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)
Abdominal discomfort07.01.06.0010.001066%Not Available
Abdominal pain07.01.05.0020.001598%
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.000139%Not Available
Alopecia23.02.02.001--
Anaemia01.03.02.0010.001066%
Arrhythmia02.03.02.0010.000533%Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000799%
Bacteraemia11.01.11.0010.000533%
Blood bilirubin increased13.03.01.0080.000533%
Body temperature increased13.15.01.0010.000533%Not Available
Bone pain15.02.01.0010.000799%
Cardiac failure02.05.01.0010.000278%
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.0110.000799%Not Available
Colitis07.08.01.0010.000533%
Constipation07.02.02.0010.001598%
Cough22.02.03.001--
Death08.04.01.0010.003127%
Diarrhoea07.02.01.0010.005062%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dysphagia07.01.06.0030.002664%
Dyspnoea22.02.01.004; 02.01.03.002--
Electrocardiogram QT prolonged13.14.05.0040.001598%
Epistaxis24.07.01.005; 22.04.03.0010.000533%
Fatigue08.01.01.002--
Febrile neutropenia01.02.03.002; 08.05.02.0040.000139%
Gastrooesophageal reflux disease07.02.02.0030.000533%
Gastrointestinal disorder07.11.01.0010.001066%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.000799%Not Available
Graft versus host disease12.02.09.001; 10.02.01.0270.000139%Not Available
Haemoglobin decreased13.01.05.0030.000533%Not Available
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