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)
Testicular seminoma (pure)16.25.03.003; 21.13.02.0070.000362%Not Available
Spider vein24.10.04.003; 23.06.03.0060.000940%Not Available
Dysplastic naevus23.10.01.011; 16.26.01.0110.004147%Not Available
Relapsing-remitting multiple sclerosis17.16.01.0070.002291%Not Available
Secondary progressive multiple sclerosis17.16.01.0080.007595%Not Available
Primary progressive multiple sclerosis17.16.01.0050.000241%Not Available
Spondylolisthesis12.04.04.008; 15.10.04.0040.000530%Not Available
Metastatic squamous cell carcinoma16.16.01.0100.000241%Not Available
Eyelid cyst23.07.04.024; 06.04.04.0160.000241%Not Available
Lip squamous cell carcinoma16.13.07.005; 07.21.07.0070.000241%Not Available
Nail growth abnormal23.02.05.0240.000530%Not Available
Necrotising retinitis24.04.10.006; 06.04.06.0120.000362%Not Available
Stress urinary incontinence20.02.02.0220.001254%Not Available
Weight bearing difficulty15.03.05.0340.000820%Not Available
Melanoma recurrent23.08.01.009; 16.03.01.0090.000241%Not Available
Apparent death08.01.03.0620.000482%Not Available
Uhthoff's phenomenon17.16.01.009; 06.02.07.0080.002700%Not Available
Delivery18.08.02.0060.004653%Not Available
Skin plaque23.03.03.0440.000892%Not Available
Facial asymmetry15.10.05.0040.000241%Not Available
Narrow anterior chamber angle06.06.07.0040.000651%Not Available
Autoimmune pancreatitis10.04.08.010; 07.18.01.0090.000241%Not Available
Subretinal fluid12.01.04.031; 06.09.03.0270.000362%Not Available
Vertebral foraminal stenosis17.10.01.024; 15.01.08.0150.000241%Not Available
Motor developmental delay17.01.02.023; 19.22.01.0050.000362%Not Available
Band sensation17.16.01.0040.002315%Not Available
Seizure like phenomena17.12.03.0300.000241%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.003930%Not Available
Encephalitis autoimmune17.06.05.002; 16.32.01.006; 10.04.10.0120.000482%Not Available
Pelvic cyst21.07.04.010; 16.04.01.0050.000241%Not Available
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