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)
Flushing24.03.01.002; 23.06.05.003; 08.01.03.0250.031224%
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.004051%
Gastritis07.08.02.0010.000820%
Gastrooesophageal reflux disease07.02.02.0030.002049%
Gastrointestinal disorder07.11.01.0010.005690%Not Available
Headache17.14.01.0010.015238%
Hypersensitivity10.01.03.0030.005980%
Hypoaesthesia23.03.03.081; 17.02.06.0230.006148%Not Available
Liver disorder09.01.08.0010.001640%Not Available
Lymphopenia01.02.02.0020.001881%Not Available
Memory impairment19.20.01.003; 17.03.02.0030.004051%
Migraine24.03.05.003; 17.14.02.0010.002170%Not Available
Mood altered19.04.02.0070.001230%Not Available
Mood swings19.04.03.0010.000820%Not Available
Multiple sclerosis10.04.10.008; 17.16.01.0010.010440%Not Available
Muscle spasms15.05.03.0040.003400%
Muscle twitching15.05.03.0050.000820%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.002580%
Nasal congestion22.04.04.0010.000820%
Nausea07.01.07.0010.013719%
Night sweats23.02.03.006; 08.01.03.0310.001230%Not Available
Pain in extremity15.03.04.0100.003689%
Pancreatitis07.18.01.0010.000241%
Paraesthesia23.03.03.094; 17.02.06.0050.005329%
Pruritus23.03.12.0010.011839%
Rash23.03.13.0010.011308%Not Available
Rash pruritic23.03.13.0300.002049%Not Available
Rhinorrhoea22.12.03.0210.001640%
Sexual dysfunction21.03.02.003; 19.08.05.0020.000820%Not Available
Skin exfoliation23.03.07.0030.000820%Not Available
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