
Catheter site extravasation 14.58 10.00 9 148729 423 90479286
Device maintenance issue 14.55 10.00 7 148731 199 90479510
Haemorrhage 14.53 10.00 176 148562 69193 90410516
Tracheitis 14.50 10.00 12 148726 898 90478811
Hyperglycaemia 14.25 10.00 137 148601 50833 90428876
Hepatotoxicity 14.24 10.00 34 148704 45808 90433901
Pneumorrhachis 14.17 10.00 3 148735 3 90479706
Flashback 14.15 10.00 8 148730 319 90479390
Impaired work ability 14.14 10.00 7 148731 19319 90460390
Spondylitis 14.13 10.00 3 148735 14175 90465534
Procalcitonin increased 14.05 10.00 15 148723 1549 90478160
Nephropathy 13.98 10.00 40 148698 9195 90470514
Brain oedema 13.89 10.00 61 148677 17324 90462385
Catheter site haemorrhage 13.85 10.00 23 148715 3645 90476064
Blood potassium increased 13.78 10.00 69 148669 20680 90459029
Stenotrophomonas test positive 13.77 10.00 4 148734 25 90479684
Skin infection 13.76 10.00 62 148676 17802 90461907
Apallic syndrome 13.74 10.00 11 148727 785 90478924
Exposure via contaminated device 13.71 10.00 3 148735 4 90479705
Medication error 13.71 10.00 82 148656 84570 90395139
Left ventricular dysfunction 13.70 10.00 54 148684 14615 90465094
Hyperphosphataemia 13.65 10.00 23 148715 3688 90476021
Hypoaesthesia 13.61 10.00 402 148336 313808 90165901
Haemoglobin decreased 13.56 10.00 355 148383 161601 90318108
Device issue 13.56 10.00 89 148649 29448 90450261
Tremor 13.48 10.00 338 148400 152835 90326874
Hypovolaemia 13.47 10.00 48 148690 12383 90467326
Marasmus 13.42 10.00 11 148727 812 90478897
Hypophagia 13.41 10.00 103 148635 35834 90443875
Neuromuscular blockade 13.31 10.00 8 148730 358 90479351
Anterior chamber disorder 13.29 10.00 6 148732 147 90479562
Corneal oedema 13.28 10.00 16 148722 1885 90477824
Sinusitis 13.19 10.00 689 148049 342399 90137310
Disseminated intravascular coagulation 13.18 10.00 70 148668 21468 90458241
Granuloma annulare 13.18 10.00 11 148727 833 90478876
Joint effusion 13.17 10.00 8 148730 19702 90460007
Ulcer 13.15 10.00 21 148717 32861 90446848
Product availability issue 13.14 10.00 34 148704 7370 90472339
Foetal death 13.05 10.00 9 148729 20714 90458995
Enterovirus infection 13.00 10.00 14 148724 1460 90478249
Incontinence 12.99 10.00 50 148688 13385 90466324
Administration site phlebitis 12.96 10.00 3 148735 6 90479703
Neutrophil percentage abnormal 12.92 10.00 4 148734 32 90479677
Tumour lysis syndrome 12.90 10.00 44 148694 11108 90468601
Mycobacterium abscessus infection 12.77 10.00 12 148726 1063 90478646
Quadriplegia 12.76 10.00 17 148721 2214 90477495
Sodium retention 12.76 10.00 6 148732 162 90479547
Full blood count decreased 12.75 10.00 88 148650 29601 90450108
Hypomagnesaemia 12.73 10.00 101 148637 35487 90444222
Respiratory arrest 12.73 10.00 96 148642 33215 90446494
Rash rubelliform 12.64 10.00 3 148735 7 90479702
Ankylosing spondylitis 12.64 10.00 3 148735 13130 90466579
Endotracheal intubation 12.58 10.00 21 148717 3343 90476366
Urine analysis abnormal 12.56 10.00 27 148711 5194 90474515
Product selection error 12.50 10.00 7 148731 274 90479435
Neck pain 12.50 10.00 123 148615 113840 90365869
Fungal sepsis 12.49 10.00 14 148724 1527 90478182
Product substitution issue 12.47 10.00 7 148731 18001 90461708
Lymph node pain 12.46 10.00 15 148723 1766 90477943
Multiple sclerosis relapse 12.44 10.00 44 148694 52261 90427448
Haemorrhage subcutaneous 12.43 10.00 21 148717 3375 90476334
Troponin I increased 12.42 10.00 18 148720 2537 90477172
Corneal disorder 12.36 10.00 16 148722 2026 90477683
Bacterial sepsis 12.35 10.00 26 148712 4929 90474780
Pancreatitis chronic 12.35 10.00 19 148719 2824 90476885
Therapeutic product effect incomplete 12.31 10.00 234 148504 193662 90286047
Urine output decreased 12.26 10.00 47 148691 12556 90467153
Wisdom teeth removal 12.23 10.00 10 148728 736 90478973
Vascular access site occlusion 12.22 10.00 4 148734 39 90479670
Angina pectoris 12.20 10.00 29 148709 39131 90440578
Nasal pruritus 12.18 10.00 10 148728 740 90478969
Catheter site swelling 12.16 10.00 15 148723 1810 90477899
Cyanosis central 12.15 10.00 5 148733 97 90479612
Meningitis 12.13 10.00 36 148702 8445 90471264
Myositis 12.12 10.00 13 148725 24115 90455594
Pseudohyperphosphataemia 12.10 10.00 3 148735 9 90479700
Norovirus infection 12.04 10.00 15 148723 1829 90477880
Poisoning deliberate 12.02 10.00 6 148732 16480 90463229
Blood chloride increased 11.95 10.00 20 148718 3190 90476519
Coagulopathy 11.82 10.00 72 148666 23217 90456492
Hypophosphataemia 11.77 10.00 52 148686 14802 90464907
Retinal detachment 11.77 10.00 31 148707 6791 90472918
Procedural nausea 11.76 10.00 12 148726 1176 90478533
Staphylococcal sepsis 11.73 10.00 38 148700 9345 90470364
Liver injury 11.72 10.00 203 148535 170364 90309345
Procedural vomiting 11.72 10.00 10 148728 781 90478928
Small intestinal obstruction 11.65 10.00 67 148671 21167 90458542
Paranoia 11.64 10.00 47 148691 12861 90466848
Rhabdomyolysis 11.61 10.00 44 148694 51212 90428497
Infusion site warmth 11.56 10.00 16 148722 2162 90477547
Schizophrenia 11.54 10.00 5 148733 14909 90464800
Injection site pain 11.53 10.00 208 148530 173491 90306218
Coagulation time prolonged 11.44 10.00 14 148724 1676 90478033
Central venous catheter removal 11.44 10.00 8 148730 465 90479244
Catheter site erythema 11.42 10.00 25 148713 4869 90474840
Wrong product administered 11.41 10.00 33 148705 7632 90472077
Nephropathy toxic 11.28 10.00 46 148692 12642 90467067
Uveitis 11.28 10.00 6 148732 15897 90463812
Infusion site urticaria 11.27 10.00 14 148724 1701 90478008
Parasitic encephalitis 11.26 10.00 4 148734 51 90479658
Suture related complication 11.24 10.00 7 148731 334 90479375
Perineal cellulitis 11.24 10.00 3 148735 13 90479696
Aneurysm ruptured 11.24 10.00 9 148729 643 90479066
Thrombosis in device 11.24 10.00 19 148719 3056 90476653
General symptom 11.22 10.00 5 148733 14663 90465046
Haemorrhage intracranial 11.21 10.00 52 148686 15110 90464599
Abnormal faeces 11.16 10.00 30 148708 6652 90473057
Hepatocellular injury 11.11 10.00 19 148719 28939 90450770
Vascular parkinsonism 11.10 10.00 5 148733 122 90479587
Bacillus bacteraemia 11.10 10.00 5 148733 122 90479587
Hypoxic-ischaemic encephalopathy 11.07 10.00 24 148714 4644 90475065
Cystic fibrosis hepatic disease 11.06 10.00 3 148735 14 90479695
Mitral valve incompetence 11.03 10.00 69 148669 22455 90457254
Joint destruction 11.02 10.00 4 148734 13283 90466426
Aortic disorder 10.99 10.00 10 148728 850 90478859
Mean cell haemoglobin decreased 10.99 10.00 27 148711 5668 90474041
Blood phosphorus decreased 10.94 10.00 25 148713 5009 90474700
Blood glucose false positive 10.89 10.00 3 148735 15 90479694
Drug eruption 10.82 10.00 97 148641 35310 90444399
Breath sounds absent 10.78 10.00 6 148732 232 90479477
Blood bilirubin increased 10.78 10.00 114 148624 43356 90436353
Adrenocortical insufficiency acute 10.76 10.00 17 148721 2584 90477125
Exophthalmos 10.72 10.00 14 148724 1788 90477921
Nasal obstruction 10.71 10.00 17 148721 2595 90477114
Synovial cyst 10.71 10.00 3 148735 11749 90467960
Local anaesthetic systemic toxicity 10.70 10.00 20 148718 3480 90476229
Pneumonia pseudomonal 10.67 10.00 19 148719 3184 90476525
Fungal infection 10.64 10.00 112 148626 42549 90437160
Alanine aminotransferase decreased 10.63 10.00 10 148728 887 90478822
Systemic inflammatory response syndrome 10.63 10.00 29 148709 6487 90473222
Status asthmaticus 10.61 10.00 10 148728 889 90478820
Cystic fibrosis related diabetes 10.60 10.00 4 148734 61 90479648
Balance disorder 10.55 10.00 105 148633 96975 90382734
Gastroenteritis rotavirus 10.55 10.00 6 148732 242 90479467
Papule 10.54 10.00 33 148705 7969 90471740
Device difficult to use 10.53 10.00 8 148730 17517 90462192
Abdominal infection 10.42 10.00 16 148722 2374 90477335
No adverse event 10.37 10.00 163 148575 67819 90411890
Neutrophil percentage decreased 10.32 10.00 8 148730 545 90479164
Sinus operation 10.30 10.00 18 148720 2973 90476736
Carbon dioxide increased 10.29 10.00 14 148724 1861 90477848
Abnormal behaviour 10.27 10.00 68 148670 22560 90457149
Leukostasis syndrome 10.26 10.00 4 148734 67 90479642
Suffocation feeling 10.24 10.00 13 148725 1615 90478094
Oxygen consumption increased 10.21 10.00 23 148715 4566 90475143
Steatorrhoea 10.13 10.00 8 148730 560 90479149
Neonatal infection 10.12 10.00 6 148732 262 90479447
Brachial plexopathy 10.12 10.00 6 148732 262 90479447
Wound abscess 10.12 10.00 5 148733 151 90479558
Dry skin 10.11 10.00 94 148644 87979 90391730
Myocardial necrosis marker increased 10.09 10.00 15 148723 2163 90477546
Granulocytosis 10.09 10.00 5 148733 152 90479557
Noninfectious peritonitis 10.09 10.00 5 148733 152 90479557
Ocular icterus 10.06 10.00 21 148717 3959 90475750
Respiratory tract procedural complication 10.04 10.00 3 148735 21 90479688

