VFEND Side Effects

Generic Name: voriconazole

Please note - some side effects for VFEND 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 VFEND - for the Consumer

Vfend

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 Vfend:

Blurred vision; change in color perception; diarrhea; dizziness; headache; mental or mood changes; nausea; sensitivity to light; sensitivity to the sun; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; chest pain; dark urine; decreased urination; depression; fast or irregular heartbeat; fever or chills; flushing; hallucinations; one-sided weakness; pain or numbness of an arm or leg; red, swollen, or blistered skin; seizures; severe stomach pain; shortness of breath; speech changes; sudden, severe headache, nausea, dizziness, or fainting; suicidal thoughts; swelling of the arms or legs; unusual bruising or bleeding; unusual fatigue; unusual vaginal bleeding; yellowing of the eyes or skin.

Vfend Suspension

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 Vfend Suspension:

Blurred vision; change in color perception; diarrhea; dizziness; headache; mental or mood changes; nausea; sensitivity to light; sensitivity to the sun; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; chest pain; dark urine; decreased urination; depression; fast or irregular heartbeat; fever or chills; flushing; hallucinations; one-sided weakness; pain or numbness of an arm or leg; red, swollen, or blistered skin; seizures; severe stomach pain; shortness of breath; speech changes; sudden, severe headache, nausea, dizziness, or fainting; suicidal thoughts; swelling of the arms or legs; unusual bruising or bleeding; unusual fatigue; unusual vaginal bleeding; yellowing of the eyes or skin.

Vfend Tablets

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 Vfend Tablets:

Blurred vision; change in color perception; diarrhea; dizziness; headache; mental or mood changes; nausea; sensitivity to light; sensitivity to the sun; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; chest pain; dark urine; decreased urination; depression; fast or irregular heartbeat; fever or chills; flushing; hallucinations; one-sided weakness; pain or numbness of an arm or leg; red, swollen, or blistered skin; seizures; severe stomach pain; shortness of breath; speech changes; sudden, severe headache, nausea, dizziness, or fainting; suicidal thoughts; swelling of the arms or legs; unusual bruising or bleeding; unusual fatigue; unusual vaginal bleeding; yellowing of the eyes or skin.

VFEND Side Effects - for the Professional

Vfend

Overview

The most frequently reported adverse events (all causalities) in the therapeutic trials were visual disturbances, fever, rash, vomiting, nausea, diarrhea, headache, sepsis, peripheral edema, abdominal pain, and respiratory disorder. The treatment-related adverse events which most often led to discontinuation of voriconazole therapy were elevated liver function tests, rash, and visual disturbances.

Discussion of Adverse Reactions

The data described in Table 13 reflect exposure to voriconazole in 1655 patients in the therapeutic studies. This represents a heterogeneous population, including immunocompromised patients, e.g., patients with hematological malignancy or HIV and non-neutropenic patients. This subgroup does not include healthy subjects and patients treated in the compassionate use and non-therapeutic studies. This patient population was 62% male, had a mean age of 46 years (range 11–90, including 51 patients aged 12–18 years), and was 78% white and 10% black. In the initial regulatory filing, 561 patients had a duration of voriconazole therapy of greater than 12 weeks, with 136 patients receiving voriconazole for over six months. Table 13 includes all adverse events which were reported at an incidence of ≥2% during voriconazole therapy in the all therapeutic studies population, studies 307/602 and 608 combined, or study 305, as well as events of concern which occurred at an incidence of <2%.

In study 307/602, 381 patients (196 on voriconazole, 185 on amphotericin B) were treated to compare voriconazole to amphotericin B followed by other licensed antifungal therapy in the primary treatment of patients with acute invasive aspergillosis. In study 608, 403 patients with candidemia were treated to compare voriconazole (272 patients) to the regimen of amphotericin B followed by fluconazole (131 patients). Study 305 evaluated the effects of oral voriconazole (200 patients) and oral fluconazole (191 patients) in the treatment of esophageal candidiasis. Laboratory test abnormalities for these studies are discussed under Clinical Laboratory Values below.

