Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Alectinib
Drug ID BADD_D02480
Description Alectinib is a second generation oral drug that selectively inhibits the activity of anaplastic lymphoma kinase (ALK) tyrosine kinase. It is specifically used in the treatment of non-small cell lung cancer (NSCLC) expressing the ALK-EML4 (echinoderm microtubule-associated protein-like 4) fusion protein that causes proliferation of NSCLC cells. Inhibition of ALK prevents phosphorylation and subsequent downstream activation of STAT3 and AKT resulting in reduced tumour cell viability. Approved under accelerated approval in 2015, alectinib is indicated for use in patients who have progressed on or were not tolerant of crizotinib, which is associated with the development of resistance.
Indications and Usage Alectinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Marketing Status approved; investigational
ATC Code L01ED03
DrugBank ID DB11363
KEGG ID D10542
MeSH ID C582670
PubChem ID 49806720
TTD Drug ID D0U3SY
NDC Product Code 69988-0047
UNII LIJ4CT1Z3Y
Synonyms alectinib | Alecensa | CH5424802 | RO5424802
Chemical Information
Molecular Formula C30H34N4O2
CAS Registry Number 1256580-46-7
SMILES CCC1=CC2=C(C=C1N3CCC(CC3)N4CCOCC4)C(C5=C(C2=O)C6=C(N5)C=C(C=C6)C#N)(C)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Urinary retention20.02.02.0110.000112%
Visual impairment06.02.10.0130.000604%Not Available
Mental status changes19.07.01.0010.000246%Not Available
Hydrothorax22.05.02.0040.000336%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.001175%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000168%
General physical health deterioration08.01.03.0180.000504%Not Available
Muscle fatigue15.05.03.0060.000246%Not Available
Lung cancer metastatic16.19.02.003; 22.08.01.0040.000112%Not Available
Malignant neoplasm progression16.16.01.005--Not Available
Cerebral disorder17.02.10.0170.000168%Not Available
Haemorrhage24.07.01.002--Not Available
Pulmonary mass22.02.07.0040.000168%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000112%Not Available
Ocular icterus01.06.04.007; 09.01.01.007; 06.08.03.0090.000224%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.000336%Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.001679%Not Available
Drug resistance08.06.01.0050.000168%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000246%Not Available
Cardiac disorder02.11.01.003--Not Available
Motor dysfunction17.01.02.031; 15.05.06.0060.000112%Not Available
Neoplasm progression16.16.02.0050.000672%Not Available
Ill-defined disorder08.01.03.0490.000280%Not Available
Red blood cell abnormality01.07.02.0060.000112%Not Available
Disease progression08.01.03.0380.003112%
Non-small cell lung cancer22.08.01.002; 16.19.01.0010.000280%Not Available
Pulmonary toxicity22.01.02.007; 12.03.01.0130.000280%Not Available
Lung neoplasm16.19.04.001; 22.08.01.0060.000112%Not Available
Metastasis16.22.01.0010.000168%Not Available
Renal impairment20.01.03.0100.000616%Not Available
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