Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Ixazomib
Drug ID BADD_D01223
Description Ixazomib a second generation proteasome inhibitor (PI) and the first oral PI approved by the FDA in November 2015 for multiple myeloma treatment in combination with 2 other therapies (lenalidomide and dexamethasone) for patients who have received at least 1 prior therapy. It was found to have similar efficacy to bortezomib (the first PI approved for multiple myeloma therapy) in the control of myeloma growth and prevention of bone loss. Ixazomib citrate is marketed by Takeda Pharmaceuticals under the brand name Ninlaro, which is a prodrug that becomes quickly converted to its active metabolite, ixazomib, after administration.
Indications and Usage Ixazomib is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Marketing Status approved; investigational
ATC Code L01XG03
DrugBank ID DB09570
KEGG ID D10130
MeSH ID C548400
PubChem ID 25183872
TTD Drug ID Not Available
NDC Product Code 63020-078; 63020-400; 63020-230; 63020-079; 63020-080; 63020-390
UNII 71050168A2
Synonyms ixazomib | MLN 9708 | MLN9708 | MLN-9708 | Ninlaro
Chemical Information
Molecular Formula C14H19BCl2N2O4
CAS Registry Number 1072833-77-2
SMILES B(C(CC(C)C)NC(=O)CNC(=O)C1=C(C=CC(=C1)Cl)Cl)(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)
Erythema multiforme23.03.01.003; 10.01.03.0150.000168%
Eye discharge06.04.05.0010.000381%Not Available
Eye disorder06.08.03.0010.000739%Not Available
Eye swelling06.08.03.0030.000873%Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.0040.000112%Not Available
Fatigue08.01.01.0020.019655%
Fluid retention20.01.02.003; 14.05.06.0020.001063%Not Available
Food poisoning12.03.01.024; 11.07.02.001; 07.11.01.0070.000246%Not Available
Gastric ulcer07.04.03.0020.000302%
Generalised oedema14.05.06.007; 08.01.07.0040.000246%
Gingival pain07.09.13.0100.000437%
Groin pain15.03.02.0040.000437%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.000224%Not Available
Hair texture abnormal23.02.06.0040.000246%
Head discomfort17.02.05.0270.000302%Not Available
Hepatotoxicity09.01.07.009; 12.03.01.008--Not Available
Hiccups22.12.01.001; 07.01.06.0090.000492%
Hypersomnia19.02.05.001; 17.15.01.0010.000437%
Hyperthermia12.05.01.002; 08.05.01.0010.000112%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.0230.003794%Not Available
Hypoalbuminaemia14.10.01.002; 09.01.02.0030.000168%
Hypocalcaemia14.04.01.0040.000280%
Hypogeusia07.14.03.002; 17.02.07.0040.000437%Not Available
Immune system disorder10.02.01.0010.000571%Not Available
Increased tendency to bruise24.07.06.012; 23.06.01.009; 01.01.03.0050.000381%Not Available
Lacrimation increased06.08.02.0040.000437%
Lung disorder22.02.07.0010.000582%Not Available
Lymphoma16.20.01.001; 01.12.01.0010.000112%Not Available
Malaise08.01.01.0030.006402%
Mass08.03.05.0030.000112%Not Available
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