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)
Erythema multiforme23.03.01.003; 10.01.03.0150.000533%
Erythema of eyelid23.03.06.006; 06.04.04.0030.000533%Not Available
Eye disorder06.08.03.0010.000533%Not Available
Faeces discoloured07.01.03.002--Not Available
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.002--
Feeling abnormal08.01.09.014--Not Available
Flatulence07.01.04.002--
Folliculitis11.01.12.018; 23.09.04.0070.001066%
Fracture15.08.02.001; 12.04.02.0010.000799%
Fungal infection11.03.05.001--Not Available
Furuncle11.02.05.008; 23.09.01.0040.000533%Not Available
Gait disturbance17.02.05.016; 08.01.02.002--
Gastric haemorrhage07.12.01.001; 24.07.02.007--
Gastric ulcer07.04.03.0020.001865%
Gastric ulcer haemorrhage24.07.02.003; 07.04.03.0050.000533%Not Available
Gastritis07.08.02.0010.001066%
Gastritis haemorrhagic24.07.02.008; 07.08.02.0020.000533%Not Available
Gastroenteritis07.19.03.001; 11.01.07.0040.001598%Not Available
Gastrointestinal disorder07.11.01.0010.003730%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal perforation07.04.04.0010.000139%Not Available
Generalised oedema14.05.06.007; 08.01.07.0040.000139%
Genital rash23.03.13.016; 21.10.01.0090.000533%Not Available
Gingival bleeding24.07.02.010; 07.09.07.0010.000533%Not Available
Gingivitis11.01.04.013; 07.09.03.0030.000533%
Glomerular filtration rate decreased13.13.01.0090.000533%Not Available
Glossitis07.14.01.0010.001598%Not Available
Glossodynia07.14.02.0010.001066%Not Available
Haematemesis07.12.02.002; 24.07.02.0110.001332%Not Available
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