iopamidol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
iodine-containing contrast media 1464 60166-93-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • iopamidol
  • iopamiron
A non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiological procedures.
  • Molecular weight: 777.09
  • Formula: C17H22I3N3O8
  • CLOGP: -1.91
  • LIPINSKI: 3
  • HAC: 11
  • HDO: 8
  • TPSA: 188.45
  • ALOGS: -2.99
  • ROTB: 10

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 96 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1530.44 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.28 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.90 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.10 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 100 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Dec. 31, 1985 FDA BRACCO

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
Contrast media reaction 277.17 31.94 47 2660 1078 63485237
Anaphylactic reaction 152.08 31.94 68 2639 66032 63420283
Anaphylactic shock 138.87 31.94 48 2659 23585 63462730
Contrast encephalopathy 126.17 31.94 17 2690 71 63486244
No adverse event 86.86 31.94 40 2667 41365 63444950
Urticaria 78.07 31.94 61 2646 165741 63320574
Extravasation 70.27 31.94 17 2690 2355 63483960
Anaphylactoid reaction 62.66 31.94 17 2690 3706 63482609
Throat tightness 61.57 31.94 27 2680 24860 63461455
Maternal exposure during pregnancy 61.19 31.94 60 2647 220002 63266313
Wrong product administered 54.26 31.94 17 2690 6124 63480191
Drug reaction with eosinophilia and systemic symptoms 53.66 31.94 27 2680 33809 63452506
Sneezing 52.42 31.94 22 2685 18196 63468119
Contrast media allergy 50.11 31.94 13 2694 2388 63483927
Hypersensitivity 47.12 31.94 60 2647 292625 63193690
Dyspnoea 44.56 31.94 91 2616 661222 62825093
Infusion site extravasation 38.27 31.94 15 2692 10411 63475904
Cardio-respiratory arrest 36.96 31.94 26 2681 59933 63426382
Throat irritation 32.12 31.94 20 2687 37627 63448688
Respiratory arrest 32.11 31.94 19 2688 32626 63453689

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
Contrast media reaction 273.52 25.99 49 2487 897 34953498
Anaphylactic shock 235.96 25.99 74 2462 15867 34938528
Anaphylactic reaction 140.85 25.99 61 2475 32240 34922155
Contrast media allergy 107.39 25.99 20 2516 455 34953940
Contrast encephalopathy 103.48 25.99 15 2521 62 34954333
Urticaria 84.90 25.99 54 2482 62323 34892072
Hepatic artery stenosis 71.79 25.99 12 2524 142 34954253
Pruritus 47.83 25.99 55 2481 141926 34812469
Cardio-respiratory arrest 40.73 25.99 33 2503 55240 34899155
Extravasation 37.39 25.99 11 2525 1879 34952516
No adverse event 36.56 25.99 22 2514 22905 34931490
Hypersensitivity 35.87 25.99 32 2504 61003 34893392
Cardiac arrest 31.89 25.99 37 2499 96122 34858273
Blood pressure decreased 28.27 25.99 26 2510 51489 34902906
Vomiting 27.09 25.99 57 2479 247564 34706831

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
Contrast media reaction 505.14 24.97 91 4970 1979 79737348
Anaphylactic shock 319.62 24.97 110 4951 35886 79703441
Anaphylactic reaction 254.40 24.97 118 4943 83625 79655702
Contrast encephalopathy 220.73 24.97 32 5029 156 79739171
Urticaria 141.98 24.97 107 4954 185094 79554233
Contrast media allergy 116.84 24.97 28 5033 2494 79736833
Hepatic artery stenosis 84.11 24.97 14 5047 186 79739141
Pruritus 69.73 24.97 104 4957 394544 79344783
Drug reaction with eosinophilia and systemic symptoms 69.72 24.97 46 5015 64198 79675129
Cardio-respiratory arrest 66.39 24.97 55 5006 108455 79630872
Anaphylactoid reaction 65.72 24.97 21 5040 5401 79733926
Hypersensitivity 61.07 24.97 79 4982 262160 79477167
Sneezing 60.39 24.97 28 5033 19655 79719672
Extravasation 60.14 24.97 18 5043 3732 79735595
Throat tightness 59.59 24.97 31 5030 27876 79711451
Throat irritation 53.56 24.97 33 5028 40913 79698414
Cardiac arrest 49.98 24.97 58 5003 172038 79567289
Pulse absent 49.48 24.97 20 5041 10083 79729244
Nephropathy toxic 47.40 24.97 24 5037 20395 79718932
Dyspnoea 46.53 24.97 139 4922 856886 78882441
Unresponsive to stimuli 37.72 24.97 30 5031 55758 79683569
Erythema 35.30 24.97 56 5005 223234 79516093
Pharyngeal oedema 34.51 24.97 18 5043 16254 79723073
Blood pressure decreased 33.08 24.97 36 5025 99430 79639897
Vomiting 30.50 24.97 102 4959 665726 79073601
Oxygen saturation decreased 30.15 24.97 39 5022 129008 79610319
No adverse event 29.51 24.97 22 5039 37170 79702157
Loss of consciousness 27.74 24.97 43 5018 167900 79571427
Flushing 27.70 24.97 31 5030 88237 79651090
Cyanosis 27.21 24.97 18 5043 25164 79714163
Infusion site extravasation 26.77 24.97 13 5048 10095 79729232
Spinal cord ischaemia 25.51 24.97 5 5056 172 79739155
Drug ineffective 25.45 24.97 19 5042 1080894 78658433
Wrong product administered 25.11 24.97 12 5049 9000 79730327

