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)
Malignant neoplasm of unknown primary site16.16.01.0190.000362%-
Melanocytic hyperplasia23.05.01.0170.000362%-
Meningoradiculitis17.10.01.0270.000241%-
Mucoepidermoid carcinoma16.16.01.0210.000241%-
Multiple sclerosis pseudo relapse17.16.01.0110.000362%-
Naevoid melanoma16.03.01.012; 23.08.01.0120.000482%-
Near death experience17.02.04.023; 19.10.05.007---
Normocytic anaemia01.03.02.0220.000362%-
Ophthalmic migraine06.02.07.009; 17.14.02.005---
Penile squamous cell carcinoma16.25.05.002; 21.12.03.0030.000362%-
Perinatal depression18.06.03.003; 19.15.01.0110.000772%-
Periorbital pain06.08.03.0310.000241%-
Peripheral nerve lesion17.09.02.0190.000530%-
Pituitary enlargement05.03.04.0040.000241%-
Placental transfusion syndrome01.05.01.031; 18.05.02.0100.000362%-
Pregnancy on oral contraceptive18.08.01.0050.000482%-
Primary biliary cholangitis09.01.04.010; 10.04.09.0040.000241%-
Prosopagnosia17.02.03.022; 19.21.01.0150.000362%-
Pseudofolliculitis23.02.06.0130.000820%-
Pulmonary hilum mass22.09.03.0150.000241%-
Pulpless tooth07.09.12.0020.000362%-
Relapsing multiple sclerosis17.16.01.0120.000603%-
Renal hamartoma16.27.01.011; 20.01.04.0260.000241%-
Retention cyst08.03.05.012; 16.02.02.0170.000530%-
Retinal migraine06.02.06.023; 17.14.02.006; 24.03.05.0190.000530%-
Retinal telangiectasia06.10.01.015; 24.03.03.0510.000241%-
Retinal thickening06.09.03.0350.000241%-
Right hemisphere deficit syndrome17.02.03.024; 19.21.01.0160.000241%-
Saccadic eye movement06.05.02.030; 17.02.02.0220.000362%-
Sensitive skin23.03.03.0970.000940%-
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