iopamidol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK2,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 49
kinase-selectivity-class ALK,AURKA,AURKC,AXL,BMX,BRAF,CAMK2B,CAMK2D,CDK1,CDK16,CDK2,CDK3,CDK4,CDK6,CDK7,CDK9,CLK2,CLK4,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3A,GSK3B,IRAK3,MAP2K6,MAP3K21,MAP4K1,MAPK1,MAPK11,MAPK7,MET,PDK1,PIK3CB,PIK3CD,PIK3CG,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1 45
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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 338.11 28.00 56 3538 1195 90623658
Anaphylactic reaction 200.97 28.00 88 3506 87436 90537417
Anaphylactic shock 158.43 28.00 56 3538 31561 90593292
Contrast encephalopathy 154.21 28.00 22 3572 163 90624690
Urticaria 97.64 28.00 88 3506 312646 90312207
No adverse event 96.10 28.00 49 3545 67933 90556920
Drug reaction with eosinophilia and systemic symptoms 88.33 28.00 40 3554 42718 90582135
Contrast media allergy 77.06 28.00 19 3575 3062 90621791
Throat tightness 75.20 28.00 32 3562 29452 90595401
Sneezing 74.80 28.00 32 3562 29837 90595016
Extravasation 72.73 28.00 18 3576 2946 90621907
Sialoadenitis 62.45 28.00 15 3579 2167 90622686
Anaphylactoid reaction 60.80 28.00 17 3577 4451 90620402
Cardio-respiratory arrest 57.33 28.00 34 3560 63106 90561747
Dyspnoea 51.90 28.00 110 3484 880845 89744008
Wrong product administered 51.75 28.00 17 3577 7648 90617205
Throat irritation 48.90 28.00 28 3566 48667 90576186
Maternal exposure during pregnancy 43.64 28.00 62 3532 360001 90264852
Hypersensitivity 42.00 28.00 69 3525 454608 90170245
Pulse absent 39.15 28.00 13 3581 6042 90618811
Respiratory arrest 38.46 28.00 21 3573 33290 90591563
Infusion site extravasation 35.88 28.00 14 3580 10314 90614539
Unresponsive to stimuli 35.82 28.00 21 3573 38100 90586753
Cardiac arrest 35.52 28.00 31 3563 104904 90519949
Erythema 34.65 28.00 44 3550 229202 90395651
Pruritus 32.16 28.00 68 3526 541457 90083396
Product physical issue 32.05 28.00 11 3583 5649 90619204
Pharyngeal oedema 31.99 28.00 14 3580 13757 90611096
Blood pressure decreased 29.18 28.00 24 3570 74871 90549982
Rapidly progressive osteoarthritis 28.62 28.00 4 3590 25 90624828

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 285.37 24.75 52 3001 1064 42617218
Anaphylactic shock 259.05 24.75 87 2966 23430 42594852
Anaphylactic reaction 178.53 24.75 78 2975 42665 42575617
Contrast encephalopathy 150.74 24.75 23 3030 146 42618136
Hepatic artery stenosis 149.04 24.75 23 3030 159 42618123
Contrast media allergy 121.44 24.75 24 3029 763 42617519
Urticaria 84.10 24.75 57 2996 73979 42544303
Extravasation 61.39 24.75 17 3036 2373 42615909
Hepatic artery occlusion 47.77 24.75 8 3045 97 42618185
Cardio-respiratory arrest 45.71 24.75 36 3017 58600 42559682
Kounis syndrome 43.13 24.75 14 3039 3354 42614928
Pruritus 41.79 24.75 59 2994 188712 42429570
No adverse event 39.42 24.75 28 3025 38993 42579289
Cardiac arrest 36.57 24.75 42 3011 109278 42509004
Blood pressure decreased 35.42 24.75 31 3022 58301 42559981
Drug reaction with eosinophilia and systemic symptoms 35.31 24.75 27 3026 42048 42576234
Hypersensitivity 31.55 24.75 32 3021 72338 42545944
Sialoadenitis 31.43 24.75 8 3045 807 42617475
Unresponsive to stimuli 30.48 24.75 22 3031 31381 42586901
Vomiting 29.14 24.75 64 2989 289659 42328623
Oxygen saturation decreased 28.92 24.75 29 3024 64658 42553624
Throat irritation 24.87 24.75 14 3039 13022 42605260

