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)
Abdominal discomfort07.01.06.0010.001880%-
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.001858%
Acne23.02.01.0010.000683%-
Alanine aminotransferase13.03.04.002---
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.0010.001522%
Anaemia01.03.02.001--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Aphasia17.02.03.001; 19.21.01.0010.000112%
Arthralgia15.01.02.001--
Ascites02.05.04.002; 07.07.01.001; 09.01.05.0030.000168%
Aspartate aminotransferase13.03.04.008---
Asthenia08.01.01.001---
Back pain15.03.04.005--
Blister12.01.06.002; 23.03.01.0010.001007%-
Blood bilirubin13.03.04.015---
Blood bilirubin increased13.03.04.018--
Bone pain15.02.01.0010.000381%
Breast cancer16.10.01.001; 21.05.01.0030.001366%-
Cardiac failure02.05.01.001--
Cheilitis07.05.01.001; 23.03.03.0250.000437%
Chest discomfort02.02.02.009; 08.01.08.019; 22.12.02.0020.000739%-
Cholangiocarcinoma09.04.02.009; 16.07.01.0020.000112%-
Colitis07.08.01.0010.000112%
Coma17.02.09.001---
Constipation07.02.02.001--
Cough22.02.03.001--
Death08.04.01.0010.009682%
Dehydration14.05.05.0010.002037%
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ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene