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Voriconazole is an antifungal medicine.
Voriconazole is used to treat infections caused by yeast or other types of fungus.
Voriconazole may also be used for purposes not listed in this medication guide.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.
You should not use voriconazole if you are allergic to it.
Some medicines can cause unwanted or dangerous effects when used with voriconazole. Your doctor may change your treatment plan if you also use:
carbamazepine;
cisapride;
efavirenz;
pimozide;
quinidine;
rifabutin, rifampin;
ritonavir;
sirolimus;
St. John's wort;
certain barbiturates (mephobarbital, phenobarbital); or
"ergot" migraine headache medicines (dihydroergotamine, ergotamine, ergonovine, methylergonovine).
Tell your doctor if you have ever had:
heart disease, or a heart rhythm disorder;
high or low levels of calcium, potassium, or magnesium in your blood;
liver or kidney disease; or
trouble digesting sugar or dairy products (voriconazole tablets contain lactose, voriconazole liquid contains sucrose).
Do not use voriconazole if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using voriconazole.
Voriconazole can interact with certain birth control pills, which may increase side effects. Ask your doctor about the best form of birth control to use during treatment with voriconazole.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
Voriconazole is not approved for use by anyone younger than 2 years old.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take oral voriconazole (tablets or liquid) at least 1 hour before or 1 hour after eating a meal.
Shake the liquid before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Do not mix voriconazole liquid with any other medicine or liquid.
Voriconazole injection is given as a slow infusion into a vein, over 1 to 2 hours. Voriconazole is usually given by injection only if you are unable to take the medicine by mouth. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.
Voriconazole injection is a powder medicine that must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.
Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
If you cannot use the mixed injection right away, store it in the refrigerator and use it within 24 hours. Do not freeze.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Voriconazole is sometimes given for up to several days after lab tests show that the infection has cleared. Very severe infections may need to be treated for several weeks.
Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Voriconazole will not treat a viral infection such as the flu or a common cold.
You may need frequent blood tests. Your vision and kidney or liver function may also need to be checked.
Store voriconazole tablets or liquid at room temperature away from moisture and heat. Do not store in a refrigerator or freezer. Keep the medicine bottle tightly closed when not in use. Throw away any unused liquid after 14 days.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Call your doctor for instructions if you miss a dose of injectable voriconazole.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Voriconazole may cause vision changes such as blurred vision and sensitivity to light. Wear sunglasses during the day to protect your eyes from bright light. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
Avoid exposure to sunlight or tanning beds. Voriconazole can make you more sensitive to sunlight or cause a serious skin reaction, including lesions that may lead to skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have chest tightness or trouble breathing.
Call your doctor at once if you have:
fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
a sunburn;
vision problems, changes in your color vision;
slow heart rate, weak pulse, fainting, slow breathing;
kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
liver problems--nausea, vomiting, flu-like symptoms, itching, tiredness, or jaundice (yellowing of the skin or eyes).
Common side effects may include:
vision changes;
rash;
headache, hallucinations;
fast heart rate;
nausea, vomiting; or
abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Many drugs can affect voriconazole, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Voriconazole (www.drugs.com/mtm/voriconazole-oral-injection.html).
Commonly reported side effects of voriconazole include: blurred vision, vision color changes, visual disturbance, and enhanced visual perception. Other side effects include: fever, nausea, skin rash, vomiting, and chills. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to voriconazole: oral powder for suspension, oral tablet
Other dosage forms:
Along with its needed effects, voriconazole 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
Less common
Rare
Incidence not known
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
For Healthcare Professionals
Applies to voriconazole: intravenous powder for injection, oral powder for reconstitution, oral tablet
GeneralThe most frequently reported side effects in clinical trials were visual disturbances, fever/pyrexia, nausea, rash, vomiting, diarrhea, chills, headache, increased/abnormal liver function test, peripheral edema, respiratory distress, abdominal pain, tachycardia, and hallucinations. Side effects that most frequently led to the discontinuation of voriconazole treatment included visual disturbances, rash, and elevated liver function tests.
OcularVery common (10% or more): Abnormal vision (up to 28.1%), visual disturbances/impairment (including altered/enhanced visual perception, blurred vision, chromatopsia, color vision change, photophobia)
Common (1% to 10%): Photophobia, chromatopsia, retinal hemorrhage
Uncommon (0.1% to 1%): Papilledema, optic nerve disorder, optic neuritis, scleritis, blepharitis, diplopia, oculogyric crisis/oculogyration
Rare (less than 0.1%): Optic atrophy, corneal opacity
Frequency not reported: Eye hemorrhage, abnormality of accommodation, color blindness, conjunctivitis, eye pain, dry eyes, keratitis, keratoconjunctivitis, mydriasis, night blindness, retinitis, uveitis, visual field defect, transient altered perception of light, blurred vision, wavy lines on television or on going to sleep
Postmarketing reports: Prolonged visual adverse events (including optic neuritis and papilledema)
The visual disturbances were usually mild and rarely resulted in the discontinuation of therapy.
