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)
Cerebral venous sinus thrombosis24.01.04.021; 17.08.03.0060.000241%Not Available
Cervix carcinoma stage I21.06.02.010; 16.12.01.0070.000241%Not Available
Cervix carcinoma stage IV21.06.02.011; 16.12.01.0080.000241%Not Available
Colon cancer stage III16.13.01.018; 07.21.01.0180.000241%Not Available
Colorectal adenoma07.20.01.019; 16.05.02.0090.000892%Not Available
Corneal thickening06.06.03.0200.000241%Not Available
Cutaneous T-cell lymphoma23.07.04.029; 16.17.03.002; 01.11.03.0020.001447%Not Available
Dermatochalasis23.01.05.004; 06.06.04.0240.000530%Not Available
Detachment of macular retinal pigment epithelium06.09.03.0290.000241%Not Available
Detrusor sphincter dyssynergia20.03.03.009; 17.05.03.0180.000241%Not Available
Dilated cardiomyopathy02.04.01.0170.001085%Not Available
Drug effect less than expected08.06.01.036--Not Available
Dry age-related macular degeneration06.09.03.0300.000482%Not Available
Dyschromatopsia06.02.09.0030.000772%Not Available
Electric shock sensation17.02.07.024; 08.06.02.023--Not Available
External ear neoplasm malignant16.16.05.003; 04.01.01.0060.000241%Not Available
Eye haematoma24.07.05.017; 12.01.04.034; 06.07.02.0090.000362%Not Available
Focal dyscognitive seizures17.12.02.0050.000723%Not Available
Gait inability17.02.05.069; 08.01.02.0110.012007%Not Available
Gliomatosis cerebri17.20.02.008; 16.30.02.0080.000241%Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.0090.000241%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hemihypoaesthesia17.02.06.044; 23.03.03.079--Not Available
Hemiparaesthesia17.02.06.0450.000603%Not Available
Illness08.01.03.091--Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.004581%Not Available
Impaired reasoning19.10.03.0130.000241%Not Available
Laryngeal papilloma16.38.02.002; 22.08.02.011; 11.05.07.0060.000241%Not Available
Left atrial enlargement02.04.02.042--Not Available
Lung opacity22.12.01.006--Not Available
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