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

Stem definitionDrug idCAS RN
3152 9006-65-9

Description:

MoleculeDescription

Synonyms:

  • simethicone
  • dimethicone
  • Silicone Fluid 350
  • polydimethylsiloxane
  • dimeticone
  • dimethicone 410
A poly(dimethylsiloxane) which is a polymer of 200-350 units of dimethylsiloxane, along with added silica gel. It is used as an antiflatulent, surfactant, and ointment base.
  • Molecular weight:
  • Formula: C6H18Si2(C2H6O2Si)n
  • CLOGP: 3.39
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
June 26, 1997 FDA MCNEIL

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
Completed suicide 351.25 9.35 23 276074 145035 90207315
Drug ineffective 349.50 9.35 2631 273466 1381667 88970683
Milk-alkali syndrome 341.06 9.35 133 275964 1140 90351210
Liver injury 310.68 9.35 1183 274914 169384 90182966
Psoriatic arthropathy 276.42 9.35 1401 274696 226934 90125416
Wheezing 265.59 9.35 1428 274669 236652 90115698
Toxicity to various agents 250.40 9.35 305 275792 287541 90064809
Rheumatic fever 245.81 9.35 1021 275076 152100 90200250
Joint range of motion decreased 214.99 9.35 901 275196 134742 90217608
Macular degeneration 213.34 9.35 401 275696 37569 90314781
Swollen joint count increased 206.27 9.35 776 275321 110430 90241920
Schizophrenia 196.68 9.35 235 275862 14679 90337671
Type 2 diabetes mellitus 186.05 9.35 1157 274940 202087 90150263
Product dose omission issue 173.80 9.35 395 275702 291292 90061058
Facet joint syndrome 163.31 9.35 663 275434 97726 90254624
Fibromyalgia 160.77 9.35 1128 274969 205141 90147209
Deep vein thrombosis postoperative 159.63 9.35 527 275570 70282 90282068
Adjustment disorder with depressed mood 152.53 9.35 449 275648 56304 90296046
Hypomania 151.21 9.35 160 275937 8737 90343613
Injury 150.75 9.35 1074 275023 196275 90156075
Dyspepsia 149.97 9.35 1076 275021 197084 90155266
Intentional overdose 140.31 9.35 55 276042 93779 90258571
Sciatica 139.76 9.35 646 275451 100736 90251614
Lip dry 139.70 9.35 644 275453 100311 90252039
Autoimmune disorder 139.36 9.35 532 275565 76212 90276138
Dislocation of vertebra 139.31 9.35 431 275666 55537 90296813
Injection site pain 137.71 9.35 197 275900 173502 90178848
Jaundice cholestatic 136.97 9.35 161 275936 9882 90342468
Grip strength decreased 132.15 9.35 596 275501 91980 90260370
Road traffic accident 124.94 9.35 653 275444 106973 90245377
Duodenal ulcer perforation 122.55 9.35 1119 274978 220169 90132181
Mobility decreased 121.65 9.35 1233 274864 249501 90102849
Helicobacter infection 121.04 9.35 1138 274959 225712 90126638
Blood cholesterol increased 120.38 9.35 1062 275035 206950 90145400
Oedema 120.28 9.35 1031 275066 199264 90153086
Wound infection 116.99 9.35 636 275461 105766 90246584
Peripheral venous disease 115.11 9.35 534 275563 83387 90268963
Neurologic neglect syndrome 109.49 9.35 135 275962 8712 90343638
Hypercholesterolaemia 108.86 9.35 600 275497 100292 90252058
Carotid artery thrombosis 108.13 9.35 136 275961 8956 90343394
Rheumatoid arthritis 108.12 9.35 1627 274470 360987 89991363
Hypocalcaemia 107.98 9.35 329 275768 42039 90310311
Death 103.97 9.35 890 275207 455661 89896689
Gastrooesophageal reflux disease 101.85 9.35 860 275237 165477 90186873
Myelosuppression 101.31 9.35 20 276077 53571 90298779
Vaginal flatulence 100.80 9.35 156 275941 12482 90339868
Adjustment disorder 98.77 9.35 134 275963 9508 90342842
Proctitis 98.24 9.35 171 275926 15088 90337262
Device expulsion 97.43 9.35 7 276090 40879 90311471
Gait inability 97.09 9.35 771 275326 145685 90206665
Injection site erythema 94.75 9.35 96 276001 98406 90253944
Lower limb fracture 94.69 9.35 510 275587 84503 90267847
Amnesia 90.78 9.35 604 275493 107901 90244449
Lupus vulgaris 89.87 9.35 322 275775 44737 90307613
Irritable bowel syndrome 89.75 9.35 997 275100 206451 90145899
Rheumatoid factor positive 89.48 9.35 857 275240 170793 90181557
Recalled product 87.78 9.35 54 276043 1334 90351016
Cholelithiasis 86.45 9.35 353 275744 52153 90300197
Folliculitis 83.83 9.35 972 275125 203381 90148969
Asthma-chronic obstructive pulmonary disease overlap syndrome 83.08 9.35 88 276009 4811 90347539
Pulmonary fibrosis 82.57 9.35 586 275511 106917 90245433
Frequent bowel movements 82.33 9.35 368 275729 56567 90295783
Delirium 81.99 9.35 572 275525 103787 90248563
Radiculopathy 81.91 9.35 177 275920 18328 90334022
X-ray abnormal 81.72 9.35 314 275783 45110 90307240
Drug interaction 81.71 9.35 500 275597 275953 90076397
Hyperhidrosis 79.96 9.35 186 275911 136119 90216231
Total lung capacity increased 79.54 9.35 87 276010 4934 90347416
Female genital tract fistula 79.20 9.35 171 275926 17697 90334653
Accidental exposure to product 77.63 9.35 17 276080 42349 90310001
Injection site swelling 77.22 9.35 43 276054 59796 90292554
Colitis ulcerative 77.20 9.35 376 275721 59890 90292460
Hypoaesthesia 74.80 9.35 1359 274738 312851 90039499
Personality disorder 74.38 9.35 135 275962 12309 90340041
Nasal oedema 74.38 9.35 96 276001 6488 90345862
Prescribed overdose 73.15 9.35 529 275568 97096 90255254
Chronic sinusitis 72.43 9.35 197 275900 23605 90328745
COVID-19 71.76 9.35 268 275829 168575 90183775
Breast cancer stage II 71.74 9.35 254 275843 35080 90317270
C-reactive protein 71.16 9.35 234 275863 31133 90321217
Gangrene 71.09 9.35 135 275962 12741 90339609
Angioedema 71.06 9.35 56 276041 64820 90287530
Prescribed underdose 69.77 9.35 429 275668 74590 90277760
Vomiting 69.26 9.35 2998 273099 785295 89567055
Nasal obstruction 69.18 9.35 60 276037 2552 90349798
Sleep disorder 69.17 9.35 914 275183 197116 90155234
Dry mouth 68.71 9.35 860 275237 183199 90169151
Obesity 68.58 9.35 553 275544 104954 90247396
Walking aid user 67.65 9.35 250 275847 35256 90317094
Injection site pruritus 66.19 9.35 41 276056 53793 90298557
Arterial occlusive disease 65.66 9.35 128 275969 12318 90340032
Suicidal ideation 65.47 9.35 77 276020 73778 90278572
Abdominal pain 65.15 9.35 1622 274475 394099 89958251
Pneumonia aspiration 64.84 9.35 272 275825 40668 90311682
C-reactive protein abnormal 63.35 9.35 630 275467 126799 90225551
Coordination abnormal 62.25 9.35 174 275923 21182 90331168
Vaginal discharge 62.16 9.35 164 275933 19300 90333050
Sleep disorder due to general medical condition, insomnia type 61.93 9.35 632 275465 128062 90224288
Stomatitis 61.51 9.35 1177 274920 273521 90078829
Herpes zoster 61.45 9.35 122 275975 94522 90257828
Pericarditis 61.34 9.35 1160 274937 268991 90083359
Suicide attempt 61.24 9.35 84 276013 75315 90277035
Nephrocalcinosis 60.79 9.35 41 276056 1191 90351159
Bursitis 60.73 9.35 641 275456 131013 90221337
Hemiplegia 59.80 9.35 144 275953 16016 90336334
Osteoarthritis 59.32 9.35 881 275216 194849 90157501
Retinitis 58.96 9.35 253 275844 38205 90314145
Wrong technique in product usage process 58.87 9.35 79 276018 71492 90280858
Drug ineffective for unapproved indication 58.52 9.35 70 276027 66574 90285776
Sensory loss 58.44 9.35 153 275944 17922 90334428
Therapy interrupted 56.47 9.35 42 276055 50066 90302284
Injection site bruising 56.22 9.35 46 276051 52261 90300089
Breast cancer stage III 56.17 9.35 445 275652 84002 90268348
Impaired healing 55.37 9.35 1012 275085 233187 90119163
Wound 55.36 9.35 1260 274837 301720 90050630
Seizure 54.50 9.35 259 275838 152370 90199980
Nicotine dependence 54.35 9.35 36 276061 1014 90351336
Decreased appetite 54.34 9.35 1517 274580 375023 89977327
Hip arthroplasty 53.14 9.35 406 275691 75802 90276548
Gastrointestinal procedural complication 53.09 9.35 27 276070 455 90351895
Colitis 52.97 9.35 380 275717 69562 90282788
Multiple sclerosis relapse 52.58 9.35 49 276048 52256 90300094
Hypotension 52.56 9.35 687 275410 324710 90027640
Hypercalcaemia 52.30 9.35 225 275872 34015 90318335
Drug resistance 52.30 9.35 14 276083 30435 90321915
Eating disorder 52.09 9.35 196 275901 27877 90324473
Sinus congestion 50.50 9.35 191 275906 27233 90325117
Abortion spontaneous 50.49 9.35 54 276043 54002 90298348
Joint dislocation 50.00 9.35 268 275829 44314 90308036
Throat clearing 49.71 9.35 60 276037 3787 90348563
Anti-cyclic citrullinated peptide antibody 49.64 9.35 189 275908 27032 90325318
Anaphylactic reaction 49.29 9.35 122 275975 87402 90264948
Disease progression 49.03 9.35 278 275819 156337 90196013
Skin haemorrhage 48.95 9.35 160 275937 21220 90331130
Asthma 48.66 9.35 1021 275076 241139 90111211
Affect lability 48.61 9.35 143 275954 17920 90334430
General physical health deterioration 48.55 9.35 1421 274676 353694 89998656
Myocardial infarction 48.49 9.35 163 275934 105809 90246541
Full blood count abnormal 48.07 9.35 230 275867 36367 90315983
Bradycardia 47.90 9.35 116 275981 83731 90268619
Motor dysfunction 47.76 9.35 148 275949 19082 90333268
Loss of consciousness 47.74 9.35 242 275855 139996 90212354
Inappropriate schedule of product administration 47.01 9.35 266 275831 149667 90202683
Muscle injury 46.64 9.35 777 275320 175877 90176473
Segmental diverticular colitis 45.98 9.35 18 276079 156 90352194
Therapy cessation 45.67 9.35 27 276070 36334 90316016
Neutropenia 45.66 9.35 451 275646 224453 90127897
Liver disorder 45.40 9.35 567 275530 120702 90231648
Ulcer haemorrhage 44.95 9.35 179 275918 26142 90326208
Psychotic disorder 44.50 9.35 201 275896 31029 90321321
Cardiac arrest 44.29 9.35 167 275930 104768 90247582
General symptom 44.23 9.35 121 275976 14547 90337803
Oedema peripheral 44.15 9.35 1063 275034 256852 90095498
Sputum purulent 44.01 9.35 35 276062 1317 90351033
Hand deformity 43.86 9.35 1198 274899 295164 90057186
Glossodynia 43.81 9.35 1287 274810 320492 90031858
Food allergy 43.22 9.35 12 276085 25466 90326884
Night sweats 43.16 9.35 590 275507 128176 90224174
Seronegative arthritis 43.14 9.35 138 275959 18096 90334254
Foetal death 43.02 9.35 6 276091 20717 90331633
Nasal polyps 42.48 9.35 99 275998 10781 90341569
Lactic acidosis 42.22 9.35 55 276042 50408 90301942
Rectal haemorrhage 42.04 9.35 411 275686 82333 90270017
Bone erosion 41.86 9.35 291 275806 52730 90299620
Respiratory tract congestion 41.77 9.35 180 275917 27230 90325120
Calcium ionised decreased 41.66 9.35 21 276076 347 90352003
Paraesthesia oral 41.60 9.35 199 275898 31460 90320890
Pedal pulse abnormal 41.59 9.35 18 276079 206 90352144
Alanine aminotransferase increased 41.55 9.35 202 275895 118136 90234214
Sarcoidosis 41.54 9.35 97 276000 10576 90341774
Diarrhoea 41.44 9.35 3359 272738 935831 89416519
Taste disorder 41.30 9.35 325 275772 61221 90291129
Intentional product misuse 40.20 9.35 139 275958 89465 90262885
Sneezing 40.16 9.35 189 275908 29680 90322670
Irritability 40.05 9.35 30 276067 35632 90316718
Knee arthroplasty 39.77 9.35 408 275689 82774 90269576
Hypophosphataemic osteomalacia 39.62 9.35 18 276079 233 90352117
Drug reaction with eosinophilia and systemic symptoms 39.62 9.35 43 276054 42715 90309635
Cardio-respiratory arrest 39.62 9.35 83 276014 63057 90289293
Multiple drug therapy 39.33 9.35 74 276023 6935 90345415
Lupus-like syndrome 39.10 9.35 269 275828 48577 90303773
Blister 38.92 9.35 1035 275062 253963 90098387
Vision blurred 38.88 9.35 188 275909 110105 90242245
No adverse event 38.88 9.35 94 276003 67888 90284462
Blood glucose increased 38.64 9.35 154 275943 95092 90257258
Hepatocellular injury 38.55 9.35 20 276077 28938 90323412
Feeling abnormal 37.98 9.35 326 275771 166909 90185441
Back pain 37.89 9.35 709 275388 316466 90035884
Foetal exposure during pregnancy 37.88 9.35 45 276052 42930 90309420
Blood calcium decreased 37.71 9.35 187 275910 29995 90322355
Weight decreased 37.61 9.35 1464 274633 378446 89973904
Exostosis 37.56 9.35 284 275813 52850 90299500
