(voriconazole)

Prescribing Information
Download Prescribing Information

HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VFEND safely and effectively. See full prescribing information for VFEND.

VFEND® (voriconazole) tablets, for oral use
VFEND® (voriconazole) for oral suspension
VFEND® (voriconazole) for injection, for intravenous use
Initial U.S. Approval: 2002

RECENT MAJOR CHANGES

Contraindications (4)

1/2026

INDICATIONS AND USAGE

VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:

•
Invasive aspergillosis (1.1)
•
Candidemia in non-neutropenics and other deep tissue Candida infections (1.2)
•
Esophageal candidiasis (1.3)
•
Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)

DOSAGE AND ADMINISTRATION

•
Dosage in Adults (2.3)

Infection

Loading dose

Maintenance Dose

Intravenous infusion

Intravenous infusion

Oral tablets

Oral suspension

Invasive Aspergillosis

6 mg/kg every 12 hours for the first 24 hours

4 mg/kg every 12 hours

200 mg every 12 hours

5 mL every 12 hours

Candidemia in nonneutropenics and other deep tissue Candida infections

3–4 mg/kg every 12 hours

200 mg every 12 hours

5 mL every 12 hours

Scedosporiosis and Fusariosis

4 mg/kg every 12 hours

200 mg every 12 hours

5 mL every 12 hours

Esophageal Candidiasis

Not Evaluated

Not Evaluated

200 mg every 12 hours

5 mL every 12 hours

o
Adult patients weighing less than 40 kg: oral maintenance dose 100 mg or 150 mg every 12 hours
o
Hepatic Impairment: Use half the maintenance dose in adult patients with mild to moderate hepatic impairment (Child-Pugh Class A and B) (2.5)
o
Renal Impairment: Avoid intravenous administration in adult patients with moderate to severe renal impairment (creatinine clearance <50 mL/min) (2.6)

 

•
Dosage in Pediatric Patients 2 years of age and older (2.4)
o
For pediatric patients 2 to less than 12 years of age and 12 to 14 years of age weighing less than 50 kg see Table below.

Infection

Loading Dose

Maintenance Dose

Intravenous infusion

Intravenous infusion

Oral tablets

Oral suspension

Invasive Aspergillosis

9 mg/kg every 12 hours for the first 24 hours

8 mg/kg every 12 hours after the first 24 hours

9 mg/kg every 12 hours
(maximum dose of 350 mg every 12 hours)

0.225 mL/kg every 12 hours
[maximum dose of 8.75 mL (350 mg) every 12 hours]

Candidemia in nonneutropenics and other deep tissue Candida infections

Scedosporiosis and Fusariosis

Esophageal Candidiasis

Not Evaluated

4 mg/kg every 12 hours

9 mg/kg every 12 hours
(maximum dose of 350 mg every 12 hours)

0.225 mL/kg every 12 hours

[maximum dose of 8.75 mL (350 mg) every 12 hours]

o
For pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight use adult dosage. (2.4)
o
Dosage adjustment of VFEND in pediatric patients with renal or hepatic impairment has not been established (2.5, 2.6)
•
See full prescribing information for instructions on reconstitution of VFEND lyophilized powder for intravenous use and reconstitution of VFEND oral suspension and important administration instructions (2.1, 2.6, 2.7)

DOSAGE FORMS AND STRENGTHS

•
Tablets: 50 mg, 200 mg (3)
•
For Oral Suspension: 40 mg/mL (200 mg/5 mL) when reconstituted (3)
•
For Injection: Lyophilized powder containing 200 mg of voriconazole and 3,200 mg of sulfobutyl ether beta-cyclodextrin sodium (SBECD); after reconstitution 10 mg/mL of voriconazole and 160 mg/mL of SBECD (3)