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
Myelosuppression 2032.14 10.41 1249 102178 39212 42478696
Infective pulmonary exacerbation of cystic fibrosis 663.60 10.41 341 103086 7477 42510431
Hyperchloraemia 409.71 10.41 119 103308 465 42517443
Peritonitis bacterial 312.57 10.41 200 103227 6715 42511193
Chills 243.75 10.41 635 102792 93431 42424477
White blood cell count decreased 242.11 10.41 701 102726 109695 42408213
Drug ineffective 217.48 10.41 794 102633 629403 41888505
Peritoneal dialysis complication 217.14 10.41 102 103325 1825 42516083
Pyrexia 211.50 10.41 1655 101772 392387 42125521
Drug interaction 205.66 10.41 207 103220 266792 42251116
Temperature intolerance 193.21 10.41 129 103298 4659 42513249
Cystic fibrosis 192.95 10.41 96 103331 1959 42515949
Toxicity to various agents 181.76 10.41 173 103254 228963 42288945
Completed suicide 180.89 10.41 14 103413 96451 42421457
Chest discomfort 171.44 10.41 436 102991 63180 42454728
Drug abuse 166.95 10.41 27 103400 104744 42413164
Neutrophil count decreased 166.11 10.41 430 102997 62985 42454923
Fungal peritonitis 154.70 10.41 65 103362 880 42517028
Infusion related reaction 144.78 10.41 398 103029 60408 42457500
Granulocyte count decreased 143.45 10.41 72 103355 1498 42516410
Cytokine release syndrome 143.39 10.41 327 103100 44200 42473708
Hereditary angioedema 132.62 10.41 67 103360 1414 42516494
Tachypnoea 132.16 10.41 209 103218 21453 42496455
Peritonitis 129.52 10.41 191 103236 18442 42499466
Osmotic demyelination syndrome 127.87 10.41 58 103369 954 42516954
Toxic anterior segment syndrome 126.62 10.41 64 103363 1352 42516556
Hyperpyrexia 113.88 10.41 83 103344 3457 42514451
Infusion site extravasation 109.07 10.41 97 103330 5384 42512524
Hepatic function abnormal 106.72 10.41 321 103106 51246 42466662
Flushing 100.97 10.41 255 103172 36773 42481135
Sputum increased 90.22 10.41 69 103358 3094 42514814
Hypernatraemia 77.28 10.41 108 103319 9924 42507984
Bone marrow failure 75.16 10.41 213 103214 32880 42485028
Infusion site pain 74.32 10.41 78 103349 5317 42512591
Arthralgia 73.30 10.41 254 103173 204984 42312924
Rapid correction of hyponatraemia 72.99 10.41 24 103403 153 42517755
Incorrect drug administration rate 72.57 10.41 52 103375 2108 42515800
Dysphoria 69.28 10.41 56 103371 2724 42515184
Disorganised speech 66.26 10.41 42 103385 1386 42516522
Psoriasis 66.16 10.41 18 103409 48586 42469322
Device interaction 65.97 10.41 31 103396 555 42517353
Oxygen saturation decreased 65.74 10.41 321 103106 64366 42453542
Therapeutic product effect incomplete 65.52 10.41 46 103381 70893 42447015
Rheumatoid arthritis 65.23 10.41 12 103415 42428 42475480
Sinusitis 65.06 10.41 257 103170 47035 42470873
Air embolism 64.97 10.41 24 103403 225 42517683
Epilepsy 63.93 10.41 173 103254 25998 42491910
Disease progression 63.40 10.41 161 103266 143495 42374413
Pneumonia 62.72 10.41 1401 102026 420748 42097160
Anaphylactic shock 62.07 10.41 160 103267 23357 42494551
Depression 61.49 10.41 110 103317 111253 42406655
Platelet count decreased 59.58 10.41 555 102872 138026 42379882
Acidosis hyperchloraemic 58.66 10.41 30 103397 650 42517258
Vomiting 56.52 10.41 1002 102425 288721 42229187
Intentional overdose 55.05 10.41 28 103399 51428 42466480
Sepsis 54.86 10.41 731 102696 198603 42319305
Administration site extravasation 54.83 10.41 30 103397 749 42517159
Treatment failure 53.49 10.41 44 103383 62580 42455328
Cough 53.15 10.41 663 102764 177440 42340468
Increased bronchial secretion 51.68 10.41 44 103383 2302 42515606
Dysbiosis 51.33 10.41 29 103398 772 42517136
Suicide attempt 50.96 10.41 24 103403 46076 42471832
Device infusion issue 49.95 10.41 32 103395 1076 42516832
Encapsulating peritoneal sclerosis 49.92 10.41 26 103401 586 42517322
Monocyte chemotactic protein-1 increased 49.39 10.41 22 103405 346 42517562
Ultrafiltration failure 49.28 10.41 21 103406 295 42517613
Infusion site erythema 49.24 10.41 52 103375 3570 42514338
Alpha tumour necrosis factor increased 49.10 10.41 22 103405 351 42517557
Cystic fibrosis respiratory infection suppression 48.67 10.41 20 103407 255 42517653
Product preparation issue 48.34 10.41 31 103396 1044 42516864
Insurance issue 47.13 10.41 54 103373 4062 42513846
Spinal muscular atrophy 46.81 10.41 22 103405 394 42517514
Haemarthrosis 46.70 10.41 53 103374 3945 42513963
Pulmonary function test decreased 46.09 10.41 63 103364 5669 42512239
Drug dependence 45.20 10.41 8 103419 29086 42488822
Drug reaction with eosinophilia and systemic symptoms 44.85 10.41 23 103404 42052 42475856
Upper respiratory tract infection 43.35 10.41 210 103217 41963 42475945
Hyponatraemia 42.90 10.41 405 103022 101057 42416851
Dyspnoea 41.93 10.41 1386 102041 441235 42076673
Poor venous access 41.53 10.41 68 103359 7184 42510724
Joint swelling 39.54 10.41 65 103362 67957 42449951
Noninfectious peritonitis 39.40 10.41 15 103412 154 42517754
Hypervolaemia 38.78 10.41 134 103293 22991 42494917
Hypoxia 38.72 10.41 296 103131 69490 42448418
Erectile dysfunction 38.38 10.41 7 103420 24906 42493002
Product contamination 38.21 10.41 26 103401 969 42516939
Disease complication 38.09 10.41 42 103385 3028 42514880
Interleukin level increased 37.88 10.41 25 103402 885 42517023
Drug resistance 37.59 10.41 18 103409 34230 42483678
Infusion site swelling 37.37 10.41 43 103384 3249 42514659
Extravasation 37.37 10.41 37 103390 2353 42515555
Pallor 37.34 10.41 154 103273 28732 42489176
Product packaging confusion 36.89 10.41 13 103414 105 42517803
Eosinophil count 36.88 10.41 15 103412 186 42517722
Heart rate increased 36.63 10.41 238 103189 53017 42464891
Eosinophilia 36.56 10.41 17 103410 32882 42485026
Liver injury 35.70 10.41 115 103312 19033 42498875
Vocal cord dysfunction 35.70 10.41 15 103412 203 42517705
Cyanosis 35.35 10.41 98 103329 14933 42502975
Therapeutic product effect decreased 35.34 10.41 26 103401 39124 42478784
Hypokalaemia 35.31 10.41 296 103131 71425 42446483
Psoriatic arthropathy 34.44 10.41 9 103418 24958 42492950
Arthritis 34.16 10.41 31 103396 42034 42475874
Prostate cancer 33.81 10.41 35 103392 44608 42473300
Pneumococcal sepsis 33.51 10.41 28 103399 1427 42516481
Myalgia 33.51 10.41 120 103307 95960 42421948
Peritoneal cloudy effluent 32.64 10.41 17 103410 383 42517525
Traumatic haemorrhage 32.41 10.41 26 103401 1251 42516657
Product preparation error 31.79 10.41 48 103379 4730 42513178
Body temperature increased 31.59 10.41 115 103312 20243 42497665
Cardiovascular disorder 31.29 10.41 87 103340 13278 42504630
Hepatic cytolysis 31.20 10.41 13 103414 26831 42491077
Cardiac failure congestive 31.14 10.41 105 103322 85497 42432411
Psychotic disorder 31.08 10.41 16 103411 29192 42488716
Respiratory tract infection 30.68 10.41 136 103291 26186 42491722
Foetal exposure during pregnancy 30.60 10.41 42 103385 47269 42470639
Gait disturbance 30.58 10.41 128 103299 97872 42420036
Productive cough 30.45 10.41 222 103205 51345 42466563
Angioedema 30.30 10.41 35 103392 42442 42475466
Burkholderia test positive 30.15 10.41 23 103404 1027 42516881
Overdose 30.13 10.41 142 103285 105122 42412786
Acute respiratory failure 30.06 10.41 179 103248 38679 42479229
Suicidal ideation 29.91 10.41 44 103383 48117 42469791
Suspected product contamination 29.74 10.41 13 103414 195 42517713
Pantoea agglomerans infection 29.74 10.41 10 103417 69 42517839
Infusion site oedema 29.28 10.41 17 103410 477 42517431
Cardiac arrest 29.23 10.41 399 103028 108921 42408987
Blood fibrinogen decreased 29.20 10.41 27 103400 1576 42516332
Sedation 29.15 10.41 19 103408 30456 42487452
Neuroleptic malignant syndrome 29.12 10.41 8 103419 21464 42496444
Arthropathy 28.93 10.41 18 103409 29579 42488329
Suffocation feeling 28.83 10.41 19 103408 671 42517237
Delirium 28.70 10.41 222 103205 52297 42465611
Drug eruption 28.25 10.41 121 103306 22954 42494954
Cholestasis 28.19 10.41 23 103404 32856 42485052
Contraindicated product administered 28.17 10.41 13 103414 25259 42492649
Stoma closure 27.77 10.41 14 103413 294 42517614
Serotonin syndrome 27.73 10.41 14 103413 25831 42492077
Cataract operation complication 27.63 10.41 10 103417 88 42517820
Suspected transmission of an infectious agent via product 27.62 10.41 21 103406 933 42516975
Motor neurone disease 27.34 10.41 17 103410 542 42517366
Oxygen therapy 26.95 10.41 24 103403 1334 42516574
Unresponsive to stimuli 26.47 10.41 148 103279 31255 42486653
Disease recurrence 26.41 10.41 20 103407 29658 42488250
Bloody peritoneal effluent 26.15 10.41 10 103417 104 42517804
Device related infection 26.12 10.41 108 103319 20171 42497737
Incorrect route of product administration 25.67 10.41 122 103305 24183 42493725
Disturbance in attention 25.47 10.41 21 103406 29845 42488063
Product contamination microbial 25.07 10.41 18 103409 732 42517176
Cauda equina syndrome 24.97 10.41 20 103407 960 42516948
Lower respiratory tract infection bacterial 24.71 10.41 16 103411 548 42517360
Spinal cord infarction 24.62 10.41 17 103410 649 42517259
Haemorrhage 24.22 10.41 239 103188 60324 42457584
Transurethral resection syndrome 24.17 10.41 7 103420 27 42517881
Lymphadenectomy 23.88 10.41 15 103412 487 42517421
Therapeutic response decreased 23.79 10.41 33 103394 36979 42480929
Tumour lysis syndrome 23.78 10.41 112 103315 22119 42495789
Complication associated with device 23.67 10.41 51 103376 6630 42511278
Renal failure 23.50 10.41 229 103198 143497 42374411
Respiratory failure 23.43 10.41 439 102988 127693 42390215
Infectious crystalline keratopathy 23.33 10.41 8 103419 59 42517849
Transaminases increased 23.24 10.41 148 103279 32737 42485171
Peritoneal effluent abnormal 22.99 10.41 8 103419 62 42517846
Leukoplakia oral 22.94 10.41 10 103417 149 42517759
Muscle haemorrhage 22.71 10.41 38 103389 4087 42513821
Hospitalisation 22.68 10.41 278 103149 74052 42443856
Product distribution issue 22.56 10.41 26 103401 1968 42515940
Pancreatic enzyme abnormality 22.54 10.41 9 103418 106 42517802
Tetany 22.45 10.41 20 103407 1112 42516796
Endotracheal intubation 22.36 10.41 36 103391 3749 42514159
Drug intolerance 22.13 10.41 110 103317 80314 42437594
Illness 22.02 10.41 119 103308 24811 42493097
Infusion site discharge 21.98 10.41 13 103414 378 42517530
Intentional self-injury 21.90 10.41 5 103422 15197 42502711
Injection site pain 21.63 10.41 70 103357 57728 42460180
Immune effector cell-associated neurotoxicity syndrome 21.57 10.41 61 103366 9400 42508508
SARS-CoV-2 test negative 21.54 10.41 24 103403 1751 42516157
Product prescribing error 21.49 10.41 19 103408 26093 42491815
Suspected product quality issue 21.48 10.41 11 103416 239 42517669
Pain in extremity 21.37 10.41 248 103179 150356 42367552
Blood sodium abnormal 21.33 10.41 15 103412 590 42517318
Blood pressure decreased 21.33 10.41 226 103201 58106 42459802
Pancreatic failure 21.16 10.41 19 103408 1068 42516840
Blood pressure systolic increased 21.10 10.41 22 103405 27946 42489962
Metabolic disorder 21.07 10.41 40 103387 4748 42513160
Loss of personal independence in daily activities 21.05 10.41 57 103370 49759 42468149
Hypotension 20.88 10.41 793 102634 256838 42261070
Hyperphosphataemia 20.64 10.41 74 103353 12930 42504978
Dry skin 19.91 10.41 56 103371 48282 42469626
Neuropathy peripheral 19.88 10.41 155 103272 101698 42416210
Vascular device infection 19.79 10.41 45 103382 6065 42511843
Vasculitis 19.68 10.41 10 103417 18384 42499524
Ischaemic cerebral infarction 19.57 10.41 22 103405 1621 42516287
Spinal meningeal cyst 19.54 10.41 8 103419 101 42517807
Mouth ulceration 19.51 10.41 80 103347 14883 42503025
Eczema 19.40 10.41 33 103394 34053 42483855
Blood pressure fluctuation 19.37 10.41 22 103405 26886 42491022
Myasthenia gravis 19.28 10.41 84 103343 16053 42501855
Gangrene 19.16 10.41 40 103387 5086 42512822
Catheter site infection 19.15 10.41 30 103397 3053 42514855
Catheter site swelling 19.12 10.41 14 103413 587 42517321
Fungal sepsis 19.11 10.41 18 103409 1076 42516832
Infective exacerbation of bronchiectasis 19.07 10.41 13 103414 486 42517422
Pulmonary fibrosis 19.01 10.41 22 103405 26659 42491249
Extrapyramidal disorder 18.99 10.41 8 103419 16404 42501504
Sinus congestion 18.94 10.41 48 103379 6932 42510976
Bronchial disorder 18.88 10.41 20 103407 1378 42516530
Gadolinium deposition disease 18.70 10.41 6 103421 35 42517873
Anal inflammation 18.68 10.41 25 103402 2204 42515704
Cystic fibrosis lung 18.64 10.41 7 103420 69 42517839
Hepatocellular injury 18.57 10.41 18 103409 23660 42494248
Infusion site haemorrhage 18.56 10.41 19 103408 1258 42516650
Coagulation time prolonged 18.48 10.41 20 103407 1412 42516496
Hypersensitivity 18.46 10.41 262 103165 72108 42445800
Respiratory rate increased 18.46 10.41 64 103363 10998 42506910
Gynaecomastia 18.37 10.41 4 103423 12563 42505345
Endophthalmitis 18.25 10.41 36 103391 4397 42513511
Catheter site extravasation 18.16 10.41 9 103418 182 42517726
Coronary artery disease 18.13 10.41 68 103359 53652 42464256
Infusion site reaction 18.08 10.41 19 103408 1297 42516611
Osteonecrosis of jaw 18.05 10.41 12 103415 19037 42498871
Poor quality product administered 18.00 10.41 25 103402 2283 42515625
Cystic fibrosis related diabetes 17.85 10.41 9 103418 189 42517719
Rash erythematous 17.72 10.41 136 103291 31955 42485953
Resuscitation 17.70 10.41 22 103405 1803 42516105
Fibrin D dimer increased 17.60 10.41 38 103389 4947 42512961
Accidental overdose 17.48 10.41 26 103401 28304 42489604
Melaena 17.40 10.41 43 103384 38703 42479205
Arteriosclerosis coronary artery 17.38 10.41 12 103415 18665 42499243
Rectal haemorrhage 17.26 10.41 62 103365 49544 42468364
Obstructive airways disorder 17.01 10.41 21 103406 24738 42493170
Procedural pain 17.01 10.41 41 103386 5738 42512170
Basal cell carcinoma 17.01 10.41 18 103409 22715 42495193
Respiratory tract infection bacterial 16.91 10.41 22 103405 1887 42516021
Blood sodium increased 16.86 10.41 29 103398 3189 42514719
Angina pectoris 16.82 10.41 34 103393 32862 42485046
Tubulointerstitial nephritis 16.65 10.41 32 103395 31516 42486392
Hypercalcaemia 16.50 10.41 87 103340 17971 42499937
Blood glucose false positive 16.46 10.41 6 103421 54 42517854
Adverse drug reaction 16.45 10.41 42 103385 37392 42480516
Respiratory depression 16.42 10.41 13 103414 18855 42499053
Visual impairment 16.28 10.41 52 103375 43061 42474847
Oropharyngeal discomfort 16.25 10.41 33 103394 4116 42513792
Bronchopulmonary aspergillosis allergic 16.17 10.41 35 103392 4563 42513345
Post procedural complication 16.17 10.41 67 103360 12523 42505385
Brain herniation 16.16 10.41 36 103391 4787 42513121
Deafness permanent 16.05 10.41 9 103418 236 42517672
Sopor 15.99 10.41 6 103421 13196 42504712
Therapeutic response unexpected 15.89 10.41 4 103423 11377 42506531
Procedural complication 15.86 10.41 33 103394 4186 42513722
Product deposit 15.48 10.41 11 103416 440 42517468
Hyponatraemic encephalopathy 15.39 10.41 6 103421 66 42517842
Granulocytopenia 15.38 10.41 45 103382 7069 42510839
Catheter site bruise 15.31 10.41 6 103421 67 42517841
Nasal congestion 15.18 10.41 123 103304 29378 42488530
Insomnia 15.16 10.41 199 103228 118054 42399854
Ischaemic stroke 15.13 10.41 19 103408 22214 42495694
Fluid imbalance 15.08 10.41 10 103417 357 42517551
Influenza 15.03 10.41 223 103204 61952 42455956
Acute kidney injury 14.92 10.41 734 102693 366603 42151305
Haematochezia 14.91 10.41 82 103345 58354 42459554
Myelodysplastic syndrome 14.90 10.41 20 103407 22725 42495183
Chemical peritonitis 14.86 10.41 7 103420 126 42517782
Skin lesion 14.84 10.41 27 103400 27147 42490761
Aggression 14.83 10.41 56 103371 44107 42473801
Hyperhidrosis 14.81 10.41 305 103122 90207 42427701
Death 14.78 10.41 1331 102096 469854 42048054
Bacterial infection 14.76 10.41 117 103310 27762 42490146
Lower respiratory tract infection 14.76 10.41 159 103268 41047 42476861
Respiratory rate decreased 14.73 10.41 26 103401 2919 42514989
Rhinovirus infection 14.72 10.41 42 103385 6506 42511402
Osteoporosis 14.66 10.41 9 103418 14897 42503011
Febrile neutropenia 14.64 10.41 570 102857 185133 42332775
Hepatitis cholestatic 14.62 10.41 3 103424 9821 42508087
Abdominal distension 14.60 10.41 250 103177 71485 42446423
Infusion site pruritus 14.47 10.41 16 103411 1157 42516751
Paranoia 14.46 10.41 8 103419 14018 42503890
Streptococcal infection 14.44 10.41 40 103387 6092 42511816
Failure to thrive 14.43 10.41 53 103374 9369 42508539
Withdrawal syndrome 14.42 10.41 9 103418 14766 42503142
Aplastic anaemia 14.39 10.41 6 103421 12378 42505530
Progressive multifocal leukoencephalopathy 14.38 10.41 5 103422 11531 42506377
Balance disorder 14.38 10.41 63 103364 47582 42470326
Vocal cord paralysis 14.24 10.41 16 103411 1178 42516730
Hepatorenal failure 14.21 10.41 12 103415 621 42517287
Weight decreased 14.20 10.41 390 103037 207558 42310350
Lactic acidosis 14.18 10.41 59 103368 45202 42472706
Activated partial thromboplastin time prolonged 14.10 10.41 76 103351 15827 42502081
Catheter site pain 14.08 10.41 19 103408 1688 42516220
Ear infection 14.05 10.41 65 103362 12739 42505169
Myocardial infarction 14.01 10.41 214 103213 123795 42394113
Diabetes insipidus 13.91 10.41 29 103398 3684 42514224
Toxic skin eruption 13.91 10.41 8 103419 13722 42504186
Bronchial obstruction 13.89 10.41 19 103408 1710 42516198
Feeling hot 13.80 10.41 101 103326 23381 42494527
Polyneuropathy 13.72 10.41 15 103412 18646 42499262
Infusion site rash 13.68 10.41 12 103415 654 42517254
Scoliosis 13.62 10.41 26 103401 3100 42514808
Infusion site bruising 13.54 10.41 14 103413 938 42516970
Multiple sclerosis relapse 13.49 10.41 9 103418 14255 42503653
Febrile bone marrow aplasia 13.43 10.41 4 103423 10177 42507731
Catheter site haemorrhage 13.40 10.41 23 103404 2525 42515383
Antacid therapy 13.39 10.41 33 103394 4684 42513224
Drug-induced liver injury 13.39 10.41 147 103280 38126 42479782
Respiratory syncytial virus infection 13.37 10.41 43 103384 7109 42510799
Blood creatine phosphokinase increased 13.36 10.41 66 103361 48272 42469636
Respiration abnormal 13.35 10.41 30 103397 4012 42513896
Catheter site warmth 13.32 10.41 6 103421 97 42517811
Tuberculosis 13.26 10.41 4 103423 10095 42507813
Product administration error 13.24 10.41 83 103344 18260 42499648
Anaphylactoid reaction 13.23 10.41 25 103402 2958 42514950
Coma 13.20 10.41 76 103351 53478 42464430
Anticoagulant therapy 13.16 10.41 32 103395 4503 42513405
Rhegmatogenous retinal detachment 13.10 10.41 6 103421 101 42517807
Memory impairment 13.07 10.41 70 103357 50152 42467756
Anion gap decreased 13.01 10.41 8 103419 250 42517658
Moraxella infection 13.00 10.41 9 103418 345 42517563
Peritoneal effluent leukocyte count increased 12.98 10.41 4 103423 20 42517888
Pruritus 12.96 10.41 571 102856 188200 42329708
Nasal obstruction 12.95 10.41 14 103413 987 42516921
Normochromic normocytic anaemia 12.95 10.41 3 103424 9028 42508880
Pharyngitis streptococcal 12.94 10.41 29 103398 3871 42514037
Fatigue 12.92 10.41 897 102530 434744 42083164
Eye infection 12.90 10.41 31 103396 4330 42513578
Blood bilirubin increased 12.87 10.41 158 103269 42094 42475814
Staphylococcus test positive 12.87 10.41 28 103399 3664 42514244
Sinus operation 12.87 10.41 13 103414 847 42517061
Coagulopathy 12.84 10.41 95 103332 22067 42495841
Hypophosphataemia 12.84 10.41 91 103336 20854 42497054
Nasopharyngitis 12.76 10.41 280 103147 83716 42434192
Alopecia 12.75 10.41 33 103394 29243 42488665
Injection site bruising 12.73 10.41 6 103421 11519 42506389
COVID-19 12.73 10.41 370 103057 115578 42402330
Respiratory acidosis 12.70 10.41 39 103388 6292 42511616
Infection 12.68 10.41 359 103068 111709 42406199
Blood pressure abnormal 12.68 10.41 53 103374 9945 42507963
Sweat test abnormal 12.66 10.41 4 103423 22 42517886
Pemphigoid 12.62 10.41 6 103421 11461 42506447
Demyelination 12.57 10.41 27 103400 3502 42514406
Sleep disorder therapy 12.49 10.41 41 103386 6853 42511055
Panic reaction 12.40 10.41 18 103409 1712 42516196
Electrocardiogram QT prolonged 12.38 10.41 67 103360 47878 42470030
Lung consolidation 12.35 10.41 40 103387 6637 42511271
Tachycardia 12.34 10.41 327 103100 100760 42417148
Pancreatitis acute 12.31 10.41 41 103386 33523 42484385
Pneumonia aspiration 12.25 10.41 180 103247 49898 42468010
Bladder cancer 12.20 10.41 14 103413 17033 42500875
Second primary malignancy 12.20 10.41 4 103423 9571 42508337
Endocrine ophthalmopathy 12.17 10.41 7 103420 193 42517715
Complication of device removal 12.15 10.41 5 103422 64 42517844
Tracheostomy malfunction 12.08 10.41 5 103422 65 42517843
Hiccups 12.07 10.41 60 103367 12111 42505797
International normalised ratio increased 12.06 10.41 68 103359 48100 42469808
Anti-thyroid antibody positive 11.95 10.41 5 103422 67 42517841
Exposure during pregnancy 11.94 10.41 3 103424 8545 42509363
Carbon dioxide increased 11.80 10.41 15 103412 1257 42516651
Urine analysis abnormal 11.80 10.41 20 103407 2174 42515734
Extravasation of urine 11.79 10.41 3 103424 6 42517902
Musculoskeletal stiffness 11.69 10.41 87 103340 57678 42460230
Neoplasm progression 11.65 10.41 34 103393 28966 42488942
Bacteraemia 11.61 10.41 102 103325 24938 42492970
Device issue 11.60 10.41 64 103363 13445 42504463
Peritoneal fluid analysis abnormal 11.49 10.41 4 103423 31 42517877
Therapy non-responder 11.46 10.41 79 103348 53280 42464628
Renal cyst 11.45 10.41 5 103422 10034 42507874
Toxic epidermal necrolysis 11.40 10.41 107 103320 26643 42491265
Osteonecrosis 11.39 10.41 13 103414 15852 42502056
Musculoskeletal pain 11.38 10.41 42 103385 33298 42484610
Type 2 diabetes mellitus 11.35 10.41 17 103410 18454 42499454
Laryngeal oedema 11.34 10.41 28 103399 3980 42513928
Sleep apnoea syndrome 11.33 10.41 22 103405 21586 42496322
Abdominal pain 11.33 10.41 568 102859 189903 42328005
Glaucoma 11.32 10.41 3 103424 8245 42509663
Vertigo 11.25 10.41 44 103383 34303 42483605
Brain oedema 11.24 10.41 73 103354 16254 42501654
Dermatitis contact 11.23 10.41 30 103397 4473 42513435
Drug delivery system issue 11.20 10.41 5 103422 79 42517829
Convulsions local 11.17 10.41 4 103423 34 42517874
Limb mass 11.17 10.41 12 103415 840 42517068
Viral infection 11.17 10.41 93 103334 22390 42495518
Mucosal inflammation 11.16 10.41 72 103355 49302 42468606
Ejection fraction decreased 11.14 10.41 23 103404 22064 42495844
Angina unstable 11.13 10.41 7 103420 11441 42506467
Glycosylated haemoglobin increased 11.13 10.41 9 103418 12915 42504993
Incision site pain 11.11 10.41 18 103409 1885 42516023
Alanine aminotransferase increased 11.08 10.41 287 103140 88119 42429789
Lactobacillus test positive 11.07 10.41 4 103423 35 42517873
Chronic respiratory failure 11.03 10.41 17 103410 1705 42516203
Fracture 11.02 10.41 3 103424 8100 42509808
Aspartate aminotransferase increased 11.02 10.41 255 103172 76908 42441000
Infusion site discolouration 11.02 10.41 7 103420 232 42517676
Tendon rupture 10.98 10.41 3 103424 8080 42509828
Impaired work ability 10.95 10.41 8 103419 12083 42505825
Hepatic cyst ruptured 10.93 10.41 3 103424 9 42517899
Central venous catheter removal 10.93 10.41 5 103422 84 42517824
Bronchial hyperreactivity 10.93 10.41 18 103409 1911 42515997
Recalled product administered 10.92 10.41 11 103416 714 42517194
Cystic fibrosis hepatic disease 10.88 10.41 4 103423 37 42517871
Product substitution issue 10.85 10.41 7 103420 11283 42506625
Herpes zoster 10.79 10.41 53 103374 38824 42479084
Respiratory tract congestion 10.77 10.41 42 103385 7636 42510272
Skin fissures 10.75 10.41 5 103422 9671 42508237
Vitamin A increased 10.70 10.41 3 103424 10 42517898
Stridor 10.60 10.41 22 103405 2786 42515122
Lung transplant 10.58 10.41 20 103407 2366 42515542
Condition aggravated 10.57 10.41 521 102906 260233 42257675
Intestinal ischaemia 10.56 10.41 48 103379 9340 42508568
Systemic immune activation 10.51 10.41 4 103423 41 42517867
Seasonal allergy 10.45 10.41 43 103384 8012 42509896
Cognitive disorder 10.42 10.41 45 103382 34127 42483781

