dimethicone 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
Milk-alkali syndrome 547.44 23.73 69 1307 47 2356662
Pneumonia aspiration 363.62 23.73 79 1297 3663 2353046
Somnolence 347.47 23.73 111 1265 23374 2333335
Coma 337.43 23.73 88 1288 8968 2347741
Hypercalcaemia 327.43 23.73 68 1308 2524 2354185
Gastrooesophageal reflux disease 327.36 23.73 86 1290 9009 2347700
Diarrhoea 182.71 23.73 101 1275 83463 2273246
Drug ineffective 172.10 23.73 104 1272 101520 2255189
Asphyxia 171.94 23.73 34 1342 970 2355739
Arteriosclerosis coronary artery 160.77 23.73 33 1343 1140 2355569
Overdose 117.60 23.73 48 1328 19859 2336850
Constipation 117.12 23.73 49 1327 21580 2335129
Vomiting 102.05 23.73 66 1310 71536 2285173
Drug hypersensitivity 100.12 23.73 56 1320 46587 2310122
Acute kidney injury 98.58 23.73 47 1329 28075 2328634
Intentional overdose 90.38 23.73 34 1342 11287 2345422
Toxicity to various agents 88.87 23.73 46 1330 32708 2324001
Suicide attempt 79.69 23.73 31 1345 11251 2345458
Abdominal pain 78.35 23.73 43 1333 34331 2322378
Fatigue 78.27 23.73 60 1316 84813 2271896
Pyrexia 72.59 23.73 48 1328 53660 2303049
Weight decreased 71.62 23.73 38 1338 28333 2328376
Peripheral swelling 69.54 23.73 32 1344 17565 2339144
Nausea 69.51 23.73 63 1313 112126 2244583
Asthenia 68.42 23.73 44 1332 46882 2309827
Confusional state 68.27 23.73 35 1341 24309 2332400
Dehydration 68.20 23.73 34 1342 22261 2334448
Metabolic alkalosis 66.51 23.73 13 1363 346 2356363
Exposure during pregnancy 64.24 23.73 34 1342 25185 2331524
Drug abuse 64.09 23.73 27 1349 11999 2344710
Intentional self-injury 62.44 23.73 20 1356 4107 2352602
Drug interaction 59.61 23.73 34 1342 29129 2327580
Status epilepticus 58.88 23.73 17 1359 2461 2354248
Salivary gland calculus 58.37 23.73 9 1367 54 2356655
Intestinal obstruction 53.21 23.73 18 1358 4375 2352334
Cough 53.05 23.73 33 1343 33084 2323625
Maternal exposure during pregnancy 52.40 23.73 25 1351 14838 2341871
Pruritus 51.92 23.73 36 1340 43304 2313405
Calciphylaxis 51.79 23.73 11 1365 446 2356263
Tetany 50.94 23.73 11 1365 483 2356226
Rash 50.13 23.73 40 1336 59518 2297191
Completed suicide 49.71 23.73 27 1349 21007 2335702
Intentional product misuse 49.52 23.73 21 1355 9468 2347241
Incorrect dose administered 49.08 23.73 21 1355 9674 2347035
Pneumonia 47.75 23.73 36 1340 49260 2307449
Liver injury 46.74 23.73 14 1362 2300 2354409
Sialoadenitis 45.91 23.73 9 1367 243 2356466
Hypotension 43.70 23.73 29 1347 32407 2324302
Nephrocalcinosis 41.91 23.73 8 1368 187 2356522
Dyspnoea 40.47 23.73 40 1336 78693 2278016
Abdominal pain upper 40.42 23.73 24 1352 22076 2334633
Renal failure 40.22 23.73 22 1354 17327 2339382
Headache 39.85 23.73 40 1336 80139 2276570
Hypocalcaemia 39.62 23.73 14 1362 3869 2352840
Mental disorder 39.19 23.73 14 1362 3993 2352716
Crohn's disease 38.98 23.73 16 1360 6639 2350070
