(voriconazole)

Prescribing Information
Download Prescribing Information

7 DRUG INTERACTIONS

7 DRUG INTERACTIONS

Voriconazole is metabolized by cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4. Therefore, inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively. Voriconazole is a strong inhibitor of CYP3A4, and also inhibits CYP2C19 and CYP2C9. Therefore, voriconazole may increase the plasma concentrations of substances metabolized by these CYP450 isoenzymes.

Table 10 and Table 11 provide listings of clinically significant drug interactions, including contraindicated drugs [see Contraindications (4)]. Drugs listed in Table 10 and Table 11 are a guide and not considered a comprehensive list of all possible drugs and herbal products that are contraindicated or may interact with VFEND.

Table 10: Effect of Other Drugs on Voriconazole Pharmacokinetics [see Clinical Pharmacology (12.3)]

Drug/Drug Class
(Mechanism of Interaction by the Drug)
Voriconazole Plasma Exposure
(Cmax and AUCτ after 200 mg every 12 hours)
Prevention or Management Recommendations
*
Results based on in vivo clinical studies generally following repeat oral dosing with 200 mg every 12 hours voriconazole to healthy subjects
Results based on in vivo clinical study following repeat oral dosing with 400 mg every 12 hours for 1 day, then 200 mg every 12 hours for at least 2 days voriconazole to healthy subjects
Non-Nucleoside Reverse Transcriptase Inhibitors

Rifampin* and Rifabutin*
(CYP450 Induction)

Significantly Reduced

Contraindicated

Efavirenz (400 mg every 24 hours)
(CYP450 Induction)

Significantly Reduced

Contraindicated

Efavirenz (300 mg every 24 hours)
(CYP450 Induction)

Slight Decrease in AUCτ

When voriconazole is concomitantly administered with efavirenz, voriconazole oral maintenance dose should be increased to 400 mg every 12 hours and efavirenz should be decreased to 300 mg every 24 hours.

High-dose Ritonavir (400 mg every 12 hours) (CYP450 Induction)

Significantly Reduced

Contraindicated

Low-dose Ritonavir (100 mg every 12 hours) (CYP450 Induction)

Reduced

Concomitant administration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.

Carbamazepine
(CYP450 Induction)

Not Studied In Vivo or In Vitro, but Likely to Result in Significant Reduction

Contraindicated

Long Acting Barbiturates (e.g., phenobarbital, mephobarbital)
(CYP450 Induction)

Not Studied In Vivo or In Vitro, but Likely to Result in Significant Reduction

Contraindicated

Phenytoin*
(CYP450 Induction)

Significantly Reduced

Increase voriconazole maintenance dose from 4 mg/kg to 5 mg/kg IV every 12 hours or from 200 mg to 400 mg orally every 12 hours (100 mg to 200 mg orally every 12 hours in patients weighing less than 40 kg).

Letermovir
(CYP2C9/2C19 Induction)

Reduced

If concomitant administration of voriconazole with letermovir cannot be avoided, monitor for reduced effectiveness of voriconazole.

St. John's Wort
(CYP450 inducer; P-gp inducer)

Significantly Reduced

Contraindicated

Oral Contraceptives containing ethinyl estradiol and norethindrone (CYP2C19 Inhibition)

Increased

Monitoring for adverse reactions and toxicity related to voriconazole is recommended for concomitant administration with oral contraceptives.

Fluconazole (CYP2C9, CYP2C19 and CYP3A4 Inhibition)

Significantly Increased

Avoid concomitant administration of voriconazole and fluconazole. Monitoring for adverse reactions and toxicity related to voriconazole is started within 24 hours after the last dose of fluconazole.

Other HIV Protease Inhibitors
(CYP3A4 Inhibition)

In Vivo Studies Showed No Significant Effects of Indinavir on Voriconazole Exposure

No dosage adjustment in the voriconazole dosage needed for concomitant administration with indinavir.

In Vitro Studies Demonstrated Potential for Inhibition of Voriconazole Metabolism (Increased Plasma Exposure)

Frequent monitoring for adverse reactions and toxicity related to voriconazole for concomitant administration with other HIV protease inhibitors.

