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)
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.001--
Hepatic function abnormal09.01.02.0010.000533%Not Available
Hepatitis09.01.07.0040.000533%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.004263%Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.000533%
Hypersensitivity10.01.03.003--
Hypoaesthesia17.02.06.0230.002931%Not Available
Hypokalaemia14.05.03.002--
Hyponatraemia14.05.04.002--
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Laceration23.03.11.004; 12.01.06.0060.000533%Not Available
Leukopenia01.02.02.001--Not Available
Lung disorder22.02.07.0010.000533%Not Available
Malaise08.01.01.0030.003996%
Memory impairment19.20.01.003; 17.03.02.003--
Menopausal symptoms21.02.02.002--Not Available
Metastases to liver16.22.02.001; 09.04.02.0040.000417%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.000625%Not Available
Mucosal inflammation08.01.06.0020.000533%Not Available
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Nail discolouration23.02.05.0010.000533%
Nail disorder23.02.05.0020.000799%
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
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