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)
Skin lesion23.03.03.010--Not Available
Skin necrosis23.03.03.0110.000112%Not Available
Skin reaction23.03.03.013; 10.01.03.0190.000224%Not Available
Skin ulcer23.07.03.003; 24.04.03.007--
Sleep disorder19.02.04.001--Not Available
Small cell lung cancer22.08.01.013; 16.19.08.0030.000112%Not Available
Small intestinal obstruction07.13.06.0010.000280%
Sodium retention14.05.04.0030.000246%Not Available
Speech disorder19.19.02.002; 17.02.08.003; 22.12.03.027--Not Available
Spinal cord compression17.10.01.0060.000470%
Squamous cell carcinoma of skin16.03.02.005; 23.08.02.0050.000112%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
Subdural haematoma17.08.05.002; 24.07.04.005; 12.01.10.003--Not Available
Sudden death08.04.01.003; 02.03.04.013--
Suicidal ideation19.12.01.003--
Supraventricular tachycardia02.03.03.0120.000168%
Syncope17.02.04.008; 02.11.04.015; 24.06.02.012--
Synovial cyst16.18.01.004; 15.04.02.002--Not Available
Tachycardia02.03.02.007--Not Available
Tachypnoea22.02.01.014--Not Available
Temporomandibular joint syndrome17.14.01.017; 15.01.08.008--Not Available
Tenderness08.01.08.005--Not Available
Testicular disorder21.13.01.002--
Therapeutic response decreased08.06.01.0160.000783%Not Available
Thirst08.01.09.021; 14.03.02.007--Not Available
Throat irritation22.12.03.029; 07.05.05.037--Not Available
Throat tightness19.01.02.005; 22.12.03.031--Not Available
Thrombocytopenia01.08.01.0020.004981%Not Available
Thrombocytopenic purpura23.06.01.007; 01.08.01.0030.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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