Other NNRTIs
(CYP3A4 Inhibition or CYP450 Induction)

In Vitro Studies Demonstrated Potential for Inhibition of Voriconazole Metabolism by Delavirdine and Other NNRTIs (Increased Plasma Exposure)

Frequent monitoring for adverse reactions and toxicity related to voriconazole.

A Voriconazole-Efavirenz Drug Interaction Study Demonstrated the Potential for the Metabolism of Voriconazole to be Induced by Efavirenz and Other NNRTIs
(Decreased Plasma Exposure)

Careful assessment of voriconazole effectiveness.

Table 11: Effect of Voriconazole on Pharmacokinetics of Other Drugs [see Clinical Pharmacology (12.3)]

Drug/Drug Class
(Mechanism of Interaction by Voriconazole)
Drug Plasma Exposure
(Cmax and AUCτ)
Prevention or Management Recommendations
*
Results based on in vivo clinical studies generally following repeat oral dosing with 200 mg BID voriconazole to healthy subjects
Results based on in vivo clinical study following repeat oral dosing with 400 mg every 12 hours for 1 day, then 200 mg every 12 hours for at least 2 days voriconazole to healthy subjects
Results based on in vivo clinical study following repeat oral dosing with 400 mg every 12 hours for 1 day, then 200 mg every 12 hours for 4 days voriconazole to subjects receiving a methadone maintenance dose (30–100 mg every 24 hours)
§
Non-Steroidal Anti-Inflammatory Drug
Non-Nucleoside Reverse Transcriptase Inhibitors

Sirolimus*
(CYP3A4 Inhibition)

Significantly Increased

Contraindicated

Rifabutin*
(CYP3A4 Inhibition)

Significantly Increased

Contraindicated

Efavirenz (400 mg every 24 hours)
(CYP3A4 Inhibition)

Significantly Increased

Contraindicated

Efavirenz (300 mg every 24 hours)
(CYP3A4 Inhibition)

Slight Increase in AUCτ

When voriconazole is concomitantly administered with efavirenz, voriconazole oral maintenance dose should be increased to 400 mg every 12 hours and efavirenz should be decreased to 300 mg every 24 hours.

High-dose Ritonavir (400 mg every 12 hours)(CYP3A4 Inhibition)

No Significant Effect of Voriconazole on Ritonavir Cmax or AUCτ

Contraindicated because of significant reduction of voriconazole Cmax and AUCτ.

Low-dose Ritonavir (100 mg every 12 hours)

Slight Decrease in Ritonavir Cmax and AUCτ

Concomitant administration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided (due to the reduction in voriconazole Cmax and AUCτ) unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.

Pimozide, Quinidine, Ivabradine
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased

Contraindicated because of potential for QT prolongation and rare occurrence of torsade de pointes.

Ergot Alkaloids
(CYP450 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased

Contraindicated

Naloxegol
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased which may Increase the Risk of Adverse Reactions

Contraindicated

Tolvaptan
(CYP3A4 Inhibition)

Although Not Studied Clinically, Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Tolvaptan

Contraindicated

Lurasidone

(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Lurasidone

Contraindicated

Finerenone

(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Finerenone

Contraindicated

Eplerenone

(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Eplerenone

Contraindicated

Voclosporin

(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Voriconazole is Likely to Significantly Increase the Plasma Concentrations of Voclosporin

Contraindicated

Venetoclax
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Venetoclax Plasma Exposure Likely to be Significantly Increased

Concomitant administration of voriconazole is contraindicated at initiation and during the ramp-up phase in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Refer to the venetoclax labeling for safety monitoring and dose reduction in the steady daily dosing phase in CLL/SLL patients.
For patients with acute myeloid leukemia (AML), dose reduction and safety monitoring are recommended across all dosing phases when concomitantly administered VFEND with venetoclax. Refer to the venetoclax prescribing information for dosing instructions.

Lemborexant
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased

Avoid concomitant use of VFEND with lemborexant.

Glasdegib
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased

Consider alternative therapies. If concomitant use cannot be avoided, monitor patients for increased risk of adverse reactions including QTc interval prolongation.

