dimethicone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

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 1937.57 9.32 1967 120706 129922 50352529
Toxicity to various agents 904.19 9.32 1744 120929 210755 50271696
Drug abuse 549.60 9.32 701 121972 59145 50423306
Cardio-respiratory arrest 374.85 9.32 552 122121 53340 50429111
Milk-alkali syndrome 311.50 9.32 100 122573 585 50481866
Intentional overdose 311.24 9.32 550 122123 61954 50420497
Drug ineffective 290.29 9.32 1020 121653 818313 49664138
Alcohol interaction 265.12 9.32 121 122552 2023 50480428
Overdose 206.26 9.32 620 122053 99107 50383344
Suicide attempt 190.84 9.32 401 122272 51331 50431120
Suspected suicide 175.64 9.32 127 122546 5230 50477221
Coma 162.06 9.32 398 122275 56481 50425970
Hypocalcaemia 137.31 9.32 239 122434 26577 50455874
Pneumonia aspiration 131.82 9.32 255 122418 30749 50451702
Alcohol poisoning 125.88 9.32 69 122604 1731 50480720
Diarrhoea 110.64 9.32 2020 120653 586456 49895995
Macular degeneration 109.64 9.32 154 122519 14234 50468217
Alcohol abuse 106.39 9.32 63 122610 1838 50480613
Recalled product 104.06 9.32 55 122618 1280 50481171
Alcohol use 101.01 9.32 62 122611 1933 50480518
Somnolence 99.52 9.32 680 121993 154305 50328146
Contraindicated product administered 97.48 9.32 131 122542 148827 50333624
Therapeutic product effect decreased 92.78 9.32 116 122557 135934 50346517
Pemphigus 91.14 9.32 94 122579 120072 50362379
Infusion related reaction 87.69 9.32 174 122499 169383 50313068
Gastrooesophageal reflux disease 87.23 9.32 392 122281 76036 50406415
Drug hypersensitivity 85.78 9.32 316 122357 250694 50231757
Liver injury 83.10 9.32 185 122488 24621 50457830
Hypomania 82.38 9.32 76 122597 4429 50478022
Treatment failure 82.23 9.32 129 122544 137508 50344943
Respiratory arrest 81.25 9.32 206 122467 29803 50452648
Systemic lupus erythematosus 80.09 9.32 136 122537 140486 50341965
Off label use 78.81 9.32 753 121920 473673 50008778
Hand deformity 76.40 9.32 78 122595 100121 50382330
Jaundice cholestatic 74.26 9.32 76 122597 5035 50477416
Asphyxia 74.00 9.32 78 122595 5349 50477102
Schizophrenia 73.15 9.32 90 122583 7307 50475144
Synovitis 72.19 9.32 118 122555 123747 50358704
Drug intolerance 71.49 9.32 281 122392 218823 50263628
Hypercalcaemia 71.41 9.32 168 122505 23184 50459267
Hepatotoxicity 70.71 9.32 184 122489 27042 50455409
Pain 70.04 9.32 986 121687 577917 49904534
Dehydration 69.58 9.32 618 122055 151831 50330620
Maternal exposure during pregnancy 69.56 9.32 180 122493 159598 50322853
Glossodynia 68.38 9.32 109 122564 115460 50366991
Swelling 64.64 9.32 259 122414 200613 50281838
Nephrocalcinosis 64.44 9.32 36 122637 938 50481513
Rheumatoid arthritis 64.03 9.32 263 122410 202287 50280164
Rash 63.73 9.32 716 121957 436755 50045696
Joint swelling 60.43 9.32 348 122325 244938 50237513
Methaemoglobinaemia 59.28 9.32 45 122628 1997 50480454
Anti-cyclic citrullinated peptide antibody positive 58.44 9.32 51 122622 70536 50411915
Sleep disorder due to general medical condition, insomnia type 57.63 9.32 5 122668 31442 50451009
Intentional product misuse 56.56 9.32 244 122429 46490 50435961
Discomfort 54.48 9.32 113 122560 108267 50374184
Alopecia 53.95 9.32 360 122313 244687 50237764
Abdominal pain 53.62 9.32 837 121836 235391 50247060
Lower respiratory tract infection 53.33 9.32 93 122580 95108 50387343
Hypersensitivity 52.59 9.32 306 122367 214855 50267596
Product dose omission issue 51.87 9.32 249 122424 183589 50298862
Infection 49.53 9.32 233 122440 172721 50309730
Device expulsion 49.16 9.32 6 122667 28816 50453635
Exposure to toxic agent 47.10 9.32 51 122622 3607 50478844
Calcium ionised decreased 45.72 9.32 19 122654 250 50482201
Flatulence 45.48 9.32 166 122507 29292 50453159
Tetany 45.47 9.32 35 122638 1586 50480865
Arthropathy 44.46 9.32 214 122459 157692 50324759
Postmortem blood drug level abnormal 43.62 9.32 20 122653 338 50482113
Cardiac arrest 43.36 9.32 349 122324 83302 50399149
Hypophosphataemic osteomalacia 42.87 9.32 16 122657 155 50482296
Nicotine dependence 42.77 9.32 24 122649 631 50481820
Headache 42.41 9.32 921 121752 505614 49976837
Blood alcohol increased 42.25 9.32 23 122650 569 50481882
Small intestinal obstruction 41.11 9.32 108 122565 15960 50466491
Ill-defined disorder 38.93 9.32 45 122628 54609 50427842
Segmental diverticular colitis 38.51 9.32 14 122659 125 50482326
Sinusitis 38.30 9.32 249 122424 170309 50312142
Wound 38.20 9.32 130 122543 105664 50376787
Injection site reaction 38.06 9.32 39 122634 49993 50432458
Pedal pulse abnormal 37.75 9.32 14 122659 133 50482318
Alcoholism 36.98 9.32 31 122642 1589 50480862
Injection site erythema 36.92 9.32 79 122594 74857 50407594
Pericarditis 35.50 9.32 87 122586 78602 50403849
Arteriosclerosis coronary artery 35.16 9.32 65 122608 7571 50474880
Constipation 34.79 9.32 638 122035 185070 50297381
Salivary gland calculus 32.97 9.32 13 122660 148 50482303
Full blood count abnormal 32.95 9.32 128 122545 23260 50459191
Vomiting 32.82 9.32 1397 121276 459361 50023090
Large intestine polyp 32.00 9.32 61 122612 7271 50475180
Folliculitis 31.67 9.32 29 122644 39196 50443255
Blood calcium decreased 31.38 9.32 116 122557 20590 50461861
Feeding intolerance 31.15 9.32 18 122655 501 50481950
Hypokalaemia 30.96 9.32 338 122335 87654 50394797
Abdominal distension 30.41 9.32 290 122383 72613 50409838
Sputum purulent 29.69 9.32 22 122651 941 50481510
Weight increased 29.46 9.32 330 122343 201561 50280890
Muscle injury 29.30 9.32 28 122645 37083 50445368
Head banging 29.27 9.32 16 122657 399 50482052
Pruritus 29.03 9.32 498 122175 283070 50199381
Arthralgia 28.72 9.32 827 121846 437875 50044576
Urticaria 28.64 9.32 190 122483 129371 50353080
Victim of sexual abuse 28.46 9.32 17 122656 504 50481947
Peripheral swelling 28.34 9.32 341 122332 205595 50276856
Loss of personal independence in daily activities 28.15 9.32 82 122591 69968 50412483
Injection site swelling 28.05 9.32 36 122637 41737 50440714
Injection site pruritus 28.00 9.32 34 122639 40377 50442074
Crohn's disease 27.98 9.32 45 122628 4688 50477763
Arteriovenous fistula occlusion 27.81 9.32 15 122658 364 50482087
Calciphylaxis 27.55 9.32 33 122640 2605 50479846
Stress fracture 27.34 9.32 55 122618 6820 50475631
Product quality issue 27.14 9.32 21 122652 30837 50451614
Rheumatoid factor positive 26.75 9.32 50 122623 49809 50432642
Red blood cell sedimentation rate abnormal 26.45 9.32 4 122669 16339 50466112
Blood bilirubin increased 26.42 9.32 150 122523 31888 50450563