CONTRAINDICATIONS

•
Known hypersensitivity to voriconazole or its excipients (4)
•
Concomitant use with drugs that are highly dependent on CYP3A4 for metabolism, and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions (4, 7)
•
Concomitant use with drugs and herbal products that induce CYP2C19, CYP2C9, and/or CYP3A4 and for which significantly reduced voriconazole plasma concentrations may be associated with loss of efficacy (4, 7)

WARNINGS AND PRECAUTIONS

•
Hepatic Toxicity: Serious hepatic reactions reported. Evaluate liver function tests at start of and during VFEND therapy (5.1)
•
Arrhythmias and QT Prolongation: Correct potassium, magnesium and calcium prior to use; caution patients with proarrhythmic conditions (5.2)
•
Infusion Related Reactions (including anaphylaxis): Stop the infusion (5.3)
•
Visual Disturbances (including optic neuritis and papilledema): Monitor visual function if treatment continues beyond 28 days (5.4)
•
Severe Cutaneous Adverse Reactions: Discontinue for exfoliative cutaneous reactions (5.5)
•
Photosensitivity: Avoid sunlight due to risk of photosensitivity (5.6)
•
Adrenal Dysfunction: Carefully monitor patients receiving VFEND and corticosteroids (via all routes of administration) for adrenal dysfunction both during and after VFEND treatment. Instruct patients to seek immediate medical care if they develop signs and symptoms of Cushing's syndrome or adrenal insufficiency (5.8)
•
Embryo-Fetal Toxicity: Voriconazole can cause fetal harm when administered to a pregnant woman. Inform pregnant patients of the potential hazard to the fetus. Advise females of reproductive potential to use effective contraception during treatment with VFEND (5.9, 8.1, 8.3)
•
Skeletal Adverse Reactions: Fluorosis and periostitis with long-term voriconazole therapy. Discontinue if these adverse reactions occur (5.12)
•
Clinically Significant Drug Interactions: Review patient's concomitant medications (5.13, 7)
•
Patients with Hereditary Galactose Intolerance, Lapp Lactase Deficiency or Glucose-Galactose Malabsorption: VFEND tablets should not be given to these patients because it contains lactose (5.14)

ADVERSE REACTIONS

•
Adult Patients: The most common adverse reactions (incidence ≥2%) were visual disturbances, fever, nausea, rash, vomiting, chills, headache, liver function test abnormal, tachycardia, hallucinations (6)
•
Pediatric Patients: The most common adverse reactions (incidence ≥5%) were visual disturbances, pyrexia, vomiting, epistaxis, nausea, rash, abdominal pain, diarrhea, hypertension, hypokalemia, cough, headache, thrombocytopenia, ALT abnormal, hypotension, peripheral edema, hyperglycemia, tachycardia, dyspnea, hypocalcemia, hypophosphatemia, LFT abnormal, mucosal inflammation, photophobia, abdominal distention, constipation, dizziness, hallucinations, hemoptysis, hypoalbuminemia, hypomagnesemia, renal impairment, upper respiratory tract infection (6)



To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
CYP3A4, CYP2C9, and CYP2C19 inhibitors and inducers: Adjust VFEND dosage and monitor for adverse reactions or lack of efficacy (4, 7)
•
VFEND may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce dosage of these other drugs and monitor for adverse reactions (4, 7)
•
Phenytoin or Efavirenz: With coadministration, increase maintenance oral and intravenous dosage of VFEND (2.3, 2.7, 7)

USE IN SPECIFIC POPULATIONS

•
Pediatrics: Safety and effectiveness in patients younger than 2 years has not been established (8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2026

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration.     Revised: 1/2026

PATIENT INFORMATION
VFEND®
(VEE-fend)
(voriconazole)
tablets, for oral use
VFEND®
(VEE-fend)
(voriconazole)
for oral suspension
VFEND®
(VEE-fend)
(voriconazole)
for injection, for intravenous use

Read the Patient Information that comes with VFEND before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your condition or treatment.

