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)
Oral mucosal exfoliation07.05.05.0110.000600%Not Available
Chronic kidney disease20.01.03.017--
Immune reconstitution inflammatory syndrome10.02.01.043; 08.06.02.0140.001600%Not Available
Infusion site haemorrhage24.07.01.058; 12.07.05.018; 08.02.05.0180.000400%Not Available
Bone loss15.02.04.0200.001560%Not Available
Thyroid cancer16.24.03.001; 05.02.05.0010.002680%Not Available
Treatment failure08.06.01.0170.096298%Not Available
Pharyngeal disorder22.04.05.0070.000880%Not Available
Adverse reaction08.06.01.0180.042128%Not Available
Low birth weight baby18.04.02.0030.003401%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.001000%Not Available
Type 2 diabetes mellitus14.06.01.003; 05.06.01.003--Not Available
Vulvovaginal burning sensation21.08.02.0070.002040%Not Available
Gastrointestinal sounds abnormal07.01.01.0020.001360%Not Available
Renal cell carcinoma20.01.04.003; 16.08.02.0020.002080%Not Available
Brain injury19.07.03.007; 17.11.01.0030.002080%Not Available
Androgenetic alopecia23.02.02.002; 05.05.04.0010.000880%Not Available
Hypertransaminasaemia09.01.02.0050.003601%Not Available
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.003801%Not Available
Neurological decompensation17.02.05.0300.000400%Not Available
Brain stem stroke24.04.06.024; 17.08.01.0330.000400%Not Available
Bladder dysfunction20.03.03.0020.000400%Not Available
Gastrointestinal tract irritation07.08.03.0080.003801%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.007201%Not Available
White matter lesion24.04.06.027; 17.11.01.0090.000880%Not Available
Intraductal proliferative breast lesion21.05.01.014; 16.10.01.0060.001000%Not Available
Platelet dysfunction01.08.03.0030.000600%Not Available
Diffuse alopecia23.02.02.0070.001280%Not Available
Faeces soft07.01.03.0080.002360%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.001560%Not Available
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