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)
JC virus test positive13.08.03.0300.047477%Not Available
Narrow anterior chamber angle06.06.07.0040.001737%Not Available
Subretinal fluid12.01.04.031; 06.09.03.0270.001737%Not Available
Vertebral foraminal stenosis17.10.01.024; 15.01.08.0150.001158%Not Available
Varicella virus test positive13.08.03.0330.002316%Not Available
Executive dysfunction19.21.02.0100.001158%Not Available
Motor developmental delay19.22.01.005; 17.01.02.0230.001737%Not Available
Mycobacterium tuberculosis complex test positive13.08.05.0040.001737%Not Available
Band sensation17.16.01.0040.007527%Not Available
Walking distance test abnormal13.15.01.0480.001158%Not Available
Seizure like phenomena17.12.03.0300.001158%Not Available
Hepatitis B surface antibody positive13.08.03.0200.001158%Not Available
Expanded disability status scale13.07.03.0130.000906%Not Available
Expanded disability status scale score increased13.07.03.0140.059057%Not Available
Vertebral artery dissection24.02.04.006; 17.08.06.0040.000604%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.009264%Not Available
Skin wound23.03.11.022; 12.01.06.0150.001737%Not Available
Enzyme level increased13.04.02.0150.001158%Not Available
Encephalitis autoimmune17.06.05.002; 16.32.01.006; 10.04.10.0120.000604%Not Available
Pelvic cyst16.04.01.005; 21.07.04.0100.001158%Not Available
Sensitivity to weather change08.01.03.0770.001737%Not Available
Meniscus injury15.07.03.006; 12.04.03.0080.002316%Not Available
Invasive ductal breast carcinoma21.05.01.021; 16.10.01.0130.017370%Not Available
Invasive lobular breast carcinoma21.05.01.022; 16.10.01.0140.001737%Not Available
Clear cell renal cell carcinoma16.08.02.004; 20.01.04.0080.001158%Not Available
Anal squamous cell carcinoma16.13.05.002; 07.21.05.0040.000906%Not Available
Herpes zoster meningoencephalitis17.06.06.005; 11.05.02.0300.001737%Not Available
Herpes zoster cutaneous disseminated23.09.03.013; 11.05.02.0270.002895%Not Available
Noninfective encephalitis17.06.05.0050.001737%Not Available
Internal haemorrhage24.07.01.072--Not Available
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