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)
Tunnel vision17.17.01.013; 06.02.07.0050.000482%Not Available
Ulcer08.03.06.001--Not Available
Ureteric obstruction20.06.01.0050.000241%Not Available
Urge incontinence20.02.02.0080.001206%Not Available
Urinary hesitation20.02.02.0090.001905%Not Available
Urinary incontinence17.05.01.008; 20.02.02.0100.015552%
Urinary retention20.02.02.0110.007643%
Urinary tract disorder20.08.01.0010.000603%Not Available
Urine abnormality20.02.01.0130.000362%Not Available
Uterine cancer21.07.02.003; 16.12.05.0010.002387%Not Available
Uterine leiomyoma21.07.02.004; 16.04.02.0010.003520%Not Available
Uterine polyp21.07.02.001; 16.04.02.0020.001133%Not Available
Uveitis10.02.01.023; 06.04.03.0030.005329%
Vaginal dysplasia21.08.01.0080.000723%Not Available
Vaginal odour21.08.02.0080.000820%Not Available
Varicose vein24.10.04.0010.001302%Not Available
Vasculitis24.12.04.027; 10.02.02.0060.000844%
Vasospasm24.04.02.0020.000362%Not Available
Ventricular arrhythmia02.03.04.0060.000603%
Ventricular extrasystoles02.03.04.0070.006052%Not Available
Ventricular tachycardia02.03.04.0100.001929%
Vertigo17.02.12.002; 04.04.01.0030.034865%
Vertigo positional04.04.01.005; 17.02.12.0040.002363%Not Available
Vestibular disorder17.02.02.008; 04.04.02.0010.000362%
Vision blurred17.17.01.010; 06.02.06.0070.112768%
Visual acuity reduced06.02.10.012; 17.17.01.0110.018542%
Visual field defect17.17.01.001; 06.02.07.0030.007788%Not Available
Visual impairment06.02.10.0130.139508%Not Available
Vitamin B12 deficiency14.12.02.0040.002146%Not Available
Vitamin D deficiency14.12.03.0030.014804%Not Available
The 22th Page    First    Pre   22 23 24 25 26    Next   Last    Total 40 Pages