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
Myelosuppression 9068.10 9.75 4163 210165 90177 110284794
White blood cell count decreased 1997.59 9.75 2339 211989 227051 110147920
Infective pulmonary exacerbation of cystic fibrosis 1251.89 9.75 599 213729 14172 110360799
Neutrophil count decreased 1124.81 9.75 1277 213051 119664 110255307
Hepatic function abnormal 735.16 9.75 886 213442 88409 110286562
Chills 700.95 9.75 1295 213033 189285 110185686
Chest discomfort 640.12 9.75 1182 213146 172666 110202305
Agranulocytosis 628.66 9.75 684 213644 61076 110313895
Bone marrow failure 551.34 9.75 619 213709 57229 110317742
Pyrexia 523.21 9.75 3247 211081 895018 109479953
Synovitis 508.30 9.75 4 214324 274088 110100883
Granulocyte count decreased 501.93 9.75 213 214115 3761 110371210
Temperature intolerance 488.14 9.75 316 214012 13634 110361337
Joint swelling 442.58 9.75 153 214175 442692 109932279
Hereditary angioedema 428.38 9.75 229 214099 6885 110368086
Arthropathy 409.87 9.75 41 214287 287481 110087490
Peritonitis bacterial 409.43 9.75 255 214073 10278 110364693
Pemphigus 398.45 9.75 3 214325 214567 110160404
Hand deformity 392.34 9.75 6 214322 218500 110156471
Completed suicide 374.83 9.75 24 214304 242357 110132614
Rheumatoid arthritis 373.95 9.75 65 214263 299548 110075423
Systemic lupus erythematosus 371.19 9.75 33 214295 254305 110120666
Hyperpyrexia 366.85 9.75 216 214112 7853 110367118
Cystic fibrosis 362.15 9.75 179 214149 4552 110370419
Drug intolerance 361.13 9.75 168 214160 406344 109968627
Contraindicated product administered 360.20 9.75 33 214295 248234 110126737
Tachypnoea 347.37 9.75 405 213923 38990 110335981
Platelet count decreased 331.92 9.75 1092 213236 229351 110145620
Treatment failure 325.14 9.75 70 214258 277164 110097807
Duodenal ulcer perforation 322.84 9.75 4 214324 177696 110197275
Drug ineffective 318.70 9.75 1694 212634 1518846 108856125
Therapeutic product effect decreased 316.05 9.75 48 214280 244268 110130703
Glossodynia 312.89 9.75 33 214295 221971 110153000
Pericarditis 310.28 9.75 32 214296 219082 110155889
Psoriatic arthropathy 308.68 9.75 18 214310 196743 110178228
Helicobacter infection 300.20 9.75 12 214316 181865 110193106
Alopecia 293.89 9.75 171 214157 364582 110010389
Cytokine release syndrome 284 9.75 498 213830 69808 110305163
Flushing 276.80 9.75 621 213707 104115 110270856
Arthralgia 255.76 9.75 724 213604 778908 109596063
Wound 250.05 9.75 72 214256 234365 110140606
Muscle injury 248.06 9.75 5 214323 140802 110234169
Folliculitis 243.90 9.75 22 214306 167631 110207340
Vomiting 241.76 9.75 2761 211567 907914 109467057
Toxicity to various agents 241.56 9.75 348 213980 480207 109894764
Irritable bowel syndrome 229.86 9.75 25 214303 164190 110210781
Toxic anterior segment syndrome 227.32 9.75 118 214210 3336 110371635
Mobility decreased 226.89 9.75 88 214240 237334 110137637
Drug interaction 217.84 9.75 398 213930 499785 109875186
Nausea 216.27 9.75 3475 210853 1232215 109142756
Osmotic demyelination syndrome 213.15 9.75 96 214232 1967 110373004
Peritoneal dialysis complication 211.89 9.75 102 214226 2444 110372527
C-reactive protein abnormal 209.25 9.75 10 214318 129685 110245286
Musculoskeletal stiffness 201.18 9.75 149 214179 279673 110095298
Bursitis 194.61 9.75 15 214313 129903 110245068
Type 2 diabetes mellitus 184.30 9.75 57 214271 177175 110197796
Hypernatraemia 182.24 9.75 198 214130 17635 110357336
Osteoarthritis 177.28 9.75 66 214262 182557 110192414
Facet joint syndrome 172.33 9.75 3 214325 96825 110278146
Hyponatraemia 165.00 9.75 846 213482 216807 110158164
Ovarian hyperstimulation syndrome 159.99 9.75 110 214218 5250 110369721
Joint range of motion decreased 159.66 9.75 23 214305 121809 110253162
Anaphylactic shock 159.59 9.75 326 214002 51220 110323751
Sepsis 157.89 9.75 1131 213197 326215 110048756
Psoriasis 156.79 9.75 39 214289 139954 110235017
Drug abuse 154.80 9.75 75 214253 177336 110197635
Oxygen saturation decreased 151.03 9.75 654 213674 156328 110218643
Dyspnoea 150.37 9.75 2992 211336 1103880 109271091
Infusion site extravasation 149.31 9.75 146 214182 11488 110363483
Ill-defined disorder 148.40 9.75 59 214269 156794 110218177
Fungal peritonitis 147.61 9.75 65 214263 1260 110373711
Swollen joint count increased 143.39 9.75 4 214324 83657 110291314
Hepatic enzyme increased 140.78 9.75 254 214074 320638 110054333
Impaired healing 139.74 9.75 106 214222 196611 110178360
Depression 138.48 9.75 252 214076 317083 110057888
Grip strength decreased 136.80 9.75 4 214324 80170 110294801
Infusion site pain 133.79 9.75 167 214161 17252 110357719
Swelling 133.40 9.75 302 214026 350739 110024232
Dysphoria 131.30 9.75 105 214223 6323 110368648
Obesity 130.04 9.75 30 214298 113321 110261650
Lip dry 128.60 9.75 20 214308 100063 110274908
Stomatitis 128.58 9.75 203 214125 270039 110104932
Peripheral venous disease 128.01 9.75 9 214319 84108 110290863
Granulocytopenia 127.88 9.75 140 214188 12575 110362396
Blood pressure decreased 125.22 9.75 498 213830 114593 110260378
Pallor 124.40 9.75 312 214016 56155 110318816
Leukopenia 122.39 9.75 592 213736 148199 110226772
Hypokalaemia 121.82 9.75 685 213643 181763 110193208
Gait inability 121.51 9.75 56 214272 136320 110238651
Disorganised speech 120.93 9.75 77 214251 3226 110371745
Peritonitis 120.19 9.75 222 214106 32385 110342586
Sciatica 119.78 9.75 18 214310 92381 110282590
Acidosis hyperchloraemic 118.41 9.75 59 214269 1527 110373444
Blister 117.74 9.75 161 214167 227215 110147756
Musculoskeletal pain 117.24 9.75 109 214219 182914 110192057
Sleep disorder due to general medical condition, insomnia type 117.20 9.75 30 214298 105613 110269358
Device interaction 116.82 9.75 47 214281 720 110374251
Drug hypersensitivity 116.27 9.75 469 213859 453621 109921350
Abdominal discomfort 114.46 9.75 386 213942 393472 109981499
Blood cholesterol increased 113.77 9.75 114 214214 184671 110190300
Arthritis 113.13 9.75 95 214233 167491 110207480
Inflammation 110.31 9.75 127 214201 193111 110181860
Cyanosis 110.27 9.75 203 214125 29538 110345433
Haemarthrosis 107.44 9.75 99 214229 7230 110367741
Peripheral swelling 107.44 9.75 411 213917 403623 109971348
Pulmonary fibrosis 105.74 9.75 33 214295 102009 110272962
Fibromyalgia 105.72 9.75 105 214223 170804 110204167
Product preparation issue 104.78 9.75 66 214262 2713 110372258
Sputum increased 102.93 9.75 87 214241 5664 110369307
Suspected product quality issue 102.75 9.75 40 214288 559 110374412
Unresponsive to stimuli 97.77 9.75 309 214019 63481 110311490
Insomnia 96.38 9.75 366 213962 360224 110014747
Hypoxia 95.72 9.75 500 213828 129015 110245956
Knee arthroplasty 93.16 9.75 9 214319 64939 110310032
Poor venous access 92.96 9.75 169 214159 24353 110350618
Memory impairment 92.66 9.75 149 214179 196795 110178176
Administration site extravasation 91.21 9.75 51 214277 1678 110373293
Infusion site swelling 91.18 9.75 104 214224 9773 110365198
Abdominal distension 90.79 9.75 616 213712 174487 110200484
Febrile neutropenia 90.70 9.75 976 213352 315791 110059180
Intentional overdose 87.13 9.75 77 214251 132424 110242547
Paraesthesia oral 87.07 9.75 198 214130 33473 110341498
Incorrect drug administration rate 85.83 9.75 77 214251 5431 110369540
Injury 85.39 9.75 132 214196 177133 110197838
Sensitisation 85.20 9.75 68 214260 4083 110370888
Insurance issue 83.52 9.75 103 214225 10509 110364462
Nail disorder 83.17 9.75 8 214320 57927 110317044
Condition aggravated 82.12 9.75 970 213358 733866 109641105
Infusion site erythema 81.40 9.75 108 214220 11851 110363120
Cardiac arrest 81.39 9.75 656 213672 196097 110178874
Pantoea agglomerans infection 81.29 9.75 24 214304 132 110374839
Infusion site haemorrhage 81.15 9.75 69 214259 4529 110370442
Night sweats 80.94 9.75 84 214244 133899 110241072
Dry mouth 80.90 9.75 166 214162 199782 110175189
Polycystic ovaries 80.64 9.75 70 214258 4726 110370245
Rapid correction of hyponatraemia 79.83 9.75 26 214302 207 110374764
General physical health deterioration 77.09 9.75 495 213833 424800 109950171
Lower limb fracture 76.94 9.75 25 214303 75323 110299648
Air embolism 76.52 9.75 33 214295 607 110374364
Hypercholesterolaemia 75.35 9.75 41 214287 90796 110284175
Hypotension 74.80 9.75 1428 212900 522421 109852550
Lower respiratory tract infection 73.52 9.75 234 214094 242872 110132099
Hyponatraemic encephalopathy 73.34 9.75 28 214300 370 110374601
Suicide attempt 73.04 9.75 56 214272 103338 110271633
Blepharospasm 72.69 9.75 10 214318 54841 110320130
Erythema 72.60 9.75 874 213454 290573 110084398
Encapsulating peritoneal sclerosis 72.16 9.75 35 214293 853 110374118
Onychomadesis 72.13 9.75 4 214324 45659 110329312
Adjustment disorder with depressed mood 72.03 9.75 3 214325 43880 110331091
Cough 71.67 9.75 1275 213053 460366 109914605
Heart rate increased 71.59 9.75 501 213827 143333 110231638
Red blood cell sedimentation rate increased 71.55 9.75 31 214297 78271 110296700
Blood fibrinogen decreased 70.79 9.75 51 214277 2624 110372347
Procedural pain 70.61 9.75 189 214139 35376 110339595
Extravasation 70.16 9.75 65 214263 4780 110370191
Osteoporosis 69.90 9.75 41 214287 87111 110287860
Therapeutic response decreased 69.79 9.75 51 214277 96448 110278523
Hypervolaemia 68.96 9.75 232 214096 49228 110325743
Pain 68.62 9.75 1372 212956 953583 109421388
Ejection fraction 68.45 9.75 52 214276 2903 110372068
Hospitalisation 68.40 9.75 492 213836 142001 110232970
Intentional product use issue 67.92 9.75 249 214079 247657 110127314
Pulmonary function test decreased 67.76 9.75 84 214244 8616 110366355
Cystic fibrosis respiratory infection suppression 67.76 9.75 28 214300 461 110374510
Suspected transmission of an infectious agent via product 67.67 9.75 39 214289 1361 110373610
Gadolinium deposition disease 67.58 9.75 21 214307 141 110374830
Device infusion issue 67.06 9.75 52 214276 2993 110371978
Live birth 65.93 9.75 26 214302 69458 110305513
Prescribed underdose 65.89 9.75 22 214306 65152 110309819
Hip arthroplasty 65.56 9.75 14 214314 55799 110319172
Weight increased 65.50 9.75 510 213818 419134 109955837
Drug reaction with eosinophilia and systemic symptoms 65.30 9.75 39 214289 82056 110292915
Lung disorder 65.05 9.75 159 214169 179888 110195083
Wound infection 64.70 9.75 55 214273 96410 110278561
Respiratory failure 64.19 9.75 669 213659 214663 110160308
Abdominal pain upper 63.93 9.75 405 213923 348706 110026265
Infusion site coldness 63.80 9.75 23 214305 256 110374715
Product contamination 63.30 9.75 42 214286 1889 110373082
Acute respiratory failure 62.98 9.75 301 214027 74959 110300012
Aspartate aminotransferase increased 62.78 9.75 527 213801 159409 110215562
Transaminases increased 62.39 9.75 266 214062 63124 110311847
Endophthalmitis 62.09 9.75 78 214250 8109 110366862
Coeliac disease 61.90 9.75 6 214322 43181 110331790
Confusional state 61.85 9.75 595 213733 468085 109906886
Therapy non-responder 61.61 9.75 133 214195 157174 110217797
Wound infection pseudomonas 61.60 9.75 45 214283 2366 110372605
Vascular device infection 61.58 9.75 113 214215 16399 110358572
Tetany 61.40 9.75 53 214275 3551 110371420
Lymphatic fistula 60.14 9.75 37 214291 1458 110373513
Interleukin level increased 59.87 9.75 38 214290 1583 110373388
Femoral hernia incarcerated 59.83 9.75 37 214291 1472 110373499
