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)
Pruritus23.03.12.0010.280892%
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003--
Pulmonary thrombosis24.01.06.002; 22.06.02.0030.002400%Not Available
Pyrexia08.05.02.0030.078014%
Radiculopathy17.10.01.0050.001400%
Rash23.03.13.0010.220841%Not Available
Rash erythematous23.03.13.0290.017803%Not Available
Rash macular23.03.13.0030.009682%Not Available
Rash morbilliform23.03.13.0050.001360%Not Available
Rash papular23.03.13.0170.006721%Not Available
Rash pruritic23.03.13.0300.031046%Not Available
Raynaud's phenomenon24.04.03.0030.001280%Not Available
Rectal cancer16.13.01.003; 07.21.05.0020.000800%Not Available
Rectal prolapse07.03.01.0050.000600%Not Available
Renal colic20.02.03.0100.000600%
Renal cyst20.01.04.001; 16.27.01.0010.003801%Not Available
Respiratory disorder22.02.07.0020.007161%Not Available
Retching07.01.07.002--Not Available
Retinal detachment06.09.03.003; 12.01.04.004--
Retinal haemorrhage06.10.01.001; 24.07.05.0030.001760%Not Available
Retinal tear12.01.04.014; 06.09.03.0100.001560%
Rhinorrhoea22.12.03.0210.033766%
Rosacea23.02.08.0010.000880%Not Available
Rotator cuff syndrome12.01.07.018; 15.01.08.0020.001680%
Sciatica17.10.03.001; 15.10.01.0010.002841%Not Available
Scleral discolouration06.09.06.0010.000880%Not Available
Scoliosis15.10.04.0010.001080%
Seizure17.12.03.0010.054850%
Sensory disturbance17.02.07.0060.012002%Not Available
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