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%-
Chronic kidney disease20.01.03.017--
Immune reconstitution inflammatory syndrome08.06.02.014; 10.02.01.0430.001600%-
Infusion site haemorrhage08.02.05.018; 12.07.05.018; 24.07.01.0580.000400%-
Bone loss15.02.04.0200.001560%-
Thyroid cancer05.02.05.001; 16.24.03.0010.002680%-
Treatment failure08.06.01.0170.096298%-
Pharyngeal disorder22.04.05.0070.000880%-
Adverse reaction08.06.01.0180.042128%-
Low birth weight baby18.04.02.0030.003401%-
Type 1 diabetes mellitus05.06.01.010; 10.04.08.007; 14.06.01.0100.001000%-
Type 2 diabetes mellitus05.06.01.003; 14.06.01.003---
Vulvovaginal burning sensation21.08.02.0070.002040%-
Gastrointestinal sounds abnormal07.01.01.0020.001360%-
Renal cell carcinoma16.08.02.002; 20.01.04.0030.002080%-
Brain injury17.11.01.003; 19.07.03.0070.002080%-
Androgenetic alopecia05.05.04.001; 23.02.02.0020.000880%-
Hypertransaminasaemia09.01.02.0050.003601%-
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.003801%-
Neurological decompensation17.02.05.0300.000400%-
Brain stem stroke17.08.01.033; 24.04.06.0240.000400%-
Bladder dysfunction20.03.03.0020.000400%-
Gastrointestinal tract irritation07.08.03.0080.003801%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.007201%-
White matter lesion17.11.01.009; 24.04.06.0270.000880%-
Intraductal proliferative breast lesion16.10.01.006; 21.05.01.0140.001000%-
Platelet dysfunction01.08.03.0030.000600%-
Diffuse alopecia23.02.02.0070.001280%-
Faeces soft07.01.03.0080.002360%-
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.001560%-
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