Ocular side effects have been reported frequently and have included abnormal vision, altered/enhanced visual perception, blurred vision, color vision change, and/or photophobia in about 21% of patients. These visual disturbances were transient and fully reversible; most spontaneously resolving within 1 hour with no clinically significant long-term visual effects. Attenuation was observed with repeated doses. Visual disturbances may be related to higher plasma voriconazole levels and/or doses. The mechanism 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 drug, each indicator of visual function had returned to baseline.
MetabolicElevated alkaline phosphatase (greater than 3 times ULN; up to 22.6%) and decreased potassium (less than 0.9 times lower limit of normal; up to 16.7%) have been reported.
Very common (10% or more): Elevated alkaline phosphatase (up to 22.6%), decreased potassium (up to 16.7%)
Common (1% to 10%): Hypokalemia, hypoglycemia, hyponatremia
Uncommon (0.1% to 1%): Increased blood cholesterol, hypercholesterolemia, hypomagnesemia
Frequency not reported: Decreased glucose tolerance, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hyperuricemia, hypocalcemia, hypophosphatemia, anorexia, hyperinsulinemia
RenalIncreased creatinine (greater than 1.3 times ULN) has been reported in up to 21.4% of patients.
Acute renal failure has been reported in severely ill patients.
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%): Increased BUN, nephritis, renal tubular necrosis, increased blood urea
Frequency not reported: Decreased CrCl, hydronephrosis, kidney pain, nephrosis, uremia
HepaticThe overall incidence of clinically significant transaminase abnormalities during clinical studies was 13.5% of patients treated with voriconazole. Increased incidence of abnormal liver function tests may be related to higher plasma levels and/or doses. Most abnormal liver function tests resolved during therapy without dose adjustment or after dose adjustment (including therapy discontinuation).
Elevated AST (greater than 3 times upper limit of normal [ULN]; up to 20.3%), total bilirubin (greater than 1.5 times ULN; up to 19.4%), and ALT (greater than 3 times ULN; up to 18.9%) have been reported.
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 (including AST, ALT, alkaline phosphatase, GGT, LDH, bilirubin)
Common (1% to 10%): Increased hepatic enzymes, cholestatic jaundice, bilirubinemia, elevated GGT, elevated LDH, jaundice, hepatitis
Uncommon (0.1% to 1%): Hepatic failure, hepatomegaly/enlarged liver, cholecystitis, cholelithiasis
Rare (less than 0.1%): Serious hepatic reactions (including clinical hepatitis, cholestasis, fulminant hepatic failure including fatalities), hepatic coma
DermatologicVery common (10% or more): Rash (up to 19%)
Common (1% to 10%): Alopecia, exfoliative dermatitis, phototoxic reaction, maculopapular rash, photosensitivity skin reaction, pruritus, erythema, purpura
Uncommon (0.1% to 1%): Fixed drug eruption, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angioedema/angioneurotic edema, allergic dermatitis, urticaria, psoriasis, eczema, phototoxicity, macular rash, papular rash
Rare (less than 0.1%): Discoid lupus erythematosus, pseudoporphyria
Frequency not reported: Serious exfoliative cutaneous reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), phototoxicity (including bullous erythema, lentigines, keratosis, pseudoporphyria, photoaging), photocarcinogenesis, contact dermatitis, furunculosis, herpes simplex, melanoma, melanosis, skin discoloration, skin disorder, dry skin, squamous cell carcinoma, sweating, blistering eruptions/bullous lesions, worsening of psoriasis
Postmarketing reports: Cutaneous lupus erythematosus
Most rashes were of mild to moderate severity.
A photosensitivity reaction (manifested as facial edema and cheilitis) was reported in ambulatory patients (n=5) receiving voriconazole 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 voriconazole inhibits a step in the breakdown of all-trans retinoic acid.
A 65-year-old patient experienced pseudoporphyria after minimal sun exposure coincident with voriconazole therapy. After pseudoporphyria was diagnosed 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 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 voriconazole therapy. 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 voriconazole 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 voriconazole initiation 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.
