Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tucatinib
Drug ID BADD_D02603
Description Tucatinbib is a kinase inhibitor drug used with [trastuzumab] and [capecitabine] in the treatment of unresectable or metastatic HER-2 positive breast cancer. It was developed by Seattle Genetics and approved by the FDA on April 17, 2020.[L12951] Tucatinib is a promising new treatment for patients with metastatic breast cancer who have not responded adequately to other chemotherapy regimens.[L12945]
Indications and Usage Tucatinib is indicated with trastuzumab and capecitabine for treatment of adults diagnosed with advanced unresectable or metastatic HER2-positive breast cancer. This includes patients with brain metastases and those who have received one or more prior anti-HER2-based regimens in the metastatic setting.[L12945]
Marketing Status approved; investigational
ATC Code L01EH03
DrugBank ID DB11652
KEGG ID D11141
MeSH ID C000705452
PubChem ID 51039094
TTD Drug ID D09GRX
NDC Product Code 11014-0476; 43265-7481; 43265-7480; 51144-002; 57572-0723; 51144-001
UNII 234248D0HH
Synonyms tucatinib | irbinitinib | ONT-380 | tukysa | N6-(4,4-Dimethyl-4,5-dihydrooxazol-2-yl)-N4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)quinazoline-4,6-diamine | N6-(4,5-dihydro-4,4-dmethyl-2-oxazolyl)-N4-(3-methyl-4-((1,2,4)triazolo(1,5-A)pyridin-7-Yloxy)phenyl)-4,6-quinazolinediamine
Chemical Information
Molecular Formula C26H24N8O2
CAS Registry Number 937263-43-9
SMILES CC1=C(C=CC(=C1)NC2=NC=NC3=C2C=C(C=C3)NC4=NC(CO4)(C)C)OC5=CC6=NC=NN6C=C5
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)
Peripheral coldness23.06.04.008; 24.04.03.006; 08.01.09.0100.000381%Not Available
Peripheral sensory neuropathy17.09.03.0050.000381%
Piloerection23.02.06.0050.000381%Not Available
Pleural effusion22.05.02.0020.000112%
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.0090.000112%
Pulmonary oedema22.01.03.003; 02.05.02.0030.000112%
Pyrexia08.05.02.0030.001119%
Rash23.03.13.0010.002373%Not Available
Rash erythematous23.03.13.0290.000246%Not Available
Rash pruritic23.03.13.0300.000571%Not Available
Renal disorder20.01.02.0020.000246%Not Available
Rhinorrhoea22.12.03.0210.000627%
Skin discolouration23.03.03.0050.002854%Not Available
Skin exfoliation23.03.07.0030.001388%Not Available
Skin fissures23.03.03.0080.000246%Not Available
Skin irritation23.03.04.0090.000683%Not Available
Skin ulcer24.04.03.007; 23.07.03.0030.000437%
Somnolence17.02.04.006; 19.02.05.0030.001175%
Stomatitis07.05.06.0050.001936%
Swelling08.01.03.0150.000358%Not Available
Swelling face10.01.05.018; 08.01.03.100; 23.04.01.0180.000358%Not Available
Tenderness08.01.08.0050.000571%Not Available
Thirst14.03.02.007; 08.01.09.0210.000381%Not Available
Thrombosis24.01.01.0060.000168%Not Available
Tremor17.01.06.0020.000604%
Visual impairment06.02.10.0130.000683%Not Available
Vomiting07.01.07.0030.006548%
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000112%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.001668%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000246%
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