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)
Palmar-plantar erythrodysaesthesia syndrome23.03.05.009; 17.02.07.0090.003280%
Palpitations02.11.04.012--
Pancreatitis07.18.01.0010.000224%
Paraesthesia23.03.03.094; 17.02.06.005--
Paronychia23.11.04.006; 11.02.01.054--
Peripheral sensory neuropathy17.09.03.005--
Platelet count13.01.04.011--Not Available
Pleural effusion22.05.02.0020.000224%
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pneumonitis22.01.01.0060.000112%
Pruritus23.03.12.0010.002776%
Pulmonary hypertension24.08.03.002; 22.06.01.0010.000224%
Pulmonary thrombosis24.01.06.002; 22.06.02.0030.000381%Not Available
Rash23.03.13.0010.008104%Not Available
Rash erythematous23.03.13.0290.000381%Not Available
Rash pruritic23.03.13.0300.000571%Not Available
Respiratory arrest22.02.01.0090.000112%Not Available
Rhinorrhoea22.12.03.0210.000761%
Second primary malignancy16.16.01.0140.000112%
Seizure17.12.03.001--
Sensory disturbance17.02.07.0060.000246%Not Available
Skin discolouration23.03.03.0050.001824%Not Available
Skin disorder23.03.03.0070.000873%Not Available
Skin exfoliation23.03.07.0030.002149%Not Available
Skin fissures23.03.03.0080.001041%Not Available
Skin irritation23.03.04.0090.000627%Not Available
Skin lesion23.03.03.0100.000381%Not Available
Stomatitis07.05.06.0050.001858%
Tenderness08.01.08.0050.000761%Not Available
Vomiting07.01.07.0030.006402%
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ADReCS-Target
Drug Name ADR Term Target
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