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MONOMETHYL FUMARATE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Potential to prolong the QT interval
- In a placebo controlled thorough QT study performed in healthy subjects with dimethyl fumarate [the prodrug of BAFIERTAM], there was no evidence that dimethyl fumarate caused QT interval prolongation of clinical significance (i.e., the upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc was below 10 ms).
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587
Odds Ratio = N/A
Drug Property Information
ATC Code(s):
- L04AX07 - monomethyl fumarate
- L04AX0 -
- L04AX - Other immunosuppressants
- L04A - IMMUNOSUPPRESSANTS
- L04 - IMMUNOSUPPRESSANTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
- B03AA02 - monomethyl fumarate
- B03AA - "Iron bivalent, oral preparations"
- B03A - IRON PREPARATIONS
- B03 - ANTIANEMIC PREPARATIONS
- B - BLOOD AND BLOOD FORMING ORGANS
- B03AD02 - monomethyl fumarate
- B03AD - Iron in combination with folic acid
- B03A - IRON PREPARATIONS
- B03 - ANTIANEMIC PREPARATIONS
- B - BLOOD AND BLOOD FORMING ORGANS
Active Ingredient:monomethyl fumarate
Active Ingredient UNII:45IUB1PX8R
Drugbank ID:DB14219
PubChem Compound:N/ADIR Classification
CTD ID:C509058
CAS Number:2756-87-8
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
- 480.0 mg/day L04AX07
- 200.0 mg/day B03AA02
Chemical Structure: 
SMILE Code:
COC(=O)\C=C\C(O)=O
COC(=O)\C=C\C(O)=O
Reference
N/A
Disclaimer:
The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.
Any mention of commercial products is for clarification and not intended as endorsement.