Cholelithiasis 26.36 9.32 170 122503 37803 50444648
Nasal obstruction 26.11 9.32 21 122652 1015 50481436
No adverse event 25.74 9.32 26 122647 33552 50448899
Product use issue 25.65 9.32 235 122438 149240 50333211
Neurologic neglect syndrome 25.51 9.32 24 122649 1434 50481017
Exposure during pregnancy 25.49 9.32 180 122493 120835 50361616
Injection site pain 25.46 9.32 161 122512 110863 50371588
Gastrointestinal disorder 25.42 9.32 130 122543 94326 50388125
Injection site bruising 25.40 9.32 31 122642 36737 50445714
Hypercalciuria 25.19 9.32 12 122661 222 50482229
Herpes zoster 24.86 9.32 88 122585 70698 50411753
Intestinal obstruction 24.78 9.32 128 122545 26255 50456196
Blue toe syndrome 24.16 9.32 14 122659 392 50482059
Condition aggravated 23.67 9.32 544 122129 296514 50185937
Secondary immunodeficiency 23.60 9.32 21 122652 1167 50481284
Colitis 23.47 9.32 167 122506 38362 50444089
Product use in unapproved indication 23.08 9.32 175 122498 115644 50366807
Substance abuse 22.74 9.32 38 122635 4086 50478365
Psychotic disorder 22.74 9.32 109 122564 21703 50460748
Post procedural diarrhoea 22.71 9.32 10 122663 153 50482298
Haemorrhoids 22.68 9.32 99 122574 18954 50463497
Duodenal ulcer perforation 22.53 9.32 48 122625 45563 50436888
Wrong technique in product usage process 22.29 9.32 65 122608 55445 50427006
Gastrointestinal toxicity 21.77 9.32 40 122633 4637 50477814
Hypoparathyroidism 21.59 9.32 15 122658 579 50481872
Throat clearing 21.50 9.32 20 122653 1178 50481273
Therapy interrupted 21.46 9.32 11 122662 20141 50462310
Multiple sclerosis relapse 21.40 9.32 45 122628 42919 50439532
Carotid artery thrombosis 21.25 9.32 22 122651 1477 50480974
Chemical submission 21.24 9.32 10 122663 180 50482271
Poisoning deliberate 21.08 9.32 54 122619 7858 50474593
Abdominal discomfort 20.82 9.32 416 122257 231225 50251226
Drug use disorder 20.66 9.32 31 122642 3041 50479410
Abdominal rigidity 20.62 9.32 23 122650 1681 50480770
Fanconi syndrome 20.45 9.32 19 122654 1117 50481334
Therapy cessation 20.10 9.32 20 122653 25991 50456460
Acquired haemophilia 20.04 9.32 17 122656 886 50481565
Myocarditis 19.91 9.32 53 122620 7894 50474557
Renal tubular necrosis 19.84 9.32 62 122611 10106 50472345
Lymph node palpable 19.84 9.32 8 122665 97 50482354
Hospitalisation 19.73 9.32 91 122582 67846 50414605
Impaired healing 19.38 9.32 95 122578 69691 50412760
Gonorrhoea 19.27 9.32 8 122665 105 50482346
Skin haemorrhage 19.25 9.32 48 122625 6870 50475581
Hypophosphataemia 18.98 9.32 54 122619 8360 50474091
Protein C increased 18.87 9.32 8 122665 111 50482340
Urine calcium/creatinine ratio increased 18.81 9.32 8 122665 112 50482339
Peripheral pulse decreased 18.70 9.32 6 122667 35 50482416
Hip fracture 18.56 9.32 117 122556 25814 50456637
Multiple drug therapy 18.24 9.32 23 122650 1914 50480537
Red blood cell sedimentation rate increased 18.09 9.32 27 122646 29389 50453062
Dyspnoea 18.00 9.32 1116 121557 546492 49935959
Hepatic enzyme increased 17.94 9.32 230 122443 137150 50345301
Adjustment disorder 17.49 9.32 23 122650 1996 50480455
Pregnancy 17.38 9.32 28 122645 29549 50452902
Heavy menstrual bleeding 17.27 9.32 8 122665 15529 50466922
Depressed level of consciousness 17.10 9.32 197 122476 51756 50430695
Injection site rash 16.97 9.32 9 122664 16168 50466283
Calcification metastatic 16.87 9.32 4 122669 5 50482446
Gastrointestinal sounds abnormal 16.82 9.32 31 122642 3603 50478848
Gluten sensitivity 16.72 9.32 12 122661 488 50481963
Drug resistance 16.60 9.32 13 122660 18976 50463475
Metamyelocyte count increased 16.55 9.32 9 122664 222 50482229
Eating disorder 16.06 9.32 77 122596 15332 50467119
Rib deformity 16.01 9.32 8 122665 165 50482286
Pulmonary toxicity 15.91 9.32 39 122634 5523 50476928
Vaginal flatulence 15.82 9.32 9 122664 243 50482208
Intentional self-injury 15.75 9.32 103 122570 23009 50459442
Gastric dilatation 15.72 9.32 14 122659 779 50481672
Mydriasis 15.66 9.32 59 122614 10568 50471883
Osteomalacia 15.63 9.32 13 122660 659 50481792
Acute respiratory failure 15.40 9.32 121 122552 28661 50453790
Migraine 15.35 9.32 113 122560 75167 50407284
Anaphylactic reaction 15.34 9.32 73 122600 53982 50428469
Pathological fracture 15.14 9.32 47 122626 7635 50474816
Fracture pain 15.01 9.32 10 122663 360 50482091
Musculoskeletal disorder 15.01 9.32 12 122661 17337 50465114
Rhinorrhoea 14.97 9.32 191 122482 51392 50431059
Myelosuppression 14.97 9.32 7 122666 13510 50468941
Homicide 14.96 9.32 10 122663 362 50482089
Blood potassium decreased 14.92 9.32 146 122527 36799 50445652
Substance dependence 14.76 9.32 8 122665 196 50482255
Low turnover osteopathy 14.76 9.32 31 122642 3963 50478488
Loss of consciousness 14.74 9.32 344 122329 104009 50378442
Amnesia 14.70 9.32 162 122511 42098 50440353
Nephroangiosclerosis 14.62 9.32 7 122666 131 50482320
Noninfectious peritonitis 14.43 9.32 7 122666 135 50482316
Intestinal fibrosis 14.38 9.32 7 122666 136 50482315
Hypermagnesaemia 14.29 9.32 14 122659 880 50481571
Hyperparathyroidism secondary 14.28 9.32 17 122656 1333 50481118
Therapeutic reaction time decreased 14.26 9.32 17 122656 1335 50481116
Alcoholic 14.23 9.32 5 122668 40 50482411
Drug eruption 14.20 9.32 22 122651 23584 50458867
Tenosynovitis 14.19 9.32 4 122669 10561 50471890
Femur fracture 14.14 9.32 146 122527 37318 50445133
Blood calcium increased 14.09 9.32 46 122627 7673 50474778
Myocardial infarction 13.98 9.32 143 122530 88884 50393567
Decreased appetite 13.97 9.32 608 122065 200315 50282136
Hepatocellular injury 13.94 9.32 26 122647 25921 50456530
Unresponsive to stimuli 13.89 9.32 124 122549 30485 50451966
Induced abortion failed 13.71 9.32 8 122665 227 50482224
Poliomyelitis 13.53 9.32 5 122668 47 50482404
Frequent bowel movements 13.40 9.32 68 122605 13850 50468601
Spinal cord injury lumbar 13.35 9.32 5 122668 49 50482402
Abortion spontaneous 13.32 9.32 54 122619 41718 50440733
Hypomagnesaemia 13.31 9.32 99 122574 23057 50459394
Personality disorder 13.10 9.32 31 122642 4293 50478158
Sneezing 13.09 9.32 68 122605 13976 50468475
Skin necrosis 13.04 9.32 5 122668 10862 50471589
Myelocyte count increased 13.03 9.32 9 122664 344 50482107
Bone erosion 13.02 9.32 6 122667 11681 50470770
Periarticular disorder 13.00 9.32 5 122668 53 50482398
Device difficult to use 12.81 9.32 4 122669 9882 50472569
Postmortem blood drug level 12.69 9.32 6 122667 109 50482342
Oncocytoma 12.67 9.32 4 122669 22 50482429
Device issue 12.61 9.32 18 122655 19954 50462497
