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NEFAZODONE HYDROCHLORIDE
DIR Classification
Classification:Most-DIQT concern
Severity Score:4.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS
- Potential Terfenadine, Astemizole, Cisapride, and Pimozide Interactions
- Terfenadine, astemizole, cisapride, and pimozide are all metabolized by the cytochrome P450 3A4 (CYP3A4) isozyme, and it has been demonstrated that ketoconazole, erythromycin, and other inhibitors of CYP3A4 can block the metabolism of these drugs, which can result in increased plasma concentrations of parent drug. Increased plasma concentrations of terfenadine, astemizole, cisapride, and pimozide are associated with QT prolongation and with rare cases of serious cardiovascular adverse events, including death, due principally to ventricular tachycardia of the torsade de pointes type. Nefazodone has been shown in vitro to be an inhibitor of CYP3A4. Consequently, it is recommended that nefazodone not be used in combination with either terfenadine, astemizole, cisapride, or pimozide (see CONTRAINDICATIONS and PRECAUTIONS).
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
4
24088
Other ADRs
3119
38378468
Odds Ratio = 2.044
Drug Property Information
ATC Code(s):
- N06AX06 - nefazodone hydrochloride
- N06AX - Other antidepressants
- N06A - ANTIDEPRESSANTS
- N06 - PSYCHOANALEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:NEFAZODONE HYDROCHLORIDE
Active Ingredient UNII:27X63J94GR
Drugbank ID:DB01149
PubChem Compound:4449
CTD ID:C051752
PharmGKB:PA450603
CAS Number:83366-66-9
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 400.0 mg/day N06AX06
Chemical Structure: 
SMILE Code:
CCC1=NN(CCCN2CCN(CC2)C2=CC(Cl)=CC=C2)C(=O)N1CCOC1=CC=CC=C1
CCC1=NN(CCCN2CCN(CC2)C2=CC(Cl)=CC=C2)C(=O)N1CCOC1=CC=CC=C1
Reference
N/A
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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.
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