GANCICLOVIR SODIUM

N/A

Manufactured by Fresenius Kabi USA, LLC

23,974 FDA adverse event reports analyzed

Last updated: 2026-04-14

About GANCICLOVIR SODIUM

GANCICLOVIR SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for GANCICLOVIR SODIUM include OFF LABEL USE, DRUG INEFFECTIVE, CYTOMEGALOVIRUS INFECTION, DRUG RESISTANCE, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GANCICLOVIR SODIUM.

Top Adverse Reactions

OFF LABEL USE1,655 reports
DRUG INEFFECTIVE1,475 reports
CYTOMEGALOVIRUS INFECTION1,237 reports
DRUG RESISTANCE702 reports
PYREXIA606 reports
PRODUCT USE IN UNAPPROVED INDICATION570 reports
NEUTROPENIA569 reports
PANCYTOPENIA533 reports
DIARRHOEA452 reports
CYTOMEGALOVIRUS VIRAEMIA423 reports
PNEUMONIA419 reports
SEPSIS412 reports
RESPIRATORY FAILURE401 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME392 reports
THROMBOCYTOPENIA376 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION372 reports
LEUKOPENIA359 reports
CONDITION AGGRAVATED337 reports
RENAL IMPAIRMENT337 reports
ACUTE KIDNEY INJURY318 reports
PRODUCT USE ISSUE307 reports
PATHOGEN RESISTANCE306 reports
RENAL FAILURE300 reports
ANAEMIA286 reports
SEPTIC SHOCK266 reports
EPSTEIN BARR VIRUS INFECTION256 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER253 reports
NEPHROPATHY TOXIC246 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION240 reports
TRANSPLANT REJECTION231 reports
GRAFT VERSUS HOST DISEASE224 reports
MYELOSUPPRESSION216 reports
CYTOMEGALOVIRUS CHORIORETINITIS208 reports
CYTOMEGALOVIRUS COLITIS200 reports
CYSTITIS HAEMORRHAGIC198 reports
THROMBOTIC MICROANGIOPATHY192 reports
PNEUMONIA CYTOMEGALOVIRAL190 reports
NAUSEA186 reports
INFECTION179 reports
VOMITING177 reports
DEATH175 reports
BK VIRUS INFECTION173 reports
DISEASE PROGRESSION173 reports
ENCEPHALITIS CYTOMEGALOVIRUS170 reports
HYPOTENSION170 reports
FEBRILE NEUTROPENIA167 reports
PLEURAL EFFUSION164 reports
TREATMENT FAILURE164 reports
ABDOMINAL PAIN160 reports
INTENTIONAL PRODUCT USE ISSUE159 reports
PLATELET COUNT DECREASED157 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA157 reports
RESPIRATORY DISTRESS156 reports
BLOOD CREATININE INCREASED150 reports
BONE MARROW FAILURE144 reports
URINARY TRACT INFECTION144 reports
DYSPNOEA142 reports
ACUTE GRAFT VERSUS HOST DISEASE140 reports
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS133 reports
DRUG INTERACTION132 reports
ASPERGILLUS INFECTION128 reports
RASH126 reports
WHITE BLOOD CELL COUNT DECREASED126 reports
MULTI ORGAN FAILURE124 reports
HAEMOGLOBIN DECREASED122 reports
TOXICITY TO VARIOUS AGENTS122 reports
WEIGHT DECREASED120 reports
BRONCHOPULMONARY ASPERGILLOSIS119 reports
END STAGE RENAL DISEASE116 reports
INTERSTITIAL LUNG DISEASE116 reports
GASTROINTESTINAL HAEMORRHAGE115 reports
HEPATIC FUNCTION ABNORMAL115 reports
CARDIAC ARREST111 reports
COLITIS111 reports
ENTEROCOCCAL INFECTION108 reports
HYPERTENSION108 reports
THERAPY NON RESPONDER107 reports
ASTHENIA106 reports
CYTOMEGALOVIRUS TEST POSITIVE105 reports
ACUTE RESPIRATORY DISTRESS SYNDROME104 reports
EPSTEIN BARR VIRAEMIA103 reports
SMOOTH MUSCLE CELL NEOPLASM103 reports
COUGH102 reports
LUNG DISORDER102 reports
LYMPHOPENIA101 reports
RENAL FAILURE ACUTE101 reports
HYPOKALAEMIA99 reports
GASTRIC ULCER97 reports
HAEMORRHAGE INTRACRANIAL97 reports
CONFUSIONAL STATE96 reports
PSEUDOMONAS INFECTION96 reports
ASCITES95 reports
FUNGAL INFECTION95 reports
HEADACHE94 reports
KLEBSIELLA INFECTION93 reports
HEPATIC FAILURE92 reports
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN91 reports
ALANINE AMINOTRANSFERASE INCREASED91 reports
DECREASED APPETITE91 reports
GENERAL PHYSICAL HEALTH DETERIORATION90 reports

Report Outcomes

Out of 10,183 classified reports for GANCICLOVIR SODIUM:

Serious 97.6%Non-Serious 2.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male5,176 (58.2%)
Female3,643 (40.9%)
Unknown80 (0.9%)

Reports by Age

Age 61220 reports
Age 43215 reports
Age 60204 reports
Age 58174 reports
Age 63174 reports
Age 64170 reports
Age 55161 reports
Age 65152 reports
Age 51146 reports
Age 57144 reports
Age 6142 reports
Age 56142 reports
Age 4140 reports
Age 44133 reports
Age 59133 reports
Age 53131 reports
Age 46130 reports
Age 3129 reports
Age 62127 reports
Age 66127 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with GANCICLOVIR SODIUM?

This profile reflects 23,974 FDA FAERS reports that mention GANCICLOVIR SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GANCICLOVIR SODIUM?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, CYTOMEGALOVIRUS INFECTION, DRUG RESISTANCE, PYREXIA, PRODUCT USE IN UNAPPROVED INDICATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures GANCICLOVIR SODIUM?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with GANCICLOVIR SODIUM. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.