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
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
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.007726%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abnormal faeces07.01.03.0010.000533%Not Available
Abscess11.01.08.0010.000533%Not Available
Acne23.02.01.0010.009857%Not Available
Acne pustular23.02.01.007; Available
Acute hepatic failure09.01.03.0010.000139%Not Available
Acute myocardial infarction24.04.04.001; Available
Acute respiratory distress syndrome22.01.03.0010.000278%
Adenocarcinoma16.16.01.0040.000208%Not Available
Aggression19.05.01.001--Not Available
Alanine aminotransferase increased13.03.01.0030.002131%
Altered state of consciousness19.07.01.003; Available
Amylase increased13.05.01.0090.001598%
Anal fissure07.03.01.0020.000533%
Anaphylactic reaction10.01.07.001;
Angular cheilitis23.03.03.054;; Available
Aortic dissection24.02.03.0020.000139%Not Available
Aphthous ulcer07.05.06.0020.001598%Not Available
The 1th Page    1 2 3 4 5    Next   Last    Total 16 Pages