Valganciclovir Side Effects

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

For the Consumer

Applies to valganciclovir: oral powder for reconstitution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking valganciclovir: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using valganciclovir and call your doctor at once if you have a serious side effect such as:

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

• swelling, weight gain, feeling short of breath; or

• seizure (convulsions).

Less serious side effects of valganciclovir may include:

• dizziness, loss of balance or coordination;

• diarrhea, constipation;

• tremor (shaking); or

• cold symptoms such as stuffy nose, sneezing, sore throat, and cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to valganciclovir: oral powder for reconstitution, oral tablet

General

After oral administration, valganciclovir 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.

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.

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.

Immunologic

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

Ocular

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

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.

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.

Oncologic

Oncologic side effects have included the potential to cause cancers; therefore, valganciclovir is considered a potential carcinogen in humans. In animal studies, ganciclovir was found to be carcinogenic.

Psychiatric

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

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.

Hypersensitivity

Hypersensitivity side effects have included valganciclovir hypersensitivity.

Cardiovascular

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

Hepatic

Hepatic side effects have included abnormal hepatic function.

Metabolic

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

Musculoskeletal

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

Respiratory

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

Dermatologic

Dermatologic side effects have included dermatitis, pruritus, and acne.

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