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%Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.000336%Not Available
Onychoclasis23.02.05.0050.000761%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.001254%Not Available
Chapped lips07.05.01.0040.000246%Not Available
Onychomadesis23.02.05.0060.000761%
General physical health deterioration08.01.03.0180.000224%Not Available
Ejection fraction decreased13.14.02.003--
Central nervous system lesion17.02.10.0110.000112%Not Available
Malignant neoplasm progression16.16.01.0050.002899%Not Available
Lymphatic disorder01.09.01.003--Not Available
Nasal discomfort22.12.03.0120.000302%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Brain cancer metastatic17.20.04.001; 16.30.04.0010.000112%Not Available
Breast cancer female21.05.01.011; 16.10.01.0040.000783%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.000280%Not Available
Angiopathy24.03.02.007--Not Available
Metastases to central nervous system16.22.02.004; 17.02.10.0130.000862%Not Available
Skin toxicity12.03.01.020; 23.03.03.0320.000336%Not Available
Drug resistance08.06.01.0050.000112%Not Available
Hot flush21.02.02.001; 08.01.03.027; 24.03.01.005--
Brain neoplasm16.30.01.003; 17.20.01.0030.000604%Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Embolism24.01.01.0090.000112%
Infestation11.09.01.001; 23.11.01.002--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Metastatic neoplasm16.16.01.007--Not Available
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ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene