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)
Keratosis pilaris23.01.01.0020.001760%Not Available
Thyroid cancer16.24.03.001; 05.02.05.0010.002098%Not Available
Pharyngeal disorder22.04.05.0070.000530%Not Available
Decreased vibratory sense17.02.07.0130.000603%Not Available
Low birth weight baby18.04.02.003--Not Available
Type 2 diabetes mellitus14.06.01.003; 05.06.01.003--Not Available
Vulvovaginal burning sensation21.08.02.0070.000241%Not Available
Gastrointestinal sounds abnormal07.01.01.0020.000362%Not Available
Upper airway obstruction22.12.03.0320.000241%Not Available
Skin mass23.07.04.0140.001181%Not Available
Brain injury19.07.03.007; 17.11.01.0030.001808%Not Available
Intellectual disability19.21.06.001; 17.03.07.0010.000530%Not Available
Occipital neuralgia17.14.01.0130.000651%Not Available
Hypertransaminasaemia09.01.02.0050.001688%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.000892%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.102810%
Neurological decompensation17.02.05.0300.001326%Not Available
Bladder dysfunction20.03.03.0020.003062%Not Available
Langerhans' cell histiocytosis09.01.08.018; 22.01.01.016; 16.21.04.003; 15.09.03.008; 01.13.04.0030.000241%Not Available
Upper-airway cough syndrome22.12.03.0360.001061%
Skin sensitisation23.03.03.052; 10.02.01.0380.000530%Not Available
Macular pigmentation06.09.03.0150.000772%Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.001857%
Functional gastrointestinal disorder07.11.01.0160.001832%Not Available
Slow speech19.19.02.004; 17.02.08.0160.000362%Not Available
Macular fibrosis06.09.03.0140.000603%Not Available
Glassy eyes08.01.03.055; 06.08.03.0210.000820%Not Available
Granulomatosis with polyangiitis20.05.01.013; 10.02.02.018; 24.12.04.011; 22.01.01.015--Not Available
White matter lesion24.04.06.027; 17.11.01.0090.002869%Not Available
Intraductal proliferative breast lesion21.05.01.014; 16.10.01.0060.002411%Not Available
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