gadoterate meglumine 🐶 Veterinary Use | 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 630.96 49.85 277 4100 129284 50471463
Erythema 287.03 49.85 170 4207 146244 50454503
Pruritus 265.11 49.85 208 4169 283360 50317387
Sneezing 199.38 49.85 66 4311 13978 50586769
Dyspnoea 173.47 49.85 223 4154 547385 50053362
Throat irritation 156.66 49.85 68 4309 30171 50570576
Product use in unapproved indication 145.70 49.85 102 4275 115717 50485030
Cough 120.89 49.85 125 4252 241139 50359608
Vomiting 116.95 49.85 169 4208 460589 50140158
Contrast media reaction 111.00 49.85 24 4353 983 50599764
Nausea 89.96 49.85 191 4186 705207 49895540
Feeling hot 74.94 49.85 45 4332 39157 50561590
Throat tightness 73.72 49.85 36 4341 20811 50579936
Chest discomfort 69.08 49.85 60 4317 92662 50508085
Type I hypersensitivity 67.18 49.85 19 4358 2366 50598381
Gadolinium deposition disease 65.33 49.85 10 4367 52 50600695
Laryngeal discomfort 56.19 49.85 11 4366 273 50600474
Eye swelling 54.38 49.85 29 4348 20115 50580632

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 389.72 50.45 136 1506 54524 29518361
Pruritus 155.35 50.45 90 1552 116759 29456126
Erythema 144.05 50.45 74 1568 75532 29497353
Nausea 101.15 50.45 100 1542 289155 29283730
Vomiting 98.43 50.45 86 1556 212174 29360711
Throat irritation 78.06 50.45 26 1616 8759 29564126
Nephrogenic systemic fibrosis 66.14 50.45 19 1623 3923 29568962
Dyspnoea 52.06 50.45 76 1566 326656 29246229

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
Urticaria 928.64 55.51 385 5553 146932 64345862
Erythema 411.06 55.51 239 5699 186831 64305963
Pruritus 410.07 55.51 288 5650 312112 64180682
Sneezing 241.29 55.51 79 5859 15172 64477622
Throat irritation 226.26 55.51 92 5846 32619 64460175
Dyspnoea 200.00 55.51 284 5654 718390 63774404
Vomiting 189.95 55.51 242 5696 550875 63941919
Product use in unapproved indication 168.19 55.51 135 5803 176483 64316311
Nausea 168.11 55.51 275 5663 785525 63707269
Cough 151.01 55.51 161 5777 301987 64190807
Contrast media reaction 131.22 55.51 31 5907 1781 64491013
Feeling hot 88.27 55.51 54 5884 45609 64447185
Gadolinium deposition disease 84.37 55.51 13 5925 66 64492728
Type I hypersensitivity 83.64 55.51 25 5913 3549 64489245
Nephrogenic systemic fibrosis 83.04 55.51 28 5910 5864 64486930
Throat tightness 82.47 55.51 41 5897 23119 64469675
Eye swelling 78.03 55.51 39 5899 22242 64470552
Chest discomfort 76.34 55.51 72 5866 116034 64376760
Laryngeal discomfort 66.14 55.51 14 5924 485 64492309
Rash 63.71 55.51 134 5804 458415 64034379
Laryngeal oedema 63.13 55.51 24 5914 7089 64485705
Eyelid oedema 63.06 55.51 28 5910 12251 64480543
Anaphylactic reaction 55.78 55.51 48 5890 68616 64424178

FDA Adverse Event Reporting System (Pediatric)

None

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




🐶 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
4032690 VUID
N0000188988 NUI
4032690 VANDF
C0118538 UMLSCUI
CHEBI:73727 CHEBI
CHEMBL2219415 ChEMBL_ID
C072417 MESH_SUPPLEMENTAL_RECORD_UI
121841 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
Gadoterate Meglumine HUMAN PRESCRIPTION DRUG LABEL 1 65219-080 INJECTION 376.90 mg INTRAVENOUS ANDA 29 sections
Gadoterate Meglumine HUMAN PRESCRIPTION DRUG LABEL 1 65219-082 INJECTION 376.90 mg INTRAVENOUS ANDA 29 sections
Gadoterate Meglumine HUMAN PRESCRIPTION DRUG LABEL 1 65219-084 INJECTION 376.90 mg INTRAVENOUS ANDA 29 sections
Gadoterate Meglumine HUMAN PRESCRIPTION DRUG LABEL 1 65219-086 INJECTION 376.90 mg INTRAVENOUS ANDA 29 sections
DOTAREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-2000 Injection 376.90 mg Intravenous NDA 29 sections
DOTAREM HUMAN PRESCRIPTION DRUG LABEL 1 67684-2000 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