Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dimethyl fumarate
Drug ID BADD_D00680
Description Dimethyl fumarate is an anti-inflammatory. It is indicated for multiple sclerosis patients with relapsing forms and is also being investigated for the treatment of psoriasis. The mechanism of action of dimethyl fumarate in multiple sclerosis is not well understood. It is thought to involve dimethyl fumarate degradation to its active metabolite monomethyl fumarate (MMF) then MMF up-regulates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway that is activated in response to oxidative stress. Dimethyl fumarate is marketed under the brand name Tecfidera.
Indications and Usage Used in multiple sclerosis patients with relapsing forms.
Marketing Status approved; investigational
ATC Code L04AX07
DrugBank ID DB08908
KEGG ID D03846
MeSH ID D000069462
PubChem ID 637568
TTD Drug ID D0A7MY
NDC Product Code 69037-0012; 0093-9219; 70771-1531; 55111-975; 76055-0026; 51407-441; 49812-0255; 58159-013; 62207-003; 66039-901; 66577-043; 82920-027; 16729-416; 24979-128; 43598-429; 43598-430; 51407-442; 59651-083; 69539-042; 69539-043; 64406-005; 70710-1205; 54864-663; 55111-997; 59285-003; 62675-0393; 69667-1229; 16729-417; 31722-657; 0378-0396; 10920-598; 65015-844; 24979-127; 0378-0399; 64406-007; 67877-555; 69097-323; 70512-853; 70771-1532; 59651-061; 62512-0074; 59651-084; 62579-301; 43547-024; 50090-5288; 67877-556; 69238-1318; 69238-1319; 70512-852; 70710-1416; 70771-1530; 50379-0013; 31722-680; 43547-025; 64406-006; 69097-322; 69097-552; 69238-1626; 69539-240; 82245-0105; 31722-658; 67877-557; 70710-1204
UNII FO2303MNI2
Synonyms Dimethyl Fumarate | Fumarate, Dimethyl | 2-butenedioic acid, (2E)-, dimethyl ester | Dimethylfumarate | BG 00012 | 00012, BG | BG00012 | BG-00012 | Tecfidera | FAG 201 | 201, FAG | FAG201 | FAG-201 | Fumaderm | BG 12 compound | 12 compound, BG | compound, BG 12 | BG12 compound | compound, BG12 | BG-12 compound
Chemical Information
Molecular Formula C6H8O4
CAS Registry Number 624-49-7
SMILES COC(=O)C=CC(=O)OC
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)
Miliaria23.02.03.0140.001480%Not Available
Mixed connective tissue disease15.06.01.011; 10.04.04.0070.001360%Not Available
Monoplegia17.01.04.0030.001480%Not Available
Mood altered19.04.02.007--Not Available
Motion sickness17.02.12.001; 04.04.01.0010.002921%Not Available
Multiple allergies10.01.03.0300.005841%Not Available
Multiple sclerosis10.04.10.008; 17.16.01.0010.255167%Not Available
Muscle atrophy17.05.03.004; 15.05.03.0030.002160%Not Available
Muscle disorder15.05.03.0140.001200%Not Available
Muscle spasms15.05.03.0040.089376%
Muscle spasticity17.05.03.007; 15.05.04.0110.011242%
Muscle twitching15.05.03.0050.008482%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.080695%
Myasthenia gravis10.04.05.001; 17.05.04.001; 15.05.08.0010.000880%
Myelitis transverse17.06.02.002; 10.04.10.0060.002200%Not Available
Myelopathy17.10.01.0070.000800%Not Available
Myocardial infarction24.04.04.009; 02.02.02.0070.020244%
Narcolepsy19.02.02.002; 17.15.01.0020.000880%Not Available
Nausea07.01.07.0010.500092%
Neck pain15.03.04.0090.016683%
Neoplasm malignant16.16.01.0010.010162%Not Available
Neoplasm skin23.08.02.003; 16.03.02.0030.000400%Not Available
Nephrolithiasis20.04.01.0020.018523%
Nerve compression17.09.02.002; 12.01.12.0010.000600%Not Available
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.0030.011482%Not Available
Neuralgia17.02.07.0050.012802%
Neurodermatitis23.03.04.0070.001080%Not Available
Neurogenic bladder17.10.01.002; 20.03.03.0010.000800%Not Available
Night sweats23.02.03.006; 08.01.03.0310.021524%Not Available
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