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)
Gastrooesophageal reflux disease07.02.02.0030.000437%
Gastrointestinal disorder07.11.01.0010.000604%Not Available
Head discomfort17.02.05.0270.000381%Not Available
Headache17.14.01.0010.004332%
Hepatic steatosis14.08.04.005; 09.01.07.0030.000246%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000112%Not Available
Hydrocephalus17.07.01.0010.000168%
Hypersomnia19.02.05.001; 17.15.01.0010.000548%
Hypoaesthesia17.02.06.023; 23.03.03.0810.001500%Not Available
Hypokalaemia14.05.03.0020.000168%
Hypotension24.06.03.0020.000604%
Increased appetite14.03.01.003; 08.01.09.0270.000246%Not Available
Insomnia19.02.01.002; 17.15.03.0020.001500%
Joint swelling15.01.02.0040.001063%Not Available
Lip dry07.06.01.0030.000571%Not Available
Liver disorder09.01.08.0010.000627%Not Available
Lung disorder22.02.07.0010.000112%Not Available
Lymphadenopathy01.09.01.0020.000381%Not Available
Malaise08.01.01.0030.001041%
Memory impairment19.20.01.003; 17.03.02.0030.002071%
Metastases to liver16.22.02.001; 09.04.02.0040.000168%Not Available
Muscle spasms15.05.03.0040.002149%
Nausea07.01.07.0010.013655%
Neoplasm malignant16.16.01.0010.000224%Not Available
Neuropathy peripheral17.09.03.0030.000873%Not Available
Neurotoxicity12.03.01.011; 17.02.10.0020.000112%Not Available
Oral pain07.05.05.0340.000381%
Pain in extremity15.03.04.0100.002507%
Palmar-plantar erythrodysaesthesia syndrome23.03.05.009; 17.02.07.0090.002339%
Papule23.03.03.0380.000571%Not Available
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