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Valcyte Side Effects

Generic Name: valganciclovir

Note: This document contains side effect information about valganciclovir. Some of the dosage forms listed on this page may not apply to the brand name Valcyte.

For the Consumer

Applies to valganciclovir: oral powder for solution, oral tablet

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

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

Very common (10% or more): Diarrhea (up to 41%), nausea (up to 30%), vomiting (up to 21%), oral candidiasis (up to 20%), constipation (up to 20%), abdominal pain (up to 15%), dyspepsia (up to 12%)
Common (1% to 10%): Upper abdominal pain, abdominal distention, ascites, flatulence, dysphagia
Uncommon (0.1% to 1%): Mouth ulceration, pancreatitis

Ganciclovir:
-Frequency not reported: Abdominal distension, ascites, cholangitis, dry mouth, dyspepsia, dysphagia, eructation, esophagitis, fecal incontinence, flatulence, gastritis, gastrointestinal disorder, gastrointestinal hemorrhage, mouth ulceration, pancreatitis, tongue disorder[Ref]

Hematologic

Very common (10% or more): Anemia (up to 31%), neutropenia (including severe; up to 24%), thrombocytopenia (up to 22%), leukopenia (up to 20%)
Common (1% to 10%): Severe anemia, severe thrombocytopenia, severe leukopenia, pancytopenia (including severe)
Uncommon (0.1% to 1%): Bone marrow failure/depression
Rare (less than 0.1%): Aplastic anemia
Frequency not reported: Potentially life-threatening bleeding associated with thrombocytopenia, febrile neutropenia, neutrophil dysplasia with evidence of bone marrow hypoplasia

Ganciclovir:
-Frequency not reported: Eosinophilia, leukocytosis, lymphadenopathy, splenomegaly[Ref]

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

Very common (10% or more): Pyrexia (up to 31%), lower limb edema (up to 21%), fatigue (up to 20%), peripheral edema (up to 18%), postoperative pain (up to 13%), postoperative complications (up to 12%), CMV infection (up to 12%), edema (up to 11%), postoperative wound infection (up to 11%)
Common (1% to 10%): Catheter-related infections, pain, weakness, sepsis (bacteremia, viremia), decreased weight, increased wound drainage, wound dehiscence, CMV syndrome, ear pain, chills, chest pain, malaise, asthenia
Frequency not reported: Local and systemic infections

Ganciclovir:
-Frequency not reported: Asthenia, infections (bacterial, fungal, viral), malaise, mucous membrane disorder, pain, rigors, sepsis, decreased libido, edema, earache[Ref]

Nervous system

Very common (10% or more): Tremors (up to 28%), headache (up to 22%)
Common (1% to 10%): Peripheral neuropathy, paresthesia, dizziness (excluding vertigo), dysgeusia, hypoesthesia, convulsion
Uncommon (0.1% to 1%): Deafness
Frequency not reported: Neurotoxicity

Ganciclovir:
-Frequency not reported: Amnesia, ataxia, coma, hypertonia, myasthenic syndrome, migraine, myoclonic jerks, somnolence, tremor, taste disturbance, deafness, tinnitus[Ref]

Immunologic

Very common (10% or more): Graft/transplant rejection (up to 24%)
Common (1% to 10%): Influenza, postoperative wound infection, pneumonia
Frequency not reported: Cellulitis, sepsis[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 20%)
Common (1% to 10%): Depression, anxiety, confusion, abnormal thinking
Uncommon (0.1% to 1%): Psychotic disorder, hallucinations, agitation

Ganciclovir:
-Frequency not reported: Abnormal thinking, abnormal dreams, anxiety, decreased libido, emotional disturbance, hyperkinetic syndrome, nervousness[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 20%)
Common (1% to 10%): Arthralgia, muscle cramps/spasms, limb pain, myalgia

Ganciclovir:
-Frequency not reported: Musculoskeletal pain, increased blood creatine phosphokinase[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 19%)
Common (1% to 10%): Dysuria, hematuria
Uncommon (0.1% to 1%): Male infertility
Postmarketing reports: Decreased fertility in males

Ganciclovir:
-Frequency not reported: Hematuria present, impotence, urinary frequency[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 18%)
Common (1% to 10%): Hypotension, peripheral edema
Uncommon (0.1% to 1%): Arrhythmia

Ganciclovir:
-Frequency not reported: Arrhythmia (including ventricular arrhythmia), deep thrombophlebitis, hemorrhage, hypertension, hypotension, phlebitis, tachycardia, vasodilatation[Ref]

Dermatologic

Very common (10% or more): Dermatitis (up to 18%)
Common (1% to 10%): Night sweats, pruritus, acne, cellulitis
Uncommon (0.1% to 1%): Alopecia, urticaria, dry skin

Ganciclovir:
-Frequency not reported: Acne, alopecia, exfoliative dermatitis, dry skin, increased sweating, urticaria, photosensitivity reaction[Ref]

Renal

Very common (10% or more): Elevated serum creatinine (up to 50%)
Common (1% to 10%): Renal impairment, decreased CrCl
Uncommon (0.1% to 1%): Renal failure
Frequency not reported: Acute renal failure

Ganciclovir:
-Frequency not reported: Renal failure[Ref]

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

Very common (10% or more): Cough (up to 16%), pharyngitis/nasopharyngitis (up to 12%), dyspnea (up to 11%)
Common (1% to 10%): Productive cough, rhinorrhea, pleural effusion, sinusitis, upper respiratory tract infection, influenza, pneumonia, bronchitis, Pneumocystis carinii pneumonia

Ganciclovir:
-Frequency not reported: Pleural effusion, sinus congestion[Ref]

Ocular

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

Very common (10% or more): Retinal detachment (up to 15%)
Common (1% to 10%): Blurred vision, macular edema, vitreous floaters, eye pain
Uncommon (0.1% to 1%): Visual disturbance, conjunctivitis

Ganciclovir:
-Frequency not reported: Amblyopia, blindness, eye hemorrhage, eye pain, glaucoma, abnormal vision, vitreous disorder[Ref]

Metabolic

Very common (10% or more): Hyperkalemia (up to 14%), hypophosphatemia (up to 12%)
Common (1% to 10%): Anorexia, cachexia, hypokalemia, hypomagnesemia, hyperglycemia, decreased appetite, dehydration, hypocalcemia, increased blood alkaline phosphatase

Ganciclovir:
-Frequency not reported: Increased blood alkaline phosphatase, decreased blood glucose, increased blood lactic dehydrogenase, decreased blood magnesium, diabetes mellitus, hypocalcemia, hypokalemia, hypoproteinemia[Ref]

Hepatic

Common (1% to 10%): Abnormal hepatic function (including severe), increased AST
Uncommon (0.1% to 1%): Increased ALT

Ganciclovir:
-Frequency not reported: Hepatitis, jaundice, abnormal hepatic function[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction
Frequency not reported: Valganciclovir (the active ingredient contained in Valcyte) hypersensitivity
Postmarketing reports: Anaphylaxis[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

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

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. 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

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

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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

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

15. 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

16. 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

17. 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

18. 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

19. 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

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

21. 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

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

23. "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

24. 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

25. 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

26. 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

27. 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

Some side effects of Valcyte may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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