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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Cerebral haemorrhage17.08.01.003; 24.07.04.001--Not Available
Cerebral infarction17.08.01.004; 24.04.06.0020.000973%Not Available
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Cheilitis07.05.01.001; 23.03.03.0250.001865%
Chest discomfort02.02.02.009; 08.01.08.019; 22.02.08.001--Not Available
Chest pain02.02.02.011; 08.01.08.002; 22.02.08.003--Not Available
Chills08.01.09.001; 15.05.03.016--
Cholangitis09.02.01.0020.000139%Not Available
Chromaturia20.02.01.002--
Clostridium difficile colitis07.19.01.004; 11.02.02.0040.000799%Not Available
Coagulopathy01.01.02.0010.000533%Not Available
Colitis07.08.01.0010.001332%
Colon cancer07.21.01.001; 16.13.01.0010.000208%Not Available
Coma17.02.09.001--Not Available
Completed suicide08.04.01.010; 19.12.01.001--Not Available
Confusional state17.02.03.005; 19.13.01.001--
Conjunctival irritation06.04.01.007--Not Available
Conjunctivitis06.04.01.002; 11.01.06.0120.003463%
Constipation07.02.02.001--
Cough22.02.03.0010.006394%
Cystitis11.01.14.001; 20.03.02.0020.001332%
Deafness04.02.01.001--Not Available
Death08.04.01.0010.014178%
Dehydration14.05.05.0010.021579%
Delirium19.13.02.001--
Dementia17.03.01.001; 19.20.02.0010.000799%Not Available
Depressed level of consciousness17.02.04.002--
Depressed mood19.15.02.001--Not Available
Depression19.15.01.001--
Dermatitis23.03.04.0020.002664%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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