Valganciclovir adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Valganciclovir
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Cytomegalovirus nucleoside analog DNA polymerase inhibitor
Also reported as: Valganciclovir 450mg, Valganciclovir /01542202/, Valganciclovir Tablets

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From August 2004 to June 2026, FDA received 5,249 adverse event reports that name Valganciclovir. In these reports the drug is a suspect or interacting product.

In the same period, 6,977 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 479 reports in the 12 months to June 2026 and 727 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Valganciclovir is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 86 reports that name Valganciclovir.
In January to March 2026, FDA received 126.
In April to June 2025, FDA received 121.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 585 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 5,217 of the 5,249 reports (99.4%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 585 terms.

Reaction terms in the reports that name Valganciclovir, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 5,249 reports
Off label useused for a purpose or in a way not on the label	1,197	22.8%
Drug ineffectivethe medicine did not work as expected	755	14.4%
Cytomegalovirus infection	742	14.1%
Neutropenialow neutrophils, a type of white blood cell	635	12.1%
Drug resistance	480	9.1%
Leukopenialow white blood cells	445	8.5%
Cytomegalovirus viraemia	375	7.1%
Pancytopenialow counts of all blood cells	308	5.9%
Cytomegalovirus infection reactivation	287	5.5%
Pathogen resistance	256	4.9%
Acute kidney injurysudden loss of kidney function	253	4.8%
Thrombocytopenialow platelets	246	4.7%
Product use in unapproved indicationused for a purpose not on the label	221	4.2%
Anaemialow red blood cells	204	3.9%
Renal impairmentreduced kidney function	191	3.6%
Diarrhoealoose or frequent stools	177	3.4%
Transplant rejection	157	3%
Deaththe patient died; cause not stated by this term	155	3%
Pneumonialung infection	150	2.9%
Pyrexiafever	150	2.9%
Myelosuppression	147	2.8%
Cytomegalovirus colitis	145	2.8%
Agranulocytosis	133	2.5%
Febrile neutropeniafever with low white blood cells	127	2.4%
Septic shockshock arising from infection	126	2.4%
Cytomegalovirus chorioretinitis	117	2.2%
Intentional product use issuedeliberate use not as intended	116	2.2%
Sepsisa severe body-wide response to infection	116	2.2%
Condition aggravatedthe condition being treated got worse	114	2.2%
Nephropathy toxic	100	1.9%
Product use issuea problem in how the product was used	100	1.9%
Drug interactionan interaction between medicines	98	1.9%
Lymphopenia	96	1.8%
No adverse eventno adverse event was reported	90	1.7%
Toxicity to various agentspoisoning or toxic effect of one or more substances	86	1.6%
Cytopenia	80	1.5%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	79	1.5%
Pneumonia cytomegaloviral	79	1.5%
Bone marrow failure	74	1.4%
Encephalitis cytomegalovirus	72	1.4%
Respiratory failurethe lungs could not supply enough oxygen	72	1.4%
Urinary tract infectionbladder or urinary infection	70	1.3%
Epstein-Barr virus infection	69	1.3%
Thrombotic microangiopathy	67	1.3%
Covid-19COVID-19 infection	66	1.3%
Treatment failurethe treatment did not work	66	1.3%
Abdominal painstomach or belly pain	65	1.2%
Aspergillus infection	65	1.2%
Infectionan infection, type not specified	65	1.2%
Renal failurekidney failure	64	1.2%

Download all 585 terms of Valganciclovir (CSV)

The counts add to more than 5,249 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Valganciclovir with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Valganciclovir (this page)	Generic name	5,249
Valganciclovir hydrochloride	Generic name	1,142
Valcyte	Brand name	2,312

