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

Summary

Common side effects of Valcyte include: anemia and neutropenia. Other side effects include: thrombocytopenia. Continue reading for a comprehensive list of adverse effects.

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

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

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

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

Ganciclovir:

-Frequency not reported: Eosinophilia, leukocytosis, lymphadenopathy, splenomegaly^[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

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

Ganciclovir:

-Frequency not reported: Renal failure^[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

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]

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