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Valcyte Side Effects

Generic name: valganciclovir

Medically reviewed by Drugs.com. Last updated on May 10, 2024.

Note: This document provides detailed information about Valcyte Side Effects associated with valganciclovir. Some dosage forms listed on this page may not apply specifically to the brand name Valcyte.

Applies to valganciclovir: oral powder for solution, oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet; powder for solution)

Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir hydrochloride.

Based on animal and limited human data, valganciclovir hydrochloride may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.

Based on animal data, valganciclovir hydrochloride has the potential to cause birth defects in humans.

Based on animal data, valganciclovir hydrochloride has the potential to cause cancers in humans.

Serious side effects of Valcyte

Along with its needed effects, valganciclovir (the active ingredient contained in Valcyte) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking valganciclovir:

More common

  • black, tarry stools
  • blood in the urine or stools
  • blurred vision
  • chills
  • cough
  • dizziness
  • fever
  • headache
  • hoarseness
  • lower back or side pain
  • nervousness
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • seeing flashes or sparks of light
  • seeing floating spots before the eyes
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • slow or fast heartbeat
  • sore throat
  • trembling or shaking of the hands or feet
  • troubled breathing
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • veil or curtain appearing across part of vision

Less common

  • changes in facial skin color
  • confusion
  • false beliefs
  • fast or irregular breathing
  • feeling, hearing, or seeing things that are not there
  • hives, itching, and skin rash
  • large, hive-like swellings on the eyelids, face, lips, mouth, or tongue
  • puffiness or swelling of the eyelids or around the eyes
  • runny or stuffy nose
  • seizures
  • tightness in the chest
  • trouble thinking

Other side effects of Valcyte

Some side effects of valganciclovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • abdominal or stomach pain
  • diarrhea
  • headache
  • nausea and vomiting
  • numbness, tingling, pain, or weakness of the hands or feet
  • sleeplessness
  • tingling, burning, or prickly sensations
  • trouble with sleeping
  • unsteadiness or awkwardness

Less common

  • agitation

For healthcare professionals

Applies to valganciclovir: oral powder for reconstitution, oral tablet.

General

The most common adverse events in adults include diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting. The most common adverse events in pediatric patients include diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.[Ref]

Gastrointestinal

Ganciclovir:

Hematologic

Ganciclovir:

Neutropenia (absolute neutrophil count [ANC] less than 500/mcL: up to 19%; ANC 500 to less than 750/mcL: up to 17%; ANC 750 to less than 1000/mcL: up to 17%), anemia (hemoglobin [Hgb] less than 8 g/dL: up to 8%; Hgb less than 6.5 g/dL: up to 7%; Hgb 6.5 to less than 8 g/dL: up to 13%; Hgb 8 to less than 9.5 g/dL: up to 31%), and thrombocytopenia (less than 25,000 platelets/mcL: up to 4%; 25,000 to less than 50,000 platelets/mcL: up to 6%; 50,000 to less than 100,000 platelets/mcL: up to 22%) have been reported.

Severe neutropenia is more often seen in AIDS patients with CMV retinitis than in solid organ transplant patients.

Neutropenia has also been reported with a slightly higher incidence in 2 pediatric studies compared to adults, although neutropenia and infectious events were generally not correlated in the pediatric population.[Ref]

Other

Ganciclovir:

Nervous system

Ganciclovir:

Immunologic

Psychiatric

Ganciclovir:

Musculoskeletal

Ganciclovir:

Genitourinary

Ganciclovir:

Cardiovascular

Ganciclovir:

Dermatologic

Ganciclovir:

Renal

Ganciclovir:

Elevated serum creatinine (greater than 2.5 mg/dL: up to 17%; greater than 1.5 to 2.5 mg/dL: up to 50%) has been reported.[Ref]

Respiratory

Ganciclovir:

Ocular

Ganciclovir:

Retinal detachment has only been reported in AIDS patients treated with this drug for CMV retinitis.[Ref]

Metabolic

Ganciclovir:

Hepatic

Ganciclovir:

Hypersensitivity

References

1. (2001) "Product Information. Valcyte (valganciclovir)." Roche Laboratories

2. (2001) "Oral prodrug of ganciclovir for CMV retinitis." Am J Health Syst Pharm, 58, p. 946-8

3. Cerner Multum, Inc. "UK Summary of Product Characteristics."

4. Cerner Multum, Inc. "Australian Product Information."

5. Curran M, Noble S (2001) "Valganciclovir." Drugs, 61, p. 1145-50

6. Segarra-Newnham M, Salazar MI (2002) "Valganciclovir: A new oral alternative for cytomegalovirus retinitis in human immunodeficiency virus-seropositive individuals." Pharmacotherapy, 22, p. 1124-8

7. Babel N, Gabdrakhmanova L, Juergensen JS, et al. (2004) "Treatment of cytomegalovirus disease with valganciclovir in renal transplant recipients: a single center experience." Transplantation, 78, p. 283-5

