Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ozanimod
Drug ID BADD_D02580
Description Ozanimod is a once-daily sphingosine 1-phosphate receptor modulator for the treatment of relapsing Multiple Sclerosis (MS) and inflammatory bowel disease. It was developed by Celgene (now acquired by Bristol-Myers Squibb) [L11025] and was approved by the FDA on March 26, 2020.[L12573,L12582] In November 2021, ozanimod was also approved by the European Commission for the treatment of adults with relapsing remitting multiple sclerosis.[L39377,L39382] MS is a devastating inflammatory disease that often progresses and causes severe neurological, physical, and cognitive effects.[A176474] Inflammatory bowel disease also a chronic inflammatory condition and can cause persistent abdominal pain, diarrhea, bloody stools, and vomiting.[A189336] In clinical trials, Ozanimod has been shown to be well-tolerated and has resulted in a higher decrease in the rate of MS relapses than with intramuscular [interferon beta-1a], a current standard in MS therapy. Studies involving patients with inflammatory bowel disease have also shown promising results.[A189318,A189342]
Indications and Usage Ozanimod is indicated for adults in the treatment of relapsing forms of MS, which may include relapsing-remitting disease, clinically isolated syndrome, and active secondary progressive MS.[L12582]
Marketing Status approved; investigational
ATC Code L04AA38
DrugBank ID DB12612
KEGG ID D10968
MeSH ID C000607776
PubChem ID 52938427
TTD Drug ID D07EDB
NDC Product Code Not Available
UNII Z80293URPV
Synonyms ozanimod | RPC1063
Chemical Information
Molecular Formula C23H24N4O3
CAS Registry Number 1306760-87-1
SMILES CC(C)OC1=C(C=C(C=C1)C2=NC(=NO2)C3=C4CCC(C4=CC=C3)NCCO)C#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)
Mental status changes19.07.01.0010.001640%-
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.001760%-
Multiple sclerosis relapse17.16.01.0030.047282%-
Fibromyalgia15.05.02.0020.001181%-
Energy increased08.01.03.0170.000820%-
Breast calcifications21.05.04.0090.000820%-
Peripheral swelling02.05.04.015; 08.01.03.0530.009162%-
Muscle tightness15.05.03.0070.000530%-
Balance disorder08.01.03.081; 17.02.02.0070.010802%-
Musculoskeletal chest pain15.03.04.012; 22.09.01.0010.000820%
Central nervous system lesion17.02.10.0110.002580%-
Eye pruritus06.04.05.0060.001230%-
Ocular discomfort06.08.03.0080.001230%-
Respiratory tract congestion22.02.07.0030.001230%-
Nasal discomfort22.12.03.0120.000820%-
Cardiac flutter02.03.02.0120.000723%-
Musculoskeletal stiffness15.03.05.0270.004051%-
Musculoskeletal discomfort15.03.04.0010.000940%-
Cardiac discomfort02.11.04.0010.000820%-
Temperature intolerance08.01.09.0220.000820%-
Bipolar disorder19.16.01.0030.000241%-
Cognitive disorder17.03.03.003; 19.21.02.0010.003810%
Dysgraphia17.02.03.0060.000820%-
Restless legs syndrome15.05.03.012; 17.02.07.0080.000820%-
Adverse event08.06.01.0100.007860%-
Bladder disorder20.03.01.0020.001230%-
Feeding disorder14.03.02.003; 19.09.01.0030.000241%-
Limb discomfort15.03.04.0140.003400%-
Immunodeficiency10.03.02.0020.000241%-
Adverse drug reaction08.06.01.0090.004219%-
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