Ganciclovir
Ganciclovir is an antiviral medication used to treat or prevent cytomegalovirus (CMV) infections and, as Zirgan eye gel, to treat herpes-related corneal ulcers.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 8 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Ganciclovir is a specialist antiviral, on the U.S. market since about 2001 and available generically, that blocks the enzyme cytomegalovirus (CMV) uses to copy its DNA, mainly in infected cells; by IV infusion it treats CMV retinitis (a sight-threatening eye infection) in people with weakened immunity and prevents CMV disease after transplant, and Zirgan eye gel treats herpes corneal ulcers. The eye gel is usually well tolerated; the infusion often brings fever, diarrhea, nausea or headache. The infusion's boxed warning covers dangerous drops in blood counts, harm to fertility, birth defects and possible cancer, so expect regular blood tests and strict contraception, and report fever or unusual bruising promptly.
Clinical pearls
- Ganciclovir leaves the body through the kidneys, so kidney blood tests guide the dose; report less urine or new swelling.
- Make sure hospital teams know about it before any imipenem-cilastatin, an antibiotic that has caused seizures when combined with ganciclovir.
- Women need effective contraception for at least 30 days after the last dose; men need condoms for at least 90.
- Transplant patients on mycophenolate need closer blood count and kidney checks, since the pair adds up on both.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Ganciclovir injection carries four serious warnings that the FDA requires to be prominently displayed:
Blood toxicity: Ganciclovir can severely lower white blood cell, red blood cell, and platelet counts — a condition that can be life-threatening. Regular blood tests are required during treatment.
Fertility: Based on animal and limited human data, ganciclovir injection may temporarily or permanently reduce sperm production in men and suppress fertility in women.
Birth defects: Animal studies show ganciclovir can cause serious birth defects. It should not be used during pregnancy unless absolutely necessary, and effective contraception is required during and after treatment.
Cancer risk: Animal studies indicate ganciclovir has the potential to cause cancer in humans. It should be used only when the benefit clearly outweighs this long-term risk.
Patient information guide A plain-language walkthrough of Ganciclovir, written from its FDA label.
What Ganciclovir is used for
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Ganciclovir is an antiviral used across different formulations for distinct viral infections. The approved uses depend on the specific product and route of administration:
- Ganciclovir injection (Cytovene, Ganciclovir, and ganciclovir sodium) is indicated for the treatment of CMV retinitis in immunocompromised adults, including those with AIDS
- Ganciclovir injection is also indicated for the prevention of CMV disease in adult transplant recipients who are at risk
- Zirgan ophthalmic gel is indicated for the treatment of acute herpetic keratitis (corneal ulcers caused by herpes simplex virus) in adults and children aged 2 years and older
How Ganciclovir works
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Ganciclovir is a synthetic molecule that closely resembles a natural DNA building block. When it enters a virus-infected cell, a viral enzyme converts it to an active form called ganciclovir triphosphate. This active form blocks the viral DNA polymerase — the enzyme the virus needs to copy its genetic material — effectively stopping the virus from replicating. Because that first activation step depends mainly on a viral enzyme, the drug acts preferentially inside infected cells rather than healthy ones.
Resistance can develop when viruses develop mutations in the genes that encode the enzymes ganciclovir targets, particularly the viral kinase (pUL97) and the viral DNA polymerase (pUL54).
Ganciclovir dosage
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Ganciclovir injection is always given by slow intravenous infusion over one hour — the rate must not be exceeded to avoid serious toxicity. It is given more frequently during an initial induction phase, then less often as a maintenance dose; the exact schedule depends on whether the goal is treatment or prevention. Zirgan eye gel is applied as drops into the affected eye multiple times daily while awake until the corneal ulcer heals, then tapered for a final week. Dose adjustments are required for patients with reduced kidney function when using the injection form. Always follow your prescriber's exact schedule and never adjust the dose on your own.
