Vistide Side Effects

Generic name: cidofovir

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

Some side effects of Vistide 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 cidofovir: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking cidofovir (the active ingredient contained in Vistide) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• urinating less than usual or not at all;

• fever, chills, body aches, flu symptoms;

• any change in your vision; or

• increased thirst and urination, loss of appetite, weakness, constipation.

Less serious side effects are more likely to occur, such as:

• nausea, vomiting, diarrhea, loss of appetite;

• white patches or sores inside your mouth or on your lips;

• headache;

• mild skin rash;

• hair loss; or

• cough.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to cidofovir: intravenous solution

General

The major side effect associated with cidofovir (the active ingredient contained in Vistide) therapy is renal toxicity. The most common adverse effects reported in clinical trials were proteinuria (50%), neutropenia (24%), decreased intraocular pressure (24%), decreased serum bicarbonate levels (16%), fever (14%), infection (12%), increased serum creatinine levels >= 2 mg/dL (12%), pneumonia (9%), dyspnea (8%), and nausea/vomiting (7%). The drug was discontinued in 39% of patients because of various adverse effects.

Renal

Renal side effects have included nephrotoxicity. It may be irreversible and is the major side effect associated with cidofovir (the active ingredient contained in Vistide) therapy. Renal impairment, including cases of acute renal failure resulting in dialysis and/or contributing to death, has occurred with as few as one or two doses of the drug. Proteinuria (greater than 2+), reduced creatinine clearance (less than or equal to 55 mL/min), and/or elevations of serum creatinine concentration (greater than 0.4 mg/dL) occurred in about 59% of patients receiving a maintenance dose of 5 mg/kg every other week. Toxic nephropathy has also been reported.

Adequate hydration and concomitant administration of probenecid is essential to lessen the risk of renal toxicity associated with cidofovir. Proteinuria, as measured by urinalysis, may be an early indicator of cidofovir-associated nephrotoxicity. Serum creatinine concentrations and routine urinalysis should be monitored prior to each dose of cidofovir. In patients with proteinuria, intravenous hydration should be administered and the urinalysis repeated. Patients who have had previous therapy with foscarnet may be at increased risk of renal toxicity and should be monitored closely.

Ocular

The risk of ocular hypotony may be increased in patients with diabetes mellitus.

Uveitis or iritis was reported in 15 (11%) of 135 patients who were administered the 5 mg/kg maintenance dose. Patients should be monitored for signs and symptoms of these complications and if they develop, treatment with topical corticosteroids with or without topical cycloplegic agents may be useful.

Ocular side effects have included decreases intraocular pressure by more than 50% from baseline in 24% of patients in clinical trials; severe ocular hypotony (IOP less than 0.1 mmHg) occurred in 4%. Abnormal vision, amblyopia, blindness, cataract, conjunctivitis, corneal lesion, corneal opacity, diplopia, dry eyes, eye disorder, eye pain, iritis, keratitis, miosis, retinal detachment, retinal disorder, uveitis, and visual field defect have also been reported.

Metabolic

Metabolic side effects including a decreased serum bicarbonate level to less than or equal to 16 mEq/L (16%) and multiple abnormalities of proximal renal tubular function or Fanconi's syndrome (1%) have occurred. Cases of metabolic acidosis, in association with liver dysfunction and pancreatitis, which resulted in death have also been reported. Cachexia, dehydration, edema, hypercalcemia, hyperglycemia, hyperkalemia, hyperlipemia, hypocalcemia, hypoglycemia, hypoglycemic reaction, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, hypoproteinemia, increased alkaline phosphatase, increased BUN, increased lactic dehydrogenase, increased SGOT, increased SGPT, peripheral edema, respiratory alkalosis, thirst, weight loss, and weight gain have also been observed in clinical trials. However, it could not be definitively determined from these trials that cidofovir (the active ingredient contained in Vistide) was the causative agent.

Genitourinary

Genitourinary side effects have included dysuria, glycosuria, hematuria, kidney stone, mastitis, metrorrhagia, nocturia, polyuria, prostatic disorder, urethritis, urinary casts, urinary incontinence, urinary retention, and urinary tract infection, although a causal relationship to cidofovir (the active ingredient contained in Vistide) was difficult to determine.

Hematologic

Hematologic side effects have included neutropenia, anemia, and thrombocytopenia. Hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, lymphoma-like reaction, pancytopenia, splenic disorder, splenomegaly, thrombocytopenia, and thrombocytopenic purpura have also been reported but a causal relationship to cidofovir (the active ingredient contained in Vistide) was difficult to determine.

Neutropenia (less than 500 cells/mm3) occurred in 24% of patients receiving cidofovir for CMV retinitis in clinical trials. Granulocyte colony-stimulating factor was used in 39% of patients to manage neutropenia due to cidofovir.

