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Valganciclovir Side Effects

Medically reviewed by Last updated on Jul 4, 2023.

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


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 Valganciclovir

Along with its needed effects, valganciclovir 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

Less common

Other side effects of Valganciclovir

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

Less common

For Healthcare Professionals

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


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]


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]


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]

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]


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%)

Common (1% to 10%): Influenza, postoperative wound infection, pneumonia

Frequency not reported: Cellulitis, sepsis[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, peripheral edema

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]


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): 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]


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]

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

Postmarketing reports: Anaphylaxis[Ref]


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4. Cerner Multum, Inc. Australian Product Information.

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Further information

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.