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)
Squamous cell carcinoma of the cervix21.06.02.007; 16.12.01.0040.000362%Not Available
Squamous cell carcinoma of the tongue16.13.07.007; 07.21.07.0100.000241%Not Available
Stasis dermatitis24.10.04.004; 23.03.04.0410.000940%Not Available
Superficial spreading melanoma stage unspecified23.08.01.010; 16.03.01.0100.001206%Not Available
Teeth brittle07.09.05.0150.000772%Not Available
Thymoma16.19.07.002; 01.09.04.003; 22.09.03.0100.000241%Not Available
Tobacco abuse19.07.06.0210.000241%Not Available
Tonsil cancer22.08.02.003; 16.19.05.0020.000362%Not Available
Vesicoureteric reflux20.03.05.0020.000241%Not Available
Vitritis06.04.06.0130.000241%Not Available
Vulval cancer21.08.03.005; 16.12.08.0010.000482%Not Available
Vulval cancer stage 021.08.03.006; 16.12.08.0020.000482%Not Available
Wolff-Parkinson-White syndrome02.03.01.0160.000241%Not Available
Concomitant disease progression08.01.03.0640.000241%Not Available
Venous stenosis24.04.02.0290.000241%Not Available
Vertebral lesion15.02.04.0400.000892%Not Available
Axillary mass15.03.02.0140.000362%Not Available
Weight loss poor14.03.02.0270.000530%Not Available
Neck mass15.03.02.0070.000362%Not Available
Ovarian cyst torsion21.11.01.016; 16.04.03.0070.000241%Not Available
Renal cancer metastatic20.01.04.012; 16.08.02.0060.000241%Not Available
Cervical radiculopathy17.10.02.0030.000530%Not Available
Carotid artery dissection24.02.04.004; 17.08.06.0030.000603%Not Available
Tongue biting12.01.17.023; 17.02.05.064; 07.14.01.0130.000603%Not Available
Central nervous system inflammation17.06.01.0030.000844%Not Available
Laziness19.04.04.0050.000241%Not Available
Metastases to meninges17.02.10.012; 16.22.02.0030.000362%Not Available
Intestinal adenocarcinoma16.13.04.004; 07.21.01.0140.000241%Not Available
Focal nodular hyperplasia16.06.01.004; 09.04.01.0040.000241%Not Available
Neuroendocrine tumour16.24.01.009; 05.08.01.0130.000362%Not Available
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