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)
Temporal lobe epilepsy17.12.02.0040.000533%Not Available
Tumour marker increased13.22.01.0170.000533%Not Available
Metastases to meninges16.22.02.003; 17.02.10.0120.001876%Not Available
Lymphangiosis carcinomatosa01.09.01.027; 16.22.02.009; 24.09.02.0070.000278%Not Available
Adrenal mass05.01.03.0030.000139%Not Available
Neuroendocrine carcinoma05.08.01.011; 16.24.01.0070.000533%Not Available
Non-small cell lung cancer metastatic16.19.01.009; 22.08.01.0210.000139%Not Available
Nail bed inflammation23.02.05.0230.000533%Not Available
Skin plaque23.03.03.0440.000533%Not Available
Acquired gene mutation08.01.10.0020.000417%Not Available
Infectious pleural effusion11.01.09.011; 22.05.01.0040.000533%Not Available
EGFR gene mutation08.01.10.0040.008259%Not Available
Spinal pain08.01.08.030; 15.02.01.008; 17.10.01.0200.000799%Not Available
Prerenal failure20.01.03.022; 24.06.02.0250.001865%Not Available
Mucosal toxicity08.01.06.024; 12.03.01.0560.000533%Not Available
Cutaneous symptom23.07.04.0230.001332%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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