Sinus congestion 12.58 9.32 67 122606 13904 50468547
Coronary artery disease 12.53 9.32 34 122639 29692 50452759
Weight decreased 12.52 9.32 656 122017 220589 50261862
Blood ethanol increased 12.50 9.32 6 122667 113 50482338
Spinal compression fracture 12.30 9.32 62 122611 12594 50469857
Metabolic alkalosis 12.27 9.32 23 122650 2708 50479743
Mental status changes 12.14 9.32 138 122535 36134 50446317
Breath sounds abnormal 12.10 9.32 44 122629 7748 50474703
Anti-erythropoietin antibody positive 12.08 9.32 9 122664 388 50482063
Screaming 12.05 9.32 24 122649 2954 50479497
Psoriasis 12.04 9.32 108 122565 68892 50413559
Blood urea increased 11.99 9.32 98 122575 23487 50458964
Angioedema 11.83 9.32 49 122624 37627 50444824
Arthritis 11.76 9.32 144 122529 86577 50395874
Failure to thrive 11.71 9.32 38 122635 6320 50476131
Malabsorption 11.70 9.32 27 122646 3679 50478772
Congenital knee deformity 11.69 9.32 5 122668 71 50482380
Duodenitis 11.65 9.32 25 122648 3243 50479208
Pancreatitis chronic 11.64 9.32 20 122653 2200 50480251
Premature delivery 11.60 9.32 25 122648 23638 50458813
Congenital umbilical hernia 11.60 9.32 8 122665 305 50482146
Oesophagogastric fundoplasty 11.50 9.32 5 122668 74 50482377
Inappropriate antidiuretic hormone secretion 11.49 9.32 9 122664 13134 50469317
Ear infection 11.48 9.32 29 122644 25941 50456510
Amputation 11.45 9.32 6 122667 137 50482314
Aggression 11.42 9.32 89 122584 21027 50461424
Blood creatinine increased 11.36 9.32 253 122420 75907 50406544
Type 2 diabetes mellitus 11.24 9.32 44 122629 34331 50448120
Bradycardia 11.17 9.32 101 122572 64325 50418126
Product storage error 11.16 9.32 8 122665 12216 50470235
Parathyroid gland enlargement 11.08 9.32 4 122669 35 50482416
Leukocytosis 11.04 9.32 93 122580 22486 50459965
Periorbital cellulitis 11.01 9.32 10 122663 571 50481880
Nephrogenic systemic fibrosis 11.00 9.32 29 122644 4293 50478158
Coordination abnormal 10.86 9.32 56 122617 11478 50470973
Skin exfoliation 10.86 9.32 127 122546 33485 50448966
Nasopharyngitis 10.80 9.32 371 122302 192556 50289895
Amphetamines positive 10.75 9.32 6 122667 156 50482295
Sialoadenitis 10.69 9.32 15 122658 1385 50481066
Arteriosclerosis 10.68 9.32 47 122626 9030 50473421
Hyperglycaemia 10.65 9.32 135 122538 36270 50446181
Cytomegalovirus infection 10.56 9.32 17 122656 17945 50464506
Drug dependence 10.53 9.32 83 122590 19676 50462775
Somnambulism 10.52 9.32 31 122642 4893 50477558
Jaundice acholuric 10.52 9.32 5 122668 92 50482359
Conjunctival discolouration 10.52 9.32 4 122669 41 50482410
Product communication issue 10.48 9.32 8 122665 358 50482093
Pharyngo-oesophageal diverticulum 10.48 9.32 3 122670 11 50482440
Knee arthroplasty 10.41 9.32 48 122625 35798 50446653
Renal tubular dysfunction 10.35 9.32 8 122665 365 50482086
Self-injurious ideation 10.30 9.32 19 122654 2210 50480241
Liver function test increased 10.26 9.32 30 122643 25576 50456875
Obstructive airways disorder 10.21 9.32 69 122604 15583 50466868
Device malfunction 10.18 9.32 13 122660 15108 50467343
Sciatica 10.15 9.32 23 122650 21359 50461092
Respiratory tract congestion 10.12 9.32 64 122609 14135 50468316
Pneumothorax spontaneous 9.98 9.32 10 122663 646 50481805
Congestive hepatopathy 9.97 9.32 20 122653 2474 50479977
Bronchopulmonary aspergillosis 9.96 9.32 3 122670 7589 50474862
Blood ethanol 9.96 9.32 4 122669 48 50482403
White blood cell count decreased 9.92 9.32 361 122312 116361 50366090
Injection site urticaria 9.90 9.32 9 122664 12208 50470243
Orthostatic intolerance 9.83 9.32 12 122661 966 50481485
Gastrointestinal stoma complication 9.82 9.32 15 122658 1495 50480956
Obstruction 9.76 9.32 18 122655 2093 50480358
Adverse event 9.75 9.32 64 122609 43699 50438752
Lip discolouration 9.73 9.32 9 122664 526 50481925
Clostridium difficile colitis 9.72 9.32 75 122598 17667 50464784
Leiomyoma 9.71 9.32 8 122665 400 50482051
Surgery 9.66 9.32 39 122634 30166 50452285
Neurogenic bowel 9.36 9.32 5 122668 119 50482332

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
Drug abuse 2125.60 10.17 1701 73822 78182 29420822
Completed suicide 1673.30 10.17 1564 73959 88682 29410322
Toxicity to various agents 1294.23 10.17 1881 73642 171780 29327224
Cardio-respiratory arrest 359.71 10.17 538 74985 50063 29448941
Intentional overdose 337.95 10.17 453 75070 38075 29460929
Alcohol abuse 324.96 10.17 177 75346 4156 29494848
Alcohol interaction 315.77 10.17 149 75374 2554 29496450
Overdose 215.74 10.17 565 74958 79254 29419750
Suspected suicide 205.33 10.17 128 75395 3892 29495112
Drug ineffective 184.54 10.17 410 75113 362760 29136244
Intentional product misuse 181.42 10.17 321 75202 34340 29464664
Milk-alkali syndrome 177.42 10.17 62 75461 460 29498544
Suicide attempt 176.08 10.17 314 75209 33796 29465208
Alcohol poisoning 154.35 10.17 97 75426 2992 29496012
Substance abuse 137.41 10.17 124 75399 6663 29492341
Drug dependence 114.53 10.17 198 75325 20783 29478221
Alcohol use 92.05 10.17 71 75452 3061 29495943
Exposure to toxic agent 68.41 10.17 55 75468 2520 29496484
Off label use 66.86 10.17 472 75051 300328 29198676
Blood alcohol increased 63.70 10.17 33 75490 697 29498307
Respiratory arrest 56.97 10.17 170 75353 25663 29473341
Myocardial infarction 56.92 10.17 123 75400 110173 29388831
Respiratory depression 55.53 10.17 113 75410 13410 29485594
Product use in unapproved indication 55.43 10.17 85 75438 86790 29412214
Asphyxia 55.17 10.17 68 75455 5247 29493757
Hypercalcaemia 52.85 10.17 107 75416 12652 29486352
Poisoning deliberate 52.65 10.17 69 75454 5662 29493342
Blood mercury abnormal 49.59 10.17 19 75504 188 29498816
5-hydroxyindolacetic acid in urine increased 47.49 10.17 19 75504 213 29498791
Coma 46.56 10.17 212 75311 39238 29459766
Calciphylaxis 41.31 10.17 28 75495 984 29498020
Intentional product use issue 41.27 10.17 216 75307 42282 29456722
Aggression 41.20 10.17 190 75333 35351 29463653
Cardiac arrest 40.37 10.17 364 75159 85227 29413777
Treatment failure 40.34 10.17 22 75501 36917 29462087
Diarrhoea 39.01 10.17 1118 74405 331580 29167424
Incorrect route of product administration 37.15 10.17 84 75439 10717 29488287
Drug hypersensitivity 36.34 10.17 75 75448 68331 29430673
Alcohol withdrawal syndrome 35.78 10.17 29 75494 1344 29497660
Product dose omission issue 33.88 10.17 129 75394 96254 29402750
Drug resistance 33.59 10.17 7 75516 21533 29477471
Granulomatous pneumonitis 32.10 10.17 9 75514 28 29498976
Alcohol intolerance 32.03 10.17 17 75506 378 29498626
Small intestinal obstruction 31.73 10.17 89 75434 12972 29486032
