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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.

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.

Major Side Effects

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
  • trouble thinking

Minor Side Effects

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


After oral administration, this drug is rapidly converted to ganciclovir. Therefore, side effects that are known to be associated with ganciclovir administration can be expected to occur with this drug. The most common side effects reported with this drug were diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, thrombocytopenia, and vomiting.[Ref]


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

-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]


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

-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.[Ref]


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

-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

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


Very common (10% or more): Graft/transplant rejection (up to 24%)[Ref]


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

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


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

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


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

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


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

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


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

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


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

-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]


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

-Frequency not reported: Pleural effusion, sinus congestion[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

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


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

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


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

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


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


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11. 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

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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

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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

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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.

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