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)
Back pain15.03.04.0050.091165%
Basal cell carcinoma16.03.02.001; 23.08.02.0010.019024%Not Available
Benign breast neoplasm21.05.01.009; 16.14.01.0050.000362%Not Available
Benign neoplasm of skin23.10.01.006; 16.26.01.0060.001712%Not Available
Benign prostatic hyperplasia21.04.02.0010.000651%Not Available
Biliary colic09.02.01.0010.000362%Not Available
Bladder discomfort20.02.02.0190.001953%Not Available
Blepharitis23.03.04.012; 06.04.04.0010.001591%Not Available
Blepharospasm17.17.02.001; 06.05.01.0010.005015%Not Available
Blindness17.17.01.003; 06.02.10.0030.008222%Not Available
Blindness transient06.02.10.006; 17.17.01.0040.003737%Not Available
Blindness unilateral06.02.10.007; 17.17.01.0160.004027%Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Blood pressure fluctuation24.06.01.0020.004726%Not Available
Bowen's disease23.08.02.004; 16.03.02.0040.002291%Not Available
Bradycardia02.03.02.0020.046390%Not Available
Breast cancer21.05.01.003; 16.10.01.0010.025365%Not Available
Breast cancer stage IV16.10.01.003; 21.05.01.0100.000241%Not Available
Breast cyst21.05.01.006; 16.14.01.0040.001013%Not Available
Breast discharge21.05.05.0010.000362%Not Available
Breast mass21.05.04.0020.004485%Not Available
Breast neoplasm21.05.01.004; 16.10.02.0010.000844%Not Available
Breast pain21.05.05.0030.000723%
Breath odour07.01.06.0020.000940%Not Available
Breech presentation18.03.04.0010.000362%Not Available
Bronchitis chronic22.03.01.0190.000603%Not Available
Bruxism19.11.03.001; 07.01.06.0080.000482%Not Available
Bundle branch block02.03.01.0090.000723%Not Available
Bundle branch block left02.03.01.0070.002845%Not Available
Bundle branch block right02.03.01.0110.003110%Not Available
The 3th Page    First    Pre   3 4 5 6 7    Next   Last    Total 40 Pages