Vfend Side Effects

Generic name: voriconazole

Medically reviewed by Drugs.com. Last updated on Jan 21, 2024.

Note: This document provides detailed information about Vfend Side Effects associated with voriconazole. Some dosage forms listed on this page may not apply specifically to the brand name Vfend.

Applies to voriconazole: oral powder for suspension, oral tablet.

Other dosage forms:

• intravenous powder for solution

Serious side effects of Vfend

Along with its needed effects, voriconazole (the active ingredient contained in Vfend) 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 voriconazole:

More common

• black, tarry stools
• blistering, peeling, loosening of the skin
• chest pain
• chills
• cough
• diarrhea
• difficulty seeing at night
• fever
• increased sensitivity of the eyes to sunlight
• itching, rash
• joint or muscle pain
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision changes

Less common

• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• chapped, red, or swollen lips
• chills
• clay-colored stools
• confusion
• dark urine
• decreased urine
• dizziness
• dry mouth
• faintness or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of warmth
• increased thirst
• irregular or pounding heartbeat
• loss of appetite
• muscle pain or cramps
• muscle spasms or twitching
• nausea
• nervousness
• numbness or tingling in the hands, feet, or lips
• pounding in the ears
• rapid weight gain
• rash with flat lesions or small raised lesions on the skin
• redness of the face, neck, arms, and occasionally, the upper chest
• scaling, redness, burning, pain, or other signs of inflammation of the lips
• seizures
• stomach pain
• slow or fast heartbeat
• sweating
• trembling
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Rare

• agitation
• blistering, peeling, or loosening of the skin
• hostility or anger
• increased sensitivity of the skin to sunlight
• irritability
• redness or other discoloration of the skin
• seeing things that are not there
• severe sunburn

Incidence not known

• backache
• blindness
• blue-yellow color blindness
• bone pain
• darkening of the skin
• decreased vision
• diarrhea
• facial hair growth in females
• fainting
• fractures
• full or round face, neck, or trunk
• increased urination
• irritability
• loss of sexual desire or ability
• menstrual irregularities
• mental depression
• muscle wasting
• vomiting

Other side effects of Vfend

Some side effects of voriconazole 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:

Less common

• headache

For healthcare professionals

Applies to voriconazole: intravenous powder for injection, oral powder for reconstitution, oral tablet.

General

The most frequently reported adverse reactions in clinical trials were visual disturbances/impairment, fever/pyrexia, nausea, rash, vomiting, diarrhea, chills, headache, increased/abnormal liver function test, peripheral edema, respiratory distress, abdominal pain, tachycardia, and hallucinations. Adverse reactions that most frequently led to the discontinuation of therapy included visual disturbances, rash, and elevated liver function tests.^[Ref]

Cardiovascular

• Common (1% to 10%): Tachycardia, hypotension, phlebitis, supraventricular arrhythmia, bradycardia
• Uncommon (0.1% to 1%): Ventricular fibrillation, supraventricular tachycardia, ECG QT prolonged, vasodilatation, ventricular extrasystoles, ventricular tachycardia, thrombophlebitis
• Rare (0.01% to 0.1%): Torsade de pointes, complete atrioventricular block, bundle branch block, nodal rhythm
• Frequency not reported: Atrial arrhythmia, atrial fibrillation, bigeminy, cardiomegaly, cardiomyopathy, cerebral hemorrhage, cerebral ischemia, cerebrovascular accident, congestive heart failure, deep thrombophlebitis, endocarditis, extrasystoles, heart arrest, hypertension, myocardial infarction, nodal arrhythmia, postural hypotension, pulmonary embolus, supraventricular extrasystoles, palpitation, abnormalities in ECG, ventricular arrhythmia

