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)
Renal cell carcinoma16.08.02.002; 20.01.04.003---
Oropharyngeal blistering07.05.05.006; 22.12.03.014---
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Injection site exfoliation08.02.03.030; 12.07.03.030; 23.03.07.0080.000492%-
Acute kidney injury20.01.03.016--
Upper-airway cough syndrome22.12.03.036--
Posterior reversible encephalopathy syndrome17.13.02.0070.000560%
Functional gastrointestinal disorder07.11.01.016---
Ophthalmic herpes simplex06.04.05.019; 11.05.02.017---
Candida infection11.03.03.021--
Aspergillus infection11.03.01.004---
Peripheral venous disease24.04.02.022---
Complication associated with device08.07.01.011---
Multiple organ dysfunction syndrome08.01.03.0570.000783%
Anal incontinence07.01.06.029; 17.05.01.0210.000302%
B-cell small lymphocytic lymphoma01.15.06.001; 16.28.06.0010.000112%-
Bone cancer15.09.03.012; 16.29.02.0020.000224%-
Concomitant disease aggravated08.01.03.0630.000224%-
Metastases to bone15.09.03.006; 16.22.02.0050.000168%-
Starvation14.03.02.0250.000246%-
Terminal state08.01.03.079---
Diffuse alveolar damage22.01.01.0190.000112%-
Plasmablastic lymphoma01.17.01.004; 16.35.01.0040.000112%-
Cardiorenal syndrome02.05.01.012; 20.01.03.0180.000112%-
Acute lung injury22.01.03.0100.000224%-
Spinal pain08.01.08.030; 15.02.01.008; 17.10.01.0200.000280%-
Plasma cell myeloma recurrent01.14.02.006; 16.23.02.0060.003794%-
End stage renal disease20.01.03.0190.000168%-
Axonal and demyelinating polyneuropathy10.04.10.019; 11.07.01.019; 17.09.03.0250.000112%-
Cardiac dysfunction02.11.01.0040.000224%-
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ADReCS-Target
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