Tyrosine kinase inhibitors (including but not limited to axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib)
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased

Avoid concomitant use of VFEND. If concomitant use cannot be avoided, dose reduction of the tyrosine kinase inhibitor is recommended. Refer to the prescribing information for the relevant product.

Cyclosporine*
(CYP3A4 Inhibition)

AUCτ Significantly Increased; No Significant Effect on Cmax

When initiating therapy with VFEND in patients already receiving cyclosporine, reduce the cyclosporine dose to one-half of the starting dose and follow with frequent monitoring of cyclosporine blood levels. Increased cyclosporine levels have been associated with nephrotoxicity. When VFEND is discontinued, cyclosporine concentrations must be frequently monitored and the dose increased as necessary.

Methadone (CYP3A4 Inhibition)

Increased

Increased plasma concentrations of methadone have been associated with toxicity including QT prolongation. Frequent monitoring for adverse reactions and toxicity related to methadone is recommended when concomitantly administered with VFEND. Dose reduction of methadone may be needed.

Fentanyl (CYP3A4 Inhibition)

Increased

Reduction in the dose of fentanyl and other long-acting opiates metabolized by CYP3A4 should be considered when concomitantly administered with VFEND. Extended and frequent monitoring for opiate-associated adverse reactions may be necessary.

Alfentanil (CYP3A4 Inhibition)

Significantly Increased

An increase in the incidence of delayed and persistent alfentanil-associated nausea and vomiting were observed when concomitantly administered with VFEND. Reduction in the dose of alfentanil and other opiates metabolized by CYP3A4 (e.g., sufentanil) should be considered when concomitantly administered with VFEND. A longer period for monitoring respiratory and other opiate-associated adverse reactions may be necessary.

Oxycodone (CYP3A4 Inhibition)

Significantly Increased

Increased visual effects (heterophoria and miosis) of oxycodone were observed when concomitantly administered with VFEND.
Reduction in the dose of oxycodone and other long-acting opiates metabolized by CYP3A4 should be considered when concomitantly administered with VFEND. Extended and frequent monitoring for opiate-associated adverse reactions may be necessary.

NSAIDs§ including. ibuprofen and diclofenac
(CYP2C9 Inhibition)

Increased

Frequent monitoring for adverse reactions and toxicity related to NSAIDs. Dose reduction of NSAIDs may be needed.

Tacrolimus*
(CYP3A4 Inhibition)

Significantly Increased

When initiating therapy with VFEND in patients already receiving tacrolimus, reduce the tacrolimus dose to one-third of the starting dose and follow with frequent monitoring of tacrolimus blood levels. Increased tacrolimus levels have been associated with nephrotoxicity. When VFEND is discontinued, tacrolimus concentrations must be frequently monitored and the dose increased as necessary.

Phenytoin*
(CYP2C9 Inhibition)

Significantly Increased

Frequent monitoring of phenytoin plasma concentrations and frequent monitoring of adverse effects related to phenytoin.

Oral Contraceptives containing ethinyl estradiol and norethindrone (CYP3A4 Inhibition)

Increased

Monitoring for adverse reactions related to oral contraceptives is recommended during concomitant administration.

Prednisolone and other corticosteroids
(CYP3A4 Inhibition)

In Vivo Studies Showed No Significant Effects of VFEND on Prednisolone Exposure
Not Studied In vitro or In vivo for Other Corticosteroids, but Drug Exposure Likely to be Increased

No dosage adjustment for prednisolone when concomitantly administered with VFEND [see Clinical Pharmacology (12.3)].
Monitor for potential adrenal dysfunction when VFEND is administered with other corticosteroids [see Warnings and Precautions (5.8)].

Warfarin*
(CYP2C9 Inhibition)

Prothrombin Time Significantly Increased

If patients receiving coumarin preparations are treated simultaneously with voriconazole, the prothrombin time or other suitable anticoagulation tests should be monitored at close intervals and the dosage of anticoagulants adjusted accordingly.