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V08AB04 VARIOUS
CONTRAST MEDIA
X-RAY CONTRAST MEDIA, IODINATED
Watersoluble, nephrotropic, low osmolar X-ray contrast media
FDA MoA N0000010258 X-Ray Contrast Activity
MeSH PA D003287 Contrast Media
MeSH PA D064907 Diagnostic Uses of Chemicals
FDA EPC N0000180185 Radiographic Contrast Agent
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:37338 contrast media
CHEBI has role CHEBI:78298 environmental contaminants

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

None




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.76 acidic
pKa2 11.36 acidic
pKa3 12.12 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4017756 VUID
N0000146122 NUI
D01797 KEGG_DRUG
4017756 VANDF
C0022026 UMLSCUI
CHEBI:31711 CHEBI
CHEMBL1200932 ChEMBL_ID
D007479 MESH_DESCRIPTOR_UI
DB08947 DRUGBANK_ID
4399 INN_ID
JR13W81H44 UNII
65492 PUBCHEM_CID
5966 RXNORM
4905 MMSL
d01461 MMSL
000672 NDDF
109219007 SNOMEDCT_US
395754005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ISOVUE200 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1314 INJECTION, SOLUTION 408 mg INTRAVASCULAR NDA 23 sections
ISOVUE200 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1314 INJECTION, SOLUTION 408 mg INTRAVASCULAR NDA 23 sections
ISOVUE200 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1314 INJECTION, SOLUTION 408 mg INTRAVASCULAR NDA 23 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE250 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1317 INJECTION, SOLUTION 510 mg INTRAVASCULAR NDA 24 sections
ISOVUE250 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1317 INJECTION, SOLUTION 510 mg INTRAVASCULAR NDA 24 sections
ISOVUE250 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1317 INJECTION, SOLUTION 510 mg INTRAVASCULAR NDA 24 sections
ISOVUE250 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1317 INJECTION, SOLUTION 510 mg INTRAVASCULAR NDA 24 sections
ISOVUE250 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1317 INJECTION, SOLUTION 510 mg INTRAVASCULAR NDA 24 sections
ISOVUE-M HUMAN PRESCRIPTION DRUG LABEL 1 0270-1411 INJECTION, SOLUTION 408 mg INTRATHECAL NDA 22 sections
ISOVUE-M HUMAN PRESCRIPTION DRUG LABEL 1 0270-1411 INJECTION, SOLUTION 408 mg INTRATHECAL NDA 22 sections
ISOVUE-M HUMAN PRESCRIPTION DRUG LABEL 1 0270-1412 INJECTION, SOLUTION 612 mg INTRATHECAL NDA 22 sections
ISOVUE-M HUMAN PRESCRIPTION DRUG LABEL 1 0270-1412 INJECTION, SOLUTION 612 mg INTRATHECAL NDA 22 sections
ISOVUE-M 200 HUMAN PRESCRIPTION DRUG LABEL 1 52584-411 INJECTION, SOLUTION 408 mg INTRATHECAL NDA 11 sections
iopamidol HUMAN PRESCRIPTION DRUG LABEL 1 70436-124 INJECTION, SOLUTION 408 mg INTRATHECAL ANDA 21 sections