Dehydration 29.63 10.17 434 75089 114314 29384690
Ex-drug abuser 29.41 10.17 12 75511 142 29498862
Pouchitis 27.53 10.17 18 75505 595 29498409
Hyperparathyroidism secondary 27.20 10.17 24 75499 1251 29497753
Therapeutic product effect decreased 26.18 10.17 22 75501 29429 29469575
Interstitial lung disease 26.06 10.17 69 75454 57649 29441355
Hypocalcaemia 25.84 10.17 113 75410 20552 29478452
Hungry bone syndrome 25.73 10.17 9 75514 67 29498937
Intentional self-injury 25.59 10.17 80 75443 12381 29486623
Ileus 25.57 10.17 88 75435 14314 29484690
Low density lipoprotein decreased 25.44 10.17 21 75502 999 29498005
Drug withdrawal syndrome 25.34 10.17 102 75421 17882 29481122
Nephrogenic systemic fibrosis 23.89 10.17 39 75484 3903 29495101
Metabolic alkalosis 23.88 10.17 22 75501 1214 29497790
Poisoning 22.25 10.17 66 75457 9927 29489077
Blood parathyroid hormone increased 22.16 10.17 22 75501 1333 29497671
Growth hormone deficiency 21.82 10.17 11 75512 219 29498785
Drug intolerance 21.72 10.17 58 75465 48321 29450683
Calcinosis 21.42 10.17 16 75507 657 29498347
Methaemoglobinaemia 21.26 10.17 30 75493 2641 29496363
Atypical fracture 21.23 10.17 9 75514 118 29498886
Rheumatoid arthritis 20.93 10.17 31 75492 32121 29466883
Drug screen positive 20.90 10.17 36 75487 3765 29495239
Rash 20.55 10.17 351 75172 189468 29309536
Accidental death 20.23 10.17 26 75497 2092 29496912
Open reduction of fracture 20.13 10.17 8 75515 88 29498916
Enterocolitis bacterial 20.12 10.17 11 75512 260 29498744
Foetal alcohol syndrome 20.09 10.17 9 75514 136 29498868
Alcoholism 19.88 10.17 29 75494 2632 29496372
Joint swelling 19.73 10.17 63 75460 49567 29449437
Hypophosphatasia 19.68 10.17 6 75517 27 29498977
Enterocolonic fistula 19.51 10.17 8 75515 96 29498908
Condition aggravated 19.43 10.17 260 75263 146035 29352969
Nasal polyps 18.95 10.17 23 75500 1746 29497258
Angioedema 18.68 10.17 33 75490 31882 29467122
Gastrointestinal obstruction 18.62 10.17 15 75508 689 29498315
Haematopoietic stem cell mobilisation 18.57 10.17 9 75514 164 29498840
Abdominal distension 18.53 10.17 189 75334 45722 29453282
Mydriasis 18.39 10.17 45 75478 6040 29492964
Drug use disorder 18.28 10.17 32 75491 3390 29495614
Hepatic fibrosis 18.14 10.17 31 75492 3221 29495783
N-telopeptide urine increased 18.12 10.17 6 75517 37 29498967
Product prescribing error 17.81 10.17 12 75511 17964 29481040
Anaphylactic reaction 17.54 10.17 27 75496 27546 29471458
Intestinal obstruction 17.36 10.17 96 75427 19181 29479823
Renal impairment 17.30 10.17 129 75394 81204 29417800
Foetal exposure during pregnancy 17.25 10.17 38 75485 33829 29465175
Red blood cell count decreased 17.08 10.17 118 75405 25484 29473520
Impaired driving ability 16.83 10.17 25 75498 2306 29496698
Chest pain 16.74 10.17 194 75329 111779 29387225
Drug reaction with eosinophilia and systemic symptoms 16.33 10.17 29 75494 27963 29471041
Antineutrophil cytoplasmic antibody positive 16.12 10.17 13 75510 598 29498406
Miosis 16.06 10.17 51 75472 7958 29491046
Renal tubular dysfunction 15.85 10.17 11 75512 402 29498602
Cardiac failure 15.81 10.17 128 75395 79159 29419845
Contraindicated product administered 15.80 10.17 14 75509 18252 29480752
Colitis 15.80 10.17 135 75388 31113 29467891
Electrocardiogram QT prolonged 15.66 10.17 151 75372 35986 29463018
Accident at work 15.56 10.17 13 75510 629 29498375
Hepatic neoplasm 15.18 10.17 21 75502 1815 29497189
Dextrocardia 15.15 10.17 7 75516 114 29498890
Bone density decreased 15.08 10.17 20 75503 1660 29497344
Homicide 15.05 10.17 15 75508 913 29498091
Coronary artery disease 14.96 10.17 60 75463 44130 29454874
Nerve degeneration 14.95 10.17 8 75515 181 29498823
Urogenital fistula 14.92 10.17 3 75520 0 29499004
Drug ineffective for unapproved indication 14.75 10.17 9 75514 14205 29484799
Weight increased 14.73 10.17 125 75398 76542 29422462
Crohn's disease 14.62 10.17 27 75496 2982 29496022
Blood 25-hydroxycholecalciferol decreased 14.48 10.17 6 75517 74 29498930
Abscess intestinal 14.33 10.17 18 75505 1416 29497588
Fatty liver alcoholic 14.27 10.17 6 75517 77 29498927
Myelosuppression 13.76 10.17 7 75516 12220 29486784
Arrhythmia 13.70 10.17 38 75485 31275 29467729
Substance-induced mood disorder 13.68 10.17 6 75517 86 29498918
Sensorimotor disorder 13.64 10.17 10 75513 399 29498605
Opiates positive 13.55 10.17 11 75512 511 29498493
Gastrointestinal sounds abnormal 13.54 10.17 20 75503 1836 29497168
SARS-CoV-2 antibody test positive 13.38 10.17 8 75515 225 29498779
Myocardial fibrosis 13.30 10.17 15 75508 1053 29497951
Mean cell haemoglobin 13.12 10.17 4 75519 18 29498986
Physical assault 13.12 10.17 15 75508 1069 29497935
Bilirubin conjugated abnormal 13.08 10.17 6 75517 96 29498908
Injection site erythema 12.94 10.17 10 75513 13946 29485058
Eosinophilia 12.89 10.17 23 75500 22138 29476866
Macrognathia 12.85 10.17 3 75520 3 29499001
Systemic inflammatory response syndrome 12.84 10.17 39 75484 5942 29493062
Blood immunoglobulin E increased 12.81 10.17 20 75503 1927 29497077
Femur fracture 12.66 10.17 43 75480 6948 29492056
Synovitis 12.61 10.17 6 75517 10884 29488120
Erythema 12.49 10.17 128 75395 75478 29423526
Blood albumin decreased 12.44 10.17 61 75462 11634 29487370
Metabolic acidosis 12.42 10.17 149 75374 37513 29461491
Injection site pain 12.33 10.17 42 75481 32404 29466600
Therapeutic product effect incomplete 12.30 10.17 55 75468 39250 29459754
Rectal prolapse 12.27 10.17 8 75515 263 29498741
Type 2 diabetes mellitus 12.25 10.17 10 75513 13571 29485433
Disorientation 12.14 10.17 122 75401 29393 29469611
Headache 12.11 10.17 345 75178 173662 29325342
Arthralgia 12.09 10.17 268 75255 139349 29359655
Blood ethanol increased 12.02 10.17 10 75513 481 29498523
Musculoskeletal stiffness 11.97 10.17 52 75471 37406 29461598
Chronic sinusitis 11.85 10.17 18 75505 1693 29497311
Lower respiratory tract infection 11.72 10.17 32 75491 26470 29472534
Acute myocardial infarction 11.69 10.17 74 75449 48364 29450640
Calcification metastatic 11.64 10.17 3 75520 6 29498998
Sopor 11.61 10.17 57 75466 10877 29488127
Amnesia 11.54 10.17 98 75425 22545 29476459
Renal cyst haemorrhage 11.51 10.17 9 75514 396 29498608
Necrotising ulcerative gingivostomatitis 11.50 10.17 5 75518 70 29498934
Abdominal pain 11.42 10.17 438 75085 134919 29364085
Psoriasis 11.39 10.17 43 75480 32184 29466820
Acrochordon 11.34 10.17 8 75515 300 29498704
Respiratory symptom 11.30 10.17 13 75510 933 29498071
Blood ethanol 11.25 10.17 5 75518 74 29498930
