Prescription medicine
Valganciclovir Brand names: Valcyte
Valganciclovir (Valcyte) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $1.91 per valganciclovir 450 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the valganciclovir FDA label on DailyMed (effective December 8, 2025, H2-Pharma, LLC); the NDA 21304 record on Drugs@FDA; every valganciclovir label on DailyMed.
Highlights of the record
FDA label of December 8, 2025; 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: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with VALCYTE [see Warnings and Precautions (5.1) ]. Impairment of Fertility: Based on animal data and limited human data, VALCYTE 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, VALCYTE has the potential to cause birth defects in humans [see Warnings and Precautions (5.4) ]. Mutagenesis and Carcinogenesis: Based on animal data, VALCYTE 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: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with VALCYTE. ( 5.1 ) Impairment of Fertility: Based on animal data and limited human data, VALCYTE may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. […]
Used for
From the label: indications and usageVALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Forms and strengths
- 450 mg
- 50 mg/ml
Powder for solution; film-coated tablet; for solution; tablet.
On the market
- Earliest approval on file
- March 29, 2001 Valcyte, Cheplapharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first November 4, 2014; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 19 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 11, 2027 Valcyte for solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.91 per tablet Valganciclovir 450 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2018 0 Class I among all firms' recalls; latest November 4, 2019
- FAERS reports
- 18,742 through July 30, 2026
What is valganciclovir used for?
From the label: indications and usageVALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients ( 1.2 ) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: VALCYTE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1) ]. […]
FDA pharmacologic class: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor and Nucleoside Analog Antiviral.
Source: FDA drug label (Valcyte), NDA021304 (Cheplapharm), as published by H2-Pharma, LLC, effective December 8, 2025 (SPL set 4c517a39-2ded-4c5a-8d56-276853414b31), via openFDA; the full label on DailyMed
What does the patient leaflet for valganciclovir say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VALCYTE?VALCYTE can cause serious side effects, including: Blood and bone marrow problems. VALCYTE can affect the bone marrow lowering the amount of your white blood cells, red blood cells, and platelets and may cause serious and life-threatening problems. Kidney failure. Kidney failure may happen in people who are elderly, people who take VALCYTE with certain other medicines, or people who are not adequately hydrated. Fertility problems. VALCYTE may lower sperm count in males and cause fertility problems. VALCYTE may also cause fertility problems in women. Talk to your healthcare provider if this is a concern for you. Birth defects. VALCYTE causes birth defects in animals. It is not known if VALCYTE causes birth defects in people. If you are a female who can become pregnant, you should use effective birth control during treatment with VALCYTE and for at least 30 days after treatment. If you are pregnant, talk to your healthcare provider before starting treatment with VALCYTE. If you are a female who can become pregnant, you should have a pregnancy test done before starting VALCYTE. Tell your healthcare provider right away if you become pregnant during treatment with VALCYTE. Males should use condoms during treatment with VALCYTE, and for at least 90 days after treatment, if their female sexual partner can become pregnant. Talk to your healthcare provider if you have questions about birth control. Cancer. VALCYTE causes cancer in animals and may potentially cause cancer in people. Your healthcare provider will do regular blood tests during treatment with VALCYTE to check you for side effects. Your healthcare provider may change your dose or stop treatment with VALCYTE if you have serious side effects.
From the patient leaflet: What should I avoid during treatment with VALCYTE?VALCYTE can cause seizures, dizziness, and confusion. You should not drive a car or operate machinery until you know how VALCYTE affects you.
From the patient leaflet: How should I store VALCYTE?Store VALCYTE tablets at room temperature between 68°F to 77°F (20°C to 25°C). Store VALCYTE for oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C), for no longer than 49 days. Do not freeze. Do not keep VALCYTE that is out of date or that you no longer need. Keep VALCYTE and all medicines out of the reach of children.
Source: FDA drug label (Valcyte), NDA021304 (Cheplapharm), as published by H2-Pharma, LLC, effective December 8, 2025 (SPL set 4c517a39-2ded-4c5a-8d56-276853414b31), via openFDA; the full label on DailyMed
Is there a generic for valganciclovir (Valcyte)?
The FDA approved the first generic valganciclovir on November 4, 2014. 18 generic applications are approved; 16 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 valganciclovir from 19 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.
The Orange Book lists 2 patents for Valcyte for solution, the last expiring on December 11, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2001 earliest approval on file
- 2014 first generic approved
- 2027 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 valganciclovir (Valcyte)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.91 per Valganciclovir 450 mg tablet, down 23% from $2.48 on October 8, 2025. 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.
- Valganciclovir 450 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Valganciclovir 450 mg tablet | Generic | $1.91 per tablet | $57.45 | -23% |
| Valganciclovir HCl 50 mg/mL | Generic | $1.01 per mL | n/a | -20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has valganciclovir been recalled?
The FDA's Enforcement Report lists 2 recalls naming valganciclovir since 2018: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 4, 2019 | Class II | Teva Pharmaceuticals USA, Inc. | Presence of foreign substance: Brown/black particles found during stability testing. |
| February 13, 2018 | Class II | Hetero Labs Limited Unit V | Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the valganciclovir label say about other medicines?
The valganciclovir label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 18 other medicines name valganciclovir. 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 VALCYTE is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see ]. |
| 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 VALCYTE is coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine [see ]. |
| Dapsone | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine); … |
| Doxorubicin | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine); … |
| Flucytosine | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine); … |
| Ganciclovir | contraindications | CONTRAINDICATIONS VALCYTE is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see Adverse Reactions (6.1) ]. Hypersensitivity to valganciclovir or ganciclovir. |
| Hydroxyurea | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine); … |
| 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: VALCYTE 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., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine); … |
| Trimethoprim | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine); … |
| Vinblastine | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine); … |
| Vincristine | drug interactions | Name of the Concomitant Drug: Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine); … |
Every other medicine the valganciclovir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Zidovudine | drug interactions | … tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine); Change in the Concentration of Ganciclovir or Concomitant Drug: Unknown; … |
Other labels that name valganciclovir
Source: FDA drug label (Valcyte), NDA021304 (Cheplapharm), as published by H2-Pharma, LLC, effective December 8, 2025 (SPL set 4c517a39-2ded-4c5a-8d56-276853414b31), via openFDA; the full label on DailyMed
What do FAERS reports show for valganciclovir?
The FDA Adverse Event Reporting System holds 18,742 reports that list valganciclovir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,234 are coded as a death and 9,212 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?
- Alternatives to valganciclovir
- medicines labeled for the same conditions
- Other cytomegalovirus nucleoside analog dna polymerase inhibitors
- the pharmacologic class, with prices and generics
- Valganciclovir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other