Other Oral Coumarin Anticoagulants
(CYP2C9/3A4 Inhibition)

Not Studied In Vivo or In Vitro for other Oral Coumarin Anticoagulants, but Drug Plasma Exposure Likely to be Increased

Ivacaftor
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased which may Increase the Risk of Adverse Reactions

Dose reduction of ivacaftor is recommended. Refer to the prescribing information for ivacaftor.

Eszopiclone
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased which may Increase the Sedative Effect of Eszopiclone

Dose reduction of eszopiclone is recommended. Refer to the prescribing information for eszopiclone.

Mavacamten

(CYP2C19/3A4/2C9 Inhibition)

Not Studied In Vivo or In Vitro, but Mavacamten Drug Plasma Exposure Likely to be Increased which may Increase the Risk of Heart Failure

Refer to the prescribing information for mavacamten.

Omeprazole*
(CYP2C19/3A4 Inhibition)

Significantly Increased

When initiating therapy with VFEND in patients already receiving omeprazole doses of 40 mg or greater, reduce the omeprazole dose by one-half. The metabolism of other proton pump inhibitors that are CYP2C19 substrates may also be inhibited by voriconazole and may result in increased plasma concentrations of other proton pump inhibitors.

Other HIV Protease Inhibitors
(CYP3A4 Inhibition)

In Vivo Studies Showed No Significant Effects on Indinavir Exposure

No dosage adjustment for indinavir when concomitantly administered with VFEND.

In Vitro Studies Demonstrated Potential for Voriconazole to Inhibit Metabolism
(Increased Plasma Exposure)

Frequent monitoring for adverse reactions and toxicity related to other HIV protease inhibitors.

Other NNRTIs
(CYP3A4 Inhibition)

A Voriconazole-Efavirenz Drug Interaction Study Demonstrated the Potential for Voriconazole to Inhibit Metabolism of Other NNRTIs
(Increased Plasma Exposure)

Frequent monitoring for adverse reactions and toxicity related to NNRTI.

Tretinoin
(CYP3A4 Inhibition)

Although Not Studied, Voriconazole may Increase Tretinoin Concentrations and Increase the Risk of Adverse Reactions

Frequent monitoring for signs and symptoms of pseudotumor cerebri or hypercalcemia.

Midazolam
(CYP3A4 Inhibition)

Significantly Increased

Increased plasma exposures may increase the risk of adverse reactions and toxicities related to benzodiazepines.

Other benzodiazepines including triazolam and alprazolam
(CYP3A4 Inhibition)

In Vitro Studies Demonstrated Potential for Voriconazole to Inhibit Metabolism
(Increased Plasma Exposure)

Refer to drug-specific labeling for details.

HMG-CoA Reductase Inhibitors (Statins)
(CYP3A4 Inhibition)

In Vitro Studies Demonstrated Potential for Voriconazole to Inhibit Metabolism
(Increased Plasma Exposure)

Frequent monitoring for adverse reactions and toxicity related to statins. Increased statin concentrations in plasma have been associated with rhabdomyolysis. Adjustment of the statin dosage may be needed.

Dihydropyridine Calcium Channel Blockers
(CYP3A4 Inhibition)

In Vitro Studies Demonstrated Potential for Voriconazole to Inhibit Metabolism
(Increased Plasma Exposure)

Frequent monitoring for adverse reactions and toxicity related to calcium channel blockers. Adjustment of calcium channel blocker dosage may be needed.

Sulfonylurea Oral Hypoglycemics
(CYP2C9 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased

Frequent monitoring of blood glucose and for signs and symptoms of hypoglycemia. Adjustment of oral hypoglycemic drug dosage may be needed.

Vinca Alkaloids
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased

Frequent monitoring for adverse reactions and toxicity (i.e., neurotoxicity) related to vinca alkaloids. Reserve azole antifungals, including voriconazole, for patients receiving a vinca alkaloid who have no alternative antifungal treatment options.

Everolimus
(CYP3A4 Inhibition)

Not Studied In Vivo or In Vitro, but Drug Plasma Exposure Likely to be Increased

Concomitant administration of voriconazole and everolimus is not recommended.

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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