Autoimmune disorder 59.71 9.75 26 214302 65457 110309514
Adverse drug reaction 59.55 9.75 70 214258 105489 110269482
Sleep disorder 59.50 9.75 192 214136 198452 110176519
Pain in extremity 59.48 9.75 630 213698 486488 109888483
Exostosis 59.45 9.75 9 214319 45947 110329024
Pneumonia 58.99 9.75 2164 212164 874550 109500421
Onychomycosis 58.98 9.75 4 214324 38527 110336444
Gait disturbance 58.84 9.75 308 214020 277900 110097071
Macular degeneration 57.82 9.75 129 214199 21530 110353441
Chronic sinusitis 57.78 9.75 141 214187 24943 110350028
Prescribed overdose 57.45 9.75 51 214277 87530 110287441
Maternal exposure during pregnancy 57.43 9.75 276 214052 254607 110120364
Ejection fraction abnormal 57.16 9.75 50 214278 3410 110371561
Hepatic cytolysis 56.68 9.75 18 214310 55035 110319936
Drug eruption 56.59 9.75 230 214098 53429 110321542
Suspected product contamination 56.54 9.75 21 214307 256 110374715
Fatigue 56.31 9.75 1863 212465 1214095 109160876
Loss of personal independence in daily activities 56.17 9.75 130 214198 149890 110225081
Back injury 55.45 9.75 12 214316 47387 110327584
Lymphocyte count decreased 54.64 9.75 238 214090 57005 110317966
Cardiovascular disorder 54.64 9.75 130 214198 22630 110352341
Spinal muscular atrophy 54.30 9.75 23 214305 404 110374567
Incorrect route of product administration 54.18 9.75 257 214071 63804 110311167
Amnesia 54.17 9.75 75 214253 105333 110269638
Monocyte chemotactic protein-1 increased 54.15 9.75 22 214306 346 110374625
Injection site reaction 52.49 9.75 57 214271 89013 110285958
Gamma-glutamyltransferase decreased 52.33 9.75 22 214306 379 110374592
Device related infection 52.14 9.75 182 214146 39337 110335634
Maternal exposure during delivery 51.95 9.75 48 214280 3517 110371454
Nasopharyngitis 51.86 9.75 501 213827 393860 109981111
Product preparation error 51.83 9.75 83 214245 10796 110364175
Alpha tumour necrosis factor increased 51.75 9.75 22 214306 390 110374581
Foot deformity 51.45 9.75 15 214313 48465 110326506
Joint stiffness 50.66 9.75 34 214294 67209 110307762
Pregnancy 50.31 9.75 18 214310 51049 110323922
Liver disorder 50.30 9.75 127 214201 142116 110232855
Infusion site induration 50.19 9.75 32 214296 1344 110373627
Intentional self-injury 49.18 9.75 7 214321 37422 110337549
Body temperature increased 48.84 9.75 223 214105 54490 110320481
Productive cough 48.83 9.75 384 213944 113921 110261050
Pancreatic steatosis 48.81 9.75 35 214293 1787 110373184
Immune effector cell-associated neurotoxicity syndrome 48.75 9.75 96 214232 14686 110360285
Anaphylactoid reaction 48.56 9.75 63 214265 6763 110368208
Vaginal flatulence 47.70 9.75 85 214243 12059 110362912
Disease complication 46.57 9.75 57 214271 5770 110369201
Alanine aminotransferase increased 46.56 9.75 553 213775 183220 110191751
Cold sweat 45.69 9.75 119 214209 21912 110353059
Ultrafiltration failure 45.31 9.75 20 214308 390 110374581
Cataract operation complication 45.26 9.75 18 214310 267 110374704
Overdose 44.98 9.75 267 214061 233527 110141444
Drug resistance 44.53 9.75 27 214301 56347 110318624
Hypersensitivity 44.37 9.75 535 213793 403463 109971508
Rash erythematous 44.26 9.75 291 214037 81541 110293430
Contusion 44.11 9.75 268 214060 233093 110141878
Eosinophilia 44.04 9.75 29 214299 57907 110317064
Abdominal pain 43.87 9.75 1303 213025 511686 109863285
Hepatic cirrhosis 43.61 9.75 40 214288 67586 110307385
Product administration error 42.86 9.75 164 214164 37053 110337918
Blood sodium decreased 42.62 9.75 167 214161 38152 110336819
Lupus-like syndrome 42.60 9.75 13 214315 40779 110334192
Adverse event 42.60 9.75 92 214236 108717 110266254
Anaphylactic reaction 41.89 9.75 371 213957 113929 110261042
Arterial haemorrhage 41.84 9.75 44 214284 3775 110371196
Respiratory rate increased 41.68 9.75 125 214203 24958 110350013
Tumour lysis syndrome 41.64 9.75 143 214185 30658 110344313
Seroma 41.56 9.75 41 214287 3260 110371711
Sopor 41.26 9.75 10 214318 36536 110338435
Proctitis 40.97 9.75 97 214231 16830 110358141
Eosinophil count 40.90 9.75 15 214313 176 110374795
Hyperphosphataemia 40.88 9.75 95 214233 16286 110358685
Hepatorenal failure 40.80 9.75 28 214300 1332 110373639
Illness 40.74 9.75 286 214042 81885 110293086
Drug-induced liver injury 40.10 9.75 382 213946 119685 110255286
Cytopenia 40.00 9.75 139 214189 29977 110344994
Seizure 39.81 9.75 626 213702 220559 110154412
Poor quality product administered 39.71 9.75 47 214281 4594 110370377
Hepatitis 39.70 9.75 71 214257 89983 110284988
Suicidal ideation 39.69 9.75 76 214252 93861 110281110
Feeling cold 39.33 9.75 150 214178 33837 110341134
Injection site pain 39.29 9.75 194 214134 177728 110197243
Blood test abnormal 38.98 9.75 133 214195 28421 110346550
Breast cancer stage II 38.72 9.75 4 214324 27371 110347600
Therapeutic product effect incomplete 38.24 9.75 265 214063 223540 110151431
Hyperhidrosis 37.95 9.75 541 213787 186757 110188214
Dysbiosis 37.64 9.75 32 214296 2100 110372871
Full blood count decreased 37.42 9.75 142 214186 31957 110343014
Drug tolerance decreased 36.54 9.75 5 214323 27535 110347436
Pulmonary oedema 36.52 9.75 326 214002 100333 110274638
Product contamination microbial 36.36 9.75 24 214304 1070 110373901
Suffocation feeling 36.13 9.75 31 214297 2060 110372911
Catheter site pain 36.09 9.75 53 214275 6393 110368578
Infusion site bruising 35.98 9.75 40 214288 3654 110371317
Road traffic accident 35.60 9.75 99 214229 107299 110267672
Increased bronchial secretion 35.48 9.75 41 214287 3907 110371064
Traumatic haemorrhage 35.29 9.75 29 214299 1815 110373156
Peripheral coldness 35.27 9.75 97 214231 18443 110356528
Oropharyngeal discomfort 35.19 9.75 68 214260 10259 110364712
Sinus tachycardia 35.11 9.75 175 214153 44318 110330653
Pruritus 35.10 9.75 1419 212909 580141 109794830
Female genital tract fistula 35.05 9.75 90 214238 16429 110358542
Haemodialysis complication 34.44 9.75 16 214312 353 110374618
Infusion related reaction 34.43 9.75 975 213353 380187 109994784
Respiratory distress 34.31 9.75 240 214088 68634 110306337
Diabetes insipidus 33.90 9.75 52 214276 6518 110368453
Oral candidiasis 33.88 9.75 174 214154 44586 110330385
Nephrectomy 33.63 9.75 33 214295 2607 110372364
Rhinovirus infection 33.50 9.75 72 214256 11717 110363254
Discomfort 33.43 9.75 261 214067 214446 110160525
Tachycardia 33.36 9.75 621 213707 226024 110148947
Myocardial reperfusion injury 33.33 9.75 12 214316 133 110374838
Product use issue 32.99 9.75 416 213912 311279 110063692
Bacteraemia 32.93 9.75 166 214162 42224 110332747
Poisoning 32.79 9.75 8 214320 29097 110345874
Coagulation time prolonged 32.66 9.75 34 214294 2883 110372088
Laryngitis 32.55 9.75 21 214307 42390 110332581
Peritoneal cloudy effluent 32.51 9.75 19 214309 681 110374290
Electrolyte imbalance 32.37 9.75 150 214178 36878 110338093
Eructation 32.36 9.75 79 214249 13978 110360993
Ventricular fibrillation 32.25 9.75 162 214166 41151 110333820
Poisoning deliberate 32.19 9.75 6 214322 26325 110348646
C-reactive protein increased 32.05 9.75 269 214059 217650 110157321
Failure to thrive 32.01 9.75 77 214251 13497 110361474
Anaesthetic complication 31.66 9.75 37 214291 3569 110371402
Toxic epidermal necrolysis 31.45 9.75 203 214125 56524 110318447
Osteonecrosis of jaw 31.44 9.75 28 214300 47989 110326982
Vaginal discharge 31.43 9.75 91 214237 17817 110357154
Hypoaesthesia oral 31.40 9.75 88 214240 16914 110358057
Blood bilirubin increased 31.22 9.75 253 214075 75719 110299252
Infective exacerbation of bronchiectasis 31.03 9.75 20 214308 856 110374115
Urinary tract infection 30.98 9.75 840 213488 325442 110049529
Mental disorder 30.91 9.75 153 214175 38638 110336333
COVID-19 30.89 9.75 656 213672 244404 110130567
Radiculopathy 30.85 9.75 95 214233 19241 110355730
Pneumococcal sepsis 30.73 9.75 29 214299 2183 110372788
Noninfectious peritonitis 30.64 9.75 14 214314 297 110374674
Drug dependence 30.61 9.75 31 214297 49989 110324982
Retching 30.39 9.75 105 214223 22577 110352394
Product label confusion 30.37 9.75 4 214324 22673 110352298
Hypophosphataemia 30.18 9.75 136 214192 33046 110341925
Dehydration 29.86 9.75 731 213597 278780 110096191
Infusion site oedema 29.85 9.75 24 214304 1456 110373515
Haemorrhage 29.68 9.75 327 214001 106365 110268606
Feeling hot 29.50 9.75 288 214040 90818 110284153
Blood glucose false positive 29.28 9.75 9 214319 58 110374913
Laryngeal oedema 29.14 9.75 61 214267 9746 110365225
Pulse abnormal 29.06 9.75 38 214290 4111 110370860
Mouth ulceration 29.02 9.75 176 214152 47962 110327009
Coagulopathy 28.88 9.75 156 214172 40755 110334216
Staphylococcal infection 28.78 9.75 233 214095 69711 110305260
Throat irritation 28.69 9.75 190 214138 53362 110321609
Activated partial thromboplastin time prolonged 28.64 9.75 102 214226 22266 110352705
Taste disorder 28.42 9.75 52 214276 65335 110309636
Cholestasis 28.32 9.75 51 214277 64467 110310504
Aortic valve stenosis 28.29 9.75 47 214281 6303 110368668
Hypochloraemia 28.29 9.75 35 214293 3583 110371388
Endotracheal intubation 28.08 9.75 46 214282 6098 110368873
Throat tightness 28.06 9.75 134 214194 33355 110341616
Hypoalbuminaemia 28.06 9.75 121 214207 28853 110346118
Cauda equina syndrome 27.92 9.75 27 214301 2095 110372876
Blood pressure systolic increased 27.88 9.75 76 214252 82915 110292056
Epilepsy 27.82 9.75 307 214021 99902 110275069
Tachyarrhythmia 27.66 9.75 54 214274 8207 110366764
Deafness permanent 27.54 9.75 19 214309 912 110374059
Oedema 27.47 9.75 267 214061 209709 110165262
Bloody peritoneal effluent 27.43 9.75 11 214317 167 110374804
Vein disorder 27.39 9.75 46 214282 6224 110368747
Inappropriate antidiuretic hormone secretion 27.32 9.75 134 214194 33717 110341254
Motor neurone disease 26.81 9.75 17 214311 707 110374264
Papule 26.65 9.75 60 214268 10073 110364898
Serotonin syndrome 26.65 9.75 46 214282 59107 110315864
Stoma closure 26.61 9.75 14 214314 407 110374564
Myasthenia gravis 26.61 9.75 97 214231 21414 110353557
Cognitive disorder 26.60 9.75 84 214244 87427 110287544
Burkholderia test positive 26.53 9.75 16 214312 608 110374363
Coordination abnormal 26.42 9.75 8 214320 25220 110349751
Balance disorder 26.36 9.75 126 214202 116434 110258537
Laboratory test abnormal 26.20 9.75 28 214300 44051 110330920
Blood creatinine decreased 26.19 9.75 56 214272 9081 110365890
Product distribution issue 26.18 9.75 37 214291 4309 110370662
Haemodilution 26.14 9.75 10 214318 133 110374838
Disturbance in social behaviour 26.05 9.75 40 214288 5018 110369953
Tremor 26.01 9.75 543 213785 201689 110173282
Hyperchloraemia 25.97 9.75 21 214307 1285 110373686
Muscle spasticity 25.94 9.75 19 214309 35896 110339075
Disease recurrence 25.83 9.75 49 214279 60735 110314236
Bacterial infection 25.68 9.75 165 214163 45871 110329100
Nasal obstruction 25.54 9.75 32 214296 3318 110371653
Burning sensation 25.54 9.75 225 214103 68987 110305984
Liver function test increased 25.53 9.75 87 214241 88461 110286510
Eyelid oedema 25.30 9.75 76 214252 15186 110359785
Discoloured vomit 25.30 9.75 25 214303 1992 110372979
Ischaemic contracture of the left ventricle 25.29 9.75 10 214318 146 110374825
Complication associated with device 25.24 9.75 91 214237 19982 110354989
Hepatocellular injury 25.06 9.75 37 214291 50605 110324366
Impaired work ability 24.87 9.75 10 214318 26409 110348562
Sedation 24.79 9.75 62 214266 69621 110305350
