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)
Abulia17.02.05.040; 19.01.02.0090.001360%-
Sudden onset of sleep17.15.04.0030.000880%-
Lung cancer metastatic16.19.02.003; 22.08.01.0040.001400%-
Lumbar radiculopathy17.10.03.0030.000400%-
Dysstasia08.01.03.089; 15.03.05.011; 17.02.02.0120.010082%-
Intervertebral disc protrusion15.10.01.0040.006321%-
Lupus-like syndrome10.04.03.003; 15.06.02.004; 23.03.02.0040.001280%-
Skin tightness23.03.03.0180.002720%-
Extremity contracture15.03.05.0120.000880%-
Lacunar infarction17.08.01.016; 24.04.06.0090.000400%-
Dyschezia07.02.03.0050.000880%-
Bladder necrosis20.03.01.017; 24.04.09.0060.000400%-
Central nervous system lesion17.02.10.0110.049169%-
Bile duct stenosis09.02.02.0010.000400%
Eyelids pruritus06.08.03.007; 23.03.12.0050.000880%-
Gastrointestinal hypomotility07.02.02.0050.000600%-
Ear discomfort04.03.01.0050.002921%-
Ocular discomfort06.08.03.008---
Upper respiratory tract congestion22.12.03.0330.002720%-
Lymphatic disorder01.09.01.0030.001360%-
Colorectal cancer metastatic07.21.01.005; 16.13.01.0050.000400%-
Colorectal adenocarcinoma07.21.01.007; 16.13.01.0090.000400%-
Paranasal sinus discomfort22.12.03.0180.001560%-
Large intestinal haemorrhage07.12.03.003; 24.07.02.0260.000600%
Adenocarcinoma pancreas07.21.09.003; 16.13.10.0020.000400%-
Drug tolerance08.06.01.003---
Cardiac flutter02.03.02.0120.001080%-
Musculoskeletal stiffness15.03.05.027---
Epigastric discomfort07.01.02.0040.004881%-
Organ failure08.01.03.0410.000800%-
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