Voriconazole treatment-related visual disturbances are common. In therapeutic trials, approximately 21% of patients experienced abnormal vision, color vision change and/or photophobia. The visual disturbances were generally mild and rarely resulted in discontinuation. Visual disturbances may be associated with higher plasma concentrations and/or doses.

There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema. These events occurred primarily in severely ill patients who had underlying conditions and/or concomitant medications which may have caused or contributed to these events.

The mechanism of action of the visual disturbance is unknown, although the site of action is most likely to be within the retina. In a study in healthy subjects investigating the effect of 28-day treatment with voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude, a decrease in the visual field, and an alteration in color perception. The ERG measures electrical currents in the retina. The effects were noted early in administration of voriconazole and continued through the course of study drug dosing. Fourteen days after end of dosing, ERG, visual fields and color perception returned to normal.

Dermatological Reactions

Dermatological reactions were common in the patients treated with voriconazole. The mechanism underlying these dermatologic adverse events remains unknown. In clinical trials, rashes considered related to therapy were reported by 7% (110/1655) of voriconazole-treated patients. The majority of rashes were of mild to moderate severity. Cases of photosensitivity reactions appear to be more likely to occur with long-term treatment. Patients have rarely developed serious cutaneous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme during treatment with Vfend. If patients develop a rash, they should be monitored closely and consideration given to discontinuation of Vfend. It is recommended that patients avoid strong, direct sunlight during Vfend therapy.

Less Common Adverse Events

The following adverse events occurred in < 2% of all voriconazole-treated patients in all therapeutic studies (N=1655). This listing includes events where a causal relationship to voriconazole cannot be ruled out or those which may help the physician in managing the risks to the patients. The list does not include events included in Table 13 above and does not include every event reported in the voriconazole clinical program.

Body as a Whole: abdominal pain, abdomen enlarged, allergic reaction, anaphylactoid reaction, ascites, asthenia, back pain, chest pain, cellulitis, edema, face edema, flank pain, flu syndrome, graft versus host reaction, granuloma, infection, bacterial infection, fungal infection, injection site pain, injection site infection/inflammation, mucous membrane disorder, multi-organ failure, pain, pelvic pain, peritonitis, sepsis, substernal chest pain

Cardiovascular: atrial arrhythmia, atrial fibrillation, AV block complete, bigeminy, bradycardia, bundle branch block, cardiomegaly, cardiomyopathy, cerebral hemorrhage, cerebral ischemia, cerebrovascular accident, congestive heart failure, deep thrombophlebitis, endocarditis, extrasystoles, heart arrest, hypertension, hypotension, myocardial infarction, nodal arrhythmia, palpitation, phlebitis, postural hypotension, pulmonary embolus, QT interval prolonged, supraventricular extrasystoles, supraventricular tachycardia, syncope, thrombophlebitis, vasodilatation, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia (including torsade de pointes)

Digestive: anorexia, cheilitis, cholecystitis, cholelithiasis, constipation, diarrhea, duodenal ulcer perforation, duodenitis, dyspepsia, dysphagia, dry mouth, esophageal ulcer, esophagitis, flatulence, gastroenteritis, gastrointestinal hemorrhage, GGT/LDH elevated, gingivitis, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hepatic coma, hepatic failure, hepatitis, intestinal perforation, intestinal ulcer, jaundice, enlarged liver, melena, mouth ulceration, pancreatitis, parotid gland enlargement, periodontitis, proctitis, pseudomembranous colitis, rectal disorder, rectal hemorrhage, stomach ulcer, stomatitis, tongue edema

Endocrine: adrenal cortex insufficiency, diabetes insipidus, hyperthyroidism, hypothyroidism

Hemic and Lymphatic: agranulocytosis, anemia (macrocytic, megaloblastic, microcytic, normocytic), aplastic anemia, hemolytic anemia, bleeding time increased, cyanosis, DIC, ecchymosis, eosinophilia, hypervolemia, leukopenia, lymphadenopathy, lymphangitis, marrow depression, pancytopenia, petechia, purpura, enlarged spleen, thrombocytopenia, thrombotic thrombocytopenic purpura

