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)
Atrial fibrillation02.03.03.002--
Autoimmune hepatitis10.04.09.001; 09.01.07.0190.001600%Not Available
Autonomic nervous system imbalance24.06.01.005; 17.05.01.011; 08.01.01.0100.001360%Not Available
B-cell lymphoma01.15.01.001; 16.28.01.0010.001400%Not Available
Back disorder15.03.05.0030.004201%Not Available
Back pain15.03.04.0050.058051%
Barrett's oesophagus07.11.03.0020.001080%Not Available
Basal cell carcinoma16.03.02.001; 23.08.02.0010.007161%Not Available
Benign hydatidiform mole21.07.02.006; 18.05.03.001; 16.04.01.0020.000400%Not Available
Benign ovarian tumour21.11.01.011; 16.04.03.0040.000400%Not Available
Bile duct cancer16.07.01.001; 09.04.02.0010.000400%Not Available
Bile duct stone09.02.02.0030.000400%Not Available
Blepharospasm17.17.02.001; 06.05.01.0010.003321%Not Available
Blindness06.02.10.003; 17.17.01.0030.015763%Not Available
Blindness transient06.02.10.006; 17.17.01.0040.002560%Not Available
Blindness unilateral17.17.01.016; 06.02.10.0070.006321%Not Available
Bone neoplasm16.29.01.001; 15.09.02.0010.000400%Not Available
Bone pain15.02.01.001--
Bowen's disease23.08.02.004; 16.03.02.0040.000400%Not Available
Brain neoplasm benign17.18.01.001; 16.09.01.0010.000400%Not Available
Breast cancer21.05.01.003; 16.10.01.0010.027965%Not Available
Breast cancer stage IV21.05.01.010; 16.10.01.0030.000400%Not Available
Breast cyst21.05.01.006; 16.14.01.0040.001080%Not Available
Breast mass21.05.04.0020.002440%Not Available
Breast tenderness21.05.05.0040.001760%Not Available
Breath odour07.01.06.0020.001360%Not Available
Breech presentation18.03.04.0010.001800%Not Available
Bronchitis chronic22.03.01.0190.000880%Not Available
Bruxism19.11.03.001; 07.01.06.0080.001560%Not Available
Burkitt's lymphoma16.28.04.001; 01.15.04.0010.000800%Not Available
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