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TERIFLUNOMIDE


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 teriflunomide 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
2
24090
Other ADRs
98863
38282724

Odds Ratio = 0.033

Drug Property Information



ATC Code(s):
  • L04AA31 - teriflunomide
    • L04AA3 -
    • L04AA - Selective immunosuppressants
    • L04A - IMMUNOSUPPRESSANTS
    • L04 - IMMUNOSUPPRESSANTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:TERIFLUNOMIDE
Active Ingredient UNII:1C058IKG3B
Drugbank ID:DB08880
PubChem Compound:54684141
CTD ID: C527525
PharmGKB:
CAS Number:163451-81-8
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 14.0 mg/day L04AA31
Chemical Structure:
SMILE Code:
C\C(O)=C(/C#N)C(=O)NC1=CC=C(C=C1)C(F)(F)F

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.