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)
Gallbladder disorder09.03.02.0010.001808%Not Available
Gastritis07.08.02.0010.003882%
Gastrointestinal carcinoma16.13.04.001; 07.21.03.0010.001447%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.0050.002025%
Generalised oedema14.05.06.007; 08.01.07.0040.001085%
Generalised tonic-clonic seizure17.12.01.0020.004461%Not Available
Genital rash23.03.13.016; 21.10.01.0090.000362%Not Available
Gestational diabetes18.02.04.001; 14.06.01.008; 05.06.01.0080.000482%Not Available
Glaucoma06.03.01.0020.006052%
Glioblastoma17.20.02.002; 16.30.02.0020.000723%Not Available
Glioblastoma multiforme17.20.02.001; 16.30.02.0010.000482%Not Available
Glioma16.30.01.004; 17.20.01.0040.000482%Not Available
Goitre14.11.01.008; 05.02.01.0010.002483%Not Available
Granuloma23.03.15.001; 08.01.05.0010.000772%Not Available
Groin pain15.03.02.0040.001302%Not Available
Haemangioma24.03.06.004; 16.02.01.0020.006076%Not Available
Haemangioma of liver24.03.06.006; 16.06.01.003; 09.04.01.0030.000362%Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemoglobinaemia01.06.04.0010.000362%Not Available
Haemolytic anaemia01.06.03.0020.001567%Not Available
Haemorrhage in pregnancy24.07.03.015; 18.02.01.0030.000482%Not Available
Hair disorder23.02.06.0030.000820%Not Available
Hair texture abnormal23.02.06.0040.000651%
Halo vision06.02.06.0030.001423%Not Available
Hangover08.01.09.0180.000530%Not Available
Head discomfort17.02.05.0270.005763%Not Available
Headache17.14.01.0010.292470%
Hemianopia17.17.01.012; 06.02.07.0040.000844%Not Available
Hemiparesis17.01.04.0010.016130%
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