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)
Respiratory symptom22.12.02.0130.000400%Not Available
Invasive breast carcinoma16.10.01.005; 21.05.01.0130.000800%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.012402%
Frustration tolerance decreased19.04.02.0160.005641%Not Available
Ureterolithiasis20.04.03.0030.000600%Not Available
Somatic symptom disorder19.24.01.0060.000880%Not Available
Abnormal loss of weight14.03.02.0190.002240%Not Available
Adenocarcinoma of colon16.13.01.010; 07.21.01.0080.001000%Not Available
Adenocarcinoma of the cervix21.06.02.005; 16.12.01.0030.001000%Not Available
Adjustment disorder with depressed mood19.23.01.0020.000400%Not Available
Agraphia19.21.01.007; 17.02.03.0130.002560%Not Available
Alopecia universalis23.02.02.0100.000400%Not Available
Bladder transitional cell carcinoma20.03.04.003; 16.08.01.0020.000600%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000600%Not Available
Breast cancer stage I21.05.01.018; 16.10.01.0100.000800%Not Available
Breast cancer stage II21.05.01.019; 16.10.01.0110.000400%Not Available
Central nervous system lymphoma18.04.04.013; 17.02.10.028; 16.20.01.005; 01.12.01.0050.000400%Not Available
Cervical spinal stenosis15.10.04.006; 17.10.02.0060.000800%Not Available
Cholangitis acute09.02.01.0060.000400%Not Available
Chronic gastritis11.07.01.016; 10.04.04.011; 07.08.02.0050.000800%Not Available
Eosinophilic fasciitis15.06.01.013; 10.04.02.008; 01.02.04.0100.001080%Not Available
Faeces pale07.01.03.0050.003121%Not Available
Gait spastic17.01.04.018; 08.01.02.0090.002720%Not Available
Gastroenteritis eosinophilic07.08.03.014; 01.02.04.0180.001360%Not Available
Large for dates baby18.04.02.0040.000400%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000600%Not Available
Lung carcinoma cell type unspecified stage IV16.19.02.006; 22.08.01.0190.000400%Not Available
Malignant melanoma in situ23.08.01.004; 16.03.01.0040.001000%Not Available
Malignant melanoma stage I23.08.01.005; 16.03.01.0050.001200%Not Available
Malignant melanoma stage III23.08.01.007; 16.03.01.0070.000400%Not Available
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