Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fingolimod hydrochloride
Drug ID BADD_D00899
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 indicated for the treatment of patients aged 10 and above with relapsing forms of multiple sclerosis, which may include clinically isolated syndrome, relapsing-remitting disease, as well as active secondary progressive disease.[L12651] This drug is being studied for administration in patients infected with COVID-19 with a high risk for acute respiratory distress syndrome, or ARDS.[L12654] As of April 3 2020, this is currently not an approved indication and clinical trials are underway.[L12657]
Marketing Status approved; investigational
ATC Code L04AA27
DrugBank ID DB08868
KEGG ID D04187
MeSH ID D000068876
PubChem ID 107969
TTD Drug ID D0HI1K
NDC Product Code 57741-3100; 16729-342; 67877-476; 54893-0025; 65015-834; 69037-0006; 65035-138; 66039-886; 82920-019; 65727-036; 82245-0106
UNII G926EC510T
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 C19H34ClNO2
CAS Registry Number 162359-56-0
SMILES CCCCCCCCC1=CC=C(C=C1)CCC(CO)(CO)N.Cl
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)
Viral infection11.05.04.001--Not Available
Vision blurred17.17.01.010; 06.02.06.007--
Visual acuity reduced06.02.10.012; 17.17.01.011--
Weight decreased13.15.01.005--
Multiple sclerosis relapse17.16.01.003--Not Available
Bradyarrhythmia02.03.02.015--Not Available
Lymphatic disorder01.09.01.003--Not Available
Electrocardiogram PR prolongation13.14.05.012--Not Available
Tinea versicolour23.11.03.013; 11.03.08.006--Not Available
Pre-existing disease08.01.03.059--Not Available
Angiopathy24.03.02.007--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Tinea infection23.11.03.011; 11.03.08.002--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Lymphoproliferative disorder16.21.02.001; 01.13.02.001--Not Available
Ischaemic stroke24.04.06.010; 17.08.01.018--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Blood disorder01.05.01.004--Not Available
Autoimmune disorder10.04.04.003--
Obstructive airways disorder22.03.01.011--Not Available
Peripheral arterial occlusive disease24.04.03.010--Not Available
Liver injury12.01.17.012; 09.01.07.022--Not Available
Traumatic liver injury09.01.08.010; 12.01.17.027--Not Available
X-linked lymphoproliferative syndrome16.21.02.003; 11.05.10.005; 10.03.01.003; 03.17.01.002; 01.13.02.003--Not Available
Posterior reversible encephalopathy syndrome17.13.02.007--
Varicella zoster virus infection11.05.02.023--Not Available
Haemophagocytic lymphohistiocytosis16.32.03.038; 10.02.01.077; 01.05.01.026--Not Available
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