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)
Breast cancer stage III21.05.01.020; 16.10.01.0120.000362%Not Available
Bronchial carcinoma22.08.01.015; 16.19.02.0040.000844%Not Available
Bulbar palsy17.04.10.0010.000241%Not Available
Cafe au lait spots23.05.01.0150.001085%Not Available
Central nervous system lymphoma18.04.04.013; 17.02.10.028; 16.20.01.005; 01.12.01.0050.000362%Not Available
Cervical spinal stenosis17.10.02.006; 15.10.04.0060.000723%Not Available
Chronic gastritis11.07.01.016; 10.04.04.011; 07.08.02.0050.000530%Not Available
Coeliac disease14.02.01.007; 07.17.01.008; 10.04.04.0120.000723%Not Available
Colon cancer stage IV07.21.01.012; 16.13.01.0140.000241%Not Available
Concomitant disease aggravated08.01.03.0630.017047%Not Available
Deja vu19.10.05.002; 17.12.05.0020.000241%Not Available
Dyslalia19.19.03.009; 17.02.08.0180.000362%Not Available
Eczema asteatotic23.03.04.0250.000651%Not Available
Exostosis of jaw15.02.04.0330.000241%Not Available
Faeces pale07.01.03.0050.000651%Not Available
Gait spastic17.01.04.018; 08.01.02.0090.001254%Not Available
Gliosis17.06.01.0040.000241%Not Available
Haemangioma of skin16.26.01.013; 24.03.06.008; 23.10.01.0130.007306%Not Available
Haemorrhoids thrombosed24.10.02.006; 07.15.03.0050.000241%Not Available
Hemianopia homonymous17.17.01.024; 06.02.07.0070.000844%Not Available
Hyperbilirubinaemia neonatal09.01.01.014; 18.04.08.003; 17.13.01.009; 14.11.01.0380.000241%Not Available
Hypergammaglobulinaemia benign monoclonal16.23.01.004; 01.14.01.0040.000241%Not Available
Hypermetropia06.02.04.0100.001881%Not Available
Impulsive behaviour19.18.01.0010.000362%Not Available
Irregular sleep phase17.15.06.003; 19.02.06.0030.000241%Not Available
Leiomyosarcoma16.33.07.001; 15.09.03.0160.000362%Not Available
Lentigo maligna23.08.01.003; 16.03.01.0030.000603%Not Available
Locked-in syndrome17.01.04.0190.000482%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000964%Not Available
Lung adenocarcinoma stage IV22.08.01.017; 16.19.01.0070.000603%Not Available
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