Valganciclovir Side Effects

Brand Names: Valcyte

Please note - some side effects for Valganciclovir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Valganciclovir - for the Consumer

Valganciclovir

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Valganciclovir:

Back pain; constipation; diarrhea; dizziness; drowsiness; headache; nausea; stomach pain; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; confusion; dark urine; decreased coordination; hallucinations; irregular heartbeat; mental or mood changes (eg, depression); muscle weakness; numbness or tingling of the skin, hands, or feet; seizures; severe or persistent headache, dizziness, or drowsiness; swelling of the arms or legs; symptoms of infection (eg, fever, chills, sore throat); tremors, unsteady movements; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Valganciclovir Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Valganciclovir Solution:

Back pain; constipation; cough; diarrhea; dizziness; drowsiness; headache; nausea; stomach pain; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; confusion; dark urine; decreased coordination; hallucinations; irregular heartbeat; mental or mood changes (eg, depression); muscle weakness; numbness or tingling of the skin, hands, or feet; seizures; severe or persistent headache, dizziness, or drowsiness; swelling of the arms or legs; symptoms of infection (eg, fever, chills, sore throat); tremors; unsteady movements; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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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