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)
Skin swelling23.03.03.0390.000880%Not Available
Type IV hypersensitivity reaction10.01.03.0220.000400%Not Available
Vascular occlusion24.04.02.015--Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.019964%Not Available
Transaminases13.03.04.033--Not Available
Cerebral disorder17.02.10.0170.004201%Not Available
Scrotal erythema23.03.06.013; 21.12.02.0080.001360%Not Available
Dysphemia19.19.03.005; 17.02.08.0100.003601%Not Available
Brain cancer metastatic16.30.04.001; 17.20.04.0010.000400%Not Available
Hepatic cancer metastatic16.07.02.002; 09.04.02.0060.000400%Not Available
Fluid intake reduced14.05.10.0010.002720%Not Available
Pulmonary mass22.02.07.0040.002560%Not Available
Vulvovaginal pruritus21.08.02.004; 23.03.12.0090.001960%Not Available
Temperature intolerance08.01.09.0220.011962%Not Available
Urine odour abnormal20.02.01.0200.007601%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.008402%Not Available
Paraesthesia oral17.02.06.008; 07.05.05.0350.007481%Not Available
Paranasal sinus hypersecretion22.04.06.0040.000880%Not Available
Testis cancer21.13.02.001; 16.25.03.0010.000400%Not Available
Breast cancer female21.05.01.011; 16.10.01.0040.005601%Not Available
Anxiety disorder19.06.01.0020.000400%Not Available
Bipolar disorder19.16.01.0030.004961%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.072293%
Major depression19.15.01.0030.002600%Not Available
Ocular icterus06.08.03.009; 01.06.04.007; 09.01.01.0070.019964%Not Available
Dysplasia08.03.04.0070.000400%Not Available
Dysgraphia17.02.03.0060.005961%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.001--Not Available
Menopausal disorder21.02.02.0050.000400%Not Available
Thyroid mass05.02.01.0030.000800%Not Available
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