Metabolic and Nutritional: albuminuria, BUN increased, creatine phosphokinase increased, edema, glucose tolerance decreased, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hyperuricemia, hypocalcemia, hypoglycemia, hypomagnesemia, hyponatremia, hypophosphatemia, peripheral edema, uremia

Musculoskeletal: arthralgia, arthritis, bone necrosis, bone pain, leg cramps, myalgia, myasthenia, myopathy, osteomalacia, osteoporosis

Nervous System: abnormal dreams, acute brain syndrome, agitation, akathisia, amnesia, anxiety, ataxia, brain edema, coma, confusion, convulsion, delirium, dementia, depersonalization, depression, diplopia, dizziness, encephalitis, encephalopathy, euphoria, Extrapyramidal Syndrome, grand mal convulsion, Guillain-Barré syndrome, hypertonia, hypesthesia, insomnia, intracranial hypertension, libido decreased, neuralgia, neuropathy, nystagmus, oculogyric crisis, paresthesia, psychosis, somnolence, suicidal ideation, tremor, vertigo

Respiratory System: cough increased, dyspnea, epistaxis, hemoptysis, hypoxia, lung edema, pharyngitis, pleural effusion, pneumonia, respiratory disorder, respiratory distress syndrome, respiratory tract infection, rhinitis, sinusitis, voice alteration

Skin and Appendages: alopecia, angioedema, contact dermatitis, discoid lupus erythematosis, eczema, erythema multiforme, exfoliative dermatitis, fixed drug eruption, furunculosis, herpes simplex, maculopapular rash, melanosis, photosensitivity skin reaction, pruritus, psoriasis, skin discoloration, skin disorder, skin dry, Stevens-Johnson syndrome, sweating, toxic epidermal necrolysis, urticaria

Special Senses: abnormality of accommodation, blepharitis, color blindness, conjunctivitis, corneal opacity, deafness, ear pain, eye pain, eye hemorrhage, dry eyes, hypoacusis, keratitis, keratoconjunctivitis, mydriasis, night blindness, optic atrophy, optic neuritis, otitis externa, papilledema, retinal hemorrhage, retinitis, scleritis, taste loss, taste perversion, tinnitus, uveitis, visual field defect

Urogenital: anuria, blighted ovum, creatinine clearance decreased, dysmenorrhea, dysuria, epididymitis, glycosuria, hemorrhagic cystitis, hematuria, hydronephrosis, impotence, kidney pain, kidney tubular necrosis, metrorrhagia, nephritis, nephrosis, oliguria, scrotal edema, urinary incontinence, urinary retention, urinary tract infection, uterine hemorrhage, vaginal hemorrhage

Clinical Laboratory Values

The overall incidence of clinically significant transaminase abnormalities in all therapeutic studies was 12.4% (206/1655) of patients treated with voriconazole. Increased incidence of liver function test abnormalities may be associated with higher plasma concentrations and/or doses. The majority of abnormal liver function tests either resolved during treatment without dose adjustment or following dose adjustment, including discontinuation of therapy.

Voriconazole has been infrequently associated with cases of serious hepatic toxicity including cases of jaundice and rare cases of hepatitis and hepatic failure leading to death. Most of these patients had other serious underlying conditions.

Liver function tests should be evaluated at the start of and during the course of Vfend therapy. Patients who develop abnormal liver function tests during Vfend therapy should be monitored for the development of more severe hepatic injury. Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin). Discontinuation of Vfend must be considered if clinical signs and symptoms consistent with liver disease develop that may be attributable to Vfend.

Acute renal failure has been observed in severely ill patients undergoing treatment with Vfend. Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medications and have concurrent conditions that may result in decreased renal function. It is recommended that patients are monitored for the development of abnormal renal function. This should include laboratory evaluation, particularly serum creatinine.

