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 Not Available
ATC Code L04AA42
DrugBank ID DB12371
KEGG ID D11460
MeSH ID C578989
PubChem ID 44599207
TTD Drug ID D07FKQ
NDC Product Code 0078-1014; 0078-0986; 0078-0979
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
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)
Palpitations02.01.02.0030.002316%
Paraesthesia17.02.06.0050.001737%
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Seizure17.12.03.0010.004053%
Sinusitis22.07.03.007; 11.01.13.0050.002316%
Somnolence17.02.04.006; 19.02.05.0030.003474%
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.0030.002895%Not Available
Swelling08.01.03.0150.002316%Not Available
Tremor17.01.06.0020.004053%
Upper respiratory tract infection22.07.03.011; 11.01.13.0090.001158%
Urinary tract infection20.08.02.001; 11.01.14.0040.006369%
Vertigo17.02.12.002; 04.04.01.0030.001158%
Vision blurred17.17.01.010; 06.02.06.0070.005211%
Visual acuity reduced17.17.01.011; 06.02.03.0010.001737%
Visual impairment06.02.06.0080.005211%Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.0050.002895%
Weight increased13.15.01.0060.004053%
White blood cell count decreased13.01.06.0120.002316%
Mobility decreased17.02.05.018; 15.03.01.003; 08.01.03.0300.001737%Not Available
Multiple sclerosis relapse17.16.01.0030.021423%Not Available
Peripheral swelling02.05.04.015; 08.01.03.0530.008106%Not Available
Abasia17.02.05.035; 08.01.02.0070.001158%Not Available
Balance disorder17.02.02.0070.004053%Not Available
Contusion24.07.06.001; 23.03.11.002; 15.03.01.008; 12.01.06.0010.002316%
Musculoskeletal stiffness15.03.01.0050.001737%Not Available
Transaminases increased13.03.01.0150.001158%Not Available
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