Product deposit 24.73 9.75 16 214312 689 110374282
Quadriplegia 24.66 9.75 35 214293 4092 110370879
Dermatitis contact 24.58 9.75 71 214257 13882 110361089
Dry skin 24.57 9.75 116 214212 107537 110267434
Respiratory tract infection 24.48 9.75 229 214099 71388 110303583
Wound dehiscence 24.22 9.75 50 214278 7912 110367059
Angina pectoris 24.11 9.75 53 214275 62242 110312729
Cystic fibrosis lung 24.07 9.75 10 214318 167 110374804
Aggression 24.07 9.75 49 214279 59161 110315810
Rhinitis allergic 24.04 9.75 83 214245 17839 110357132
SARS-CoV-2 test negative 23.93 9.75 25 214303 2128 110372843
Inappropriate schedule of product administration 23.71 9.75 539 213789 203098 110171873
Adverse reaction 23.62 9.75 14 214314 29580 110345391
Visual impairment 23.54 9.75 158 214170 134270 110240701
Femur fracture 23.49 9.75 31 214297 44438 110330533
Post-traumatic neck syndrome 23.41 9.75 27 214301 2568 110372403
Neuroleptic malignant syndrome 23.35 9.75 19 214309 34040 110340931
Myocardial necrosis marker increased 23.33 9.75 33 214295 3847 110371124
Brain death 23.28 9.75 44 214284 6529 110368442
Maternal exposure timing unspecified 23.24 9.75 6 214322 21007 110353964
Haemoglobin decreased 23.22 9.75 639 213689 248088 110126883
Laryngeal discomfort 23.21 9.75 16 214312 767 110374204
Tension 23.18 9.75 38 214290 5040 110369931
Lip erosion 23.17 9.75 23 214305 1843 110373128
Joint effusion 23.06 9.75 6 214322 20899 110354072
Peritoneal effluent abnormal 23.06 9.75 7 214321 43 110374928
Acute pulmonary oedema 23.05 9.75 79 214249 16917 110358054
Infectious crystalline keratopathy 23.05 9.75 8 214320 79 110374892
Oxygen therapy 23.04 9.75 34 214294 4119 110370852
Urine analysis abnormal 22.99 9.75 45 214283 6852 110368119
Pancreatic enzyme abnormality 22.94 9.75 10 214318 189 110374782
Walking aid user 22.79 9.75 10 214318 25065 110349906
Hepatic cyst 22.65 9.75 48 214280 7735 110367236
Medication error 22.62 9.75 116 214212 105250 110269721
Anal inflammation 22.56 9.75 26 214302 2470 110372501
Catheter site swelling 22.35 9.75 25 214303 2299 110372672
Upper respiratory tract infection 22.23 9.75 368 213960 130960 110244011
Anaemia 22.22 9.75 1284 213044 545802 109829169
Hiccups 22.21 9.75 65 214263 12804 110362167
Infusion site rash 22.19 9.75 25 214303 2318 110372653
Hypovolaemia 22.14 9.75 92 214236 21582 110353389
Facial discomfort 22.02 9.75 12 214316 375 110374596
Post procedural complication 21.85 9.75 106 214222 26552 110348419
Blood chloride decreased 21.81 9.75 52 214276 9063 110365908
Catheter site infection 21.75 9.75 48 214280 7952 110367019
Cystic fibrosis related diabetes 21.68 9.75 10 214318 217 110374754
Sleep disorder therapy 21.65 9.75 46 214282 7425 110367546
Regurgitation 21.49 9.75 30 214298 3455 110371516
Distal intestinal obstruction syndrome 21.48 9.75 17 214311 1008 110373963
Infusion site thrombosis 21.45 9.75 11 214317 303 110374668
Excessive eye blinking 21.30 9.75 22 214306 1848 110373123
Fibrin D dimer increased 21.26 9.75 54 214274 9791 110365180
Herpes zoster 21.24 9.75 123 214205 108256 110266715
Incorrect product formulation administered 21.23 9.75 10 214318 228 110374743
Groin pain 21.18 9.75 72 214256 15356 110359615
Haematuria 21.11 9.75 250 214078 82755 110292216
Blood sodium abnormal 21.05 9.75 19 214309 1351 110373620
Antacid therapy 21.05 9.75 38 214290 5446 110369525
Myalgia 20.91 9.75 304 214024 222077 110152894
Brain oedema 20.89 9.75 117 214211 30981 110343990
Procalcitonin increased 20.79 9.75 32 214296 4024 110370947
Resuscitation 20.76 9.75 27 214301 2906 110372065
Lower respiratory tract infection bacterial 20.63 9.75 17 214311 1068 110373903
Basal cell carcinoma 20.58 9.75 35 214293 45235 110329736
Spinal cord infarction 20.46 9.75 17 214311 1081 110373890
Blood urea increased 20.45 9.75 179 214149 54778 110320193
Vocal cord dysfunction 20.44 9.75 16 214312 934 110374037
Anticoagulant therapy 20.39 9.75 37 214291 5324 110369647
Catheter site haemorrhage 20.38 9.75 39 214289 5841 110369130
Injection site pruritus 20.34 9.75 43 214285 51215 110323756
Infusion site discharge 20.32 9.75 22 214306 1951 110373020
Postoperative wound infection 20.31 9.75 72 214256 15681 110359290
Prostate cancer 20.13 9.75 26 214302 37615 110337356
Abortion spontaneous 20.13 9.75 22 214306 34260 110340711
Neck pain 19.95 9.75 148 214180 122982 110251989
Respiratory tract infection bacterial 19.91 9.75 24 214304 2392 110372579
Polyarthritis 19.88 9.75 6 214322 18957 110356014
Vasodilatation 19.84 9.75 30 214298 3714 110371257
Drug tolerance 19.81 9.75 4 214324 16581 110358390
Fungal sepsis 19.72 9.75 23 214305 2214 110372757
Nightmare 19.62 9.75 28 214300 38835 110336136
Porphyria acute 19.58 9.75 6 214322 18774 110356197
Intentional product misuse 19.56 9.75 164 214164 132740 110242231
Haemorrhage subcutaneous 19.52 9.75 37 214291 5502 110369469
Blood pressure diastolic abnormal 19.51 9.75 13 214315 25802 110349169
Lung transplant 19.49 9.75 36 214292 5250 110369721
Hypocalcaemia 19.42 9.75 203 214125 65163 110309808
Spinal meningeal cyst 19.34 9.75 8 214320 132 110374839
Mental status changes postoperative 19.31 9.75 9 214319 200 110374771
Blood pressure fluctuation 19.28 9.75 77 214251 74747 110300224
Erectile dysfunction 19.22 9.75 6 214322 18550 110356421
Blood albumin decreased 19.22 9.75 105 214223 27547 110347424
Psychotic disorder 19.17 9.75 44 214284 50893 110324078
Vasculitis 18.96 9.75 25 214303 35848 110339123
Bone density decreased 18.89 9.75 4 214324 16038 110358933
Chemical peritonitis 18.88 9.75 10 214318 295 110374676
Disease progression 18.85 9.75 346 213982 243688 110131283
Necrotic lymphadenopathy 18.80 9.75 9 214319 213 110374758
Bronchial disorder 18.79 9.75 25 214303 2751 110372220
Angioedema 18.66 9.75 113 214215 98387 110276584
Blood phosphorus decreased 18.63 9.75 44 214284 7621 110367350
Malnutrition 18.57 9.75 103 214225 27176 110347795
Gingival bleeding 18.56 9.75 82 214246 19757 110355214
Migraine 18.56 9.75 228 214100 171424 110203547
Pulse absent 18.50 9.75 56 214272 11236 110363735
Respiratory syncytial virus infection 18.50 9.75 66 214262 14418 110360553
Disturbance in attention 18.49 9.75 60 214268 61935 110313036
Coma 18.47 9.75 143 214185 117726 110257245
Carbon dioxide decreased 18.47 9.75 33 214295 4691 110370280
Initial insomnia 18.43 9.75 53 214275 10336 110364635
Fall 18.37 9.75 969 213359 602513 109772458
Asphyxia 18.35 9.75 65 214263 14150 110360821
Product substitution issue 18.28 9.75 11 214317 23050 110351921
Haemoptysis 18.18 9.75 215 214113 71139 110303832
Accidental exposure to product 18.18 9.75 44 214284 49964 110325007
Blood pressure systolic abnormal 18.14 9.75 13 214315 24837 110350134
Oliguria 18.13 9.75 78 214250 18579 110356392
Procedural complication 18.05 9.75 46 214282 8359 110366612
Body temperature abnormal 18.04 9.75 26 214302 3083 110371888
Analgesic therapy 17.91 9.75 42 214286 7242 110367729
Pneumonia aspiration 17.81 9.75 238 214090 80995 110293976
Hepatotoxicity 17.80 9.75 63 214265 63337 110311634
Gastrointestinal disorder 17.77 9.75 346 213982 241606 110133365
Fluid imbalance 17.70 9.75 13 214315 689 110374282
Catheter site extravasation 17.69 9.75 12 214316 560 110374411
Mouth haemorrhage 17.69 9.75 62 214266 13426 110361545
Pharyngeal paraesthesia 17.63 9.75 30 214298 4102 110370869
Blood pressure abnormal 17.55 9.75 88 214240 22336 110352635
B-lymphocyte abnormalities 17.54 9.75 8 214320 169 110374802
Pseudomonas infection 17.54 9.75 103 214225 27750 110347221
Dermatitis allergic 17.53 9.75 86 214242 21638 110353333
Neutrophil count increased 17.40 9.75 121 214207 34531 110340440
Cataract 17.35 9.75 87 214241 79398 110295573
Injection site granuloma 17.24 9.75 7 214321 110 110374861
Leukoplakia oral 17.23 9.75 11 214317 463 110374508
Carpal tunnel syndrome 17.18 9.75 88 214240 22522 110352449
Pancreatic failure 17.17 9.75 22 214306 2332 110372639
Meningitis aseptic 17.17 9.75 50 214278 9820 110365151
Vein rupture 17.13 9.75 23 214305 2552 110372419
Meningitis chemical 17.07 9.75 10 214318 360 110374611
Bronchopulmonary aspergillosis allergic 16.95 9.75 45 214283 8381 110366590
Product container issue 16.95 9.75 18 214310 1562 110373409
Multiple sclerosis relapse 16.88 9.75 46 214282 50194 110324777
Panic reaction 16.87 9.75 34 214294 5288 110369683
Muscular weakness 16.86 9.75 360 213968 248108 110126863
Fracture 16.78 9.75 14 214314 24774 110350197
Aortic arteriosclerosis 16.77 9.75 53 214275 10885 110364086
Therapeutic response unexpected 16.73 9.75 13 214315 23830 110351141
Kounis syndrome 16.62 9.75 36 214292 5889 110369082
Product packaging confusion 16.61 9.75 10 214318 379 110374592
Epidermolysis bullosa 16.56 9.75 10 214318 381 110374590
Pharyngitis streptococcal 16.53 9.75 60 214268 13217 110361754
Staphylococcus test positive 16.52 9.75 41 214287 7329 110367642
Red blood cell count decreased 16.52 9.75 198 214130 65725 110309246
Respiration abnormal 16.41 9.75 49 214279 9760 110365211
Blood pressure increased 16.38 9.75 634 213694 257739 110117232
Infusion site discomfort 16.38 9.75 19 214309 1818 110373153
Osteonecrosis 16.36 9.75 25 214303 33716 110341255
Drug dose omission by device 16.33 9.75 4 214324 14512 110360459
Post transplant lymphoproliferative disorder 16.26 9.75 5 214323 15608 110359363
Ankylosing spondylitis 16.26 9.75 5 214323 15607 110359364
Hepatitis acute 16.26 9.75 8 214320 18758 110356213
Foaming at mouth 16.22 9.75 21 214307 2249 110372722
Septic shock 16.22 9.75 410 213918 157118 110217853
Infusion site infection 16.21 9.75 21 214307 2251 110372720
Pemphigoid 16.19 9.75 9 214319 19698 110355273
Decreased appetite 16.03 9.75 1099 213229 474747 109900224
Brain injury 16.03 9.75 60 214268 13416 110361555
Blood creatine increased 16.02 9.75 54 214274 11467 110363504
Blood sodium increased 16.00 9.75 34 214294 5489 110369482
Hepatitis cholestatic 15.97 9.75 7 214321 17559 110357412
Seasonal allergy 15.86 9.75 78 214250 19644 110355327
Mental status changes 15.86 9.75 221 214107 75901 110299070
Viral infection 15.77 9.75 165 214163 52974 110321997
Drug therapy 15.75 9.75 40 214288 7251 110367720
Incontinence 15.75 9.75 69 214259 16566 110358405
Product barcode issue 15.74 9.75 3 214325 0 110374971
Central venous catheter removal 15.69 9.75 11 214317 542 110374429
Blood phosphorus increased 15.64 9.75 68 214260 16272 110358699
Infusion site mass 15.62 9.75 18 214310 1710 110373261
Dysphagia 15.59 9.75 399 213929 153201 110221770
Hyperaemia 15.58 9.75 27 214301 3746 110371225
Brain herniation 15.52 9.75 45 214283 8818 110366153
Corneal disorder 15.48 9.75 22 214306 2575 110372396
Diverticulum intestinal 15.48 9.75 54 214274 11665 110363306
Convulsions local 15.47 9.75 6 214322 83 110374888
Systemic inflammatory response syndrome 15.45 9.75 58 214270 12985 110361986
COVID-19 pneumonia 15.43 9.75 124 214204 37019 110337952
Breath sounds abnormal 15.39 9.75 93 214235 25311 110349660
Extrapyramidal disorder 15.38 9.75 20 214308 28847 110346124
Exposure during pregnancy 15.35 9.75 230 214098 167194 110207777
Infusion site phlebitis 15.30 9.75 7 214321 149 110374822
Colitis 15.26 9.75 281 214047 102042 110272929
Schizophrenia 15.18 9.75 12 214316 21814 110353157
Muscle haemorrhage 15.17 9.75 38 214290 6831 110368140
Blood pressure immeasurable 15.15 9.75 21 214307 2402 110372569
