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 Prescription
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; 63379-096; 72969-112; 43744-332; 61187-009
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
FatigueReceptor tyrosine-protein kinase erbB-2P04626T1459726362459
FatigueEpidermal growth factor receptorP00533T5932826362459
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Nausea07.01.07.0010.017317%
Neoplasm16.16.02.0010.000278%Not Available
Neoplasm malignant16.16.01.0010.000486%Not Available
Nervous system disorder17.02.10.001--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Neutropenia01.02.03.004--Not Available
Neutrophil count13.01.06.046--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oral pain07.05.03.0020.001332%
Pain08.01.08.004--
Pain in extremity15.03.04.0100.003996%
Palmar-plantar erythrodysaesthesia syndrome23.07.04.001; 17.02.07.0090.005595%
Palpitations02.01.02.003--
Pancreatitis07.18.01.0010.000533%
Paraesthesia17.02.06.005--
Paronychia11.01.12.001; 23.09.04.0010.000533%
Peripheral sensory neuropathy17.09.03.005--
Pharyngitis streptococcal22.07.04.001; 11.02.06.0020.000533%Not Available
Platelet count13.01.04.011--Not Available
Pleural effusion22.05.02.002--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pneumonitis22.01.01.0060.000533%
Pruritus23.03.12.0010.003463%
Psoriasis23.03.14.002; 10.02.01.036--Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary hypertension24.08.03.002; 22.06.01.0010.000278%
Pulmonary thrombosis24.01.06.002; 22.06.02.0030.000533%Not Available
Pyrexia08.05.02.003--
Rash23.03.13.0010.012788%Not Available
Rash erythematous23.03.06.0030.000533%Not Available
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