Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bortezomib
Drug ID BADD_D00284
Description Bortezomib is a dipeptide boronic acid derivative and proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma.[A204083] The 26S proteasome is a protein complex that degrades ubiquitinated proteins in the ubiquitin-proteasome pathway: reversible inhibition of the 26S proteasome, leading to cell cycle arrest and apoptosis of cancer cells, is thought to be the main mechanism of action of bortezomib.[L14180] However, multiple mechanisms may be involved in the anticancer activity of bortezomib.[A204083] Bortezomib was first synthesized in 1995.[A204083] In May 2003, bortezomib became the first anticancer proteasome inhibitor that was approved by the FDA under the trade name VELCADE.[A204146] Phase I, II, III, and IV clinical trials are undergoing to investigate the therapeutic efficacy of bortezomib in leukemia, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, and solid tumours.[A214307]
Indications and Usage Bortezomib is indicated for the treatment of adult patients with multiple myeloma or mantle cell lymphoma.[L14177]
Marketing Status approved; investigational
ATC Code L01XG01
DrugBank ID DB00188
KEGG ID D03150
MeSH ID D000069286
PubChem ID 387447
TTD Drug ID D0SH3I
NDC Product Code 62158-0011; 65129-1264; 0409-1703; 70710-1411; 51817-586; 68001-541; 14096-140; 0143-9098; 67184-0530; 71288-118; 72205-183; 63323-821; 12502-5268; 42385-716; 55111-922; 63323-721; 68001-534; 48957-0018; 10019-991; 70225-1102; 50742-484; 70511-161; 47848-031; 54893-0011; 66529-0006; 76055-0027; 82920-006; 0409-1704; 70771-1708; 72266-243; 72266-244; 54245-7004; 62207-972; 67184-0026; 60505-6050; 70511-162; 25021-244; 68001-540; 42973-140; 55150-337; 63020-049; 0409-1700; 70860-225; 62756-982; 68554-0051; 78848-009
UNII 69G8BD63PP
Synonyms Bortezomib | LDP-341 | LDP 341 | LDP341 | PS 341 | 341, PS | PS-341 | PS341 | Velcade
Chemical Information
Molecular Formula C19H25BN4O4
CAS Registry Number 179324-69-7
SMILES B(C(CC(C)C)NC(=O)C(CC1=CC=CC=C1)NC(=O)C2=NC=CN=C2)(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)
Pigmentation disorder23.05.03.001--Not Available
Venoocclusive disease24.03.02.0160.000112%Not Available
Urine analysis abnormal13.13.02.008--Not Available
Renal impairment20.01.03.010--Not Available
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Non-cardiac chest pain22.12.02.009; 08.01.08.0060.000112%
Increased upper airway secretion22.12.03.007--Not Available
Brain stem syndrome17.02.10.016--Not Available
Jessner's lymphocytic infiltration23.03.08.009; 01.02.01.010--Not Available
Hypophagia07.01.06.010; 19.09.01.004; 14.03.01.0060.000280%Not Available
Gastrointestinal inflammation07.08.03.007--Not Available
Osteonecrosis of jaw24.04.05.005; 15.02.04.0100.000783%
Device related infection11.01.08.018; 08.07.01.005--
Infusion site extravasation12.07.05.008; 08.02.05.0070.000437%
Chronic kidney disease20.01.03.0170.000448%
Procedural pain12.02.05.007; 08.01.08.009--Not Available
Bronchial disorder22.03.02.009--Not Available
Supraventricular tachyarrhythmia02.03.03.0140.000112%Not Available
Bone marrow failure01.03.03.0050.002295%
Bronchial hyperreactivity22.03.01.016--Not Available
Acute graft versus host disease12.02.09.002; 10.02.01.0280.000392%Not Available
Chronic graft versus host disease12.02.09.003; 10.02.01.0290.000336%Not Available
Cytopenia01.03.03.0120.000616%Not Available
Injection site streaking12.07.03.039; 08.02.03.0390.000381%Not Available
Injection site dryness23.03.03.056; 12.07.03.045; 08.02.03.0450.000571%Not Available
Organising pneumonia22.01.02.0080.000224%Not Available
Adverse reaction08.06.01.0180.000437%Not Available
Oral disorder07.05.01.005--Not Available
Toxic neuropathy17.09.03.017; 12.03.01.055--Not Available
Skin mass23.07.04.014--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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