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GANCICLOVIR


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • ADVERSE REACTIONS
  • Postmarketing Experience
  • The following adverse reactions have been identified during post-approval use of intravenous ganciclovir. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Blood and lymphatic system disorders: hemolytic anemia
  • Cardiac disorders: cardiac arrest, cardiac conduction abnormality, torsades de pointes, ventricular tachycardia

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
1
24091
Other ADRs
4404
38377183

Odds Ratio = 0.362

Drug Property Information



ATC Code(s):
  • J05AB06 - ganciclovir
    • J05AB - Nucleosides and nucleotides excl. reverse transcriptase inhibitors
    • J05A - DIRECT ACTING ANTIVIRALS
    • J05 - ANTIVIRALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
  • S01AD09 - ganciclovir
    • S01AD - Antivirals
    • S01A - ANTIINFECTIVES
    • S01 - OPHTHALMOLOGICALS
    • S - SENSORY ORGANS
Active Ingredient:GANCICLOVIR
Active Ingredient UNII:P9G3CKZ4P5
Drugbank ID:DB01004
PubChem Compound:3454
CTD ID:D015774
PharmGKB:PA449733
CAS Number:82410-32-0
Dosage Form(s):injection, solution
Route(s) Of Administrator:intravenous
Daily Dose:
  • 3000.0 mg/day J05AB06
Chemical Structure:
SMILE Code:
NC1=NC2=C(N=CN2COC(CO)CO)C(=O)N1

Reference

1: The Contribution of National Spontaneous Reporting Systems to Detect Signals of Torsadogenicity: Issues Emerging from the ARITMO Project.

[Raschi Emanuel,Poluzzi Elisabetta,Salvo Francesco,Koci Ariola,Suling Marc,Antoniazzi Stefania,Perina Luisella,Hazell Lorna,Moretti Ugo,Sturkenboom Miriam,Garbe Edeltraut,Pariente Antoine,De Ponti Fabrizio]
Drug Saf,2016 Jan;39(1):59-68. PMID: 26446144

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.

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