Dosing details from the FDA-approved label
From the Ganciclovir prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Treatment of CMV retinitis in adults with normal renal function: induction
- 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days
- The recommended dosage and infusion rate should not be exceeded
- Treatment of CMV retinitis in adults with normal renal function: maintenance
- 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week
- Prevention of CMV disease in transplant recipients: induction
- 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days
- Prevention of CMV disease in transplant recipients: maintenance
- 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week until 100 to 120 days post-transplantation
- Adults with renal impairment, creatinine clearance 50-69 mL/min
- Induction 2.5 mg/kg every 12 hours
- Maintenance 2.5 mg/kg every 24 hours
- Adjust dosage based on creatinine clearance
- Adults with renal impairment, creatinine clearance 25-49 mL/min
- Induction 2.5 mg/kg every 24 hours
- Maintenance 1.25 mg/kg every 24 hours
- Adjust dosage based on creatinine clearance
- Adults with renal impairment, creatinine clearance 10-24 mL/min
- Induction 1.25 mg/kg every 24 hours
- Maintenance 0.625 mg/kg every 24 hours
- Adjust dosage based on creatinine clearance
- Adults with creatinine clearance less than 10 mL/min or undergoing hemodialysis
- Induction 1.25 mg/kg 3 times per week, following hemodialysis
- Maintenance 0.625 mg/kg 3 times per week, following hemodialysis
- Maximum: Induction not to exceed 1.25 mg/kg 3 times per week; maintenance not to exceed 0.625 mg/kg 3 times per week
- Give shortly after completion of the hemodialysis session
- Zirgan (ophthalmic gel): corneal ulcer
- 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Ganciclovir for injection is administered only intravenously. ( 2.1 ) Dosage in Adult Patients with Normal Renal Function Treatment of CMV retinitis ( 2.3 ) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week. Prevention of CMV disease in transplant recipients ( 2.4 ) Induction: 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 7 to 14 days. Maintenance: 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily, 7 days per week, or 6 mg/kg once daily, 5 days per week until 100 to 120 days post- transplantation. Adults with renal impairment: Adjust dosage based on creatinine clearance. ( 2.5 ) 2.1 Important Dosing and Administration Information To avoid phlebitis/pain at the infusion site, ganciclovir for injection must only be administered by intravenous infusion over 1 hour, preferably via plastic cannula, into a vein with adequate blood flow to permit rapid dilution and distribution. Do not administer ganciclovir for injection by rapid or bolus intravenous injection which may increase toxicity as a result of excessive plasma levels. The recommended dosage and infusion rate for ganciclovir should not be exceeded. Do not administer the reconstituted ganciclovir for injection solution intramuscularly or subcutaneously because it may result in severe tissue irritation due to high pH [see Description ( 11 )]. Administration of ganciclovir for injection should be accompanied by adequate hydration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 2.2 Testing Before and During Treatment Females of reproductive potential should undergo pregnancy testing before initiation of treatment with ganciclovir [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 , 8.3 )].
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Ganciclovir side effects
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The most commonly reported side effects with ganciclovir injection include:
Common side effects
- Fever
- Diarrhea
- Nausea
- Low white blood cell count (leukopenia)
- Anemia (low red blood cell count)
- Headache
- Decreased appetite
- Excessive sweating
- Weakness or fatigue (asthenia)
- Abdominal pain
When to get medical help
- Call your doctor right away if you notice unusual bruising or bleeding — this may signal a dangerously low platelet count
- Seek medical help for signs of serious infection (chills, high fever, feeling very unwell) — low white cell counts raise infection risk
- Tell your doctor immediately if you notice changes in urination or swelling — this may indicate kidney problems
- Contact your doctor if you experience new or worsening eye symptoms such as flashes of light or new floaters, which could signal retinal detachment
- Get emergency help for seizures — these have been reported with overdose and with certain drug combinations
- Tell your care team if you notice severe fatigue or pallor, which can be signs of serious anemia
Seriously low blood counts — especially white blood cells and platelets — are among the most dangerous effects and require regular blood monitoring. Retinal detachment has also been observed in patients with CMV retinitis, though its connection to the drug is not fully established.
Ganciclovir warnings and precautions
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- Blood toxicity: Ganciclovir injection commonly and significantly lowers white blood cells, red blood cells, and platelets. This usually begins in the first two weeks but can happen at any time. It can be life-threatening, and blood counts must be monitored frequently throughout treatment.
- Kidney damage: The drug is cleared almost entirely by the kidneys; impaired kidney function causes drug levels to build up, increasing toxicity risk. Elderly patients and those taking other kidney-stressing drugs (such as cyclosporine or amphotericin B) face the highest risk — kidney function must be monitored throughout.
- Fertility effects: Ganciclovir injection may temporarily or permanently reduce sperm production in men and suppress fertility in women. Discuss this risk with your doctor before starting treatment.
- Pregnancy and birth defects: Animal data show potential for serious birth defects. Effective contraception is required during and after treatment (at least 30 days for women, 90 days for men using barrier contraception).
- Cancer risk: Animal data indicate a potential to cause cancer in humans. This drug is reserved for situations where benefits clearly outweigh risks.
Ganciclovir interactions
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Ganciclovir injection can interact with several other medications, sometimes seriously. Key interactions include:
- Imipenem-cilastatin: Generalized seizures have been reported — combined use is not recommended
- Cyclosporine and amphotericin B: Increase the risk of kidney damage; kidney function must be monitored closely
- Mycophenolate mofetil (MMF): Combined use raises the risk of blood and kidney toxicity; both drugs need monitoring
- Didanosine: Ganciclovir can raise didanosine levels, increasing the risk of pancreatitis
- Probenecid: Can raise ganciclovir blood levels; watch for signs of ganciclovir toxicity
- Other bone-marrow-suppressing or kidney-toxic drugs (e.g., dapsone, doxorubicin, zidovudine, vincristine, flucytosine, pentamidine, trimethoprim/sulfamethoxazole, hydroxyurea, tacrolimus, vinblastine): Combined use should only occur when benefits outweigh the added risks
Interactions listed in the FDA-approved label
From the Ganciclovir prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Imipenem-cilastatin: Generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin. Coadministration is not recommended unless the potential benefits outweigh the risks.