8. Wang TJ, Lin CP, Yang CM, Lin LL (2004) "Valgancyclovir as maintenance therapy for cytomegalovirus retinitis in a lung transplant patient-a case report." Transplant Proc, 36, p. 2826-9

9. Gabardi S, Magee CC, Baroletti SA, Powelson JA, Cina JL, Chandraker AK (2004) "Efficacy and safety of low-dose valganciclovir for prevention of cytomegalovirus disease in renal transplant recipients: a single-center, retrospective analysis." Pharmacotherapy, 24, p. 1323-30

10. Cvetkovic RS, Wellington K (2005) "Valganciclovir: a review of its use in the management of CMV infection and disease in immunocompromised patients." Drugs, 65, p. 859-78

11. Ayala E, Greene J, Sandin R, et al. (2006) "Valganciclovir is safe and effective as pre-emptive therapy for CMV infection in allogeneic hematopoietic stem cell transplantation." Bone Marrow Transplant, 37, p. 851-6

12. Diaz-Pedroche C, Lumbreras C, San Juan R, et al. (2006) "Valganciclovir Preemptive Therapy for the Prevention of Cytomegalovirus Disease in High-Risk Seropositive Solid-Organ Transplant Recipients." Transplantation, 82, p. 30-35

13. Czock D, Scholle C, Rasche FM, Schaarschmidt D, Keller F (2002) "Pharmacokinetics of valganciclovir and ganciclovir in renal impairment." Clin Pharmacol Ther, 72, p. 142-150

14. Keven K, Basu A, Tan HP, et al. (2004) "Cytomegalovirus prophylaxis using oral ganciclovir or valganciclovir in kidney and pancreas-kidney transplantation under antibody preconditioning." Transplant Proc, 36, p. 3107-12

15. Fellay J, Venetz JP, Aubert JD, Seydoux C, Pascual M, Meylan PR (2005) "Treatment of cytomegalovirus infection or disease in solid organ transplant recipients with valganciclovir." Transplant Proc, 37, p. 949-51

16. Wiltshire H, Paya CV, Pescovitz MD, et al. (2005) "Pharmacodynamics of Oral Ganciclovir and Valganciclovir in Solid Organ Transplant Recipients." Transplantation, 79, p. 1477-1483

17. Taegtmeyer AB, Halil O, Bell AD, Carby M, Cummins D, Banner NR (2005) "Neutrophil dysplasia (acquired pseudo-pelger anomaly) caused by ganciclovir." Transplantation, 80, p. 127-30

18. Humar A, Siegal D, Moussa G, Kumar D (2005) "A prospective assessment of valganciclovir for the treatment of cytomegalovirus infection and disease in transplant recipients." J Infect Dis, 192, p. 1154-7

19. (2006) "Agranulocytosis in kidney transplant recipients receiving tacrolimus, mycophenolate mofetil and valganciclovir." Transplantation, 82(1 Suppl 2), p. 952

20. (2006) "Efficacy and safety of CMV prophylaxis with valganciclovir 900 mg/day for 100 days versus 450 mg/day for 6 months post-renal transplantation." Transplantation, 82(1 Suppl 2), p. 585

21. (2006) "Pharmacokinetics of low and maintenance dose valganciclovir in kidney transplant recipients." Transplantation, 82(1 Suppl 2), p. 266-7

22. Cochrane AB (2006) "Antiviral dosing and efficacy for prophylaxis of cytomegalovirus disease in solid organ transplant recipients." Am J Health Syst Pharm, 63(19 Suppl 5), S17-21

23. Said T, Nampoory MR, Pacsa AS, et al. (2007) "Oral valgancyclovir versus intravenous gancyclovir for cytomegalovirus prophylaxis in kidney transplant recipients." Transplant Proc, 39, p. 997-9

24. Dupuis R, Harris M, Gillis K, et al. (2007) "Experience with low-dose valganciclovir prophylaxis in adult liver transplant recipients." Transplant Proc, 39, p. 3266-70

25. Brum S, Nolasco F, Sousa J, et al. (2008) "Leukopenia in kidney transplant patients with the association of valganciclovir and mycophenolate mofetil." Transplant Proc, 40, p. 752-4

26. Molina Perez E, Fernandez Castroagudin J, Seijo Rios S, et al. (2009) "Valganciclovir-induced leukopenia in liver transplant recipients: influence of concomitant use of mycophenolate mofetil." Transplant Proc, 41, p. 1047-9

27. Pescovitz MD, Jain A, Robson R, Mulgaonkar S, Freeman R, Bouw MR (2007) "Establishing pharmacokinetic bioequivalence of valganciclovir oral solution versus the tablet formulation." Transplant Proc, 39, p. 3111-6

Further information

Valcyte side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.