Dermatologic

• Very common (10% or more): Rash (up to 19%)
• Common (1% to 10%): Alopecia, exfoliative dermatitis, maculopapular rash, pruritus, erythema, phototoxicity
• Uncommon (0.1% to 1%): Stevens-Johnson syndrome, allergic dermatitis, purpura, urticaria, eczema, photosensitivity reaction, macular rash, papular rash
• Rare (0.01% to 0.1%): Toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme, angioedema, pseudoporphyria, psoriasis, drug eruption
• Frequency not reported: Severe cutaneous adverse reactions, phototoxicity, photocarcinogenesis, contact dermatitis, discoid lupus erythematosus, fixed drug eruption, furunculosis, herpes simplex, melanoma, melanosis, skin discoloration, skin disorder, dry skin, sweating, blistering eruptions/bullous lesions, worsening of psoriasis, photosensitivity-related skin reactions (e.g., pseudoporphyria, cheilitis, cutaneous lupus erythematosus), dermatitis, phototoxic reaction
• Postmarketing reports: Cutaneous lupus erythematosus, ephelides, lentigo, DRESS, actinic keratosis, increased risk of skin toxicity^[Ref]

Most rashes were of mild to moderate severity. In pediatric trials, rash included rash, generalized rash, macular rash, maculopapular rash, and pruritic rash.

Severe cutaneous adverse reactions included Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS.

Phototoxicity included bullous erythema, lentigines, keratosis, pseudoporphyria, and photoaging.

Increased risk of skin toxicity with concomitant use of methotrexate (a drug associated with UV reactivation) was observed in postmarketing reports.

A photosensitivity reaction (manifested as facial edema and cheilitis) was reported in ambulatory patients (n=5) receiving 200 mg twice daily for chronic invasive Aspergillus 4 weeks after starting therapy. Symptoms resolved shortly after stopping the drug. Plasma and serum levels of all-trans retinol and 13-cis retinol were elevated in all the cases (n=3) measured supporting a hypothesis that this drug inhibits a step in the breakdown of all-trans retinoic acid.

A 65-year-old patient experienced pseudoporphyria after minimal sun exposure coincident with use of this drug. After pseudoporphyria was diagnosed and because the drug could not be stopped, the patient was instructed to avoid the sun and use sunscreens with ultraviolet A and B protection. The drug was stopped after a year of therapy, but the patient continued to be extremely photosensitive for several months.

A 45-year-old female with a history of non-Hodgkin's lymphoma 3 years post allogeneic bone marrow transplant experienced blistering eruptions coincident with use of this drug. Her posttransplant course had been complicated by chronic, grade 2, cutaneous graft versus host disease requiring therapy. The patient had no history of bullous skin lesions. She was started on 200 mg twice daily as prophylactic antifungal therapy. One week later, tense blisters were observed on the hips and later on the hands. There were prodromal burning sensations, but no associated pruritus or pain. The lesions resolved over 5 to 7 days without scarring. She experienced recurrent episodes involving her legs and feet. A biopsy obtained from the knee showed moderate hyperkeratosis, striking atrophy, and extensive basal vacuolization and colloid body formation. The temporal association of the start of this drug and onset of the eruption raised suspicion that it was the etiologic factor; thus, the drug was discontinued. The blistering resolved within 2 weeks with no further episodes.^[Ref]

Endocrine

• Uncommon (0.1% to 1%): Adrenal cortex insufficiency/adrenal insufficiency, hypothyroidism
• Rare (0.01% to 0.1%): Hyperthyroidism
• Frequency not reported: Diabetes insipidus
• Postmarketing reports: Adrenal insufficiency, Cushing's syndrome (when coadministered with corticosteroids)

Cushing's syndrome has been reported during postmarketing experience when this drug was used concomitantly with corticosteroids.