Drug abuser 11.25 10.17 28 75495 3799 29495205
Frequent bowel movements 11.15 10.17 50 75473 9189 29489815
Road traffic accident 11.14 10.17 73 75450 15488 29483516
Neuroleptic malignant syndrome 11.07 10.17 15 75508 16133 29482871
Haematocrit decreased 11.01 10.17 118 75405 28904 29470100
Rash maculo-papular 10.99 10.17 29 75494 24260 29474744
Premature baby 10.92 10.17 17 75506 17263 29481741
Medication error 10.91 10.17 92 75431 21119 29477885
Alcoholic liver disease 10.88 10.17 10 75513 550 29498454
Blood potassium decreased 10.78 10.17 73 75450 15661 29483343
Thrombocytopenia 10.77 10.17 262 75261 134561 29364443
Withdrawal syndrome 10.75 10.17 56 75467 10936 29488068
Pain in extremity 10.73 10.17 208 75315 110225 29388779
Therapy interrupted 10.71 10.17 4 75519 8382 29490622
Intraductal papillary mucinous neoplasm 10.63 10.17 8 75515 332 29498672
Dyspnoea 10.53 10.17 706 74817 326026 29172978
Central nervous system mass 10.47 10.17 5 75518 88 29498916
Colitis ulcerative 10.45 10.17 62 75461 12707 29486297
Psychiatric disorder prophylaxis 10.40 10.17 4 75519 40 29498964
Muscle swelling 10.39 10.17 8 75515 344 29498660
Proctalgia 10.38 10.17 29 75494 4216 29494788
Tachycardia 10.34 10.17 250 75273 72160 29426844
Abdominal wall haemorrhage 10.25 10.17 7 75516 249 29498755

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
Completed suicide 3503.49 9.46 3486 155939 220928 64118379
Drug abuse 2507.08 9.46 2291 157134 130083 64209224
Toxicity to various agents 2165.44 9.46 3490 155935 360023 63979284
Cardio-respiratory arrest 744.28 9.46 1059 158366 97334 64241973
Intentional overdose 510.82 9.46 848 158577 89096 64250211
Alcohol interaction 482.83 9.46 230 159195 4171 64335136
Milk-alkali syndrome 478.04 9.46 159 159266 1034 64338273
Drug ineffective 410.38 9.46 922 158503 839325 63499982
Suspected suicide 352.14 9.46 236 159189 8418 64330889
Overdose 343.86 9.46 1019 158406 158547 64180760
Alcohol abuse 322.35 9.46 181 159244 4671 64334636
Alcohol poisoning 227.81 9.46 138 159287 4117 64335190
Suicide attempt 214.17 9.46 514 158911 70493 64268814
Intentional product misuse 213.43 9.46 519 158906 71776 64267531
Coma 177.67 9.46 548 158877 87067 64252240
Alcohol use 162.46 9.46 115 159310 4487 64334820
Respiratory arrest 136.17 9.46 361 159064 52624 64286683
Substance abuse 120.09 9.46 131 159294 9161 64330146
Off label use 116.02 9.46 1004 158421 631802 63707505
Hypercalcaemia 114.25 9.46 245 159180 31171 64308136
Exposure to toxic agent 113.02 9.46 105 159320 6054 64333253
Hypocalcaemia 110.87 9.46 288 159137 41465 64297842
Asphyxia 110.17 9.46 127 159298 9439 64329868
Drug hypersensitivity 108.08 9.46 270 159155 237545 64101762
Drug dependence 102.40 9.46 243 159182 33069 64306238
Blood alcohol increased 92.09 9.46 49 159376 1133 64338174
Pneumonia aspiration 86.22 9.46 332 159093 58939 64280368
Therapeutic product effect decreased 85.83 9.46 95 159330 115256 64224051
Contraindicated product administered 83.35 9.46 86 159339 107743 64231564
Treatment failure 80.71 9.46 102 159323 116714 64222593
Infusion related reaction 80.04 9.46 180 159245 164287 64175020
Cardiac arrest 79.65 9.46 652 158773 153412 64185895
Product dose omission issue 77.34 9.46 236 159189 194511 64144796
Methaemoglobinaemia 75.71 9.46 72 159353 4276 64335031
Rheumatoid arthritis 72.69 9.46 189 159236 164105 64175202
Hypomania 68.39 9.46 77 159348 5577 64333730
Small intestinal obstruction 66.10 9.46 166 159259 23407 64315900
Arthropathy 65.08 9.46 125 159300 120842 64218465
Drug intolerance 64.95 9.46 242 159183 187750 64151557
Poisoning deliberate 64.70 9.46 118 159307 13340 64325967
Diarrhoea 64.69 9.46 2285 157140 720419 63618888
Myocardial infarction 64.37 9.46 203 159222 165618 64173689
Somnolence 64.36 9.46 778 158647 202867 64136440
Schizophrenia 61.57 9.46 104 159321 11064 64328243
Dehydration 60.80 9.46 810 158615 215953 64123354
Nephrocalcinosis 60.65 9.46 39 159386 1295 64338012
Product use in unapproved indication 57.39 9.46 233 159192 176385 64162922
Calciphylaxis 56.06 9.46 54 159371 3258 64336049
Gastrooesophageal reflux disease 55.54 9.46 374 159051 82769 64256538
Joint swelling 53.28 9.46 313 159112 215069 64124238
Sleep disorder due to general medical condition, insomnia type 52.72 9.46 3 159422 26267 64313040
Recalled product 52.29 9.46 31 159394 888 64338419
Blood mercury abnormal 50.19 9.46 19 159406 188 64339119
Rash 49.95 9.46 815 158610 457734 63881573
Hand deformity 49.71 9.46 49 159376 62722 64276585
Synovitis 49.38 9.46 107 159318 98983 64240324
Drug resistance 49.10 9.46 13 159412 35089 64304218
Pain 49.00 9.46 1020 158405 552491 63786816
Headache 48.86 9.46 969 158456 528498 63810809
Postmortem blood drug level abnormal 48.10 9.46 26 159399 621 64338686
5-hydroxyindolacetic acid in urine increased 47.93 9.46 19 159406 215 64339092
Pemphigus 47.37 9.46 48 159377 60653 64278654
Infection 47.15 9.46 266 159159 184614 64154693
Jaundice cholestatic 46.82 9.46 80 159345 8590 64330717
Systemic lupus erythematosus 42.79 9.46 79 159346 77533 64261774
Injection site erythema 42.76 9.46 68 159357 70732 64268575
Lower respiratory tract infection 41.70 9.46 109 159316 94505 64244802
Anti-cyclic citrullinated peptide antibody positive 41.23 9.46 37 159388 49525 64289782
Calcium ionised decreased 41.06 9.46 22 159403 516 64338791
Abdominal pain 40.03 9.46 1033 158392 311342 64027965
Maternal exposure during pregnancy 38.89 9.46 115 159310 95769 64243538
Hypersensitivity 38.38 9.46 306 159119 196146 64143161
Injection site bruising 38.38 9.46 21 159404 36352 64302955
Segmental diverticular colitis 38.25 9.46 14 159411 125 64339182
Anaphylactic reaction 37.76 9.46 70 159355 68594 64270713
Incorrect route of product administration 37.62 9.46 135 159290 23163 64316144
Feeding intolerance 37.08 9.46 21 159404 551 64338756
Hypophosphataemic osteomalacia 36.83 9.46 17 159408 286 64339021
Arthralgia 36.76 9.46 823 158602 441437 63897870
Liver injury 36.65 9.46 159 159266 29773 64309534
Pedal pulse abnormal 36.42 9.46 14 159411 145 64339162
Weight increased 36.06 9.46 345 159080 213003 64126304
Drug use disorder 35.55 9.46 58 159367 5996 64333311
Vomiting 35.44 9.46 1683 157742 549434 63789873
Alcoholism 35.43 9.46 43 159382 3374 64335933
Injection site pain 34.91 9.46 149 159276 111259 64228048
Gastrointestinal disorder 34.67 9.46 110 159315 89599 64249708
Intentional self-injury 34.59 9.46 153 159272 28891 64310416
Aggression 34.56 9.46 214 159211 46018 64293289
