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valganciclovir

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Brand names: Valcyte

Antiviral (Nucleoside Analog) Rx

Valganciclovir is an antiviral medicine. It helps prevent cytomegalovirus (CMV) disease in children who have received kidney or heart transplants.

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 →

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.

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.

How to Take It

Give this medicine to your child exactly as prescribed by their doctor. It is usually taken once a day with food. The dose is based on your child's body surface area and kidney function. The pharmacist will prepare the oral solution before you give it to your child.

Pregnancy & Breastfeeding

This medicine can cause birth defects. Do not take it if you are pregnant or plan to become pregnant. Breastfeeding is not recommended while taking this medicine.

Missed Dose

If you miss a dose, give it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with the regular schedule.

Storage

Store the dry powder at room temperature. Store the mixed solution in the refrigerator for up to 49 days. Do not freeze.

Side Effects (from patient reports)

Based on 12,178 FDA adverse event reports.

Using the medicine for a condition it is not approved for
2,858
CMV infection
1,756
The medicine is not working
1,425
Low white blood cell count
1,096
Fever
940
Diarrhea
916
Low white blood cell count
914
Sudden kidney damage
797
Death
754
CMV in the blood
722

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

Death-Related Reports

3,133

Hospitalization Reports

8,858

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 6,365 (40%)
Male 9,377 (59%)

Age Distribution

0–17 1,514
18–44 3,269
45–64 5,201
65–74 2,466
75+ 566

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 OFF LABEL USE 2,858
2 CYTOMEGALOVIRUS INFECTION 1,756
3 DRUG INEFFECTIVE 1,426
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

Reactions in Death Reports

DEATH 754
OFF LABEL USE 591
DRUG INEFFECTIVE 398
SEPSIS 300
CYTOMEGALOVIRUS INFECTION 256
PANCYTOPENIA 255
SEPTIC SHOCK 234
ACUTE KIDNEY INJURY 227
MULTIPLE ORGAN DYSFUNCTION SYNDROME 214
RESPIRATORY FAILURE 213

Reactions in Hospitalization Reports

OFF LABEL USE 1,004
PYREXIA 736
CYTOMEGALOVIRUS INFECTION 710
DRUG INEFFECTIVE 665
DIARRHOEA 658
NEUTROPENIA 585
ACUTE KIDNEY INJURY 531
LEUKOPENIA 514
ANAEMIA 461
PANCYTOPENIA 420

Source: FDA FAERS (Adverse Event Reporting System) 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.

What to do: Your healthcare provider should monitor your kidney function tests regularly while you are using both drugs.

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.

What to do: Your doctor should check your kidney function frequently to ensure the organs are working properly during treatment.

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.

What to do: Your doctor should only use these drugs together if the benefits outweigh the risks and will likely monitor your blood counts and kidney function.

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.

What to do: Avoid taking these two drugs together as it can lead to an overdose of the active medication.

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.

What to do: Your doctor may need to lower your dose of valganciclovir to keep the drug at a safe level in your body.

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Common Questions

What is valganciclovir used for?
It is used to prevent CMV disease in children who have had a kidney or heart transplant.
How often should I give this medicine?
Give it once a day, exactly as your doctor tells you.
Should I give it with food?
Yes, give valganciclovir with food.
What should I do if my child vomits after taking a dose?
Call your doctor for advice.
How long will my child need to take this medicine?
Your child will take it for a certain number of days after their transplant. Your doctor will tell you how long.
What are the most common side effects?
The most common side effects are diarrhea, fever, and vomiting.
Can this medicine affect my child's ability to have children in the future?
Yes, it can cause fertility problems. Talk to your doctor if you have concerns.
What blood tests will my child need while taking this medicine?
Your child will need regular blood tests to check their blood cell counts and kidney function.
Can valganciclovir interact with other medicines?
Yes, it can interact with some medicines. Tell your doctor about all the medicines your child takes.
What should I do if my child experiences side effects?
Contact your doctor if your child experiences side effects.
What are the common side effects of valganciclovir?
The most commonly reported side effects of valganciclovir include Diarrhea, Fever, Upper respiratory infection, Urinary tract infection, Vomiting. Based on 12,178 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does valganciclovir interact with other medications?
Yes, valganciclovir has 8 known drug interactions. Notable interactions include cyclosporine, amphotericin B, trimethoprim. Always inform your doctor about all medications you are taking.
What drug class is valganciclovir?
valganciclovir belongs to the Antiviral (Nucleoside Analog) drug class. It requires a prescription (Rx). This medicine prevents CMV disease in children after they get a kidney or heart transplant.
Is valganciclovir safe during pregnancy?
This medicine can cause birth defects. Do not take it if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Related Medications in Antiviral (Nucleoside Analog)

Other drugs grouped near valganciclovir — same-class peers and common alternatives.

Compare valganciclovir vs acyclovir side-by-side →

Medication Guides

Related Health & Safety Data

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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 12,178 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: January 19, 2026

All federal data sources used on this page