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)
Sensory loss17.02.07.0070.001480%Not Available
Sjogren's syndrome15.06.01.015; 10.04.04.009; 07.06.01.010; 06.08.02.0110.001560%Not Available
Skin cancer23.08.02.002; 16.03.02.0020.004801%Not Available
Skin discolouration23.03.03.0050.014523%Not Available
Skin hypertrophy23.01.04.002--Not Available
Skin lesion23.03.03.0100.008602%Not Available
Skin odour abnormal23.03.03.0120.002040%
Skin warm23.03.03.0140.004761%Not Available
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.0010.004201%
Sleep disorder19.02.04.001--Not Available
Sluggishness08.01.01.0040.003601%Not Available
Small cell lung cancer16.19.08.003; 22.08.01.0130.000400%Not Available
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.028125%Not Available
Spinal osteoarthritis15.01.04.003--Not Available
Spleen disorder01.09.02.0030.000400%Not Available
Splenomegaly01.09.02.0010.005761%Not Available
Sputum discoloured22.02.03.0100.000880%Not Available
Squamous cell carcinoma16.16.01.0020.003281%Not Available
Squamous cell carcinoma of skin23.08.02.005; 16.03.02.0050.002160%Not Available
Strabismus17.17.01.009; 06.05.02.0040.002640%Not Available
Stress19.06.02.0040.040247%Not Available
Suicidal ideation19.12.01.003--
Supraventricular tachycardia02.03.03.0120.001600%
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.019244%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.016363%Not Available
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.004--Not Available
T-cell lymphoma01.11.02.001; 16.17.02.001; 11.05.17.0060.000400%Not Available
Tearfulness19.15.02.0050.001560%Not Available
Tension headache19.24.01.009; 17.14.01.0040.002240%Not Available
Therapeutic response unexpected08.06.01.001--Not Available
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