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)
Lymphopenia01.02.02.0020.093118%Not Available
Macrocytosis01.07.02.0030.000362%Not Available
Macular degeneration06.09.03.0010.003954%Not Available
Macular oedema06.04.06.0050.039639%Not Available
Macule23.03.03.0370.002122%Not Available
Maculopathy06.09.03.0070.003520%Not Available
Malaise08.01.01.0030.100231%
Malignant melanoma23.08.01.001; 16.03.01.0010.014997%Not Available
Mass08.03.05.0030.002266%Not Available
Meibomianitis06.04.04.0080.000530%Not Available
Melanocytic naevus16.26.01.007; 23.10.01.0070.045088%Not Available
Memory impairment19.20.01.003; 17.03.02.0030.081183%
Meningioma17.20.01.005; 16.30.01.0050.001326%Not Available
Meningism17.02.05.0070.000482%
Menometrorrhagia21.01.03.0010.000362%Not Available
Menopausal symptoms21.02.02.0020.000892%Not Available
Menstrual disorder21.01.01.0040.002821%Not Available
Menstruation delayed21.01.02.003; 05.05.01.010--Not Available
Menstruation irregular21.01.01.005; 05.05.01.0080.005835%
Mental impairment17.03.03.002; 19.21.02.0030.002869%Not Available
Metastases to liver16.22.02.001; 09.04.02.0040.002291%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.001326%Not Available
Metastatic malignant melanoma16.03.01.002; 23.08.01.0020.000964%Not Available
Micturition disorder20.02.02.0050.001061%Not Available
Micturition urgency20.02.02.0060.018517%
Middle insomnia19.02.01.003; 17.15.03.0030.001953%Not Available
Migraine24.03.05.003; 17.14.02.0010.046631%Not Available
Migraine with aura24.03.05.005; 17.14.02.0020.002845%Not Available
Milia23.02.03.0110.001133%Not Available
Mitral valve incompetence02.07.01.0020.000844%Not Available
The 13th Page    First    Pre   13 14 15 16 17    Next   Last    Total 40 Pages