GANCICLOVIR

Generic: GANCICLOVIR SODIUM

Hikma Pharmaceuticals USA Inc.Manufacturer
INTRAVENOUSRoute
GANCICLOVIR SODIUMActive Substance
2003-07-16Original Approval

GANCICLOVIR is FDA application ANDA076222, sponsored by HIKMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2022-12-16
Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE Gm

Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count c

Top Reported Reactions

1
OFF LABEL USE
1,806 reports
2
DRUG INEFFECTIVE
1,533 reports
3
CYTOMEGALOVIRUS INFECTION
1,266 reports
4
DRUG RESISTANCE
731 reports
5
PYREXIA
616 reports
6
NEUTROPENIA
597 reports
7
PRODUCT USE IN UNAPPROVED INDICATION
573 reports
8
PANCYTOPENIA
554 reports
9
DIARRHOEA
463 reports
10
CYTOMEGALOVIRUS VIRAEMIA
438 reports