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 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 Not Available
ATC Code L04AA27
DrugBank ID DB08868
KEGG ID D10001
MeSH ID D000068876
PubChem ID 107970
TTD Drug ID D07UHS
NDC Product Code 54893-0026; 65035-201
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
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.0040.001737%Not Available
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abnormal faeces07.01.03.0010.002895%Not Available
Abnormal labour18.07.02.0010.001158%Not Available
Abnormal sensation in eye06.01.01.0010.008106%Not Available
Abortion18.01.01.0010.006948%Not Available
Abortion missed18.01.01.0020.001158%Not Available
Abortion spontaneous18.01.04.0010.079322%Not Available
Abscess11.01.08.001--Not Available
Acne23.02.01.0010.025476%Not Available
Acrochordon23.10.01.005; 16.26.01.0050.009264%Not Available
Actinic keratosis23.01.06.0010.016791%Not Available
Activated partial thromboplastin time prolonged13.01.02.001--
Acute abdomen07.01.06.0150.001158%Not Available
Acute disseminated encephalomyelitis17.16.02.003; 10.04.10.0100.002316%Not Available
Acute myeloid leukaemia01.10.05.001; 16.01.05.001--Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute respiratory failure22.02.06.001; 14.01.04.004--Not Available
Acute sinusitis22.07.03.013; 11.01.13.0120.004053%Not Available
Adenocarcinoma16.16.01.0040.000755%Not Available
Affective disorder19.04.04.0010.005790%Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Alanine aminotransferase abnormal13.03.01.0010.001158%Not Available
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