Drugs › Cytomegalovirus nucleoside analog DNA polymerase inhibitor
Generic name
Ganciclovir: adverse event reports filed with FDA
4,729 reports list it as a suspect or interacting product, 2004–2026. Class: Cytomegalovirus nucleoside analog DNA polymerase inhibitor. Also reported as Ganciclovir For Injection, Ganciclovir /00784202/, Ganciclovir For Injection Usp.
- 4,729
- reports as suspect product
- 0% of all reports · about 211 a year
- 339
- reports, 12 months to June 2026
- 422 in the 12 months before
- 97.9%
- marked serious by the reporter
- 94.2% across the class
- 30.6%
- record death among outcomes, as reported
- 1,448 reports · not verified by FDA
4,729 adverse event reports received by FDA list ganciclovir, a generic name as a suspect or interacting product, from February 2004 to June 2026. A further 5,157 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 339 reports listed it, down 20% from 422 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 211 reports a year and 0% of the 20,646,523 reports in the database, and 33.8% of the reports for the cytomegalovirus nucleoside analog DNA polymerase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are off label use (22.2%), drug ineffective (18.9%) and cytomegalovirus infection (14.3%). A report can list several reactions, so shares add to more than 100%; 990 different terms appear across these reports. Off label use is recorded in 22.2% of these reports, about the same share as in the median cytomegalovirus nucleoside analog DNA polymerase inhibitor drug (24.1%).
97.9% of the reports are marked serious by the reporter (94.2% across the class); 30.6% record death among the outcomes and 35.5% record hospitalisation, as reported. 60.5% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (28%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Ganciclovir reports recording the termmedian drug in cytomegalovirus nucleoside analog dna polymerase inhibitor
- Off label useused for a purpose or in a way not on the label22.2%1,049
- Drug ineffectivethe medicine did not work as expected18.9%893
- Cytomegalovirus infection14.3%674
- Drug resistance12.5%590
- Pancytopenialow counts of all blood cells8.5%402
- Product use in unapproved indicationused for a purpose not on the label7.7%364
- Neutropenialow neutrophils, a type of white blood cell7.7%362
- Cytomegalovirus viraemia6.3%296
- Cytomegalovirus infection reactivation6.1%289
- Product use issuea problem in how the product was used5.5%260
- Pathogen resistance5.4%257
- Multiple organ dysfunction syndromeseveral organs failing5%238
- Pyrexiafever5%235
- Thrombocytopenialow platelets4.9%232
- Leukopenialow white blood cells4.6%219
- Condition aggravatedthe condition being treated got worse4.4%208
- Acute kidney injurysudden loss of kidney function4.2%199
- Sepsisa severe body-wide response to infection3.8%181
- Myelosuppression3.8%180
- Renal impairmentreduced kidney function3.8%178
- Nephropathy toxic3.7%174
- Pneumonialung infection3.7%173
- Respiratory failurethe lungs could not supply enough oxygen3.6%172
- Diarrhoealoose or frequent stools3.2%152
- Encephalitis cytomegalovirus3.2%150
- Renal failurekidney failure2.9%138
- Cytomegalovirus chorioretinitis2.8%133
- Anaemialow red blood cells2.7%129
- Epstein-Barr virus infection2.7%127
Top 30 of 990 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the cytomegalovirus nucleoside analog dna polymerase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 14,000 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 19.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Cytomegalovirus infection | 1,013 | 21.4% |
| Antiviral prophylaxis | 413 | 8.7% |
| Cytomegalovirus viraemia | 241 | 5.1% |
| Cytomegalovirus chorioretinitis | 194 | 4.1% |
| Cytomegalovirus infection reactivation | 107 | 2.3% |
| Prophylaxis | 105 | 2.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 4,729 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Ganciclovir reports |
|---|---|---|
| Valganciclovir | 1,385 | 29.3% |
| Mycophenolate mofetil | 1,305 | 27.6% |
| Tacrolimus | 1,243 | 26.3% |
| Prednisone | 807 | 17.1% |
| Methylprednisolone | 727 | 15.4% |
| Cyclosporine | 703 | 14.9% |
| Cyclophosphamide | 681 | 14.4% |
| Foscarnet | 674 | 14.3% |
| Rituximab | 572 | 12.1% |
| Prednisolone | 570 | 12.1% |
Other products listed in reports where Ganciclovir is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Ganciclovir | Cytomegalovirus nucleoside analog DNA polymerase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 4,729 | 14,000 | 20,646,523 |
| Share of that pool | — | 33.8% | 0% |
| Reports, latest 12 months | 339 | — | 1,332,454 |
| Marked serious | 97.9% | 94.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 306 | 231 | 91 |
| Hospitalisation recorded, per 1,000 reports | 355 | 379 | 213 |
| Consumer-filed share | 5.3% | 11.8% | 45.8% |
| Top term, share of reports | Off label use 22.2% | median 24.1% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the cytomegalovirus nucleoside analog dna polymerase inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Valganciclovir | generic | 5,249 | 479 | 96% |
| Valcyte | brand | 2,312 | 23 | 80.1% |
| Valganciclovir hydrochloride | generic | 1,142 | 159 | 97.2% |
| Ganciclovir sodium | generic | 568 | 86 | 96.5% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Ganciclovir reports
How many adverse event reports has FDA received for Ganciclovir?
4,729 reports list Ganciclovir as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 339 of them arrived in the latest 12 months. Another 5,157 list it only as a concomitant medication.
What reactions are recorded in Ganciclovir reports?
off label use (22.2%), drug ineffective (18.9%), cytomegalovirus infection (14.3%), drug resistance (12.5%) and pancytopenia (8.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Ganciclovir was responsible.
How serious are the reports?
97.9% are marked serious by the reporter. Among the outcomes recorded, 30.6% of reports include death and 35.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (60.5%), physician (29.2%) and consumer or non-health professional (5.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Ganciclovir rising?
339 reports in the 12 months to June 2026, down 20% from 422 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Ganciclovir was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Ganciclovir?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Ganciclovir as a suspect or interacting product; reports listing it only as a concomitant medication (5,157) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.