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)
Non-alcoholic fatty liver14.08.04.023; 09.01.07.0340.000400%Not Available
Ovarian cyst ruptured21.11.01.015; 16.04.03.0060.001280%Not Available
Overweight14.03.02.0210.001960%Not Available
Pancreatic carcinoma metastatic16.13.10.003; 07.21.09.0060.000600%Not Available
Placenta praevia18.05.02.0040.000600%Not Available
Post-traumatic stress disorder19.06.06.0020.001760%Not Available
Prolonged pregnancy18.07.01.0040.000400%Not Available
Ruptured cerebral aneurysm24.02.04.005; 17.08.01.0590.000400%Not Available
Seminoma21.13.02.004; 16.25.03.0020.000400%Not Available
Superficial spreading melanoma stage unspecified23.08.01.010; 16.03.01.0100.000400%Not Available
Thyroid cyst16.37.01.003; 05.02.05.0100.001360%Not Available
Tonsil cancer16.19.05.002; 22.08.02.0030.000600%Not Available
Umbilical cord around neck18.04.14.0040.001280%Not Available
Uterine leiomyosarcoma16.33.07.003; 21.07.02.0130.000800%Not Available
Wolff-Parkinson-White syndrome02.03.01.0160.000400%Not Available
Kidney enlargement20.01.06.0030.000400%Not Available
Weight loss poor14.03.02.0270.001360%Not Available
Cervical radiculopathy17.10.02.0030.000400%Not Available
Carotid artery dissection17.08.06.003; 24.02.04.0040.000400%Not Available
Transient acantholytic dermatosis23.03.03.0690.001080%Not Available
Laziness19.04.04.0050.001360%Not Available
Neuroendocrine tumour16.24.01.009; 05.08.01.0130.000800%Not Available
Progressive multiple sclerosis17.16.01.0060.006001%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.0080.002000%Not Available
Colon cancer metastatic16.13.01.012; 07.21.01.0100.000800%Not Available
Lymphomatoid papulosis23.03.08.0110.001080%Not Available
Gastrointestinal mucosal disorder07.11.03.0080.000400%Not Available
Biliary dilatation09.02.03.004--Not Available
Ovarian cancer metastatic16.12.04.004; 21.11.01.0130.001000%Not Available
Non-small cell lung cancer metastatic22.08.01.021; 16.19.01.0090.000400%Not Available
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