Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sodium ferric gluconate complex
Drug ID BADD_D02038
Description Sodium ferric gluconate complex is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 – 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate. It is used in adult and in pediatric patients over the age of 6 years with chronic kidney disease (CKD) receiving hemodialysis and receiving supplemental epoetin therapy.
Indications and Usage Used to replete the total body content of iron during iron deficiency anemia in patients age 6 years and older with chronic kidney disease receiving hemodialysis and receiving supplemental epoetin therapy.
Marketing Status approved
ATC Code Not Available
DrugBank ID DB09517
KEGG ID D05859
MeSH ID C035552
PubChem ID 23693558
TTD Drug ID D0VM8K
NDC Product Code 0024-2794; 0024-2792; 44498-001; 68022-7505
UNII CC9149U2QX
Synonyms ferric gluconate | ferric gluconate trihydrate | ferric gluconate anhydrous | sodium iron(III)gluconate | sodium ferrigluconate | ferric gluconate, sodium salt | Ferrlecit | Ferrlecit 100
Chemical Information
Molecular Formula C6H11FeNaO7+3
CAS Registry Number 34089-81-1
SMILES C(C(C(C(C(C(=O)[O-])O)O)O)O)O.[Na+].[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)
Skin discolouration23.03.03.005--
Skin warm23.03.03.014--
Somnolence17.02.04.006; 19.02.05.003--
Swelling08.01.03.015--
Swelling face08.01.03.100; 10.01.05.018; 23.04.01.018--
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.014--
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012-
Tachycardia02.03.02.007--
Tension19.06.02.005---
Throat irritation07.05.05.037; 22.12.03.029--
Throat tightness19.01.02.005; 22.12.03.031--
Thrombosis24.01.01.006---
Tinnitus04.04.01.002; 17.04.07.004-
Tremor17.01.06.002-
Unresponsive to stimuli17.02.05.031--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urinary incontinence17.05.01.008; 20.02.02.010-
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria10.01.06.001; 23.04.02.001-
Vasodilatation23.06.05.006; 24.03.02.003---
Visual impairment06.02.10.013---
Vomiting07.01.07.003-
Wheezing22.03.01.009--
Mental status changes19.07.01.001--
Peripheral swelling02.05.04.015; 08.01.03.053--
Muscle tightness15.05.03.007--
Balance disorder08.01.03.081; 17.02.02.007--
Uterine contractions during pregnancy18.08.02.005--
Injection site discolouration08.02.03.038; 12.07.03.038; 23.03.03.046--
Acute coronary syndrome02.02.02.015; 24.04.04.011---
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