Gastrointestinal

• Very common (10% or more): Abdominal pain, nausea, vomiting, diarrhea
• Common (1% to 10%): Cheilitis, dry mouth, gingivitis, dyspepsia, constipation
• Uncommon (0.1% to 1%): Pancreatitis, peritonitis, duodenitis, gastroenteritis, glossitis, swollen tongue, pseudomembranous colitis
• Frequency not reported: Duodenal ulcer perforation, dysphagia, esophageal ulcer, esophagitis, flatulence, gastrointestinal hemorrhage, gum hemorrhage, gum hyperplasia, hematemesis, intestinal perforation, intestinal ulcer, melena, mouth ulceration, parotid gland enlargement, periodontitis, proctitis, rectal disorder, rectal hemorrhage, stomach ulcer, stomatitis, tongue edema, abdominal distention, abdominal tenderness^[Ref]

In pediatric trials, abdominal pain included abdominal pain and upper abdominal pain.

There have been postmarketing reports of pancreatitis in pediatric patients.^[Ref]

Genitourinary

• Common (1% to 10%): Hematuria
• Uncommon (0.1% to 1%): Proteinuria
• Frequency not reported: Albuminuria, anuria, blighted ovum, dysmenorrhea, dysuria, epididymitis, glycosuria, hemorrhagic cystitis, impotence, metrorrhagia, oliguria, scrotal edema, urinary incontinence, urinary retention, urinary tract infection, uterine hemorrhage, vaginal hemorrhage

Hematologic

• Common (1% to 10%): Thrombocytopenia, anemia, leukopenia, pancytopenia, agranulocytosis
• Uncommon (0.1% to 1%): Lymphadenopathy, eosinophilia, lymphangitis, bone marrow failure
• Rare (0.01% to 0.1%): Disseminated intravascular coagulation
• Frequency not reported: Anemia (macrocytic, megaloblastic, microcytic, normocytic), aplastic anemia, hemolytic anemia, bleeding time increased, cyanosis, ecchymosis, hypervolemia, marrow depression, petechiae, enlarged spleen, thrombotic thrombocytopenic purpura

Thrombocytopenia included immune thrombocytopenic purpura.

Agranulocytosis included febrile neutropenia and neutropenia.

Hepatic

• Very common (10% or more): Elevated AST (up to 20.3%), elevated total bilirubin (up to 19.4%), elevated ALT (up to 18.9%), abnormal liver function test
• Common (1% to 10%): Increased hepatic enzymes, cholestatic jaundice, bilirubinemia, jaundice, hepatitis
• Uncommon (0.1% to 1%): Hepatic failure, hepatomegaly/enlarged liver, cholecystitis, cholelithiasis
• Frequency not reported: Serious hepatic reactions, hepatic coma, elevated GGT/LDH, abnormal ALT, hyperbilirubinemia^[Ref]

In clinical trials, the overall incidence of transaminase increases greater than 3 times the upper limit of normal (3 x ULN), not necessarily comprising an adverse reaction, was 18% in adult patients and 25.8% in pediatric patients treated with this drug. Increased incidence of abnormal liver function tests may have been related to higher plasma levels and/or doses. Most abnormal liver function tests resolved during therapy without dose adjustment or resolved after dose adjustment (including therapy discontinuation).

Elevated AST (greater than 3 x ULN; up to 20.3%), total bilirubin (greater than 1.5 x ULN; up to 19.4%), and ALT (greater than 3 x ULN; up to 18.9%) have been reported.

In pediatric trials, abnormal ALT included abnormal ALT and increased ALT.

Hepatitis included drug-induced liver injury, toxic hepatitis, hepatocellular injury, and hepatotoxicity.

Serious hepatic reactions included clinical hepatitis, cholestasis, and fulminant hepatic failure (including fatalities).^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity
• Rare (0.01% to 0.1%): Anaphylactoid reaction
• Frequency not reported: Allergic reaction, anaphylactoid-type reactions, drug hypersensitivity

Anaphylactoid-type reactions included flushing, fever, sweating, tachycardia, chest tightness, dyspnea, faintness, nausea, pruritus, and rash. Anaphylactoid-type reactions have been reported during infusion of the IV formulation in healthy subjects, with symptoms appearing immediately upon starting the infusion.

