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)
Abulia19.01.02.009; 17.02.05.0400.001360%Not Available
Sudden onset of sleep17.15.04.0030.000880%Not Available
Lung cancer metastatic22.08.01.004; 16.19.02.0030.001400%Not Available
Lumbar radiculopathy17.10.03.0030.000400%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.010082%Not Available
Intervertebral disc protrusion15.10.01.0040.006321%Not Available
Lupus-like syndrome10.04.03.003; 23.03.02.004; 15.06.02.0040.001280%Not Available
Skin tightness23.03.03.0180.002720%Not Available
Extremity contracture15.03.05.0120.000880%Not Available
Lacunar infarction17.08.01.016; 24.04.06.0090.000400%Not Available
Dyschezia07.02.03.0050.000880%Not Available
Bladder necrosis24.04.09.006; 20.03.01.0170.000400%Not Available
Central nervous system lesion17.02.10.0110.049169%Not Available
Bile duct stenosis09.02.02.0010.000400%
Eyelids pruritus23.03.12.005; 06.08.03.0070.000880%Not Available
Gastrointestinal hypomotility07.02.02.0050.000600%Not Available
Ear discomfort04.03.01.0050.002921%Not Available
Ocular discomfort06.08.03.008--Not Available
Upper respiratory tract congestion22.12.03.0330.002720%Not Available
Lymphatic disorder01.09.01.0030.001360%Not Available
Colorectal cancer metastatic16.13.01.005; 07.21.01.0050.000400%Not Available
Colorectal adenocarcinoma16.13.01.009; 07.21.01.0070.000400%Not Available
Paranasal sinus discomfort22.12.03.0180.001560%Not Available
Large intestinal haemorrhage24.07.02.026; 07.12.03.0030.000600%
Adenocarcinoma pancreas16.13.10.002; 07.21.09.0030.000400%Not Available
Drug tolerance08.06.01.003--Not Available
Cardiac flutter02.03.02.0120.001080%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Epigastric discomfort07.01.02.0040.004881%Not Available
Organ failure08.01.03.0410.000800%Not Available
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