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)
Invasive ductal breast carcinoma21.05.01.021; 16.10.01.0130.004340%Not Available
Invasive lobular breast carcinoma16.10.01.014; 21.05.01.0220.000482%Not Available
Postural tremor17.01.06.0090.000241%Not Available
Clear cell renal cell carcinoma20.01.04.008; 16.08.02.0040.000241%Not Available
Anal squamous cell carcinoma16.13.05.002; 07.21.05.0040.000603%Not Available
Noninfective encephalitis17.06.05.0050.000362%Not Available
Bone marrow infiltration01.05.01.0180.000362%Not Available
Skin texture abnormal23.03.03.0680.001230%Not Available
Disorganised speech19.19.02.005; 17.02.08.017--Not Available
Fine motor skill dysfunction17.01.02.0200.001664%Not Available
Mental fatigue19.21.02.012; 17.03.03.0060.001302%Not Available
Hemianaesthesia17.02.06.0430.001688%Not Available
Infantile apnoea22.11.02.004; 18.04.15.0030.000241%Not Available
Intracranial mass17.11.01.0170.000482%Not Available
Tongue discomfort07.14.02.0190.000530%Not Available
Neuromyelitis optica spectrum disorder17.16.02.005; 10.04.10.015; 06.04.08.0030.001929%Not Available
Adenocarcinoma of appendix07.21.01.017; 16.13.01.0170.000241%Not Available
Allergy to animal10.01.03.0510.000241%Not Available
Anembryonic gestation18.01.03.0070.000482%Not Available
Anisocoria17.02.11.009; 06.05.03.0130.000530%Not Available
Anogenital dysplasia21.10.05.007; 07.03.01.0060.000362%Not Available
Astrocytoma malignant17.20.02.007; 16.30.02.0070.000241%Not Available
Attention deficit hyperactivity disorder19.21.04.004--Not Available
Autoimmune uveitis10.04.04.023; 06.04.03.0070.000241%Not Available
Bell's palsy17.04.03.011--Not Available
Benign bone neoplasm16.11.02.001; 15.09.01.0030.000241%Not Available
Benign neoplasm of thyroid gland16.37.01.002; 05.02.05.0040.000241%Not Available
Catarrh22.12.03.0020.000241%Not Available
Central nervous system vasculitis24.12.04.005; 17.08.02.029; 10.02.02.0300.000241%Not Available
Central serous chorioretinopathy06.10.02.009--Not Available
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