- Cyclosporine or amphotericin B: Potential increase in serum creatinine; risk of nephrotoxicity may be increased. Monitor renal function.
- Mycophenolate mofetil (MMF): Risk of hematological and renal toxicity may be increased. Monitor patients for hematological and renal toxicity.
- Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine, zidovudine): Potential for higher toxicity. Consider coadministration only if the potential benefits are judged to outweigh the risks.
- Didanosine: Increases didanosine levels. Closely monitor for didanosine toxicity (e.g., pancreatitis).
- Probenecid: May increase ganciclovir levels. Ganciclovir dose may need to be reduced. Monitor for evidence of ganciclovir toxicity.
Read the label’s full interactions text
7 DRUG INTERACTIONS Drug-drug interaction studies were conducted in patients with normal renal function. Patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug following concomitant administration of Ganciclovir Injection Drug-drug interaction studies were conducted in patients with normal renal function. Patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug following concomitant administration of Ganciclovir Injection and drugs excreted by the same pathway as ganciclovir. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug. Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 6 . Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 6 [see Clinical Pharmacology (12.3) ] . Table 6. Established and Other Potentially Significant Drug Interactions with Ganciclovir Name of the Concomitant Drug Change in the Concentration of Ganciclovir or Concomitant Drug Clinical Comment Imipenem-cilastatin Unknown Coadministration with imipenem-cilastatin is not recommended because generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastatin. 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)]. Mycophenolate mofetil (MMF) ↔ Ganciclovir (in patients with normal renal function) ↔ MMF (in patients with normal renal function) Based on increased risk, patients should be monitored for hematological and renal toxicity.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Ganciclovir
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- Tell your doctor if you have ever had a serious allergic reaction (such as anaphylaxis) to ganciclovir or valganciclovir — ganciclovir injection is contraindicated in this case
- Tell your doctor if you have kidney disease or reduced kidney function — dose adjustment is required and monitoring is essential
- Females who could become pregnant must have a pregnancy test before starting ganciclovir injection and use effective contraception during treatment and for at least 30 days afterward
- Males should use barrier contraception during treatment and for at least 90 days after, given the potential for mutagenic effects
- Do not breastfeed while using ganciclovir injection — the drug may pass into milk and harm a nursing infant
- Safety and effectiveness of ganciclovir injection have not been established in children — discuss risks and benefits carefully with a specialist
- Older adults are at higher risk of kidney-related side effects and should be monitored especially closely
- If you have low blood counts or take other drugs that suppress the bone marrow, discuss added risks with your doctor before starting
Ganciclovir overdose
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Taking too much ganciclovir injection can cause serious, potentially fatal harm. Reported effects of overdose include severe suppression of blood cell production (bone marrow failure), liver damage, kidney injury, stomach and gut symptoms (abdominal pain, vomiting, diarrhea), and seizures. Because ganciclovir can be removed from the blood by dialysis, this may be used to lower drug levels after an overdose; staying well hydrated and using blood-cell growth factors are also part of overdose management.
What Ganciclovir does in the body
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Ganciclovir works by blocking the viral DNA polymerase enzyme that cytomegalovirus (and herpes simplex virus, in the case of Zirgan) needs to copy its DNA. This stops viral replication — described as virustatic activity — meaning it halts the virus from spreading rather than directly killing existing virus particles. The effect is preferentially concentrated in virus-infected cells because the drug's activation depends largely on a viral enzyme.
How your body processes Ganciclovir
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When given intravenously, ganciclovir distributes widely through the body, reaching cerebrospinal fluid (the fluid around the brain and spinal cord) at levels roughly 24–70% of those in the blood. It is not significantly bound to proteins in the blood. The body does not substantially metabolize ganciclovir; instead, about 91% of the drug is excreted unchanged by the kidneys. The half-life — the time it takes for blood levels to fall by half — is about 3.5 hours in people with normal kidney function, but rises significantly when kidney function is reduced. Hemodialysis can reduce ganciclovir blood levels by about 50%.
How to store Ganciclovir
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Store vials at 20° to 25°C (68° to 77°F) . Store reconstituted solution in the vial at 25°C (77°F) for no longer than 12 hours. Do not refrigerate or freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Ganciclovir
17 supplements and herbal products have documented interactions with Ganciclovir in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Ganciclovir: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Ganciclovir — the kind of thing our pharmacy team would talk through with you at the counter.
