sucroferric oxyhydroxide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5121 8047-67-4

Description:

MoleculeDescription

Synonyms:

  • ferric oxyhydroxide
  • sucroferric oxyhydroxide
  • velphoro
  • ferric oxide saccharated
  • saccharated iron oxide
an oral phosphate binder for treatment of hyperphosphatemia
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.11 g O
1.50 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Nov. 27, 2013 FDA VIFOR FRESENIUS

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
Death 296.02 45.23 155 1255 357077 52990579
Shunt stenosis 86.79 45.23 14 1396 384 53347272
Diarrhoea 75.81 45.23 87 1323 625459 52722197
Loss of employment 68.00 45.23 14 1396 1513 53346143
Product taste abnormal 57.97 45.23 13 1397 2100 53345556
Shunt occlusion 55.12 45.23 10 1400 555 53347101
Gastric disorder 48.64 45.23 21 1389 30144 53317512
Hepatic steatosis 48.05 45.23 20 1390 26239 53321417

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
Death 599.58 36.52 300 1185 382217 32129824
Shunt stenosis 146.14 36.52 25 1460 563 32511478
Haemoglobin increased 131.30 36.52 30 1455 3052 32508989
Faeces discoloured 108.02 36.52 36 1449 14841 32497200
Shunt occlusion 82.57 36.52 16 1469 729 32511312
Diarrhoea 71.79 36.52 85 1400 364717 32147324
Product taste abnormal 68.80 36.52 15 1470 1227 32510814
Tooth discolouration 42.50 36.52 8 1477 311 32511730
Transferrin saturation increased 38.99 36.52 6 1479 67 32511974
Haematocrit increased 38.33 36.52 10 1475 1753 32510288

Pharmacologic Action:

SourceCodeDescription
ATC B03AB02 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
IRON PREPARATIONS
Iron trivalent, oral preparations
ATC V03AE05 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Drugs for treatment of hyperkalemia and hyperphosphatemia
FDA MoA N0000020074 Phosphate Chelating Activity
FDA EPC N0000175597 Phosphate Binder

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hyperphosphatemia indication 20165001 DOID:0050459

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 500MG IRON VELPHORO VIFOR FRESENIUS N205109 Nov. 27, 2013 RX TABLET, CHEWABLE ORAL 9561251 Jan. 23, 2030 CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
20344-49-4 SECONDARY_CAS_RN
D04616 KEGG_DRUG
4021278 VANDF
4033084 VANDF
C3696416 UMLSCUI
CHEMBL3039566 ChEMBL_ID
91663255 PUBCHEM_CID
DB09146 DRUGBANK_ID
CHEMBL1200823 ChEMBL_ID
C000599459 MESH_SUPPLEMENTAL_RECORD_UI
C092844 MESH_SUPPLEMENTAL_RECORD_UI
87PZU03K0K UNII
DB14695 DRUGBANK_ID
1484283 RXNORM
15814 MMSL
221324 MMSL
30331 MMSL
30334 MMSL
d04725 MMSL
d08266 MMSL
007471 NDDF
008975 NDDF
015366 NDDF
129497004 SNOMEDCT_US
387206004 SNOMEDCT_US
421953007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Velphoro HUMAN PRESCRIPTION DRUG LABEL 1 49230-645 TABLET, CHEWABLE 500 mg ORAL NDA 26 sections