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 Not Available
ATC Code L01EX10
DrugBank ID DB06595
KEGG ID D05029
MeSH ID C059539
PubChem ID 9829523
TTD Drug ID D07NVU
NDC Product Code 55361-0016; 46016-1200; 68554-0126; 71796-021; 54893-0094; 52076-6262; 71796-018; 68254-0021
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Rash23.03.13.0010.004795%Not Available
Rectal haemorrhage07.12.03.001; 24.07.02.0180.000533%
Respiratory failure22.02.06.002; 14.01.04.0030.000208%
Second primary malignancy16.16.01.0140.000208%
Sepsis11.01.11.0030.000278%
Septic shock11.01.11.004; 24.06.02.0110.000278%Not Available
Swelling08.01.03.0150.000799%Not Available
Tachycardia02.03.02.0070.000533%Not Available
Thrombocytopenia01.08.01.0020.002931%Not Available
Tremor17.01.06.002--
Vomiting07.01.07.0030.007726%
Weight increased13.15.01.0060.001332%
White blood cell count decreased13.01.06.012--
Hypoacusis04.02.01.0060.000533%
Ejection fraction decreased13.14.02.0030.000533%
Malignant neoplasm progression16.16.01.0050.000208%Not Available
Hepatic enzyme increased13.03.01.0190.000533%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000533%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.001066%
Respiratory syncytial virus infection22.07.02.002; 11.05.13.0010.000799%Not Available
Disease progression08.01.03.0380.000208%
Disease recurrence08.01.03.0500.000533%Not Available
Drug intolerance08.06.01.0130.001066%Not Available
Neutropenic colitis07.08.01.014; 01.02.03.0100.000139%Not Available
Bone marrow failure01.03.03.0050.000799%
Cytopenia01.03.03.0120.002664%Not Available
Liver function test increased13.03.01.0440.000799%Not Available
Full blood count abnormal13.01.07.0030.000533%Not Available
Full blood count decreased13.01.07.0040.000139%Not Available
Systemic mastocytosis10.02.01.014; 01.05.01.0110.000139%Not Available
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