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)
Neoplasm skin23.08.02.003; 16.03.02.0030.002797%Not Available
Nephritis20.05.02.0010.000241%Not Available
Nephrolithiasis20.04.01.0020.006100%
Nerve compression17.09.02.002; 12.01.12.0010.001471%Not Available
Nervous system disorder17.02.10.0010.005859%Not Available
Nervousness19.06.02.0030.009283%Not Available
Neuralgia17.02.07.0050.012297%
Neuritis17.09.03.0010.000651%Not Available
Neuroendocrine carcinoma of the skin23.08.02.008; 16.03.02.008; 05.08.01.0090.000844%Not Available
Neurogenic bladder20.03.03.001; 17.10.01.0020.002339%Not Available
Night sweats08.01.03.031; 23.02.03.0060.008005%Not Available
Nocturia20.02.03.0010.002315%Not Available
Nodal rhythm02.03.03.0210.000482%Not Available
Non-Hodgkin's lymphoma16.35.01.001; 01.17.01.0010.001085%Not Available
Normochromic normocytic anaemia01.03.02.0050.000241%Not Available
Nystagmus17.02.02.006; 06.05.02.0060.003954%
Ocular hyperaemia06.04.05.0040.004967%Not Available
Ocular hypertension06.03.01.0030.000362%Not Available
Odynophagia07.01.06.0360.001181%Not Available
Oedema genital21.10.01.0110.000241%
Oesophagitis07.08.05.0010.001543%
Ophthalmoplegia17.17.02.005; 06.05.02.0030.002218%Not Available
Optic atrophy06.09.02.0010.002580%Not Available
Optic ischaemic neuropathy06.07.03.001; 24.04.10.001; 17.04.05.0060.000362%Not Available
Optic nerve cupping06.09.02.0030.000241%Not Available
Optic neuritis10.02.01.097; 17.04.05.001; 06.04.08.0020.023581%Not Available
Oropharyngeal squamous cell carcinoma07.21.07.005; 22.08.02.006; 16.19.05.0040.000241%Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteitis15.02.04.0150.000482%Not Available
Osteoarthritis15.01.04.0010.003978%Not Available
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