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)
Limb mass15.03.05.0190.000880%Not Available
Loss of therapeutic response08.06.01.0410.002240%Not Available
Malignant glioma17.20.02.003; 16.30.02.0030.000400%Not Available
Marburg's variant multiple sclerosis17.16.01.0100.000800%Not Available
Mesenteritis07.08.03.0260.000400%Not Available
Multiple sclerosis pseudo relapse17.16.01.0110.001360%Not Available
Myelin oligodendrocyte glycoprotein antibody-associated disease17.16.02.009; 10.04.10.020; 06.04.08.0040.000400%Not Available
Myelomalacia17.10.01.0290.000400%Not Available
Near death experience19.10.05.007; 17.02.04.0230.000400%Not Available
Neurosarcoidosis17.06.01.005; 10.02.06.0050.000400%Not Available
Noninfectious myelitis17.06.02.005; 10.02.01.0950.000880%Not Available
Pancreatic failure07.18.02.0110.001000%Not Available
Pancreatic haemorrhage24.07.02.067; 07.18.02.0120.000400%
Perinatal depression19.15.01.011; 18.06.03.0030.001360%Not Available
Periorbital swelling23.04.01.025; 10.01.05.025; 06.08.03.0320.002040%Not Available
Pharyngeal swelling22.04.05.0280.004281%Not Available
Primary biliary cholangitis10.04.09.004; 09.01.04.0100.000600%Not Available
Pseudomyxoma peritonei16.32.03.045; 07.07.01.0190.000400%Not Available
Relapsing multiple sclerosis17.16.01.0120.002240%Not Available
Sensitive skin23.03.03.0970.001360%Not Available
Spinal stenosis17.10.01.031; 15.10.04.0140.002160%Not Available
Squamous cell carcinoma of the vulva21.08.03.009; 16.12.08.0040.000400%Not Available
Subcapsular renal haematoma24.07.07.006; 20.01.02.021; 12.01.05.0080.000400%Not Available
Subchorionic haematoma18.02.01.008; 24.07.03.0370.000600%Not Available
Testicular germ cell tumour mixed21.13.02.011; 16.25.03.0060.000400%Not Available
Therapeutic product effect decreased08.06.01.050--Not Available
Therapy non-responder08.06.01.063--Not Available
Treatment noncompliance12.09.02.006; 08.06.01.067--Not Available
Triple negative breast cancer21.05.01.032; 16.10.01.0200.000400%Not Available
Tumefactive multiple sclerosis17.16.01.0130.001760%Not Available
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