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)
Dermatitis acneiform23.02.01.0040.013054%
Diarrhoea07.02.01.0010.185688%
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.000799%Not Available
Dilatation ventricular02.04.02.0260.000533%Not Available
Diplopia17.17.01.005; 06.02.06.002--Not Available
Disorientation19.13.01.002; 17.02.05.0150.001598%Not Available
Disseminated intravascular coagulation24.01.01.010; 01.01.02.0020.000208%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.002398%Not Available
Dry eye06.08.02.0010.002131%
Dry mouth07.06.01.0020.002398%
Dry skin23.03.03.0010.006394%
Duodenal ulcer07.04.02.0020.001066%
Duodenal ulcer haemorrhage24.07.02.020; 07.04.02.0040.000533%Not Available
Dysgeusia17.02.07.003; 07.14.03.0010.003463%
Dyspepsia07.01.02.0010.002131%
Dysphagia07.01.06.0030.006394%
Dysphonia22.02.05.005; 19.19.03.002; 17.02.08.0040.001332%
Dyspnoea22.02.01.004; 02.01.03.002--
Dyspnoea exertional02.01.03.003; 22.02.01.0050.002131%Not Available
Eating disorder19.09.01.008; 14.03.01.0080.002131%Not Available
Eczema23.03.04.0060.000799%
Electrolyte imbalance14.05.01.0020.002398%Not Available
Embolic stroke24.01.04.010; 17.08.01.0320.000533%Not Available
Empyema11.01.08.0200.001865%Not Available
Encephalitis17.06.05.001; 11.01.03.0080.000139%
Enterocolitis07.08.03.0030.001598%
Epilepsy17.12.03.0020.002131%Not Available
Epistaxis22.04.03.001; 24.07.01.0050.006660%
Erythema23.03.06.001--Not Available
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