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%-
Invasive breast carcinoma16.10.01.005; 21.05.01.0130.000800%-
Anal incontinence07.01.06.029; 17.05.01.0210.012402%
Frustration tolerance decreased19.04.02.0160.005641%-
Ureterolithiasis20.04.03.0030.000600%-
Somatic symptom disorder19.24.01.0060.000880%-
Abnormal loss of weight14.03.02.0190.002240%-
Adenocarcinoma of colon07.21.01.008; 16.13.01.0100.001000%-
Adenocarcinoma of the cervix16.12.01.003; 21.06.02.0050.001000%-
Adjustment disorder with depressed mood19.23.01.0020.000400%-
Agraphia17.02.03.013; 19.21.01.0070.002560%-
Alopecia universalis23.02.02.0100.000400%-
Bladder transitional cell carcinoma16.08.01.002; 20.03.04.0030.000600%-
Breast cancer recurrent16.10.01.009; 21.05.01.0170.000600%-
Breast cancer stage I16.10.01.010; 21.05.01.0180.000800%-
Breast cancer stage II16.10.01.011; 21.05.01.0190.000400%-
Central nervous system lymphoma01.12.01.005; 16.20.01.005; 17.02.10.028; 18.04.04.0130.000400%-
Cervical spinal stenosis15.10.04.006; 17.10.02.0060.000800%-
Cholangitis acute09.02.01.0060.000400%-
Chronic gastritis07.08.02.005; 10.04.04.011; 11.07.01.0160.000800%-
Eosinophilic fasciitis01.02.04.010; 10.04.02.008; 15.06.01.0130.001080%-
Faeces pale07.01.03.0050.003121%-
Gait spastic08.01.02.009; 17.01.04.0180.002720%-
Gastroenteritis eosinophilic01.02.04.018; 07.08.03.0140.001360%-
Large for dates baby18.04.02.0040.000400%-
Lung adenocarcinoma16.19.01.002; 22.08.01.0070.000600%-
Lung carcinoma cell type unspecified stage IV16.19.02.006; 22.08.01.0190.000400%-
Malignant melanoma in situ16.03.01.004; 23.08.01.0040.001000%-
Malignant melanoma stage I16.03.01.005; 23.08.01.0050.001200%-
Malignant melanoma stage III16.03.01.007; 23.08.01.0070.000400%-
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