Rash 37.34 9.35 2014 274083 794086 89558264
Hypoparathyroidism 37.13 9.35 28 276069 973 90351377
Rheumatoid nodule 37.13 9.35 8 276089 20158 90332192
Confusional state 37.00 9.35 1483 274614 384722 89967628
Heart rate increased 36.65 9.35 198 275899 112704 90239646
Urticaria 36.55 9.35 1228 274869 311506 90040844
Tremor 36.41 9.35 295 275802 152878 90199472
Serotonin syndrome 36.34 9.35 37 276060 37850 90314500
Poisoning deliberate 36.11 9.35 4 276093 16482 90335868
Hepatic cirrhosis 36.05 9.35 322 275775 62931 90289419
Flushing 35.95 9.35 143 275954 88348 90264002
Respiratory tract infection 35.89 9.35 305 275792 58773 90293577
Inflammation 35.86 9.35 753 275344 177839 90174511
Pneumonia 35.77 9.35 2327 273770 635732 89716618
Oropharyngeal pain 35.76 9.35 205 275892 114982 90237368
Myositis 35.66 9.35 157 275940 23971 90328379
Immunodeficiency 35.27 9.35 48 276049 43186 90309164
Off label use 35.25 9.35 2886 273211 1099366 89252984
Hepatic function abnormal 35.20 9.35 54 276043 46234 90306116
Illness 34.88 9.35 130 275967 81839 90270511
Laryngitis 34.60 9.35 269 275828 50484 90301866
Systemic lupus erythematosus 33.59 9.35 1385 274712 360511 89991839
Oxygen saturation decreased 33.52 9.35 191 275906 107292 90245058
Drug eruption 33.48 9.35 35 276062 35372 90316978
Subcutaneous drug absorption impaired 33.41 9.35 104 275993 13441 90338909
Pemphigus 33.15 9.35 1263 274834 325601 90026749
Tinnitus 33.04 9.35 50 276047 43052 90309298
Muscular weakness 33.03 9.35 844 275253 205822 90146528
Muscle spasticity 32.21 9.35 201 275896 35121 90317229
Musculoskeletal disorder 32.14 9.35 13 276084 21756 90330594
Electrocardiogram QT prolonged 32.09 9.35 113 275984 72343 90280007
Amyloid arthropathy 31.77 9.35 32 276065 1648 90350702
Rib deformity 31.76 9.35 16 276081 264 90352086
Injection site rash 31.73 9.35 17 276080 24156 90328194
Surgery 31.67 9.35 55 276042 44832 90307518
Methaemoglobinaemia 31.24 9.35 49 276048 3966 90348384
Neuropathy peripheral 31.10 9.35 267 275830 136703 90215647
Blood bilirubin increased 31.09 9.35 233 275864 43237 90309113
Erythema 30.71 9.35 502 275595 228744 90123606
Spondylitis 30.59 9.35 104 275993 14074 90338276
Hepatic enzyme increased 30.44 9.35 1367 274730 359369 89992981
Skin ulcer 30.44 9.35 67 276030 50008 90302342
Metabolic acidosis 30.27 9.35 79 276018 55597 90296753
Burning sensation 30.13 9.35 96 276001 63356 90288994
Incorrect route of product administration 30.03 9.35 260 275837 50366 90301984
Arthralgia 30.02 9.35 2006 274091 776516 89575834
Cholestasis 29.92 9.35 40 276057 36259 90316091
Therapy partial responder 29.67 9.35 15 276082 22028 90330322
Sinus disorder 29.55 9.35 193 275904 34254 90318096
Oral candidiasis 29.42 9.35 197 275900 35258 90317092
Pruritus 29.41 9.35 1349 274748 540176 89812174
Impaired quality of life 29.33 9.35 17 276080 23127 90329223
Secondary immunodeficiency 28.86 9.35 34 276063 2092 90350258
Skin necrosis 28.70 9.35 8 276089 16933 90335417
Headache 28.59 9.35 2252 273845 860494 89491856
Liver function test abnormal 28.52 9.35 71 276026 50774 90301576
Product storage error 28.43 9.35 13 276084 20228 90332122
Device difficult to use 28.37 9.35 9 276088 17516 90334834
Acute kidney injury 28.30 9.35 751 275346 319636 90032714
Tetany 28.14 9.35 37 276060 2547 90349803
Neuroleptic malignant syndrome 27.77 9.35 6 276091 15090 90337260
Coronary artery disease 27.76 9.35 37 276060 33586 90318764
Rhabdomyolysis 27.66 9.35 73 276024 51183 90301167
Disability 27.25 9.35 215 275882 40530 90311820
Dyspnoea 27.14 9.35 2313 273784 878642 89473708
Incorrect dose administered 26.97 9.35 136 275961 78794 90273556
Salivary gland calculus 26.97 9.35 13 276084 194 90352156
Throat tightness 26.93 9.35 30 276067 29454 90322896
Speech disorder 26.89 9.35 62 276035 45523 90306827
Foot deformity 26.82 9.35 289 275808 59362 90292988
Hepatic cytolysis 26.58 9.35 33 276064 30883 90321467
Blindness 26.57 9.35 25 276072 26543 90325807
Exercise tolerance decreased 26.57 9.35 66 276031 7485 90344865
Withdrawal syndrome 26.54 9.35 18 276079 22506 90329844
Carbuncle 26.52 9.35 27 276070 1409 90350941
Renal impairment 26.46 9.35 200 275897 105221 90247129
Agranulocytosis 26.45 9.35 41 276056 34961 90317389
Eye irritation 26.45 9.35 39 276058 33939 90318411
Acute respiratory distress syndrome 26.41 9.35 29 276068 28657 90323693
Hypertension 26.39 9.35 1673 274424 455859 89896491
Feeding intolerance 26.27 9.35 23 276074 991 90351359
Disturbance in attention 26.26 9.35 66 276031 47043 90305307
Malignant neoplasm progression 26.24 9.35 204 275893 106666 90245684
Multiple organ dysfunction syndrome 26.15 9.35 113 275984 68223 90284127
Rhinorrhoea 26.14 9.35 396 275701 87920 90264430
Dermatitis atopic 26.03 9.35 20 276077 23452 90328898
Chest pain 26.03 9.35 1207 274890 318438 90033912
Lung disorder 26.00 9.35 619 275478 149264 90203086
Restlessness 25.90 9.35 43 276054 35677 90316673
Overdose 25.79 9.35 332 275765 157377 90194973
Aspartate aminotransferase increased 25.50 9.35 196 275901 102741 90249609
Drug withdrawal syndrome 25.40 9.35 30 276067 28693 90323657
Musculoskeletal stiffness 25.29 9.35 1125 274972 295407 90056943
Swollen tongue 25.14 9.35 65 276032 45891 90306459
Rash vesicular 25.09 9.35 116 275981 18081 90334269
Breast cancer 25.07 9.35 82 276015 53679 90298671
Arteriovenous fistula occlusion 24.92 9.35 15 276082 356 90351994
Epilepsy 24.87 9.35 370 275727 81836 90270514
Drug abuse 24.79 9.35 148 275949 82199 90270151
Brain oedema 24.68 9.35 11 276086 17374 90334976
Device dislocation 24.64 9.35 36 276061 31446 90320904
Calciphylaxis 24.62 9.35 40 276057 3336 90349014
Procedural pain 24.53 9.35 180 275917 33180 90319170
Adverse event 24.52 9.35 498 275599 116920 90235430
Metabolic alkalosis 24.46 9.35 41 276056 3508 90348842
Bronchopulmonary aspergillosis 24.38 9.35 3 276094 11395 90340955
Cardiotoxicity 24.35 9.35 3 276094 11386 90340964
Poisoning 24.31 9.35 8 276089 15209 90337141
Disease recurrence 24.04 9.35 49 276048 37604 90314746
Shunt stenosis 23.82 9.35 17 276080 542 90351808
Mood swings 23.79 9.35 17 276080 20685 90331665
Sopor 23.71 9.35 24 276073 24620 90327730
Epistaxis 23.56 9.35 157 275940 84968 90267382
Cardiac failure congestive 23.48 9.35 190 275907 98504 90253846
Blepharospasm 23.27 9.35 265 275832 55180 90297170
Injection site urticaria 23.15 9.35 13 276084 17998 90334352
Swelling face 23.04 9.35 149 275948 81203 90271147
Musculoskeletal pain 23.02 9.35 684 275413 170567 90181783
Fungal infection 22.83 9.35 61 276036 42600 90309750
Red blood cell sedimentation rate abnormal 22.80 9.35 24 276073 24180 90328170
Creatinine renal clearance increased 22.74 9.35 38 276059 3243 90349107
Injection site haemorrhage 22.54 9.35 32 276065 28286 90324064
Monoclonal immunoglobulin present 22.49 9.35 30 276067 2094 90350256
Hepatotoxicity 22.46 9.35 226 275871 45616 90306734
Pancytopenia 22.41 9.35 246 275851 120017 90232333
Therapeutic response shortened 22.34 9.35 22 276075 22857 90329493
Hypotonia 22.16 9.35 4 276093 11422 90340928
Heavy menstrual bleeding 22.13 9.35 18 276079 20512 90331838
Product prescribing error 22.13 9.35 36 276061 30109 90322241
C-reactive protein increased 22.13 9.35 716 275381 180673 90171677
Thrombocytopenia 22.08 9.35 476 275621 208249 90144101
Contusion 22.06 9.35 956 275141 250260 90102090
Device issue 21.94 9.35 35 276062 29502 90322848
Hemiparesis 21.88 9.35 169 275928 31650 90320700
Blood pressure fluctuation 21.73 9.35 84 276013 52329 90300021
Basal cell carcinoma 21.70 9.35 43 276054 33346 90319004
Rhinitis allergic 21.69 9.35 105 275992 16680 90335670
Acute hepatic failure 21.67 9.35 22 276075 22539 90329811
Gonorrhoea 21.64 9.35 10 276087 135 90352215
Memory impairment 21.64 9.35 769 275328 196475 90155875
Obstructive airways disorder 21.62 9.35 144 275953 25725 90326625
Cardiac murmur 21.52 9.35 111 275986 18083 90334267
Hypercalciuria 21.49 9.35 14 276083 383 90351967
Blood pressure inadequately controlled 21.48 9.35 54 276043 6170 90346180
Product preparation error 21.23 9.35 3 276094 10258 90342092
Drug dose omission by device 21.15 9.35 3 276094 10228 90342122
Stress 21.11 9.35 153 275944 81242 90271108
Labelled drug-drug interaction medication error 21.06 9.35 9 276088 14573 90337777
Back disorder 21.01 9.35 142 275955 25489 90326861
Eye pruritus 21.00 9.35 35 276062 28992 90323358
Amenorrhoea 20.88 9.35 5 276092 11717 90340633
Live birth 20.88 9.35 348 275749 78759 90273591
Migraine 20.81 9.35 742 275355 189650 90162700
Cardiac failure 20.80 9.35 223 275874 109273 90243077
Flatulence 20.78 9.35 205 275892 41162 90311188
Injection site warmth 20.63 9.35 14 276083 17501 90334849
Intentional product use issue 20.54 9.35 832 275265 216060 90136290
Mydriasis 20.53 9.35 10 276087 15002 90337348
Central nervous system lupus 20.53 9.35 23 276074 1340 90351010
Head banging 20.42 9.35 14 276083 418 90351932
Malaise 20.28 9.35 2060 274037 583926 89768424
Leukopenia 19.99 9.35 203 275894 100507 90251843
Agitation 19.98 9.35 121 275976 66977 90285373
Abdominal discomfort 19.81 9.35 1700 274397 475628 89876722
Sedation complication 19.78 9.35 103 275994 16841 90335509
Complication of device insertion 19.50 9.35 4 276093 10432 90341918
Respiratory failure 19.46 9.35 249 275848 118169 90234181
Abortion induced 19.43 9.35 6 276091 11882 90340468
Renal function test abnormal 19.42 9.35 57 276040 7134 90345216
Tendonitis 19.24 9.35 22 276075 21350 90331000
Vertigo 19.20 9.35 129 275968 69682 90282668
Interstitial lung disease 19.15 9.35 145 275952 76260 90276090
Product substitution issue 19.15 9.35 16 276081 17992 90334358
Constipation 19.14 9.35 1041 275056 279354 90072996
Dry eye 19.13 9.35 101 275996 57830 90294520
Treatment failure 19.01 9.35 745 275352 303183 90049167
Spinal fusion surgery 18.98 9.35 81 276016 12202 90340148
Blue toe syndrome 18.93 9.35 14 276083 472 90351878
Nightmare 18.88 9.35 23 276074 21702 90330648
Sleep apnoea syndrome 18.87 9.35 43 276054 31704 90320646
Bone marrow failure 18.86 9.35 44 276053 32177 90320173
Crohn's disease 18.79 9.35 44 276053 4807 90347543
Shock 18.76 9.35 37 276060 28741 90323609
Abdominal distension 18.75 9.35 526 275571 130075 90222275
Large intestine polyp 18.65 9.35 67 276030 9319 90343031
Anti-cyclic citrullinated peptide antibody positive 18.64 9.35 890 275207 235543 90116807
Epidermal necrosis 18.63 9.35 29 276068 2332 90350018
Hypothyroidism 18.46 9.35 91 276006 53036 90299314
Intermenstrual bleeding 18.39 9.35 3 276094 9220 90343130
Encephalopathy 18.26 9.35 76 276021 46368 90305982
Haematochezia 18.00 9.35 310 275787 70603 90281747
Blood pressure decreased 17.90 9.35 144 275953 74751 90277599
Arthropathy 17.89 9.35 1321 274776 364921 89987429
Hypophosphataemia 17.83 9.35 91 276006 14763 90337587
Pustular psoriasis 17.81 9.35 107 275990 18449 90333901
Acute myeloid leukaemia 17.78 9.35 22 276075 20618 90331732
Hypoglycaemia 17.77 9.35 132 275965 69716 90282634
Osteoporosis 17.77 9.35 402 275695 96129 90256221
Akathisia 17.59 9.35 6 276091 11153 90341197
Sleep disorder due to a general medical condition 17.52 9.35 211 275886 44527 90307823
Dehydration 17.52 9.35 742 275355 193705 90158645
Platelet count decreased 17.33 9.35 303 275794 136666 90215684
Post procedural diarrhoea 17.31 9.35 12 276085 365 90351985
Pharyngitis 17.27 9.35 25 276072 21922 90330428
Cerebral haemorrhage 17.26 9.35 51 276046 34471 90317879
Onychomadesis 17.17 9.35 215 275882 45783 90306567
Anaphylactic shock 17.08 9.35 45 276052 31572 90320778
Small intestinal obstruction 17.03 9.35 117 275980 21117 90331233
Hemianopia 17.02 9.35 26 276071 2056 90350294
