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)
Renal disorder20.01.02.0020.000582%-
Renal pain20.02.03.0030.000246%-
Respiratory distress22.02.01.0120.000470%-
Retching07.01.07.0020.000437%-
Rhinorrhoea22.12.03.021--
Skin disorder23.03.03.0070.000548%-
Skin exfoliation23.03.07.0030.001007%-
Skin reaction10.01.03.019; 23.03.03.013---
Sleep apnoea syndrome17.15.05.001; 19.02.05.002; 22.02.01.0130.000381%
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Thrombocytopenia01.08.01.0020.002138%-
Thrombotic microangiopathy01.01.02.006; 20.01.07.004; 24.01.01.0130.000112%-
Thrombotic thrombocytopenic purpura01.08.01.005; 23.06.01.011; 24.07.06.014--
Tongue blistering07.14.02.0140.000246%-
Toothache07.09.06.0010.000571%
Tumour lysis syndrome14.05.01.004; 16.32.03.002--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Vision blurred06.02.06.007; 17.17.01.0100.002619%
Visual impairment06.02.10.0130.002071%-
Vomiting07.01.07.0030.015289%
Cardiotoxicity02.11.01.009; 12.03.01.0070.000246%-
Hypoacusis04.02.01.0060.000604%
Seasonal allergy06.04.01.013; 10.01.04.001; 22.04.04.0080.000112%-
Performance status decreased08.01.03.042---
Peripheral swelling02.05.04.015; 08.01.03.0530.008171%-
General physical health deterioration08.01.03.0180.001198%-
Muscle tightness15.05.03.0070.000437%-
Balance disorder08.01.03.081; 17.02.02.0070.001813%-
Dysstasia08.01.03.089; 15.03.05.011; 17.02.02.0120.000246%-
Musculoskeletal chest pain15.03.04.012; 22.09.01.0010.000627%
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