Local

• Uncommon (0.1% to 1%): Infusion site reaction
• Frequency not reported: Injection site pain, injection site infection/inflammation, catheter site pain

Metabolic

• Common (1% to 10%): Hypokalemia, hypoglycemia, hyponatremia
• Uncommon (0.1% to 1%): Hypercholesterolemia, hypomagnesemia
• Frequency not reported: Decreased glucose tolerance, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hyperuricemia, hypocalcemia, hypophosphatemia, anorexia, hyperinsulinemia, hypoalbuminemia, hyperphosphatemia

Musculoskeletal

• Common (1% to 10%): Back pain
• Uncommon (0.1% to 1%): Arthritis
• Frequency not reported: Arthralgia, increased creatine phosphokinase, bone necrosis, bone pain, leg cramps, myalgia, myasthenia, myopathy, osteomalacia, osteoporosis, periostitis deformans
• Postmarketing reports: Fluorosis, periostitis

Fluorosis and periostitis have been reported with long-term therapy.

Nervous system

• Very common (10% or more): Headache
• Common (1% to 10%): Dizziness, paresthesia, tremor, convulsion, hypertonia, somnolence, syncope
• Uncommon (0.1% to 1%): Ataxia, brain edema, vertigo, hypoesthesia, dysgeusia/altered taste perception/taste perversion, encephalopathy, extrapyramidal syndrome/disorder, peripheral neuropathy, hypoacusis, tinnitus
• Rare (0.01% to 0.1%): Hepatic encephalopathy, Guillain-Barre syndrome, nystagmus
• Frequency not reported: Acute brain syndrome, akathisia, amnesia, coma, deafness, dementia, ear pain, encephalitis, grand mal convulsion, intracranial hypertension, neuralgia, neuropathy, otitis externa, taste loss, somnolence during infusion

Hypertonia included nuchal rigidity and tetany.

Encephalopathy included hypoxic-ischemic encephalopathy, and metabolic encephalopathy.

Extrapyramidal disorder included akathisia and parkinsonism.

Ocular

• Very common (10% or more): Abnormal vision (up to 28.1%), visual disturbances/impairment
• Common (1% to 10%): Photophobia, chromatopsia, retinal hemorrhage
• Uncommon (0.1% to 1%): Papilledema, optic nerve disorder, scleritis, blepharitis, diplopia, oculogyric crisis
• Rare (0.01% to 0.1%): Optic atrophy, corneal opacity
• Frequency not reported: Eye hemorrhage, abnormality of accommodation, conjunctivitis, eye pain, dry eyes, keratitis, keratoconjunctivitis, mydriasis, retinitis, uveitis, alterations in color perception, decreases in electroretinogram (ERG) waveform amplitude, decreases in the visual field, transient altered perception of light, wavy lines on television or on going to sleep
• Postmarketing reports: Prolonged visual adverse events^[Ref]

Drug-related visual disturbances were common. In clinical trials, abnormal vision, color vision change, and/or photophobia were reported in about 21% of patients.

Visual impairments included blurred vision, photophobia, chloropsia, chromatopsia, color blindness, cyanopsia, eye disorder, halo vision, night blindness, oscillopsia, photopsia, scintillating scotoma, visual acuity reduced, visual brightness, visual field defect, vitreous floaters, and xanthopsia. In clinical trials, visual impairments were very common with this drug. These visual impairments were transient and fully reversible; most spontaneously resolved within 1 hour with no clinically significant long-term visual effects. Attenuation was observed with repeated doses. The visual impairments were usually mild, rarely resulted in discontinuation of therapy, and were not associated with long-term sequelae.

Visual disturbances/impairments may have been related to higher plasma levels and/or doses.

The mechanism of action of the visual disturbances is unknown; however, the site of action is most likely within the retina. In a study in healthy subjects examining the effect of this drug on retinal function, this drug caused alterations in color perception, decreases in ERG waveform amplitude, and decreases in the visual field; the ERG changes did not progress over 29 days of therapy. At 14 days after the last dose, color perception, ERG, and visual fields returned to baseline.