Asphyxia 17.02 9.35 54 276043 7049 90345301
Tardive dyskinesia 17.02 9.35 6 276091 10924 90341426
Hepatic failure 16.90 9.35 63 276034 39665 90312685
Synovitis 16.90 9.35 1194 274903 328558 90023792
Neuralgia 16.89 9.35 45 276052 31455 90320895
Psychomotor hyperactivity 16.83 9.35 9 276088 12804 90339546
Unevaluable event 16.81 9.35 98 275999 54750 90297600
Lymph node palpable 16.74 9.35 8 276089 117 90352233
Cerebral infarction 16.65 9.35 35 276062 26561 90325789
Urinary tract infection 16.63 9.35 761 275336 304871 90047479
Inappropriate antidiuretic hormone secretion 16.58 9.35 21 276076 19484 90332866
Vaginal haemorrhage 16.52 9.35 45 276052 31226 90321124
Device malfunction 16.40 9.35 24 276073 20953 90331397
Myalgia 16.38 9.35 407 275690 174718 90177632
Intentional dose omission 16.34 9.35 18 276079 17765 90334585
Creatinine renal clearance decreased 16.28 9.35 106 275991 18793 90333557
Drug intolerance 16.25 9.35 1159 274938 446432 89905918
Altered state of consciousness 16.19 9.35 46 276051 31486 90320864
Gestational diabetes 16.15 9.35 6 276091 10576 90341774
Hallucination 16.14 9.35 126 275971 65833 90286517
Mucosal inflammation 16.09 9.35 106 275991 57519 90294831
Discoloured vomit 16.07 9.35 19 276078 1173 90351177
Tachypnoea 16.06 9.35 25 276072 21284 90331066
Deep vein thrombosis 16.06 9.35 190 275907 91430 90260920
Bronchospasm 15.90 9.35 24 276073 20685 90331665
Injection site induration 15.87 9.35 6 276091 10462 90341888
Swollen joint count 15.71 9.35 60 276037 8593 90343757
Body mass index abnormal 15.70 9.35 15 276082 724 90351626
Gait disturbance 15.64 9.35 956 275141 259540 90092810
Body height decreased 15.62 9.35 75 276022 11874 90340476
Premature delivery 15.51 9.35 63 276034 38699 90313651
Erythema multiforme 15.51 9.35 9 276088 12237 90340113
Dyskinesia 15.50 9.35 58 276039 36476 90315874
Ulcer 15.43 9.35 50 276047 32832 90319518
Disseminated cryptococcosis 15.19 9.35 15 276082 754 90351596
Paralysis 15.17 9.35 8 276089 11470 90340880
Adrenal insufficiency 15.11 9.35 44 276053 29877 90322473
Joint injury 15.10 9.35 50 276047 32614 90319736
Syncope 15.07 9.35 299 275798 132364 90219986
Decreased immune responsiveness 15.07 9.35 4 276093 8744 90343606
Stress fracture 15.06 9.35 59 276038 8552 90343798
Peripheral pulse decreased 15.03 9.35 6 276091 55 90352295
Joint stiffness 14.99 9.35 327 275770 77715 90274635
Throat irritation 14.93 9.35 87 276010 48608 90303742
Ankylosing spondylitis 14.81 9.35 11 276086 13122 90339228
Chronic fatigue syndrome 14.76 9.35 21 276076 1558 90350792
Pain 14.71 9.35 2743 273354 993598 89358752
Diplopia 14.67 9.35 42 276055 28672 90323678
Loose tooth 14.55 9.35 34 276063 3709 90348641
Onychomycosis 14.52 9.35 176 275921 37200 90315150
Discomfort 14.51 9.35 996 275101 273339 90079011
Fear of injection 14.46 9.35 4 276093 8511 90343839
Eosinophilic cellulitis 14.43 9.35 9 276088 228 90352122
Oral herpes 14.37 9.35 53 276044 33471 90318879
Impaired work ability 14.26 9.35 23 276074 19303 90333047
Tenosynovitis 14.23 9.35 14 276083 14553 90337797
Intentional self-injury 14.19 9.35 44 276053 29290 90323060
Apathy 14.15 9.35 8 276089 11032 90341318
Maternal exposure timing unspecified 14.14 9.35 117 275980 22366 90329984
Unintended pregnancy 14.12 9.35 3 276094 7634 90344716
Respiratory depression 14.06 9.35 16 276081 15559 90336791
Respiratory arrest 14.06 9.35 53 276044 33258 90319092
Deformity 13.97 9.35 10 276087 12160 90340190
Abdominal pain upper 13.97 9.35 1186 274911 331488 90020862
Ill-defined disorder 13.94 9.35 693 275404 184198 90168152
Sinusitis 13.92 9.35 1220 274877 341868 90010482
Injection site mass 13.89 9.35 29 276068 22061 90330289
Bronchial wall thickening 13.87 9.35 24 276073 2107 90350243
Urine calcium/creatinine ratio increased 13.87 9.35 7 276090 116 90352234
Aphasia 13.86 9.35 195 275902 42617 90309733
Cardiogenic shock 13.85 9.35 34 276063 24434 90327916
Circulatory collapse 13.79 9.35 35 276062 24869 90327481
Breast cancer female 13.76 9.35 15 276082 14871 90337479
Hyponatraemia 13.69 9.35 306 275791 133232 90219118
Haemorrhage 13.69 9.35 140 275957 69229 90283121
Product dose omission in error 13.68 9.35 26 276071 20477 90331873
Hyperphosphataemia 13.66 9.35 33 276064 3678 90348672
Pelvic pain 13.62 9.35 16 276081 15341 90337009
Lipid metabolism disorder 13.59 9.35 8 276089 182 90352168
Eye injury 13.57 9.35 68 276029 10952 90341398
Bacterial disease carrier 13.46 9.35 22 276075 1844 90350506
Congestive cardiomyopathy 13.37 9.35 3 276094 7351 90344999
Polyneuropathy 13.37 9.35 24 276073 19317 90333033
Arteriosclerosis coronary artery 13.08 9.35 61 276036 9542 90342808
Fracture 13.04 9.35 30 276067 22046 90330304
Nystagmus 13.04 9.35 3 276094 7224 90345126
Renal failure 12.93 9.35 302 275795 130705 90221645
Hypothalamo-pituitary disorder 12.92 9.35 24 276073 2228 90350122
Exposure during pregnancy 12.89 9.35 594 275503 237816 90114534
Bronchiectasis 12.89 9.35 114 275983 22216 90330134
Oncocytoma 12.80 9.35 4 276093 16 90352334
Atrioventricular block complete 12.73 9.35 7 276090 9804 90342546
Acquired haemophilia 12.73 9.35 16 276081 1053 90351297
Hysterectomy 12.68 9.35 10 276087 11574 90340776
Posterior reversible encephalopathy syndrome 12.68 9.35 31 276066 22308 90330042
Hyperparathyroidism secondary 12.67 9.35 21 276076 1780 90350570
Porphyria acute 12.66 9.35 96 276001 17879 90334471
Pneumothorax spontaneous 12.64 9.35 15 276082 930 90351420
Subarachnoid haemorrhage 12.57 9.35 22 276075 17882 90334468
Pulmonary pain 12.37 9.35 39 276058 5075 90347275
Gastroenteritis viral 12.36 9.35 49 276048 30306 90322044
Product label confusion 12.35 9.35 115 275982 22735 90329615
Nephroangiosclerosis 12.34 9.35 8 276089 217 90352133
Post transplant lymphoproliferative disorder 12.31 9.35 3 276094 6946 90345404
Hypomagnesaemia 12.30 9.35 164 275933 35424 90316926
Fibrosis 12.26 9.35 43 276054 5909 90346441
Noninfectious peritonitis 12.26 9.35 7 276090 150 90352200
Spinal cord injury lumbar 12.24 9.35 5 276092 49 90352301
Hypokinesia 12.24 9.35 18 276079 15679 90336671
Nodule 12.23 9.35 41 276056 26645 90325705
Aggression 12.21 9.35 41 276056 26627 90325723
Visual acuity reduced 12.13 9.35 34 276063 23376 90328974
Periarticular disorder 12.06 9.35 5 276092 51 90352299
Coagulopathy 11.94 9.35 34 276063 23255 90329095
Delayed graft function 11.94 9.35 18 276079 1407 90350943
Drug-induced liver injury 11.93 9.35 360 275737 89958 90262392
Tension headache 11.90 9.35 4 276093 7505 90344845
Poliomyelitis 11.89 9.35 5 276092 53 90352297
Gastroenteritis bacterial 11.78 9.35 10 276087 413 90351937
Sinus bradycardia 11.75 9.35 21 276076 16931 90335419
Anti-saccharomyces cerevisiae antibody test positive 11.73 9.35 5 276092 55 90352295
Hypervitaminosis 11.73 9.35 5 276092 55 90352295
Dissociation 11.70 9.35 3 276094 6712 90345638
Diverticulitis 11.68 9.35 85 276012 45102 90307248
Ocular hyperaemia 11.68 9.35 58 276039 33740 90318610
Pharyngeal swelling 11.64 9.35 8 276089 9936 90342414
Stevens-Johnson syndrome 11.59 9.35 48 276049 29328 90323022
Hyperparathyroidism 11.57 9.35 29 276068 3308 90349042
Fanconi syndrome 11.51 9.35 21 276076 1922 90350428
Dystonia 11.51 9.35 21 276076 16798 90335552
Pulmonary arterial hypertension 11.49 9.35 41 276056 26146 90326204
Lacrimation increased 11.46 9.35 43 276054 27019 90325331
Blood glucose decreased 11.44 9.35 35 276062 23394 90328956
Toxic skin eruption 11.43 9.35 19 276078 15755 90336595
Localised infection 11.37 9.35 58 276039 33504 90318846
Clostridium difficile colitis 11.37 9.35 128 275969 26578 90325772
Therapeutic product effect decreased 11.37 9.35 711 275386 276860 90075490
Gastrointestinal sounds abnormal 11.31 9.35 35 276062 4508 90347842
Lip swelling 11.30 9.35 70 276027 38540 90313810
Urinary retention 11.27 9.35 68 276029 37676 90314674
Pulmonary embolism 11.18 9.35 308 275789 130512 90221838
Caesarean section 11.17 9.35 25 276072 18552 90333798
Cold sweat 11.12 9.35 16 276081 14065 90338285
Mesenteric phlebosclerosis 11.11 9.35 3 276094 6 90352344
Gluten sensitivity 11.10 9.35 13 276084 795 90351555
Parkinsonism 11.09 9.35 16 276081 14049 90338301
Abdominal rigidity 11.09 9.35 24 276073 2488 90349862
Urinary incontinence 11.05 9.35 68 276029 37498 90314852
Blood parathyroid hormone increased 11.01 9.35 29 276068 3408 90348942
Appetite disorder 11.00 9.35 56 276041 9077 90343273
Low turnover osteopathy 10.98 9.35 33 276064 4185 90348165
Respiratory rate increased 10.93 9.35 20 276077 15981 90336369
Candida infection 10.90 9.35 60 276037 33997 90318353
Toxic epidermal necrolysis 10.87 9.35 149 275948 32379 90319971
Therapeutic reaction time decreased 10.85 9.35 30 276067 3628 90348722
Grip strength 10.81 9.35 55 276042 8910 90343440
Polyarthritis 10.79 9.35 25 276072 18325 90334025
Dry skin 10.77 9.35 196 275901 87877 90264473
Sensory disturbance 10.77 9.35 19 276078 15394 90336956
Drug use disorder 10.76 9.35 6 276091 8337 90344013
Pulmonary mass 10.75 9.35 48 276049 28724 90323626
Eczema 10.72 9.35 106 275991 52764 90299586
Neoplasm malignant 10.67 9.35 60 276037 33820 90318530
Eye disorder 10.66 9.35 45 276052 27345 90325005
Miosis 10.62 9.35 8 276089 9476 90342874
Parathyroid gland enlargement 10.61 9.35 4 276093 31 90352319
Congenital knee deformity 10.59 9.35 5 276092 71 90352279
Extrapyramidal disorder 10.59 9.35 21 276076 16282 90336068
Underdose 10.59 9.35 227 275870 53790 90298560
Nail disorder 10.56 9.35 245 275852 58822 90293528
Metastases to lymph nodes 10.56 9.35 12 276085 11677 90340673
Middle insomnia 10.52 9.35 22 276075 16729 90335621
Atrial septal defect 10.50 9.35 6 276091 8228 90344122
Haemoptysis 10.50 9.35 59 276038 33261 90319089
Anti-erythropoietin antibody positive 10.49 9.35 9 276088 377 90351973
Platelet count increased 10.30 9.35 31 276066 20828 90331522
Arrhythmia 10.30 9.35 81 276016 42251 90310099
Hypocalcaemic seizure 10.29 9.35 4 276093 34 90352316
Muscle spasms 10.26 9.35 896 275201 250987 90101363
Infusion related reaction 10.25 9.35 1434 274663 415346 89937004
Pain of skin 10.20 9.35 21 276076 16061 90336289
Viral infection 10.19 9.35 79 276018 41335 90311015
Cytomegalovirus infection 10.17 9.35 44 276053 26558 90325792
Intracranial pressure increased 10.17 9.35 4 276093 6807 90345543
Haematotoxicity 10.14 9.35 14 276083 12521 90339829
Facial paralysis 10.10 9.35 20 276077 15514 90336836
Anal erosion 10.09 9.35 4 276093 36 90352314
Lung neoplasm 10.09 9.35 44 276053 6691 90345659
Eye pain 10.06 9.35 86 276011 44082 90308268
Incorrect product administration duration 10.06 9.35 28 276069 19294 90333056
Epstein-Barr virus infection 10.04 9.35 10 276087 10334 90342016
Osteomalacia 10.03 9.35 13 276084 882 90351468
Catatonia 10.00 9.35 3 276094 6053 90346297
Skin laceration 9.99 9.35 43 276054 25992 90326358
Chronic kidney disease-mineral and bone disorder 9.98 9.35 6 276091 142 90352208
Tongue disorder 9.97 9.35 11 276086 10849 90341501
Anal incontinence 9.96 9.35 84 276013 16146 90336204
Disseminated intravascular coagulation 9.94 9.35 33 276064 21505 90330845
Therapeutic product effect incomplete 9.91 9.35 702 275395 193194 90159156
Shunt occlusion 9.87 9.35 12 276085 763 90351587
Dysphonia 9.87 9.35 134 275963 62950 90289400
Hypervitaminosis A 9.80 9.35 3 276094 11 90352339
Faecalith 9.80 9.35 3 276094 11 90352339
Drug effective for unapproved indication 9.77 9.35 6 276091 7912 90344438
Body temperature increased 9.77 9.35 88 276009 44622 90307728
Sepsis 9.72 9.35 448 275649 179366 90172984
Hypertriglyceridaemia 9.71 9.35 6 276091 7883 90344467
Polyglandular disorder 9.70 9.35 7 276090 227 90352123
Intestinal fibrosis 9.70 9.35 7 276090 227 90352123
