Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Diroximel fumarate
Drug ID BADD_D02550
Description Multiple Sclerosis (MS) is a chronic, debilitating neurological disease that can lead to profound cognitive and physical symptoms, severely affecting quality of life.[A176474] It is the main cause of neurological disability not caused by trauma in the young adult population of both North America and Europe. Relapsing-remitting forms of MS lead to neurological symptoms that resolve and recur periodically. More than 80% of patients suffering from this disease have relapsing-remitting MS.[A187535] Diroximel fumarate is a new drug from the fumarate class formulated to treat various relapsing forms of MS. This drug is bioequivalent to [Dimethyl fumarate][A187544,L9626](initially manufactured in 2013), but is less likely to cause gastrointestinal side effects, owing to its unique chemical structure. Diroximel fumarate was formulated by Alkermes in collaboration with Biogen, and was approved by the FDA in October 2019[L9626] and by the EMA in November 2021.[L39225]
Indications and Usage Diroximel fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults; specifically active secondary progressive disease and clinically isolated syndrome, as well as relapsing-remitting MS.[L9623,L9629,L9632]
Marketing Status approved; investigational
ATC Code L04AX09
DrugBank ID DB14783
KEGG ID D11154
MeSH ID Not Available
PubChem ID 73330464
TTD Drug ID D0TD7J
NDC Product Code 71796-036; 66039-966; 69037-0059; 64406-020; 11722-067; 56125-700; 69766-086
UNII K0N0Z40J3W
Synonyms Not Available
Chemical Information
Molecular Formula C11H13NO6
CAS Registry Number 1577222-14-0
SMILES COC(=O)C=CC(=O)OCCN1C(=O)CCC1=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)
Abdominal discomfort07.01.06.0010.009138%Not Available
Abdominal distension07.01.04.0010.001230%
Abdominal pain07.01.05.0020.003930%
Abdominal pain upper07.01.05.0030.007788%
Abortion spontaneous18.01.04.0010.000362%Not Available
Alopecia23.02.02.0010.004509%
Anaphylactic reaction24.06.03.006; 10.01.07.0010.000772%
Back pain15.03.04.0050.004099%
Burning sensation17.02.06.001; 08.01.09.0290.001640%Not Available
Chromaturia20.02.01.0020.010199%
Clumsiness17.01.02.0050.000530%Not Available
Condition aggravated08.01.03.0040.019916%Not Available
Constipation07.02.02.0010.002869%
Coordination abnormal17.02.02.0040.000820%Not Available
Depressed mood19.15.02.0010.000820%Not Available
Depression19.15.01.0010.003400%
Diarrhoea07.02.01.0010.013189%
Diplopia17.17.01.005; 06.02.06.0020.000241%Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.011308%
Drug ineffective08.06.01.0060.039181%Not Available
Dry mouth07.06.01.0020.002049%
Dyspepsia07.01.02.0010.004099%
Dysuria20.02.02.0020.000820%
Erythema23.03.06.0010.004219%Not Available
Eye disorder06.08.03.0010.001230%Not Available
Eye pain06.08.03.0020.002049%
Fatigue08.01.01.0020.010247%
Feeling abnormal08.01.09.0140.003279%Not Available
Feeling hot08.01.09.0090.001230%Not Available
Flatulence07.01.04.0020.001760%
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