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)
Abdominal discomfort07.01.06.0010.003474%Not Available
Abdominal pain07.01.05.0020.003474%
Abdominal pain upper07.01.05.0030.002895%
Alopecia23.02.02.0010.002316%
Anxiety19.06.02.0020.002895%
Appendicitis11.01.07.001; 07.19.01.0010.001158%
Arthralgia15.01.02.001--
Asthenia08.01.01.0010.006948%Not Available
Back pain15.03.04.005--
Basal cell carcinoma16.03.02.001; 23.08.02.0010.002316%Not Available
Blood pressure increased13.14.03.0050.011001%Not Available
Bradycardia02.03.02.0020.002316%Not Available
Burning sensation17.02.06.001; 08.01.09.0290.001158%Not Available
Chills15.05.03.016; 08.01.09.0010.001158%
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Crying08.01.03.005; 19.04.02.002; 17.02.05.013; 12.02.11.0010.001158%Not Available
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.013896%
Drug hypersensitivity10.01.01.001--Not Available
Dysphagia07.01.06.003--
Dyspnoea02.01.03.002; 22.02.01.0040.007527%
Dysuria20.02.02.0020.001158%
Erythema23.03.06.0010.001737%Not Available
Faeces discoloured07.01.03.0020.001158%Not Available
Fatigue08.01.01.0020.019686%
Feeling abnormal08.01.09.0140.004053%Not Available
Flushing08.01.03.025; 24.03.01.002; 23.06.05.0030.001158%
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