Immune thrombocytopenia 9.70 9.35 16 276081 13310 90339040
Proctalgia 9.68 9.35 50 276047 8148 90344202
Atypical femur fracture 9.66 9.35 42 276055 6379 90345971
Maternal exposure during pregnancy 9.64 9.35 955 275142 359108 89993242
Nephrogenic systemic fibrosis 9.64 9.35 31 276066 4077 90348273
Joint destruction 9.63 9.35 16 276081 13271 90339079
Haemorrhoids 9.62 9.35 124 275973 26578 90325772
Blood pH increased 9.61 9.35 11 276086 656 90351694
Foot operation 9.57 9.35 8 276089 8993 90343357
Diabetic ketoacidosis 9.56 9.35 40 276057 24367 90327983
Cytomegalovirus infection reactivation 9.51 9.35 6 276091 7794 90344556
Jaundice 9.49 9.35 59 276038 32458 90319892
Jaundice acholuric 9.49 9.35 5 276092 91 90352259
Blood potassium increased 9.43 9.35 32 276065 20717 90331633
Mitral valve incompetence 9.40 9.35 36 276061 22488 90329862
Nerve injury 9.40 9.35 12 276085 11094 90341256
Gastrointestinal disorder 9.38 9.35 906 275191 255781 90096569

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
Milk-alkali syndrome 346.16 10.25 104 83739 603 42536889
Drug ineffective 215.68 10.25 588 83255 629609 41907883
Pulmonary vasculitis 167.77 10.25 121 83722 6145 42531347
Neuritis 161.73 10.25 118 83725 6102 42531390
Respiratory symptom 157.09 10.25 148 83695 10958 42526534
Completed suicide 153.52 10.25 9 83834 96456 42441036
Diarrhoea 137.45 10.25 1446 82397 459403 42078089
Antineutrophil cytoplasmic antibody positive 127.75 10.25 89 83754 4276 42533216
Obstructive airways disorder 125.73 10.25 196 83647 24563 42512929
Neurological symptom 120.46 10.25 122 83721 9869 42527623
Eosinophilic granulomatosis with polyangiitis 118.14 10.25 113 83730 8525 42528967
Toxicity to various agents 111.58 10.25 174 83669 228962 42308530
Total lung capacity abnormal 105.90 10.25 80 83763 4363 42533129
Mycotic allergy 105.51 10.25 83 83760 4808 42532684
Mite allergy 105.35 10.25 84 83759 4962 42532530
Spirometry abnormal 103.90 10.25 84 83759 5062 42532430
Conjunctivitis allergic 101.77 10.25 88 83755 5823 42531669
Dust allergy 101.28 10.25 84 83759 5248 42532244
Hypercalcaemia 91.74 10.25 143 83700 17915 42519577
Pulmonary alveolar haemorrhage 86.20 10.25 125 83718 14691 42522801
Fractional exhaled nitric oxide increased 85.69 10.25 48 83795 1561 42535931
Drug abuse 82.63 10.25 52 83791 104719 42432773
Nodule 79.20 10.25 110 83733 12424 42525068
Arteriosclerosis coronary artery 78.79 10.25 136 83707 18541 42518951
Normochromic normocytic anaemia 77.10 10.25 92 83751 8939 42528553
Full blood count abnormal 77.00 10.25 177 83666 29699 42507793
Shunt stenosis 76.12 10.25 35 83808 742 42536750
Wheezing 72.53 10.25 255 83588 54526 42482966
Forced expiratory volume decreased 72.28 10.25 82 83761 7548 42529944
Sleep disorder due to a general medical condition 72.21 10.25 126 83717 17327 42520165
Blood mercury abnormal 70.76 10.25 25 83818 257 42537235
Pulmonary fibrosis 64.31 10.25 154 83689 26527 42510965
Vasculitis 63.73 10.25 123 83720 18271 42519221
Dehydration 58.68 10.25 478 83365 141289 42396203
Plantar fasciitis 57.55 10.25 48 83795 3022 42534470
Nasal polyps 55.76 10.25 52 83791 3799 42533693
Haemoptysis 55.27 10.25 208 83635 45959 42491533
Myoglobin blood increased 53.85 10.25 50 83793 3632 42533860
Hypothyroidism 52.01 10.25 160 83683 31924 42505568
Calciphylaxis 51.85 10.25 31 83812 1142 42536350
Sensation of foreign body 50.80 10.25 48 83795 3565 42533927
Hypocalcaemia 50.34 10.25 152 83691 30021 42507471
Product use in unapproved indication 49.46 10.25 191 83652 184265 42353227
Abdominal distension 49.04 10.25 274 83569 71461 42466031
Proctalgia 48.98 10.25 65 83778 7028 42530464
Lung disorder 48.59 10.25 205 83638 47718 42489774
Abdominal pain 47.05 10.25 577 83266 189894 42347598
Brain natriuretic peptide increased 46.69 10.25 62 83781 6708 42530784
Arteriosclerosis 45.71 10.25 106 83737 17883 42519609
Off label use 44.70 10.25 938 82905 637397 41900095
5-hydroxyindolacetic acid in urine increased 43.84 10.25 16 83827 182 42537310
Frequent bowel movements 43.68 10.25 116 83727 21291 42516201
Colitis ulcerative 42.86 10.25 131 83712 26044 42511448
Small intestinal obstruction 42.77 10.25 100 83743 16961 42520531
Capillaritis 42.11 10.25 35 83808 2193 42535299
Hyperparathyroidism secondary 41.33 10.25 32 83811 1810 42535682
Asthma 41.25 10.25 236 83607 62078 42475414
SARS-CoV-2 test negative 40.19 10.25 31 83812 1744 42535748
Chronic sinusitis 40.12 10.25 41 83802 3351 42534141
Anal inflammation 40.03 10.25 34 83809 2195 42535297
Pulmonary embolism 39.51 10.25 384 83459 119228 42418264
Loss of personal independence in daily activities 39.32 10.25 198 83645 49618 42487874
Low density lipoprotein decreased 39.12 10.25 27 83816 1277 42536215
Myocardial infarction 37.50 10.25 122 83721 123887 42413605
Treatment failure 37.13 10.25 41 83802 62583 42474909
Methaemoglobinaemia 36.96 10.25 51 83792 5723 42531769
Drug resistance 36.46 10.25 11 83832 34237 42503255
Death 36.32 10.25 681 83162 470504 42066988
Drug ineffective for unapproved indication 36.25 10.25 23 83820 46140 42491352
Productive cough 35.92 10.25 198 83645 51369 42486123
Thrombosis 35.68 10.25 244 83599 68267 42469225
Nephrogenic systemic fibrosis 35.52 10.25 39 83804 3462 42534030
Exostosis 34.95 10.25 49 83794 5582 42531910
Granulomatous pneumonitis 33.74 10.25 9 83834 31 42537461
Metabolic alkalosis 33.60 10.25 30 83813 2071 42535421
Suicide attempt 33.50 10.25 25 83818 46075 42491417
Hungry bone syndrome 32.99 10.25 13 83830 185 42537307
Shunt occlusion 32.55 10.25 22 83821 1005 42536487
Myelosuppression 31.99 10.25 20 83823 40441 42497051
Drug interaction 31.34 10.25 355 83488 266644 42270848
Colitis 31.22 10.25 177 83666 46395 42491097
Blood calcium increased 27.43 10.25 55 83788 8399 42529093
Hyperphosphataemia 27.07 10.25 71 83772 12933 42524559
Pouchitis 26.95 10.25 19 83824 930 42536562
Hepatic neoplasm 26.86 10.25 27 83816 2164 42535328
Oesophageal perforation 26.76 10.25 21 83822 1212 42536280
Intestinal obstruction 26.61 10.25 115 83728 27043 42510449
Hypophosphataemia 26.42 10.25 96 83747 20849 42516643
Ileus 26.10 10.25 90 83753 19049 42518443
Aggression 26.08 10.25 29 83814 44134 42493358
Hypoxia 26.02 10.25 230 83613 69556 42467936
Blood parathyroid hormone increased 25.95 10.25 25 83818 1902 42535590
Soft tissue mass 25.86 10.25 19 83824 993 42536499
Open reduction of fracture 25.18 10.25 9 83834 96 42537396
Suicidal ideation 24.91 10.25 35 83808 48126 42489366
Multimorbidity 24.86 10.25 18 83825 919 42536573
Foetal exposure during pregnancy 24.85 10.25 34 83809 47277 42490215
5-hydroxyindolacetic acid increased 24.23 10.25 9 83834 108 42537384
Carcinoid tumour of the small bowel 23.98 10.25 13 83830 396 42537096
Vascular device infection 23.84 10.25 43 83800 6067 42531425
Cutaneous T-cell lymphoma stage I 23.79 10.25 9 83834 114 42537378
Blood pressure diastolic increased 23.63 10.25 44 83799 6361 42531131
Haemorrhoids 22.97 10.25 80 83763 17017 42520475
Coma 22.96 10.25 44 83799 53510 42483982
Blood pressure systolic increased 22.65 10.25 112 83731 27856 42509636
Hypomagnesaemia 22.31 10.25 113 83730 28375 42509117
Contraindicated product administered 22.13 10.25 11 83832 25261 42512231
Therapeutic product effect decreased 21.73 10.25 27 83816 39123 42498369
Hyperparathyroidism 21.68 10.25 19 83824 1280 42536212
Blood follicle stimulating hormone increased 21.66 10.25 10 83833 214 42537278
Secretion discharge 21.64 10.25 47 83796 7588 42529904
Enterocolonic fistula 21.61 10.25 8 83835 95 42537397
Sedation 21.54 10.25 17 83826 30458 42507034
Calcinosis 21.53 10.25 16 83827 851 42536641
Intentional overdose 21.43 10.25 43 83800 51413 42486079
Wrong technique in product usage process 21.05 10.25 32 83811 42603 42494889
Growth hormone deficiency 20.84 10.25 11 83832 317 42537175
Therapeutic reaction time decreased 20.82 10.25 23 83820 2055 42535437
Atypical fracture 20.38 10.25 9 83834 173 42537319
Foreign body in throat 20.27 10.25 13 83830 543 42536949
Increased upper airway secretion 20.13 10.25 25 83818 2531 42534961
Fistula discharge 20.10 10.25 17 83826 1091 42536401
Crohn's disease 20.07 10.25 27 83816 2957 42534535
Red blood cell count decreased 19.77 10.25 121 83722 32594 42504898
Bone density decreased 19.70 10.25 23 83820 2183 42535309
Immunosuppressant drug level decreased 19.70 10.25 21 83822 1803 42535689
N-telopeptide urine increased 19.66 10.25 6 83837 37 42537455
Electrolyte imbalance 19.59 10.25 76 83767 17025 42520467
Nerve degeneration 19.35 10.25 9 83834 196 42537296
Interstitial lung disease 19.27 10.25 84 83759 78378 42459114
Enterocolitis bacterial 19.09 10.25 11 83832 378 42537114
Respiratory tract infection bacterial 18.91 10.25 21 83822 1888 42535604
Femur fracture 18.84 10.25 52 83791 9760 42527732
Transfusion-related circulatory overload 18.67 10.25 14 83829 755 42536737
Hypophosphatasia 18.65 10.25 6 83837 45 42537447
Synovitis 18.49 10.25 4 83839 15563 42521929
Expired product administered 18.46 10.25 31 83812 4132 42533360
Abscess intestinal 18.12 10.25 20 83823 1786 42535706
Drug hypersensitivity 17.97 10.25 118 83725 99271 42438221
Neuroleptic malignant syndrome 17.84 10.25 10 83833 21462 42516030
Hallucination 17.77 10.25 56 83787 57451 42480041
Anaphylactic reaction 17.56 10.25 36 83807 42707 42494785
Renal tubular dysfunction 17.51 10.25 11 83832 443 42537049
Blood potassium decreased 17.49 10.25 83 83760 20301 42517191
Gastrointestinal obstruction 17.44 10.25 16 83827 1144 42536348
Constipation 17.38 10.25 430 83413 161861 42375631
Pain in extremity 17.33 10.25 403 83440 150201 42387291
Clostridium difficile colitis 17.13 10.25 85 83758 21167 42516325
Poisoning 17.01 10.25 4 83839 14695 42522797
Flatulence 16.46 10.25 95 83748 25057 42512435
Lactic acidosis 16.26 10.25 41 83802 45220 42492272
Haematocrit decreased 16.23 10.25 121 83722 34787 42502705
Activated partial thromboplastin time prolonged 16.09 10.25 68 83775 15835 42521657
Blood immunoglobulin E increased 16.08 10.25 27 83816 3598 42533894
Accident at work 15.92 10.25 14 83829 947 42536545
Therapy non-responder 15.77 10.25 53 83790 53306 42484186
Agitation 15.70 10.25 69 83774 64245 42473247
Urogenital fistula 15.70 10.25 3 83840 0 42537492
Hypergastrinaemia 15.57 10.25 8 83835 218 42537274
Erythema 15.50 10.25 138 83705 108655 42428837
Respiratory depression 15.37 10.25 9 83834 18859 42518633
Primary familial brain calcification 15.37 10.25 5 83838 39 42537453
Central nervous system mass 15.32 10.25 13 83830 838 42536654
Gastrointestinal stoma output increased 15.29 10.25 10 83833 432 42537060
Wall motion score index abnormal 15.27 10.25 13 83830 842 42536650
Dyspnoea 14.77 10.25 1035 82808 441586 42095906
Airway remodelling 14.69 10.25 13 83830 887 42536605
Fibrous histiocytoma 14.68 10.25 9 83834 347 42537145
Respiratory tract infection viral 14.62 10.25 25 83818 3381 42534111
Haematopoietic stem cell mobilisation 14.54 10.25 9 83834 353 42537139
Bilirubin conjugated abnormal 14.26 10.25 6 83837 102 42537390
Angioedema 14.10 10.25 40 83803 42437 42495055
Psoriatic arthropathy 14.08 10.25 17 83826 24950 42512542
Rheumatoid arthritis 14.07 10.25 40 83803 42400 42495092
Hepatic function abnormal 14.05 10.25 53 83790 51514 42485978
Cardiac septal defect 13.97 10.25 13 83830 947 42536545
Hypovolaemia 13.95 10.25 52 83791 11433 42526059
Psoriasis 13.87 10.25 49 83794 48555 42488937
Atopy 13.80 10.25 13 83830 962 42536530
Bronchial obstruction 13.76 10.25 17 83826 1712 42535780
Neoplasm 13.72 10.25 35 83808 6270 42531222
SARS-CoV-2 antibody test positive 13.64 10.25 9 83834 395 42537097
Weight decreased 13.44 10.25 518 83325 207430 42330062
