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)
White blood cell disorder01.02.05.0020.002240%Not Available
Carcinoma in situ16.16.01.0060.000400%Not Available
Feeling of body temperature change08.01.09.0120.004281%Not Available
Gastrointestinal ulcer07.04.04.0020.000600%Not Available
Intervertebral disc disorder15.10.01.0030.001080%Not Available
Inner ear disorder04.04.02.0020.000880%Not Available
Mitral valve disease02.07.01.0030.000400%
Pituitary tumour benign16.37.02.001; 05.03.05.0030.000600%Not Available
Ulcer haemorrhage08.03.06.003; 24.07.01.0400.001200%Not Available
Autoimmune disorder10.04.04.0030.001880%
Bone marrow disorder01.05.01.0060.000400%Not Available
Drug intolerance08.06.01.0130.190275%Not Available
Pancreatic neoplasm16.13.11.005; 07.21.09.0040.000600%Not Available
Food intolerance14.02.01.0050.001280%Not Available
Gastrointestinal obstruction07.13.01.0050.000400%Not Available
Hepatic lesion09.01.08.0050.001280%Not Available
Immunosuppression10.03.02.0010.001280%Not Available
Leukoplakia23.01.06.002; 08.01.06.0130.001360%Not Available
Lung neoplasm16.19.04.001; 22.08.01.0060.000800%Not Available
Renal impairment20.01.03.010--Not Available
Nail ridging23.02.05.0200.001360%
Non-cardiac chest pain22.12.02.009; 08.01.08.0060.000600%
Middle ear effusion04.05.03.0010.002240%Not Available
Arterial occlusive disease24.04.02.0210.000400%Not Available
Facial spasm17.04.03.0100.001360%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.012442%Not Available
Lichenoid keratosis23.01.01.0040.000600%Not Available
Solar lentigo23.05.01.0130.000880%Not Available
Gastrointestinal inflammation07.08.03.0070.001080%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.002720%Not Available
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