Voriconazole Side Effects

Brand Names: Vfend

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

Voriconazole

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 Voriconazole:

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.

Voriconazole 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 Voriconazole 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.

Voriconazole 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 Voriconazole 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.

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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