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

Applies to cidofovir: intravenous solution.

Serious side effects of Vistide

Along with its needed effects, cidofovir (the active ingredient contained in Vistide) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Medicines like cidofovir can sometimes cause serious side effects such as blood problems and kidney problems; these are described below. Cidofovir has also been found to cause cancer in animals, and there is a chance it could cause cancer in humans as well. Discuss these possible side effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking cidofovir:

More common

• Fever, chills, or sore throat

Check with your doctor as soon as possible if any of the following side effects occur while taking cidofovir:

More common

• Decreased urination
• increased thirst and urination

Rare

• Decreased vision or any change in vision

Other side effects of Vistide

Some side effects of cidofovir 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

• Diarrhea
• headache
• loss of appetite
• nausea
• vomiting

Less common

• Generalized weakness
• loss of strength

For Healthcare Professionals

Applies to cidofovir: intravenous solution.

General

The most commonly reported adverse events include proteinuria, increased serum creatinine, neutropenia, decreased serum bicarbonate, decreased intraocular pressure, fever, and infection.^[Ref]

Renal

Nephrotoxicity may be irreversible. 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.^[Ref]

Very common (10% or more): Proteinuria (up to 88%), elevated creatinine (up to 24%), nephrotoxicity (up to 59%)

Frequency not reported: Increased BUN^[Ref]

Ocular

Very common (10% or more): Anterior uveitis/iritis (11%); decreased intraocular pressure (24%)

Rare (0.01% to 0.1%): Ocular hypotony

Frequency not reported: Abnormal vision, amblyopia, blindness, cataract, conjunctivitis, corneal lesion, corneal opacity, diplopia, dry eyes, eye pain, iritis, keratitis, refraction disorder, retinal detachment, retinal disorder, uveitis, visual field defect, miosis^[Ref]

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.^[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 23%), decreased serum bicarbonate (16%)

Common (1% to 10%): Fanconi-like syndrome

Frequency not reported: Weight loss, weight gain, thirst, respiratory alkalosis, hyperkalemia, hypophosphatemia, hypokalemia, hypomagnesemia, hyperglycemia, dehydration, hypocalcemia, cachexia, hypercalcemia, hyperlipidemia, hypoglycemia, hypoglycemic reaction, hyponatremia, hypoproteinemia, metabolic acidosis^[Ref]

Genitourinary

Frequency not reported: Glycosuria^[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 43%), anemia (up to 24%)

Frequency not reported: Hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, lymphoma like reaction, pancytopenia, splenic disorder, splenomegaly, thrombocytopenia, thrombocytopenic purpura^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity, allergic reaction^[Ref]

Gastrointestinal

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

Very common (10% or more): Nausea (up to 69%), diarrhea (up to 26%). oral moniliasis (up to 18%)

Common (1% to 10%): Nausea with vomiting

Frequency not reported: Dyspepsia, constipation, abdominal pain, cholangitis, colitis, esophagitis, dysphagia, fecal incontinence, flatulence, gastritis, gastrointestinal hemorrhage, gingivitis, melena, pancreatitis, proctitis, rectal disorder, stomatitis, aphthous stomatitis, tongue discoloration, mouth ulceration, tooth caries, dry mouth^[Ref]

Cardiovascular

Frequency not reported: Cardiomyopathy, cardiovascular disorder, congestive heart failure, hypertension, hypotension, peripheral vascular disorder, phlebitis, postural hypotension, shock, syncope, tachycardia, vascular disorder, edema, chest pain^[Ref]

Dermatologic

Very common (10% or more): Alopecia (up to 27%), rash (up to 30%)

Frequency not reported: Cellulitis, cyst, face edema, photosensitivity reaction, acne, angioedema, dry skin, eczema, exfoliative dermatitis, furunculosis, herpes, simplex nail disorder, pruritus, rash, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin ulcer, sweating, urticaria^[Ref]

Local

Frequency not reported: Blocked catheter, injection site reaction^[Ref]

Endocrine

Frequency not reported: Adrenal cortex insufficiency^[Ref]

Hepatic

Frequency not reported: Hepatitis, hepatomegaly, hepatosplenomegaly, jaundice, abnormal liver function, liver damage, liver necrosis, increased transaminases, increased alkaline phosphatase, increased lactic dehydrogenase^[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, arthrosis, bone necrosis, bone pain, joint disorder, leg cramps, myalgia, myasthenia, pathological fracture, neck pain^[Ref]

Nervous system

Very common (10% or more): Headache (up to 30%)

Frequency not reported: Acute brain syndrome, cerebrovascular disorder, convulsion, delirium, dementia, dizziness, encephalopathy, facial paralysis, hemiplegia, hyperesthesia, hypertonia, hypotony, incoordination, myoclonus, neuropathy, paresthesia, somnolence, tremor, twitching, ataxia, taste perversion, speech disorder, abnormal gait, peripheral neuritis^[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 23%), increased cough (up to 19%)

Frequency not reported: Asthma, bronchitis, epistaxis, hemoptysis, hiccup, hyperventilation, hypoxia, increased sputum, larynx edema, lung disorder, pharyngitis, pneumothorax, rhinitis, sinusitis, hyperventilation^[Ref]

Other

Very common (10% or more): Fever (up to 58%), asthenia (up to 43%), chills (up to 22%)

Frequency not reported: Ear disorder, ear pain, hyperacusis, otitis externa, otitis media, tinnitus, hearing loss, vertigo, malaise^[Ref]

Immunologic

Very common (10% or more): Infection (up to 28%)

Frequency not reported: Sepsis, flu-like syndrome

Psychiatric

Frequency not reported: Abnormal dreams, agitation, amnesia, anxiety, confusion, depression, drug dependence, insomnia, personality disorder