In pediatric trials, visual disturbances included amaurosis (partial/total blindness without visible change in the eye), asthenopia (eye strain), chromatopsia (abnormally colored vision), color blindness, diplopia, photopsia, retinal disorder, blurred vision, decreased visual acuity, visual brightness, and visual impairment. Several patients had more than 1 visual disturbance.

Prolonged visual adverse events included optic neuritis and papilledema.^[Ref]

Oncologic

• Frequency not reported: Melanoma, squamous cell carcinoma of the skin
• Postmarketing reports: Squamous cell carcinoma^[Ref]

Melanoma and squamous cell carcinoma of the skin have been reported during long-term therapy in patients with photosensitivity skin reactions.

Squamous cell carcinoma included cutaneous squamous cell carcinoma in situ (Bowen's disease).^[Ref]

Other

• Very common (10% or more): Elevated alkaline phosphatase (up to 22.6%), decreased potassium (up to 16.7%), fever/pyrexia, peripheral edema
• Common (1% to 10%): Chills, asthenia, face edema, chest pain
• Uncommon (0.1% to 1%): Increased blood cholesterol, influenza-like illness
• Frequency not reported: Enlarged abdomen, ascites, cellulitis, edema, flank pain, graft versus host reaction, granuloma, infection, bacterial infection, fungal infection, mucous membrane disorder, multi-organ failure, pain, pelvic pain, sepsis, substernal chest pain, infusion-related reactions, mucosal inflammation, hypothermia, lethargy, flushing

Elevated alkaline phosphatase (greater than 3 x ULN; up to 22.6%) and decreased potassium (less than 0.9 times the lower limit of normal; up to 16.7%) have been reported.

Face edema included periorbital edema, lip edema, and mouth edema.

Infusion-related reactions included immediate anaphylactoid-type reactions (including flushing, fever, sweating, tachycardia, chest tightness, dyspnea, faintness, nausea, pruritus, rash).

Psychiatric

• Common (1% to 10%): Hallucinations, confusion/confusional state, anxiety, depression, agitation, insomnia
• Frequency not reported: Abnormal dreams, delirium, depersonalization, euphoria, decreased libido, psychosis, suicidal ideation, musical hallucinations, affect lability^[Ref]

In pediatric trials, hallucinations included hallucination, auditory hallucination, and visual hallucination. Several patients had both visual and auditory hallucinations.

A 78-year-old man diagnosed with acute myelogenous leukemia experienced musical hallucinations coincident with use of this drug. The musical hallucinations began acutely and almost immediately after starting therapy (300 mg orally twice daily) for prevention of fungal infection. After therapy was discontinued, the music became sporadic after 2 days and by the third day the music had ceased.^[Ref]

Renal

• Very common (10% or more): Increased blood creatinine (up to 21.4%)
• Common (1% to 10%): Acute renal failure, abnormal kidney function
• Uncommon (0.1% to 1%): Nephritis, renal tubular necrosis, increased blood urea
• Frequency not reported: Increased BUN, decreased CrCl, hydronephrosis, kidney pain, nephrosis, uremia, renal impairment, renal failure

Increased creatinine (greater than 1.3 x ULN) has been reported in up to 21.4% of patients.

Acute renal failure has been reported in severely ill patients treated with this drug.

In pediatric trials, renal impairment included renal failure and at least 1 patient with renal impairment.

Respiratory

• Very common (10% or more): Respiratory distress
• Common (1% to 10%): Acute respiratory distress syndrome, pulmonary edema, sinusitis
• Frequency not reported: Increased cough, dyspnea, epistaxis, influenza syndrome, hemoptysis, hypoxia, pharyngitis, pleural effusion, pneumonia, respiratory disorder, respiratory tract infection, rhinitis, voice alteration, upper respiratory tract infection, bronchospasm, nasal congestion, respiratory failure, tachypnea

Respiratory distress included dyspnea and exertional dyspnea.

Further information

Vfend side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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