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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.002518%
Abdominal pain upper07.01.05.003--
Abnormal faeces07.01.03.0010.000112%Not Available
Acne23.02.01.0010.002966%Not Available
Acne pustular23.02.01.007; 11.01.12.016--Not Available
Acute hepatic failure09.01.03.0010.000168%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000280%
Adenocarcinoma16.16.01.0040.000336%Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Anal fissure07.03.01.0020.000112%
Angular cheilitis23.03.03.054; 07.05.07.0130.000168%Not Available
Aortic dissection24.02.03.0020.000112%Not Available
Aphthous ulcer07.05.06.0020.000336%Not Available
Ascites07.07.01.001; 02.05.04.002; 09.01.05.0030.000526%
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.003347%Not Available
Azotaemia20.01.01.0010.000168%Not Available
B-cell lymphoma16.28.01.001; 01.15.01.0010.000112%Not Available
Back pain15.03.04.005--
Basosquamous carcinoma16.16.01.0120.000112%Not Available
Bladder pain20.02.02.001--Not Available
Blood potassium decreased13.11.01.010--Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.0040.000112%Not Available
Cachexia16.32.03.011; 14.03.02.001; 08.01.01.0090.000168%Not Available
Cardiac failure02.05.01.0010.001287%
Cardiac tamponade02.06.01.0010.000112%
Cerebral infarction24.04.06.002; 17.08.01.0040.000839%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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