Valcyte Side Effects
Generic name: valganciclovir
Note: This document contains side effect information about valganciclovir. Some of the dosage forms listed on this page may not apply to the brand name Valcyte.
Some side effects of Valcyte 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 solution, oral tablet
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
- lower back or side pain
- 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
- Changes in facial skin color
- 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
- tightness in the chest or wheezing
- trouble thinking
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
- nausea and vomiting
- numbness, tingling, pain, or weakness of the hands or feet
- tingling, burning, or prickly sensations
- trouble with sleeping
- unsteadiness or awkwardness
For Healthcare Professionals
Applies to valganciclovir: oral powder for reconstitution, oral tablet
After oral administration, valganciclovir (the active ingredient contained in Valcyte) 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 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 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 side effects have included graft rejection in transplant patients (up to 24%).
Ocular side effects have included retinal detachment (15%).
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 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 side effects have included the potential to cause cancers; therefore, valganciclovir (the active ingredient contained in Valcyte) is considered a potential carcinogen in humans. In animal studies, ganciclovir was found to be carcinogenic.
Psychiatric side effects have included psychosis, depression, hallucinations, confusion, and agitation.
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 side effects have included valganciclovir (the active ingredient contained in Valcyte) hypersensitivity.
Cardiovascular side effects have included hypertension (up to 18%) and hypotension.
Hepatic side effects have included abnormal hepatic function.
Metabolic side effects have included hyperkalemia, hypokalemia, hypomagnesemia, hyperglycemia, decreased appetite, dehydration, hypophosphatemia, and hypocalcemia.
Musculoskeletal side effects have included back pain, arthralgia, muscle cramps, and limb pain.
Respiratory side effects have included cough, dyspnea, rhinorrhea, and pleural effusion.
Dermatologic side effects have included dermatitis, pruritus, and acne.
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