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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Blood count abnormal13.01.07.001--Not Available
Oral mucosa erosion07.05.06.009--Not Available
Malignant transformation16.16.01.0130.000278%Not Available
Ulcerative keratitis06.04.02.004; 10.02.01.0210.000533%
Bone marrow failure01.03.03.005--
Treatment failure08.06.01.0170.000764%Not Available
Liver injury12.01.02.003; 09.01.07.022--Not Available
Organising pneumonia22.01.02.0080.000533%Not Available
Oral disorder07.05.01.0050.000799%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.0160.007992%
Drug-induced liver injury12.03.01.044; 09.01.07.0230.001332%Not Available
Pneumocystis jirovecii pneumonia22.07.08.009; 11.03.07.0050.000208%Not Available
Candida infection11.03.03.0210.000799%
Faeces soft07.01.03.0080.000533%Not Available
Multiple organ dysfunction syndrome08.01.03.057--
Liver function test increased13.03.01.044--Not Available
Abnormal loss of weight14.03.02.0190.000533%Not Available
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000208%Not Available
Carcinoembryonic antigen increased13.22.01.0090.000799%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000417%Not Available
Lymphadenopathy mediastinal22.09.03.006; 01.09.01.0250.000278%Not Available
Malignant ascites16.32.03.013; 07.07.01.0040.000208%Not Available
Malignant pleural effusion22.05.04.001; 16.32.03.0140.000556%Not Available
Metastases to adrenals16.22.02.012; 05.01.04.0070.000533%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.002154%Not Available
Metastases to lymph nodes01.09.01.015; 16.22.02.0060.000347%Not Available
Metastases to pleura22.05.04.002; 16.22.02.0220.000278%Not Available
Recurrent cancer16.16.01.0150.001066%Not Available
Small cell carcinoma16.16.01.0170.000417%Not Available
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