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 as monotherapy [L2937] for the first-line [FDA Label] treatment of (a) Epidermal Growth Factor Receptor (EGFR) TKI (tyrosine kinase inhibitor)-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant EGFR mutations as detected by an FDA-approved test [FDA Label], and (b) adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy [FDA Label, L2937]. Recently, as of January 2018, the US FDA approved a supplemental New Drug Application for Boehringer Ingelheim's Gilotrif (afatinib) for the first line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test [L2939]. The new label includes data on three additional EGFR mutations: L861Q, G719X and S768I [L2939].
Marketing Status approved
ATC Code L01EB03
DrugBank ID DB08916
KEGG ID D09724
MeSH ID D000077716
PubChem ID 10184653
TTD Drug ID D05UFG
NDC Product Code 0597-0137; 0597-0138; 0597-0141
UNII 41UD74L59M
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
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Adverse reaction08.06.01.0180.000168%Not Available
Oral disorder07.05.01.0050.000302%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Acute kidney injury20.01.03.0160.002127%
Faeces soft07.01.03.0080.000112%Not Available
Abnormal loss of weight14.03.02.0190.000381%Not Available
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000224%Not Available
Bronchial carcinoma22.08.01.015; 16.19.02.0040.000112%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000504%Not Available
Lymphadenopathy mediastinal01.09.01.025; 22.09.03.0060.000280%Not Available
Malignant ascites07.07.01.004; 16.32.03.0130.000168%Not Available
Malignant pleural effusion22.05.04.001; 16.32.03.0140.000504%Not Available
Metastases to adrenals16.22.02.012; 05.01.04.0070.000336%Not Available
Metastases to bone15.09.03.006; 16.22.02.0050.002071%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000280%Not Available
Metastases to pleura22.05.04.002; 16.22.02.0220.000224%Not Available
Recurrent cancer16.16.01.0150.000224%Not Available
Small cell carcinoma16.16.01.0170.000392%Not Available
Temporal lobe epilepsy17.12.02.0040.000112%Not Available
Metastases to thorax22.08.03.001; 16.22.02.0280.000112%Not Available
Metastases to meninges17.02.10.012; 16.22.02.0030.001903%Not Available
Lymphangiosis carcinomatosa24.09.02.007; 16.22.02.009; 01.09.01.0270.000392%Not Available
Adrenal mass05.01.03.0030.000112%Not Available
Neuroendocrine carcinoma16.24.01.007; 05.08.01.0110.000112%Not Available
Non-small cell lung cancer metastatic22.08.01.021; 16.19.01.0090.000168%Not Available
Nail bed inflammation23.02.05.0230.000112%Not Available
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.000112%Not Available
Skin plaque23.03.03.0440.000112%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.000112%Not Available
Prerenal failure20.01.03.022; 24.06.02.0250.000392%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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