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)
Vitamin B12 deficiency14.12.02.0040.002040%Not Available
Vitamin D deficiency14.12.03.0030.002560%Not Available
Vitiligo23.05.02.004; 10.04.02.0040.001360%Not Available
Vitreous detachment12.01.04.005; 06.09.01.0020.000880%Not Available
Volvulus07.13.01.0120.000400%Not Available
Vomiting07.01.07.0030.326380%
Vomiting projectile07.01.07.0120.003401%Not Available
Waldenstrom's macroglobulinaemia16.28.03.001; 01.15.03.0010.000400%Not Available
Yellow skin23.03.03.042; 09.01.01.009; 08.01.03.0460.025285%Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.055370%Not Available
Multiple sclerosis relapse17.16.01.0030.310297%Not Available
Fibromyalgia15.05.02.0020.002841%Not Available
Musculoskeletal disorder15.03.05.0250.025525%Not Available
Postictal state19.13.01.005; 17.02.04.0140.000600%Not Available
Deafness unilateral04.02.01.0110.002280%Not Available
Underweight14.03.02.0170.000800%Not Available
Hypoacusis04.02.01.0060.013162%
Onychoclasis23.02.05.0050.002720%Not Available
Seasonal allergy10.01.04.001; 22.04.04.008; 06.04.01.0130.005161%Not Available
Uterine cyst21.07.02.007; 16.04.02.0030.000400%Not Available
Carotid artery occlusion24.04.06.008; 17.08.01.0120.000400%Not Available
Autoimmune thyroiditis10.04.08.006; 05.02.04.0020.000880%Not Available
Chapped lips07.05.01.0040.002720%Not Available
Precancerous skin lesion23.01.06.0040.001080%Not Available
Muscle fatigue15.05.03.0060.001560%Not Available
Homicidal ideation19.05.01.0080.001080%Not Available
Gallbladder polyp16.06.02.002; 09.03.02.0030.001960%Not Available
Muscle tightness15.05.03.0070.015003%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.090977%Not Available
Impatience19.05.01.0140.001560%Not Available
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