Valcyte Side Effects

Generic Name: valganciclovir

Note: This page contains side effects data for the generic drug valganciclovir. It is possible that some of the dosage forms included below may not apply to the brand name Valcyte.

It is possible that some side effects of Valcyte may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to valganciclovir: oral powder for solution, oral tablet

As well as its needed effects, valganciclovir (the active ingredient contained in Valcyte) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking valganciclovir, check with your doctor immediately:

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 or wheezing
  • trouble thinking

Some valganciclovir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

After oral administration, valganciclovir (the active ingredient contained in Valcyte) is rapidly converted to ganciclovir. Therefore, side effects that are known to be associated with ganciclovir administration can be expected to occur with the administration of valganciclovir.

The most common side effects reported in at least one indication by greater than or equal to 20% of patients treated with valganciclovir tablets are diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, thrombocytopenia, and vomiting.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 41%), nausea (up to 30%), vomiting (up to 21%), and abdominal pain (up to 15%). Constipation, dyspepsia, abdominal distention, and ascites have been reported.[Ref]

Hematologic

Hematologic side effects have included 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%). Leukopenia, pancytopenia, bone marrow depression, aplastic anemia, and potentially life-threatening bleeding associated with thrombocytopenia have been reported. Neutrophil dysplasia with evidence of bone marrow hypoplasia has also been reported.[Ref]

Immunologic

Immunologic side effects have included graft rejection in transplant patients (up to 24%).[Ref]

Ocular

Ocular side effects have included retinal detachment (15%).[Ref]

Nervous system

Nervous system side effects have included headache (up to 22%), tremors (up to 28%), insomnia (up to 20%), peripheral neuropathy (9%), and paresthesia (up to 8%). Neurotoxicity, dizziness (excluding vertigo), and convulsions have also been reported.[Ref]

Renal

Renal side effects have included elevated serum creatinine (greater than 2.5 mg/dL: up to 17%; greater than 1.5 to 2.5 mg/dL: up to 50%), acute renal failure, renal impairment, dysuria, and decreased creatinine clearance.[Ref]

Oncologic

Oncologic side effects have included the potential to cause cancers; therefore, valganciclovir (the active ingredient contained in Valcyte) is considered a potential carcinogen in humans. In animal studies, ganciclovir was found to be carcinogenic.[Ref]

Psychiatric

Psychiatric side effects have included psychosis, depression, hallucinations, confusion, and agitation.[Ref]

Other

Other side effects have included pyrexia (up to 31%), catheter-related infections (3%), fatigue, pain, edema, peripheral edema, and weakness. Local and systemic infections, sepsis, pharyngitis/nasopharyngitis, upper respiratory tract infection, urinary tract infection, postoperative wound infection, postoperative complications, postoperative pain, increased wound drainage, and wound dehiscence have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects have included valganciclovir (the active ingredient contained in Valcyte) hypersensitivity.[Ref]

Cardiovascular

Cardiovascular side effects have included hypertension (up to 18%) and hypotension.[Ref]

Hepatic

Hepatic side effects have included abnormal hepatic function.[Ref]

Metabolic

Metabolic side effects have included hyperkalemia, hypokalemia, hypomagnesemia, hyperglycemia, decreased appetite, dehydration, hypophosphatemia, and hypocalcemia.[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain, arthralgia, muscle cramps, and limb pain.[Ref]

Respiratory

Respiratory side effects have included cough, dyspnea, rhinorrhea, and pleural effusion.[Ref]

Dermatologic

Dermatologic side effects have included dermatitis, pruritus, and acne.[Ref]

References

1. "Product Information. Valcyte (valganciclovir)" Roche Laboratories, Nutley, NJ.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

21. "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) (2006): 585

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

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

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

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

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