Pleural effusion 13.42 10.25 267 83576 96899 42440593
Psychotic disorder 13.41 10.25 23 83820 29185 42508307
Injection site erythema 13.37 10.25 12 83831 20183 42517309
Disturbance in attention 13.27 10.25 24 83819 29842 42507650
Blood calcium decreased 13.24 10.25 50 83793 11058 42526434
End stage renal disease 13.19 10.25 66 83777 16492 42521000
Extrapyramidal disorder 13.13 10.25 8 83835 16404 42521088
Stoma complication 13.11 10.25 10 83833 553 42536939
Rectal prolapse 13.03 10.25 10 83833 558 42536934
Accident 13.02 10.25 35 83808 6468 42531024
Shunt aneurysm 12.80 10.25 4 83839 27 42537465
Monoclonal immunoglobulin increased 12.79 10.25 9 83834 439 42537053
Sleep disorder therapy 12.71 10.25 36 83807 6858 42530634
Failure to thrive 12.58 10.25 44 83799 9378 42528114
Product dose omission issue 12.48 10.25 221 83622 154144 42383348
Blood 25-hydroxycholecalciferol decreased 12.46 10.25 8 83835 335 42537157
Paranoia 12.44 10.25 6 83837 14020 42523472
Calcification metastatic 12.42 10.25 3 83840 6 42537486
Circulatory collapse 12.40 10.25 17 83826 23619 42513873
Overgrowth bacterial 12.37 10.25 6 83837 144 42537348
Dysphonia 12.32 10.25 97 83746 28353 42509139
Skin induration 12.30 10.25 17 83826 1910 42535582
Cardiac failure 12.14 10.25 143 83700 106713 42430779
Alkalosis 12.11 10.25 6 83837 151 42537341
Systemic inflammatory response syndrome 12.11 10.25 37 83806 7353 42530139
Intentional dose omission 12.03 10.25 42 83801 8944 42528548
Overdose 11.91 10.25 141 83702 105123 42432369
Haemoglobin decreased 11.88 10.25 343 83500 132128 42405364
Superinfection 11.81 10.25 21 83822 2930 42534562
Renal mass 11.80 10.25 17 83826 1985 42535507
Premature baby 11.80 10.25 17 83826 23136 42514356
Necrotising ulcerative gingivostomatitis 11.78 10.25 5 83838 87 42537405
Myocarditis 11.66 10.25 12 83831 18926 42518566
Gastroenteritis staphylococcal 11.61 10.25 7 83836 262 42537230
Peripheral motor neuropathy 11.59 10.25 18 83825 2246 42535246
Drug use disorder 11.59 10.25 3 83840 10330 42527162
Mixed dementia 11.49 10.25 7 83836 267 42537225
Dermatitis atopic 11.48 10.25 5 83838 12399 42525093
Hepatocellular injury 11.47 10.25 18 83825 23660 42513832
Blood test abnormal 11.40 10.25 53 83790 12853 42524639
Vomiting 11.36 10.25 687 83156 289036 42248456
Ulcer 11.35 10.25 63 83780 16378 42521114
Renal cyst haemorrhage 11.33 10.25 10 83833 680 42536812
Blood parathyroid hormone decreased 11.26 10.25 15 83828 1628 42535864
Poisoning deliberate 11.26 10.25 3 83840 10131 42527361
Hepatic enzyme increased 11.25 10.25 49 83794 45735 42491757
Blood phosphorus decreased 11.21 10.25 23 83820 3570 42533922
Disease progression 11.19 10.25 207 83636 143449 42394043
Erectile dysfunction 11.09 10.25 20 83823 24893 42512599
High turnover osteopathy 11.08 10.25 4 83839 44 42537448
Anal fistula 11.02 10.25 32 83811 6181 42531311
Device related infection 11.01 10.25 73 83770 20206 42517286
Microangiopathy 10.98 10.25 15 83828 1667 42535825
Therapy partial responder 10.91 10.25 14 83829 20007 42517485
Transurethral prostatectomy 10.82 10.25 8 83835 422 42537070
Respiratory arrest 10.80 10.25 25 83818 28399 42509093
Drug eruption 10.75 10.25 18 83825 23057 42514435
Chronic respiratory failure 10.71 10.25 15 83828 1707 42535785
Lung consolidation 10.54 10.25 33 83810 6644 42530848
Neuromyopathy 10.42 10.25 12 83831 1122 42536370
Ascites 10.41 10.25 163 83680 56515 42480977
Hepatic infection 10.39 10.25 10 83833 760 42536732
Autoimmune colitis 10.36 10.25 12 83831 1129 42536363
Pneumonia 10.32 10.25 964 82879 421185 42116307
Muscle swelling 10.28 10.25 8 83835 456 42537036
Puncture site pain 10.28 10.25 4 83839 55 42537437
Injection site pain 10.25 10.25 69 83774 57729 42479763

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
Milk-alkali syndrome 651.67 9.60 234 299896 1771 110287398
Completed suicide 529.71 9.60 32 300098 242349 110046820
Drug ineffective 430.87 9.60 2400 297730 1518140 108771029
Toxicity to various agents 400.59 9.60 428 299702 480127 109809042
Wheezing 346.58 9.60 1492 298638 253738 110035431
Rheumatic fever 298.56 9.60 869 299261 121710 110167459
Swollen joint count increased 244.37 9.60 634 299496 83027 110206142
Psoriatic arthropathy 217.29 9.60 1083 299047 195678 110093491
Facet joint syndrome 215.48 9.60 665 299465 96163 110193006
Joint range of motion decreased 209.35 9.60 767 299363 121065 110168104
Lip dry 197.85 9.60 660 299470 99423 110189746
Liver injury 196.15 9.60 869 299261 149544 110139625
Type 2 diabetes mellitus 169.16 9.60 937 299193 176295 110112874
Intentional overdose 165.61 9.60 76 300054 132425 110156744
Duodenal ulcer perforation 164.64 9.60 932 299198 176768 110112401
Fibromyalgia 164.07 9.60 905 299225 170004 110119165
Sciatica 162.35 9.60 586 299544 91813 110197356
Schizophrenia 162.13 9.60 245 299885 21581 110267588
Myelosuppression 155.50 9.60 33 300097 94307 110194862
Death 155.15 9.60 1185 298945 697684 109591485
Deep vein thrombosis postoperative 153.69 9.60 430 299700 58861 110230308
Hypomania 153.57 9.60 163 299967 10047 110279122
Peripheral venous disease 152.51 9.60 539 299591 83578 110205591
Drug interaction 148.63 9.60 775 299355 499408 109789761
Helicobacter infection 148.62 9.60 923 299207 180954 110108215
Rheumatoid factor positive 139.95 9.60 717 299413 130923 110158246
Injury 133.37 9.60 881 299249 176384 110112785
Autoimmune disorder 130.43 9.60 433 299697 65050 110224119
Rheumatoid arthritis 130.19 9.60 1314 298816 298299 109990870
Product dose omission issue 129.94 9.60 443 299687 321339 109967830
Pulmonary vasculitis 128.71 9.60 121 300009 6439 110282730
Mobility decreased 127.16 9.60 1089 299041 236333 110052836
Full blood count abnormal 126.58 9.60 387 299743 55665 110233504
Neurologic neglect syndrome 121.73 9.60 138 299992 9160 110280009
Hypocalcaemia 120.34 9.60 421 299709 64945 110224224
Blood cholesterol increased 119.42 9.60 885 299245 183900 110105269
Road traffic accident 119.10 9.60 592 299538 106806 110182363
Frequent bowel movements 118.88 9.60 445 299685 70945 110218224
Hypercalcaemia 118.60 9.60 336 299794 46321 110242848
Carotid artery thrombosis 117.69 9.60 138 299992 9500 110279669
Gastrooesophageal reflux disease 116.89 9.60 863 299267 179113 110110056
Neuritis 116.42 9.60 121 300009 7278 110281891
Adjustment disorder with depressed mood 115.45 9.60 320 299810 43563 110245606
Chronic sinusitis 114.50 9.60 227 299903 24857 110264312
Jaundice cholestatic 112.82 9.60 167 299963 14441 110274728
Drug abuse 112.18 9.60 193 299937 177218 110111951
Myocardial infarction 109.94 9.60 222 299908 191861 110097308
Irritable bowel syndrome 109.84 9.60 793 299337 163422 110125747
Dyspepsia 109.21 9.60 889 299241 190076 110099093
Grip strength decreased 108.89 9.60 469 299661 79705 110209464
Pulmonary fibrosis 108.59 9.60 556 299574 101486 110187683
Folliculitis 107.79 9.60 802 299328 166851 110122318
Asthma 106.93 9.60 1094 299036 249197 110039972
Colitis ulcerative 105.41 9.60 453 299677 76910 110212259
Systemic lupus erythematosus 104.08 9.60 1102 299028 253236 110035933
Cholelithiasis 102.84 9.60 392 299738 63030 110226139
Nasal polyps 102.09 9.60 151 299979 13049 110276120
Dislocation of vertebra 101.66 9.60 305 299825 43416 110245753
Dry mouth 101.27 9.60 906 299224 199042 110090127
Injection site pain 100.66 9.60 207 299923 177715 110111454
Adjustment disorder 100.57 9.60 135 299995 10660 110278509
Suicide attempt 100.28 9.60 80 300050 103314 110185855
Sleep disorder 99.54 9.60 898 299232 197746 110091423
Drug resistance 98.67 9.60 17 300113 56357 110232812
Obstructive airways disorder 98.08 9.60 312 299818 45837 110243332
C-reactive protein 97.04 9.60 238 299892 30093 110259076
Drug ineffective for unapproved indication 96.72 9.60 82 300048 102756 110186413
Pericarditis 96.60 9.60 964 299166 218150 110071019
Wound infection 94.67 9.60 514 299616 95951 110193218
Wound 94.62 9.60 1013 299117 233424 110055745
Respiratory symptom 93.38 9.60 155 299975 14790 110274379
Obesity 93.03 9.60 576 299554 112775 110176394
Lower limb fracture 92.70 9.60 428 299702 74920 110214249
Vaginal flatulence 92.60 9.60 138 299992 12006 110277163
Total lung capacity increased 92.17 9.60 90 300040 5022 110284147
Bursitis 91.31 9.60 635 299495 129283 110159886
Glossodynia 90.39 9.60 961 299169 221043 110068126
Vomiting 90.35 9.60 3166 296964 907509 109381660
Oedema 89.30 9.60 917 299213 209059 110080110
Abdominal pain 89.18 9.60 1918 298212 511071 109778098
Antineutrophil cytoplasmic antibody positive 88.97 9.60 88 300042 4988 110284181
Angioedema 88.48 9.60 82 300048 98418 110190751
C-reactive protein abnormal 88.28 9.60 629 299501 129066 110160103
Shunt stenosis 87.31 9.60 52 300078 1364 110287805
X-ray abnormal 86.83 9.60 264 299866 37853 110251316
Eosinophilic granulomatosis with polyangiitis 86.64 9.60 125 300005 10561 110278608
Personality disorder 85.44 9.60 137 299993 12700 110276469
Nasal oedema 85.31 9.60 99 300031 6740 110282429
Sleep disorder due to general medical condition, insomnia type 84.92 9.60 534 299596 105109 110184060
Macular degeneration 84.77 9.60 184 299946 21475 110267694
Lupus vulgaris 84.16 9.60 242 299888 33641 110255528
Sleep disorder due to a general medical condition 83.59 9.60 321 299809 51791 110237378
Suicidal ideation 83.44 9.60 79 300051 93858 110195311
Total lung capacity abnormal 83.22 9.60 81 300049 4502 110284667
Lung disorder 83.20 9.60 800 299330 179247 110109922
Spirometry abnormal 81.34 9.60 87 300043 5410 110283759
Stomatitis 80.75 9.60 1103 299027 269139 110020030
Female genital tract fistula 78.44 9.60 152 299978 16367 110272802
Proctitis 78.24 9.60 154 299976 16773 110272396
Hand deformity 77.22 9.60 920 299210 217586 110071583
Pemphigus 76.52 9.60 905 299225 213665 110075504
Asthma-chronic obstructive pulmonary disease overlap syndrome 76.08 9.60 90 300040 6254 110282915
Arteriosclerosis coronary artery 75.01 9.60 192 299938 24926 110264243
Hyperhidrosis 74.11 9.60 260 299870 187038 110102131
Mite allergy 74.06 9.60 85 300045 5718 110283451
Mycotic allergy 73.95 9.60 86 300044 5868 110283301
Osteoarthritis 73.61 9.60 789 299341 181834 110107335
Lactic acidosis 73.51 9.60 86 300044 92725 110196444
Dust allergy 73.40 9.60 86 300044 5915 110283254
Injection site erythema 72.74 9.60 89 300041 94087 110195082
Hypotension 71.92 9.60 995 299135 522854 109766315
Conjunctivitis allergic 71.28 9.60 91 300039 6840 110282329
Radiculopathy 69.75 9.60 159 299971 19177 110269992
Anaphylactic reaction 68.95 9.60 128 300002 114172 110174997
Breast cancer stage III 68.05 9.60 407 299723 78710 110210459
Wrong technique in product usage process 68.05 9.60 82 300048 87266 110201903
Prescribed overdose 66.88 9.60 437 299693 87144 110202025
Gangrene 66.46 9.60 141 299989 16200 110272969
Nephrocalcinosis 66.24 9.60 48 300082 1766 110287403
Gait inability 66 9.60 612 299518 135764 110153405
Muscle injury 65.71 9.60 627 299503 140180 110148989
Accidental exposure to product 65.14 9.60 27 300103 49981 110239188
Injection site swelling 64.85 9.60 44 300086 61746 110227423
Disease progression 64.31 9.60 393 299737 243641 110045528
Night sweats 64.21 9.60 600 299530 133383 110155786
Arterial occlusive disease 63.32 9.60 133 299997 15175 110273994
Colitis 63.21 9.60 485 299645 101838 110187331
Taste disorder 63.20 9.60 347 299783 65040 110224129
Blood mercury abnormal 62.93 9.60 25 300105 257 110288912
Blister 62.67 9.60 915 299215 226461 110062708
Nasal obstruction 62.32 9.60 60 300070 3290 110285879
Diarrhoea 61.91 9.60 3728 296402 1135777 109153392
Agitation 61.86 9.60 134 299996 112917 110176252
