Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Siponimod
Drug ID BADD_D02511
Description Siponimod, also known as _Mayzent_, by Novartis, is a new drug formulated for the management of Multiple Sclerosis (MS). It was approved by the FDA on March 26, 2019 [L5792] and by Health Canada on February 20, 2020.[L12171] This drug is considered a _sphingosine-1-phosphate (S1P) receptor modulator_ and is thought to play a role in suppressing the central nervous system inflammation that is associated with MS [FDA label]. Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system that is chronic and inflammatory, disrupting communication between the brain and other parts of the body. Most patients diagnosed with this illness experience their initial disease symptoms between the age of 20 to 40, often the most productive years of life. Symptoms may include but are not limited to fatigue, gait changes, bowel or bladder dysfunction, abnormal muscle twitching, vision disturbance, and depressing or mood swings.[L5801] MS is one of the most common causes of neurological disability in young adults and is found to occur more frequently in women than in men.[A176474,L5792]
Indications and Usage This drug is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults [FDA label].
Marketing Status approved; investigational
ATC Code L04AA42
DrugBank ID DB12371
KEGG ID D11460
MeSH ID C578989
PubChem ID 44599207
TTD Drug ID D07FKQ
NDC Product Code 0078-0986; 0078-0979; 0078-1014
UNII RR6P8L282I
Synonyms siponimod | 1-(4-(1-((E)-4-cyclohexyl-3-trifluoromethylbenzyloxyimino)-ethyl)-2-ethylbenzyl)-azetidine-3-carboxylic acid | Mayzent | BAF312 | BAF-312
Chemical Information
Molecular Formula C29H35F3N2O3
CAS Registry Number 1230487-00-9
SMILES CCC1=C(C=CC(=C1)C(=NOCC2=CC(=C(C=C2)C3CCCCC3)C(F)(F)F)C)CN4CC(C4)C(=O)O
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)
Ear pain04.03.01.0030.000530%
Eating disorder14.03.01.008; 19.09.01.0080.000362%Not Available
Epilepsy17.12.03.0020.000482%Not Available
Eye disorder06.08.03.0010.002483%Not Available
Eye haemorrhage24.07.05.002; 06.07.02.001; 12.02.02.0120.000362%Not Available
Eye inflammation06.04.05.0020.000241%Not Available
Eye pain06.08.03.0020.002122%
Eye swelling06.08.03.0030.000772%Not Available
Facial pain08.01.08.012--
Faeces discoloured07.01.03.0020.001230%Not Available
Fatigue08.01.01.0020.039229%
Feeling abnormal08.01.09.0140.011139%Not Available
Feeling cold08.01.09.0080.000940%Not Available
Feeling hot08.01.09.009--Not Available
Feeling jittery08.01.09.0160.001350%Not Available
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Frequent bowel movements07.02.04.002--Not Available
Gait disturbance15.03.05.013; 08.01.02.002; 17.02.05.0160.019168%
Gastrointestinal disorder07.11.01.0010.003810%Not Available
Glaucoma06.03.01.0020.000651%
Haemolytic anaemia01.06.03.0020.000241%Not Available
Hallucination19.10.04.0030.001133%
Head discomfort17.02.05.027--Not Available
Headache17.14.01.0010.048367%
Hemiparesis17.01.04.0010.001013%
Hepatic steatosis14.08.04.005; 09.01.07.0030.000362%Not Available
Hepatotoxicity09.01.07.009; 12.03.01.0080.000362%Not Available
Hypertension24.08.02.0010.014901%
Hypertensive crisis24.08.01.0010.000362%Not Available
Hypoaesthesia17.02.06.023; 23.03.03.0810.010730%Not Available
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