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)
Hypovolaemia14.05.05.002---
Hypovolaemic shock24.06.02.0170.000112%-
Hypoxia22.02.02.0030.000392%
Ichthyosis03.05.01.004; 23.01.02.002---
Ichthyosis acquired23.01.02.001---
Ileus07.13.01.0010.000336%
Ileus paralytic07.02.05.0010.000504%-
Immune system disorder10.02.01.001---
Impaired healing08.03.02.001---
Increased appetite08.01.09.027; 14.03.01.003---
Infection11.01.08.002---
Infertility21.03.02.001---
Influenza11.05.03.001; 22.07.02.001---
Injection site bruising08.02.03.042; 12.07.03.042; 23.03.11.015; 24.07.06.0170.002093%-
Injection site erythema08.02.03.001; 12.07.03.001; 23.03.06.0150.013028%-
Injection site extravasation08.02.03.002; 12.07.03.0020.000381%-
Injection site haemorrhage08.02.03.005; 12.07.03.005; 24.07.01.010---
Injection site induration08.02.03.007; 12.07.03.0070.000873%-
Injection site inflammation08.02.03.008; 12.07.03.0090.000381%-
Injection site irritation08.02.03.027; 12.07.03.0270.001198%-
Injection site pain08.02.03.010; 12.07.03.0110.005955%-
Injection site phlebitis08.02.03.011; 12.07.03.012; 24.12.03.003---
Injection site pruritus08.02.03.013; 12.07.03.014; 23.03.12.0070.002586%-
Injection site rash08.02.03.032; 12.07.03.032; 23.03.13.0100.001903%-
Injection site reaction08.02.03.014; 12.07.03.0150.006559%
Injection site ulcer08.02.03.016; 12.07.03.017; 23.07.03.0120.000112%-
Injection site urticaria08.02.03.029; 10.01.06.003; 12.07.03.029; 23.04.02.0030.001142%-
Injection site vesicles08.02.03.051; 12.07.03.051; 23.03.01.0240.000492%-
Injection site warmth08.02.03.036; 12.07.03.0360.000761%-
Insomnia17.15.03.002; 19.02.01.002--
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ADReCS-Target
Drug Name ADR Term Target
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