GANCICLOVIR

N/A

Manufactured by Bausch & Lomb Incorporated

22,779 FDA adverse event reports analyzed

Last updated: 2026-04-14

About GANCICLOVIR

GANCICLOVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch & Lomb Incorporated. The most commonly reported adverse reactions for GANCICLOVIR 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.

Top Adverse Reactions

OFF LABEL USE1,542 reports
DRUG INEFFECTIVE1,395 reports
CYTOMEGALOVIRUS INFECTION1,170 reports
DRUG RESISTANCE653 reports
PYREXIA589 reports
PRODUCT USE IN UNAPPROVED INDICATION545 reports
NEUTROPENIA503 reports
PANCYTOPENIA503 reports
DIARRHOEA434 reports
CYTOMEGALOVIRUS VIRAEMIA413 reports
PNEUMONIA411 reports
SEPSIS401 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME379 reports
RESPIRATORY FAILURE377 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION355 reports
THROMBOCYTOPENIA351 reports
LEUKOPENIA331 reports
CONDITION AGGRAVATED320 reports
RENAL IMPAIRMENT313 reports
ACUTE KIDNEY INJURY305 reports
PRODUCT USE ISSUE300 reports
PATHOGEN RESISTANCE294 reports
RENAL FAILURE280 reports
ANAEMIA275 reports
SEPTIC SHOCK251 reports
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER250 reports
EPSTEIN BARR VIRUS INFECTION249 reports
NEPHROPATHY TOXIC237 reports
TRANSPLANT REJECTION220 reports
GRAFT VERSUS HOST DISEASE214 reports
MYELOSUPPRESSION199 reports
CYSTITIS HAEMORRHAGIC195 reports
CYTOMEGALOVIRUS CHORIORETINITIS194 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION191 reports
THROMBOTIC MICROANGIOPATHY191 reports
CYTOMEGALOVIRUS COLITIS185 reports
NAUSEA184 reports
PNEUMONIA CYTOMEGALOVIRAL179 reports
INFECTION173 reports
VOMITING170 reports
BK VIRUS INFECTION168 reports
ENCEPHALITIS CYTOMEGALOVIRUS165 reports
DISEASE PROGRESSION163 reports
HYPOTENSION163 reports
DEATH157 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA156 reports
ABDOMINAL PAIN155 reports
INTENTIONAL PRODUCT USE ISSUE154 reports
RESPIRATORY DISTRESS154 reports
FEBRILE NEUTROPENIA153 reports
PLEURAL EFFUSION153 reports
PLATELET COUNT DECREASED152 reports
TREATMENT FAILURE143 reports
DYSPNOEA142 reports
BLOOD CREATININE INCREASED141 reports
URINARY TRACT INFECTION141 reports
ACUTE GRAFT VERSUS HOST DISEASE138 reports
HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS132 reports
BONE MARROW FAILURE128 reports
DRUG INTERACTION127 reports
ASPERGILLUS INFECTION124 reports
RASH124 reports
TOXICITY TO VARIOUS AGENTS122 reports
WHITE BLOOD CELL COUNT DECREASED122 reports
WEIGHT DECREASED116 reports
HAEMOGLOBIN DECREASED115 reports
INTERSTITIAL LUNG DISEASE114 reports
BRONCHOPULMONARY ASPERGILLOSIS113 reports
GASTROINTESTINAL HAEMORRHAGE109 reports
COLITIS108 reports
END STAGE RENAL DISEASE108 reports
HYPERTENSION107 reports
HEADACHE106 reports
HEPATIC FUNCTION ABNORMAL106 reports
MULTI ORGAN FAILURE106 reports
CARDIAC ARREST105 reports
SMOOTH MUSCLE CELL NEOPLASM103 reports
ASTHENIA102 reports
EPSTEIN BARR VIRAEMIA101 reports
LYMPHOPENIA101 reports
COUGH99 reports
HYPOKALAEMIA99 reports
ENTEROCOCCAL INFECTION98 reports
ACUTE RESPIRATORY DISTRESS SYNDROME97 reports
CYTOMEGALOVIRUS TEST POSITIVE97 reports
LUNG DISORDER97 reports
THERAPY NON RESPONDER96 reports
HAEMORRHAGE INTRACRANIAL95 reports
RENAL FAILURE ACUTE95 reports
PSEUDOMONAS INFECTION94 reports
EYE PAIN93 reports
GASTRIC ULCER93 reports
ASCITES92 reports
CONFUSIONAL STATE92 reports
FUNGAL INFECTION92 reports
KLEBSIELLA INFECTION90 reports
DECREASED APPETITE88 reports
HEPATIC FAILURE86 reports
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN84 reports
ADENOVIRUS INFECTION84 reports

Report Outcomes

Out of 9,879 classified reports for GANCICLOVIR:

Serious 95.0%Non-Serious 5.0%

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

Male4,937 (57.1%)
Female3,636 (42.0%)
Unknown80 (0.9%)

Reports by Age

Age 43208 reports
Age 61198 reports
Age 60195 reports
Age 63168 reports
Age 58164 reports
Age 64153 reports
Age 55152 reports
Age 57140 reports
Age 65137 reports
Age 51136 reports
Age 6135 reports
Age 56132 reports
Age 4129 reports
Age 59129 reports
Age 53128 reports
Age 46124 reports
Age 66124 reports
Age 62121 reports
Age 3120 reports
Age 45117 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?

This profile reflects 22,779 FDA FAERS reports that mention GANCICLOVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GANCICLOVIR?

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?

Labeling and FAERS entries often list Bausch & Lomb Incorporated in connection with GANCICLOVIR. 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.