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)
Cutaneous symptom23.07.04.0230.001360%Not Available
Fine motor skill dysfunction17.01.02.0200.000400%Not Available
Vein rupture24.03.02.032; 12.01.11.0110.000400%Not Available
Hemianaesthesia17.02.06.0430.003241%Not Available
Intracranial mass17.11.01.0170.001680%Not Available
Neuromyelitis optica spectrum disorder10.04.10.015; 06.04.08.003; 17.16.02.0050.001200%Not Available
Abdominal hernia obstructive07.16.06.0080.000400%Not Available
Allergic eosinophilia10.01.03.049; 01.02.04.0190.000400%Not Available
Anembryonic gestation18.01.03.0070.000400%Not Available
Benign neoplasm of thyroid gland16.37.01.002; 05.02.05.0040.000400%Not Available
Carcinoid tumour of the small bowel05.08.01.017; 16.24.04.007; 07.21.04.0120.000400%Not Available
Cerebellar stroke24.04.06.046; 17.08.01.0700.000400%Not Available
Clinically isolated syndrome17.16.02.0060.000400%Not Available
Cutaneous T-cell lymphoma23.07.04.029; 16.17.03.002; 01.11.03.0020.000400%Not Available
Dilated cardiomyopathy02.04.01.0170.001200%Not Available
Disease complication08.01.03.0870.001000%Not Available
Drug effect less than expected08.06.01.0360.000880%Not Available
Dyschromatopsia06.02.09.0030.001360%Not Available
Electric shock sensation17.02.07.024; 08.06.02.023--Not Available
Eosinophilic granulomatosis with polyangiitis24.12.04.010; 22.01.01.025; 10.02.02.031; 01.02.04.0220.000800%Not Available
Focal dyscognitive seizures17.12.02.0050.000800%Not Available
Gait inability08.01.02.011; 17.02.05.0690.033446%Not Available
Haemoperitoneum12.01.17.007; 07.07.02.007; 24.07.02.0650.000600%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hemihypoaesthesia23.03.03.079; 17.02.06.044--Not Available
Hormone receptor positive breast cancer21.05.01.028; 16.10.01.0180.000400%Not Available
Humidity intolerance08.01.09.0330.002040%Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.003001%Not Available
Intestinal metaplasia07.11.03.0150.000400%Not Available
Joint noise15.01.02.0120.001360%Not Available
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