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)
Throat tightness22.12.03.031; 19.01.02.0050.011722%Not Available
Thyroid disorder05.02.01.0020.003801%Not Available
Thyroid neoplasm16.24.01.002; 05.02.05.0020.000880%Not Available
Thyrotoxic crisis19.07.03.006; 14.11.01.016; 06.09.04.004; 05.02.02.0040.000600%Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue coated07.14.02.0110.002040%Not Available
Tongue discolouration07.14.02.0060.001560%Not Available
Tongue disorder07.14.01.0020.001560%Not Available
Toothache07.09.06.0010.005641%
Transitional cell carcinoma16.08.04.002; 20.08.01.0100.000600%Not Available
Tremor17.01.06.0020.055730%
Trigeminal neuralgia17.04.08.0010.007161%Not Available
Tunnel vision06.02.07.005; 17.17.01.0130.000880%Not Available
Ulcer08.03.06.0010.004401%Not Available
Umbilical hernia07.16.03.0010.000400%Not Available
Urinary hesitation20.02.02.0090.001560%Not Available
Urinary incontinence17.05.01.008; 20.02.02.0100.012322%
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.0010.001680%Not Available
Urine abnormality20.02.01.0130.000400%Not Available
Urticaria23.04.02.001; 10.01.06.0010.124023%
Uterine cancer21.07.02.003; 16.12.05.0010.002400%Not Available
Uterine leiomyoma21.07.02.004; 16.04.02.0010.002881%Not Available
Varicose vein24.10.04.0010.001360%Not Available
Vein disorder24.03.02.0150.000800%Not Available
Venous thrombosis24.01.01.0080.000800%Not Available
Vertigo17.02.12.002; 04.04.01.0030.023564%
Vertigo positional17.02.12.004; 04.04.01.0050.000600%Not Available
Visual acuity reduced06.02.10.012; 17.17.01.0110.007841%
Visual impairment06.02.10.0130.044928%Not Available
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