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)
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.000246%-
Cardiotoxicity02.11.01.009; 12.03.01.0070.000336%-
Onychoclasis23.02.05.0050.000761%-
Peripheral swelling02.05.04.015; 08.01.03.0530.001254%-
Chapped lips07.05.01.0040.000246%-
Onychomadesis23.02.05.0060.000761%
General physical health deterioration08.01.03.0180.000224%-
Ejection fraction decreased13.14.02.003--
Central nervous system lesion17.02.10.0110.000112%-
Malignant neoplasm progression16.16.01.0050.002899%-
Lymphatic disorder01.09.01.003---
Nasal discomfort22.12.03.0120.000302%-
Musculoskeletal discomfort15.03.04.001---
Brain cancer metastatic16.30.04.001; 17.20.04.0010.000112%-
Breast cancer female16.10.01.004; 21.05.01.0110.000783%-
Gastrointestinal toxicity07.08.03.006; 12.03.01.0190.000280%-
Angiopathy24.03.02.007---
Metastases to central nervous system16.22.02.004; 17.02.10.0130.000862%-
Skin toxicity12.03.01.020; 23.03.03.0320.000336%-
Drug resistance08.06.01.0050.000112%-
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.005--
Brain neoplasm16.30.01.003; 17.20.01.0030.000604%-
Cardiac disorder02.11.01.003---
Connective tissue disorder10.04.04.026; 15.06.01.006---
Embolism24.01.01.0090.000112%
Infestation11.09.01.001; 23.11.01.002---
Malnutrition14.03.02.004---
Mediastinal disorder22.09.03.001---
Mental disorder19.07.01.002---
Metastatic neoplasm16.16.01.007---
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ADReCS-Target
Drug Name ADR Term Target
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