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
FatigueEpidermal growth factor receptorP00533T5932826362459
FatigueReceptor tyrosine-protein kinase erbB-2P04626T1459726362459
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Rash generalised23.03.13.0020.000799%Not Available
Rash pruritic23.03.12.0020.000799%Not Available
Rash pustular11.01.12.002; 23.03.10.0030.000533%
Respiratory arrest22.02.01.0090.000139%Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
Rhinorrhoea22.02.05.0100.000533%
Seizure17.12.03.001--
Sensory disturbance17.02.07.0060.000533%Not Available
Sepsis11.01.11.003--
Sinusitis22.07.03.007; 11.01.13.0050.000799%
Skin discolouration23.03.03.0050.003197%Not Available
Skin disorder23.03.03.0070.001598%Not Available
Skin exfoliation23.03.07.0030.002931%Not Available
Skin fissures23.03.03.0080.002398%Not Available
Skin irritation23.03.04.0090.000799%Not Available
Skin lesion23.03.03.0100.000533%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stomatitis07.05.06.0050.003197%
Swelling08.01.03.015--Not Available
Tenderness08.01.08.0050.001066%Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombosis24.01.01.006--Not Available
Tremor17.01.06.002--
Urinary tract infection20.08.02.001; 11.01.14.004--
Viral infection11.05.04.0010.000533%Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.0030.012521%
Weight decreased13.15.01.0050.003463%
Weight increased13.15.01.006--
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