Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Midostaurin
Drug ID BADD_D02453
Description Midostaurin (as Rydapt) is a multitarget kinase inhibitor for the treatment for adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3. It was initially characterized as a potential broad-spectrum antineoplastic agent, with activity toward diverse solid and hematopoietic tumors [A19108]. It was approved on April 28, 2017 and has shown to increase the overall survival rate in patients with AML as an adjunct therapy along with chemotherapeutic agents.
Indications and Usage Investigated for use/treatment in adult patients with high-risk acute myeloid leukemia (AML) who are FLT3 mutation-positive, agressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
Marketing Status approved; investigational
ATC Code L01EX10
DrugBank ID DB06595
KEGG ID D05029
MeSH ID C059539
PubChem ID 9829523
TTD Drug ID D07NVU
NDC Product Code 68554-0126; 71796-018; 54893-0094; 52076-6262; 68254-0021; 55361-0016; 71796-021; 46016-1200
UNII ID912S5VON
Synonyms midostaurin | benzamide, N-(2,3,9,10,11,12-hexahydro-9-methoxy-8-methyl-1-oxo-8,12-epoxy-1H,8H-2,7b,12a-triazadibenzo(a,g)cyclonona(cde)trinden-10-yl)-N-methyl-, (8alpha,9beta,10beta,12alpha)- | 4'-N-benzoylstaurosporine | benzoylstaurosporine | 4'-N-benzoyl staurosporine | N-((9S,10R,11R,13R)-10-methoxy-9-methyl-1-oxo-2,3,10,11,12,13-hexahydro-9,13-epoxy-1H,9H-diindolo(1,2,3-GH:3',2',1'-lm)pyrrolo(3,4-j)(1,7)benzodiazonin-11-yl)-n-methylbenzamide | PKC412 | PKC 412 | PKC-412 | Rydapt | CGP 41251 | CGP 41 251 | CGP-41251
Chemical Information
Molecular Formula C35H30N4O4
CAS Registry Number 120685-11-2
SMILES CC12C(C(CC(O1)N3C4=CC=CC=C4C5=C6C(=C7C8=CC=CC=C8N2C7=C53)CNC6=O)N(C)C(=O)C9=CC=C C=C9)OC
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)
Pulmonary haemorrhage22.12.01.009; 24.07.01.0160.000112%
Pulmonary oedema02.05.02.003; 22.01.03.0030.000168%
Pyrexia08.05.02.0030.002798%
Rash23.03.13.0010.003481%-
Rash maculo-papular23.03.13.0040.000112%
Rectal haemorrhage07.12.03.001; 24.07.02.0180.000112%
Respiratory failure14.01.04.003; 22.02.06.0020.000224%
Second primary malignancy16.16.01.0140.000168%
Stomatitis07.05.06.0050.000112%
Swelling08.01.03.0150.000358%-
Tachycardia02.03.02.0070.000358%-
Thrombocytopenia01.08.01.0020.001030%-
Vomiting07.01.07.0030.005563%
Hypoacusis04.02.01.0060.000246%
Malignant neoplasm progression16.16.01.0050.000616%-
Dysplasia08.03.04.0070.000112%-
Cardiac disorder02.11.01.0030.000224%-
Feeding disorder14.03.02.003; 19.09.01.0030.000112%-
Decreased appetite08.01.09.028; 14.03.01.0050.000795%
Ill-defined disorder08.01.03.0490.000224%-
Blood disorder01.05.01.0040.000302%-
Disease progression08.01.03.0380.000280%
Disease recurrence08.01.03.0500.000414%-
Drug intolerance08.06.01.0130.001007%-
Neutropenic colitis01.02.03.010; 07.08.01.0140.000112%-
Bone marrow failure01.03.03.0050.000224%
Cytopenia01.03.03.0120.000862%-
Treatment failure08.06.01.0170.000112%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.000112%
Jugular vein thrombosis24.01.02.0070.000112%-
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