Hypersensitivity

Hypersensitivity or allergic reactions may include rash, fever, chills, and anaphylaxis. Patients receiving concomitant probenecid and cidofovir (the active ingredient contained in Vistide) may experience hypersensitivity reactions caused by probenecid. Cidofovir and probenecid therapy should be discontinued in patients who experience severe systemic reactions.

Two patients developed erythroderma associated with concomitant administration of cidofovir and probenecid. Prophylactic or therapeutic use of antihistamines and/or acetaminophen may alleviate hypersensitivity reactions associated with the use of probenecid.

Gastrointestinal

Administration of probenecid after a meal and/or therapy with antiemetics may alleviate the nausea and vomiting associated with probenecid.

Gastrointestinal side effects such as nausea and/or vomiting have occurred in 69% of patients receiving concomitant probenecid and cidofovir for CMV retinitis. Diarrhea (26%), anorexia (23%), and abdominal pain (17%) also have been reported. Cholangitis, colitis, constipation, dysphagia, dyspepsia, esophagitis, fecal incontinence, flatulence, gastritis, gastrointestinal hemorrhage, gingivitis, melena, pancreatitis, proctitis, rectal disorder, stomatitis, aphthous stomatitis, tongue discoloration, mouth ulceration, and tooth caries have also been reported; however, a causal relationship to cidofovir was difficult to determine.

Cardiovascular

Cardiovascular side effects such as cardiomyopathy, cardiovascular disorder, congestive heart failure, hypertension, hypotension, migraine, pallor, peripheral vascular disorder, postural hypotension, shock, syncope, tachycardia, vascular disorder, and edema have been reported from clinical trials. It was difficult, however, to prove a causal relationship to cidofovir (the active ingredient contained in Vistide) because many of the studied patients had very advanced disease and were administered numerous concomitant medications.

Dermatologic

Dermatological side effects which included rash (30%) and alopecia (27%) were observed in clinical trials that included the use of probenecid. Acne, angioedema, dry skin, eczema, exfoliative dermatitis, furunculosis, herpes simplex, nail disorder, pruritus, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin ulcer, sweating, and urticaria have also been reported in clinical trials. It is important to note that these trials included patients with very advanced disease who were also taking numerous concomitant medications, therefore, a causal relationship to cidofovir (the active ingredient contained in Vistide) was difficult to determine.

Local

Phlebitis has been reported with the use of intravenous cidofovir (the active ingredient contained in Vistide)

Endocrine

Endocrine adverse effects are not common. Adrenal cortex insufficiency has been reported, although, a direct causal relationship to cidofovir (the active ingredient contained in Vistide) was not determined.

Hepatic

Hepatic adverse effects are not common. Hepatitis, hepatomegaly, hepatosplenomegaly, jaundice, abnormal liver function, liver damage, and liver necrosis were reported in clinical trials although a causal relationship to cidofovir (the active ingredient contained in Vistide) was difficult to determine due to the fact that most of the patients received many concomitant medications and due to the broad manifestations of the underlying disease.

Musculoskeletal

Musculoskeletal side effects which have been reported in clinical trials regardless of the relationship to cidofovir (the active ingredient contained in Vistide) or probenecid include arthralgia, asthenia, arthrosis, bone necrosis, bone pain, joint disorder, leg cramps, myalgia, myasthenia, back pain, neck pain, and pathological fracture.

Nervous system

Nervous system side effects have included abnormal dreams, abnormal gait, acute brain syndrome, agitation, amnesia, anxiety, ataxia, cerebrovascular disorder, confusion, convulsion, delirium, dementia, depression, dizziness, drug dependence, dry mouth, encephalopathy, facial paralysis, hallucinations, headache, hemiplegia, hyperesthesia, hypertonia, hypotony, incoordination, increased libido, insomnia, myoclonus, nervousness, neuropathy, paresthesia, personality disorder, somnolence, speech disorder, tremor, twitching, vasodilatation, and vertigo. A definitive causal relationship to cidofovir (the active ingredient contained in Vistide) was difficult to make, however, from these trials.

Oncologic

Oncologic side effects have not been observed in humans. In a 26-week animal study, however, cidofovir (the active ingredient contained in Vistide) was found to be carcinogenic in rats.

Respiratory

Respiratory side effects such as asthma, bronchitis, dyspnea, epistaxis, hemoptysis, hiccup, hyperventilation, hypoxia, increased sputum, larynx edema, lung disorder, pharyngitis, pneumonia, pneumothorax, rhinitis, sinusitis, and increased cough have been reported in clinical trials, however, a causal relationship to cidofovir (the active ingredient contained in Vistide) was difficult to determine.

Other

Other side effects reported in clinical trials regardless of the relationship to cidofovir (the active ingredient contained in Vistide) or probenecid were flu-like syndrome, hypothermia, malaise, mucous membrane disorder, photosensitivity reaction, sarcoma, infection, sepsis, oral moniliasis, taste perversion, ear disorder, ear pain, hyperacusis, otitis externa, otitis media, tinnitus, and hearing loss.

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