Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Afatinib
Drug ID BADD_D00047
Description Afatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor in the form of a dimaleate salt available as Boehringer Ingelheim's brand name Gilotrif [FDA Label]. For oral use, afatinib tablets are a first-line (initial) treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test [L2939]. Gilotrif (afatinib) is the first FDA-approved oncology product from Boehringer Ingelheim [L2939].
Indications and Usage Afatinib is a kinase inhibitor indicated for the first-line treatment of patient with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
Marketing Status Prescription
ATC Code L01EB03
DrugBank ID DB08916
KEGG ID D09724
MeSH ID D000077716
PubChem ID 10184653
TTD Drug ID D05UFG
NDC Product Code 0597-0138; 0597-0141; 0597-0137
Synonyms Afatinib | (2E)-N-(4-(3-Chloro-4-fluoroanilino)-7-(((3S)-oxolan-3-yl)oxy)quinoxazolin-6-yl)-4-(dimethylamino)but-2-enamide | BIBW-2992-MA2 | BIBW 2992 MA2 | BIBW-2992MA2 | BIBW 2992MA2 | BIBW2992 MA2 | Afatinib Maleate | BIBW 2992 | BIBW2992 | BIBW-2992 | Gilotrif | Afatinib Dimaleate
Chemical Information
Molecular Formula C24H25ClFN5O3
CAS Registry Number 850140-72-6
SMILES CN(C)CC=CC(=O)NC1=C(C=C2C(=C1)C(=NC=N2)NC3=CC(=C(C=C3)F)Cl)OC4CCOC4
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Diastolic dysfunction02.04.02.022--Not Available
Nasal discomfort22.02.05.0200.000799%Not Available
Pruritus generalised23.03.12.003--Not Available
Drug tolerance08.06.01.0030.000533%Not Available
Nodule08.03.05.0020.000533%Not Available
Skin burning sensation17.02.06.009; 23.03.03.0210.000533%Not Available
Transaminases increased13.03.01.015--Not Available
Cerebral disorder17.02.10.0170.000799%Not Available
Brain cancer metastatic17.20.04.001; 16.30.04.0010.000799%Not Available
Haemorrhage24.07.01.002--Not Available
Pulmonary mass22.02.07.0040.001066%Not Available
Bile duct obstruction09.02.02.0020.000533%Not Available
Pneumatosis intestinalis07.01.06.0210.001066%Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
Cancer pain16.32.03.0040.001066%Not Available
Staphylococcal infection11.02.05.0020.000799%Not Available
Troponin increased13.04.01.0040.000533%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.000834%Not Available
Gastrointestinal toxicity07.08.03.006; 12.03.01.0190.002398%Not Available
Ventricular dysfunction02.04.02.005--Not Available
Nail toxicity23.02.05.016; 12.03.01.0450.000799%Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.007714%Not Available
Skin toxicity23.03.03.032; 12.03.01.0200.007726%Not Available
Blood alkaline phosphatase increased13.04.02.004--
Blood alkaline phosphatase abnormal13.04.02.0050.000139%Not Available
Drug resistance08.06.01.0050.002502%Not Available
Hepatic enzyme increased13.03.01.019--Not Available
Bacterial infection11.02.01.0050.000533%Not Available
Pneumonia bacterial22.07.06.004; 11.02.01.0090.001066%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000139%Not Available
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