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MIFEPRISTONE
DIR Classification
Classification:Moderate-DIR concern
Severity Score:3
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- QT Interval Prolongation
- Mifepristone and its metabolites block IKr. KORLYM prolongs the QTc interval in a dose-related manner. There is little or no experience with high exposure, concomitant dosing with other QT-prolonging drugs, or potassium channel variants resulting in a long QT interval. [See Warnings & Precautions (5.6)] To minimize risk, the lowest effective dose should always be used.
- [MEDICATION GUIDE]
- KORLYM can cause serious side effects including:
- problems with the electrical system of your heart (QT interval prolongation).
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
2
42910
Other ADRs
5215
14112064
Odds Ratio = 0.127
Drug Property Information
ATC Code(s):
- G03XB01 - mifepristone
- G03XB - Antiprogestogens
- G03X - OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
- G03 - SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
- G - GENITO URINARY SYSTEM AND SEX HORMONES
- G03XB51 - mifepristone
- G03XB - Antiprogestogens
- G03X - OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
- G03 - SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
- G - GENITO URINARY SYSTEM AND SEX HORMONES
Active Ingredient:mifepristone
Active Ingredient UNII:320T6RNW1F
Drugbank ID:DB00834
PubChem Compound:55245
CAS Number:84371-65-3
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 200.0 mg/day G03XB01
Chemical Structure: 
SMILE Code:
CC#C[C@@]1(CC[C@@H]2[C@@]1(C[C@@H](C3=C4CCC(=O)C=C4CC[C@@H]23)C5=CC=C(C=C5)N(C)C)C)O
CC#C[C@@]1(CC[C@@H]2[C@@]1(C[C@@H](C3=C4CCC(=O)C=C4CC[C@@H]23)C5=CC=C(C=C5)N(C)C)C)O
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
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