Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fingolimod hydrochloride
Drug ID BADD_D00899
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 a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Marketing Status Prescription
ATC Code L04AA27
DrugBank ID DB08868
KEGG ID D04187
MeSH ID D000068876
PubChem ID 107969
TTD Drug ID D0HI1K
NDC Product Code 66039-886; 62756-948; 54893-0025; 69037-0006; 63759-0019; 46708-827; 65015-834; 43451-007; 65035-138; 65727-036; 57741-3100; 82245-0106
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 C19H34ClNO2
CAS Registry Number 162359-56-0
SMILES CCCCCCCCC1=CC=C(C=C1)CCC(CO)(CO)N.Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acute disseminated encephalomyelitis17.16.02.003; 10.04.10.010--Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block complete02.03.01.003--
Atrioventricular block first degree02.03.01.004--
Atrioventricular block second degree02.03.01.005--
B-cell lymphoma16.28.01.001; 01.15.01.001--Not Available
Back pain15.03.04.005--
Blood triglycerides increased13.12.03.001--Not Available
Bradycardia02.03.02.002--Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Cardiac arrest02.03.04.001--
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Cough22.02.03.001--
Death08.04.01.001--
Depressed mood19.15.02.001--Not Available
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Diffuse large B-cell lymphoma16.28.02.001; 01.15.02.001--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dyspnoea22.02.01.004; 02.01.03.002--
Eczema23.03.04.006--
Eye disorder06.08.03.001--Not Available
Eye pain06.08.03.002--
Fatigue08.01.01.002--
Gamma-glutamyltransferase increased13.03.01.011--
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