Valcyte Side Effects

Generic Name: valganciclovir

Please note - some side effects for Valcyte may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Valcyte - for the Consumer

Valcyte

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 Valcyte:

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); chills; confusion; cough; decreased urination; depression; fever; hallucinations; loss of coordination; numbness or tingling of the skin, hands, or feet; seizures; sore throat; swelling of the legs; tremors; unsteady movements; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

Side Effects by Body System

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.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (41%), nausea (30%), vomiting (21%), and abdominal pain (15%). Constipation, dyspepsia, abdominal distention, and ascites have also been reported.

Hematologic

Hematologic side effects have included neutropenia (27%), anemia (26%) and thrombocytopenia (6%). Potentially life-threatening bleeding, leukopenia, pancytopenia, and aplastic anemia 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 (24%) and bone marrow depression.

Ocular

Ocular side effects such as retinal detachment (15%) have occurred.

Nervous system

Nervous system side effects such as insomnia (16%), peripheral neuropathy (9%), and paresthesia (8%) have been reported. Neurotoxicity, tremors, dizziness, and convulsions have also been reported.

Renal

Renal side effects have included serum creatinine elevations to greater than 1.5 mg/dL (15%), renal impairment, dysuria, and decreased creatinine clearance.

Oncologic

In animal studies, ganciclovir was found to be carcinogenic. Because valganciclovir could potentially cause cancers, it is considered a potential carcinogen in humans.

Psychiatric

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

Other

Pyrexia (31%), headache (22%), fatigue, pain, edema, peripheral edema, and weakness have been reported with the use of valganciclovir.

Other

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 in transplant patients.

Hypersensitivity

Valganciclovir hypersensitivity has been reported by the manufacturer.

Cardiovascular

Cardiovascular side effects have included hypertension (18%) and hypotension in organ transplant patients.

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 in transplant patients.

Musculoskeletal

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

Respiratory

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

Dermatologic

Dermatologic side effects have included dermatitis, pruritus, and acne in transplant patients.

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