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DIMETHYL 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, 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
5
24087
Other ADRs
257839
38123748

Odds Ratio = 0.031

Drug Property Information



ATC Code(s):
  • L04AX07 - dimethyl fumarate
    • L04AX - Other immunosuppressants
    • L04A - IMMUNOSUPPRESSANTS
    • L04 - IMMUNOSUPPRESSANTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:DIMETHYL FUMARATE
Active Ingredient UNII:FO2303MNI2
Drugbank ID:DB08908
PubChem Compound:637568
CTD ID:
PharmGKB:PA166152838
CAS Number:624-49-7
Dosage Form(s):capsule, delayed release
Route(s) Of Administrator:oral
Daily Dose:
  • 480.0 mg/day L04AX07
Chemical Structure:
SMILE Code:
[H]\C(=C(\[H])C(=O)OC)C(=O)OC

Reference

N/A

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