Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fingolimod
Drug ID BADD_D02464
Description Multiple sclerosis or MS is a devastating inflammatory disease that often progresses and causes severe neurological, physical, and cognitive effects.[A176474] Fingolimod is a sphingosine 1-phosphate receptor modulator for the treatment of relapsing-remitting multiple sclerosis. It was developed by Novartis and initially approved by the FDA in 2010.[L12651] Fingolimod is currently being studied for the treatment of COVID-19, the disease caused by infection with the SARS-CoV-2 virus. Phase 2 clinical trials are currently underway and completion is expected in July 2020.[L12654]
Indications and Usage Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Marketing Status Not Available
ATC Code L04AA27
DrugBank ID DB08868
KEGG ID D10001
MeSH ID D000068876
PubChem ID 107970
TTD Drug ID D07UHS
NDC Product Code 54893-0026; 65035-201
Synonyms Fingolimod Hydrochloride | 2-Amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol hydrochloride | FTY-720 | FTY 720 | FTY720 | Gilenya | Gilenia | Fingolimod
Chemical Information
Molecular Formula C19H33NO2
CAS Registry Number 162359-55-9
SMILES CCCCCCCCC1=CC=C(C=C1)CCC(CO)(CO)N
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)
Atypical pneumonia22.07.01.010; 11.01.09.0120.001737%Not Available
Aura17.02.07.0110.003474%Not Available
Autoimmune hepatitis10.04.09.001; 09.01.07.0190.004053%Not Available
Autonomic nervous system imbalance24.06.01.005; 17.05.01.011; 08.01.01.0100.002316%Not Available
B-cell lymphoma01.15.01.001; 16.28.01.0010.001359%Not Available
Back disorder15.03.01.0140.006369%Not Available
Back pain15.03.04.0050.212490%
Bacteraemia11.01.11.0010.003474%
Bacteriuria20.02.01.023; 11.02.01.0140.001737%Not Available
Basal cell carcinoma23.08.02.001; 16.03.02.0010.082217%Not Available
Basedow's disease10.04.08.004; 06.09.04.003; 05.02.02.0030.001158%Not Available
Basophil count decreased13.01.06.0010.006948%Not Available
Basophil count increased13.01.06.0020.001737%Not Available
Benign breast neoplasm16.14.01.005; 21.05.01.0090.001158%Not Available
Benign neoplasm of skin23.10.01.006; 16.26.01.0060.004053%Not Available
Benign prostatic hyperplasia21.04.02.0010.001737%Not Available
Biliary colic09.02.01.0010.002895%Not Available
Bilirubin conjugated increased13.03.01.0070.003474%Not Available
Bladder cancer20.03.04.001; 16.08.01.001--Not Available
Bladder discomfort20.02.02.0190.002895%Not Available
Blepharitis23.03.04.012; 06.04.04.0010.003474%Not Available
Blepharospasm17.17.02.001; 06.05.01.0010.011001%Not Available
Blighted ovum18.01.03.0010.001737%Not Available
Blindness17.17.01.003; 06.02.02.0010.030108%Not Available
Blindness transient17.17.01.004; 06.02.02.0020.008685%Not Available
Blindness unilateral17.17.01.016; 06.02.02.0090.016212%Not Available
Blister12.01.06.002; 23.03.01.001--Not Available
Blood albumin decreased13.09.01.0010.005211%Not Available
Blood albumin increased13.09.01.0020.001737%Not Available
Blood bicarbonate decreased13.11.01.0190.002316%
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