Prescription medication · Antiviral (Nucleoside Analog)
valganciclovir
Also sold as Valcyte. This medicine prevents CMV disease in children after they get a kidney or heart transplant.
Data updated 2026-05-15
- 18,056
- FDA reportsModerately reported
- 8
- InteractionsFew interactions
- $2.00
- Generic price (NADAC)
What the data shows
valganciclovir (Valcyte) is a prescription Antiviral (Nucleoside Analog), reported at a middle-of-the-pack volume (18,056 FDA reports), with 8 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
valganciclovir (Valcyte) is a prescription Antiviral (Nucleoside Analog). This medicine prevents CMV disease in children after they get a kidney or heart transplant.
Valganciclovir is an antiviral medicine. It helps prevent cytomegalovirus (CMV) disease in children who have received kidney or heart transplants.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$2.00/unit
Generic Available
Yes (13 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: VALGANCICLOVIR 450 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -22.6% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $2.59/EA | - | 2 |
| December 18, 2024 | $2.00/EA | -22.6% | 15 |
What it does
This medicine prevents CMV disease in children after they get a kidney or heart transplant.
Common side effects
Diarrhea, Fever, Upper respiratory infection
Key warnings
Valganciclovir can cause serious side effects, including: - Lowered blood cell counts.
The sections below are summarized in plain English from valganciclovir's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Valganciclovir changes into ganciclovir in your body. Ganciclovir stops CMV from making copies of itself. This helps to prevent or treat CMV infections.
Side Effects (from patient reports)
Based on 18,056 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for valganciclovir, by number of reports
- Cytomegalovirus Infection
Cytomegalovirus Infection
1,756 reports
- Neutropenia
Neutropenia
1,096 reports
- Pyrexia
Pyrexia
939 reports
- Diarrhoea
Diarrhoea
916 reports
- Leukopenia
Leukopenia
914 reports
- Acute Kidney Injury
Acute Kidney Injury
797 reports
- Death
Death
754 reports
- Cytomegalovirus Viraemia
Cytomegalovirus Viraemia
722 reports
- Pancytopenia 662
Pancytopenia
662 reports
- Drug Resistance 637
Drug Resistance
637 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for valganciclovir each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where valganciclovir sits
valganciclovir has more FDA adverse-event reports than 53% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is valganciclovir; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 18,056 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
18,056
Reports Mentioning Death
3,133
17.4% of reports — not proof of cause
Hospitalization Reports
8,858
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | CYTOMEGALOVIRUS INFECTION | 1,756 |
| 4 | NEUTROPENIA | 1,096 |
| 5 | PYREXIA | 939 |
| 6 | DIARRHOEA | 916 |
| 7 | LEUKOPENIA | 914 |
| 8 | ACUTE KIDNEY INJURY | 797 |
| 9 | DEATH | 754 |
| 10 | CYTOMEGALOVIRUS VIRAEMIA | 722 |
| 11 | PANCYTOPENIA | 662 |
| 12 | DRUG RESISTANCE | 637 |
| 13 | TRANSPLANT REJECTION | 631 |
| 14 | ANAEMIA | 621 |
| 15 | THROMBOCYTOPENIA | 605 |
| 16 | PNEUMONIA | 587 |
| 18 | NAUSEA | 501 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Valganciclovir can cause serious side effects, including: - Lowered blood cell counts. This can lead to infections and bleeding. - Fertility problems in both men and women. - Birth defects if taken during pregnancy. - Cancer. Talk to your doctor about these risks.
Known Drug Interactions
Cyclosporine or amphotericin B Unknown Monitor renal function when valganciclovir is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see Warnings and Precautions (5.2)]. ( 7 ) Cyclosporine or amphotericin B: When coadministered with valganciclovir, the risk of nephrotoxicity may be increased.
Mechanism: Taking these two medications together can increase the risk of damage to your kidneys.
Cyclosporine or amphotericin B Unknown Monitor renal function when valganciclovir is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see Warnings and Precautions (5.2)]. ( 7 ) Cyclosporine or amphotericin B: When coadministered with valganciclovir, the risk of nephrotoxicity may be increased.
Mechanism: Both of these drugs can be hard on the kidneys, and using them at the same time increases the chance of kidney injury.
Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine) Unknown Because of potential for higher toxicity, coadministration with valganciclovir should be considered only if the potential benefits are judged to outweigh the risks.
Mechanism: Both drugs can cause similar side effects like bone marrow suppression or kidney damage, which increases the risk of these problems when used together.
7 DRUG INTERACTIONS In vivo drug-drug interaction studies were not conducted with valganciclovir. However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for valganciclovir. Drug-drug interaction studies with ganciclovir were conducted in patients with normal renal function.
Mechanism: Valganciclovir is quickly changed into ganciclovir by the body, so taking both at the same time is like taking the same medicine twice.
Didanosine ↔ Ganciclovir ↑ Didanosine Patients should be closely monitored for didanosine toxicity (e.g., pancreatitis) Probenecid ↑ Ganciclovir Valganciclovir dose may need to be reduced. ( 7 ) Probenecid: May increase ganciclovir levels.
Mechanism: Probenecid makes it harder for the body to remove ganciclovir, which can lead to higher amounts of the drug staying in your blood.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What is valganciclovir used for?
How often should I give this medicine?
Should I give it with food?
What should I do if my child vomits after taking a dose?
How long will my child need to take this medicine?
What are the most common side effects?
Can this medicine affect my child's ability to have children in the future?
What blood tests will my child need while taking this medicine?
Can valganciclovir interact with other medicines?
What should I do if my child experiences side effects?
What are the common side effects of valganciclovir?
Does valganciclovir interact with other medications?
What drug class is valganciclovir?
What pregnancy or breastfeeding source fields are listed for valganciclovir?
Related Medications in Antiviral (Nucleoside Analog)
Other drugs grouped near valganciclovir - same-class peers and common alternatives.
acyclovir
Zovirax
Acyclovir is an antiviral medicine.
Compare with valganciclovir →
albendazole
Albenza
Albendazole is a medicine that fights parasites.
Compare with valganciclovir →
amphotericin B
Ambisome, Fungizone
Amphotericin B liposome is an antifungal medicine.
Compare with valganciclovir →
anidulafungin
Eraxis
Eraxis is an antifungal medicine.
Compare with valganciclovir →
atovaquone/proguanil
Malarone
Malarone is a drug used to prevent and treat malaria.
Compare with valganciclovir →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for valganciclovir: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 18,056.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 17.35%.
- amiodarone Δ 0.07 pts · 10,687 reports · Class III Antiarrhythmic 17.28%death share
- chlorpheniramine Δ 0.07 pts · 6,221 reports · First-Generation Antihistamine 17.42%death share
- bisacodyl Δ 0.15 pts · 13,500 reports · Stimulant Laxative 17.50%death share
- ceftriaxone Δ 0.15 pts · 31,340 reports · Third-Generation Cephalosporin 17.20%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for valganciclovir
The FDA label for valganciclovir (sold under brand names such as Valcyte) classifies it as a prescription-only medication in the Antiviral (Nucleoside Analog) class. This medicine prevents CMV disease in children after they get a kidney or heart transplant. Official labeling lists 8 commonly reported side effects, including Diarrhea, Fever, Upper respiratory infection.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 18,056 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $2.00.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: January 19, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages