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)
Burning sensation17.02.06.001; 08.01.09.0290.068052%Not Available
Bursitis12.04.03.010; 15.04.01.0010.004001%Not Available
Cardiovascular disorder02.11.01.010; 24.03.02.009--Not Available
Carotid artery stenosis24.04.06.001; 17.08.02.0010.000600%Not Available
Carpal tunnel syndrome17.09.02.0010.004001%Not Available
Cerebral atrophy17.11.01.0010.000880%Not Available
Cerebral venous thrombosis24.01.04.005; 17.08.03.0020.000600%Not Available
Cervical dysplasia21.06.01.0020.002480%Not Available
Cervix carcinoma21.06.02.001; 16.12.01.0010.003601%Not Available
Cervix disorder21.06.01.0030.000400%Not Available
Change of bowel habit07.02.03.0020.002040%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.036087%Not Available
Chills15.05.03.016; 08.01.09.0010.031886%
Choking22.12.03.0030.004321%Not Available
Choking sensation22.12.03.004; 19.01.02.0020.001280%Not Available
Cholangiocarcinoma16.07.01.002; 09.04.02.0090.000400%Not Available
Cholangitis sclerosing10.04.09.002; 09.02.01.003--Not Available
Cholecystitis09.03.01.0010.002400%
Cholelithiasis09.03.01.0020.010202%Not Available
Chromaturia20.02.01.0020.056570%
Chronic lymphocytic leukaemia16.01.06.001; 01.10.06.0010.001600%Not Available
Chronic myeloid leukaemia16.01.07.001; 01.10.07.0010.001000%Not Available
Clumsiness17.01.02.0050.003241%Not Available
Coccydynia15.02.01.0040.001360%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.007681%Not Available
Colitis07.08.01.0010.008001%
Colitis ischaemic24.04.08.012; 07.08.01.0040.001200%Not Available
Colon cancer16.13.01.001; 07.21.01.0010.002801%Not Available
Coma17.02.09.001--Not Available
Confusional state19.13.01.001; 17.02.03.0050.065412%
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