Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cefiderocol
Drug ID BADD_D02541
Description Cefiderocol is a cephalosporin antibacterial drug and exerts a mechanism of action similar to other β-lactam antibiotics.[FDA Label] Unlike other agents in this category, cefiderocol is a siderophore able to undergo active transport into the bacterial cell through iron channels.[A189057] It represents a significant addition to antibacterial treatment option as it has proven to be effective *in vitro* against multidrug resistant strains including extended spectrum β-lactamase producers and carbapenemase producing bacteria. Cefiderocol was granted designation as a Qualified Infectious Disease Product and granted priority review status by the FDA on November 14, 2019.[L10893] It is indicated for use in complicated urinary tract infections in patients with limited or no alternative treatments available.[FDA Label] This indication was supported by a positive clinical trial composed of 448 patients with complicated urinary tract infections which demonstrated a 72.6% rate of symptom resolution and bacterial eradication with cefiderocol compared to 54.6% with the comparator, imipenem/cilastatin.[A189150] A concern noted in the trial was a 0.3% higher rate of all cause mortality, the cause of which has not been determined.
Indications and Usage Cefiderocol is indicated for the treatment of complicated urinary tract infections with or without pyelonephritis.[FDA Label]
Marketing Status approved; investigational
ATC Code J01DI04
DrugBank ID DB14879
KEGG ID D11302
MeSH ID C000612166
PubChem ID 77843966
TTD Drug ID D0Q7MA
NDC Product Code Not Available
UNII SZ34OMG6E8
Synonyms cefiderocol | S-649266
Chemical Information
Molecular Formula C30H34ClN7O10S2
CAS Registry Number 1225208-94-5
SMILES CC(C)(C(=O)O)ON=C(C1=CSC(=N1)N)C(=O)NC2C3N(C2=O)C(=C(CS3)C[N+]4(CCCC4)CCNC(=O)C5 =C(C(=C(C=C5)O)O)Cl)C(=O)[O-]
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)
Cardiac arrest02.03.04.0010.000049%
Cholestasis09.01.01.0010.000049%Not Available
Chromaturia20.02.01.0020.000165%
Condition aggravated08.01.03.0040.000049%Not Available
Death08.04.01.0010.000365%
Hepatic function abnormal09.01.02.0010.000073%Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.0030.000049%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.0050.000049%
Drug resistance08.06.01.0050.000131%Not Available
Treatment failure08.06.01.0170.000194%Not Available
Acute kidney injury20.01.03.0160.000073%
Hepatic cytolysis09.01.07.0360.000073%Not Available
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