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 585.39 23.93 104 6296 2294 110580605
Anaphylactic shock 372.55 23.93 132 6268 51414 110531485
Anaphylactic reaction 335.90 23.93 153 6247 114147 110468752
Contrast encephalopathy 298.01 23.93 45 6355 337 110582562
Hepatic artery stenosis 172.42 23.93 27 6373 263 110582636
Contrast media allergy 162.06 23.93 38 6362 3385 110579514
Urticaria 133.48 23.93 125 6275 318732 110264167
Drug reaction with eosinophilia and systemic symptoms 115.36 23.93 67 6333 82028 110500871
Cardio-respiratory arrest 94.23 23.93 67 6333 115769 110467130
Sialoadenitis 92.24 23.93 23 6377 2650 110580249
Sneezing 84.89 23.93 40 6360 31944 110550955
Extravasation 83.12 23.93 24 6376 4821 110578078
Throat irritation 75.97 23.93 44 6356 53508 110529391
Throat tightness 74.16 23.93 37 6363 33452 110549447
Pruritus 68.09 23.93 121 6279 581439 110001460
Cardiac arrest 65.16 23.93 68 6332 196685 110386214
Pulse absent 63.18 23.93 24 6376 11268 110571631
Anaphylactoid reaction 62.87 23.93 21 6379 6805 110576094
Unresponsive to stimuli 61.51 23.93 41 6359 63749 110519150
Erythema 52.55 23.93 74 6326 291373 110291526
Hypersensitivity 52.35 23.93 88 6312 403910 110178989
Dyspnoea 50.32 23.93 159 6241 1106713 109476186
Kounis syndrome 49.73 23.93 17 6383 5908 110576991
Blood pressure decreased 49.67 23.93 46 6354 115045 110467854
Hepatic artery occlusion 48.75 23.93 8 6392 107 110582792
Oxygen saturation decreased 47.95 23.93 52 6348 156930 110425969
Nephropathy toxic 42.77 23.93 24 6376 27454 110555445
Rapidly progressive osteoarthritis 41.17 23.93 6 6394 34 110582865
Loss of consciousness 40.12 23.93 53 6347 196253 110386646
Cyanosis 38.38 23.93 23 6377 29718 110553181
No adverse event 36.76 23.93 32 6368 73807 110509092
Product physical issue 36.68 23.93 13 6387 5023 110577876
Pharyngeal oedema 35.91 23.93 18 6382 16410 110566489
Vomiting 35.20 23.93 124 6276 910551 109672348
Flushing 34.27 23.93 36 6364 104700 110478199
Foaming at mouth 33.46 23.93 10 6390 2260 110580639
Respiratory arrest 32.57 23.93 27 6373 58272 110524627
Acute kidney injury 32.21 23.93 95 6305 635335 109947564
Chest discomfort 31.08 23.93 44 6356 173804 110409095
Drug ineffective 28.22 23.93 28 6372 1520512 109062387
Nausea 27.31 23.93 142 6258 1235548 109347351
Angioedema 27.25 23.93 31 6369 98469 110484430
Wrong product administered 26.91 23.93 13 6387 10947 110571952
Infusion site extravasation 26.17 23.93 13 6387 11621 110571278
Documented hypersensitivity to administered product 25.76 23.93 7 6393 1127 110581772
Blood pressure immeasurable 24.50 23.93 8 6392 2415 110580484
Spinal cord ischaemia 24.36 23.93 5 6395 239 110582660
Aphasia 24.32 23.93 23 6377 58974 110523925
Product deposit 23.99 23.93 6 6394 699 110582200

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
FDA EPC N0000180185 Radiographic Contrast Agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:37338 radioopaque medium
CHEBI has role CHEBI:78298 environmental contaminant

Related Drugs by ATC class:

V08AB Watersoluble, nephrotropic, low osmolar X-ray contrast media 11 drugs

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
41% ISOVUE-200 BRACCO N018735 July 7, 1987 RX INJECTABLE INJECTION Oct. 10, 2028 FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS
51% ISOVUE-250 BRACCO N018735 July 6, 1992 RX INJECTABLE INJECTION Oct. 10, 2028 FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS
61% ISOVUE-300 BRACCO N018735 Dec. 31, 1985 RX INJECTABLE INJECTION Oct. 10, 2028 FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS
76% ISOVUE-370 BRACCO N018735 Dec. 31, 1985 RX INJECTABLE INJECTION Oct. 10, 2028 FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS

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
206534 MMSL
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 21 sections
ISOVUE200 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1314 INJECTION, SOLUTION 408 mg INTRAVASCULAR NDA 21 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 21 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 21 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 21 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 21 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 21 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 21 sections
ISOVUE250 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1317 INJECTION, SOLUTION 510 mg INTRAVASCULAR NDA 21 sections
ISOVUE250 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1317 INJECTION, SOLUTION 510 mg INTRAVASCULAR NDA 21 sections
ISOVUE-M HUMAN PRESCRIPTION DRUG LABEL 1 0270-1411 INJECTION, SOLUTION 408 mg INTRATHECAL NDA 17 sections
ISOVUE-M HUMAN PRESCRIPTION DRUG LABEL 1 0270-1412 INJECTION, SOLUTION 612 mg INTRATHECAL NDA 17 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
iopamidol HUMAN PRESCRIPTION DRUG LABEL 1 70436-125 INJECTION, SOLUTION 510 mg INTRAVASCULAR ANDA 27 sections
iopamidol HUMAN PRESCRIPTION DRUG LABEL 1 70436-126 INJECTION, SOLUTION 612 mg INTRATHECAL ANDA 21 sections
iopamidol HUMAN PRESCRIPTION DRUG LABEL 1 70436-127 INJECTION, SOLUTION 755 mg INTRAVASCULAR ANDA 27 sections
iopamidol HUMAN PRESCRIPTION DRUG LABEL 1 70436-211 INJECTION, SOLUTION 408 mg INTRAVASCULAR ANDA 27 sections
iopamidol HUMAN PRESCRIPTION DRUG LABEL 1 70436-219 INJECTION, SOLUTION 612 mg INTRAVASCULAR ANDA 27 sections