Why has my doctor prescribed ganciclovir — what exactly does it do?
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What side effects should I actually watch out for?
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Can I take my other medications alongside ganciclovir?
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Is it safe to use if I'm pregnant or planning to become pregnant?
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I have kidney disease — does that affect how I use ganciclovir?
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Will ganciclovir affect my fertility?
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Is Ganciclovir available over the counter?
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When was Ganciclovir first available?
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Who makes Ganciclovir?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Ganciclovir on HelloPharmacist
Ganciclovir forms and strengths (how it comes)
Ganciclovir is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ganciclovir inactive ingredients by manufacturer.
Injection
How this form is used
- Treatment of CMV retinitis in immunocompromised adults, including patients with AIDS
- Prevention of CMV disease in adult transplant recipients at risk for CMV disease
- Given only by slow intravenous infusion over one hour — never by rapid or bolus injection, never into muscle or under the skin
- Infusion site should be in a vein with good blood flow to reduce irritation; a plastic cannula is preferred
- Adequate hydration must be maintained throughout treatment
- Dose must be adjusted for patients with reduced kidney function — creatinine clearance guides dosing
Eye ointment
How this form is used
- Zirgan is used to treat acute herpetic keratitis (dendritic ulcers caused by the herpes simplex virus) in adults and children aged 2 years and older
- Zirgan: apply one drop into the affected eye five times per day (roughly every 3 hours while awake) until the corneal ulcer heals
- Zirgan: after the ulcer heals, continue one drop three times per day for 7 more days
Ganciclovir on the U.S. market: products, makers and brands
How Ganciclovir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
7 companies list 8 Ganciclovir product records with the FDA, mostly as injection, eye ointment; the earliest marketing or approval year on record is 1989. Brand names on the directory include Cytovene Oral, Zirgan; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Ganciclovir is used (Medicaid data)
A general measure of how commonly Ganciclovir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ganciclovir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ganciclovir prescribed? Of the 1,601 medications we measure, Ganciclovir ranks #1,179 by Medicaid prescriptions — more than 26% of them.
Utilization by Ganciclovir product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
ganciclovir 0.0015 MG/MG Ophthalmic Gel Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 388052
ganciclovir 500 MG Injection
Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310442
10 ML ganciclovir 50 MG/ML Injection
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1999531
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ganciclovir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 16 listed Ganciclovir NDCs with Medicaid activity.
Compare Ganciclovir products
A representative set of FDA-listed product records for Ganciclovir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye ointment | ||||
| 1.5 mg/g | Ophthalmic | Bausch & Lomb Incorporated | NDA | View NDC → |
| 💊Injection | ||||
| 500 mg/10 mL | Intravenous | Endo USA, Inc. | ANDA | View NDC → |
| 500 mg/10 mL | Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 500 mg/10 mL | Intravenous | Pharmascience Inc. | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 500 mg/10 mL | Intravenous | Slate Run Pharmaceuticals, LLC × 2 listings | ANDA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Ganciclovir NDCs →
Ganciclovir side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ganciclovir — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ganciclovir in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Ganciclovir FDA approval history
How Ganciclovir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Ganciclovir recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Ganciclovir recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01 Lots: Lot#: BQ0006, Exp 08/2023 FDA record D-0090-2023 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4678 4 dose forms · 7 strengths
-
Dose form (SCDF) Drug Implant RxCUI 604019No current FDA listingClinical drug / strength (SCD) 4.5 MGRxCUI 604020 -
Dose form (SCDF) Injection RxCUI 1732140In current FDA listingsClinical drug / strength (SCD) 10 ML ganciclovir 50 MG/MLRxCUI 1999531250 ML ganciclovir 2 MG/MLRxCUI 1872065500 MGRxCUI 310442 -
Dose form (SCDF) Ophthalmic Gel RxCUI 393324In current FDA listingsClinical drug / strength (SCD) 0.0015 MG/MGRxCUI 388052 -
Dose form (SCDF) Oral Capsule RxCUI 372292No current FDA listingClinical drug / strength (SCD) 250 MGRxCUI 314007500 MGRxCUI 200206
Look up RxCUI 4678 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Ganciclovir supply and shortage status
Whether Ganciclovir is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Ganciclovir costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Gel · Ophthalmic | 1.5 mg/g | $91.24 per gram | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Ganciclovir brand names
Ganciclovir is sold under 2 brand names in the FDA directory — Cytovene Oral, Zirgan. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Ganciclovir: manufacturers and labelers
7 companies list Ganciclovir products with the FDA. By number of product records, the largest are Slate Run Pharmaceuticals, LLC, Bausch & Lomb Incorporated, Endo USA, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Ganciclovir drug class (RxNorm)
Ganciclovir belongs to the Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Ganciclovir page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Exela Pharma Sciences, Llc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →