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)
Malignant neoplasm progression16.16.01.0050.001679%Not Available
Ocular discomfort06.08.03.0080.000168%Not Available
Oesophageal rupture12.01.17.015; 07.04.05.0050.000112%Not Available
Musculoskeletal discomfort15.03.04.0010.000246%Not Available
Febrile bone marrow aplasia08.05.02.005; 01.03.03.0070.000112%Not Available
Depressive symptom19.15.02.0030.001713%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000548%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.001903%
Cancer pain16.32.03.0040.000112%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.006--Not Available
Neurological symptom17.02.05.0100.001679%Not Available
Adverse event08.06.01.0100.056501%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000112%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000302%Not Available
Haematotoxicity12.03.01.025; 01.05.01.0070.000168%Not Available
Paraproteinaemia16.23.01.001; 01.14.01.0010.000112%Not Available
Partial seizures17.12.03.0100.000112%Not Available
Spinal disorder15.02.04.0230.000246%Not Available
Anal cancer16.13.05.001; 07.21.05.0010.000112%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.004869%
Polyp16.02.02.005; 08.01.06.0100.000112%Not Available
Bone lesion15.02.04.0160.000168%Not Available
Disease progression08.01.03.0380.003940%
Cytopenia01.03.03.0120.000448%Not Available
Adverse reaction08.06.01.0180.000302%Not Available
Posterior reversible encephalopathy syndrome17.13.02.007--
Plasma cell myeloma recurrent16.23.02.006; 01.14.02.0060.001903%Not Available
End stage renal disease20.01.03.0190.000112%Not Available
Burning feet syndrome23.06.05.010; 17.02.06.038; 15.03.04.0190.000381%Not Available
Disease complication08.01.03.0870.000168%Not Available
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