ganciclovir Side Effects
Also known as: Cytovene
Analysis of 9,877 adverse event reports submitted to the FDA from 2001 to 2025.
Total Reports
9,877
Death-Related
3,034
30.7% of reports
Hospitalizations
3,970
40.2% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 3,034 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 589 |
| OFF LABEL USE | 528 |
| CYTOMEGALOVIRUS INFECTION | 362 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 333 |
| SEPSIS | 276 |
| RESPIRATORY FAILURE | 254 |
| PANCYTOPENIA | 251 |
| PNEUMONIA | 230 |
| PYREXIA | 229 |
| SEPTIC SHOCK | 202 |
| POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER | 166 |
| DEATH | 156 |
| EPSTEIN-BARR VIRUS INFECTION | 154 |
| GRAFT VERSUS HOST DISEASE | 149 |
| PRODUCT USE IN UNAPPROVED INDICATION | 149 |
| RENAL FAILURE | 145 |
| CYTOMEGALOVIRUS INFECTION REACTIVATION | 140 |
| ACUTE KIDNEY INJURY | 139 |
| NEUTROPENIA | 139 |
| THROMBOCYTOPENIA | 137 |
Reactions in Hospitalization Reports
Top reactions in 3,970 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 674 |
| OFF LABEL USE | 569 |
| CYTOMEGALOVIRUS INFECTION | 555 |
| PYREXIA | 384 |
| DIARRHOEA | 275 |
| PANCYTOPENIA | 244 |
| PNEUMONIA | 229 |
| RESPIRATORY FAILURE | 223 |
| NEUTROPENIA | 201 |
| SEPSIS | 200 |
| ACUTE KIDNEY INJURY | 196 |
| THROMBOCYTOPENIA | 193 |
| CYTOMEGALOVIRUS INFECTION REACTIVATION | 189 |
| LEUKOPENIA | 167 |
| CONDITION AGGRAVATED | 166 |
| RENAL FAILURE | 164 |
| DRUG RESISTANCE | 160 |
| ANAEMIA | 159 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 152 |
| RENAL IMPAIRMENT | 151 |
Nearby — Related Medications
What the FAERS Data Reveals About ganciclovir Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 9,877 voluntary reports linked to ganciclovir and its brand equivalents (Cytovene), spanning 2001 through 2025. Of those, 3,034 (30.7%) listed death as an outcome and 3,970 (40.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 42% were female and 57% male; age distribution skews toward 45-64, with 2,676 reports in that bracket. The single most reported reaction is off label use with 1,542 submissions, followed by drug ineffective and cytomegalovirus infection.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.