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)
Pulmonary oedema22.01.03.003; 02.05.02.0030.001598%
Purpura24.07.06.005; 23.06.01.004; 01.01.04.0030.000533%
Pyrexia08.05.02.0030.012521%
Rash23.03.13.0010.075927%Not Available
Rash erythematous23.03.06.003--Not Available
Rash generalised23.03.13.002--Not Available
Rash macular23.03.13.0030.000799%Not Available
Rash maculo-papular23.03.13.0040.002131%
Rash papular23.03.13.0170.001332%Not Available
Rash pruritic23.03.12.002--Not Available
Rash pustular23.03.10.003; 11.01.12.0020.003197%
Renal cancer20.01.04.002; 16.08.02.0010.000139%Not Available
Renal disorder20.01.02.0020.001865%Not Available
Renal failure20.01.03.0050.001390%Not Available
Respiratory disorder22.02.07.0020.001066%Not Available
Respiratory distress22.02.01.012--Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.001946%
Rhinorrhoea22.02.05.0100.001598%
Sarcoma16.33.01.002; 15.09.03.0020.000208%Not Available
Scab23.03.03.0040.001066%Not Available
Sciatica17.10.03.001; 15.10.01.0010.000533%Not Available
Seizure17.12.03.001--
Sepsis11.01.11.0030.001042%
Septic shock24.06.02.011; 11.01.11.0040.000417%Not Available
Shock24.06.02.0020.000799%Not Available
Skin disorder23.03.03.0070.008792%Not Available
Skin exfoliation23.03.07.0030.003197%Not Available
Skin fissures23.03.03.0080.003463%Not Available
Skin infection23.09.04.002; 11.01.12.0030.000799%
Skin lesion23.03.03.0100.002131%Not Available
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