Vaginal discharge 61.03 9.60 144 299986 17764 110271405
Sensory loss 60.98 9.60 161 299969 21296 110267873
Hepatic function abnormal 60.31 9.60 93 300037 89202 110199967
Impaired healing 60.01 9.60 806 299324 195911 110093258
Methaemoglobinaemia 59.87 9.60 97 300033 9071 110280098
Device expulsion 59.47 9.60 7 300123 30884 110258285
Bradycardia 59.45 9.60 219 299911 155298 110133871
Neurological symptom 59.27 9.60 131 299999 15477 110273692
Affect lability 58.31 9.60 145 299985 18492 110270677
Calciphylaxis 57.99 9.60 64 300066 4123 110285046
Interstitial lung disease 57.43 9.60 190 299940 139144 110150025
Hepatocellular injury 57.38 9.60 33 300097 50609 110238560
Hypoaesthesia 54.25 9.60 1174 298956 313049 109976120
Sinus congestion 54.18 9.60 194 299936 30265 110258904
Drug reaction with eosinophilia and systemic symptoms 54.02 9.60 87 300043 82008 110207161
Gastrointestinal procedural complication 53.92 9.60 26 300104 439 110288730
Amnesia 53.53 9.60 478 299652 104930 110184239
Recalled product 53.14 9.60 34 300096 1016 110288153
Injection site bruising 53.14 9.60 37 300093 51226 110237943
Throat clearing 52.84 9.60 62 300068 4271 110284898
Breast cancer stage II 52.72 9.60 179 299951 27196 110261973
Off label use 52.38 9.60 3440 296690 1496745 108792424
Seizure 52.30 9.60 368 299762 220817 110068352
Metabolic alkalosis 52.17 9.60 70 300060 5525 110283644
Neuroleptic malignant syndrome 52.02 9.60 14 300116 34045 110255124
Cardio-respiratory arrest 51.96 9.60 152 299978 115684 110173485
Eating disorder 51.90 9.60 193 299937 30665 110258504
Injection site pruritus 51.82 9.60 38 300092 51220 110237949
Prescribed underdose 51.48 9.60 328 299802 64846 110224323
Respiratory tract infection 51.46 9.60 352 299778 71265 110217904
Loss of consciousness 50.74 9.60 318 299812 195988 110093181
Inflammation 50.66 9.60 771 299359 192467 110096702
Poisoning deliberate 50.60 9.60 6 300124 26325 110262844
Muscle spasticity 50.22 9.60 212 299918 35703 110253466
Hepatic enzyme increased 49.79 9.60 1181 298949 319711 109969458
Hypercholesterolaemia 49.29 9.60 418 299712 90419 110198750
Cardiac arrest 49.18 9.60 322 299808 196431 110092738
Synovitis 48.90 9.60 1029 299101 273063 110016106
Poisoning 48.33 9.60 10 300120 29095 110260074
Segmental diverticular colitis 48.01 9.60 18 300112 156 110289013
Abdominal discomfort 47.95 9.60 1404 298726 392454 109896715
Vision blurred 47.81 9.60 184 299946 128838 110160331
Coordination abnormal 47.74 9.60 164 299966 25064 110264105
Skin haemorrhage 47.51 9.60 162 299968 24665 110264504
Paraesthesia oral 47.28 9.60 199 299931 33472 110255697
Acute kidney injury 46.96 9.60 1339 298791 634091 109655078
Retinitis 46.13 9.60 192 299938 32135 110257034
Anti-cyclic citrullinated peptide antibody positive 45.75 9.60 721 299409 181263 110107906
Live birth 45.54 9.60 334 299796 69150 110220019
Hip arthroplasty 45.39 9.60 283 299847 55530 110233639
Erythema 45.34 9.60 539 299591 290908 109998261
Liver disorder 45.11 9.60 587 299543 141656 110147513
Sneezing 44.88 9.60 189 299941 31795 110257374
Therapeutic product effect incomplete 44.84 9.60 855 299275 222950 110066219
Hemiplegia 44.78 9.60 150 299980 22632 110266537
Multiple organ dysfunction syndrome 44.44 9.60 236 299894 151474 110137695
Rhinorrhoea 44.39 9.60 450 299680 102216 110186953
Drug eruption 44.37 9.60 48 300082 53611 110235558
Pancytopenia 44.23 9.60 360 299770 209253 110079916
Sinus disorder 44.08 9.60 191 299939 32537 110256632
Motor dysfunction 43.88 9.60 156 299974 24250 110264919
Nicotine dependence 43.62 9.60 33 300097 1298 110287871
Cardiac failure 43.46 9.60 314 299816 187312 110101857
Intentional product misuse 43.39 9.60 199 299931 132705 110156464
Abdominal distension 43.36 9.60 692 299438 174411 110114758
Therapy cessation 43.12 9.60 35 300095 44822 110244347
Sarcoidosis 42.70 9.60 101 300029 12478 110276691
Pulmonary alveolar haemorrhage 42.60 9.60 136 299994 20014 110269155
Aggression 42.59 9.60 59 300071 59151 110230018
Cardiac murmur 42.23 9.60 155 299975 24473 110264696
Therapy partial responder 42.20 9.60 24 300106 37037 110252132
Small intestinal obstruction 41.87 9.60 186 299944 32027 110257142
Therapy interrupted 41.83 9.60 44 300086 49778 110239391
Pedal pulse abnormal 41.83 9.60 18 300112 230 110288939
Respiratory tract congestion 41.50 9.60 180 299950 30677 110258492
Fractional exhaled nitric oxide increased 41.45 9.60 26 300104 750 110288419
Disturbance in attention 41.45 9.60 65 300065 61930 110227239
Neutropenia 41.43 9.60 741 299389 373879 109915290
Normochromic normocytic anaemia 41.28 9.60 102 300028 12955 110276214
Swelling 41.26 9.60 1246 298884 349795 109939374
Exostosis 41.19 9.60 239 299891 45717 110243452
Agranulocytosis 41.06 9.60 65 300065 61695 110227474
Renal impairment 40.98 9.60 321 299809 188124 110101045
Migraine 40.14 9.60 672 299458 170980 110118189
Neuropathy peripheral 40.10 9.60 303 299827 178974 110110195
Calcium ionised decreased 39.88 9.60 24 300106 642 110288527
Blepharospasm 39.65 9.60 270 299860 54581 110234588
Ill-defined disorder 39.64 9.60 622 299508 156231 110132938
Ulcer haemorrhage 39.50 9.60 143 299987 22428 110266741
Blood calcium decreased 39.30 9.60 197 299933 35648 110253521
Irritability 39.27 9.60 43 300087 47766 110241403
Herpes zoster 39.23 9.60 156 299974 108223 110180946
Sputum purulent 39.15 9.60 36 300094 1862 110287307
Altered state of consciousness 38.93 9.60 60 300070 57566 110231603
Muscular weakness 38.69 9.60 915 299215 247553 110041616
5-hydroxyindolacetic acid in urine increased 38.68 9.60 16 300114 184 110288985
Serotonin syndrome 38.62 9.60 63 300067 59090 110230079
Alanine aminotransferase increased 38.59 9.60 316 299814 183457 110105712
COVID-19 38.58 9.60 452 299678 244608 110044561
Multiple drug therapy 38.37 9.60 74 300056 7940 110281229
Rheumatoid nodule 38.09 9.60 5 300125 20291 110268878
Blindness 38.01 9.60 26 300104 36333 110252836
Abortion spontaneous 37.90 9.60 23 300107 34259 110254910
Sinusitis 37.85 9.60 1064 299066 295624 109993545
Hypophosphataemic osteomalacia 37.69 9.60 20 300110 417 110288752
Respiratory depression 37.49 9.60 20 300110 31981 110257188
Bone marrow failure 37.41 9.60 62 300068 57786 110231383
Proctalgia 37.36 9.60 99 300031 13123 110276046
Rectal haemorrhage 37.36 9.60 493 299637 119340 110169829
Circulatory collapse 37.20 9.60 37 300093 42956 110246213
Adverse event 37.04 9.60 455 299675 108354 110180815
Thrombocytopenia 37.04 9.60 695 299435 348190 109940979
Hyperparathyroidism secondary 36.56 9.60 45 300085 3259 110285910
Overdose 36.50 9.60 432 299698 233362 110055807
Hypoparathyroidism 35.47 9.60 31 300099 1499 110287670
Musculoskeletal pain 35.23 9.60 695 299435 182328 110106841
Amyloid arthropathy 34.91 9.60 32 300098 1648 110287521
Feeling abnormal 34.71 9.60 318 299812 180393 110108776
Sopor 34.53 9.60 29 300101 36517 110252652
Acute hepatic failure 34.38 9.60 29 300101 36439 110252730
Anal inflammation 34.31 9.60 38 300092 2458 110286711
Multiple sclerosis relapse 34.23 9.60 52 300078 50188 110238981
Hypophosphataemia 34.04 9.60 179 299951 33003 110256166
Shunt occlusion 34.00 9.60 32 300098 1705 110287464
Feeding intolerance 33.69 9.60 27 300103 1157 110288012
Hungry bone syndrome 33.50 9.60 17 300113 322 110288847
Rib deformity 33.19 9.60 15 300115 217 110288952
Malaise 32.86 9.60 2179 297951 669640 109619529
Cytomegalovirus infection 32.80 9.60 61 300069 54383 110234786
Knee arthroplasty 32.19 9.60 293 299837 64655 110224514
Lower respiratory tract infection 32.17 9.60 876 299254 242230 110046939
Rhabdomyolysis 32.17 9.60 193 299937 120208 110168961
Hallucination 31.86 9.60 154 299976 101278 110187891
Nephrogenic systemic fibrosis 31.78 9.60 55 300075 5428 110283741
Cholestasis 31.67 9.60 81 300049 64437 110224732
Respiratory failure 31.31 9.60 404 299726 214928 110074241
Blood creatine phosphokinase increased 31.26 9.60 98 300032 72979 110216190
Procedural pain 31.25 9.60 184 299946 35381 110253788
Respiratory arrest 31.15 9.60 70 300060 58229 110230940
Discomfort 31.11 9.60 783 299347 213924 110075245
Oedema peripheral 31.04 9.60 1137 298993 327523 109961646
Lupus-like syndrome 30.81 9.60 203 299927 40589 110248580
Heart rate increased 30.81 9.60 246 299884 143588 110145581
Oxygen saturation decreased 30.69 9.60 275 299855 156707 110132462
Therapeutic reaction time decreased 30.66 9.60 53 300077 5226 110283943
Shock 30.59 9.60 62 300068 53526 110235643
Weight decreased 30.51 9.60 1558 298572 466499 109822670
Cerebral infarction 30.43 9.60 59 300071 51779 110237390
Miosis 30.07 9.60 11 300119 21972 110267197
Cerebral haemorrhage 30.05 9.60 84 300046 64884 110224285
Foetal death 30.00 9.60 4 300126 16041 110273128
Musculoskeletal stiffness 29.91 9.60 982 299148 278840 110010329
Capillaritis 29.91 9.60 35 300095 2404 110286765
Bone erosion 29.87 9.60 222 299908 46149 110243020
General physical health deterioration 29.87 9.60 1426 298704 423869 109865300
Urticaria 29.85 9.60 1102 299028 317755 109971414
Product prescribing error 29.63 9.60 59 300071 51272 110237897
Product storage error 29.50 9.60 11 300119 21717 110267452
Low density lipoprotein decreased 29.39 9.60 27 300103 1395 110287774
Cytomegalovirus infection reactivation 29.03 9.60 7 300123 18326 110270843
Intentional product use issue 28.86 9.60 879 299251 247027 110042142
Hyperparathyroidism 28.62 9.60 43 300087 3767 110285402
Decreased appetite 28.62 9.60 1572 298558 474274 109814895
Tremor 28.46 9.60 382 299748 201850 110087319
Acute respiratory distress syndrome 28.32 9.60 64 300066 53134 110236035
Device difficult to use 28.21 9.60 8 300122 18797 110270372
Confusional state 28.12 9.60 1548 298582 467132 109822037
Anti-cyclic citrullinated peptide antibody 28.03 9.60 118 300012 19846 110269323
Hyperphosphataemia 28.00 9.60 103 300027 16278 110272891
Onychomadesis 27.95 9.60 216 299914 45447 110243722
Blood parathyroid hormone increased 27.81 9.60 45 300085 4203 110284966
Inappropriate antidiuretic hormone secretion 27.20 9.60 31 300099 33820 110255349
Metabolic acidosis 27.11 9.60 159 299971 99585 110189584
Seronegative arthritis 27.01 9.60 88 300042 13089 110276080
Leukopenia 26.80 9.60 266 299864 148525 110140644
Musculoskeletal disorder 26.79 9.60 14 300116 22650 110266519
Carbuncle 26.77 9.60 26 300104 1441 110287728
Speech disorder 26.74 9.60 82 300048 61487 110227682
Laryngitis 26.73 9.60 202 299928 42209 110246960
Post transplant lymphoproliferative disorder 26.69 9.60 5 300125 15608 110273561
Sleep apnoea syndrome 26.48 9.60 43 300087 40404 110248765
Dehydration 26.40 9.60 967 299163 278544 110010625
Drug dose omission by device 26.25 9.60 4 300126 14512 110274657
Walking aid user 26.22 9.60 136 299994 24939 110264230
Forced expiratory volume decreased 26.12 9.60 87 300043 13089 110276080
Diplopia 26.08 9.60 46 300084 41848 110247321
Haemorrhoids 26.02 9.60 176 299954 35496 110253673
Blood glucose increased 25.95 9.60 232 299898 132264 110156905
Arteriovenous fistula occlusion 25.88 9.60 17 300113 532 110288637
Restlessness 25.83 9.60 73 300057 56186 110232983
Delirium 25.73 9.60 512 299618 134513 110154656
Food allergy 25.61 9.60 11 300119 19937 110269232
Hepatic cytolysis 25.60 9.60 71 300059 54982 110234187
Brain oedema 25.51 9.60 28 300102 31070 110258099
Burning sensation 25.44 9.60 99 300031 69113 110220056
Visual acuity reduced 25.27 9.60 30 300100 32143 110257026
Exposure via skin contact 25.25 9.60 3 300127 13144 110276025
Rhinitis allergic 25.22 9.60 106 300024 17816 110271353
Vasculitis 24.99 9.60 175 299955 35698 110253471
Arteriosclerosis 24.99 9.60 133 299997 24634 110264535