Skin fissures 15.14 9.75 15 214313 24443 110350528
Hyperglycaemia 14.98 9.75 240 214088 84850 110290121
Acute generalised exanthematous pustulosis 14.96 9.75 12 214316 21652 110353319
Nephrocalcinosis 14.91 9.75 18 214310 1796 110373175
Steatorrhoea 14.91 9.75 14 214314 1047 110373924
Metabolic acidosis 14.91 9.75 274 214054 99470 110275501
Urine output decreased 14.86 9.75 77 214251 19799 110355172
Corneal oedema 14.83 9.75 24 214304 3149 110371822
Transurethral resection syndrome 14.79 9.75 4 214324 15 110374956
Gastrointestinal infection 14.74 9.75 60 214268 13945 110361026
Toxic skin eruption 14.72 9.75 19 214309 27496 110347475
Cardiogenic shock 14.71 9.75 173 214155 57165 110317806
Anterior chamber disorder 14.68 9.75 7 214321 164 110374807
Dyspnoea paroxysmal nocturnal 14.63 9.75 21 214307 2481 110372490
Acidosis 14.63 9.75 84 214244 22447 110352524
Moaning 14.60 9.75 16 214312 1439 110373532
Drug delivery system issue 14.59 9.75 8 214320 253 110374718
Device related sepsis 14.54 9.75 40 214288 7607 110367364
Neoplasm progression 14.50 9.75 70 214258 64525 110310446
Sinus operation 14.50 9.75 23 214305 2968 110372003
Anterior chamber inflammation 14.44 9.75 12 214316 763 110374208
Metabolic disorder 14.38 9.75 49 214279 10461 110364510
Cardiac failure congestive 14.34 9.75 206 214122 150794 110224177
Bladder cancer 14.32 9.75 11 214317 20281 110354690
Vitamin A increased 14.21 9.75 4 214324 18 110374953
Oropharyngeal pain 14.20 9.75 353 213975 134923 110240048
Myoglobinaemia 14.05 9.75 7 214321 181 110374790
Tracheitis 14.02 9.75 17 214311 1704 110373267
Carbon dioxide increased 13.96 9.75 22 214306 2822 110372149
Musculoskeletal disorder 13.92 9.75 14 214314 22650 110352321
Economic problem 13.83 9.75 27 214301 4104 110370867
Intervertebral disc degeneration 13.82 9.75 9 214319 18076 110356895
Second primary malignancy 13.79 9.75 9 214319 18059 110356912
Cystic fibrosis hepatic disease 13.76 9.75 5 214323 57 110374914
Triple negative breast cancer 13.75 9.75 10 214318 522 110374449
Skin toxicity 13.75 9.75 3 214325 11780 110363191
Vascular access site occlusion 13.74 9.75 6 214322 114 110374857
Infusion site ischaemia 13.67 9.75 3 214325 3 110374968
Pneumorrhachis 13.67 9.75 3 214325 3 110374968
Foetal death 13.66 9.75 7 214321 16038 110358933
Cytarabine syndrome 13.64 9.75 6 214322 116 110374855
Bicytopenia 13.61 9.75 36 214292 6688 110368283
Progressive multifocal leukoencephalopathy 13.59 9.75 17 214311 24939 110350032
Device difficult to use 13.52 9.75 10 214318 18795 110356176
Transmission of an infectious agent via product 13.48 9.75 7 214321 198 110374773
Metabolic alkalosis 13.47 9.75 32 214296 5563 110369408
Status asthmaticus 13.45 9.75 13 214315 1008 110373963
Feeding disorder 13.45 9.75 79 214249 21283 110353688
Lactic acidosis 13.44 9.75 115 214213 92696 110282275
Back pain 13.41 9.75 862 213466 370134 110004837
Cardiac disorder 13.37 9.75 215 214113 76065 110298906
Bilirubin conjugated increased 13.30 9.75 34 214294 6190 110368781
Dermatitis atopic 13.29 9.75 18 214310 25523 110349448
Nodule 13.26 9.75 27 214301 32604 110342367
Pleural effusion 13.21 9.75 444 213884 177265 110197706
Congenital hiatus hernia 13.17 9.75 34 214294 6225 110368746
Eczema 13.14 9.75 84 214244 72209 110302762
Bone disorder 13.12 9.75 13 214315 21179 110353792
Stridor 13.04 9.75 36 214292 6859 110368112
Panniculitis 12.97 9.75 7 214321 15575 110359396
Substance abuse 12.96 9.75 4 214324 12459 110362512
Wheezing 12.94 9.75 386 213942 254844 110120127
Gastroenteritis viral 12.83 9.75 104 214224 31122 110343849
Thrombotic microangiopathy 12.83 9.75 23 214305 29126 110345845
Respiratory acidosis 12.82 9.75 57 214271 13769 110361202
Neuromuscular blockade 12.79 9.75 11 214317 733 110374238
Arteriosclerosis coronary artery 12.77 9.75 18 214310 25100 110349871
Alanine aminotransferase decreased 12.77 9.75 17 214311 1871 110373100
Ulcer haemorrhage 12.69 9.75 15 214313 22556 110352415
Uveitis 12.67 9.75 14 214314 21696 110353275
COVID-19 treatment 12.65 9.75 9 214319 454 110374517
Glaucoma 12.62 9.75 15 214313 22502 110352469
Conjunctival hyperaemia 12.61 9.75 32 214296 5799 110369172
Skin ulcer 12.59 9.75 72 214256 63573 110311398
Drug chemical incompatibility 12.57 9.75 6 214322 141 110374830
Blood uric acid increased 12.53 9.75 78 214250 21451 110353520
Wrong product stored 12.46 9.75 3 214325 6 110374965
Administration site phlebitis 12.46 9.75 3 214325 6 110374965
Ileus 12.44 9.75 102 214226 30627 110344344
Gastric disorder 12.40 9.75 29 214299 33328 110341643
Incision site pain 12.38 9.75 22 214306 3113 110371858
Wrong product administered 12.38 9.75 48 214280 10912 110364059
Left ventricular dysfunction 12.37 9.75 83 214245 23410 110351561
Urinary tract pain 12.34 9.75 9 214319 472 110374499
Accidental overdose 12.33 9.75 55 214273 51779 110323192
Sodium retention 12.28 9.75 7 214321 239 110374732
Vitamin E decreased 12.27 9.75 4 214324 32 110374939
Lymphadenectomy 12.24 9.75 15 214313 1521 110373450
Peripheral nerve injury 12.17 9.75 13 214315 1135 110373836
Disseminated intravascular coagulation 12.16 9.75 128 214200 41158 110333813
Exposure via contaminated device 12.15 9.75 3 214325 7 110374964
Rash rubelliform 12.15 9.75 3 214325 7 110374964
Blood creatinine increased 12.12 9.75 451 213877 182438 110192533
Device issue 12.09 9.75 111 214217 34424 110340547
Conjunctival oedema 12.08 9.75 15 214313 1541 110373430
Confusion postoperative 12.05 9.75 8 214320 360 110374611
Alkalosis 12.03 9.75 11 214317 795 110374176
Infusion site irritation 11.92 9.75 13 214315 1162 110373809
Mental fatigue 11.92 9.75 12 214316 978 110373993
Blood urea decreased 11.91 9.75 23 214305 3467 110371504
Upper airway obstruction 11.85 9.75 16 214312 1786 110373185
Serratia infection 11.83 9.75 18 214310 2241 110372730
Blood chloride increased 11.79 9.75 33 214295 6339 110368632
Asthenia 11.78 9.75 1516 212812 687483 109687488
Lactobacillus test positive 11.76 9.75 4 214324 37 110374934
Streptococcal infection 11.74 9.75 47 214281 10843 110364128
Hypoaldosteronism 11.73 9.75 10 214318 659 110374312
Injection site rash 11.70 9.75 17 214311 23402 110351569
Diffuse large B-cell lymphoma refractory 11.69 9.75 19 214309 2502 110372469
Therapy partial responder 11.67 9.75 35 214293 37026 110337945
Sensation of foreign body 11.64 9.75 38 214290 7937 110367034
Restlessness 11.58 9.75 163 214165 56096 110318875
Neutrophil percentage abnormal 11.57 9.75 4 214324 39 110374932
Vertigo 11.55 9.75 110 214218 86760 110288211
Rash 11.54 9.75 1404 212924 819560 109555411
Central venous catheterisation 11.54 9.75 24 214304 3818 110371153
Rhabdomyolysis 11.52 9.75 164 214164 120237 110254734
Small intestinal obstruction 11.51 9.75 104 214224 32109 110342862
Bronchopulmonary dysplasia 11.44 9.75 7 214321 273 110374698
Infusion site pruritus 11.37 9.75 28 214300 4980 110369991
Abdominal infection 11.33 9.75 27 214301 4704 110370267
Synovial cyst 11.31 9.75 4 214324 11426 110363545
Anion gap decreased 11.30 9.75 11 214317 861 110374110
Internal haemorrhage 11.29 9.75 44 214284 10027 110364944
Heparin-induced thrombocytopenia 11.28 9.75 48 214280 11376 110363595
Blood urea abnormal 11.23 9.75 16 214312 1878 110373093
Respiratory rate decreased 11.18 9.75 32 214296 6226 110368745
Unmasking of previously unidentified disease 11.17 9.75 20 214308 2848 110372123
Pneumothorax 11.16 9.75 111 214217 35174 110339797
Pseudohyperphosphataemia 11.14 9.75 3 214325 11 110374960
Sweat test abnormal 11.14 9.75 4 214324 44 110374927
Delusion 11.14 9.75 18 214310 23737 110351234
Hypomania 11.13 9.75 3 214325 10207 110364764
Lung consolidation 11.12 9.75 45 214283 10431 110364540
Drug level abnormal 11.03 9.75 9 214319 558 110374413
Recalled product administered 11.00 9.75 13 214315 1269 110373702
Product availability issue 10.99 9.75 37 214291 7853 110367118
Respiratory depression 10.98 9.75 29 214299 31972 110342999
Tubulointerstitial nephritis 10.96 9.75 61 214267 54223 110320748
Respiratory alkalosis 10.95 9.75 30 214298 5691 110369280
Tonsillar hypertrophy 10.94 9.75 16 214312 1922 110373049
Ischaemic stroke 10.93 9.75 42 214286 41221 110333750
Affect lability 10.90 9.75 12 214316 18625 110356346
Tuberculosis 10.89 9.75 11 214317 17763 110357208
Palpitations 10.88 9.75 394 213934 158818 110216153
Granulocytosis 10.86 9.75 8 214320 426 110374545
Hemiparesis 10.80 9.75 46 214282 43857 110331114
Ischaemic cerebral infarction 10.79 9.75 20 214308 2925 110372046
Hypercalcaemia 10.77 9.75 138 214190 46519 110328452
Multimorbidity 10.77 9.75 14 214314 1506 110373465
Spinal cord injury cervical 10.74 9.75 6 214322 197 110374774
Poor feeding infant 10.74 9.75 6 214322 197 110374774
Influenza 10.73 9.75 415 213913 168686 110206285
Neuropathy peripheral 10.68 9.75 265 214063 179012 110195959
Hypophagia 10.64 9.75 152 214176 52474 110322497
Staphylococcal sepsis 10.64 9.75 64 214264 17390 110357581
Vessel puncture site pain 10.61 9.75 4 214324 51 110374920
Photosensitivity reaction 10.55 9.75 21 214307 25568 110349403
Parasitic encephalitis 10.47 9.75 4 214324 53 110374918
Atelectasis 10.43 9.75 113 214215 36599 110338372
Cardiovascular insufficiency 10.42 9.75 21 214307 3267 110371704
Vascular parkinsonism 10.42 9.75 5 214323 119 110374852
Drug clearance decreased 10.39 9.75 24 214304 4098 110370873
Sputum retention 10.39 9.75 13 214315 1346 110373625
Myocardial infarction 10.37 9.75 288 214040 191795 110183176
Hepatic steatosis 10.34 9.75 54 214274 48777 110326194
Sedation complication 10.33 9.75 14 214314 19841 110355130
Febrile infection 10.24 9.75 25 214303 4423 110370548
Autonomic failure syndrome 10.24 9.75 3 214325 16 110374955
Multiple allergies 10.22 9.75 49 214279 12214 110362757
Hungry bone syndrome 10.22 9.75 7 214321 332 110374639
Wisdom teeth removal 10.21 9.75 10 214318 788 110374183
Disseminated Bacillus Calmette-Guerin infection 10.20 9.75 7 214321 333 110374638
Pulmonary hypertension 10.19 9.75 157 214171 55063 110319908
Blood bilirubin unconjugated increased 10.17 9.75 12 214316 1169 110373802
Chronic respiratory failure 10.14 9.75 23 214305 3880 110371091
Orthostatic hypotension 10.09 9.75 81 214247 66168 110308803
Infusion site plaque 10.09 9.75 3 214325 17 110374954
Pustular psoriasis 10.09 9.75 7 214321 13598 110361373
Haemorrhage intracranial 10.08 9.75 93 214235 28876 110346095
Genital erosion 10.08 9.75 10 214318 801 110374170
Tardive dyskinesia 10.05 9.75 7 214321 13572 110361399
Melaena 10.04 9.75 85 214243 68672 110306299
Procedural nausea 10.03 9.75 12 214316 1187 110373784
Gastrointestinal stoma output increased 10 9.75 11 214317 993 110373978
Physical disability 10.00 9.75 27 214301 5079 110369892
Faecaloma 9.95 9.75 56 214272 14852 110360119
Gastrostomy tube site complication 9.95 9.75 6 214322 228 110374743
Dystonia 9.95 9.75 22 214306 25783 110349188
Sarcomatoid carcinoma of the lung 9.94 9.75 3 214325 18 110374953
Peritoneal disorder 9.92 9.75 10 214318 816 110374155
Infusion site urticaria 9.89 9.75 12 214316 1204 110373767
Haematotoxicity 9.86 9.75 16 214312 21066 110353905
Nasal mucosal disorder 9.85 9.75 15 214313 1868 110373103
Oesophageal carcinoma 9.85 9.75 5 214323 11519 110363452
Injection site erythema 9.83 9.75 126 214202 94050 110280921
Creatinine renal clearance decreased 9.79 9.75 17 214311 21798 110353173