Toxic epidermal necrolysis 38.53 23.73 13 1363 3131 2353578
Dizziness 38.17 23.73 34 1342 58631 2298078
Blood pressure systolic increased 38.10 23.73 12 1364 2327 2354382
Blood pressure increased 37.88 23.73 21 1355 16965 2339744
Hypokalaemia 37.76 23.73 18 1358 10636 2346073
Pain 36.62 23.73 34 1342 61823 2294886
Fall 36.11 23.73 30 1346 47069 2309640
Malaise 35.72 23.73 32 1344 55553 2301156
Foetal exposure during pregnancy 35.50 23.73 14 1362 5238 2351471
Hypervitaminosis D 34.97 23.73 5 1371 16 2356693
Mental status changes 34.67 23.73 14 1362 5568 2351141
Condition aggravated 34.60 23.73 25 1351 31954 2324755
Pain in extremity 34.49 23.73 28 1348 42512 2314197
Arthralgia 34.38 23.73 31 1345 54254 2302455
Off label use 33.42 23.73 35 1341 73563 2283146
Muscle spasms 33.23 23.73 21 1355 21545 2335164
Tachycardia 33.10 23.73 19 1357 16390 2340319
N-terminal prohormone brain natriuretic peptide increased 31.73 23.73 6 1370 133 2356576
Waist circumference increased 31.20 23.73 6 1370 146 2356563
Vitamin B12 decreased 31.14 23.73 7 1369 370 2356339
Disturbance in attention 31.03 23.73 13 1363 5672 2351037
Menstruation delayed 30.99 23.73 7 1369 378 2356331
Pancytopenia 30.68 23.73 16 1360 11436 2345273
Foetal arrhythmia 30.64 23.73 5 1371 45 2356664
Nasopharyngitis 30.34 23.73 20 1356 22036 2334673
End stage renal disease 29.59 23.73 7 1369 464 2356245
Renal tubular necrosis 29.44 23.73 9 1367 1581 2355128
Head banging 29.10 23.73 5 1371 63 2356646
Blood creatinine increased 29.02 23.73 15 1361 10518 2346191
Foetal alcohol syndrome 29.00 23.73 4 1372 9 2356700
Pancreatitis acute 28.61 23.73 11 1365 3842 2352867
Blood potassium decreased 28.51 23.73 12 1364 5293 2351416
Gait disturbance 27.55 23.73 19 1357 22526 2334183
Stevens-Johnson syndrome 27.54 23.73 11 1365 4248 2352461
Blood calcium increased 27.13 23.73 8 1368 1243 2355466
Electrocardiogram QT prolonged 27.06 23.73 13 1363 7801 2348908
Flatulence 26.90 23.73 11 1365 4514 2352195
Premature baby 26.87 23.73 10 1366 3194 2353515
Tremor 26.64 23.73 18 1358 20643 2336066
Polyhydramnios 26.47 23.73 6 1370 329 2356380
Hypertension 26.45 23.73 20 1356 27341 2329368
Seizure 26.15 23.73 19 1357 24447 2332262
Soft tissue infection 26.13 23.73 6 1370 349 2356360
Loss of consciousness 25.76 23.73 17 1359 18750 2337959
Death 25.53 23.73 32 1344 81436 2275273
Chronic kidney disease-mineral and bone disorder 25.53 23.73 4 1372 27 2356682
Productive cough 25.18 23.73 11 1365 5310 2351399
Periventricular leukomalacia 24.82 23.73 4 1372 33 2356676
Swelling face 24.67 23.73 13 1363 9480 2347229
Inappropriate schedule of product administration 24.25 23.73 14 1362 12190 2344519
Haemoglobin decreased 23.84 23.73 16 1360 18135 2338574
Segmental diverticular colitis 23.75 23.73 3 1373 2 2356707

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 383.07 30.85 49 880 34 1745818
