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GANCICLOVIR


DIR Classification


Classification:Less-DIR concern
Severity Score:1

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
Rhabdomyolysis
4
42908
Other ADRs
983
14116296

Odds Ratio = 1.339

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
CAS Number:82410-32-0
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
  • 3000.0 mg/day J05AB06
Chemical Structure:
SMILE Code:
C1=NC2=C(N1COC(CO)CO)NC(=NC2=O)N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Rhabdomyolysis associated with cytomegalovirus infection in kidney transplant recipients.

[Jung H-Y,Kim K-H,Park S-C,Lee J-H,Choi J-Y,Cho J-H,Park S-H,Kim Y-L,Kim H-K,Huh S,Kim C-D]
Transpl Infect Dis.2014 Dec;16(6):993-8. doi: 10.1111/tid.12297. Epub 2014 Sep 24. PMID: 25251070

2: Acute rhabdomyolysis and myonecrosis complicating aeromonas bacteremia in neutropenic patients with hematologic malignancies: report of two cases.

[Martino R,Santamaría A,Pericas R,Sureda A,Brunet S]
Haematologica.1997 Nov-Dec;82(6):692-4. PMID: 9499669

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