What is VFEND?
VFEND is a prescription medicine used to treat certain serious fungal infections in your blood and body. These infections are called "aspergillosis," "esophageal candidiasis," "Scedosporium," "Fusarium," and "candidemia".


It is not known if VFEND is safe and effective in children younger than 2 years old.

Do not take VFEND if you:

•
are allergic to voriconazole or any of the ingredients in VFEND. See the end of this leaflet for a complete list of ingredients in VFEND.
•
are taking any of the following medicines:
o
carbamazepine
o
efavirenz
o
eplerenone
o
ergotamine, dihydroergotamine (ergot alkaloids)
o
finerenone
o
ivabradine
o
long-acting barbiturates like phenobarbital
o
lurasidone
o
naloxegol
o
pimozide
o
quinidine
o
rifabutin
o
rifampin
o
ritonavir
o
sirolimus
o
St. John’s Wort (herbal supplement)
o
tolvaptan
o
venetoclax
o
voclosporin

Ask your healthcare provider or pharmacist if you are not sure if you are taking any of the medicines listed above.
Do not start taking a new medicine without talking to your healthcare provider or pharmacist.

Before you take VFEND, tell your healthcare provider about all of your medical conditions, including if you:

•
have or ever had heart disease, or an abnormal heart rate or rhythm. Your healthcare provider may order a test to check your heart (EKG) before starting VFEND.
•
have low potassium levels, low magnesium levels, and low calcium levels. Your healthcare provider may do blood tests before starting and during treatment with VFEND.
•
have liver or kidney problems. Your healthcare provider may do blood tests to make sure you can take VFEND.
•
have trouble digesting dairy products, lactose (milk sugar), or regular table sugar. VFEND tablets contain lactose. VFEND oral suspension contains sucrose (table sugar).
•
are pregnant or plan to become pregnant. VFEND can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. Women who can become pregnant should use effective birth control while taking VFEND. Talk to your healthcare provider about birth control methods that may be right for you.
•
are breastfeeding or plan to breastfeed. It is not known if VFEND passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take VFEND.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
VFEND may affect the way other medicines work, and other medicines may affect how VFEND works.
Know what medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take VFEND?

•
VFEND may be prescribed to you as:
o
VFEND I.V. (intravenous infusion) or
o
VFEND tablets or
o
VFEND oral suspension
•
VFEND I.V. will be given to you by a healthcare provider over 1 to 3 hours.
•
Take VFEND tablets or oral suspension exactly as your healthcare provider tells you to.
•
Take VFEND tablets or oral suspension at least 1 hour before or at least 1 hour after meals.
•
VFEND oral suspension will be mixed for you by your pharmacist. Shake the bottle of VFEND oral suspension for 10 seconds each time before you use it.
•
Only use the oral dispenser that comes with your VFEND oral suspension to administer your medicine.
•
Do not mix VFEND oral suspension with any other medicine, flavored liquid, or syrup.
•
If you take too much VFEND, call your healthcare provider or go to the nearest hospital emergency room.

What should I avoid while taking VFEND?

•
You should not drive at night while taking VFEND. VFEND can cause changes in your vision such as blurring or sensitivity to light.
•
Do not drive or operate machinery, or do other dangerous activities until you know how VFEND affects you.
•
Avoid direct sunlight. VFEND can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your healthcare provider if you get sunburn.

What are the possible side effects of VFEND?

VFEND may cause serious side effects including:

