gadoterate meglumine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
diagnostic agents, gadolinium derivatives 1267 92943-93-6

Description:

MoleculeDescription

Synonyms:

  • dotarem
  • gadoterate meglumine
  • magnescope
  • Gd-DOTA meglumine
  • Molecular weight: 753.86
  • Formula: C23H42GdN5O13
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 20, 2013 FDA GUERBET

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
Urticaria 533.15 48.42 237 3668 117655 46564502
Pruritus 247.88 48.42 185 3720 242167 46439990
Erythema 243.96 48.42 150 3755 142670 46539487
Sneezing 167.31 48.42 56 3849 12685 46669472
Dyspnoea 153.21 48.42 200 3705 515348 46166809
Throat irritation 142.03 48.42 62 3843 28839 46653318
Product use in unapproved indication 141.46 48.42 90 3815 90183 46591974
Cough 102.00 48.42 110 3795 230139 46452018
Vomiting 101.65 48.42 154 3751 452640 46229517
Contrast media reaction 95.08 48.42 21 3884 984 46681173
Nausea 75.68 48.42 172 3733 687282 45994875
Feeling hot 72.46 48.42 43 3862 37885 46644272
Type I hypersensitivity 68.13 48.42 19 3886 2327 46679830
Throat tightness 63.28 48.42 32 3873 20607 46661550
Laryngeal discomfort 56.14 48.42 11 3894 284 46681873
Chest discomfort 54.22 48.42 51 3854 90218 46591939
Laryngeal oedema 49.09 48.42 18 3887 5301 46676856
Rash 49.02 48.42 98 3807 356414 46325743

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
Urticaria 344.88 52.11 120 1336 54486 29896536
Pruritus 141.06 52.11 81 1375 118123 29832899
Erythema 133.98 52.11 68 1388 77383 29873639
Nausea 96.87 52.11 93 1363 296864 29654158
Vomiting 91.37 52.11 79 1377 219739 29731283
Nephrogenic systemic fibrosis 66.71 52.11 19 1437 4352 29946670
Throat irritation 65.90 52.11 22 1434 8526 29942496

Pharmacologic Action:

SourceCodeDescription
MeSH PA D003287 Contrast Media
MeSH PA D064907 Diagnostic Uses of Chemicals

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Magnetic resonance imaging indication 113091000

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
4032690 VUID
N0000188988 NUI
4032690 VANDF
C0114857 UMLSCUI
CHEBI:73727 CHEBI
CHEMBL2219415 ChEMBL_ID
C072417 MESH_SUPPLEMENTAL_RECORD_UI
6918037 PUBCHEM_CID
L0ND3981AG UNII
1421151 RXNORM
29771 MMSL
92135 MMSL
d06307 MMSL
006172 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CLARISCAN HUMAN PRESCRIPTION DRUG LABEL 1 0407-2943 INJECTION, SOLUTION 376.90 mg INTRAVENOUS ANDA 33 sections
CLARISCAN HUMAN PRESCRIPTION DRUG LABEL 1 0407-2943 INJECTION, SOLUTION 376.90 mg INTRAVENOUS ANDA 33 sections
DOTAREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-2000 Injection 376.90 mg Intravenous NDA 29 sections
DOTAREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-2000 Injection 376.90 mg Intravenous NDA 29 sections
DOTAREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-2001 Injection 376.90 mg Intravenous NDA 29 sections
DOTAREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-2001 Injection 376.90 mg Intravenous NDA 29 sections
DOTAREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-3001 Injection 376.90 mg Intravenous NDA 29 sections