Nervous systemVery 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, nystagmus, dysgeusia/altered taste perception/taste perversion, encephalopathy, extrapyramidal syndrome/disorder, peripheral neuropathy, hypoacusis, tinnitus
Rare (less than 0.1%): Hepatic encephalopathy, Guillain-Barre syndrome, somnolence during infusion
Frequency not reported: Acute brain syndrome, akathisia, amnesia, coma, decreased libido, deafness, delirium, dementia, ear pain, encephalitis, euphoria, grand mal convulsion, intracranial hypertension, neuralgia, neuropathy, otitis externa, taste loss
OtherVery common (10% or more): Fever/pyrexia, peripheral edema
Common (1% to 10%): Chills, influenza-like illness, asthenia, face edema, flu syndrome, chest pain
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 side effects (including immediate anaphylactoid-type reactions)
Infusion-related side effects have included immediate anaphylactoid-type reactions (including flushing, fever, sweating, tachycardia, chest tightness, dyspnea, faintness, nausea, pruritus, rash).
GastrointestinalVery common (10% or more): Abdominal pain, nausea, vomiting, diarrhea
Common (1% to 10%): Cheilitis, gastroenteritis, dry mouth, gingivitis, dyspepsia, constipation
Uncommon (0.1% to 1%): Pancreatitis, peritonitis, duodenitis, glossitis, tongue edema, 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
RespiratoryVery common (10% or more): Respiratory distress
Common (1% to 10%): Acute respiratory distress syndrome, pulmonary edema, sinusitis
Frequency not reported: Increased cough, dyspnea, epistaxis, hemoptysis, hypoxia, pharyngitis, pleural effusion, pneumonia, respiratory disorder, respiratory tract infection, rhinitis, voice alteration
CardiovascularCommon (1% to 10%): Tachycardia, hypotension, phlebitis, thrombophlebitis, supraventricular arrhythmia, bradycardia
Uncommon (0.1% to 1%): Atrial arrhythmia, ventricular arrhythmia, ventricular fibrillation, supraventricular tachycardia, ECG QT prolonged, vasodilatation, ventricular extrasystoles, ventricular tachycardia
Rare (less than 0.1%): Torsade de pointes, complete atrioventricular block, bundle branch block, nodal rhythm, nodal arrhythmia
Frequency not reported: Atrial fibrillation, bigeminy, cardiomegaly, cardiomyopathy, cerebral hemorrhage, cerebral ischemia, cerebrovascular accident, congestive heart failure, deep thrombophlebitis, endocarditis, extrasystoles, heart arrest, hypertension, myocardial infarction, postural hypotension, pulmonary embolus, supraventricular extrasystoles, palpitation, abnormalities in ECG
HematologicCommon (1% to 10%): Thrombocytopenia, anemia (including macrocytic, megaloblastic, microcytic, normocytic, aplastic), leukopenia, pancytopenia, agranulocytosis
Uncommon (0.1% to 1%): Disseminated intravascular coagulation, lymphadenopathy, eosinophilia, lymphangitis, bone marrow failure
Frequency not reported: Hemolytic anemia, bleeding time increased, cyanosis, ecchymosis, hypervolemia, petechiae, enlarged spleen, thrombotic thrombocytopenic purpura
PsychiatricCommon (1% to 10%): Hallucinations, confusion/confusional state, anxiety, depression, agitation, insomnia
Frequency not reported: Abnormal dreams, depersonalization, psychosis, suicidal ideation, musical hallucinations
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 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.
MusculoskeletalFluorosis and periostitis have been reported with long-term therapy.
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
GenitourinaryCommon (1% to 10%): Hematuria
Uncommon (0.1% to 1%): Albuminuria, proteinuria
Frequency not reported: 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
LocalCommon (1% to 10%): Injection site reaction/inflammation
Frequency not reported: Injection site pain, injection site infection/inflammation
HypersensitivityCommon (1% to 10%): Hypersensitivity
Uncommon (0.1% to 1%): Allergic reaction, anaphylactoid reaction, drug hypersensitivity
Rare (less than 0.1%): Anaphylactoid-type reactions (including flushing, fever, sweating, tachycardia, chest tightness, dyspnea, faintness, nausea, pruritus, rash)
During infusion of the IV formulation in healthy subjects, anaphylactoid-type reactions (including flushing, fever, sweating, tachycardia, chest tightness, dyspnea, faintness, nausea, pruritus, rash) have been reported rarely, with symptoms appearing immediately upon starting the infusion.
EndocrineUncommon (0.1% to 1%): Adrenal cortex insufficiency, hypothyroidism
Rare (less than 0.1%): Hyperthyroidism
Frequency not reported: Diabetes insipidus
OncologicMelanoma and squamous cell carcinoma of the skin have been reported during long-term therapy in patients with photosensitivity skin reactions.
Frequency not reported: Melanoma, squamous cell carcinoma of the skin
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Voriconazole (www.drugs.com/mtm/voriconazole-oral-injection.html).
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