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)
Diffuse alopecia23.02.02.0070.000241%Not Available
Autoimmune haemolytic anaemia10.04.01.005; 01.06.01.0040.001447%Not Available
Language disorder19.19.01.006; 17.02.08.0150.000723%Not Available
Peripheral venous disease24.04.02.0220.000241%Not Available
Invasive breast carcinoma21.05.01.013; 16.10.01.0050.000482%Not Available
Stenosis08.01.03.0600.000241%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.005232%
Frustration tolerance decreased19.04.02.0160.003834%Not Available
Persistent depressive disorder19.15.01.0060.000241%Not Available
Ureterolithiasis20.04.03.0030.000241%Not Available
Somatic symptom disorder19.24.01.0060.000362%Not Available
Abdominal mass07.01.01.0030.000362%Not Available
Abnormal loss of weight14.03.02.0190.002001%Not Available
Acanthosis23.01.04.0030.000651%Not Available
Acoustic neuroma17.18.02.002; 16.09.02.002; 04.04.04.0030.000241%Not Available
Adenocarcinoma gastric16.13.03.002; 07.21.02.0020.000482%Not Available
Adenocarcinoma of colon16.13.01.010; 07.21.01.0080.000844%Not Available
Adenocarcinoma of the cervix21.06.02.005; 16.12.01.0030.000482%Not Available
Adjustment disorder with depressed mood19.23.01.0020.000530%Not Available
Alopecia areata23.02.02.008; 10.04.02.0110.000530%Not Available
Anaplastic large cell lymphoma T- and null-cell types16.17.02.002; 01.11.02.0020.000482%Not Available
Antiphospholipid syndrome10.04.01.009; 01.01.02.016; 24.01.01.029; 18.02.04.0020.000241%Not Available
Astigmatism06.02.04.0090.000603%Not Available
Bladder sphincter atony20.03.03.006; 17.05.01.0230.000241%Not Available
Bone cancer16.29.02.002; 15.09.03.0120.000603%Not Available
Borderline glaucoma06.03.01.0050.000940%Not Available
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000241%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000603%Not Available
Breast cancer stage I21.05.01.018; 16.10.01.0100.000603%Not Available
Breast cancer stage II21.05.01.019; 16.10.01.0110.000362%Not Available
The 31th Page    First    Pre   31 32 33 34 35    Next   Last    Total 40 Pages