ferric carboxymaltose Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5128 53858-86-9

Description:

MoleculeDescription

Synonyms:

  • ferric carboxymaltose
  • injectafer
  • iron dextri-maltose
effective for treatment of postpartum anemia
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 25, 2013 FDA LUITPOLD

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
Hypophosphataemia 615.66 25.56 166 9487 7201 46669208
Urticaria 290.38 25.56 220 9433 117672 46558737
Pruritus 242.52 25.56 273 9380 242079 46434330
Infusion site discolouration 235.86 25.56 47 9606 509 46675900
Maternal exposure during pregnancy 181.51 25.56 158 9495 102391 46574018
Flushing 173.03 25.56 127 9526 64487 46611922
Blood phosphorus decreased 153.42 25.56 49 9604 3831 46672578
Infusion site extravasation 146.50 25.56 51 9602 5205 46671204
Extravasation 136.65 25.56 39 9614 2076 46674333
Chest discomfort 126.26 25.56 122 9531 90147 46586262
Tachycardia 125.20 25.56 127 9526 99495 46576914
Dyspnoea 122.17 25.56 303 9350 515245 46161164
Drug ineffective 104.64 25.56 10 9643 677828 45998581
Exposure during pregnancy 104.42 25.56 120 9533 108092 46568317
Nausea 95.43 25.56 334 9319 687120 45989289
Skin discolouration 91.36 25.56 66 9587 32614 46643795
Respiratory distress 66.23 25.56 54 9599 31862 46644547
Serum ferritin increased 63.96 25.56 28 9625 5255 46671154
Circulatory collapse 63.46 25.56 45 9608 21579 46654830
Dizziness 61.94 25.56 182 9471 340232 46336177
Product preparation error 60.84 25.56 25 9628 4014 46672395
Anhedonia 59.51 25.56 33 9620 10302 46666107
Erythema 59.31 25.56 106 9547 142714 46533695
Infusion site pain 57.45 25.56 32 9621 10075 46666334
Headache 56.37 25.56 221 9432 478131 46198278
Angioedema 54.57 25.56 53 9600 39289 46637120
Myalgia 53.20 25.56 93 9560 122995 46553414
Suspected product quality issue 51.68 25.56 11 9642 168 46676241
Product quality issue 51.28 25.56 49 9604 35599 46640810
Throat irritation 49.90 25.56 44 9609 28857 46647552
Hyperventilation 49.75 25.56 24 9629 5623 46670786
Iron overload 48.99 25.56 14 9639 748 46675661
Osteomalacia 46.44 25.56 13 9640 644 46675765
Rash 46.25 25.56 170 9483 356342 46320067
Pneumonia 45.52 25.56 11 9642 376309 46300100
Chest pain 44.92 25.56 107 9546 176217 46500192
Anaphylactoid reaction 43.88 25.56 19 9634 3472 46672937
Feeling hot 43.30 25.56 46 9607 37882 46638527
Throat tightness 42.97 25.56 35 9618 20604 46655805
Anaphylactic reaction 41.50 25.56 53 9600 53059 46623350
Emotional distress 40.03 25.56 40 9613 30667 46645742
Presyncope 35.90 25.56 34 9619 24420 46651989
Hypotension 35.36 25.56 117 9536 232472 46443937
Vomiting 35.06 25.56 185 9468 452609 46223800
Death 34.77 25.56 13 9640 335535 46340874
Influenza like illness 33.74 25.56 50 9603 57520 46618889
Bronchospasm 33.46 25.56 27 9626 15680 46660729
Malaise 32.56 25.56 145 9508 331087 46345322
Paraesthesia 31.76 25.56 73 9580 117364 46559045
Urine phosphorus increased 31.61 25.56 5 9648 11 46676398
Hypersensitivity 30.74 25.56 84 9569 150237 46526172
Fall 30.51 25.56 15 9638 329082 46347327
Chills 29.69 25.56 63 9590 95969 46580440
Drug hypersensitivity 29.69 25.56 7 9646 243818 46432591
Hyperphosphaturia 29.58 25.56 5 9648 19 46676390
Ear swelling 28.36 25.56 10 9643 1058 46675351
Pallor 28.04 25.56 29 9624 23137 46653272
Loss of consciousness 26.78 25.56 65 9588 108173 46568236

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
Hypophosphataemia 208.36 29.52 55 1650 8190 29942583
Osteomalacia 64.53 29.52 14 1691 894 29949879
Hypophosphataemic osteomalacia 63.26 29.52 10 1695 106 29950667
Fibroblast growth factor 23 increased 43.88 29.52 5 1700 0 29950773
Blood phosphorus decreased 43.57 29.52 13 1692 2979 29947794
Extravasation 40.41 29.52 11 1694 1817 29948956
Foetal exposure during pregnancy 34.29 29.52 23 1682 36848 29913925
Skin discolouration 33.95 29.52 17 1688 15777 29934996
Malaise 30.23 29.52 42 1663 166920 29783853

Pharmacologic Action:

None

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Iron deficiency anemia indication 87522002

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
9007-72-1 SECONDARY_CAS_RN
D08920 KEGG_DRUG
4032651 VANDF
C2001867 UMLSCUI
CHEMBL2108597 ChEMBL_ID
DB08917 DRUGBANK_ID
C522335 MESH_SUPPLEMENTAL_RECORD_UI
8853 INN_ID
6897GXD6OE UNII
86278165 PUBCHEM_CID
1433693 RXNORM
204720 MMSL
29586 MMSL
d07305 MMSL
012722 NDDF
430077004 SNOMEDCT_US
430819007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Injectafer HUMAN PRESCRIPTION DRUG LABEL 1 0517-0620 INJECTION, SOLUTION 50 mg INTRAVENOUS NDA 26 sections
Injectafer HUMAN PRESCRIPTION DRUG LABEL 1 0517-0650 INJECTION, SOLUTION 50 mg INTRAVENOUS NDA 26 sections