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)
Lung carcinoma cell type unspecified stage IV22.08.01.019; 16.19.02.0060.000241%Not Available
Lymphadenopathy mediastinal01.09.01.025; 22.09.03.0060.000241%Not Available
Macrosomia08.01.03.0730.000241%Not Available
Macular cyst06.09.03.0190.000603%Not Available
Malignant melanoma in situ23.08.01.004; 16.03.01.0040.002411%Not Available
Malignant melanoma stage I23.08.01.005; 16.03.01.0050.000241%Not Available
Metastases to adrenals16.22.02.012; 05.01.04.0070.000362%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.002170%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.001495%Not Available
Mitral valve prolapse02.07.01.0080.000241%Not Available
Nasal turbinate hypertrophy22.04.03.0210.000241%Not Available
Neurologic neglect syndrome19.21.01.009; 17.02.03.017; 06.02.06.0180.000362%Not Available
Normal newborn18.08.06.0010.029802%Not Available
Oesophageal adenocarcinoma16.13.06.002; 07.21.06.0020.000362%Not Available
Oral lichen planus23.03.08.012; 07.05.01.0180.000241%Not Available
Overweight14.03.02.0210.000892%Not Available
Peripheral T-cell lymphoma unspecified16.17.06.001; 01.11.06.0010.000241%Not Available
Pityriasis rosea23.03.08.0030.001350%Not Available
Placenta praevia18.05.02.0040.000241%Not Available
Pleocytosis17.02.05.0590.001206%Not Available
Pneumothorax spontaneous22.05.02.0070.000241%Not Available
Postmature baby18.04.02.0060.000530%Not Available
Prolactin-producing pituitary tumour16.24.07.001; 05.03.05.0050.000241%Not Available
Reading disorder19.21.05.0030.000482%Not Available
Rectal adenocarcinoma16.13.01.016; 07.21.05.0050.000482%Not Available
Recurrent cancer16.16.01.0150.000651%Not Available
Retinal cyst06.09.03.0220.001326%Not Available
Retinal pigment epitheliopathy06.09.03.0240.000241%Not Available
Ruptured cerebral aneurysm17.08.01.059; 24.02.04.0050.000362%Not Available
Seminoma21.13.02.004; 16.25.03.0020.000241%Not Available
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