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)
Myocardial infarction24.04.04.009; 02.02.02.0070.002170%
Nasal congestion22.04.04.001--
Nausea07.01.07.0010.021242%
Neck pain15.03.04.0090.002122%
Neoplasm malignant16.16.01.001--Not Available
Nephrolithiasis20.04.01.0020.000362%
Nervousness19.06.02.0030.000892%Not Available
Neuralgia17.02.07.0050.001471%
Nystagmus17.02.02.006; 06.05.02.0060.000241%
Oedema14.05.06.010; 08.01.07.0060.002990%Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.0110.007523%
Ophthalmoplegia17.17.02.005; 06.05.02.0030.000241%Not Available
Optic neuritis10.02.01.097; 17.04.05.001; 06.04.08.0020.000723%Not Available
Osteoarthritis15.01.04.0010.000530%Not Available
Osteoporosis14.04.04.002; 15.02.03.0020.000530%
Ovarian cancer21.11.01.003; 16.12.04.0010.000241%Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.0100.010320%
Pain in jaw15.02.01.0030.000940%Not Available
Palpitations02.11.04.0120.003134%
Panic attack19.06.04.0010.000241%Not Available
Papilloedema06.09.02.002; 24.03.07.001; 17.07.02.0040.000241%
Paraesthesia23.03.03.094; 17.02.06.0050.003906%
Paralysis17.01.04.0040.000241%Not Available
Paraparesis17.01.04.0060.000603%Not Available
Paraplegia17.01.04.0070.000241%Not Available
Paresis17.01.04.0080.001206%Not Available
Peripheral coldness23.06.04.008; 24.04.03.006; 08.01.09.0100.000530%Not Available
Peroneal nerve palsy17.09.02.0030.001350%Not Available
Personality change19.05.01.006; 17.02.05.0190.000530%
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