Tables 14 and 15 and 16 show the number of patients with hypokalemia and clinically significant changes in renal and liver function tests in three randomized, comparative multicenter studies. In study 305, patients with esophageal candidiasis were randomized to either oral voriconazole or oral fluconazole. In study 307/602, patients with definite or probable invasive aspergillosis were randomized to either voriconazole or amphotericin B therapy. In study 608, patients with candidemia were randomized to either voriconazole or the regimen of amphotericin B followed by fluconazole.

Side Effects by Body System

General

In general, the most frequently reported side effects in clinical trials (n=1493) have included visual disturbances (24.5%), rash (6.9%), fever (6.2%), nausea (5.9%), vomiting (4.8%), headache (3.2%), abdominal pain (1.7%), diarrhea (1.1%), peripheral edema (1.1%), and respiratory disorder (less than 1%). Side effects that most frequently led to the discontinuation of voriconazole treatment included visual disturbances (24.5%), rash (6.9%), and elevated liver enzyme levels (2.7%).

A comparative trial with voriconazole and amphotericin reported the following side effects: visual disturbances (voriconazole 32.7% vs. amphotericin 0.5% ), rash (voriconazole 7% vs. amphotericin 4.9%), fever (voriconazole 3.6% vs. amphotericin 13.5%), nausea (voriconazole 7.1% vs. amphotericin 15.7%), vomiting (voriconazole 5.5% vs. amphotericin 9.7%), headache (voriconazole 3.6% vs. amphotericin 4.3%), abdominal pain (voriconazole 2.6 % vs. amphotericin 3.2 %), diarrhea (voriconazole 1.5% vs. amphotericin 3.2%), peripheral edema (voriconazole 3.6% vs. amphotericin 4.9%), and abnormal liver function tests (voriconazole 4.6% vs. amphotericin 2.2%).

Hepatic

Hepatic side effects have included increased ALT (14.6%), increased AST (14.6%), increased alkaline phosphatase levels (3.6% to 14.6%), increased hepatic enzyme levels (1.9%), increased SGOT (1.9%), increased SGPT (1.8%), cholestatic jaundice (1.1%), bilirubinemia (0.8%), and jaundice (0.2%). Serious and sometimes fatal cases of clinical hepatitis, cholestasis, and fulminant hepatic failure have rarely been reported. Additional possible side effects reported in less than 1% of patients have included increases in creatine phosphokinase, and GGT/LDH, enlarged liver, and hepatic coma.

Ocular

Ocular side effects have been reported the most frequently including color vision changes, blurred vision, and wavy lines on television or on going to sleep have been reported in 37.5% of patients. Other side effects have included photophobia (2.2% to 37.5%) and abnormal vision (18.7%). These effects were usually mild and rarely resulted in the discontinuation of therapy. Additional possible side effects reported in less than 2% of patients have included chromatopsia, eye hemorrhage, abnormality of accommodation, blepharitis, color blindness, conjunctivitis, corneal opacity, eye pain, dry eyes, keratitis, keratoconjunctivitis, mydriasis, night blindness, optic atrophy, optic neuritis, papilledema, retinal hemorrhage, retinitis, scleritis, uveitis, and visual field defect. Transient altered perception of light has also been reported.

Ocular side effects may be related to higher plasma voriconazole concentrations or higher doses. The mechanism responsible for producing this side effect has not been fully identified, however, the site of action is most likely within the retina. In a 28-day study of the effect of voriconazole on retinal activity in healthy subjects, alterations in color perception, decreases in electroretinogram waveform amplitude, and diminished visual field measurements were linked to the administration of voriconazole. Within 14 days of stopping the medication, each indicator of visual function had returned to baseline.

Dermatologic

Dermatologic side effects have included rashes (5.3% to 18.75%), cheilitis (15.6%), and photosensitivity skin reaction (less than 2% to 10%). The majority of rashes were of mild to moderate severity. The risk of photosensitivity may be higher with long-term treatment. Additional possible side effects reported in less than 2% of patients have included alopecia, angioedema, contact dermatitis, discoid lupus erythematosus, eczema, exfoliative dermatitis, fixed drug eruption, furunculosis, herpes simplex, maculopapular rash, melanosis, pruritus, psoriasis, skin discoloration, skin disorder, dry skin, sweating, and urticaria. At least one case of pseudoporphyria has also been reported, in addition to two cases of blistering eruptions.

