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%-
Fine motor skill dysfunction17.01.02.0200.000400%-
Vein rupture12.01.11.011; 24.03.02.0320.000400%-
Hemianaesthesia17.02.06.0430.003241%-
Intracranial mass17.11.01.0170.001680%-
Neuromyelitis optica spectrum disorder06.04.08.003; 10.04.10.015; 17.16.02.0050.001200%-
Abdominal hernia obstructive07.16.06.0080.000400%-
Allergic eosinophilia01.02.04.019; 10.01.03.0490.000400%-
Anembryonic gestation18.01.03.0070.000400%-
Benign neoplasm of thyroid gland05.02.05.004; 16.37.01.0020.000400%-
Carcinoid tumour of the small bowel05.08.01.017; 07.21.04.012; 16.24.04.0070.000400%-
Cerebellar stroke17.08.01.070; 24.04.06.0460.000400%-
Clinically isolated syndrome17.16.02.0060.000400%-
Cutaneous T-cell lymphoma01.11.03.002; 16.17.03.002; 23.07.04.0290.000400%-
Dilated cardiomyopathy02.04.01.0170.001200%-
Disease complication08.01.03.0870.001000%-
Drug effect less than expected08.06.01.0360.000880%-
Dyschromatopsia06.02.09.0030.001360%-
Electric shock sensation08.06.02.023; 17.02.07.024---
Eosinophilic granulomatosis with polyangiitis01.02.04.022; 10.02.02.031; 22.01.01.025; 24.12.04.0100.000800%-
Focal dyscognitive seizures17.12.02.0050.000800%-
Gait inability08.01.02.011; 17.02.05.0690.033446%-
Haemoperitoneum07.07.02.007; 12.01.17.007; 24.07.02.0650.000600%-
Heavy menstrual bleeding21.01.03.005---
Hemihypoaesthesia17.02.06.044; 23.03.03.079---
Hormone receptor positive breast cancer16.10.01.018; 21.05.01.0280.000400%-
Humidity intolerance08.01.09.0330.002040%-
Immune thrombocytopenia01.08.01.013; 10.02.01.0830.003001%-
Intestinal metaplasia07.11.03.0150.000400%-
Joint noise15.01.02.0120.001360%-
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