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)
Ventricular dysfunction02.04.02.0050.000400%Not Available
Cluster headache17.14.01.0030.001360%Not Available
Early satiety14.03.01.010; 08.01.09.004; 07.01.06.0270.002040%Not Available
Anogenital warts21.10.03.004; 16.26.01.003; 11.05.07.002; 07.19.04.002; 23.10.01.0030.000880%Not Available
Radicular pain17.10.01.0130.001360%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.116941%
Neurological symptom17.02.05.0100.001480%Not Available
General symptom08.01.03.0210.045688%Not Available
Abdominal symptom07.01.06.0070.002240%Not Available
Appetite disorder14.03.01.004; 19.09.01.0020.002240%Not Available
Arterial disorder24.03.02.0200.000400%Not Available
Bladder disorder20.03.01.0020.007841%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.002961%Not Available
Cardiac disorder02.11.01.003--Not Available
Eye movement disorder17.02.05.025; 06.05.02.008--Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.013402%Not Available
Gastrointestinal motility disorder07.02.03.0010.001760%Not Available
Inflammation08.01.05.007; 10.02.01.0890.006681%Not Available
Limb discomfort15.03.04.0140.015563%Not Available
Intervertebral disc degeneration15.10.01.0020.001000%Not Available
Ischaemia24.04.02.0040.000600%Not Available
Joint lock15.01.08.0040.000600%Not Available
Malnutrition14.03.02.0040.002000%Not Available
Mental disorder19.07.01.0020.016643%Not Available
Motor dysfunction17.01.02.031; 15.05.06.0060.014643%Not Available
Nasopharyngeal cancer22.08.02.005; 16.19.05.0010.000400%Not Available
Oesophageal disorder07.11.02.0010.002160%Not Available
Optic nerve disorder17.04.05.004; 06.02.08.0010.001480%
Partial seizures17.12.03.0100.001000%Not Available
Spinal disorder15.02.04.0230.003041%Not Available
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