A photosensitivity reaction manifested as facial edema and cheilitis is reported in a group of ambulatory patients (n=5) receiving voriconazole 200 mg twice daily for chronic invasive aspergillus 4 weeks from the start of therapy. Symptoms resolved shortly after stopping the drug treatment. Plasma and serum concentrations of all-trans retinol and 13-cis retinol were elevated in all the cases (n=3) measured supporting a hypothesis that voriconazole inhibits a step in the breakdown of all-trans retinoic acid. It is recommended that patients avoid strong, direct sunlight during voriconazole treatment.

A 65-year-old patient experienced pseudoporphyria after minimal sun exposure coincident with voriconazole therapy. Following the diagnosis of pseudoporphyria and because the drug could not be stopped, the patient was instructed to avoid the sun and use sunscreens with UVA and UVB protection. The drug was stopped after a year of treatment, 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 voriconazole therapy. Her post-transplant 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 voriconazole 200 mg twice daily as prophylactic antifungal treatment. 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 voriconazole initiation and onset of the eruption raised suspicion that it was the etiologic factor; thus, voriconazole therapy was discontinued. The blistering resolved within 2 weeks with no further episodes.

Gastrointestinal

Gastrointestinal (GI) side effects have included nausea (5.9%), vomiting (4.8%), diarrhea (1.1%), and dry mouth (1%). Additional possible side effects reported in less than 1% of patients have included anorexia, cheilitis, cholecystitis, cholelithiasis, constipation, duodenal ulcer perforation, duodenitis, dyspepsia, dysphagia, esophageal ulcer, esophagitis, flatulence, gastroenteritis, GI hemorrhage, gingivitis, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, intestinal perforation, intestinal ulcer, melena, mouth ulceration, pancreatitis, parotid gland enlargement, periodontitis, proctitis, pseudomembranous colitis, rectal disorder, rectal hemorrhage, stomach ulcer, stomatitis, and tongue edema.

Hypersensitivity

Hypersensitivity side effects associated with the administration of voriconazole have occurred uncommonly and have included anaphylactoid-type reactions in patients receiving the IV form of the drug. These reactions presented immediately upon initiation of the infusion, and were characterized by signs and symptoms consistent with anaphylactoid-type side effects including flushing, fever, sweating, tachycardia, chest tightness, dyspnea, faintness, nausea, pruritus, and rash. The rate of administration and/or the concentration of the infusion drug may be responsible for the reaction. Additional possible side effects reported in less than 2% of patients have included erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Cardiovascular

Cardiovascular side effects have included abnormalities in ECG (3.13%), tachycardia (2.5%), hypertension (1.9%), hypotension (1.7%), and vasodilatation (1.5%). Additional possible side effects reported in less than 1% of patients have included atrial arrhythmia, atrial fibrillation, complete AV block, bigeminy, bradycardia, bundle branch block, cardiomegaly, cardiomyopathy, cerebral hemorrhage, cerebral ischemia, cerebrovascular accident, congestive heart failure, deep thrombophlebitis, edema, endocarditis, extrasystoles, heart arrest, myocardial infarction, nodal arrhythmia, palpitation, phlebitis, postural hypotension, pulmonary embolus, QT interval prolongation, supraventricular tachycardia, syncope, thrombophlebitis, vasodilatation, ventricular arrhythmia, ventricular fibrillation, and ventricular tachycardia including possible torsade de pointes.

Hematologic

Hematologic side effects have included thrombocytopenia (0.5%), anemia (0.1%), leukopenia (0.3%), and pancytopenia (0.1%). Additional possible side effects reported in less than 1% of patients have included agranulocytosis, aplastic anemia, hemolytic anemia, bleeding time increased, cyanosis, disseminated intravascular coagulation, ecchymosis, eosinophilia, hypervolemia, lymphadenopathy, lymphangitis, marrow depression, petechiae, purpura, enlarged spleen, and thrombotic thrombocytopenic purpura.

