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)
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 pustular11.01.12.016; 23.02.01.007--Not Available
Acute hepatic failure09.01.03.0010.000139%Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.001--Not 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%
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.003--Not Available
Amnesia17.03.02.001; 19.20.01.001--
Amylase increased13.05.01.0090.001598%
Anaemia01.03.02.001--
Anal fissure07.03.01.0020.000533%
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Angular cheilitis07.05.07.013; 11.01.04.014; 23.03.03.0540.000799%Not Available
Anxiety19.06.02.002--
Aortic dissection24.02.03.0020.000139%Not Available
Aphasia17.02.03.001; 19.21.01.001--
Aphthous ulcer07.05.06.0020.001598%Not Available
Appendicitis07.19.01.001; 11.01.07.0010.000799%
Arthralgia15.01.02.001--
Ascites02.05.04.002; 07.07.01.001; 09.01.05.0030.001865%
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ADReCS-Target
Drug Name ADR Term Target
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