Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ferrosoferric oxide
Drug ID BADD_D00886
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 14789
TTD Drug ID D06CTM
NDC Product Code 69766-104; 0781-3154; 59338-775; 42973-331
UNII XM0M87F357
Synonyms Ferrosoferric Oxide | Oxide, Ferrosoferric | Ferriferrous Oxide | Oxide, Ferriferrous | Magnetite | Feraheme | Ferumoxytol
Chemical Information
Molecular Formula Fe3H2O4
CAS Registry Number 1317-61-9
SMILES O[Fe]=O.O[Fe]=O.[Fe]
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)
Laryngeal oedema10.01.05.003; 22.04.02.001; 23.04.01.005--
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.007---
Loss of consciousness17.02.04.004---
Malignant hypertension24.08.01.002---
Menopausal symptoms21.02.02.002---
Muscle spasms15.05.03.004--
Muscular weakness15.05.06.001; 17.05.03.005--
Myalgia15.05.02.001--
Myocardial infarction02.02.02.007; 24.04.04.009--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Night sweats08.01.03.031; 23.02.03.006---
Oedema08.01.07.006; 14.05.06.010---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Oxygen saturation decreased13.02.01.004---
Pain08.01.08.004--
Paraesthesia17.02.06.005; 23.03.03.094--
Pharyngeal oedema10.01.05.016; 22.04.05.003; 23.04.01.016---
Prurigo23.03.04.017---
Pruritus23.03.12.001--
Pulse absent13.14.04.005---
Pyrexia08.05.02.003--
Rash23.03.13.001---
Respiratory arrest22.02.01.009---
Respiratory failure14.01.04.003; 22.02.06.002--
Serum ferritin increased13.11.01.026---
Shock24.06.02.002---
Skin hyperpigmentation23.05.01.003--
Somnolence17.02.04.006; 19.02.05.003--
Swelling08.01.03.015---
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