Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dacomitinib
Drug ID BADD_D02545
Description Dacomitinib, designed as (2E)-N-16-4-(piperidin-1-yl) but-2-enamide, is an oral highly selective quinazalone part of the second-generation tyrosine kinase inhibitors which are characterized by the irreversible binding at the ATP domain of the epidermal growth factor receptor family kinase domains.[A40009] Dacomitinib was developed by Pfizer Inc and approved by the FDA on September 27, 2018.[L4810] Some evidence in the literature suggests the therapeutic potential of dacomitinib in the epithelial ovarian cancer model[A39624], although further investigations are needed.
Indications and Usage Dacomitinib is indicated as the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as verified by an FDA-approved test.[L4812] Lung cancer is the leading cause of cancer death and NSCLC accounts for 85% of lung cancer cases. From the cases of NSCLC, approximately 75% of the patients present a late diagnosis with metastatic and advanced disease which produces a survival rate of 5%. The presence of a mutation in EGFR accounts for more than the 60% of the NSCLC cases and the overexpression of EGFR is associated with frequent lymph node metastasis and poor chemosensitivity.[A40018, A19201]
Marketing Status approved; investigational
ATC Code L01EB07
DrugBank ID DB11963
KEGG ID D09883; D10514
MeSH ID C525726
PubChem ID 11511120
TTD Drug ID D06XXH
NDC Product Code 63539-197; 0069-0197; 0069-2299; 0069-1198
UNII 5092U85G58
Synonyms dacomitinib | Vizimpro | N-(4-(3-chloro-4-fluoroanilino)-7-methoxy-6-quinazolinyl)-4-(1-piperidinyl)-2-butenamide | PF 00299804 | PF00299804 | PF-00299804
Chemical Information
Molecular Formula C24H25ClFN5O2
CAS Registry Number 1110813-31-4
SMILES COC1=C(C=C2C(=C1)N=CN=C2NC3=CC(=C(C=C3)F)Cl)NC(=O)C=CCN4CCCCC4
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)
Anaemia01.03.02.0010.000112%
Aphasia17.02.03.001; 19.21.01.0010.000112%
Asthenia08.01.01.0010.000112%-
Atrial fibrillation02.03.03.0020.000112%
Death08.04.01.0010.001847%
Diarrhoea07.02.01.0010.001242%
Drug eruption08.01.06.015; 10.01.01.005; 23.03.05.0010.000168%-
Dry skin23.03.03.0010.000246%
Dyspnoea02.11.05.003; 22.02.01.0040.000358%
Eczema23.03.04.0060.000112%
Erythema23.03.06.0010.000246%-
Febrile neutropenia01.02.03.002; 08.05.02.0040.000112%
Gastrointestinal disorder07.11.01.0010.000112%-
Liver disorder09.01.08.0010.000112%-
Malaise08.01.01.0030.000112%
Mouth ulceration07.05.06.0040.000336%-
Palmar-plantar erythrodysaesthesia syndrome17.02.07.009; 23.03.05.0090.000112%
Pleural effusion22.05.02.0020.000112%
Pulmonary embolism22.06.02.001; 24.01.06.0010.000112%-
Pyrexia08.05.02.0030.000224%
Rash23.03.13.0010.001130%-
Second primary malignancy16.16.01.0140.000112%
Skin disorder23.03.03.0070.000224%-
Skin exfoliation23.03.07.0030.000112%-
Skin ulcer23.07.03.003; 24.04.03.0070.000168%
Stomatitis07.05.06.0050.000302%
Neoplasm progression16.16.02.0050.001657%-
Decreased appetite08.01.09.028; 14.03.01.0050.000168%
Renal impairment20.01.03.0100.000112%-
Acute kidney injury20.01.03.0160.000112%
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