Haematotoxicity 24.95 9.60 13 300117 21069 110268100
Dyskinesia 24.93 9.60 65 300065 51381 110237788
SARS-CoV-2 test negative 24.92 9.60 30 300100 2123 110287046
Drug use disorder 24.79 9.60 9 300121 18065 110271104
Low turnover osteopathy 24.77 9.60 29 300101 1993 110287176
Acute graft versus host disease 24.59 9.60 3 300127 12878 110276291
Blood pressure inadequately controlled 24.53 9.60 60 300070 7573 110281596
Incorrect route of product administration 24.52 9.60 274 299856 63787 110225382
Liver function test abnormal 24.48 9.60 100 300030 68850 110220319
Mydriasis 24.31 9.60 15 300115 22142 110267027
Injection site rash 24.14 9.60 17 300113 23402 110265767
Hypoglycaemia 23.75 9.60 201 299929 115903 110173266
Extrapyramidal disorder 23.67 9.60 26 300104 28841 110260328
Coronary artery disease 23.60 9.60 107 300023 71583 110217586
Anaphylactic shock 23.58 9.60 67 300063 51479 110237690
Pneumonia 23.50 9.60 2720 297410 873994 109415175
Stress fracture 23.46 9.60 57 300073 7164 110282005
5-hydroxyindolacetic acid increased 23.36 9.60 10 300120 126 110289043
Epilepsy 23.30 9.60 392 299738 99817 110189352
Psychomotor hyperactivity 23.28 9.60 13 300117 20264 110268905
Dermatitis atopic 23.24 9.60 21 300109 25520 110263649
Creatinine renal clearance increased 23.19 9.60 38 300092 3587 110285582
Epstein-Barr virus infection 23.01 9.60 11 300119 18727 110270442
Flushing 22.95 9.60 178 299952 104558 110184611
Central nervous system lupus 22.87 9.60 23 300107 1330 110287839
Withdrawal syndrome 22.84 9.60 31 300099 31349 110257820
Maternal exposure timing unspecified 22.69 9.60 115 300015 20898 110268271
Pruritus 22.69 9.60 1319 298811 580241 109708928
Akathisia 22.68 9.60 9 300121 17104 110272065
Oropharyngeal pain 22.26 9.60 247 299883 135029 110154140
Bronchopulmonary aspergillosis 22.25 9.60 29 300101 29834 110259335
Cardiac failure congestive 22.05 9.60 283 299847 150717 110138452
Vascular device infection 21.96 9.60 96 300034 16416 110272753
Tendonitis 21.94 9.60 23 300107 26060 110263109
Bladder cancer 21.90 9.60 14 300116 20278 110268891
Spondylitis 21.71 9.60 74 300056 11264 110277905
Arthropathy 21.67 9.60 971 299159 286551 110002618
Swollen joint count 21.59 9.60 62 300068 8612 110280557
Hypotonia 21.33 9.60 8 300122 15737 110273432
Substance abuse 21.29 9.60 4 300126 12459 110276710
Onychomycosis 21.26 9.60 178 299952 38353 110250816
Melaena 21.24 9.60 105 300025 68652 110220517
Renal failure 21.14 9.60 461 299669 226113 110063056
Joint dislocation 21.08 9.60 162 299968 34028 110255141
Delusion 21.06 9.60 20 300110 23735 110265434
Ankylosing spondylitis 21.04 9.60 8 300122 15604 110273565
Acute myeloid leukaemia 20.98 9.60 45 300085 38065 110251104
Skin ulcer 20.94 9.60 95 300035 63550 110225619
Infusion related reaction 20.93 9.60 1249 298881 379913 109909256
Candida infection 20.80 9.60 64 300066 47945 110241224
Apathy 20.78 9.60 9 300121 16230 110272939
Memory impairment 20.74 9.60 690 299440 196254 110092915
Salivary gland calculus 20.73 9.60 12 300118 298 110288871
Stevens-Johnson syndrome 20.70 9.60 62 300068 46839 110242330
Tetany 20.69 9.60 36 300094 3568 110285601
Granuloma skin 20.65 9.60 3 300127 11280 110277889
Myocarditis 20.58 9.60 31 300099 30024 110259145
Pouchitis 20.48 9.60 22 300108 1375 110287794
Psychotic disorder 20.47 9.60 220 299910 50717 110238452
Unevaluable event 20.34 9.60 87 300043 59140 110230029
Nail disorder 20.03 9.60 243 299887 57692 110231477
Back pain 19.84 9.60 814 299316 370182 109918987
Throat tightness 19.75 9.60 38 300092 33451 110255718
Porphyria acute 19.74 9.60 102 300028 18678 110270491
Diabetic ketoacidosis 19.73 9.60 54 300076 42004 110247165
Swelling face 19.72 9.60 158 299972 92163 110197006
Congestive cardiomyopathy 19.64 9.60 7 300123 14212 110274957
Sinus bradycardia 19.62 9.60 31 300099 29452 110259717
Monoclonal immunoglobulin present 19.56 9.60 29 300101 2511 110286658
Drug effective for unapproved indication 19.53 9.60 7 300123 14160 110275009
Cytomegalovirus viraemia 19.52 9.60 12 300118 17752 110271417
Renal function test abnormal 19.48 9.60 61 300069 8885 110280284
Posterior reversible encephalopathy syndrome 19.47 9.60 39 300091 33822 110255347
Carcinoid tumour of the small bowel 19.23 9.60 13 300117 427 110288742
Tachycardia 19.22 9.60 468 299662 226177 110062992
Cutaneous T-cell lymphoma stage I 19.21 9.60 9 300121 142 110289027
Red blood cell sedimentation rate abnormal 19.09 9.60 23 300107 24486 110264683
Malignant neoplasm progression 19.05 9.60 346 299784 174221 110114948
Injection site haemorrhage 19.03 9.60 38 300092 32990 110256179
Open reduction of fracture 18.94 9.60 11 300119 275 110288894
Abdominal rigidity 18.88 9.60 35 300095 3645 110285524
Alopecia 18.87 9.60 1189 298941 363564 109925605
Injection site warmth 18.80 9.60 12 300118 17393 110271776
Muscle spasms 18.74 9.60 929 299201 277228 110011941
Eye pruritus 18.64 9.60 38 300092 32737 110256432
Catatonia 18.52 9.60 4 300126 11296 110277873
Fungal infection 18.47 9.60 73 300057 50733 110238436
Discoloured vomit 18.45 9.60 25 300105 1992 110287177
Product label confusion 18.45 9.60 115 300015 22562 110266607
Foot deformity 18.39 9.60 207 299923 48273 110240896
Arrhythmia 18.33 9.60 112 300018 69463 110219706
Blue toe syndrome 18.12 9.60 15 300115 673 110288496
Contusion 18.00 9.60 790 299340 232571 110056598
Granulomatous pneumonitis 17.97 9.60 10 300120 230 110288939
Intramedullary rod insertion 17.97 9.60 10 300120 230 110288939
Cold sweat 17.89 9.60 20 300110 22011 110267158
Illness 17.84 9.60 140 299990 82031 110207138
Gonorrhoea 17.77 9.60 10 300120 235 110288934
Rash maculo-papular 17.77 9.60 123 300007 74099 110215070
Gastrointestinal disorder 17.77 9.60 815 299315 241137 110048032
Nasopharyngitis 17.64 9.60 1270 298860 393091 109896078
Sedation complication 17.62 9.60 103 300027 19752 110269417
Blood bilirubin increased 17.59 9.60 297 299833 75675 110213494
Underdose 17.59 9.60 256 299874 63298 110225871
Bradyphrenia 17.58 9.60 5 300125 11723 110277446
Product preparation error 17.53 9.60 4 300126 10875 110278294
Hypomagnesaemia 17.43 9.60 245 299885 60125 110229044
Paranoia 17.43 9.60 21 300109 22353 110266816
Blood pressure fluctuation 17.42 9.60 125 300005 74699 110214470
Multimorbidity 17.30 9.60 21 300109 1499 110287670
Dystonia 17.30 9.60 27 300103 25778 110263391
Mucosal inflammation 17.26 9.60 172 299958 95969 110193200
N-telopeptide urine increased 17.23 9.60 6 300124 41 110289128
Surgery 17.21 9.60 56 300074 41227 110247942
Eye irritation 17.20 9.60 41 300089 33411 110255758
BK virus infection 17.19 9.60 7 300123 13099 110276070
Dissociation 17.15 9.60 3 300127 9839 110279330
Incorrect dose administered 17.15 9.60 189 299941 103452 110185717
Hallucination, visual 17.02 9.60 53 300077 39552 110249617
Constipation 17.01 9.60 1158 298972 356628 109932541
Syncope 16.96 9.60 419 299711 202117 110087052
Skin necrosis 16.96 9.60 20 300110 21492 110267677
Nephroangiosclerosis 16.96 9.60 12 300118 425 110288744
Blood calcium increased 16.94 9.60 95 300035 17945 110271224
Epidermal necrosis 16.91 9.60 30 300100 3020 110286149
Device malfunction 16.89 9.60 27 300103 25531 110263638
Flatulence 16.86 9.60 216 299914 51933 110237236
Fluid retention 16.81 9.60 169 299961 94138 110195031
Hypertension 16.80 9.60 1605 298525 508479 109780690
Lymphoma 16.72 9.60 18 300112 20153 110269016
Hepatic neoplasm 16.46 9.60 34 300096 3833 110285336
Pallor 16.44 9.60 88 300042 56379 110232790
Blood pH increased 16.41 9.60 20 300110 1434 110287735
Haemodynamic instability 16.27 9.60 23 300107 22865 110266304
Head banging 16.26 9.60 13 300117 555 110288614
Therapeutic response shortened 16.23 9.60 35 300095 29548 110259621
Myelodysplastic syndrome 16.22 9.60 50 300080 37434 110251735
Dry eye 16.22 9.60 87 300043 55706 110233463
Transfusion-related circulatory overload 16.20 9.60 16 300114 905 110288264
Bacterial disease carrier 16.19 9.60 25 300105 2244 110286925
Haematemesis 16.18 9.60 94 300036 59014 110230155
Mood swings 16.14 9.60 23 300107 22789 110266380
Pulmonary oedema 16.09 9.60 185 299945 100474 110188695
Oral candidiasis 16.03 9.60 189 299941 44571 110244598
Eye disorder 16.03 9.60 34 300096 28872 110260297
Erectile dysfunction 16.02 9.60 16 300114 18540 110270629
Hemiparesis 16.00 9.60 186 299944 43717 110245452
Skin toxicity 15.94 9.60 6 300124 11777 110277392
Disease recurrence 15.94 9.60 98 300032 60686 110228483
Exercise tolerance decreased 15.93 9.60 70 300060 11997 110277172
Disseminated intravascular coagulation 15.86 9.60 58 300072 41228 110247941
Polyneuropathy 15.86 9.60 40 300090 31972 110257197
Oesophageal perforation 15.84 9.60 21 300109 1638 110287531
Breast cancer female 15.81 9.60 7 300123 12461 110276708
Clostridium difficile colitis 15.74 9.60 185 299945 43593 110245576
Device issue 15.71 9.60 45 300085 34490 110254679
Ketoacidosis 15.68 9.60 4 300126 10083 110279086
Pathogen resistance 15.53 9.60 15 300115 17657 110271512
Pneumonia aspiration 15.46 9.60 308 299822 80925 110208244
Secretion discharge 15.44 9.60 101 300029 20143 110269026
Encephalopathy 15.40 9.60 143 299987 80912 110208257
Metastases to lymph nodes 15.38 9.60 11 300119 15021 110274148
Blood bicarbonate increased 15.34 9.60 19 300111 1385 110287784
Acute graft versus host disease in skin 15.33 9.60 5 300125 10735 110278434
Jaundice 15.27 9.60 96 300034 59140 110230029
Cystitis haemorrhagic 15.25 9.60 7 300123 12202 110276967
Grip strength 15.23 9.60 57 300073 9084 110280085
Cardiotoxicity 15.22 9.60 14 300116 16867 110272302
Haemophagocytic lymphohistiocytosis 15.20 9.60 40 300090 31519 110257650
Erythema multiforme 15.20 9.60 21 300109 21076 110268093
Lymphadenopathy 15.18 9.60 106 300024 63729 110225440
Immune reconstitution inflammatory syndrome 15.18 9.60 13 300117 16213 110272956
Mucormycosis 15.08 9.60 5 300125 10623 110278546
Neutrophil count decreased 15.06 9.60 234 299896 120707 110168462
Paradoxical drug reaction 15.06 9.60 4 300126 9813 110279356
Acute myocardial infarction 14.99 9.60 150 299980 83627 110205542
Hepatic failure 14.98 9.60 117 300013 68622 110220547
Gastrointestinal sounds abnormal 14.96 9.60 43 300087 5975 110283194
Hypertensive crisis 14.95 9.60 27 300103 24345 110264824
Rebound effect 14.93 9.60 11 300119 14795 110274374
Haemorrhage 14.83 9.60 202 299928 106490 110182679
Subarachnoid haemorrhage 14.80 9.60 37 300093 29665 110259504
Neutropenic sepsis 14.78 9.60 39 300091 30707 110258462
Enterocolonic fistula 14.77 9.60 8 300122 174 110288995
Acute coronary syndrome 14.73 9.60 25 300105 23087 110266082
Adrenal insufficiency 14.72 9.60 62 300068 42328 110246841
Injection site urticaria 14.68 9.60 15 300115 17200 110271969
Device dislocation 14.65 9.60 41 300089 31663 110257506
Product substitution issue 14.65 9.60 25 300105 23036 110266133
Immune thrombocytopenia 14.64 9.60 24 300106 22470 110266699
Basal cell carcinoma 14.64 9.60 68 300062 45202 110243967
Ocular hyperaemia 14.56 9.60 56 300074 39230 110249939
Hyperkalaemia 14.55 9.60 270 299860 135526 110153643
Osteoporosis 14.50 9.60 324 299806 86828 110202341
Body height decreased 14.50 9.60 62 300068 10501 110278668
Aspartate aminotransferase increased 14.46 9.60 327 299803 159609 110129560
Neoplasm malignant 14.39 9.60 52 300078 37091 110252078
Vaginal haemorrhage 14.32 9.60 29 300101 25045 110264124
Anosmia 14.31 9.60 8 300122 12464 110276705
Gynaecomastia 14.31 9.60 4 300126 9486 110279683
Bradypnoea 14.30 9.60 3 300127 8646 110280523
Finger deformity 14.28 9.60 145 299985 32947 110256222
Drug withdrawal syndrome 14.27 9.60 54 300076 38000 110251169
Intestinal obstruction 14.18 9.60 213 299917 53014 110236155
Somnolence 14.17 9.60 661 299469 296788 109992381
Lymph node palpable 14.10 9.60 8 300122 191 110288978
Atypical femur fracture 14.09 9.60 43 300087 6176 110282993
Hypophosphatasia 14.07 9.60 7 300123 127 110289042
Nightmare 14.02 9.60 56 300074 38807 110250362
Fracture nonunion 14.01 9.60 19 300111 1515 110287654
Immunodeficiency 13.99 9.60 56 300074 38782 110250387
Paralysis 13.99 9.60 13 300117 15587 110273582
Appetite disorder 13.92 9.60 58 300072 9711 110279458
Shunt aneurysm 13.91 9.60 5 300125 38 110289131
Diversion colitis 13.90 9.60 4 300126 13 110289156
Abdominal pain upper 13.89 9.60 1114 299016 347997 109941172
Myalgia 13.86 9.60 479 299651 221902 110067267
Blood 25-hydroxycholecalciferol decreased 13.85 9.60 11 300119 465 110288704
Adverse drug reaction 13.85 9.60 380 299750 105179 110183990
Nerve degeneration 13.83 9.60 9 300121 277 110288892
Growth hormone deficiency 13.83 9.60 11 300119 466 110288703
Haematochezia 13.81 9.60 411 299719 115113 110174056
Creatinine renal clearance decreased 13.80 9.60 104 300026 21711 110267458
Primary familial brain calcification 13.79 9.60 5 300125 39 110289130
Amenorrhoea 13.71 9.60 4 300126 9227 110279942
Weight fluctuation 13.69 9.60 105 300025 22040 110267129
Shock haemorrhagic 13.53 9.60 34 300096 27213 110261956
Hepatic necrosis 13.51 9.60 5 300125 9917 110279252
Tuberculosis 13.51 9.60 17 300113 17757 110271412
Electrocardiogram QT prolonged 13.51 9.60 211 299919 108749 110180420
Atrioventricular block complete 13.48 9.60 21 300109 20061 110269108
Bronchiectasis 13.47 9.60 155 299975 36338 110252831
Epistaxis 13.42 9.60 261 299869 130111 110159058
Adverse reaction 13.41 9.60 131 299999 29463 110259706
Platelet count decreased 13.31 9.60 501 299629 229942 110059227
Gastrointestinal stoma output increased 13.31 9.60 15 300115 989 110288180
Progressive multifocal leukoencephalopathy 13.30 9.60 30 300100 24926 110264243
Hypothalamo-pituitary disorder 13.28 9.60 26 300104 2820 110286349
Thrombotic microangiopathy 13.25 9.60 38 300092 29111 110260058
Polyomavirus-associated nephropathy 13.25 9.60 3 300127 8198 110280971
Monoclonal immunoglobulin increased 13.24 9.60 12 300118 609 110288560
Unresponsive to stimuli 13.24 9.60 110 300020 63680 110225489
Eosinophilic cellulitis 13.20 9.60 9 300121 300 110288869
Hepatitis acute 13.20 9.60 19 300111 18747 110270422
Hemianopia 13.14 9.60 26 300104 2842 110286327
Urine calcium/creatinine ratio increased 13.10 9.60 7 300123 148 110289021
Failure to thrive 13.09 9.60 72 300058 13502 110275667
Blood follicle stimulating hormone increased 13.05 9.60 10 300120 401 110288768
Fracture 13.05 9.60 30 300100 24758 110264411
Product monitoring error 13.02 9.60 4 300126 8923 110280246
Breast cancer 13.00 9.60 57 300073 38485 110250684
General symptom 12.98 9.60 53 300077 8793 110280376
Febrile bone marrow aplasia 12.97 9.60 17 300113 17448 110271721
Mood altered 12.83 9.60 24 300106 21351 110267818
Complication of device insertion 12.82 9.60 4 300126 8834 110280335
Injection site mass 12.79 9.60 30 300100 24583 110264586
Urinary retention 12.78 9.60 124 300006 69559 110219610
Tinnitus 12.75 9.60 104 300026 60436 110228733
Atypical fracture 12.74 9.60 15 300115 1037 110288132
Depressed level of consciousness 12.74 9.60 221 299909 112057 110177112
Hepatic cirrhosis 12.74 9.60 256 299874 67370 110221799
Aphasia 12.71 9.60 228 299902 58769 110230400
Body mass index abnormal 12.53 9.60 14 300116 914 110288255
Soft tissue mass 12.53 9.60 18 300112 1515 110287654
Pulmonary calcification 12.52 9.60 11 300119 536 110288633
Quality of life decreased 12.48 9.60 12 300118 14157 110275012
Paraesthesia 12.44 9.60 891 299239 275630 110013539
Oncocytoma 12.38 9.60 4 300126 21 110289148
Papule 12.37 9.60 6 300124 10127 110279042
Cardiogenic shock 12.30 9.60 98 300032 57240 110231929
Anti-saccharomyces cerevisiae antibody test positive 12.29 9.60 5 300125 55 110289114
Fungal cystitis 12.22 9.60 4 300126 22 110289147
Delayed graft function 12.16 9.60 32 300098 4225 110284944
Poliomyelitis 12.13 9.60 5 300125 57 110289112
Heavy menstrual bleeding 12.08 9.60 16 300114 16349 110272820
Pancreatitis acute 12.03 9.60 105 300025 60169 110229000
Headache 11.99 9.60 2160 297970 880217 109408952
Sedation 11.96 9.60 126 300004 69557 110219612
Pharyngitis 11.94 9.60 32 300098 25066 110264103
Product dose omission in error 11.94 9.60 29 300101 23483 110265686
Ear pain 11.93 9.60 207 299923 53019 110236150
Fibrous histiocytoma 11.92 9.60 13 300117 826 110288343
Productive cough 11.91 9.60 400 299730 113905 110175264
Urinary incontinence 11.89 9.60 80 300050 48507 110240662
Caesarean section 11.83 9.60 12 300118 13805 110275364
Oral herpes 11.78 9.60 54 300076 36026 110253143
Coagulopathy 11.78 9.60 64 300066 40847 110248322
Toxic skin eruption 11.69 9.60 37 300093 27478 110261691
Spinal cord injury lumbar 11.68 9.60 5 300125 63 110289106
Autoimmune colitis 11.62 9.60 20 300110 1965 110287204
Haematoma 11.62 9.60 102 300028 58374 110230795
Hepatotoxicity 11.61 9.60 239 299891 63161 110226008
Enterocolitis bacterial 11.58 9.60 12 300118 719 110288450
Muscle twitching 11.53 9.60 42 300088 29893 110259276
Congenital knee deformity 11.53 9.60 4 300126 27 110289142
Tongue oedema 11.51 9.60 4 300126 8252 110280917
Drug dependence 11.44 9.60 84 300046 49936 110239233
Graft versus host disease 11.39 9.60 21 300109 18785 110270384
Labelled drug-drug interaction medication error 11.36 9.60 41 300089 29261 110259908
Endophthalmitis 11.36 9.60 4 300126 8183 110280986
Septic shock 11.33 9.60 333 299797 157195 110131974
Personality change 11.32 9.60 8 300122 10994 110278175
Fear of injection 11.30 9.60 5 300125 8906 110280263
Abnormal behaviour 11.28 9.60 61 300069 38978 110250191
Diffuse large B-cell lymphoma 11.28 9.60 16 300114 15882 110273287
Intestinal haemorrhage 11.24 9.60 3 300127 7338 110281831
Secondary immunodeficiency 11.23 9.60 33 300097 4643 110284526
Bronchial wall thickening 11.16 9.60 26 300104 3181 110285988
Rash pustular 11.14 9.60 11 300119 12818 110276351
Gluten sensitivity 11.11 9.60 10 300120 503 110288666
Gastroenteritis bacterial 11.11 9.60 10 300120 503 110288666
Death neonatal 11.10 9.60 18 300112 1685 110287484
Femur fracture 11.10 9.60 176 299954 44293 110244876
Status epilepticus 11.07 9.60 46 300084 31525 110257644
Chronic kidney disease-mineral and bone disorder 11.07 9.60 11 300119 627 110288542
Skin exfoliation 11.07 9.60 314 299816 87337 110201832
Herpes simplex 11.05 9.60 16 300114 15748 110273421
Product prescribing issue 11.04 9.60 11 300119 12761 110276408
Generalised tonic-clonic seizure 11.03 9.60 95 300035 54585 110234584
Obsessive-compulsive disorder 11.01 9.60 3 300127 7238 110281931
Foreign body in throat 11.00 9.60 14 300116 1049 110288120
Face oedema 10.99 9.60 50 300080 33419 110255750
Transient ischaemic attack 10.85 9.60 116 300014 63866 110225303
SARS-CoV-2 antibody test positive 10.83 9.60 9 300121 406 110288763
Guillain-Barre syndrome 10.81 9.60 8 300122 10736 110278433
Injection site induration 10.79 9.60 9 300121 11374 110277795
Hypothermia 10.74 9.60 36 300094 26266 110262903
Facial paralysis 10.69 9.60 32 300098 24182 110264987
Large intestine polyp 10.68 9.60 74 300056 15043 110274126
Leiomyoma 10.66 9.60 9 300121 415 110288754
Mesenteric phlebosclerosis 10.60 9.60 3 300127 9 110289160
Pulmonary toxicity 10.59 9.60 20 300110 17726 110271443
Electrolyte imbalance 10.58 9.60 150 299980 36878 110252291
Rash 10.50 9.60 2016 298114 818948 109470221
Drug level increased 10.50 9.60 81 300049 47638 110241531
Haematopoietic stem cell mobilisation 10.50 9.60 9 300121 424 110288745
Blood pressure decreased 10.49 9.60 235 299895 114856 110174313
Cytopenia 10.49 9.60 44 300086 30072 110259097
Nodule 10.48 9.60 135 299995 32496 110256673
Cardiomyopathy 10.47 9.60 51 300079 33474 110255695
Swollen tongue 10.42 9.60 109 300021 60253 110228916
Intracranial pressure increased 10.40 9.60 8 300122 10527 110278642
Plantar fasciitis 10.39 9.60 34 300096 5067 110284102
Pelvic pain 10.39 9.60 17 300113 15925 110273244
Calcification metastatic 10.37 9.60 6 300124 149 110289020
Hypermagnesaemia 10.36 9.60 17 300113 1606 110287563
Ureteral stent removal 10.36 9.60 3 300127 10 110289159
Intermenstrual bleeding 10.31 9.60 3 300127 6931 110282238
Myopathy 10.31 9.60 34 300096 24926 110264243
Pulmonary pain 10.28 9.60 39 300091 6254 110282915
Central nervous system mass 10.28 9.60 12 300118 822 110288347
Eye injury 10.24 9.60 45 300085 7710 110281459
Immunosuppressant drug level decreased 10.23 9.60 23 300107 2748 110286421
Hyperthermia 10.21 9.60 27 300103 21245 110267924
Cystitis 10.21 9.60 243 299887 65793 110223376
Wall motion score index abnormal 10.20 9.60 12 300118 829 110288340
Skin laceration 10.16 9.60 52 300078 33701 110255468
Hypervitaminosis B12 10.15 9.60 3 300127 11 110289158
Tumour lysis syndrome 10.12 9.60 46 300084 30755 110258414
Polyglandular disorder 10.12 9.60 7 300123 239 110288930
Asthenia 10.01 9.60 2066 298064 686933 109602236
Respiratory tract infection bacterial 10.00 9.60 21 300109 2395 110286774
Abnormal dreams 9.95 9.60 12 300118 12768 110276401
Polyarthritis 9.94 9.60 23 300107 18940 110270229
Pulseless electrical activity 9.90 9.60 19 300111 16738 110272431
Tension headache 9.89 9.60 7 300123 9611 110279558
Hepatitis B 9.88 9.60 7 300123 9605 110279564
Hypergastrinaemia 9.88 9.60 8 300122 348 110288821
Foetal exposure during pregnancy 9.86 9.60 4 300126 7501 110281668
Hepatitis B reactivation 9.81 9.60 4 300126 7480 110281689
Metastases to lung 9.81 9.60 31 300099 23032 110266137
Spinal fusion surgery 9.81 9.60 50 300080 9106 110280063
Pathological fracture 9.78 9.60 61 300069 11971 110277198
Respiratory acidosis 9.72 9.60 14 300116 13812 110275357
Joint injury 9.71 9.60 66 300064 39928 110249241
Eye pain 9.68 9.60 88 300042 50011 110239158
Gestational diabetes 9.61 9.60 4 300126 7385 110281784

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC P03AX05 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS
ECTOPARASITICIDES, INCL. SCABICIDES
Other ectoparasiticides, incl. scabicides
FDA PE N0000010282 Skin Barrier Activity
MeSH PA D000934 Antifoaming Agents
MeSH PA D003879 Dermatologic Agents
MeSH PA D004643 Emollients
MeSH PA D013501 Surface-Active Agents
CHEBI has role CHEBI:35442 antiparasitic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:35480 analgesic

Related Drugs by ATC class:

P03AX Other ectoparasiticides, incl. scabicides 4 drugs
abametapirbenzyl alcoholbenzyl benzoatemalathion

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

DiseaseRelationSNOMED_IDDOID
Diaper rash indication 91487003




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4018922 VUID
N0000147215 NUI
D01540 KEGG_DRUG
4018922 VANDF
4019331 VANDF
C1113707 UMLSCUI
CHEBI:31498 CHEBI
CHEMBL2108200 ChEMBL_ID
DB11074 DRUGBANK_ID
CHEMBL4297192 ChEMBL_ID
C501844 MESH_SUPPLEMENTAL_RECORD_UI
C013830 MESH_SUPPLEMENTAL_RECORD_UI
DB09512 DRUGBANK_ID
DB14005 DRUGBANK_ID
1299921 RXNORM
4607 MMSL
5175 MMSL
5464 MMSL
d01027 MMSL
001144 NDDF
001915 NDDF
387442005 SNOMEDCT_US
396031000 SNOMEDCT_US
420874002 SNOMEDCT_US
77898008 SNOMEDCT_US
D012841 MESH_DESCRIPTOR_UI
6433516 PUBCHEM_CID
TYU5GP6XGE UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Simethicone HUMAN OTC DRUG LABEL 1 10267-5328 CAPSULE, LIQUID FILLED 180 mg ORAL Export only 1 sections
Gas Relief Ultra Strength HUMAN OTC DRUG LABEL 1 53345-003 CAPSULE, LIQUID FILLED 180 mg ORAL OTC Monograph Drug 10 sections
Infants Relief Non-Staining Formula HUMAN OTC DRUG LABEL 1 59779-102 LIQUID 20 mg ORAL OTC MONOGRAPH FINAL 10 sections