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 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 D10001
MeSH ID D000068876
PubChem ID 107970
TTD Drug ID D07UHS
NDC Product Code 54893-0026; 60505-4332; 70771-1603; 68462-166; 64380-776; 65035-201; 31722-889; 62756-064; 68382-912; 43598-285; 43547-003; 0378-4525
UNII 3QN8BYN5QF
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
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)
Brain oedema17.07.02.003; 12.01.10.0100.003255%
Weight fluctuation14.03.02.0020.001640%Not Available
Rectal discharge07.03.03.0050.000530%Not Available
Emotional distress19.04.02.008--Not Available
Lip blister23.03.01.016; 07.05.01.0070.000820%Not Available
Precancerous skin lesion23.01.06.0040.000892%Not Available
General physical health deterioration08.01.03.0180.016637%Not Available
Tachyarrhythmia02.03.02.0080.000723%Not Available
Muscle fatigue15.05.03.0060.001495%Not Available
Quadriparesis17.01.04.0120.001808%Not Available
Lhermitte's sign17.02.06.0140.001206%Not Available
Bradyarrhythmia02.03.02.0150.000241%Not Available
Left ventricular hypertrophy02.04.02.0140.000482%Not Available
Muscle tightness15.05.03.0070.006269%Not Available
Balance disorder17.02.02.007; 08.01.03.0810.062954%Not Available
Impatience19.05.01.0140.000362%Not Available
Bradyphrenia19.10.03.002; 17.03.03.0040.001133%Not Available
Lung cancer metastatic22.08.01.004; 16.19.02.0030.000723%Not Available
Skin fibrosis23.03.03.0610.000241%Not Available
Lumbar radiculopathy17.10.03.0030.000651%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.007499%Not Available
Intervertebral disc protrusion15.10.01.0040.005618%Not Available
Ventricular hypokinesia02.04.02.0130.000241%Not Available
Extremity contracture15.03.05.0120.000651%Not Available
Hypochromasia01.07.02.0110.000241%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.005690%
Eye naevus06.12.02.001; 16.34.02.0010.000651%Not Available
Macular hole06.09.03.0090.000482%Not Available
Foreign body sensation in eyes06.01.01.0060.000362%Not Available
Self-injurious ideation19.12.01.0070.000651%Not Available
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