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)
Abdominal discomfort07.01.06.0010.002931%Not Available
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.003463%
Acne23.02.01.0010.001066%Not Available
Alanine aminotransferase13.03.01.031--Not Available
Alanine aminotransferase increased13.03.01.0030.001066%
Alopecia23.02.02.0010.001865%
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Arthralgia15.01.02.001--
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000533%
Aspartate aminotransferase13.03.01.032--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Blister23.03.01.001; 12.01.06.0020.001598%Not Available
Blood bilirubin13.03.01.040--Not Available
Blood bilirubin increased13.03.01.0080.001332%
Blood potassium decreased13.11.01.0100.000799%Not Available
Bone pain15.02.01.0010.000533%
Breast cancer21.05.01.003; 16.10.01.0010.001251%Not Available
Burning sensation17.02.06.001; 08.01.09.0290.000533%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cellulitis11.02.01.001; 23.09.01.0010.001066%Not Available
Cheilitis23.03.03.025; 07.05.01.0010.000533%
Chest discomfort02.02.02.009; 22.02.08.001; 08.01.08.0190.001332%Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Cholangiocarcinoma16.07.01.002; 09.04.02.0090.000139%Not Available
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