Metabolic

Metabolic side effects have included hypokalemia (1.6%), hypomagnesemia (1.1%), and peripheral edema (1.1%). Additional possible side effects reported in less than 1% of patients have included decreased glucose tolerance, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hyperuricemia, hypocalcemia, hypoglycemia, hyponatremia, hypophosphatemia, and uremia.

Renal

Renal side effects have included abnormal kidney function (0.5%), acute kidney failure (0.5%), and increased creatinine (0.3%). Additional possible side effects reported in less than 1% of patients have included anuria, decreased creatinine clearance, glycosuria, hydronephrosis, kidney pain, nephritis, nephrosis, tubular necrosis, and uremia.

Genitourinary

Genitourinary side effects reported in less than 1% of patients have included dysmenorrhea, dysuria, hemorrhagic cystitis, hematuria, impotence, metrorrhagia, oliguria, scrotal edema, urinary incontinence, urinary retention, urinary tract infection, uterine hemorrhage, and vaginal hemorrhage.

Musculoskeletal

Musculoskeletal side effects reported in less than 1% of patients have included arthralgia, arthritis, bone necrosis, bone pain, leg cramps, myalgia, myasthenia, myopathy, osteomalacia, and osteoporosis.

Nervous system

Nervous system side effects have included hallucinations (2.5%) and dizziness (1.3%). Additional possible side effects reported in less than 1% of patients have included abnormal dreams, acute brain syndrome, agitation, akathisia, amnesia, anxiety, ataxia, brain edema, coma, confusion, convulsion, decreased libido, deafness, delirium, dementia, depersonalization, depression, diplopia, ear pain, encephalitis, encephalopathy, euphoria, extrapyramidal syndrome, grand mal convulsion, Guillain-Barre syndrome, hypertonia, hypesthesia, insomnia, intracranial hypertension, neuralgia, neuropathy, nystagmus, oculogyric crisis, otitis externa, paresthesia, psychosis, somnolence, suicidal ideation, taste loss, taste perversion, tinnitus, tremor, and vertigo.

Endocrine

Endocrine side effects reported in less than 1% of patients have included adrenal cortex insufficiency, diabetes insipidus, hyperthyroidism, and hypothyroidism.

Local

Local side effects have been reported in less than 1% of patients have included injection site pain and injection site infection/inflammation.

Respiratory

Respiratory side effects have been reported in less than 1% of patients and have included increased cough, dyspnea, epistaxis, hemoptysis, hypoxia, lung edema, pharyngitis, pleural effusion, pneumonia, respiratory disorder, respiratory distress syndrome, respiratory tract infection, rhinitis, sinusitis, and voice alteration.

Psychiatric

A 78-year-old man diagnosed with acute myelogenous leukemia experienced musical hallucinations coincident with voriconazole therapy. The musical hallucinations began acutely and almost immediately following the initiation of voriconazole therapy (300 mg orally twice daily) for prevention of fungal infection. Following discontinuation of voriconazole, the music had become sporadic after 2 days and by the third day the music had ceased.

Psychiatric side effects including at least one case report of musical hallucinations have been reported.

Other

Other side effects affecting the body as a whole have included fever (6.2%), chills (4.1%), headache (3.2%), abdominal pain (1.7%), and chest pain (0.9%). Additional possible side effects reported in less than 1% of patients have included enlarged abdomen, ascites, asthenia, back pain, cellulitis, edema, face edema, flank pain, flu syndrome, graft versus host reaction, granuloma, bacterial and fungal infection, mucous membrane disorder, multi-organ failure, pain, pelvic pain, peritonitis, sepsis, and substernal chest pain. Infusion related side effects have included immediate anaphylactoid-type reactions (flushing, fever, sweating, tachycardia, chest tightness, dyspnea, faintness, nausea, pruritus, and rash).

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