FDA Adverse Event Reporting System (Pediatric)

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
Toxicity to various agents 31.28 29.39 15 324 232 113382
Neurotoxicity 29.92 29.39 8 331 16 113598
Bone marrow failure 29.92 29.39 8 331 16 113598
Gasping syndrome 29.92 29.39 8 331 16 113598
Circulatory collapse 29.64 29.39 10 329 56 113558

Pharmacologic Action:

SourceCodeDescription
ATC A12CA01 ALIMENTARY TRACT AND METABOLISM
MINERAL SUPPLEMENTS
OTHER MINERAL SUPPLEMENTS
Sodium
ATC B05CB01 BLOOD AND BLOOD FORMING ORGANS
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
IRRIGATING SOLUTIONS
Salt solutions
ATC B05XA03 BLOOD AND BLOOD FORMING ORGANS
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
I.V. SOLUTION ADDITIVES
Electrolyte solutions
ATC S01XA03 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:35845 gout suppressant
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50247 antidote
CHEBI has role CHEBI:50503 laxative
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:50779 appetite enhancer
CHEBI has role CHEBI:50864 insulin-sensitizing drug
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:51177 antitussive
CHEBI has role CHEBI:55323 antidiarrhoeal drug
CHEBI has role CHEBI:55324 gastrointestinal drug
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:64951 anti-HBV agent
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:76916 hyperglycemic agent
CHEBI has role CHEBI:79314 flame retardant
CHEBI has role CHEBI:149552 emetic
CHEBI has role CHEBI:149553 anticoronaviral agent
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:228364 NMR chemical shift reference compound
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