Sum of the separately reported names: 8,703. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Valganciclovir, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	8	8	1	2	8	0	0	1	0
2005	16	16	2	3	13	0	0	2	0
2006	1	1	1	0	0	0	0	1	0
2007	1	1	0	0	1	1	0	0	0
2008	6	6	0	0	4	0	0	3	0
2009	0	0	0	0	0	0	0	0	0
2010	32	32	18	4	14	0	0	11	0
2011	52	52	13	3	28	1	0	27	0
2012	66	66	15	5	37	5	1	32	0
2013	56	56	14	2	29	3	1	27	0
2014	53	53	8	1	24	1	0	33	0
2015	88	85	28	5	38	0	1	60	3
2016	97	94	9	3	38	1	0	65	3
2017	144	127	38	7	50	1	0	78	17
2018	288	279	56	33	134	7	4	175	9
2019	399	390	67	28	136	4	5	303	9
2020	583	574	99	77	251	12	0	433	9
2021	486	461	60	33	133	10	0	384	25
2022	504	453	58	25	189	1	18	341	51
2023	453	441	85	21	184	2	1	317	12
2024	815	791	114	55	354	18	8	594	24
2025	798	761	121	68	328	9	15	622	37
2026	303	292	44	41	137	2	1	221	11

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Valganciclovir, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Valganciclovir, by the year in which FDA received them
Year	Reports
2004	6
2005	18
2006	1
2007	2
2008	7
2009	2
2010	31
2011	56
2012	75
2013	56
2014	56
2015	93
2016	101
2017	171
2018	345
2019	508
2020	616
2021	514
2022	472
2023	514
2024	795
2025	598
2026	212

Reports that name Valganciclovir, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Valganciclovir
Age	Reports	Share
Under 2	206	3.9%
2 to 11	207	3.9%
12 to 17	143	2.7%
18 to 44	940	17.9%
45 to 64	1,652	31.5%
65 to 74	656	12.5%
75 and over	187	3.6%
Age not given	1,258	24%

Sex of the patient in the reports that name Valganciclovir
Sex	Reports	Share
Female	1,779	33.9%
Male	2,588	49.3%
Unknown or not given	882	16.8%

Type of reporter in the reports that name Valganciclovir
Reporter	Reports	Share
Physician	1,750	33.3%
Pharmacist	246	4.7%
Other health professional	2,824	53.8%
Lawyer	0	0%
Consumer or non-health professional	391	7.4%
Not given	38	0.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 29.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Valganciclovir record
Indication as recorded (MedDRA)	Reports	Share
Antiviral prophylaxis	1,091	20.8%
Cytomegalovirus infection	955	18.2%
Prophylaxis	294	5.6%
Cytomegalovirus viraemia	223	4.2%
Cytomegalovirus infection reactivation	133	2.5%
Cytomegalovirus chorioretinitis	128	2.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 5,249 reports.

Drugs in the same reports

Other drugs that the reports of Valganciclovir name, in any role, in order of name
Drug	Reports that name the two
Basiliximab	392
Cyclosporine	449
Foscarnet	499
Ganciclovir	1,398
Methylprednisolone	687
Mycophenolate mofetil	1,610
Prednisolone	690
Prednisone	1,327
Rituximab	425
Tacrolimus	2,067

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Valganciclovir hydrochloride same ingredient
Valcyte same ingredient
Ganciclovir sodium same class
Ganciclovir same class
Valdoxan next in the A to Z list
Valganciclovir hcl next in the A to Z list
Valchlor next in the A to Z list
Valium next in the A to Z list
Valbenazine next in the A to Z list
Valixa next in the A to Z list
Valacyclovir hydrochloride next in the A to Z list
Valproate next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for ValganciclovirThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Valganciclovir: adverse event reports that FDA received. https://reportedreactions.com/drug/valganciclovir/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Valganciclovir as a suspect or interacting product. The 6,977 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Valganciclovir was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Valganciclovir?

No. It is a count of what people reported to FDA: 5,249 reports from August 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (53.8%), physician (33.3%) and consumer or non-health professional (7.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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