Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ferumoxytol non-stoichiometric magnetite
Drug ID BADD_D00890
Description Ferumoxytol is an intravenously administered iron preparation indicated in the EU and the US for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD) [A32478]. It is comprised of superparamagnetic iron oxide nanoparticles which are coated by a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution that may be administered at relatively high dose by rapid intravenous injection [L2181].
Indications and Usage This drug is indicated for the treatment of iron deficiency anemia in adult patients who have experienced intolerance to oral iron or have experienced an unsatisfactory response to oral iron or who have chronic kidney disease (CKD) [FDA label].
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB06215
KEGG ID D04177; D09142
MeSH ID D052203
PubChem ID 6432052
TTD Drug ID D06CTM
NDC Product Code 63552-026
UNII CLH5FT6412
Synonyms Ferrosoferric Oxide | Oxide, Ferrosoferric | Ferriferrous Oxide | Oxide, Ferriferrous | Magnetite | Feraheme | Ferumoxytol
Chemical Information
Molecular Formula Fe3O4
CAS Registry Number 119683-68-0
SMILES [O-2].[O-2].[O-2].[O-2].[Fe+2].[Fe+3].[Fe+3]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Vomiting07.01.07.003-
Wheezing22.03.01.009-
Injection site discolouration23.03.03.046; 12.07.03.038; 08.02.03.038-Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015-Not Available
Eye pruritus06.04.05.006-Not Available
Oral pruritus07.05.05.002-Not Available
Musculoskeletal discomfort15.03.04.001-Not Available
Infusion site swelling12.07.05.003; 08.02.05.002--Not Available
Foetal death08.04.01.011; 18.01.02.003-
Paraesthesia oral07.05.05.035; 17.02.06.008-Not Available
Pulseless electrical activity02.03.04.020-Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027-
Adverse event08.06.01.010-Not Available
Sensation of foreign body08.01.09.002-Not Available
Adverse drug reaction08.06.01.009-Not Available
Infusion site extravasation12.07.05.008; 08.02.05.007-
Chronic kidney disease20.01.03.017--
Adverse reaction08.06.01.018-Not Available
Hypoxic-ischaemic encephalopathy24.04.06.021; 22.02.02.011; 17.13.02.006-Not Available
Anal incontinence17.05.01.021; 07.01.06.029-
Seizure like phenomena17.12.03.030-Not Available
Administration site discolouration23.03.03.070; 12.07.04.017; 08.02.04.017-Not Available
Fishbane reaction15.03.04.020; 08.06.01.039-Not Available
Infusion site discolouration23.03.03.084; 12.07.05.026; 08.02.05.026-Not Available
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