Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Vfend. If you are concerned about side effects, discuss the risks and benefits of Vfend with your doctor.

The following side effects have been reported by at least 1% of people taking Vfend. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Diarrhea
• Fever
• headache
• itchiness
• nausea
• rash
• stomach pain
• vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bone pain
• sensations of burning, tingling, or numbness
• chest pain or tightness
• cough
• feeling faint
• difficulty breathing
• dizziness
• flu-like symptoms (e.g., fever, chills, flushing, sweating, cough)
• hallucinations (e.g., seeing, hearing, or feeling things that are not actually there)
• increased sensitivity of the skin to the sun
• joint pain
• muscle aches or pains
• irregular or rapid heartbeat
• signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of the feet and ankles)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• swelling of the hands and feet
• symptoms of liver problems (e.g., yellow eyes or skin, itching, unusual tiredness or weakness, stomach pain, nausea, vomiting)
• symptoms of low sodium levels in the blood (e.g., achy, stiff, or uncoordinated muscles; confusion; tiredness; weakness)
• tingling
• vision changes (e.g., blurry vision, colour vision change, reduced vision, increased sensitivity of the eyes to light)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of Heart Attack (e.g., sudden chest pain or pain radiating to back, down arm, or jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• symptoms of a Anaphylaxis (severe allergic reaction) (e.g., itching; skin rash or blisters; shortness of breath; difficulty breathing; swelling of the face, lips, or tongue)
• symptoms of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Vfend.

Injection
Each single-use vial of white, sterile, lyophilized powder contains voriconazole 200 mg and sulphobutylether-ß-cyclodextrin sodium (SBECD) 3,200 mg. Preservative free. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with water for injection to produce a solution containing 10 mg/mL voriconazole and 160 mg/mL of (SBECD) as a molecular inclusion complex.

Powder for Oral Suspension
White-to-off-white powder providing a white-to-off-white, orange-flavoured suspension when reconstituted. Bottles contain 3 g voriconazole in 45 g powder for oral suspension (40 mg/mL when reconstituted). Nonmedicinal ingredients: colloidal silicon dioxide, titanium dioxide, xanthan gum, sodium citrate dehydrate, sodium benzoate, anhydrous citric acid, natural orange flavour, and sucrose.

Tablets

50 mg
Each white, film-coated, round tablet, debossed with "Pfizer" on one side and "VOR50" on the other, contains voriconazole 50 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch; coating: hypromellose, lactose monohydrate, titanium dioxide, and triacetin.

200 mg
Each white, film-coated, capsule-shaped tablet, debossed with "Pfizer" on one side and "VOR200" on the other, contains voriconazole 200 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch; coating: hypromellose, lactose monohydrate, titanium dioxide, and triacetin.

Do not take voriconazole if you:

• are allergic to voriconazole or any ingredients of the medication (It is not known if people who are allergic to other "azole" antifungal medications [e.g., ketoconazole, fluconazole, and itraconazole] will also be allergic to voriconazole.)
• are also taking any of the following medications:
• astemizole
• Carbamazepine
• cisapride
• efavirenz
• ergot alkaloids (ergotamine and Dihydroergotamine)
• long-acting barbiturates (e.g., Phenobarbital)
• Pimozide
• quinidine
• rifabutin
• rifampin
• ritonavir
• Sirolimus
• St. John's wort
• terfenadine

There may be an interaction between voriconazole and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Vfend. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Vfend.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, droperidol, pimozide, gatifloxacin, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, Dolasetron mesylate, probucol, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with voriconazole. You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have Diabetes
• have had a Stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications, discuss with your doctor how Vfend may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vfend, and whether any special monitoring is needed.

Allergy: It is not clear whether people who have previously had an allergic reaction to another "azole" antifungal will have an allergic reaction to voriconazole. Make certain all medical professionals involved in your care know if you have had an allergic reaction to a different antifungal medication in this class, before taking voriconazole.

Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Infusion related problems: Reactions may occur during the infusion of the intravenous formulation of voriconazole. These include flushing, fever, sweating, rapid heart rate, chest tightness, difficulty breathing, feeling faint, nausea, itching, and rash. Report these to your doctor if they occur, as the infusion may have to be stopped.

Kidney problems: Rarely, voriconazole has been linked to developing kidney problems. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Vfend may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vfend, and whether any special monitoring is needed.

Signs of decreasing kidney function include the production of very small amounts of urine, swelling in your legs and feet, loss of appetite, nausea, vomiting, confusion and anxiousness, or excessive sleepiness. If you notice any of these, contact your doctor as soon as possible.

Lactose: Voriconazole tablets contain lactose. If you have or suspect you have galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, voriconazole tablets may worsen your condition.

Liver function: Liver disease or reduced liver function may cause Vfend to build up in the body, causing side effects. As well, voriconazole may reduce liver function and can cause liver failure. Your doctor will monitor the function of your liver while you are taking Vfend. If you have liver problems, discuss with your doctor how Vfend may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Vfend, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Vfend.

Although serious liver reactions have been rare, contact your doctor if you notice signs of liver problems such as unusual fatigue, loss of appetite, nausea or vomiting, yellowing of the skin or eyes, dark urine, or pale stools. If you have severe liver cirrhosis, voriconazole should only be used if the benefits outweigh the risks, and you should be closely monitored by your doctor while you are taking the medication.

Pancreatitis (inflammation of the pancreas): Voriconazole may cause or worsen pancreatitis. If you have a history of or are at risk for developing pancreatitis (i.e., have had chemotherapy or a stem cell transplant), you should be closely monitored by your doctor while taking Vfend. If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.

Skin reactions: In rare cases, people have had skin reactions when they have taken Vfend. If you get a skin rash that worsens, or if you experience exfoliating skin conditions such as peeling, shedding, or scaling of the skin, or any other unusual reaction of the skin, contact your doctor immediately. Your skin may also become sensitive to sunlight. Try to avoid strong sunlight while taking Vfend.

Vision changes: Voriconazole may cause blurry vision, reduced vision, colour vision change, and increased sensitivity of the eyes to sunlight. Most visual symptoms should clear up within 60 minutes. Avoid driving or operating machinery if you experience any changes in vision. Do not drive at night while taking voriconazole.

Pregnancy: Voriconazole can cause harm to the fetus when the medication is taken during pregnancy. Voriconazole should not be used during pregnancy. Women who may become pregnant should always use an effective form of birth control during treatment with voriconazole. If you become pregnant while taking Vfend, contact your doctor immediately.

Breast-feeding: It is not known if voriconazole passes into breast milk. If you are a breast-feeding mother and are taking Vfend, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Vfend have not been established for children less than 12 years of age.