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)
Skin reaction23.03.03.013; 10.01.03.0190.002664%Not Available
Skin ulcer24.04.03.007; 23.07.03.0030.002398%
Sleep disorder19.02.04.001--Not Available
Small cell lung cancer16.19.08.003; 22.08.01.0130.000903%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.003--Not Available
Spinal cord compression17.10.01.0060.001066%
Squamous cell carcinoma16.16.01.0020.000533%Not Available
Squamous cell carcinoma of skin23.08.02.005; 16.03.02.0050.000533%Not Available
Stevens-Johnson syndrome11.07.01.005; 10.01.03.020; 23.03.01.007; 12.03.01.0140.002131%
Stomatitis07.05.06.0050.041027%
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.0110.000799%Not Available
Sudden death08.04.01.003; 02.03.04.0130.000139%
Superior vena cava syndrome24.04.09.008; 16.32.03.0190.000139%
Swelling face23.04.01.018; 10.01.05.018--Not Available
Swollen tongue23.04.01.014; 07.14.02.003; 10.01.05.0150.001066%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombotic thrombocytopenic purpura24.07.06.014; 23.06.01.011; 01.08.01.0050.001066%
Tongue blistering07.14.02.0140.000533%Not Available
Toxic epidermal necrolysis10.01.01.006; 23.03.01.008; 12.03.01.015; 11.07.01.006--
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.002--
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000533%
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
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