•
liver problems. Symptoms of liver problems may include:
o
itchy skin
o
flu-like symptoms
o
yellowing of your eyes
o
nausea or vomiting
o
feeling very tired
•
serious heart problems. VFEND may cause changes in your heart rate or rhythm, including your heart stopping (cardiac arrest).
•
allergic reactions. Symptoms of an allergic reaction may include:
o
fever
o
chest tightness
o
nausea
o
flushing
o
sweating
o
trouble breathing
o
itching
o
feels like your heart is beating fast (tachycardia)
o
feel faint
o
skin rash
•
vision changes. Symptoms of vision changes may include:
o
blurred vision
o
changes in the way you see colors
•
serious skin reactions. Symptoms of serious skin reactions may include:
o
rash or hives
o
mouth sores
o
blistering or peeling of your skin
o
trouble swallowing or breathing
•
sensitivity to light or sun (photosensitivity). VFEND can cause serious photosensitivity. There is an increased chance of skin toxicity while taking VFEND. This can happen with or without taking other medicines like methotrexate. Photosensitivity reactions may also increase your risk of:
o
faster skin aging from the sun
o
skin cancer

Call your healthcare provider right away if you get a new skin rash or your skin rash gets worse.

•
kidney problems. VFEND may cause new or worse problems with kidney function, including kidney failure. Your healthcare provider should check your kidney function while you are taking VFEND. Your healthcare provider will decide if you can keep taking VFEND.
•
adrenal gland problems:
o
VFEND may cause reduced adrenal function (adrenal insufficiency).
o
VFEND may cause overactive adrenal function (Cushing’s syndrome) when voriconazole is used at the same time with corticosteroids.
 
Symptoms of adrenal insufficiency include:
o
feeling tired
o
nausea and vomiting
o
abdominal pain
o
lack of energy
o
feeling dizzy or lightheaded
o
weakness
o
weight loss

Symptoms of Cushing's syndrome include:

o
weight gain
o
thinning skin
o
excessive hair growth
o
fatty hump between the shoulders (buffalo hump) and a rounded face (moon face)
o
bruising easily
o
excessive sweating
o
darkening of the skin on the stomach, thighs, breasts, and arms
o
high blood sugar
•
inflammation of the pancreas (pancreatitis). Symptoms of pancreatitis may include pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back. The pain may happen with or without vomiting.
•
bone problems. VFEND may cause weakening of bones and bone pain. Tell your healthcare provider if you have bone pain.

Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

The most common side effects of VFEND in adults include:

o
vision changes
o
nausea
o
hallucinations (seeing or hearing things that are not there)
o
rash
o
headache
o
abnormal liver function tests
o
chills
o
vomiting
o
fast heart beat (tachycardia)
o
fever

The most common side effects of VFEND in children include:

o
fever
o
diarrhea
o
low platelet counts
o
abnormal liver function tests
o
low blood calcium levels
o
low blood phosphate levels
o
vision changes
o
rash
o
stomach pain
o
trouble breathing
o
dizziness
o
high blood pressure
o
cough
o
low blood pressure
o
swelling in the arms and legs
o
high blood sugar levels
o
headache
o
fast heart beat (tachycardia)
o
nose bleeds
o
low blood potassium levels
o
low blood levels of albumin
o
kidney problems
o
inflammation of mucous membranes
o
hallucinations (seeing or hearing things that are not there)
o
coughing up blood
o
constipation
o
low blood magnesium levels
o
fullness of the stomach area
o
vomiting
o
nausea
o
upper respiratory tract infection

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of VFEND.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VFEND?

•
Store VFEND tablets and oral suspension at room temperature between 59°F to 86°F (15°C to 30°C). Do not refrigerate or freeze.
•
VFEND oral suspension should be thrown away (discarded) after 14 days.
•
Keep VFEND tablets and oral suspension in a tightly closed container.
•
Safely throw away medicine that is out of date or no longer needed.
•
Keep VFEND, as well as all other medicines, out of the reach of children.

General information about the safe and effective use of VFEND.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VFEND for a condition for which it was not prescribed. Do not give VFEND to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about VFEND that is written for health professionals.

What are the ingredients in VFEND?
Active ingredient: voriconazole.
Inactive ingredients:
VFEND IV: sulfobutyl ether beta-cyclodextrin sodium.
VFEND tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin.
VFEND oral suspension: anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum.

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
For more information, go to www.pfizer.com or call 1-800-438-1985.

LAB-0311-23.0

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