Hypercalcaemia 264.88 30.85 55 874 1831 1744021
Diarrhoea 127.00 30.85 71 858 53781 1692071
Acute kidney injury 110.05 30.85 56 873 34888 1710964
Intentional overdose 99.86 30.85 34 895 7636 1738216
Metabolic alkalosis 97.00 30.85 17 912 217 1745635
Abdominal pain 93.31 30.85 43 886 21447 1724405
Overdose 90.33 30.85 39 890 16662 1729190
Calciphylaxis 85.39 30.85 15 914 194 1745658
Condition aggravated 63.64 30.85 33 896 21117 1724735
Urinary retention 62.68 30.85 22 907 5373 1740479
Constipation 61.77 30.85 29 900 14971 1730881
Disorientation 54.83 30.85 20 909 5449 1740403
Drug ineffective 52.23 30.85 44 885 63757 1682095
Drug dependence 52.15 30.85 17 912 3310 1742542
Intestinal obstruction 51.27 30.85 17 912 3490 1742362
Drug withdrawal syndrome 50.81 30.85 18 911 4507 1741345
Drug interaction 49.87 30.85 31 898 27927 1717925
Rash erythematous 49.22 30.85 17 912 3948 1741904
N-telopeptide urine increased 49.00 30.85 6 923 1 1745851
Dehydration 48.63 30.85 26 903 17632 1728220
Nausea 47.46 30.85 38 891 51158 1694694
Vertigo 47.44 30.85 17 912 4396 1741456
Confusional state 46.75 30.85 27 902 21251 1724601
Ascites 43.54 30.85 17 912 5569 1740283
Oedema peripheral 43.08 30.85 23 906 15527 1730325
Cerebrovascular accident 42.80 30.85 24 905 17842 1728010
Drug reaction with eosinophilia and systemic symptoms 41.53 30.85 16 913 5054 1740798
Toxic epidermal necrolysis 40.75 30.85 13 916 2358 1743494
Intentional self-injury 39.22 30.85 13 916 2660 1743192
Abdominal distension 37.82 30.85 16 913 6428 1739424
Completed suicide 36.59 30.85 21 908 16291 1729561
Iron deficiency anaemia 35.65 30.85 10 919 1168 1744684
Renal failure 35.12 30.85 22 907 19995 1725857
Vomiting 34.47 30.85 28 901 38287 1707565
Toxicity to various agents 34.31 30.85 25 904 29116 1716736
Rash 34.23 30.85 28 901 38665 1707187
Anaemia 34.07 30.85 25 904 29432 1716420
Hypomagnesaemia 33.99 30.85 11 918 2087 1743765
Pyrexia 33.75 30.85 30 899 46370 1699482
Urticaria 33.57 30.85 18 911 12223 1733629
Pruritus 32.13 30.85 22 907 23200 1722652
Hepatitis 31.40 30.85 13 916 4942 1740910
Small intestinal obstruction 31.32 30.85 10 919 1817 1744035
Toxic skin eruption 31.02 30.85 10 919 1873 1743979

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
CHEBI has role CHEBI:78058 food antifoaming agent
CHEBI has role CHEBI:77965 food anticaking agent
CHEBI has role CHEBI:63047 food emulsifier
MeSH PA D000934 Antifoaming Agents
MeSH PA D003879 Dermatologic Agents
MeSH PA D004643 Emollients
MeSH PA D013501 Surface-Active Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diaper rash indication 91487003

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
C0037138 UMLSCUI
D01540 KEGG_DRUG
420874002 SNOMEDCT_US
396031000 SNOMEDCT_US
4607 MMSL
4019331 VANDF
324072 RXNORM
001915 NDDF
24705 PUBCHEM_CID
CHEBI:61468 CHEBI
