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)
Constipation07.02.02.0010.085496%
Conversion disorder19.24.01.0010.000800%Not Available
Coordination abnormal17.02.02.0040.008602%Not Available
Costochondritis15.07.03.0010.000400%Not Available
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.0050.009442%Not Available
Cystitis haemorrhagic20.03.02.0030.000880%Not Available
Cystocele21.07.05.004; 20.03.01.0150.001080%Not Available
Deafness04.02.01.0010.004041%Not Available
Decreased immune responsiveness10.02.01.0410.012442%Not Available
Decreased interest19.15.02.0040.002240%Not Available
Decubitus ulcer23.03.11.0060.005961%Not Available
Defaecation urgency07.02.04.0010.004081%Not Available
Dehydration14.05.05.0010.061691%
Delayed delivery18.07.01.0050.000400%Not Available
Dementia19.20.02.001; 17.03.01.0010.009962%Not Available
Demyelination17.16.02.0010.002360%Not Available
Depressed mood19.15.02.0010.019924%Not Available
Depression suicidal19.15.01.0040.001400%Not Available
Dermal cyst23.10.02.001; 16.26.02.0010.000880%Not Available
Dermatitis allergic23.03.04.003; 10.01.03.0140.014923%Not Available
Dermatitis bullous23.03.01.0020.004001%
Diabetes mellitus05.06.01.001; 14.06.01.0010.009362%Not Available
Diabetes mellitus inadequate control14.06.01.004; 05.06.01.004--Not Available
Diabetic retinopathy24.03.07.004; 14.07.01.002; 06.10.02.002; 05.07.01.0020.000400%Not Available
Diarrhoea07.02.01.0010.469486%
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.0040.001600%Not Available
Diplegia17.01.04.0150.000400%Not Available
Diplopia17.17.01.005; 06.02.06.0020.017883%Not Available
Distractibility19.21.02.0070.000880%Not Available
Disturbance in attention17.03.03.001; 19.21.02.002--
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