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)
Aspartate aminotransferase increased13.03.01.0060.001865%
Asthenia08.01.01.0010.011189%Not Available
Asthma10.01.03.010; 22.03.01.002--Not Available
Atrial fibrillation02.03.03.002--
Atypical pneumonia11.01.09.012; 22.07.01.0100.000533%Not Available
Azotaemia20.01.01.0010.000799%Not Available
B-cell lymphoma01.15.01.001; 16.28.01.0010.000139%Not Available
Back pain15.03.04.005--
Bladder pain20.02.02.001--Not Available
Blister12.01.06.002; 23.03.01.001--Not Available
Blood bilirubin increased13.03.01.008--
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.0040.005861%
Blood potassium decreased13.11.01.0100.001066%Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood thyroid stimulating hormone increased13.10.03.0060.000533%
Blood urea increased13.13.01.0060.000533%Not Available
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.001--
Breast cancer16.10.01.001; 21.05.01.003--Not Available
Bronchitis11.01.09.001; 22.07.01.001--
Burning sensation08.01.09.029; 17.02.06.001--Not Available
C-reactive protein increased13.09.01.007--Not Available
Cachexia08.01.01.009; 14.03.02.001; 16.32.03.0110.000139%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.0010.001390%
Cardiac failure congestive02.05.01.002--Not Available
Cardio-respiratory arrest02.03.04.002; 22.02.06.007--Not Available
Cataract06.06.01.001--
Cellulitis11.02.01.001; 23.09.01.0010.001332%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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