CHEMBL1200838 ChEMBL_ID
TYU5GP6XGE UNII
DB09512 DRUGBANK_ID
D012841 MESH_DESCRIPTOR_UI
CHEMBL2108200 ChEMBL_ID
CHEMBL4297192 ChEMBL_ID
C013830 MESH_SUPPLEMENTAL_RECORD_UI
C501844 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Gas-X HUMAN OTC DRUG LABEL 1 0067-0117 TABLET, CHEWABLE 125 mg ORAL OTC monograph final 9 sections
Gas-X HUMAN OTC DRUG LABEL 1 0067-0129 TABLET, CHEWABLE 125 mg ORAL OTC monograph final 9 sections
Gas-X HUMAN OTC DRUG LABEL 1 0067-6274 CAPSULE, LIQUID FILLED 180 mg ORAL OTC monograph final 9 sections
Gas-X HUMAN OTC DRUG LABEL 1 0067-6275 CAPSULE, LIQUID FILLED 125 mg ORAL OTC monograph final 9 sections
Gas-X HUMAN OTC DRUG LABEL 1 0067-6283 CAPSULE, LIQUID FILLED 250 mg ORAL OTC monograph final 9 sections
Moisturel HUMAN OTC DRUG LABEL 1 0093-3204 LOTION 30 g TOPICAL OTC MONOGRAPH FINAL 10 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 9 sections
Good Sense Antacid HUMAN OTC DRUG LABEL 3 0113-0357 SUSPENSION 40 mg ORAL OTC monograph final 9 sections
Good Sense Gas Relief HUMAN OTC DRUG LABEL 1 0113-0428 CAPSULE, LIQUID FILLED 125 mg ORAL OTC monograph final 9 sections
Good Sense Antacid HUMAN OTC DRUG LABEL 3 0113-0588 SUSPENSION 80 mg ORAL OTC monograph final 9 sections
good sense gas relief HUMAN OTC DRUG LABEL 1 0113-0657 CAPSULE, LIQUID FILLED 180 mg ORAL OTC monograph final 9 sections
good sense antacid HUMAN OTC DRUG LABEL 3 0113-0851 SUSPENSION 40 mg ORAL OTC monograph final 9 sections
good sense simethicone HUMAN OTC DRUG LABEL 1 0113-0882 EMULSION 20 mg ORAL OTC monograph final 9 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 9 sections
Mag-AL Plus HUMAN OTC DRUG LABEL 3 0121-1762 SUSPENSION 40 mg ORAL OTC monograph final 9 sections
PHAZYME HUMAN OTC DRUG LABEL 1 0132-0208 CAPSULE, GELATIN COATED 180 mg ORAL OTC MONOGRAPH FINAL 8 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 8 sections
PHAZYME HUMAN OTC DRUG LABEL 1 0132-0214 CAPSULE, GELATIN COATED 250 mg ORAL OTC MONOGRAPH FINAL 8 sections
PHAZYME HUMAN OTC DRUG LABEL 1 0132-0215 CAPSULE, GELATIN COATED 250 mg ORAL OTC MONOGRAPH FINAL 8 sections
PHAZYME HUMAN OTC DRUG LABEL 2 0132-0507 TABLET, CHEWABLE 250 mg ORAL OTC monograph final 11 sections
Tums Chewy Bites with Gas Relief HUMAN OTC DRUG LABEL 2 0135-0624 TABLET, CHEWABLE 80 mg ORAL OTC monograph final 9 sections
Selan Plus Zinc Oxide HUMAN OTC DRUG LABEL 2 0159-2200 CREAM 2.10 1 TOPICAL OTC monograph final 11 sections
Selan DM Diabetics Intensive Moisturizing HUMAN OTC DRUG LABEL 1 0159-7700 CREAM 5 g TOPICAL OTC monograph final 12 sections
Selan DF Diabetics Foot Care HUMAN OTC DRUG LABEL 1 0159-7750 CREAM 5 g TOPICAL OTC monograph final 12 sections
TheraSeal HUMAN OTC DRUG LABEL 1 0187-1660 CREAM 1.70 g TOPICAL OTC monograph final 9 sections
CeraVe HUMAN OTC DRUG LABEL 1 0187-2218 CREAM 12 mg TOPICAL OTC monograph final 9 sections