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)
Communication disorder19.19.01.0080.004401%Not Available
Foot deformity15.10.03.0050.004681%Not Available
Hand deformity15.10.03.0070.001360%Not Available
Testicular neoplasm21.13.02.006; 16.25.02.0020.001080%Not Available
Testicular seminoma (pure)21.13.02.007; 16.25.03.0030.000400%Not Available
Placenta accreta18.05.02.0030.000400%Not Available
Spinal cord oedema17.10.01.0190.000400%Not Available
Relapsing-remitting multiple sclerosis17.16.01.0070.006281%Not Available
Secondary progressive multiple sclerosis17.16.01.0080.007241%Not Available
Primary progressive multiple sclerosis17.16.01.0050.001760%Not Available
Eyelid cyst23.07.04.024; 06.04.04.0160.000400%Not Available
Burnout syndrome19.06.06.0030.000880%Not Available
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.001400%Not Available
Weight bearing difficulty15.03.05.0340.000880%Not Available
Taciturnity19.19.02.006; 17.02.08.0190.000400%Not Available
Apparent death08.01.03.0620.000600%Not Available
Uhthoff's phenomenon17.16.01.009; 06.02.07.0080.002360%Not Available
Tongue pruritus07.14.02.0210.001360%Not Available
Band sensation17.16.01.0040.005161%Not Available
Lip pruritus07.05.05.0210.000880%Not Available
Neuroendocrine carcinoma metastatic16.24.01.008; 05.08.01.0120.000600%Not Available
Spinal pain15.02.01.008; 08.01.08.030; 17.10.01.0200.004881%Not Available
Eye colour change06.06.06.0080.001360%Not Available
Invasive ductal breast carcinoma16.10.01.013; 21.05.01.0210.007201%Not Available
Invasive lobular breast carcinoma21.05.01.022; 16.10.01.0140.001000%Not Available
Clear cell renal cell carcinoma20.01.04.008; 16.08.02.0040.000800%Not Available
Diabetic metabolic decompensation14.07.03.003; 05.07.03.0030.000400%Not Available
Pulmonary pain22.12.01.0100.002720%Not Available
Noninfective encephalitis17.06.05.0050.000400%Not Available
Skin texture abnormal23.03.03.0680.001360%Not Available
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