A12CA Sodium 1 drug
sodium sulfate
B05CB Salt solutions 3 drugs
magnesium citratesodium bicarbonatesodium citrate
B05XA Electrolyte solutions 18 drugs
ammonium chloridecalcium chloridecalcium gluconatehydrochloric acidmagnesium chloridemagnesium phosphatemagnesium sulfatepotassium acetatepotassium chloridepotassium lactatepotassium phosphatesodium acetate show all 18 →
S01XA Other ophthalmologicals 24 drugs
acetylcysteinealteplasealumascorbic acidavacincaptad pegolcenegerminciclosporindexpanthenoldiquafosolethylmorphineguaiazulenheparin show all 24 →

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

None




🐶 Veterinary Drug Use

SpeciesUseRelation
Multiple Species Restore circulatory volume and maintain blood pressure in animals being treated for shock Indication
Multiple Species Early treatment of scouring Indication
Multiple Species Treatment following intravenous fluid therapy Indication
Multiple Species Early treatment of scouring Indication

🐶 Veterinary products

ProductApplicantIngredients
Intragel Zoetis Inc. 2
Re-Sorb, Vytrate Zoetis Inc. 6

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 10792306 March 9, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 11529368 March 9, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9592252 Aug. 11, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 10918723 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 12083179 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9326969 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT SUFLAVE AZURITY N215344 June 15, 2023 RX FOR SOLUTION ORAL 12239659 June 14, 2044 GASTROINTESTINAL FLAVORED SOLUTION INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY
0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT SUFLAVE AZURITY N215344 June 15, 2023 RX FOR SOLUTION ORAL 12433914 June 14, 2044 GASTROINTESTINAL FLAVORED SOLUTION INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT SUFLAVE AZURITY N215344 June 15, 2023 RX FOR SOLUTION ORAL June 15, 2026 NEW PRODUCT

Bioactivity Summary:

None

External reference:

IDSource
4017444 VUID
N0000145832 NUI
D02056 KEGG_DRUG
4017444 VANDF
C0037494 UMLSCUI
CHEBI:26710 CHEBI
CHEMBL1200574 ChEMBL_ID
D012965 MESH_DESCRIPTOR_UI
DB09153 DRUGBANK_ID
4155 INN_ID
451W47IQ8X UNII
5234 PUBCHEM_CID
9863 RXNORM
399965 MMSL
5476 MMSL
6383 MMSL
d00438 MMSL
000759 NDDF
002238 NDDF
387390002 SNOMEDCT_US
70379000 SNOMEDCT_US
786818003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
SODIUM CHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0019-1188 INJECTION 0.90 mg INTRAVASCULAR NDA 17 sections
BSS HUMAN PRESCRIPTION DRUG LABEL 6 0065-0795 SOLUTION 6.40 mg OPHTHALMIC NDA 9 sections
BSS HUMAN PRESCRIPTION DRUG LABEL 6 0065-0795 SOLUTION 6.40 mg OPHTHALMIC NDA 9 sections
BSS HUMAN PRESCRIPTION DRUG LABEL 6 0065-1795 SOLUTION 6.40 mg OPHTHALMIC NDA 9 sections
Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-1800 INJECTION, SOLUTION 9 mg INTRAVENOUS NDA 23 sections
Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-1800 INJECTION, SOLUTION 9 mg INTRAVENOUS NDA 23 sections
Balanced Salt HUMAN PRESCRIPTION DRUG LABEL 6 0264-1945 SOLUTION 6.40 mg IRRIGATION ANDA 11 sections
Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-2201 IRRIGANT 0.90 g IRRIGATION NDA 22 sections
Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-2201 IRRIGANT 0.90 g IRRIGATION NDA 22 sections
Ringers HUMAN PRESCRIPTION DRUG LABEL 3 0264-2202 IRRIGANT 0.86 g IRRIGATION NDA 22 sections
Ringers HUMAN PRESCRIPTION DRUG LABEL 3 0264-2202 IRRIGANT 0.86 g IRRIGATION NDA 22 sections
Lactated Ringers HUMAN PRESCRIPTION DRUG LABEL 4 0264-2203 IRRIGANT 0.60 g IRRIGATION NDA 18 sections
Lactated Ringers HUMAN PRESCRIPTION DRUG LABEL 4 0264-2203 IRRIGANT 0.60 g IRRIGATION NDA 18 sections
Physiolyte HUMAN PRESCRIPTION DRUG LABEL 5 0264-2205 IRRIGANT 0.53 g IRRIGATION NDA 20 sections
Physiolyte HUMAN PRESCRIPTION DRUG LABEL 5 0264-2205 IRRIGANT 0.53 g IRRIGATION NDA 20 sections
Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-5802 INJECTION, SOLUTION 0.90 g INTRAVENOUS NDA 20 sections
Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-5802 INJECTION, SOLUTION 0.90 g INTRAVENOUS NDA 20 sections
Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-5804 INJECTION, SOLUTION 0.45 g INTRAVENOUS NDA 20 sections
Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-5804 INJECTION, SOLUTION 0.45 g INTRAVENOUS NDA 20 sections
Sodium Chloride for Irrigation HUMAN PRESCRIPTION DRUG LABEL 1 0264-7388 SOLUTION 0.90 g IRRIGATION NDA 21 sections
Sodium Chloride for Irrigation HUMAN PRESCRIPTION DRUG LABEL 1 0264-7388 SOLUTION 0.90 g IRRIGATION NDA 21 sections
Lactated Ringers Irrigation HUMAN PRESCRIPTION DRUG LABEL 4 0264-7389 SOLUTION 600 mg IRRIGATION NDA 14 sections
Lactated Ringers Irrigation HUMAN PRESCRIPTION DRUG LABEL 4 0264-7389 SOLUTION 600 mg IRRIGATION NDA 14 sections
Lactated Ringers HUMAN PRESCRIPTION DRUG LABEL 4 0264-7500 INJECTION, SOLUTION 0.60 g INTRAVENOUS NDA 24 sections
Lactated Ringers HUMAN PRESCRIPTION DRUG LABEL 4 0264-7500 INJECTION, SOLUTION 0.60 g INTRAVENOUS NDA 24 sections
Dextrose And Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 2 0264-7605 INJECTION, SOLUTION 0.45 g INTRAVENOUS NDA 23 sections
Dextrose And Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 2 0264-7605 INJECTION, SOLUTION 0.45 g INTRAVENOUS NDA 23 sections
Dextrose And Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 2 0264-7608 INJECTION, SOLUTION 0.30 g INTRAVENOUS NDA 23 sections
Dextrose And Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 2 0264-7608 INJECTION, SOLUTION 0.30 g INTRAVENOUS NDA 23 sections
Dextrose And Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 2 0264-7610 INJECTION, SOLUTION 0.90 g INTRAVENOUS NDA 23 sections