gadoteridol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
diagnostic agents, gadolinium derivatives 1268 120066-54-8

Description:

MoleculeDescription

Synonyms:

  • gadoteridol
  • Gadolinium-HP-DO 3A
  • ProHance
nonionic magnetic resonance contrast agent; structure given in first source
  • Molecular weight: 557.68
  • Formula: C17H28GdN4O7
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.50 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.60 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 737 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Nov. 16, 1992 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
Nephrogenic systemic fibrosis 625.87 50.28 115 2499 4441 63481967
Skin hypertrophy 262.45 50.28 53 2561 3338 63483070
Skin induration 247.20 50.28 50 2564 3173 63483235
Skin tightness 210.17 50.28 46 2568 4270 63482138
Fibrosis 119.93 50.28 29 2585 4163 63482245
Contrast media deposition 114.29 50.28 15 2599 51 63486357
Skin fibrosis 112.73 50.28 21 2593 859 63485549
Anaphylactic reaction 110.57 50.28 54 2560 66046 63420362
Contrast media reaction 89.43 50.28 18 2596 1107 63485301
Skin hyperpigmentation 86.50 50.28 24 2590 5897 63480511
Scar 85.81 50.28 29 2585 13753 63472655
Anhedonia 79.94 50.28 26 2588 10948 63475460
Emotional distress 74.26 50.28 33 2581 32516 63453892
Joint range of motion decreased 71.17 50.28 32 2582 32396 63454012
Skin discolouration 66.46 50.28 32 2582 37796 63448612
Peau d'orange 63.92 50.28 10 2604 140 63486268
Anaphylactic shock 60.52 50.28 26 2588 23607 63462801
Joint contracture 54.84 50.28 13 2601 1711 63484697

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
Nephrogenic systemic fibrosis 529.12 59.55 101 1674 3904 34951252
Skin induration 196.69 59.55 40 1735 2111 34953045
Skin tightness 177.32 59.55 37 1738 2216 34952940
Skin hypertrophy 177.29 59.55 38 1737 2591 34952565
Contrast media deposition 173.24 59.55 22 1753 39 34955117
Fibrosis 123.04 59.55 28 1747 2508 34952648
Joint contracture 118.98 59.55 26 1749 1935 34953221
Joint range of motion decreased 115.75 59.55 33 1742 7279 34947877
Scar 99.36 59.55 28 1747 5916 34949240
Skin fibrosis 98.67 59.55 20 1755 1032 34954124
Extremity contracture 85.83 59.55 17 1758 779 34954377
Deformity 85.16 59.55 19 1756 1553 34953603
Emotional distress 77.49 59.55 29 1746 14997 34940159
Mobility decreased 73.27 59.55 34 1741 30094 34925062
Anhedonia 71.59 59.55 23 1752 7562 34947594
Pain 63.55 59.55 64 1711 204611 34750545

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
Nephrogenic systemic fibrosis 699.74 50.60 134 3384 6026 79734844
Skin hypertrophy 346.75 50.60 72 3446 4856 79736014
Skin induration 323.51 50.60 67 3451 4458 79736412
Skin tightness 304.58 50.60 66 3452 5456 79735414
Contrast media deposition 258.98 50.60 33 3485 75 79740795
Fibrosis 160.94 50.60 39 3479 5270 79735600
Skin fibrosis 159.35 50.60 31 3487 1493 79739377
Anaphylactic reaction 146.19 50.60 72 3446 83671 79657199
Contrast media reaction 132.52 50.60 28 3490 2042 79738828
Joint range of motion decreased 131.75 50.60 51 3467 33231 79707639
Scar 128.56 50.60 41 3477 15155 79725715
Joint contracture 126.99 50.60 28 3490 2496 79738374
Skin hyperpigmentation 97.45 50.60 28 3490 7275 79733595
Anhedonia 93.13 50.60 32 3486 14866 79726004
Emotional distress 83.72 50.60 39 3479 39930 79700940
Peau d'orange 81.58 50.60 14 3504 331 79740539
Skin discolouration 79.67 50.60 38 3480 40996 79699874
Joint stiffness 76.81 50.60 37 3481 40793 79700077
Anaphylactic shock 71.91 50.60 34 3484 35962 79704908
Mobility decreased 69.30 50.60 51 3467 122124 79618746
Deformity 65.38 50.60 22 3496 9583 79731287
Extremity contracture 64.30 50.60 15 3503 1717 79739153
Shock 57.26 50.60 31 3487 43517 79697353
Pain 53.54 50.60 104 3414 703698 79037172
Pruritus 52.42 50.60 75 3443 394573 79346297

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V08CA04 VARIOUS
CONTRAST MEDIA
MAGNETIC RESONANCE IMAGING CONTRAST MEDIA
Paramagnetic contrast media
MeSH PA D003287 Contrast Media
MeSH PA D064907 Diagnostic Uses of Chemicals
FDA MoA N0000175862 Magnetic Resonance Contrast Activity
FDA EPC N0000180184 Paramagnetic Contrast Agent

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

None




🐶 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
4020572 VUID
N0000148274 NUI
D01137 KEGG_DRUG
4020572 VANDF
C0060930 UMLSCUI
CHEBI:31643 CHEBI
CHEMBL1200593 ChEMBL_ID
DB00597 DRUGBANK_ID
C062402 MESH_SUPPLEMENTAL_RECORD_UI
60714 PUBCHEM_CID
6655 INN_ID
0199MV609F UNII
25483 RXNORM
4220 MMSL
4773 MMSL
d03843 MMSL
004118 NDDF
353946009 SNOMEDCT_US
420600009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ProHance HUMAN PRESCRIPTION DRUG LABEL 1 0270-1111 INJECTION, SOLUTION 279.30 mg INTRAVENOUS NDA 24 sections
ProHance HUMAN PRESCRIPTION DRUG LABEL 1 0270-1111 INJECTION, SOLUTION 279.30 mg INTRAVENOUS NDA 24 sections
ProHance HUMAN PRESCRIPTION DRUG LABEL 1 0270-1111 INJECTION, SOLUTION 279.30 mg INTRAVENOUS NDA 24 sections
ProHance HUMAN PRESCRIPTION DRUG LABEL 1 0270-1111 INJECTION, SOLUTION 279.30 mg INTRAVENOUS NDA 24 sections