Condition aggravated 34.17 9.46 682 158743 371744 63967563
Tetany 34.13 9.46 34 159391 2138 64337169
Injection site reaction 34.07 9.46 39 159386 46625 64292682
Swelling 33.92 9.46 244 159181 159974 64179333
Peripheral swelling 33.35 9.46 343 159082 208810 64130497
Device expulsion 33.27 9.46 6 159419 21130 64318177
Blood calcium decreased 33.03 9.46 138 159287 25416 64313891
Myelosuppression 33.00 9.46 9 159416 23821 64315486
Sinusitis 32.99 9.46 218 159207 145710 64193597
Abdominal distension 32.61 9.46 372 159053 95622 64243685
Metabolic alkalosis 32.20 9.46 44 159381 3884 64335423
Stress fracture 31.84 9.46 53 159372 5571 64333736
Angioedema 31.42 9.46 66 159359 61755 64277552
Nephrogenic systemic fibrosis 31.33 9.46 54 159371 5838 64333469
Arteriosclerosis coronary artery 31.32 9.46 97 159328 15432 64323875
Coronary artery disease 31.15 9.46 64 159361 60369 64278938
Granulomatous pneumonitis 30.60 9.46 10 159415 61 64339246
Hyperparathyroidism secondary 30.37 9.46 33 159392 2297 64337010
Alcohol withdrawal syndrome 29.77 9.46 29 159396 1774 64337533
Injection site swelling 29.72 9.46 35 159390 41318 64297989
Red blood cell sedimentation rate abnormal 29.52 9.46 3 159422 16303 64323004
Hepatotoxicity 29.26 9.46 184 159241 39778 64299529
Respiratory depression 29.06 9.46 125 159300 23318 64315989
Hungry bone syndrome 28.78 9.46 12 159413 156 64339151
Nicotine dependence 27.95 9.46 20 159405 794 64338513
Flatulence 27.87 9.46 167 159258 35499 64303808
Ill-defined disorder 27.85 9.46 41 159384 44011 64295296
Intentional product use issue 27.79 9.46 359 159066 95005 64244302
Glossodynia 27.40 9.46 76 159349 64620 64274687
Arteriovenous fistula occlusion 27.33 9.46 17 159408 532 64338775
Injection site pruritus 27.20 9.46 32 159393 37794 64301513
Abdominal rigidity 27.15 9.46 33 159392 2594 64336713
Low turnover osteopathy 27.02 9.46 28 159397 1845 64337462
Hepatocellular injury 26.79 9.46 44 159381 45191 64294116
Discomfort 26.69 9.46 106 159319 80772 64258535
Drug ineffective for unapproved indication 26.19 9.46 23 159402 31110 64308197
Cytomegalovirus infection 26.18 9.46 32 159393 37167 64302140
Urticaria 25.83 9.46 236 159189 147081 64192226
Drug reaction with eosinophilia and systemic symptoms 25.81 9.46 60 159365 54157 64285150
Dyspnoea 25.78 9.46 1484 157941 717190 63622117
Pouchitis 25.47 9.46 19 159406 805 64338502
Pruritus 25.45 9.46 583 158842 311817 64027490
Colitis 25.45 9.46 239 159186 58435 64280872
Gonorrhoea 25.34 9.46 11 159414 159 64339148
Product quality issue 25.08 9.46 22 159403 29777 64309530
Accidental death 25.08 9.46 38 159387 3687 64335620
Neurologic neglect syndrome 24.82 9.46 25 159400 1593 64337714
Low density lipoprotein decreased 24.82 9.46 21 159404 1069 64338238
Herpes zoster 24.75 9.46 106 159319 79081 64260226
Wrong technique in product usage process 24.18 9.46 81 159344 64893 64274414
Calcification metastatic 24.17 9.46 6 159419 10 64339297
Salivary gland calculus 24.12 9.46 12 159413 240 64339067
Mydriasis 24.11 9.46 88 159337 15224 64324083
Blood parathyroid hormone increased 24.04 9.46 34 159391 3100 64336207
Therapy cessation 23.88 9.46 27 159398 32462 64306845
Homicide 23.82 9.46 21 159404 1130 64338177
Renal impairment 23.80 9.46 216 159209 134801 64204506
Intestinal obstruction 23.49 9.46 162 159263 36124 64303183
Full blood count abnormal 23.04 9.46 139 159286 29618 64309689
Ileus 22.97 9.46 115 159310 22851 64316456
Gastrointestinal sounds abnormal 22.69 9.46 42 159383 4801 64334506
Blood ethanol increased 22.21 9.46 16 159409 642 64338665
Opiates positive 21.90 9.46 18 159407 880 64338427
Depressed level of consciousness 21.84 9.46 302 159123 81134 64258173
Product prescribing error 21.17 9.46 34 159391 35235 64304072
Throat clearing 21.13 9.46 21 159404 1317 64337990
Failure to thrive 20.99 9.46 65 159360 10339 64328968
Blood ethanol 20.99 9.46 9 159416 126 64339181
Head banging 20.92 9.46 14 159411 498 64338809
Alopecia 20.90 9.46 286 159139 165404 64173903
Nasal obstruction 20.85 9.46 21 159404 1338 64337969
Red blood cell sedimentation rate increased 20.81 9.46 28 159397 31207 64308100
Sputum purulent 20.77 9.46 20 159405 1206 64338101
Drug eruption 20.62 9.46 36 159389 36100 64303207
Therapy interrupted 20.52 9.46 12 159413 20024 64319283
Hypokalaemia 20.51 9.46 419 159006 121484 64217823
Death 20.13 9.46 1418 158007 481287 63858020
Femur fracture 20.12 9.46 149 159276 33986 64305321
Cholelithiasis 19.55 9.46 185 159240 45321 64293986
Therapeutic reaction time decreased 19.53 9.46 24 159401 1908 64337399
Hypophosphataemia 19.42 9.46 80 159345 14640 64324667
Muscle injury 19.40 9.46 22 159403 26415 64312892
Blue toe syndrome 19.38 9.46 14 159411 564 64338743
Chemical submission 19.33 9.46 10 159415 218 64339089
Psychotic disorder 19.30 9.46 149 159276 34429 64304878
Open reduction of fracture 19.24 9.46 10 159415 220 64339087
Substance dependence 19.07 9.46 13 159412 477 64338830
Alcohol intolerance 19 9.46 12 159413 386 64338921
Obstruction 18.91 9.46 31 159394 3217 64336090
Nephroangiosclerosis 18.91 9.46 11 159414 304 64339003
Amphetamines positive 18.80 9.46 10 159415 231 64339076
Poisoning 18.76 9.46 105 159320 21774 64317533
Victim of sexual abuse 18.75 9.46 12 159413 395 64338912
Pericarditis 18.74 9.46 85 159340 62431 64276876
Multiple sclerosis relapse 18.42 9.46 47 159378 41088 64298219
Impaired healing 18.26 9.46 82 159343 60391 64278916
Blood potassium decreased 18.24 9.46 166 159259 40233 64299074
Neuroleptic malignant syndrome 18.13 9.46 21 159404 24975 64314332
Hypophosphatasia 18.04 9.46 6 159419 39 64339268
Postmortem blood drug level 17.88 9.46 10 159415 256 64339051
Frequent bowel movements 17.84 9.46 91 159334 18214 64321093
Growth hormone deficiency 17.81 9.46 11 159414 340 64338967
N-telopeptide urine increased 17.78 9.46 6 159419 41 64339266
Cardiac failure congestive 17.71 9.46 222 159203 130358 64208949
Carotid artery thrombosis 17.66 9.46 22 159403 1773 64337534
Haematotoxicity 17.62 9.46 5 159420 12891 64326416
Cardiac failure 17.60 9.46 226 159199 132147 64207160
Erythema 17.59 9.46 341 159084 186729 64152578
Enterocolonic fistula 17.31 9.46 8 159417 135 64339172
Rheumatoid factor positive 17.17 9.46 38 159387 34900 64304407
Urine calcium/creatinine ratio increased 17.05 9.46 8 159417 140 64339167
Inappropriate antidiuretic hormone secretion 16.96 9.46 18 159407 22271 64317036
Haematopoietic stem cell mobilisation 16.96 9.46 9 159416 207 64339100
Bone erosion 16.79 9.46 4 159421 11591 64327716
