Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lapatinib
Drug ID BADD_D01248
Description Lapatinib is an anti-cancer drug developed by GlaxoSmithKline (GSK) as a treatment for solid tumours such as breast and lung cancer. It was approved by the FDA on March 13, 2007, for use in patients with advanced metastatic breast cancer in conjunction with the chemotherapy drug Capecitabine. Lapatinib is human epidermal growth factor receptor type 2 (HER2/ERBB2) and epidermal growth factor receptor (HER1/EGFR/ERBB1) tyrosine kinases inhibitor. It binds to the intracellular phosphorylation domain to prevent receptor autophosphorylation upon ligand binding.
Indications and Usage Indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress the human epidermal receptor type 2 (HER2) protein and who have received prior therapy including an anthracycline, a taxane, and trastuzuma.
Marketing Status approved; investigational
ATC Code L01EH01
DrugBank ID DB01259
KEGG ID D08108
MeSH ID D000077341
PubChem ID 208908
TTD Drug ID D08CDI
NDC Product Code 0078-0671; 68180-801; 61187-009
UNII 0VUA21238F
Synonyms Lapatinib | N-(3-chloro-4-(((3-fluorobenzyl)oxy)phenyl)-6-(5-(((2-methylsulfonyl)ethyl)amino)methyl) -2-furyl)-4-quinazolinamine | Tykerb | GW 282974X | GW282974X | GW-282974X | GW572016 | GW-572016 | GW 572016 | Lapatinib Ditosylate
Chemical Information
Molecular Formula C29H26ClFN4O4S
CAS Registry Number 231277-92-2
SMILES CS(=O)(=O)CCNCC1=CC=C(O1)C2=CC3=C(C=C2)N=CN=C3NC4=CC(=C(C=C4)OCC5=CC(=CC=C5)F)Cl
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)
Neoplasm progression16.16.02.0050.000280%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.002350%
Ill-defined disorder08.01.03.0490.000246%Not Available
Blood disorder01.05.01.004--Not Available
Disease progression08.01.03.0380.004645%
Disease recurrence08.01.03.050--Not Available
Hepatobiliary disease09.01.08.003--Not Available
Metastasis16.22.01.0010.000112%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.000437%Not Available
Osteonecrosis of jaw24.04.05.005; 15.02.04.0100.000224%
Pulmonary arterial hypertension24.08.03.003; 22.06.01.0020.000280%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000112%Not Available
Skin mass23.07.04.0140.000381%Not Available
Acute kidney injury20.01.03.016--
Nail bed disorder23.02.05.0170.000381%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000168%
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000414%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.000112%Not Available
Recurrent cancer16.16.01.0150.000112%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.002127%Not Available
Onychalgia23.02.05.0260.000381%Not Available
Oncologic complication16.32.03.0250.000112%Not Available
Therapy non-responder08.06.01.0630.000492%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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