Prescription medicine
Ganciclovir Brand names: Zirgan; first approved as Cytovene
Ganciclovir (Cytovene) is a prescription medicine with an FDA approval on record since 1989. A generic is approved and listed by 6 labelers, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $91.24 per gram (Zirgan 0.15% ophthalmic gel).
- Generic approved
- Boxed warning
Check it at the source: the ganciclovir FDA label on DailyMed (effective January 9, 2026, Fresenius Kabi USA, LLC); the NDA 19661 record on Drugs@FDA; every ganciclovir label on DailyMed.
Highlights of the record
FDA label of January 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS •.
Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with Ganciclovir for Injection [see Warnings and Precautions ( 5.1 )].
Impairment of Fertility: Based on animal data and limited human data, Ganciclovir for Injection may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions ( 5.3 )].
Fetal Toxicity: Based on animal data, Ganciclovir for Injection has the potential to cause birth defects in humans [see Warnings and Precautions ( 5.4 )].
Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir for Injection has the potential to cause cancers in humans [see Warnings and Precautions ( 5.5 )]. WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning.
Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with Ganciclovir for Injection. ( 5.1 )
Impairment of Fertility: Based on animal data and limited human data, Ganciclovir for Injection may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. […]
Used for
From the label: indications and usageGanciclovir for Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the:
treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS).
Forms and strengths
- 1.5 mg/g
- 50 mg/ml
- 500 mg/10ml
Injection (powder) (lyophilized) for solution; injection (solution); gel.
On the market
- Earliest approval on file
- June 23, 1989 Cytovene, Cheplapharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first July 16, 2003; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 6 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 2, 2034 Ganzyk-Rtu injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $91.24 per gram Zirgan 0.15% ophthalmic gel
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2014 0 Class I among all firms' recalls; latest December 27, 2022; 2 more by firms not listed as its makers
- FAERS reports
- 10,882 through July 30, 2026
What is ganciclovir used for?
From the label: indications and usageGanciclovir for Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the:
treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). ( 1.1 )
prevention of CMV disease in adult transplant recipients at risk for CMV disease. […]
FDA pharmacologic class: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor and Nucleoside Analog Antiviral.
Source: FDA drug label (Ganciclovir), Fresenius Kabi USA, LLC, effective January 9, 2026 (SPL set 35addab5-09db-4f8a-9c69-6fbce33ecc37), via openFDA; the full label on DailyMed
Is there a generic for ganciclovir (Cytovene)?
The FDA approved the first generic ganciclovir on July 16, 2003. 8 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ganciclovir from 6 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
The Orange Book lists no patent for Cytovene injection; a patent listed only for Ganzyk-Rtu injection runs to September 2, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1989 earliest approval on file
- 2003 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ganciclovir (Cytovene)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $91.24 per gram (Zirgan 0.15% ophthalmic gel), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Zirgan 0.15% ophthalmic gel (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Zirgan 0.15% ophthalmic gel | Brand | $91.24 per gram | n/a | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ganciclovir been recalled?
The FDA's Enforcement Report lists 4 recalls naming ganciclovir since 2014: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of ganciclovir and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 27, 2022 | Class II | Sentara Infusion Services | Lack of sterility assurance |
| December 16, 2022 | Class II | Hikma Pharmaceuticals USA Inc. | Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg. |
| May 28, 2015 | Class II | Lincare, Inc. not a listed maker | Lack of Assurance of Sterility: Sterility of product is not assured. |
| October 6, 2014 | Class II | Oregon Compounding Centers, Inc. dba Creative Compounds not a listed maker | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ganciclovir label say about other medicines?
The ganciclovir label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 25 other medicines name ganciclovir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amphotericin b | drug interactions | Name of the Concomitant Drug: Cyclosporine or amphotericin B; Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; Clinical Comment: Monitor renal function when Ganciclovir is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see Warnings and … |
| Cyclosporine | drug interactions | Name of the Concomitant Drug: Cyclosporine or amphotericin B; Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; Clinical Comment: Monitor renal function when Ganciclovir is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see Warnings and … |
| Dapsone | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine and zidovudine); Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; … |
| Doxorubicin | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine and zidovudine); Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; … |
| Flucytosine | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine and zidovudine); Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; … |
| Hydroxyurea | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine and zidovudine); Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; … |
| Mycophenolate mofetil | drug interactions | Name of the Concomitant Drug: Mycophenolate mofetil (MMF); Change in the Concentration of Ganciclovir or Concomitant Drug: ↔ Ganciclovir (in patients with normal renal function) ↔ MMF (in patients with normal renal function); … |
| Probenecid | drug interactions | Name of the Concomitant Drug: Probenecid; Change in the Concentration of Ganciclovir or Concomitant Drug: ↑Ganciclovir; Clinical Comment: Ganciclovir for Injection dose may need to be reduced. Monitor for evidence of ganciclovir toxicity. |
| Sulfamethoxazole and trimethoprim | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Tacrolimus | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine and zidovudine); Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; … |
| Valganciclovir | contraindications | CONTRAINDICATIONS Ganciclovir for Injection is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation. Hypersensitivity to ganciclovir or valganciclovir. |
| Vinblastine | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine and zidovudine); Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; … |
| Vincristine | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine and zidovudine); Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; … |
| Zidovudine | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/sulfamethoxazole, vinblastine, vincristine and zidovudine); Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; … |
Other labels that name ganciclovir
Source: FDA drug label (Ganciclovir), Fresenius Kabi USA, LLC, effective January 9, 2026 (SPL set 35addab5-09db-4f8a-9c69-6fbce33ecc37), via openFDA; the full label on DailyMed
What do FAERS reports show for ganciclovir?
The FDA Adverse Event Reporting System holds 10,882 reports that list ganciclovir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,390 are coded as a death and 4,437 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cytomegalovirus nucleoside analog dna polymerase inhibitors
- the pharmacologic class, with prices and generics
- Ganciclovir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other