Product storage error 16.71 9.46 6 159419 13312 64325995
Arthritis 16.61 9.46 130 159295 83684 64255623
Lymph node palpable 16.60 9.46 8 159417 149 64339158
Exposure during pregnancy 16.57 9.46 118 159307 77557 64261750
Nasal polyps 16.42 9.46 31 159394 3598 64335709
Bone marrow failure 16.36 9.46 62 159363 47890 64291417
Abortion spontaneous 16.29 9.46 23 159402 25120 64314187
Hepatic neoplasm 16.10 9.46 28 159397 3049 64336258
Interstitial lung disease 16.09 9.46 159 159266 97573 64241734
Hypoparathyroidism 16.04 9.46 15 159410 872 64338435
Loss of personal independence in daily activities 15.98 9.46 109 159316 72345 64266962
Protein C increased 15.95 9.46 7 159418 104 64339203
Adjustment disorder 15.71 9.46 26 159399 2719 64336588
Pregnancy 15.71 9.46 17 159408 20848 64318459
Hyperphosphataemia 15.58 9.46 32 159393 3949 64335358
Hepatic fibrosis 15.46 9.46 39 159386 5513 64333794
Venoocclusive liver disease 15.43 9.46 3 159422 10012 64329295
Folliculitis 15.37 9.46 32 159393 30045 64309262
Toxicologic test abnormal 15.36 9.46 17 159408 1208 64338099
Musculoskeletal disorder 15.34 9.46 13 159412 17893 64321414
Injection site rash 15.33 9.46 10 159415 15732 64323575
Gluten sensitivity 15.31 9.46 10 159415 341 64338966
Pathological fracture 15.24 9.46 53 159372 8952 64330355
Autoimmune colitis 15.24 9.46 18 159407 1373 64337934
Multiple drug therapy 15.18 9.46 23 159402 2231 64337076
Large intestine polyp 15.18 9.46 60 159365 10777 64328530
Hypermagnesaemia 15.11 9.46 16 159409 1081 64338226
Hepatic function abnormal 15.07 9.46 95 159330 64218 64275089
Rib deformity 14.99 9.46 7 159418 121 64339186
Fracture pain 14.98 9.46 10 159415 354 64338953
Haemorrhoids 14.86 9.46 106 159319 23895 64315412
Blood bilirubin increased 14.85 9.46 212 159213 57341 64281966
Hospitalisation 14.74 9.46 117 159308 75090 64264217
Acquired haemophilia 14.59 9.46 19 159406 1601 64337706
Wound 14.52 9.46 120 159305 76357 64262950
Labelled drug-drug interaction medication error 14.48 9.46 20 159405 22042 64317265
Red blood cell count decreased 14.45 9.46 183 159242 48203 64291104
Post transplant lymphoproliferative disorder 14.41 9.46 3 159422 9541 64329766
Enterocolitis bacterial 14.40 9.46 11 159414 483 64338824
Peripheral pulse decreased 14.36 9.46 5 159420 38 64339269
Chest pain 14.35 9.46 459 158966 235521 64103786
Rhinorrhoea 14.34 9.46 218 159207 59751 64279556
Neuralgia 14.12 9.46 27 159398 26157 64313150
Liver disorder 14.00 9.46 76 159349 53275 64286032
C-reactive protein abnormal 13.94 9.46 32 159393 29015 64310292
Amnesia 13.76 9.46 181 159244 48088 64291219
Musculoskeletal stiffness 13.68 9.46 218 159207 122988 64216319
Miosis 13.67 9.46 67 159358 13199 64326108
Electrocardiogram QT prolonged 13.66 9.46 274 159151 79174 64260133
Atypical fracture 13.64 9.46 12 159413 644 64338663
Hip fracture 13.61 9.46 114 159311 26985 64312322
Device issue 13.44 9.46 22 159403 22626 64316681
Acute graft versus host disease 13.42 9.46 3 159422 9081 64330226
Drug abuser 13.35 9.46 38 159387 5770 64333537
Poliomyelitis 13.34 9.46 5 159420 48 64339259
Skin haemorrhage 13.23 9.46 49 159376 8536 64330771
Bilirubin conjugated abnormal 13.16 9.46 6 159419 98 64339209
Compartment syndrome 13.14 9.46 31 159394 4201 64335106
SARS-CoV-2 antibody test positive 13.13 9.46 8 159417 241 64339066
Personality disorder 13.02 9.46 33 159392 4678 64334629
Device difficult to use 13.02 9.46 4 159421 9794 64329513
Duodenal ulcer perforation 12.99 9.46 43 159382 34582 64304725
Malaise 12.95 9.46 825 158600 395422 63943885
Sinus tachycardia 12.91 9.46 129 159296 32059 64307248
Therapeutic product effect incomplete 12.91 9.46 179 159246 103303 64236004
Fracture nonunion 12.90 9.46 17 159408 1449 64337858
Device related infection 12.90 9.46 124 159301 30502 64308805
Tibia fracture 12.87 9.46 33 159392 4712 64334595
Electrocardiogram QRS complex prolonged 12.80 9.46 51 159374 9193 64330114
Hepatic enzyme increased 12.79 9.46 235 159190 129708 64209599
Cerebral infarction 12.78 9.46 55 159370 40989 64298318
Congenital knee deformity 12.74 9.46 4 159421 21 64339286
Cerebral haemorrhage 12.74 9.46 74 159351 51016 64288291
Heavy menstrual bleeding 12.70 9.46 7 159418 12070 64327237
Tendonitis 12.70 9.46 19 159406 20263 64319044
Drug screen positive 12.70 9.46 37 159388 5692 64333615
Sleep disorder due to a general medical condition 12.69 9.46 47 159378 8187 64331120
Substance use disorder 12.56 9.46 9 159416 358 64338949
Blood calcium increased 12.54 9.46 48 159377 8494 64330813
Migraine 12.52 9.46 97 159328 62580 64276727
Nerve degeneration 12.51 9.46 8 159417 263 64339044
Angina pectoris 12.51 9.46 63 159362 45018 64294289
Spinal cord injury lumbar 12.50 9.46 5 159420 58 64339249
Pulmonary oedema 12.44 9.46 268 159157 78406 64260901
Hypovolaemia 12.41 9.46 73 159352 15413 64323894
Substance-induced mood disorder 12.39 9.46 6 159419 113 64339194
Blood 25-hydroxycholecalciferol decreased 12.38 9.46 7 159418 183 64339124
Chest discomfort 12.38 9.46 207 159218 115899 64223408
Induced abortion failed 12.35 9.46 7 159418 184 64339123
Pulmonary calcification 12.28 9.46 9 159416 371 64338936
Injection site haemorrhage 12.27 9.46 26 159399 24252 64315055
Visual acuity reduced 12.16 9.46 31 159394 27110 64312197
Protein total decreased 11.98 9.46 45 159380 7891 64331416
Myocardial fibrosis 11.91 9.46 17 159408 1563 64337744
Drug withdrawal syndrome 11.88 9.46 124 159301 31167 64308140
No adverse event 11.76 9.46 34 159391 28527 64310780
Metabolic acidosis 11.63 9.46 243 159182 70715 64268592
Type 2 diabetes mellitus 11.60 9.46 44 159381 33976 64305331
Skin necrosis 11.56 9.46 11 159414 14318 64324989
Device malfunction 11.55 9.46 16 159409 17617 64321690
Oncocytoma 11.54 9.46 4 159421 30 64339277
Delayed graft function 11.41 9.46 24 159401 3012 64336295
Acute respiratory failure 11.35 9.46 180 159245 49754 64289553
Post procedural diarrhoea 11.34 9.46 7 159418 216 64339091
Sleep apnoea syndrome 11.23 9.46 37 159388 29795 64309512
Polyarthritis 11.17 9.46 5 159420 9710 64329597
Lip dry 11.13 9.46 32 159393 4886 64334421
Penile erythema 11.11 9.46 6 159419 143 64339164
Rhinovirus infection 11.09 9.46 37 159388 6119 64333188
Necrotising ulcerative gingivostomatitis 11.00 9.46 4 159421 35 64339272
Gastritis alcoholic 11.00 9.46 4 159421 35 64339272
Diplopia 10.92 9.46 32 159393 26733 64312574
Unresponsive to stimuli 10.84 9.46 180 159245 50213 64289094
Alcoholic 10.80 9.46 4 159421 37 64339270
Blood albumin decreased 10.77 9.46 89 159336 20984 64318323
Abdominal infection 10.77 9.46 23 159402 2917 64336390
Renal cyst haemorrhage 10.72 9.46 9 159416 453 64338854
Fluid retention 10.65 9.46 95 159330 59511 64279796
Agitation 10.64 9.46 290 159135 88077 64251230
Noninfectious peritonitis 10.64 9.46 7 159418 242 64339065
Intraductal papillary mucinous neoplasm 10.61 9.46 10 159415 587 64338720
Osteomalacia 10.54 9.46 15 159410 1376 64337931
Psychiatric disorder prophylaxis 10.53 9.46 4 159421 40 64339267
Therapy non-responder 10.52 9.46 108 159317 65791 64273516
Ulcer 10.50 9.46 26 159399 22964 64316343
Abscess intestinal 10.48 9.46 20 159405 2340 64336967
Shunt occlusion 10.45 9.46 14 159411 1213 64338094
Central nervous system mass 10.43 9.46 5 159420 92 64339215
Bradycardia 10.36 9.46 218 159207 118001 64221306
Loss of consciousness 10.32 9.46 457 158968 147908 64191399
Hot flush 10.26 9.46 166 159259 46069 64293238
Impaired driving ability 10.26 9.46 30 159395 4624 64334683
Tachycardia 10.25 9.46 460 158965 149119 64190188
Intramedullary rod insertion 10.24 9.46 6 159419 168 64339139
Disability 10.23 9.46 9 159416 12163 64327144
Achlorhydria 10.22 9.46 3 159422 12 64339295
Angina unstable 10.17 9.46 14 159411 15453 64323854
Nasopharyngitis 10.16 9.46 389 159036 195684 64143623
Wall motion score index abnormal 10.14 9.46 5 159420 98 64339209
Hyperparathyroidism 10.09 9.46 22 159403 2830 64336477
Lip discolouration 10.05 9.46 10 159415 628 64338679
Sinus congestion 10.03 9.46 69 159356 15370 64323937
Leukopenia 9.99 9.46 183 159242 101059 64238248
Blindness 9.98 9.46 25 159400 21994 64317313
Chronic kidney disease-mineral and bone disorder 9.94 9.46 9 159416 502 64338805
Sensorimotor disorder 9.93 9.46 11 159414 782 64338525
Constipation 9.93 9.46 676 158749 228661 64110646
Sunburn 9.91 9.46 24 159401 3308 64335999
Benzodiazepine drug level therapeutic 9.88 9.46 4 159421 48 64339259
Myelodysplastic syndrome 9.84 9.46 35 159390 27544 64311763
Mucormycosis 9.75 9.46 3 159422 7338 64331969
Cirrhosis alcoholic 9.72 9.46 12 159413 958 64338349
Injection site urticaria 9.72 9.46 8 159417 11173 64328134
Unevaluable event 9.68 9.46 79 159346 50410 64288897
Mixed dementia 9.67 9.46 7 159418 283 64339024
Fanconi syndrome 9.67 9.46 20 159405 2481 64336826
Accident at work 9.64 9.46 12 159413 967 64338340
Vision blurred 9.63 9.46 161 159264 90155 64249152
Neutropenia 9.62 9.46 489 158936 239135 64100172
Epstein-Barr virus infection 9.60 9.46 10 159415 12478 64326829
Erythema multiforme 9.55 9.46 15 159410 15686 64323621
Ear infection 9.53 9.46 28 159397 23376 64315931
Loss of proprioception 9.49 9.46 10 159415 672 64338635

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:63047 food emulsifiers
CHEBI has role CHEBI:77965 food anti-caking agent
CHEBI has role CHEBI:78058 food antifoaming agents

Drug Use (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
CHEMBL1200838 ChEMBL_ID
24764 PUBCHEM_CID
C501844 MESH_SUPPLEMENTAL_RECORD_UI
C013830 MESH_SUPPLEMENTAL_RECORD_UI
2898 INN_ID
92RU3N3Y1O UNII
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Gas-XExtra Strength HUMAN OTC DRUG LABEL 1 0067-0117 TABLET, CHEWABLE 125 mg ORAL OTC monograph final 10 sections
Gas-XTotal Relief Maximum Strength HUMAN OTC DRUG LABEL 2 0067-0118 TABLET, CHEWABLE 250 mg ORAL OTC monograph final 14 sections
Gas-XTotal Relief Maximum Strength HUMAN OTC DRUG LABEL 2 0067-0119 TABLET, CHEWABLE 250 mg ORAL OTC monograph final 14 sections
Gas-XExtra Strength HUMAN OTC DRUG LABEL 1 0067-0129 TABLET, CHEWABLE 125 mg ORAL OTC monograph final 10 sections
Gas-XUltra Strength AntiGas Softgels HUMAN OTC DRUG LABEL 1 0067-6274 CAPSULE, LIQUID FILLED 180 mg ORAL OTC monograph final 10 sections
Gas-XExtra Strength Softgels HUMAN OTC DRUG LABEL 1 0067-6275 CAPSULE, LIQUID FILLED 125 mg ORAL OTC monograph final 10 sections
Gas-XMaximum Strength Softgels HUMAN OTC DRUG LABEL 1 0067-6283 CAPSULE, LIQUID FILLED 250 mg ORAL OTC monograph final 10 sections
Moisturel HUMAN OTC DRUG LABEL 1 0093-3204 LOTION 30 g TOPICAL OTC monograph final 13 sections
good sense anti diarrheal anti gas HUMAN OTC DRUG LABEL 2 0113-0087 TABLET 125 mg ORAL ANDA 16 sections
Good Sense antacid HUMAN OTC DRUG LABEL 3 0113-0340 SUSPENSION 80 mg ORAL OTC monograph final 13 sections
Good Sense AntacidRegular Strength HUMAN OTC DRUG LABEL 3 0113-0357 SUSPENSION 40 mg ORAL OTC monograph final 13 sections
Good Sense Gas ReliefExtra Strength HUMAN OTC DRUG LABEL 1 0113-0428 CAPSULE, LIQUID FILLED 125 mg ORAL OTC monograph final 10 sections
Good Sense AntacidMaximum Strength HUMAN OTC DRUG LABEL 3 0113-0588 SUSPENSION 80 mg ORAL OTC monograph final 13 sections
good sense gas relief HUMAN OTC DRUG LABEL 1 0113-0657 CAPSULE, LIQUID FILLED 180 mg ORAL OTC monograph final 11 sections
good sense antacid HUMAN OTC DRUG LABEL 3 0113-0851 SUSPENSION 40 mg ORAL OTC monograph final 13 sections
good sense simethiconeinfants HUMAN OTC DRUG LABEL 1 0113-0882 EMULSION 20 mg ORAL OTC monograph final 11 sections
Good Sense Anti Diarrheal Anti Gas HUMAN OTC DRUG LABEL 2 0113-1087 TABLET 125 mg ORAL ANDA 16 sections
basic care loperamide hydrochloride and simethicone HUMAN OTC DRUG LABEL 2 0113-7119 TABLET 125 mg ORAL ANDA 16 sections
Mag-AL Plus HUMAN OTC DRUG LABEL 3 0121-1761 SUSPENSION 20 mg ORAL OTC monograph final 14 sections
Mag-AL PlusXS HUMAN OTC DRUG LABEL 3 0121-1762 SUSPENSION 40 mg ORAL OTC monograph final 15 sections
PHAZYME HUMAN OTC DRUG LABEL 1 0132-0208 CAPSULE, GELATIN COATED 180 mg ORAL OTC MONOGRAPH FINAL 12 sections
PHAZYME HUMAN OTC DRUG LABEL 1 0132-0210 CAPSULE, GELATIN COATED 180 mg ORAL export only 10 sections
PHAZYME HUMAN OTC DRUG LABEL 1 0132-0211 CAPSULE, GELATIN COATED 250 mg ORAL OTC MONOGRAPH FINAL 12 sections
PHAZYME HUMAN OTC DRUG LABEL 1 0132-0214 CAPSULE, GELATIN COATED 250 mg ORAL OTC MONOGRAPH FINAL 11 sections
PHAZYME HUMAN OTC DRUG LABEL 1 0132-0215 CAPSULE, GELATIN COATED 250 mg ORAL OTC MONOGRAPH FINAL 11 sections
PHAZYME ULTIMATE HUMAN OTC DRUG LABEL 1 0132-0217 CAPSULE, LIQUID FILLED 500 mg ORAL OTC MONOGRAPH FINAL 12 sections
Boudreauxs Butt Barrier HUMAN OTC DRUG LABEL 1 0132-0326 OINTMENT 1 g TOPICAL OTC monograph final 13 sections
PHAZYME HUMAN OTC DRUG LABEL 2 0132-0507 TABLET, CHEWABLE 250 mg ORAL OTC monograph final 11 sections
Summers Eve Active Chafe HUMAN OTC DRUG LABEL 1 0132-8744 GEL 12 mg TOPICAL OTC MONOGRAPH FINAL 14 sections
Tums Chewy Bites with Gas Relief HUMAN OTC DRUG LABEL 2 0135-0624 TABLET, CHEWABLE 80 mg ORAL OTC monograph final 12 sections