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)
Sleep disorder19.02.04.0010.000820%Not Available
Speech disorder19.19.02.002; 17.02.08.003; 22.12.03.0270.000820%Not Available
Stress19.06.02.0040.001640%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.000940%Not Available
Throat tightness19.01.02.005; 22.12.03.0310.000530%Not Available
Tinnitus17.04.07.004; 04.04.01.0020.002459%
Urticaria23.04.02.001; 10.01.06.0010.004629%
Vertigo17.02.12.002; 04.04.01.0030.004099%
Visual impairment06.02.10.0130.002291%Not Available
Vitreous floaters06.09.01.0050.000820%
Yellow skin23.03.03.042; 09.01.01.009; 08.01.03.0460.003520%Not Available
Mental status changes19.07.01.0010.000820%Not Available
Multiple sclerosis relapse17.16.01.0030.018951%Not Available
Musculoskeletal disorder15.03.05.0250.000820%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.002869%Not Available
General physical health deterioration08.01.03.0180.001230%Not Available
Muscle tightness15.05.03.0070.001230%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.003400%Not Available
Bradyphrenia19.10.03.002; 17.03.03.0040.000940%Not Available
Central nervous system lesion17.02.10.0110.001640%Not Available
Ear discomfort04.03.01.0050.000820%Not Available
Ear pruritus04.03.01.0110.000820%Not Available
Musculoskeletal stiffness15.03.05.0270.002049%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000820%Not Available
Urine odour abnormal20.02.01.0200.000940%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.001230%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.002580%
Ocular icterus06.08.03.009; 01.06.04.007; 09.01.01.0070.002700%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.001230%
Appetite disorder19.09.01.002; 14.03.01.0040.000820%Not Available
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