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ganciclovir

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Brand names: Cytovene

Antiviral (Nucleoside Analog) Rx

Ganciclovir injection is an antiviral medicine. It helps treat and prevent cytomegalovirus (CMV) infections.

What it does

This medicine treats CMV retinitis, an eye infection, in people with weak immune systems, including those with AIDS.

Common side effects

Fever, Diarrhea, Low white blood cell count

Key warnings

This drug can cause serious side effects.

How It Works

Ganciclovir stops CMV from multiplying. It does this by blocking a key enzyme the virus needs to make copies of itself. This helps your body fight off the CMV infection.

How to Take It

Ganciclovir is given into your vein through an IV. It should be given slowly over 1 hour. You will likely get this medicine every 12 hours for 14 to 21 days to start. Then, you may get it once a day for maintenance.

Pregnancy & Breastfeeding

Ganciclovir can harm your unborn baby. Do not get pregnant while taking this medicine. Talk to your doctor about birth control. Breastfeeding is not recommended while using this medicine.

Missed Dose

Call your doctor right away if you miss a dose. They will tell you when to take your next dose.

Storage

Store this medicine at room temperature. Keep diluted medicine in the refrigerator and use within 24 hours. Do not freeze.

Side Effects (from patient reports)

Based on 7,748 FDA adverse event reports.

Using the medicine for a condition it is not approved for
1,542
The medicine is not working
1,395
CMV infection
1,170
The virus is not responding to the medicine
653
Fever
590
Using the product for a condition it is not approved for
545
Low count of a type of white blood cell
503
Low count of all types of blood cells
503
Diarrhea
434
CMV in the blood
413

FDA Adverse Event Report Analysis

Detailed analysis of 9,877 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.

Total Reports

9,877

Death-Related Reports

3,034

Hospitalization Reports

3,970

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 3,635 (42%)
Male 4,937 (57%)

Age Distribution

0–17 1,560
18–44 2,261
45–64 2,676
65–74 976
75+ 359

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 OFF LABEL USE 1,542
2 DRUG INEFFECTIVE 1,395
3 CYTOMEGALOVIRUS INFECTION 1,170
4 DRUG RESISTANCE 653
5 PYREXIA 590
6 PRODUCT USE IN UNAPPROVED INDICATION 545
7 NEUTROPENIA 503
8 PANCYTOPENIA 503
9 DIARRHOEA 434
10 CYTOMEGALOVIRUS VIRAEMIA 413
11 PNEUMONIA 411
12 SEPSIS 400
13 MULTIPLE ORGAN DYSFUNCTION SYNDROME 379
14 RESPIRATORY FAILURE 378
15 CYTOMEGALOVIRUS INFECTION REACTIVATION 355

Reactions in Death 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

Reactions in Hospitalization 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

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

This drug can cause serious side effects. It can lower blood cell counts, possibly leading to severe infections or bleeding. It may also harm fertility in both men and women. Ganciclovir can cause birth defects and may increase your risk of cancer. Talk to your doctor about these risks.

Known Drug Interactions

Cyclosporine or amphotericin B Unknown Monitor renal function when Ganciclovir Injection 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 ganciclovir, the risk of nephrotoxicity may be increased.

Mechanism: Taking these two drugs together increases the risk of kidney damage. This can be seen through an increase in creatinine, a waste product that the kidneys usually filter out.

What to do: Your healthcare provider should monitor your kidney function closely with regular blood tests. Report any changes in urination to your doctor immediately.

Cyclosporine or amphotericin B Unknown Monitor renal function when Ganciclovir Injection 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 ganciclovir, the risk of nephrotoxicity may be increased.

Mechanism: Both of these medications can be toxic to the kidneys when used at the same time. This combination may lead to a rise in serum creatinine levels, indicating kidney stress.

What to do: Your doctor will need to check your kidney function frequently while you are on both drugs. Ensure you stay hydrated and follow all scheduled lab work.

Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine and zidovudine) Unknown Because of potential for higher toxicity, coadministration with Ganciclovir Injection should be considered only if the potential benefits are judged to outweigh the risks.

Mechanism: Both medications can be hard on the kidneys and may lower your blood cell counts. Using them at the same time increases the chance of these serious side effects.

What to do: Use this combination only if your doctor decides the benefits are worth the risks. Your doctor will need to check your blood and kidney health often.

Probenecid ↑ Ganciclovir Ganciclovir Injection dose may need to be reduced. (7) Probenecid: May increase ganciclovir levels.

Mechanism: Probenecid makes it harder for your body to remove ganciclovir, causing the drug to stay in your system longer.

What to do: Your doctor may need to lower your dose of ganciclovir to prevent side effects.

Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ] .

Mechanism: These drugs are removed from the body by the kidneys using the same process. Taking them together might slow down how quickly they are cleared from your blood.

What to do: Your doctor may need to monitor your kidney health and blood levels while you are on this combination.

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Common Questions

What if I am allergic to ganciclovir or valganciclovir?
You should not take this medicine if you are allergic to ganciclovir, valganciclovir, or any of the ingredients in the injection.
Will I need blood tests?
Yes, you will need regular blood tests. This is to check for changes in your blood cell counts and kidney function.
Can I take other medicines with ganciclovir?
Some medicines can interact with ganciclovir. Tell your doctor about all the medicines you take.
What should I avoid while taking ganciclovir?
Avoid getting pregnant. Men should use condoms during and for 90 days after treatment.
How long will I need to take ganciclovir?
Your doctor will decide how long you need to take this medicine. It depends on your condition.
What if I have kidney problems?
Your doctor may need to adjust your dose if you have kidney problems.
Can ganciclovir cure CMV?
Ganciclovir helps control CMV. It may not completely get rid of the virus.
What are the signs of a serious allergic reaction?
Signs include rash, hives, swelling, trouble breathing, or dizziness. Get medical help right away.
Does ganciclovir affect fertility?
Yes, it can affect fertility in both men and women. Talk to your doctor if you have concerns.
Can I drive or operate machinery while taking ganciclovir?
Ganciclovir can cause side effects like dizziness or confusion. Be careful driving or operating machinery.
What are the common side effects of ganciclovir?
The most commonly reported side effects of ganciclovir include Fever, Diarrhea, Low white blood cell count, Nausea, Anemia (low red blood cell count). Based on 7,748 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does ganciclovir interact with other medications?
Yes, ganciclovir has 9 known drug interactions. Notable interactions include cyclosporine, amphotericin B, trimethoprim. Always inform your doctor about all medications you are taking.
What drug class is ganciclovir?
ganciclovir belongs to the Antiviral (Nucleoside Analog) drug class. It requires a prescription (Rx). This medicine treats CMV retinitis, an eye infection, in people with weak immune systems, including those with AIDS.
Is ganciclovir safe during pregnancy?
Ganciclovir can harm your unborn baby. Do not get pregnant while taking this medicine. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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Medication Guides

Related Health & Safety Data

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What the FDA Data Shows for ganciclovir

The FDA label for ganciclovir (sold under brand names such as Cytovene) classifies it as a prescription-only medication in the Antiviral (Nucleoside Analog) class. This medicine treats CMV retinitis, an eye infection, in people with weak immune systems, including those with AIDS. Official labeling lists 14 commonly reported side effects, including Fever, Diarrhea, Low white blood cell count.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 7,748 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

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).

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: December 21, 2022

All federal data sources used on this page